Active ingredients: Beclometasone (Beclometasone dipropionate), Salbutamol
CLENIL COMPOSITUM 50 mcg + 100 mcg Pressurized suspension for inhalation. Pressurized container for 200 sprays with standard dispenser
Clenil Compositum package inserts are available for pack sizes:- CLENIL COMPOSITUM 50 mcg + 100 mcg Pressurized suspension for inhalation. Pressurized container for 200 sprays with standard dispenser
- CLENIL COMPOSITUM 0,8 mg + 1,6 mg Suspension to be nebulised
Why is Clenil Compositum used? What is it for?
Selective beta2 adrenergic bronchodilator and antiasthmatic glucocorticoid for aerosol.
Treatment of bronchial asthma, chronic obstructive bronchopathy with asthmatic component
Contraindications When Clenil Compositum should not be used
Hypersensitivity to the active substance or to any of the excipients.
Beclomethasone dipropionate is contraindicated in local active or quiescent viral and tuberculous infections.
Contraindicated in pregnancy and lactation (see Special warnings).
Precautions for use What you need to know before taking Clenil Compositum
The conduct of treatment in patients already under systemic corticotherapy requires special precautions and close medical surveillance. A certain degree of adrenocortical atrophy can occur only after continued overdosing.
Sympathomimetic agents should be used with great caution in patients who may be particularly susceptible to their effects.
In patients with diseases such as coronary heart disease, arrhythmias, arterial hypertension and in patients with glaucoma, hyperthyroidism, pheochromocytoma, diabetes and prostatic hypertrophy, the product should only be used in case of absolute necessity. Inform your doctor if you have heart disease or angina before starting therapy with salbutamol.
It is important that the dose of inhaled corticosteroids is brought to the lowest effective dose for the control of asthma and that it is reviewed regularly. In fact, possible systemic effects, such as adrenal suppression, even acute, growth retardation in children and adolescents, reduction of mineral density bone, cataracts, and glaucoma may arise following treatment with high-dose inhaled corticosteroids for prolonged periods. 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; symptoms specific to treatment with inhaled corticosteroids include hypoglycemia with reduced consciousness and / or convulsions Situations that could potentiate The causes of an adrenal crisis are: trauma, surgery, infections and rapid reduction in dosage. Patients receiving high doses should be closely evaluated and the dose gradually reduced. Monitoring of the adrenal reserve may also be necessary.
Rarely, a range of psychological and behavioral effects may occur, including psychomotor hyperactivity, sleep disturbances, anxiety, depression, aggression, behavioral disturbances (predominantly in children). It is important to take the dose as directed in the package leaflet or as prescribed by your doctor. You should not increase or decrease the dose without first consulting your doctor.
Clenil Compositum does not contain chlorofluorocarbons (CFCs) and uses norflurane (HFA) as a propellant. This may result in a difference in the taste and perception of the inhalation from the previous formulation containing CFC.
Interactions Which drugs or foods can modify the effect of Clenil Compositum
Tell your doctor or pharmacist if you have recently taken any other medicines, even those without a prescription.
The concomitant administration of the preparation with beta-blockers (eg propranolol) is not recommended.
The medicinal product contains small amounts of ethyl alcohol: an interaction with disulfiram and metronidazole may be possible in particularly sensitive subjects being treated with these drugs.
Warnings It is important to know that:
To be used only in the initial period and not for prolonged treatments (uninterrupted use for more than ten days is not recommended).
The use, especially if prolonged, of products for topical use can give rise to sensitization phenomena and, exceptionally, to the classic systemic side effects of the drug. In any case it is necessary to suspend the treatment and institute a suitable therapy
Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
Its use in the first three months of pregnancy is not recommended, in the further period the opportunity to administer the product will be evaluated by the doctor according to the risk / benefit.
Its use is not recommended even during breastfeeding.
Effects on ability to drive and use machines
Not relevant.
