Active ingredients: Beclometasone (anhydrous beclomethasone dipropionate), Formoterol (Formoterol fumarate dihydrate)
FOSTER 100 micrograms / 6 micrograms inhalation powder
Foster package inserts are available for pack sizes:- FOSTER 100 micrograms / 6 micrograms inhalation powder
- FOSTER 100/6 micrograms per actuation pressurized solution for inhalation
Why is Foster used? What is it for?
FOSTER is a powder that is inhaled through the mouth and released directly into the lungs. Contains two active ingredients: anhydrous beclomethasone dipropionate and formoterol fumarate dihydrate.
- Anhydrous beclomethasone dipropionate belongs to a group of medicines commonly referred to as steroids (technically corticosteroids). Steroids are able to treat and prevent asthma symptoms. They have an anti-inflammatory action, thereby reducing swelling and irritation of the walls of the small airways in the lungs.
- Formoterol fumarate dihydrate belongs to a group of medicines called long-acting bronchodilators, which relax the muscles of the airways by dilating them, thus making it easier to breathe in and out of the lungs.
Together, these two active ingredients make breathing easier and also help prevent asthma symptoms, such as wheezing, wheezing and coughing.
FOSTER is used for the treatment of asthma in adults.
If you have been prescribed FOSTER it is likely that:
- "asthma is not adequately controlled using inhaled corticosteroids and short-acting" as-needed "bronchodilators
or
- asthma responds well to treatment with both corticosteroids and long-acting bronchodilators.
Contraindications When Foster should not be used
Do not use FOSTER
If you are allergic to beclomethasone dipropionate anhydrous or formoterol fumarate dihydrate or any of the other ingredients of this medicine (listed in section 6).
Precautions for use What you need to know before taking Foster
Talk to your doctor before using FOSTER if you have any of the following conditions:
- heart problems, which include any type of known disease of the heart and / or heart function
- heart rhythm disturbances, such as increased or irregular heart rate, fast pulse or palpitations, or if you have been told that your heart pattern is abnormal
- high blood pressure
- narrowing of the arteries (also known as arteriosclerosis), or if you know that you have an aneurysm (an abnormal dilation of blood vessel walls)
- overactive thyroid gland
- low levels of potassium in the blood
- any liver or kidney problems
- diabetes. If you inhale high doses of formoterol, your blood glucose levels may rise and as a result you may need to carry out additional tests to monitor your blood sugar level both when you start using this inhaler and periodically throughout the duration of treatment.
- adrenal gland tumor (called pheochromocytoma)
- if you need to undergo anesthesia. Depending on the type of anesthesia, treatment with FOSTER may need to be stopped at least 12 hours before anesthesia
- if you are taking, or have taken, medicines to treat tuberculosis (TB), or if you have known viral infections or chest fungal infections.
If any of the above apply to you, always tell your doctor before using FOSTER.
If you are not sure whether you can use FOSTER talk to your doctor, asthma nurse or pharmacist before using the inhaler.
Interactions Which drugs or foods can modify the Foster effect
Before starting treatment, tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including any inhaler and non-prescription medicines. This is necessary because Fostair can affect the way some other medicines work. Also, other medicines can affect the way Fostair works.
Do not use this medicine together with beta blockers. Beta blockers are medicines used to treat various conditions, including heart problems, high blood pressure or glaucoma (increased pressure in the eye). If you use beta-blockers (including eye drops), the effect of formoterol may be reduced or canceled.
Using Fostair together with the following medicines:
- other drugs with activity similar to that of formoterol (ie beta-adrenergic drugs, commonly used to treat asthma)
- quinidine, disopyramide, procainamide (to treat abnormal heart rhythms)
- some antihistamines, for example terfenadine (to treat allergic reactions)
- monoamine oxidase inhibitors or tricyclic antidepressants, for example phenelzine, isocarboxazide, amitriptyline and imipramine; phenothiazines (to treat depression or mental disorders)
- L-DOPA (for the treatment of Parkinson's disease)
- L-thyroxine (to treat an underactive thyroid)
- Medicines containing oxytocin (which causes uterine contractions)
- Monoamine oxidase inhibitors (MAOIs) (for the treatment of mental disorders), including drugs with properties similar to furazolidone and procarbazine
- digoxin (to treat heart disease)
- Other medicines to treat asthma (theophylline, aminophylline or steroids)
- diuretics (tablets to urinate)
- Some anesthetics
FOSTER with alcohol
You should avoid consuming alcohol without first talking to your doctor. Alcohol can lower heart tolerance to one of the active substances in FOSTER, formoterol.
Warnings It is important to know that:
Do not take this medicine to treat acute asthma symptoms such as wheezing, wheezing and coughing or if your asthma is getting worse or to treat acute asthma attacks. To treat your symptoms you should use your fast-acting "reliever" inhaler which you should always carry with you.
Your doctor may decide to periodically measure your blood potassium levels, especially if your asthma is severe. Like many bronchodilators, FOSTER can cause a sharp drop in serum potassium levels (hypokalaemia). This is because a reduction in oxygen in the blood associated with some other treatments taken together with Fostair can make the reduction in potassium levels worse.
If you have been taking high doses of inhaled corticosteroids for long periods of time, you may need more corticosteroids in stressful situations. Stressful situations may include being hospitalized following an accident, having sustained serious injuries or the period before a "surgery. In such cases, your doctor will decide whether or not to increase your corticosteroid dosage and may prescribe steroids in tablets or steroids for injection.
If you need to be hospitalized, remember to take all your medicines and inhalers, including FOSTER and any medicines or tablets bought without a prescription, in their original packaging, if possible.
Children and adolescents
This medicine should not be given to children and adolescents under the age of 18.
Pregnancy and breastfeeding
There are no clinical data on the use of Fostair during pregnancy.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine. Fostair should only be used during pregnancy if your doctor advises you to do so. Your doctor will decide whether you should stop taking FOSTER while breastfeeding or whether you should take FOSTER but refrain from breastfeeding. Always follow your doctor's advice carefully.
Driving and using machines
Fostair is unlikely to affect your ability to drive or use machines. However, if you notice side effects such as dizziness and / or tremor, your ability to drive or use machines may be impaired.
FOSTER contains lactose
The lactose excipient contains small amounts of milk proteins, which can cause reactions in allergic patients.
For those who play sports:
The use of the drug without therapeutic necessity constitutes doping and can in any case determine positive anti-doping tests.
Dose, Method and Time of Administration How to use Foster: Posology
Always use this medicine exactly as your doctor or pharmacist has told you. If in doubt, consult your doctor or pharmacist.
