Active ingredients: Beclometasone (Beclometasone dipropionate)
CLENIL 50 mcg Pressurized solution for inhalation
Clenil package inserts are available for pack sizes:- CLENIL 50 mcg Pressurized solution for inhalation
- CLENIL® 250 mcg Pressurized solution for inhalation
- CLENIL 0.8 mg / 2 ml suspension for nebulisation - 2 ml single-dose vials for aerosol
- CLENIL100 MICROGRAMS POWDER FOR INHALATION, CLENIL200 MICROGRAMS POWDER FOR INHALATION, CLENIL400 MICROGRAMS POWDER FOR INHALATION
Why is Clenil used? What is it for?
Control of the evolution of asthmatic disease and bronchostenosis conditions.
Contraindications When Clenil should not be used
Asthmatic attack. Hypersensitivity to beclomethasone dipropionate, to cortisones or to any of the excipients of CLENIL.
Precautions for use What you need to know before taking Clenil
Patients should be instructed on the correct use of the inhaler to ensure that the drug reaches the target areas within the lungs.
It is important that the dose of inhaled corticosteroids is brought to the lowest effective dose for asthma control and that it is reviewed regularly. Systemic effects may occur due to the administration of inhaled corticosteroids, especially at high doses prescribed for prolonged periods of time. less likely to occur than when using oral corticosteroids Possible systemic effects include adrenal suppression, including acute, growth retardation in children and adolescents, decreased bone mineral density, cataracts and glaucoma, more rarely they may occur a range of psychological and behavioral effects including psychomotor hyperactivity, sleep disturbances, anxiety, depression, aggression, behavioral disturbances (predominantly in children). It is important to take the dose as indicated in the package leaflet or as prescribed by the doctor. or decrease the dose without first consulting your doctor.
It is recommended to regularly monitor the height of children treated with inhaled corticosteroids. In the case of slowed growth, therapy should be reviewed in order to reduce, if possible, the dose of the inhaled corticosteroid until the minimum effective dose is reached to maintain the control of asthma. In addition, it is recommended to consider whether to refer the patient to a pediatrician who specializes in respiratory diseases.
There have been very rare cases of acute adrenal crisis in boys exposed to higher than recommended doses (approximately 1000 mcg / day) for prolonged periods (several months or years). Symptoms of adrenal insufficiency are initially nonspecific and include anorexia, abdominal pain, weight loss, fatigue, headache, nausea, vomiting; Specific symptoms when treated with inhaled corticosteroids include hypoglycaemia with decreased consciousness and / or convulsions. Situations that could potentially lead to an adrenal crisis are: trauma, surgery, infections and rapid dose reduction. Patients receiving high doses should be closely evaluated and the dose gradually reduced. Monitoring of the adrenal reserve may also be necessary.
The conduct of treatment in patients already under systemic corticotherapy requires special precautions and close medical surveillance, since the reactivation of adrenal function, suppressed by prolonged systemic corticosteroid therapy, is slow. In any case, it is necessary that the disease is relatively "stabilized" with systemic treatment. CLENIL is initially administered while continuing the systemic treatment; approximately after one week this should be progressively reduced by checking the patient at regular intervals (in particular periodic tests of the cortico-adrenal function should be carried out) and by modifying the dosage of CLENIL according to the results obtained. During times of stress or severe asthmatic attack, patients undergoing this transition will need to have additional systemic steroid treatment.
The magnitude of the reduction should correspond to the maintenance dose of the systemic steroid. The dose reduction should not exceed 1 mg prednisolone (or equivalent) in patients receiving a maintenance dose of 10 mg per day or less. Larger reductions may be appropriate with higher maintenance doses, oral dose reductions should be implemented at intervals of not less than one week.
Some patients experience discomfort when discontinuing systemic corticosteroid treatment, even if their lung function remains unchanged or even improves. These patients should be encouraged to continue treatment with inhaled beclomethasone dipropionate and continue systemic steroid discontinuation unless there are objective clinical signs of adrenal insufficiency.
Patients who have stopped treatment with oral corticosteroids and who have adrenal dysfunction may need additional treatment with systemic steroids in crisis situations (for example in the case of a worsening of the "asthma attack, in the case of infections of the chest, major concomitant pathologies, surgery, trauma, ...).
