CLENIL FORTE SPRAY Pressurised inhalation solution Ref.[28229] Active ingredients: Beclometasone

Source: Υπουργείο Υγείας (CY)  Revision Year: 2019  Publisher: Chiesi Hellas A.E.B.E., Geroulanou sq & 1, Renou Poggi str., 17455 Alimos, Greece

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 by inhalation.

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 times a day.

Therapy with CLENIL should not be abruptly interrupted.

Children

CLENIL 250mcg is not suitable for pediatric use.

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 continued at a dose sufficient to control asthma; adrenal function recovers in a few days and can be verified by measuring plasma cortisol.

Chronic

Use of inhaled beclamethasone dipropionate in daily doses in excess of 1,500 micrograms over prolonged periods may lead to adrenal suppression. Monitoring of adrenal reserve may be indicated. Treatment should be continued at a dose sufficient to control asthma.

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 frozen nor exposed to direct sunlight. Store below 30°C.

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. Inhaler’s working test: before using the inhaler for the first time or if it has not been used for three days or more, remove the mouthpiece protective closure by softly pressing it on its sides and press once in the air to release an actuation, so as to verify the correct working of the inhaler.

For use, carefully follow the following instructions:

  1. hold the actuator between thumb and index finger, with the mouthpiece downwards;
  2. remove the protective cap;
  3. place the mouthpiece firmly between the lips and make a complete breath;
  4. make a long and deep inspiration with the mouth only and, at the same time press once only with the index finger.

Once the inspiration is complete, hold breath as long as possible.

When inhalations are completed, close the mouthpiece again with the protective cap. The mouthpiece should always be kept clean. Cleaning should be made with lukewarm water, after having extracted the pressurised canister.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

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