Important information about some of the ingredients The medicinal product contains small amounts of ethyl alcohol (approximately 5 mg per actuation); this quantity does not constitute a risk for the patient.
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.
For those who carry out sporting activities: the use of the drug without therapeutic necessity constitutes doping and can in any case determine positive anti-doping tests.
Dosage and method of use How to use Clenil Compositum: Dosage
Adults: 2 sprays-dose up to 4-6 times a day.
Children: 1-2 sprays 2 to 4 times a day, depending on the response.
The effect of one inhalation of CLENIL COMPOSITUM Pressurized suspension persists for at least 4 hours.
Make a maximum of two administrations at a time and do not repeat the treatment for 4 hours.
Instructions for Use
Before using the medicine for the first time or if the medicine is not used for 7 days or more, two puffs should be sprayed on empty to ensure that the dispenser is working properly
- remove the protective cap;
- hold the regulator between your thumb and forefinger, with the mouthpiece at the bottom, as shown in the figure;
- shake vigorously without pressing;
- place the mouthpiece between your lips tightly closed after taking a full exhalation;
- breathe in long and deeply with your mouth only, at the same time press firmly with your index finger once. Avoid partial dispensing.
At the end of the inhalation, 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
The dispenser must be cleaned at least every 3 days from the beginning of its use. Keeping the dispenser clean is extremely important to prevent blockage due to clogging. If cleaning is not performed regularly as directed, the dispenser may block or malfunction.
Follow the cleaning instructions below:
- Remove the protective plastic cap 5
- Remove the metal can from the plastic mouthpiece
- Wash the body of the plastic mouthpiece from the bottom for one minute with warm running water, placing it under the stream of running water,
- Rotate the mouthpiece and wash the top of the mouthpiece under running hot water for a further minute, placing it under the stream of water,
- Carefully remove any water that remains inside the plastic mouthpiece by repeatedly beating it in moderation against a hard surface. Check that no water remains in the central cavity of the plastic mouthpiece into which the stem of the metal can fits.
- Carefully dry the body of the plastic mouthpiece both internally and externally, for example by leaving it in the air overnight without a metal can and protective cap, or by using a jet of hot air. Make sure the mouthpiece is completely dry before use.
- Put the metal can back in the regulator and the protective cap on the mouthpiece
IMPORTANT: Do not use the mouthpiece while still wet, make sure it is completely dry before using it. Using the wet mouthpiece can promote obstruction and blockage of the regulator.
If the dispenser should block:
Perform cleaning steps 1 to 7.
Dispense an empty dose to verify the removal of the obstruction before proceeding to normal use.
Overdose What to do if you have taken too much Clenil Compositum
At high dosages, transient side effects (modest increase in heart rate, mild muscle tremors) may occur in some patients and disappear after the first few days of treatment, reducing the dose if necessary.
In case of accidental ingestion / intake of an excessive dose of Clenil compositum, notify your doctor immediately or go to the nearest hospital.
If you have any questions about the use of Clenil compositum, ask your doctor or pharmacist.
Side Effects What are the side effects of Clenil Compositum
Like all medicines, Clenil compositum can cause side effects, although not everybody gets them
Only a few patients complained of hoarseness.
In a few patients, localized fungal-type infections have appeared in the mouth or throat which rapidly regress after appropriate local therapy with alkalizers or antifungals without interruption of treatment.
At high dosages, transient side effects (modest increase in heart rate, mild muscle tremors) may occur in some patients and disappear after the first few days of treatment by reducing the dose if necessary.
Systemic side effects are extremely unlikely due to the low doses used; their appearance, however, can be favored by treatments carried out for prolonged periods of time.
Particular caution must be taken in the prolonged use of the spray, keeping the patient under control in order to promptly reveal any systemic side effects (osteoporosis, peptic ulcer, signs of secondary adrenal insufficiency).
At high doses used for long periods adrenal suppression, growth retardation in children and adolescents, decreased bone mineral density, cataracts and glaucoma may occur.