Replacing systemic steroid treatment with inhalation therapy can sometimes result in allergies such as allergic rhinitis or eczema that were previously controlled with systemic therapy. These allergies should be treated symptomatically with antihistamines and / or local preparations, including steroids for local use. Corticosteroid treatment may mask some symptoms of pulmonary tuberculosis and other respiratory conditions of bacterial origin, as well as fungal and viral respiratory tract infections. Pulmonary tuberculosis can also be reactivated following the (re) introduction of inhaled corticosteroids. This risk should be considered when asthma disease is treated in patients with respiratory tract infections, in whom both asthma and infection need to be treated appropriately.
Patients with pulmonary abnormalities such as bronchiectasis and pneumoconiosis should be treated carefully due to the possibility of fungal infections.
It is recommended to rinse the mouth thoroughly with water after use in order to reduce the frequency of Candida infections.
Patients should be advised that the product contains small amounts of ethanol (approximately 8 mg by inhalation) and glycerol. These quantities are negligible and do not pose a risk to patients at the therapeutic doses normally used. Due to the presence of alcohol, however, the product should be used with caution in subjects suffering from liver diseases, alcoholism (see also Interactions), epilepsy, brain diseases.
Interactions Which drugs or foods can modify the effect of Clenil
Tell your doctor or pharmacist if you have recently taken any other medicines, even those without a prescription
CLENIL contains a small amount of ethanol. There is the theoretical possibility of an "interaction with disulfiram or metronidazole, in particularly sensitive subjects being treated with such drugs.
Warnings It is important to know that:
CLENIL is not effective in ongoing asthma crises; it is instead a basic treatment of asthmatic disease so it must be taken regularly at the prescribed doses and as long as the doctor deems it appropriate, even during the asymptomatic phases. In these cases it is necessary to use a fast-acting bronchodilator (administered by inhalation) Patients should have this type of medicine available.
Severe asthma requires regular medical check-ups, including pulmonary function tests, as there is a risk of severe or even fatal attacks. The patient should seek medical attention if fast-acting bronchodilator treatment becomes less effective (or if he needs to be treated. more inhalations than usual), as this may indicate worsening asthma disease control. In this situation, patients should be re-evaluated and consideration should be given to increasing anti-inflammatory therapy (e.g. increasing the dose of inhaled corticosteroids or inserting a course of oral corticosteroids). Severe exacerbations of asthma should be treated conventionally, for example by increasing the dose of inhaled beclomethasone dipropionate, by administering a systemic steroid (if needed) and / or an appropriate antibiotic in case of infection, combination with β-agonist therapy.
Treatment with beclomethasone dipropionate should not be stopped abruptly.
For those who play sports:
the use of medicines containing ethyl alcohol can determine positive anti-doping tests in relation to the alcohol concentration limits indicated by some sports federations.
Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine
In pregnant women, the product should be administered in cases of real need and under the direct supervision of the doctor.
There are insufficient data on the safe use of beclomethasone dipropionate or the propellant HFA 134a in human pregnancy.
Administration of the product during pregnancy and lactation should only be considered if the foreseeable benefit to the mother outweighs the potential risk to the fetus.
It is reasonable to assume that there are no relevant levels of beclomethasone in breast milk at the inhalation doses used.
Babies born to mothers who received substantial doses of inhaled corticosteroids during pregnancy should be carefully observed for hypoadrenalism.
Studies on the effects of the propellant HFA 134a on reproductive function and embryo-fetal development in animals did not reveal clinically relevant adverse events. Adverse events in humans are therefore unlikely.
Dosage and method of use How to use Clenil: Dosage
Adults: the average dose is 2 inhalations (= 100 mcg of active ingredient) 4 times a day. In severe cases it is advisable to start with 3-4 inhalations (= 150-200 mcg of active ingredient) 4 times a day, and adjust the dosage according to the response.
Children under 12 years of age: 1-2 inhalations (= 50-100 mcg of active ingredient) 2 to 4 times a day, depending on the response. The maximum daily administration should not exceed 20 inhalations (1 mg) in adults. It is important for the patient to understand that CLENIL is not a bronchodilator aerosol: it should be used regularly and not to achieve rapid resolution of the bronchospasm.