FOSTER delivers an extra-fine powder, which allows more of the drug contained in the dose to reach the lungs. Your doctor may then prescribe you a lower dose of this inhalation medication than you were taking with other inhalers.
Your doctor will monitor you regularly to make sure you are taking the correct dose of Fostair. Once your asthma is well controlled, your doctor may deem it appropriate to gradually reduce the dose of Fostair. Under no circumstances should you change the dose without first consulting your doctor.
How much FOSTER to use:
Adults and the elderly:The recommended dose of this medicine is 1 or 2 inhalations twice a day.
The maximum daily dose is 4 inhalations.
Do not increase the dose.
If you think the medicine is not working, always talk to your doctor before increasing the dose.
Remember: you should always carry your fast-acting "rescue" inhaler with you to treat a worsening of symptoms or a sudden asthma attack.
How to use FOSTER:
FOSTER is for inhalation use. In this pack you will find an inhaler, called Nexthaler, enclosed in a heat-sealed protective pouch, which contains the medicine in the form of a powder. The Nexthaler inhaler allows you to inhale the medicine.
If possible, stand or sit upright as you inhale.
If you forget to use FOSTER
Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the next one at the correct time. Do not take a double dose.
If you stop taking Fostair:
Even if you feel better, do not stop using FOSTER or decrease its dosage. If you intend to do this, talk to your doctor. It is very important that Fostair is used every day, as prescribed by your doctor, even if you have no symptoms.
If your breathing remains unchanged:
If your symptoms do not improve after inhaling FOSTER, you may be using the device incorrectly. Therefore check the instructions for proper use of the device at the end of this leaflet and / or contact your doctor to explain how to use it properly.
If your asthma gets worse:
If your symptoms get worse or are difficult to control (for example if you use your "reliever" inhaler more frequently), or if your "reliever" inhaler does not improve your symptoms, you should continue to use FOSTER but contact your doctor. doctor as soon as possible. Your doctor may decide to change your dose of Fostair or prescribe an additional or alternative treatment.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Overdose What to do if you have taken too much Foster
- Contact your doctor or the nearest hospital emergency department immediately for advice. Take the medicine with you so that the healthcare professional can understand which medicine you have taken;
- Undesirable effects may occur. Tell your doctor if you notice any unusual symptoms, as you may need to investigate further or take any necessary treatment measures.
Side Effects What are the side effects of Foster
Like all medicines, this medicine can cause side effects, although not everybody gets them.
As with other inhaled treatments, there is a risk of worsening wheezing, coughing and wheezing immediately after using FOSTER, and this is referred to as paradoxical bronchospasm. If this occurs, you should STOP using it immediately. of FOSTER and use your fast-acting 'reliever' inhaler as soon as possible to treat your symptoms. You should contact your doctor immediately.
Tell your doctor immediately if you have any allergic reactions, which include skin allergies, itchy skin, rash, red skin, swelling of the skin or mucous membranes, especially of the eyes, face, lips and throat.
Further possible side effects of Fostair are listed below in order of frequency.
Contact your doctor or pharmacist immediately:
- if you experience any of the side effects listed below and if these effects cause you distress or are severe in intensity or persist for several days
- if he is worried for some reason or if there is something he does not understand.
Your doctor will assess your degree of asthma and start another course of treatment if necessary. You may be told not to use FOSTER again.
Common (may affect up to 1 in 10 people):
- tremor.
Uncommon (may affect up to 1 in 100 people):
- cold symptoms, sore throat
- fungal infections (of the mouth and throat). Rinsing your mouth or gargle with water and brushing your teeth immediately after inhalation can help prevent these side effects.
- worsening of asthma symptoms, difficulty breathing
- hoarseness
- cough
- unusually fast heartbeat
- unusually slow heartbeat
- oppressive pain in the chest
- headache
- feeling of being unwell
- feeling tired or nervous
- alteration in the electrocardiogram (ECG)
- low level of cortisol in the urine or blood
- high level of potassium in the blood
- high blood glucose level
- high level of fat in the blood.
Side effects seen with similar inhaled medicinal products containing beclomethasone dipropionate and / or formoterol are:
- palpitations
- uneven heartbeat
- abnormal or altered taste
- muscle pain and muscle cramps
- restlessness, dizziness
- feeling anxious
- sleep disorders
- drop in the level of potassium in the blood.
The use of inhaled corticosteroids in high doses and for long periods of time can cause systemic effects, including:
- disturbances in the function of the adrenal glands (adrenal suppression)
- thinning of the bones
- growth retardation in children and adolescents
- increased pressure in the eye (glaucoma), cataracts
- rapid weight gain, particularly in the face and torso
- sleep disturbances, depression or worry, agitation, nervousness, overexcitation or irritability. These effects are more likely to occur in children
- Abnormal behavior.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
Expiry and Retention
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton, envelope and label after EXP. The expiry date refers to the last day of that month.
Store in the original package to protect from moisture. Remove the inhaler from its protective pouch only immediately before its first use.
Before opening the pouch for the first time: This medicine does not require any particular storage temperatures.
After first opening the pouch: Do not store above 25 ° C. After first opening the sachet, the medicine must be used within 6 months.
Use the label on the box to write the date the envelope was opened.
Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
Other_information "> Other information
What FOSTER contains
The active ingredients are: anhydrous beclomethasone dipropionate and formoterol fumarate dihydrate.
Each pre-dispensed dispensing contains 100 micrograms of anhydrous beclomethasone dipropionate and 6 micrograms of formoterol fumarate dihydrate. This corresponds to an inhaled dose delivered through the mouthpiece of 81.9 micrograms of anhydrous beclomethasone dipropionate and 5 micrograms of formoterol fumarate dihydrate.
The other ingredients are: lactose monohydrate (which contains small amounts of milk proteins) and magnesium stearate.
Description of what FOSTER looks like and contents of the pack
This medicine comes as a white or almost white inhalation powder contained in a plastic inhaler called Nexthaler.
Each pack contains one, two or three inhalers providing 120 inhalations each.
Each inhaler is packaged in a heat-sealed protective pouch (aluminum foil packaging).
Not all pack sizes may be marketed.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT -
FOSTER 100 MCG / 6 MCG POWDER FOR INHALATION
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION -
Each delivered dose of 10 mg of inhalation powder contains:
100 mcg of anhydrous beclomethasone dipropionate and 6 mcg of formoterol fumarate dihydrate.
This is equivalent to an inhaled dose of 81.9 mcg of anhydrous beclomethasone dipropionate and 5.0 mcg of formoterol fumarate dihydrate.
Excipient (s) with known effects:
Each inhalation contains 9.9 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM -
Powder for inhalation.