As with other drugs administered by inhalation, the possibility of paradoxical bronchospasm should be taken into consideration.
Very rarely, some patients may experience chest pain (due to heart problems such as angina). Inform your doctor as soon as possible, avoiding stopping therapy unless advised to do so.
Side effects that may arise, with unknown frequency, are psychomotor hyperactivity, sleep disturbances, anxiety, depression, aggression, behavioral disturbances (mainly in children).
Compliance with the instructions given in this leaflet reduces the risk of undesirable effects.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. Side effects can also be reported directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects you can help provide more information on the safety of this medicine. "
Expiry and Retention
Expiry: see the expiry date indicated on the package.
WARNING: Do not use the medicine after the expiry date indicated on the package.
The expiry date refers to the product in intact packaging, correctly stored.
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. Store taking care to avoid accidental dispensing.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
Keep this medicine out of the sight and reach of children.
COMPOSITION
A pressurized container contains: Active ingredients: Beclometasone dipropionate 0.010 g, Salbutamol 0.020 g equal to 0.024 g of salbutamol sulphate. Excipients :. HFA 134a (norflurane), anhydrous ethyl alcohol, oleic acid.
Each spray dose delivers 50 micrograms of beclomethasone dipropionate and 100 micrograms of salbutamol equal to 120 micrograms of salbutamol sulfate.
PHARMACEUTICAL FORM AND CONTENT
Pressurized suspension for inhalation. Pressurized container with standard dispenser sufficient for 200 inhalations
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 COMPOSITUM 250 MCG + 100 MCG
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
A pressurized container contains:
Active ingredients: Beclometasone dipropionate 50 mg, Salbutamol 20 mg equal to salbutamol sulphate 24 mg.
One spray-dose delivers 250 mcg of beclomethasone dipropionate and 100 mcg of salbutamol equal to 120 mcg of salbutamol sulfate.
For the full list of excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM
Pressurized suspension for inhalation.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Bronchial asthma, chronic obstructive pulmonary disease with asthmatic component.
04.2 Posology and method of administration
Adults: 2 sprays twice a day
If necessary it is possible to increase to 2 spray-dose 3-4 times a day.
Make a maximum of two administrations at a time and do not repeat the treatment for 4 hours.
Clenil Compositum therapy should not be stopped abruptly.
The package contains a pressurized container with standard dispenser together with a Jet dispenser-spacer.
The patient can use the most suitable regulator: the Jet device in case of difficulty in coordinating between inspiratory act and delivery or in other cases the standard regulator characterized by smaller dimensions.
It is important to read the instructions for use and handling carefully, see section 6.6.
04.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients, listed in section 6.1.
Beclomethasone dipropionate is contraindicated in viral infections and in active or quiescent pulmonary tuberculosis, while salbutamol has no specific contraindications.
Contraindicated in pediatric age (see section 4.4)
Contraindicated in pregnancy and lactation (see section 4.6).
04.4 Special warnings and appropriate precautions for use
To be used only in the initial period and not for prolonged treatments (uninterrupted use for more than ten days is not recommended).
The use, especially if prolonged, of products for topical use can give rise to sensitization phenomena and, exceptionally, to the classic systemic side effects of the drug. In any case it is necessary to suspend the treatment and institute a suitable therapy.
The use of inhaled corticosteroids must not exceed the recommended doses: in case of persistent bronchospasm it would be advisable to use beta2-agonists as needed.
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 Compositum is initially administered while continuing the systemic treatment; subsequently this must be progressively reduced by checking the patient at regular intervals (in particular, periodic adrenocortical function tests must be carried out) and by modifying the dosage of Clenil Compositum 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 product is not suitable for pediatric use.
Sympathomimetic agents should be used with great caution in patients who may be particularly susceptible to their effects.
In patients with diseases such as coronary heart disease, arrhythmias, arterial hypertension and in patients with glaucoma, hyperthyroidism, pheochromocytoma, diabetes and prostatic hypertrophy, the product should only be used in case of absolute necessity.