Instructions for Use
Successful treatment depends on the correct use of the inhaler. Testing the functioning of the inhaler: before using the inhaler for the first time or if it has not been used for three days or more, remove the protective cap from the mouthpiece by pressing it gently
- Hold the regulator between your thumb and forefinger, with the mouthpiece at the bottom
- remove the protective closure;
- place the mouthpiece between your lips tightly closed and make a complete exhalation;
- inhale long and deeply with the mouth only, at the same time press with the index finger only once. After the inhalation, hold the breath as long as possible.
At the end of the inhalations, close the mouthpiece with the protective closure.
The mouthpiece must always be kept clean. Cleaning must be carried out with warm water, after having extracted the container under pressure.
In children, inhalations should be carried out under the supervision of an adult. It is helpful to close the baby's nostrils during inhalation
Side Effects What are the side effects of Clenil
Any side effects that may occur following the use of beclomethasone dipropionate are the following:
- very common: candidiasis of the oral cavity (mouth and throat);
- common: hoarseness, throat irritation;
- uncommon: rash, pruritus, urticaria, erythema;
- very rare: eye, face, lip and throat edema; adrenal suppression *, growth retardation * (in children and adolescents), decreased bone mineral density *, cataract *, glaucoma *, paradoxical bronchospasm, wheezing, dyspnoea, cough, dry mouth.
(* systemic reactions represent a possible response to inhaled corticosteroids, particularly when a high dose is prescribed for an extended period of time).
As with other inhalation therapies, paradoxical bronchospasm with immediate increase in wheezing and shortness of breath and cough after administration may occur after dosing. In this case, immediate-acting inhaled bronchodilator should be treated immediately and treatment with beclomethasone dipropionate immediately discontinued.
The incidence of candidiasis of the mouth and throat increases with doses above 400 micrograms of beclomethasone dipropionate per day. This complication is more likely to develop in patients with high levels of Candida precipitins in the blood, indicating a previous infection. Patients may benefit from thoroughly rinsing the mouth with water after inhalation.
Symptomatic candidiasis can be treated with local antifungal therapy during treatment with beclomethasone dipropionate.
Hoarseness is reversible and disappears upon discontinuation of treatment and / or voice rest. Patients may be recommended to rinse their mouth with water immediately after inhalation.
Other systemic side effects are highly unlikely at recommended doses; however, patients should be closely monitored during prolonged treatments, in order to promptly ascertain the possible occurrence of systemic manifestations (osteoporosis, peptic ulcer, signs of secondary adrenocortical insufficiency, such as hypotension and weight loss), in order to avoid in the latter eventuality very serious acute hypoadrenal accidents.
Side effects that can occur with unknown frequency are psychomotor hyperactivity, sleep disturbances, anxiety, depression, aggression, behavioral disturbances (mainly in children). Compliance with the instructions contained in this leaflet reduces the risk of undesirable effects. It is important to inform your doctor or pharmacist of any undesirable effects, even those not described in the package leaflet.
Expiry and Retention
See the expiration date indicated on the package; this date is intended for the product in intact packaging, properly stored.
WARNING: do not use the medicine beyond the expiration date indicated on the package.
STORAGE PRECAUTIONS
The container under pressure must not be punctured, it must not be approached, even if empty, to heat sources, it must not be frozen and it must not be exposed to direct sunlight. Store at a temperature not exceeding 30 ° C
Keep out of the reach and sight of children
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
CLENIL 250 MCG PRESSURIZED SOLUTION FOR INHALATION
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each container contains:
Active principle:
• beclomethasone-17,21-dipropionate 50 mg (each actuation contains 250 mcg)
Excipients with known effects:
• ethanol
• glycerol
For the full list of excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM
Pressurized solution for inhalation (contains HFA 134a - norflurane as propellant).
It does not contain substances harmful to stratospheric ozone.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Control of the evolution of asthmatic disease and bronchostenosis conditions in patients who do not achieve satisfactory symptom control with the usual doses of inhaled beclomethasone dipropionate.
04.2 Posology and method of administration
Adults
Typically 2 inhalations 2 times a day. If deemed more appropriate, the dosage can also be divided into 1 inhalation 4 times a day. If necessary, it can be increased to 2 inhalations 3-4 times a day. CLENIL therapy should not be stopped abruptly.