The multidose inhaler contains a white or almost white powder.
04.0 CLINICAL INFORMATION -
04.1 Therapeutic indications -
Asthma
FOSTER is indicated in the regular treatment of asthma when the use of a combination product (inhaled corticosteroids and long-acting beta2-agonists) is appropriate:
- in patients inadequately controlled on inhaled corticosteroids and inhaled short-acting beta2-agonists used "as needed" or
- in patients who are already adequately controlled on both inhaled corticosteroids and long-acting beta2-agonists.
Fostair is indicated in adult patients.
Note: Significant clinical data on the use of FOSTER for the treatment of acute asthma attacks are not available.
COPD
Symptomatic treatment of patients with severe COPD (FEV1 history of repeated exacerbations, with the presence of significant symptoms despite regular therapy with long-acting bronchodilators.
04.2 Posology and method of administration -
FOSTER is for inhalation use.
ASTHMA
The dosage of FOSTER is on an individual basis and must be adapted in relation to the severity of the disease. This should be taken into consideration not only when initiating treatment with the combination, but also when the dosage is changed. Should a patient require a combination of doses other than those available with the fixed combination, the appropriate doses of beta2-agonists and / or corticosteroids should be prescribed in separate inhalers.
As FOSTER is characterized by a distribution of extrafine particles, a dosage adjustment is necessary when a patient switches from a formulation with a distribution of non-extrafine particles to FOSTER inhalation powder. When patients switch from previous treatments, it should be considered that the recommended total daily dose of beclomethasone dipropionate for FOSTER inhalation powder is lower than current non-extrafine particle products containing beclomethasone dipropionate and should be tailored to the individual patient's need. . However, patients switching from FOSTER pressurized inhalation solution to FOSTER inhalation powder do not require dosage adjustments.
Recommended dosage for adults from 18 years of age:
One or two inhalations twice a day.
The maximum daily dose is 4 inhalations per day.
Recommended dosage for children and adolescents under 18 years of age :
The safety and efficacy of FOSTER in children and adolescents under 18 years of age have not yet been established. No data are available in children up to 11 years of age. Currently available data in adolescents aged between 12 and 17 years are described in sections 4.8 and 5.1, but no recommendation on a posology can be made.
Patients should be monitored regularly by their doctor to ensure that the dosage of Fostair remains optimal and that it is only changed on the advice of the doctor. Dosage should be adjusted to the lowest dose capable of maintaining effective symptom control. Once symptom control is achieved with the lowest recommended dosage, inhaled corticosteroid alone can be tried as the next step.
Patients should be advised to take Fostair every day, even when asymptomatic.
COPD
Recommended dosage for adults from 18 years of age:
Two inhalations twice a day.
Special patient groups
There is no need to adjust the dosage in elderly patients.
There are no data available on the use of Fostair in patients with impaired hepatic or renal function (see section 5.2)..
Method of administration
Nexthaler is a breath-activated inhaler. Patients with moderate and severe asthma and COPD patients have been shown to be able to produce sufficient inspiratory flow to trigger dose delivery from Nexthaler (see section 5.1). The delivery of FOSTER with Nexthaler is independent of the inspiratory flow, in the range of values that this patient population is able to reach through the inhaler.
Correct use of the Nexthaler inhaler is essential for successful treatment. The patient should be advised to read the Package Leaflet carefully and follow the instructions for use described therein. For the convenience of the prescriber these instructions are given in section 6.6.
Whenever possible, patients should stand or sit upright when inhaling.
With Nexthaler, the dose is made available for inhalation only when the cap is on completely open. Opening the cap, inhaling and closing the cap in sequence guide the dose counter mechanism. The patient should be instructed to reclose completely the hood every time. The number of doses visible in the indicator window located in the lower part of the external body of the inhaler does not decrease when the cap is closed again if the patient has not inhaled through the inhaler.
The patient should be instructed to open the inhaler cap only when necessary. If the patient has opened the inhaler but has not inhaled, and the cap is then closed, the dose is returned to the powder reservoir inside. of the inhaler; the next dose can safely be inhaled.
Optimal pulmonary distribution can be achieved if the patient inhales while inhaling quickly and deeply through the inhaler. It is recommended to hold the breath for 5-10 seconds (or as comfortable as it is for the patient) before exhaling.
The patient should be advised to avoid exhaling through the Nexthaler inhaler before or after inhaling the dose, as this may impair the proper functioning of the inhaler.
After each inhalation, patients should rinse their mouth or gargle with water or brush their teeth (see section 4.4).
04.3 Contraindications -
Hypersensitivity to beclomethasone dipropionate, formoterol fumarate dihydrate or to any of the excipients listed in section 6.1.
04.4 Special warnings and appropriate precautions for use -
It is recommended to gradually reduce the dose when stopping treatment; treatment should therefore not be stopped abruptly.
Treatment of asthma should be performed normally on a gradual schedule, and the patient's response should be monitored both clinically and by respiratory function tests.
Physician caution should be exercised if the patient does not find the treatment effective. The increased use of emergency bronchodilators indicates a worsening of the underlying condition and justifies a reassessment of asthma therapy. Sudden and progressive worsening of asthma control is potentially life-threatening and the patient should be urgently evaluated. The need for increased treatment with inhaled or oral corticosteroids should be considered, or start antibiotic treatment if infection is suspected.
Patients should not start FOSTER during an exacerbation or if they have significantly worsening or acute deterioration of asthma. Serious asthma-related adverse events and exacerbations may occur during treatment with Fostair. Patients should be asked to continue treatment but to seek medical advice if asthma symptoms remain uncontrolled or if they worsen after starting FOSTER.
As with other inhalation therapies, paradoxical bronchospasm may occur, with an immediate increase in wheezing, cough and dyspnoea after administration. This should be treated immediately by inhalation with a fast acting bronchodilator. Fostair should be discontinued immediately and the patient evaluated and subjected to alternative therapy if necessary.
Fostair should not be used as initial asthma therapy.
Patients should be advised to keep their short-acting bronchodilator on hand for the treatment of acute asthma attacks at all times.
Patients should be reminded to take Fostair daily as prescribed, even when asymptomatic.
When asthma symptoms are under control, consideration may be given to gradually reducing the dose of Fostair. It is important to check patients regularly if treatment is reduced. The lowest effective dose of Fostair should be used (see section 4.2).
Pneumonia in COPD patients
An increased incidence of pneumonia, including pneumonia requiring hospitalization, has been observed in COPD patients treated with inhaled corticosteroids. There is some evidence of an increased risk of pneumonia with increasing steroid dose but this has not been conclusively demonstrated by studies. There is no conclusive clinical evidence of intra-class differences in the magnitude of the risk. of pneumonia among inhaled corticosteroids. Physicians must remain vigilant for the possible development of pneumonia in COPD patients as the clinical manifestations of this type of infections overlap with the symptoms of COPD exacerbations.