There is evidence from post-marketing data and published literature of rare cases of myocardial ischaemia associated with the use of salbutamol. Patients with pre-existing severe heart disease (eg, ischemic heart disease, tachyarrhythmia, or severe heart failure), who receive salbutamol for respiratory conditions, they should be advised to inform their doctor if chest pain or symptoms of worsening heart disease occur.
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. 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 non-specific and include anorexia, abdominal pain, weight loss, fatigue, headache, nausea, vomiting; specific symptoms in case of treatment with inhaled corticosteroids include hypoglycemia with decreased consciousness and / or seizures. Situations that could potentially lead to adrenal crisis are: trauma, surgery, infections and rapid dose reduction. Patients receiving high doses should be closely evaluated and gradually reduced dose Monitoring of adrenal reserve may also be necessary.
Clenil Compositum does not contain chlorofluorocarbons (CFCs) and uses norflurane (HFA) as a propellant. This may result in a difference in the taste and perception of the inhalation from the previous formulation containing CFC.
Important information about some of the ingredients
The medicine contains small amounts of ethyl alcohol (approximately 8 mg per actuation); this quantity does not constitute a risk for the patient.
04.5 Interactions with other medicinal products and other forms of interaction
The simultaneous administration of the preparation with beta-blockers (eg propranolol) is not recommended.
The medicinal product contains small amounts of ethyl alcohol: an interaction with disulfiram and metronidazole may be possible in particularly sensitive subjects being treated with these drugs.
04.6 Pregnancy and lactation
Its use in the first three months of pregnancy is not recommended, in the further period the opportunity to administer the product will be evaluated by the doctor according to the risk / benefit.
Its use is not recommended even during breastfeeding.
Babies born to mothers who received substantial doses of inhaled corticosteroids during pregnancy should be carefully observed for hypoadrenalism.
04.7 Effects on ability to drive and use machines
Not relevant.
04.8 Undesirable effects
No serious side effects attributable to the use of Clenil Compositum at the recommended doses have been reported: only some patients have complained of hoarseness or dysphonia.
Occasionally, localized fungal-type infections may occur in the mouth or throat and regress rapidly after appropriate local therapy with alkalizers or antifungals without interruption of treatment.
At high dosages, transient side effects (modest increase in heart rate, mild muscle tremors) may occur in some patients and disappear after the first few days of treatment by reducing the dose if necessary. Systemic side effects are extremely unlikely; their appearance, however, can be favored by treatments carried out for prolonged periods of time.
Particular caution must be taken in the prolonged use of the spray, keeping the patient under control in order to promptly reveal any systemic side effects (osteoporosis, peptic ulcer, signs of secondary adrenal insufficiency).
At high doses used for long periods adrenal suppression, growth retardation in children and adolescents, decreased bone mineral density, cataracts and glaucoma may occur.
As with other drugs administered by inhalation, the possibility of paradoxical bronchospasm should be taken into consideration.
Cardiac arrhythmias (including atrial fibrillation, supraventricular tachycardia and extrasystole), myocardial ischaemia have been reported very rarely.
Psychiatric disorders that may arise with unknown frequency are psychomotor hyperactivity, sleep disturbances, anxiety, depression, aggression, behavioral disturbances (predominantly in children).
Reporting of suspected adverse reactions
Reporting of suspected adverse reactions that occur after authorization of the medicinal product is important, as it allows continuous monitoring of the benefit / risk ratio of the medicinal product.
Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at: "www.agenziafarmaco.gov.it/it/responsabili".
04.9 Overdose
At high dosages, transient side effects (modest increase in heart rate, mild muscle tremors) may occur in some patients and disappear after the first few days of treatment by reducing the dose if necessary.
In the unlikely event that excessive use of the preparation induces alterations in adrenal function, 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
Pharmacotherapeutic group: selective beta2 adrenergic bronchodilator and antiasthmatic gluco-corticoid for aerosol.