Children
CLENIL 250 mcg is not suitable for pediatric use.
Instructions for Use
The success of the treatment depends on a correct use of the inhaler.
Testing the inhaler function: Before using the inhaler for the first time or if it has not been used for three days or more, remove the protective cap from the mouthpiece by gently pressing it on the sides and press once in the air to release a supply in order to ensure effective operation.
In use, carefully follow the instructions below:
1) hold the regulator between the thumb and forefinger with the mouthpiece from the bottom;
2) remove the protective closure;
3) place the mouthpiece between your lips tightly closed and make a complete exhalation;
4) inhale long and deeply with the mouth only, at the same time press with the index finger only once.
After inhaling, hold your breath as long as possible.
At the end of the inhalations, close the mouthpiece with the protective closure. The mouthpiece must always be kept clean. Cleaning must be carried out with warm water, after having extracted the container under pressure.
04.3 Contraindications
Asthmatic attack. Hypersensitivity to beclomethasone dipropionate, to cortisones or to any of the excipients of CLENIL.
04.4 Special warnings and appropriate precautions for use
Patients should be instructed on the correct use of the inhaler to ensure that the drug reaches the target areas within the lungs.
CLENIL is not effective in current asthma crises; it is instead a basic treatment of asthmatic disease so it must be taken regularly at the prescribed doses and as long as the doctor deems it appropriate, even during the asymptomatic phases. In these cases it is necessary to use a fast-acting bronchodilator (administered by inhalation) Patients should be advised to have this type of medicine available.
Severe asthma requires regular medical check-ups, including pulmonary function tests, as there is a risk of severe or even fatal attacks. Patients should be instructed to seek medical attention if fast-acting bronchodilator treatment becomes less effective (or if it has need more inhalations than usual), as this may indicate worsening asthma disease control. In this situation, patients should be re-evaluated and consideration should be given to increasing anti-inflammatory therapy (e.g. increasing the dose of inhaled corticosteroids or insert a course with oral corticosteroids). Severe exacerbations of asthma should be treated conventionally, for example by increasing the dose of inhaled beclomethasone dipropionate, administering a systemic steroid (if needed) and / or an appropriate antibiotic in case of infection , in combination with beta-agonist therapy.
Treatment with beclomethasone dipropionate should not be stopped abruptly.
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 aspect, 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, disturbances sleep, anxiety, depression or aggression (particularly in children). It is therefore important that the dose of inhaled corticosteroids is the lowest possible dose with which effective control of asthma is maintained.
It is recommended to regularly monitor the height of children treated with inhaled corticosteroids. In the case of slowed growth, therapy should be reviewed in order to reduce, if possible, the dose of the inhaled corticosteroid until the minimum effective dose is reached to maintain the control of asthma. In addition, it is recommended to consider whether to refer the patient to a pediatrician who specializes in respiratory diseases.
There have been very rare cases of acute adrenal crisis in boys exposed to higher than recommended doses (approximately 1000 mcg / day) for prolonged periods (several months or years). Symptoms of adrenal insufficiency are initially nonspecific and include anorexia, abdominal pain, weight loss, fatigue, headache, nausea, vomiting; Specific symptoms when treated with inhaled corticosteroids include hypoglycaemia with decreased consciousness and / or convulsions. Situations that could potentially lead to an adrenal crisis are: trauma, surgery, infections and rapid dose reduction. Patients receiving high doses should be closely evaluated and the dose gradually reduced. Monitoring of the adrenal reserve may also be necessary.
The conduct of treatment in patients already under systemic corticotherapy requires special precautions and close medical surveillance, since the reactivation of adrenal function, suppressed by prolonged systemic corticosteroid therapy, is slow. In any case, it is necessary that the disease is relatively "stabilized" with systemic treatment.
CLENIL is initially administered while continuing the systemic treatment; approximately after one week this should be progressively reduced by checking the patient at regular intervals (in particular periodic tests of the cortico-adrenal function should be carried out) and by modifying the dosage of CLENIL according to the results obtained. During times of stress or severe asthmatic attack, patients undergoing this transition will need to have additional systemic steroid treatment.
The magnitude of the reduction should correspond to the maintenance dose of the systemic steroid. The dose reduction should not exceed 1 mg prednisolone (or equivalent) in patients receiving a maintenance dose of 10 mg per day or less. Larger reductions may be appropriate with higher maintenance doses, oral dose reductions should be implemented at intervals of not less than one week.