Risk factors for pneumonia in COPD patients include smoking, older age, low body mass index (BMI), and severe COPD.
Systemic effects may occur with inhaled corticosteroids, particularly when prescribed in high doses for prolonged periods. These effects are less likely to occur than with treatment with oral corticosteroids. Possible systemic effects include: Cushing's syndrome, Cushingoid appearance, adrenal suppression, growth retardation in children and adolescents, decreased bone mineral density, cataracts, glaucoma and, more rarely, a range of psychological or behavioral effects including psychomotor hyperactivity , sleep disturbances, anxiety, depression or aggression (particularly in children). Therefore it is important that the dose of inhaled corticosteroid is adjusted to the lowest dose at which effective asthma control is maintained.
The use of high-dose inhaled corticosteroids for long periods can cause adrenal suppression and acute adrenal crisis. Children and adolescents under the age of 16 who inhale higher than recommended doses of beclomethasone dipropionate may be particularly at risk. situations that can potentially trigger acute adrenal crises include trauma, surgery, infection, or any other case involving a rapid reduction in dosage. Symptoms that arise are typically vague and may include anorexia, abdominal pain, weight loss, fatigue, headache, nausea, vomiting, hypotension, decreased level of consciousness, hypoglycemia and seizures. The need for additional systemic corticosteroid coverage during periods of stress or elective surgery should be considered.
Patients who have been transferred from oral to inhaled corticosteroid therapy may remain at risk of worsening adrenal reserve for a considerable period of time. Patients who have previously required high-dose emergency corticosteroids in an emergency or who have been treated for a prolonged period with high-dose inhaled corticosteroids may also be at risk. The possibility of residual impairment in emergency or elective stress-producing situations should always be considered, and appropriate corticosteroid treatment should be considered. The extent of adrenal impairment may require specialist advice before to adopt specific procedures.
Fostair should be administered with caution to patients with active or quiescent pulmonary tuberculosis and viral and fungal infections of the respiratory tract.
Fostair should be used with caution (which may include monitoring) in patients with cardiac arrhythmia, especially in cases of third degree atrioventricular block and tachyarrhythmia, idiopathic subvalvular aortic stenosis, hypertrophic obstructive myocardiopathy, cardiac ischaemia, severe heart failure, severe arterial hypertension and aneurysm.
Caution should also be exercised when treating patients with known or suspected prolongation of the QTc interval, whether congenital or drug-induced (QTc> 0.44 seconds). Formoterol itself can cause prolongation of the QTc interval.
Caution is also required when Fostair is used by patients with thyrotoxicosis, diabetes mellitus, pheochromocytoma and untreated hypokalaemia.
Therapy with β2-agonist medicinal products can result in potentially severe hypokalaemia. Particular caution should be exercised in patients with severe asthma as this effect may be potentiated by hypoxia. Hypokalaemia may also be potentiated by concomitant treatments with other medicinal products that can induce hypokalaemia, such as xanthine derivatives, steroids and diuretics (see section 4.5). Caution is also recommended in "unstable asthma, when certain" rescue "bronchodilators may be used. It is recommended that serum potassium levels be monitored in these cases.
Inhalation of formoterol can cause an increase in blood glucose levels. Consequently, blood glucose should be monitored constantly in diabetic patients.
If anesthesia with halogenated anesthetics is to be performed, it must be ensured that FOSTER is not administered for at least 12 hours before the start of anesthesia, as there is a risk of cardiac arrhythmias.
Patients should be advised to rinse their mouth or gargle with water or brush their teeth after inhaling the prescribed dose to minimize the risk of oropharyngeal fungal infections and dysphonia.
Lactose contains small amounts of milk proteins, which can cause allergic reactions.
04.5 Interactions with other medicinal products and other forms of interaction -
Pharmacokinetic interactions
Beclomethasone dipropionate metabolizes very rapidly via esterase enzymes without involvement of the cytochrome P450 system.
Pharmacodynamic interactions
The use of beta-blockers (including eye drops) should be avoided in patients with asthma. If beta-blockers are given for compelling reasons, the effect of formoterol will be reduced or canceled.
The use of other beta-adrenergic drugs may result in potentially additive effects, therefore caution is required when prescribing theophylline or other beta-adrenergic drugs concurrently with formoterol.
Concomitant treatment with quinidine, disopyramide, procainamide, phenothiazines, some antihistamines (eg terfenadine), monoamine oxidase inhibitors and tricyclic antidepressants can cause prolongation of the QTc interval and increase the risk of ventricular arrhythmias.
Furthermore, L-dopa, L-thyroxine, oxytocin and alcohol can alter cardiac tolerance towards beta-2 sympathomimetics.
Concomitant treatment with monoamine oxidase inhibitors, including agents with similar properties such as furazolidone and procarbazine, can precipitate hypertensive reactions.
There is a high risk of arrhythmias in patients undergoing simultaneous halogenated hydrocarbon anesthesia.
Concomitant treatment with xanthine derivatives, steroids or diuretics may potentiate a possible hypokalaemia effect of beta2-agonists (see section 4.4). In patients treated with digitalis glycosides, hypokalaemia may increase the predisposition to arrhythmias.
04.6 Pregnancy and breastfeeding -
Fertility
No human data are available. In studies performed in rats, the presence of high dose beclomethasone dipropionate in combination treatment was associated with reduced female fertility and embryotoxicity (see section 5.3).
Pregnancy
There are no relevant clinical data on the use of FOSTER in pregnant women. Animal studies with the combination of beclometasone dipropionate and formoterol have shown signs of reproductive and fetal toxicity after high systemic exposure (see section 5.3). High doses of corticosteroids administered to pregnant animals are known to cause abnormalities in fetal development, including cleft palate, and intrauterine growth retardation. Due to the tocolytic effect of beta2-sympathomimetic agents, particular caution should be exercised during labor. The use of formoterol is not recommended during pregnancy, and particularly late pregnancy or during labor, unless there is no other (and safer) alternative available. Fostair should only be used during pregnancy if the expected benefits outweigh the potential risks.
Feeding time
There are no relevant clinical data on the use of FOSTER during lactation in humans.
Although there are no data from animal studies, it is reasonable to assume that beclomethasone dipropionate is excreted in breast milk, like other corticosteroids..
While it is not known whether formoterol passes into human breast milk, it has been detected in animal milk.