ATC code: R03AK04.
Clenil Compositum is constituted by the association of a bronchodilator, salbutamol (S), and an aerosolically active cortisone, beclometasone dipropionate (BDP). Salbutamol is characterized by a rapid and safe bronchial antispastic action which determines a prompt improvement of the respiratory function. The action of salbutamol is exercised electively at the level of the bronchial muscles, without causing cardiocirculatory effects. On the other hand, beclomethasone dipropionate controls bronchial hyperreactivity, reducing edema and hypersecretion and progressively inhibiting the onset of bronchospasm. The activity of beclomethasone dipropionate is limited at the level of the bronchial tree without giving rise to general effects and therefore without inhibiting the adrenal function. Therefore the action of the two active principles completes and strengthens each other. Clenil Compositum is indicated in the regular treatment of medium-severe forms of bronchial asthma and chronic obstructive pulmonary disease with asthmatic component, to prevent the onset and reduce the frequency of asthmatic attacks. The use of high dose beclomethasone dipropionate is aimed at control the inflammatory component and bronchial hyperreactivity, allowing to reduce the frequency of use of beta-agonists.
Pharmacological tests have shown that the association has: a remarkable anti-inflammatory activity which can be compared to that possessed by beclomethasone dipropionate in the tests performed (inflammation of the cornea and foreign body granuloma); an anti-bronchospastic effect superior to both single constituents both in intensity and in duration, in all the tests performed (bronchospasm from aerosol of histamine and acetylcholine, minishock from aerosol of ovalbumin in sensitized guinea pigs).
Characteristics of the JET
The JET device has been designed to improve the efficiency of a normal spray dispenser and to facilitate the adherence to therapy of patients (especially the elderly) with little familiarity with the inhalation technique, avoiding the forced synchronism between the delivery phase and that of inspiration. The JET device reduces the deposition rate of active components at the oropharyngeal level, favoring good local tolerability. The particular configuration of the expansion chamber of the JET determines the creation of a vortex flow in which the particles supplied remain in suspension for a time sufficient to discharge their kinetic energy and to allow the partial evaporation of the propellant. It follows that most of the impact occurs in the device rather than in the oropharynx, while the decrease in the size of the particles, before their entry into the respiratory tree, favors a better penetration up to the lower airways.
05.2 Pharmacokinetic properties
After inhalation of labeled salbutamol (0.04-0.10 mg) the blood peak is found after 3-5 hours. Approximately 83% of the inhaled dose is excreted in the urine as salbutamol (approximately 70%) and as its metabolite "salbutamol-o-phenyl-glucuronide" (30%). Kinetic studies with labeled 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 absorbed fraction in the circulation is metabolised by the liver to monopropionate and beclomethasone alcohol and subsequently excreted as inactive metabolites in bile and urine.
05.3 Preclinical safety data
Acute toxicity
LD50 (rat, intratracheal route): at the maximum practicable dosages (6.2 mg / kg of BDP + 12.4 mg / kg of S) the association does not show toxicity;
LD50 (rat, i.v. route): 51.3 mg / kg of BDP + 102.7 mg / kg of S;
LD50 (mouse, per os): 1407 mg / kg of BDP + 2814 mg / kg of S.
Chronic toxicity
The administration of the combination by inhalation in the rat (26 wk.) And the dog (26 wk.) Was well tolerated up to dosages well above those foreseen in therapy.
The administration of the aerosol for 14 days in the dog did not cause any manifestation of local intolerance.
Fetal toxicity and study of the effects on fertility
From studies performed in rats and rabbits, it appears that the combination administered by inhalation does not have any negative effects on the reproductive sphere.
Mutagenesis
The product is not mutagenic.
Preclinical data on CFC-free propellant HFA-134a reveal no special hazard for humans based on conventional studies on safety pharmacology, repeated toxicity, carcinogenic potential genotoxicity and reproductive toxicity.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
HFA 134a (norflurane), anhydrous ethyl alcohol, oleic acid.