Some patients experience discomfort when discontinuing systemic corticosteroid treatment, even if their lung function remains unchanged or even improves. These patients should be encouraged to continue treatment with inhaled beclomethasone dipropionate and continue systemic steroid discontinuation unless there are objective clinical signs of adrenal insufficiency.
Patients who have stopped treatment with oral corticosteroids and who have adrenal dysfunction may need additional treatment with systemic steroids in crisis situations (for example in the case of a worsening of the "asthma attack, in the case of infections of the chest, concomitant major diseases, surgery, trauma).
Replacing systemic steroid treatment with inhalation therapy can sometimes result in allergies such as allergic rhinitis or eczema that were previously controlled with systemic therapy. These allergies should be treated symptomatically with antihistamines and / or local preparations, including steroids for local use. Corticosteroid treatment may mask some symptoms of pulmonary tuberculosis and other respiratory conditions of bacterial origin, as well as fungal and viral respiratory tract infections. Pulmonary tuberculosis can also be reactivated following the (re) introduction of inhaled corticosteroids. This risk should be considered when asthma disease is treated in patients with respiratory tract infections, in whom both asthma and infection need to be treated appropriately.
Use caution when treating patients with pulmonary abnormalities such as bronchiectasis and pneumoconiosis, due to the possibility of fungal infections.
Patients should be advised to rinse their mouth thoroughly with water after use to reduce the frequency of Candida infections.
Important information about some of the ingredients
Patients should be advised that the product contains small amounts of ethanol (approximately 9 mg by inhalation) and glycerol. These quantities are negligible and do not pose a risk to patients at the therapeutic doses normally used. Due to the presence of alcohol, however, the product should be used with caution in subjects suffering from liver diseases, alcoholism (see section 4.5), epilepsy, brain diseases.
Keep this medicine out of the reach and sight of children.
04.5 Interactions with other medicinal products and other forms of interaction
Clenil contains a small amount of ethanol. There is the theoretical possibility of an "interaction with disulfiram or metronidazole, in particularly sensitive subjects being treated with such drugs.
04.6 Pregnancy and lactation
In pregnant women, the product should be administered in cases of real need and under the direct supervision of the doctor.
There are insufficient data on the safe use of beclomethasone dipropionate or the propellant HFA 134a in human pregnancy.
Administration of the product during pregnancy and lactation should only be considered if the foreseeable benefit to the mother outweighs the potential risk to the fetus.
It is reasonable to assume that there are no relevant levels of beclomethasone in breast milk at the inhalation doses used.
Babies born to mothers who received substantial doses of inhaled corticosteroids during pregnancy should be carefully observed for hypoadrenalism.
Studies on the effects of the propellant HFA 134a on reproductive function and embryo-fetal development in animals did not reveal clinically relevant adverse events. Adverse events in humans are therefore unlikely.
04.7 Effects on ability to drive and use machines
Nobody.
04.8 Undesirable effects
Adverse events are listed below by system organ class and frequency. Frequencies are defined as follows: very common (≥1 / 10), common (≥1 / 100,
* Systemic reactions represent a possible response to inhaled corticosteroids, particularly when a high dose is prescribed for an extended period of time (section 4.4 "Special warnings and precautions for use").
As with other inhalation therapies, paradoxical bronchospasm with immediate increase in wheezing and wheezing and coughing may occur after dosing. In this case, immediate-acting inhaled bronchodilator should be treated immediately and treatment with beclomethasone dipropionate immediately discontinued.
The incidence of candidiasis of the mouth and throat increases with doses above 400 micrograms of beclomethasone dipropionate per day. This complication is more likely to develop in patients with high levels of Candida precipitins in the blood, indicating a previous infection. Patients may benefit from thoroughly rinsing their mouth with water after inhalation.
Symptomatic candidiasis can be treated with local antifungal therapy during treatment with beclomethasone dipropionate.
Hoarseness is reversible and disappears upon discontinuation of treatment and / or voice rest. Patients may be recommended to rinse their mouth with water immediately after inhalation.