The administration of Fostair to women during breastfeeding should be considered if the expected benefits outweigh the potential risks.A decision must be made whether to discontinue breast-feeding or to discontinue / abstain from FOSTER therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
04.7 Effects on ability to drive and use machines -
Fostair has no or negligible influence on the ability to drive and use machines.
04.8 Undesirable effects -
The most common adverse reaction was tremor. In a 12-week clinical study with FOSTER, tremor was observed only with the higher dose regimen (2 inhalations twice daily), and occurred more frequently at initiation of treatment and with mild intensity. No patient had to discontinue the study due to tremor.
Experience in clinical trials with asthma patients
The safety of FOSTER was evaluated in clinical trials with the active drug compared to placebo in which 719 patients 12 years of age and older with asthma of varying severity were exposed to the drug. The incidence of adverse reactions shown in the table below refers to asthma patients aged 12 years and older, and is based on safety data from two pilot clinical studies in which FOSTER was administered at the doses recommended in this SmPC. for a period of 8 to 12 weeks No psychiatric disorders were observed in clinical trials with FOSTER, but these were nevertheless reported in the table as a potential class effect of inhaled corticosteroids.
Undesirable effects that have been related to beclomethasone dipropionate and formoterol in fixed combination (FOSTER) are listed below, listed by system organ class. Frequencies were defined as: very common (≥ 1/10), common (≥ 1/100,
Among the adverse reactions observed, those typically associated with formoterol are: tremor, headache, tachycardia, sinus bradycardia, angina pectoris, myocardial ischaemia, prolongation of the QT interval.
Among the adverse reactions observed, those typically associated with beclomethasone dipropionate are: nasopharyngitis, oral candidiasis, dysphonia, throat irritation, irritability, decreased urinary free cortisol, decreased serum cortisol, increased serum glucose levels.
Additional adverse reactions, not observed in clinical experience with FOSTER but typically associated with inhaled beclomethasone dipropionate, include other oral fungal infections and pneumonia. Taste disturbances have occasionally been reported during inhaled corticosteroid therapy.
Regarding the measures to be taken to minimize the occurrence of oral fungal infections, oral candidiasis and dysphonia, see section 4.4.
Systemic effects of inhaled corticosteroids (e.g. beclomethasone dipropionate) may occur particularly when high doses of the drug are given over long periods of time, and may include: Cushing's syndrome, Cushingoid appearance, adrenal suppression, decreased bone mineral density , growth retardation in children and adolescents, cataracts and glaucoma (see also section 4.4).
Additional adverse reactions, not observed in clinical experience with FOSTER at therapeutic doses but typically associated with the administration of beta2-agonists such as formoterol, are palpitations, atrial fibrillation, ventricular extrasystoles, tachyarrhythmia, potentially severe hypokalaemia and increase / decrease in blood pressure Insomnia, dizziness, restlessness and anxiety have occasionally been reported during inhalation therapy with formoterol Formoterol may also induce muscle cramps, myalgia.
Hypersensitivity reactions including rash, hives, itching, erythema and edema of the eyes, face, lips and throat (angioedema) have also been observed.
As with other inhalation therapies, paradoxical bronchospasm may occur, with an immediate increase in wheezing, cough and dyspnoea after inhalation (see also section 4.4).
Pediatric population
There is no information available on the safety of Fostair in children up to 11 years of age, and there is only limited information for adolescents aged 12 to 17 years. In a 12-week randomized clinical trial in adult and adolescent patients, 162 adolescents 12 to 17 years of age with moderate to severe asthma received FOSTER or the corresponding pressurized inhalation solution formulation, at dose of 1 or 2 inhalations twice a day; frequency, type and severity of adverse drug reactions did not appear different in adolescents than in adults.
Reporting of suspected adverse reactions
Reporting of suspected adverse reactions occurring after authorization of the medicinal product is important as it allows continuous monitoring of the benefit / risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system. "address: www.agenziafarmaco.gov.it/it/responsabili.
04.9 Overdose -
The highest recommended dose of Fostair for a single administration is 2 inhalations. Four cumulative inhalations of FOSTER were studied in asthmatic patients (for a total of 400 mcg beclomethasone dipropionate and 24 mcg formoterol in a single administration). The cumulative treatment did not cause abnormalities, clinically relevant effects on vital signs, reactions serious or non-serious adverse events (see also section 4.8).
As regards the pressurized solution formulation for inhalation, inhalation doses of up to twelve cumulative deliveries (for a total of 1200 mcg of beclomethasone dipropionate and 72 mcg of formoterol) have been studied in asthmatic patients. These cumulative treatments did not cause abnormalities on vital signs, nor serious or non-serious adverse reactions.
Excessive doses of formoterol may lead to effects that are typical of beta-2 adrenergic agonists: nausea, vomiting, headache, tremor, somnolence, palpitations, tachycardia, ventricular arrhythmia, QTc interval prolongation, metabolic acidosis, hypokalaemia, hyperglycaemia.
In case of formoterol overdose, supportive and symptomatic treatment is indicated. In severe cases, hospitalization is required. The use of cardioselective beta-blockers may be considered, but only with extreme caution as they can cause bronchospasm. Serum potassium should be monitored.
Acute inhalations of beclomethasone dipropionate at higher than recommended dosages may result in temporary suppression of adrenal function. In this case, emergency actions are not necessary, as the adrenal function is restored in a few days, as has been verified by the plasma cortisol measurements. In these patients, treatment should be continued with doses sufficient to control asthma.
Chronic overdose of inhaled beclomethasone dipropionate: risk of adrenal suppression (see section 4.4). Monitoring of the adrenal reserve may be necessary. Treatment should be continued with a dosage sufficient to control asthma.
Single supratherapeutic doses of up to 800 mcg beclomethasone dipropionate and 48 mcg formoterol administered via FOSTER inhalation powder were generally safe and well tolerated.
05.0 PHARMACOLOGICAL PROPERTIES -
05.1 "Pharmacodynamic properties -
Pharmacotherapeutic group: Adrenergics, inhalants: formoterol and other drugs for obstructive airway diseases.
ATC code: R03AK08.
Mechanisms of action and pharmacodynamic effects
FOSTER contains beclomethasone dipropionate and formoterol in a dry powder formulation, which allows for an extra-fine aerosol with a mass median aerodynamic diameter (MMAD) averaging 1.4-1.5 microns and co-deposition of the two components. The aerosol particles of FOSTER are on average much smaller than the particles delivered in the non-extra-fine formulations.
