CLENIL FORTE SPRAY Pressurised inhalation solution (2019)

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

Clenil forte SPRAY 250mcg pressurised inhalation solution.

2. Qualitative and quantitative composition

Each canister contains: Active ingredient: Beclometasone-17,21-dipropionate 50mg (each actuation delivers 250 micrograms). For the full list of excipients, see section 6.1.

3. Pharmaceutical form

Pressurised inhalation solution (containing HFA 134a norflurane as propellant). It does not contain any substance damaging to the ozonosphere.

4.1. Therapeutic indications

Prophylactic control of the asthmatic disease and of bronchostenotic conditions in those patients who do not obtain a satisfactory control of symptoms with the usual doses of beclometasone dipropionate ...

4.2. Posology and method of administration

Adults Usually 2 inhalations twice a day. Should it be deemed suitable, posology can also be fractioned into 1 inhalation 4 times a day. In case of need, posology can be increased up to 2 inhalations 3-4 ...

4.3. Contraindications

Tuberculosis (active or quiescent) and viral local infections. Individual hypersensitivity to cortisones or to any of the ingredients. Generally contraindicated in pregnancy and lactation (see paragraph ...

4.4. Special warnings and precautions for use

Patients should be instructed on the proper use of the inhaler. They should also be made aware of the prophylactic nature of therapy with Clenil Forte and that, for optimum benefits, they should use it ...

4.5. Interaction with other medicinal products and other forms of interaction

CLENIL contains a small amount of ethanol. There is the theoretical potential for interaction in particularly sensitive patients taking disulfiram or metronidazole. Beclometasone is less dependent on CYP3A ...

4.6. Fertility, pregnancy and lactation

There is inadequate evidence in human pregnancy. Administration of corticosteroids to pregnant animals can cause abnormalities of fetal development including cleft palate and intra-uterine growth retardation. ...

4.7. Effects on ability to drive and use machines

None reported.

4.8. Undesirable effects

Adverse events are listed below by systemic organ class according to MedDRA and frequency. Frequencies are defined as: very common (1/10), common (≥1/100 and <1/10), uncommon (≥1/1,000 and <1/100), rare ...

4.9. Overdose

Acute Inhalation of the drug in doses in excess of those recommended may lead to temporary suppression of adrenal function. This does not require emergency action. In these patients treatment should be ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Respiratory system, other anti-asthmatics, inhalation remedies, corticosteroids ATC code: R03BA01 CLENIL contains beclometasone 17,21-dipropionate as its active ...

5.2. Pharmacokinetic properties

Kinetic studies with labelled beclometasone dipropionate showed that after inhalation of a high dose, only 20-25% is absorbed. A part of the administered dose is swallowed and eliminated with feces. The ...

5.3. Preclinical safety data

Acute toxicity: by oral route, in rat and mouse, LD50 values are higher than 3000mg/Kg. By nebulization, in rat and mouse, exposures to concentrations of 100mcg/l for 30 minutes are well ...

6.1. List of excipients

HFA 134a (norflurane, ethanol, glycerol)

6.2. Incompatibilities

None reported.

6.3. Shelf life

36 months. This period is intended for the medicinal product in its unopened and correctly stored packaging.

6.4. Special precautions for storage

The therapeutic effect, may decrease when the canister is cold. The pressurised contained should not be pierced and should be protected from heat sources, even when apparently empty. It must neither be ...

6.5. Nature and contents of container

Primary package: pressurised aluminium canister fitted with metering valve, actuator and protecting cap. Outer package: printed thin cardboard box. Pressurised canister providing 200 inhalations.

6.6. Special precautions for disposal and other handling

The successful result of treatment depends on the correct use of the inhaler. Inhalers working test: before using the inhaler for the first time or if it has not been used for three days or more, remove ...

7. Marketing authorization holder

Chiesi Hellas A.E.B.E., Geroulanou sq & 1, Renou Poggi str., 17455 Alimos, Greece

8. Marketing authorization number(s)

12678

9. Date of first authorization / renewal of the authorization

5th August 1989 / 22nd February 2000

10. Date of revision of the text

30/04/2019

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