Other systemic side effects are extremely unlikely at the recommended doses; however, patients must be kept under strict control during prolonged treatments, in order to promptly ascertain the possible occurrence of systemic manifestations (osteoporosis, peptic ulcer, signs of secondary adrenocortical insufficiency, such as hypotension and weight loss), in order to avoid serious accidents due to acute hypoadrenalism in the latter case.
04.9 Overdose
The use of excessive doses of beclomethasone dipropionate may cause systemic effects (such as hypercorticism and adrenal suppression). If such symptoms occur, treatment should be discontinued and the patient protected from the effects of adrenal suppression by appropriate systemic therapy.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
CLENIL contains beclomethasone 17,21-dipropionate as the active ingredient, a cortisone derivative with a strong anti-inflammatory and anti-allergic topical activity on the mucosa of the respiratory tract. In particular, beclomethasone dipropionate exerts a marked antireactive action at the bronchial level, reducing edema, hypersecretion and inhibiting the onset of bronchospasm. Beclomethasone dipropionate administered by inhalation acts exclusively on the structures of the respiratory tree and is therefore free, at the recommended dosages, of systemic effects and inhibiting action on the cortico-adrenal function. Beclomethasone dipropionate (BDP) is a synthetic corticosteroid, exclusively for topical use, with powerful anti-inflammatory activity, reduced mineralocorticoid activity and absence of systemic effects. In the skin vasoconstriction test according to Mc Kenzie BDP is 5000 times more active than hydrocortisone, 625 times more active than alcohol betamethasone, 5 times more active than fluocinolone acetonide and 1.39 times more active than betamethasone valerate.
It has intense and prolonged anti-inflammatory activity against croton oil, carrageenan, formalin, egg white and dextran edema and the granulomatous reaction from a foreign body, with superior efficacy to that of other corticosteroids.
It is devoid of thymolytic, splenolytic, mineralocorticoid activity and does not inhibit, at therapeutic doses, the pituitary-adrenal axis even after repeated administration.
CLENIL is particularly indicated for patients who do not achieve satisfactory symptom control with the usual inhaled doses of beclomethasone dipropionate.
In order to achieve complete therapeutic success, it is essential that the patient carefully follows the instructions for use relating to inhalation of the drug.
05.2 Pharmacokinetic properties
Kinetic studies with radiolabelled beclomethasone dipropionate have shown that after inhalation of a high dose only 20-25% is absorbed. Part of the administered dose is swallowed and excreted in the faeces. The fraction absorbed into the circulation is metabolised by the liver to monopropionate and beclomethasone alcohol and subsequently excreted in the form of inactive metabolites in the bile and urine.
05.3 Preclinical safety data
Acute toxicity
Orally, in rats and mice, the LD50 values are higher than 3000 mg / kg. By nebulisation, exposures at concentrations of 100 mcg / l for 30 minutes are well tolerated in rats and mice.
Chronic toxicity
The inhaled administration to the dog, for 27 weeks, does not cause alterations, at doses well above those foreseen in therapy.
Fetal toxicity
Studies carried out in rats and rabbits do not show any negative effects on the reproductive sphere.
The propellant HFA 134a did not show toxic effects at concentrations considerably higher than those expected in man, administered by nebulization in various animal species exposed daily for a period of two years.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
HFA 134a (norflurane), ethanol, glycerol.
06.2 Incompatibility
Not known.
06.3 Period of validity
36 months.
This period is intended for the specialty properly stored and with intact packaging.
06.4 Special precautions for storage
The container under pressure must not be punctured, it must not be approached, even if empty, to heat sources, it must not be frozen and it must not be exposed to direct sunlight. Store at a temperature not exceeding 30 ° C.
06.5 Nature of the immediate packaging and contents of the package
Internal packaging: aluminum pressurized container, metering valve, dispenser button and protective closure. External packaging: printed cardboard box.
Container under sufficient pressure for 200 inhalations
06.6 Instructions for use and handling
No special instructions
07.0 MARKETING AUTHORIZATION HOLDER
CHIESI FARMACEUTICI S.p.A., Via Palermo, 26 / A - Parma
08.0 MARKETING AUTHORIZATION NUMBER
CLENIL 250 mcg pressurized solution for inhalation - container 200 puffs - AIC n. 023103068
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
22/05/1985
10.0 DATE OF REVISION OF THE TEXT
December 2012