A radiolabelled drug deposition study performed in asthmatic patients demonstrated that a "high portion of the drug (estimated at 42% of the nominal dose) is deposited in the lungs, with homogeneous deposition across the respiratory tract. These delivery characteristics support the" use of a low dose corticosteroid with enhanced local pharmacodynamic effects, which were found to be equivalent to the corresponding pressurized inhalation solution (see Clinical experience).
The two active ingredients of FOSTER have different modes of action. As with other combinations of inhaled corticosteroids and beta2-agonists, additive effects are observed in relation to the reduction of asthma exacerbations.
Beclomethasone dipropionate
Beclomethasone dipropionate administered by inhalation, at recommended doses, has anti-inflammatory activity typical of glucocorticoids in the lung, with consequent reduction of symptoms and exacerbations of asthma, and less onset of adverse effects compared to systemic administration of corticosteroids.
Formoterol
Formoterol is a selective beta-2-adrenergic agonist that produces relaxation of bronchial smooth muscle in patients with reversible airway obstructions. The bronchodilator effect sets in rapidly, within 1-3 minutes after inhalation, and lasts for 12 hours after a single dose.
Clinical experience
The efficacy of the two components of FOSTER inhalation powder was compared in three different studies comparing the 100 mcg / 6 mcg pressurized inhalation solution formulation in the treatment of patients with moderate to severe persistent asthma. Overall. , in clinical practice an equivalent efficacy of the two inhaled drugs is expected both at the dose of 1 and 2 inhalations twice a day.
In one study, the primary objective was to evaluate the efficacy of the inhaled corticosteroid component as measured by bronchodilation (pre-dose FEV1). Clinically significant improvement in pre-dose FEV1 from baseline was observed in 696 patients with moderate to severe symptomatic asthma at the end of a 3-month treatment period, at a dose of 1 inhalation twice daily and 2 inhalations twice. times a day with both formulations. A mean increase of at least 250 mL was observed. There was no clinically relevant difference in pre-dose FEV1 between FOSTER inhalation powder and pressurized inhalation solution at either strength. A significant dose-response relationship was observed for the morning peak expiratory flow (PEF). Statistical significance for the dose-response relationship for pre-dose FEV1 was not reached. Measurements related to asthma control, such as the morning and evening asthma symptom scores and the percentage of symptom-free days, showed a significant improvement from baseline during and through to the end of the treatment period, in particularly for the two highest doses of both formulations.
In the second study, the primary objective was to evaluate the efficacy of the long-acting beta2-agonist component of FOSTER. In this study, bronchodilation was measured at initiation and up to 12 hours after single dose administration. through spirometric series evaluations of FEV1 (AUC for FEV1 relative to at least 80% of the duration of action of formoterol). One inhalation and four inhalations of both formulations of FOSTER significantly improved FEV1 AUC0-12 compared to placebo. Both doses of FOSTER inhalation powder appeared to be non-inferior to the corresponding dose of the pressurized inhalation solution. A relationship was found. statistically significant dose response between low and high dose with both formulations.
In the third study, after a 4-week pre-treatment phase with the fixed combination beclomethasone dipropionate / formoterol pressurized inhalation solution at a dose of 1 inhalation twice daily, 755 patients with stabilized asthma were randomized to receive treatment lasting of 8 weeks with the same inhaler already in use, with FOSTER inhalation powder or with beclomethasone dipropionate 100 mcg inhalation powder, all administered at a dose of 1 inhalation twice a day. The primary objective was the change from baseline and for the duration of the entire treatment period of morning mean expiratory flow (PEF). After 8 weeks of treatment there was no difference in the primary endpoint between the two combination inhalers, which were significantly better than beclomethasone dipropionate in monotherapy. No difference was found between the two combination inhalers in terms of symptom measurement, such as the score on the asthma control questionnaire and the number of days without rescue medication.
Finally, an open-label placebo study was carried out to verify that the inspiratory flow that can be generated through the Nexthaler inhaler is not influenced by the age, pathologies and severity of the patient's pathology, and therefore the activation and delivery. of the drug through the device may be within reach of all patients. The primary endpoint was the percentage of patients in each age and disease group capable of activating the inhaler. Eighty-nine patients, aged 5 to 84 years, including patients with moderate and severe asthma (FEV1> 60% and ≤ 60% predicted, respectively), and patients with moderate and severe COPD (FEV1 ≥ 50% and
In a further open-label placebo study, which evaluated the inspiratory flow profile via inhalation of FOSTER, patients with mild to severe COPD were shown to be able to effectively activate and use the device independently their degree of functional limitation.
Pediatric population
The European Medicines Agency has deferred the obligation to submit the results of asthma studies with FOSTER in subsets of the pediatric population aged 5 to 11 and 12 to 17 years.
At the time of writing, there is no clinical experience with FOSTER in children aged 5 to 11 years, and there is only limited information in adolescents aged 12 to 17 years.
In a 3-month randomized clinical trial, 162 adolescents aged 12-17 years diagnosed with moderate to severe asthma received FOSTER or the corresponding pressurized inhalation solution formulation, at a dose of 1 or 2 inhalations twice daily. day. The change in pre-dose FEV1 at the end of treatment appeared greater in adolescents than in adults.
For information on pediatric use see also sections 4.2 and 4.8.
05.2 "Pharmacokinetic properties -
Beclomethasone dipropionate
Beclomethasone dipropionate is a prodrug with a weak binding affinity to the glucocorticoid receptor, which is hydrolyzed via the esterase enzymes to the active metabolite beclomethasone-17-monopropionate, which has a more potent topical anti-inflammatory activity than the prodrug beclomethasone dipropionate.
Absorption, distribution and metabolism
Inhaled beclomethasone dipropionate is rapidly absorbed through the lungs; before absorption it is extensively transformed into its active metabolite, beclomethasone-17-monopropionate, by esterase enzymes found in several tissues. The systemic availability of the active metabolite originates from the lungs and from the gastrointestinal absorption of the swallowed dose . The bioavailability of swallowed beclomethasone dipropionate is negligible, however, pre-systemic conversion to beclomethasone-17-monopropionate results in part of the dose being absorbed as an active metabolite.
As the inhaled dose increases, systemic exposure increases approximately linearly.
Absolute bioavailability after inhalation from a pressurized metered dose inhaler is approximately 2% and 62% of the nominal dose for unmodified beclomethasone dipropionate and beclomethasone-17-monopropionate, respectively.
Following intravenous administration, the distribution of beclomethasone dipropionate and its active metabolite is characterized by high plasma clearance (150 and 120 l / h, respectively), with a small steady-state volume of distribution for beclomethasone dipropionate (20 l ) and a more extensive tissue distribution for its active metabolite (424 L.) Beclomethasone dipropionate is metabolised mainly (82%) to its active metabolite, beclomethasone-17-monopropionate.