06.2 Incompatibility
Not relevant.
06.3 Period of validity
2 years.
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.
Store taking care to avoid accidental dispensing.
06.5 Nature of the immediate packaging and contents of the package
Internal packaging: pressurized container in monobloc aluminum, dosing valve with inverted functioning, traditional dispenser button with protective cap, JET dispenser-spacer device in polypropylene and interlocking protective cap.
External packaging: printed cardboard box.
Packaging: pressurized container with standard dispenser and empty JET dispenser-spacer sufficient for 200 inhalations
06.6 Instructions for use and handling
Instructions for Use
Before using the medicine for the first time, or if the medicine is not used for 7 days or more, two puffs should be injected to make sure the dispenser is working properly.
Standard dispenser
In use, carefully follow the instructions below:
1) Remove the protective cap.
2) Hold the regulator between your thumb and forefinger, with the mouthpiece at the bottom.
3) Shake vigorously without pressing.
4) Place the mouthpiece between your lips tightly closed after taking a full exhalation.
5) Breathe in long and deeply with your mouth only, at the same time firmly press the index finger once. Avoid partial dispensing.
At the end of the inhalation, hold your breath as long as possible.
At the end of the inhalations, close the mouthpiece with the protective cap. The mouthpiece must always be kept clean.
Jet device
In use, carefully follow the instructions below:
1) Remove the pressurized container from the standard dispenser and insert it into the Jet device.
2) Remove the protective cap from the JET and hold it.
3) Shake vigorously without pressing.
4) Exhale completely and then place the mouthpiece between your lips tightly closed.
5) Press the index finger firmly on the container under pressure and inhale deeply even after a few moments (it is possible to perform even more inspiratory acts through the JET).
Avoid partial dispensing.
6) At the end of the inhalation, hold the breath as long as possible and close the JET with the special protective cap.
CLEANING
The dispenser must be cleaned at least every 3 days from the beginning of its use.
Keeping the dispenser clean is extremely important to prevent blockage due to clogging. If cleaning is not performed regularly as directed, the dispenser may block or malfunction.
Follow the cleaning instructions below:
• Remove the protective plastic cap
• Remove the metal can from the plastic mouthpiece
• Wash the body of the plastic mouthpiece from the bottom for one minute with hot running water, placing it under the stream of running water
4. Rotate the mouthpiece and wash the upper part of the mouthpiece for an additional minute with warm running water, placing it under the stream of water.
• Carefully remove the water remaining inside the plastic mouthpiece by repeatedly beating it in moderation against a hard surface. Check that no water remains in the central cavity of the plastic mouthpiece into which the stem of the metal can fits.
• Carefully dry the body of the plastic mouthpiece both internally and externally, for example by leaving it in the air overnight without a metal can and protective cap, or by using a jet of hot air. Make sure the mouthpiece is completely dry before use.
• Put the metal can back in the regulator and the protective cap on the mouthpiece
IMPORTANT:
Do not use the mouthpiece still wet, make sure it is completely dry before using it.Using the wet mouthpiece can promote obstruction and blockage of the regulator.
In case of need, if the standard dispenser is not dry, use the JET dispenser included in the package.
If the dispenser should block:
Perform cleaning steps 1 to 7.
Dispense an empty dose to verify the removal of the obstruction before proceeding to normal use.
To clean the Jet regulator, perform the same steps as for the standard regulator cleaning procedure from 1 to 7.
07.0 MARKETING AUTHORIZATION HOLDER
PROMEDICA S.r.l. - Via Palermo 26 / A - 43122 Parma
08.0 MARKETING AUTHORIZATION NUMBER
CLENIL COMPOSITUM 250 mcg + 100 mcg pressurized suspension for inhalation - 1 pressurized container of 200 puffs with standard dispenser and Jet AIC dispenser n. 023440062
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
25/07/1994
10.0 DATE OF REVISION OF THE TEXT
AIFA Determination of 9 December 2013