Plasma protein binding is moderately high (87%).
Excretion
Faecal excretion is the major route of elimination of beclometasone dipropionate, essentially as polar metabolites. Renal excretion of beclometasone dipropionate and its metabolites is negligible. The terminal elimination half-lives are 0.5 hours and 2.7 hours for beclomethasone dipropionate and beclomethasone-17-monopropionate, respectively.
Special populations
The pharmacokinetics of beclomethasone dipropionate in patients with renal or hepatic impairment have not been studied; however, since beclomethasone dipropionate undergoes rapid metabolism by esterase enzymes present in intestinal fluid, serum, lungs and liver to give rise to the more polar products beclomethasone-21-monopropionate, beclomethasone-17-monopropionate and beclomethasone, the pharmacokinetics and safety profile of beclomethasone dipropionate are not expected to be affected by hepatic impairment.
Since neither beclomethasone dipropionate nor its metabolites were detected in the urine, an increase in systemic exposure is not expected in patients with impaired renal function.
Formoterol
Absorption and distribution
After inhalation, formoterol is absorbed from both the lungs and the gastrointestinal tract. The fraction of the inhaled dose that is swallowed following administration with a pre-dispensed inhaler (MDI) can vary between 60% and 90%. At least 65 % of the swallowed dose is absorbed from the gastrointestinal tract. The peak plasma concentration of the unchanged drug is reached between 0.5 and 1 hour after oral administration. The binding of formoterol to plasma proteins is 61-64% with 34% of binding to albumin. There is no binding saturation in the concentration values reached at therapeutic doses. The calculated elimination half-life after oral administration is 2-3 hours. The absorption of formoterol following inhalation of doses of 12 to 96 mcg of formoterol fumarate is linear.
Metabolism
Formoterol is extensively metabolised, mainly by direct conjugation of the phenolic hydroxyl group. Conjugate with glucuronic acid is inactive. The second major route involves O-demethylation followed by conjugation of the phenolic 2-hydroxyl group. The cytochrome P450 isoenzymes CYP2D6, CYP2C19 and CYP2C9 are involved in the O-demethylation of formoterol. The liver is the primary site of metabolism Formoterol does not inhibit CYP450 enzymes at therapeutically relevant concentrations.
Excretion
The cumulative urinary excretion of formoterol following a single inhalation from a dry powder inhaler increases linearly over the dose range from 12 to 96 mcg. On average, 8% to 25% of the dose is excreted. as unchanged formoterol and total formoterol respectively. Based on plasma concentrations measured following inhalation of a single dose of 120 micrograms in 12 healthy subjects, the mean terminal elimination half-life was 10 hours. The enantiomers (RR) and (SS) represent approximately 40% and 60% respectively of the unchanged drug excreted in the urine. The relative ratio of the two enantiomers remains constant at the doses studied, and no relative accumulation of an enantiomer was observed. than the other after repeated dose.
After oral administration (40 to 80 micrograms) in healthy subjects, 6% to 10% of the dose was recovered in the urine as unchanged drug; up to 8% of the dose was recovered in the form of glucuronide.
67% of the oral dose of formoterol is excreted in the urine (mainly as metabolites) and the remainder in the faeces. Renal clearance of formoterol is 150 ml / min.
Special patient populations
Hepatic / renal impairment: The pharmacokinetics of formoterol have not been studied in patients with impaired hepatic or renal function.
Clinical experience
Systemic exposure to beclomethasone dipropionate and formoterol in combination was compared with that of the individual components. There was no evidence of pharmacokinetic or pharmacodynamic (systemic) interactions between beclomethasone dipropionate and formoterol.
The pharmacokinetics of FOSTER inhalation powder were compared with that of the corresponding pressurized inhalation solution formulation. The steroid component analysis focused on beclomethasone-17-monopropionate, the major active metabolite of beclomethasone dipropionate.
Systemic absorption and metabolism of beclomethasone dipropionate were rapid and Cmax was reached within 5 minutes post dose for both treatments, but was higher (+ 68%) with FOSTER inhalation powder. L "AUCt appeared approximately 3 times higher after inhalation of FOSTER via the Nexthaler inhaler compared to the pressurized inhalation solution. The Cmax for beclomethasone-17-monopropionate, the major active metabolite, which represents approximately 82% of the total blood level, it was achieved on average after 30 minutes and 15 minutes with Nexthaler and the pressurized inhalation solution, respectively. The plasma concentration of beclomethasone-17-monopropionate was lower (Cmax -49% and AUCt -29%) after inhalation of the inhalation powder compared to the pressurized inhalation solution. After inhalation of FOSTER with Nexthaler inhaler, the peak concentration (Cmax) of formoterol was reached in 5 minutes and was higher (+ 47%) for the inhalation powder, while the overall exposure (AUCt) appeared to be comparable in the two treatments.
In one study, the relative pulmonary distribution was evaluated using an activated carbon filter to exclude drug absorption from the gastrointestinal tract, and by adopting an approved spacer device, the AeroChamber Plus, for the reference product (the pressurized inhalation solution ). In this context, the Nexthaler inhaler and pressurized inhalation solution were shown to be equivalent in terms of AUCt of both beclomethasone-17-monopropionate and formoterol (the ratio of inhalation powder / pressurized inhalation solution and the confidence intervals of 90 % ranged from 80-125%); however, beclomethasone-17-monopropionate Cmax was lower (-38%) following administration from the Nexthaler inhaler.
05.3 Preclinical safety data -
Non-clinical data for the individual components of FOSTER reveal no special hazard for humans based on conventional studies of safety pharmacology and repeated dose toxicity. The toxicity profile of the combination reflects that of the individual components, with no increase in toxicity or unexpected events.
Reproduction studies in rats have shown dose-dependent effects. The presence of beclomethasone dipropionate at high doses has been associated with reduced female fertility, decreased number of implants and embryo-fetal toxicity. The administration of high doses of corticosteroids to pregnant animals is known to cause abnormalities in fetal development, including cleft palate, and intrauterine growth retardation, and it is likely that the effects observed with the beclomethasone dipropionate / formoterol combination are due to beclomethasone dipropionate. were found only at high systemic exposure to the active metabolite beclomethasone-17-monopropionate (more than 200 times the expected plasma levels in patients). attributable to the well known tocolytic effects of beta2-sympathomimetics These effects were noted when maternal plasma formoterol levels were below those expected in patients treated with FOSTER.
Genotoxicity studies conducted with the beclomethasone dipropionate / formoterol combination do not indicate a mutagenic potential. Carcinogenicity studies have not been performed with the proposed combination. However, animal data reported for the individual components do not suggest potential risks for human carcinogenicity.
06.0 PHARMACEUTICAL INFORMATION -
06.1 Excipients -
Lactose monohydrate (which contains small amounts of milk protein)
Magnesium stearate.
06.2 Incompatibility "-
Not relevant.
06.3 Period of validity "-
3 years.
After first opening the sachet, the medicine must be used within 6 months.
06.4 Special precautions for storage -
Store in the original package to protect from moisture.
Remove the inhaler from its foil pouch immediately before first use.
Before opening the envelope for the first time:
This medicinal product does not require any special storage temperatures.
After the first opening of the pouch:
Do not store above 25 ° C.
06.5 Nature of the immediate packaging and contents of the package -
Each box contains 1, 2 or 3 Nexthaler inhalers which contain 1.50g of inhalation powder and allow 120 puffs each. Each inhaler is contained in a heat-sealed protective bag (aluminum packaging) in PET / Al / PE (Polyethylene Terephthalate / Aluminum / Polyethylene) or PA / Al / PE (Polyamide / Aluminum / Polyethylene).
Not all pack sizes may be marketed.
FOSTER is a multidose inhalation device. The device consists of an external body equipped with a window indicating the number of doses left and equipped with an integrated cap. Upon opening the cap, which also starts the dose counting mechanism, you can see a mouthpiece through which the drug is inhaled. The external body of the device and the mouthpiece are made of acrylonitrile butadiene styrene and the cap is made of polypropylene.
06.6 Instructions for use and handling -
Unused medicine and waste derived from this medicine must be disposed of in accordance with local regulations.
Below are instructions for using the Nexthaler inhaler for the benefit of healthcare professionals.
INSTRUCTIONS FOR USING THE NEXTHALER INHALER
A. Package Contents
This pack contains:
• 1 instruction booklet
• 1 Nexthaler inhaler inside its heat-sealed protective pouch.
If the contents of the pack do not match the above, return the inhaler to your supplier and get a new one.
B. General Warnings and Precautions
• Do not remove the inhaler from its pouch if you do not intend to use it immediately.
• Use the inhaler only as directed.
• If you are not sure if the dose counter has dropped by one after inhalation, wait until your next scheduled dose and take it as normal. Do not take a double dose.
• Keep the inhaler cap closed until you are ready to take your dose.
• When you are not using the inhaler, keep it in a clean and dry place.
• Do not try to take your Nexthaler inhaler apart for any reason.
• Do not use the Nexthaler inhaler:
or after the expiration date
or if more than 6 months have passed since the opening of the envelope
or if it is broken
or if the dose counter window shows "0"
or if the dose counter cannot be read.
In all these cases, the inhaler must be disposed of properly or returned to the supplier and a new one. Ask your pharmacist how to throw away the inhalers you no longer use.
C. Main features of the Nexthaler inhaler
Taking a dose from your Nexthaler inhaler requires only three simple steps: Open, Inhale, Close
D. Before using a new Nexthaler inhaler
1. Open the pouch and take out the inhaler.
o Do not use the inhaler if the pouch is unsealed or damaged - return it to the supplier and get a new one.
2. Check your inhaler.
o If your inhaler appears broken or damaged, return it to your supplier and get a new one.
3. Check the dose counter window. If the inhaler is new, the number "120" appears in the dose counter window.
o Do not use a new inhaler if the number shown is less than "120" - return it to the supplier and get a new one.
E. How to use the Nexthaler inhaler
E.1. Visual inspection
1. Check the number of doses left: any number between "1" and "120" indicates that there are still doses left.
o If the dose counter window shows "0", it means that there are no more doses left - the inhaler must be discarded and a new one must be obtained.
2. Make sure the cap is completely closed before using the inhaler.
E.2. Opening
1. Hold the inhaler firmly in an upright position.
2. Open the hood completely.
3. Before inhaling, exhale as much as possible.
o Do not breathe through the inhaler.
E.3. Inhalation
Whenever possible, stand or sit upright while inhaling.
1. Lift the inhaler, bring it to your mouth and close your lips around the mouthpiece.
o Do not cover the air intake while holding the inhaler.
o Do not inhale through the air intake.
2. Breathe in quickly and deeply through your mouth.
o You may feel a certain taste in your mouth while taking the dose.
o You may hear or feel a 'click' as you take your dose.
o You don't breathe through your nose.
o Do not move your lips from the inhaler while inhaling.
3. Remove the inhaler from your mouth.
4. Hold your breath for 5 to 10 seconds or as long as you like.
5. Breathe out slowly.
o Do not breathe through the inhaler.
E.4. Closure
1. Put the inhaler back upright and close the cap completely.
2. Check that the dose counter has decreased by a number.
3. If you need to take another dose, repeat steps E.1 to E.4.
F. Cleaning
• Normally it is not necessary to clean the inhaler.
• If necessary, you can keep the inhaler clean after use by wiping the unit with a dry cloth or paper towel.
o Do not clean the inhaler with water or other liquids. Always keep the device dry.
G. Conservation
• When not using the inhaler, the device must be stored in a clean and dry place. You can put it back in the bag after use.
o Do not expose the inhaler to heat sources or direct sunlight.
o Do not expose the inhaler to moisture or wet environments.
• Keep out of the sight and reach of children.
• If more than 6 months have passed since opening the pouch, the inhaler must be disposed of and a new device must be obtained.
H. Disposal
• Dispose of the Nexthaler inhaler if the number "0" appears in the dose counter window.
• Ask your pharmacist how to throw away medicines you have finished or no longer use.
o Do not dispose of medicines with your normal household waste.
07.0 HOLDER OF THE "MARKETING AUTHORIZATION" -
CHIESI FARMACEUTICI S.p.A.
Via Palermo 26 / A
43122 Parma
Italy
08.0 MARKETING AUTHORIZATION NUMBER -
037789031 FOSTER 100 mcg / 6 mcg inhalation powder - 1 inhaler in ABS / PP of 120 doses
037789043 FOSTER 100 mcg / 6 mcg inhalation powder - 2 inhalers in ABS / PP of 120 doses each
037789056 FOSTER 100 mcg / 6 mcg inhalation powder - 3 inhalers in ABS / PP of 120 doses each
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION -
June 2013
10.0 DATE OF REVISION OF THE TEXT -
09/2016
11.0 FOR RADIO DRUGS, COMPLETE DATA ON THE INTERNAL RADIATION DOSIMETRY -
12.0 FOR RADIO DRUGS, FURTHER DETAILED INSTRUCTIONS ON EXEMPORARY PREPARATION AND QUALITY CONTROL -
