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CORTIS 50µg

CORTIS® 50 micrograms
Beclomethasone Dipropionate

CORTIS 50µg

CORTIS® 50 micrograms
Beclomethasone Dipropionate

Suspension for inhalation in Metered dose inhaler

Drug identification

Name:

Cortis® 50 micrograms/dose, suspension for inhalation in pressurized bottle.

Qualitative composition:

Beclomethasone Dipropionate
Excipients: Anhydrous Glycerol, Ethanol Anhydrous
Propellant Gas: HFA 134a (Norflurane)

Quantitative composition:

Beclomethasone Dipropionate: 50 micrograms/ dose

Pharmaceutical form:

Suspension for inhalation.

Pressurized canister of 200 inhalations, each inhalation contains 50 micrograms of Beclomethasone Dipropionate.

The drug doesn’t contain any harmful substance for the ozone layer.

Pharmaco therapeutic class:

Inhaled Glucocorticoïde, antiasthmatic

Holder name:

BERG Life Sciences Laboratories.

Address :Z.I Zriba Hammam-1152 Zaghouan

Manufactured by:

BERG Life Sciences Laboratories.

Address :Z.I Zriba Hammam-1152 Zaghouan

When to use this drug:

Continuous anti-inflammatory treatment of persistent asthma *
* Persistent asthma is defined by the existence of multi-weekly diurnal symptoms and/or nocturnal symptoms more than twice a month.

In case of mild persistent asthma of children, in the absence of final data about the consequence of corticoids administration via inhaled route on the growth and bone metabolism, it is advisable to start a continuous basic treatment by cromone, before switching, if this treatment failed, to an inhaled corticoids’ treatment.

Tuberculosis infections (active or quiescent) and local viral, individual hypersensitivity to cortisones.

Generally inadvisable during pregnancy and lactation (see special warning).

in case of doubt, it is essential to seek the advice of your doctor or pharmacist.

Cortis® is not effective in treating reported asthma attacks; On the other hand, it constitutes a basic treatment of asthmatic disease, which is why the dose should be taken at the prescribed doses according to the doctor’s advice.

Treatment in patients already receiving systemic corticosteroids requires special precautions and strict medical supervision, as the reactivation of adrenal function, which is dormant following systemic corticosteroid therapy, is slow.

Initially, Cortis must be administered without interrupting the systemic therapy, and then the dosage must be reduced progressively while controlling the patient at regular intervals (precisely periodic control of the adrenocortical function) and modifying the posology according to the results.

During period of stress or serious asthmatic attacks, patients should undergo an additional treatment with systemic steroids. Patients should be informed that the product contains small quantities of ethanol and glycerol. These quantities are negligible and don’t constitute a risk for the patients to therapeutic doses normally administrated. Because the presence of alcohol, the product must be used however with precaution at patients suffering from hepatic pathology, of alcoholism (see medicinal interactions), of epilepsy and cerebral pathology.

Cortis® contains a small amount of ethanol. There is the theoretical possibility of interaction with disulfiram or metronidazole in particularly sensitive patients treated with these drugs.

Pregnant women administer the product only in case of actual need and under direct medical supervision. For mankind, existing data on the safety of use of beclometasone dipropionate or HFA 134a during pregnancy are insufficient. Administration of the product during pregnancy and lactation should be considered only if the predictable benefit to the mother outweighs the potential risks to the fetus. It is legitimate to consider that at doses used in inhalation, breast milk does not contain high levels of beclometasone.

Children born to mothers who have taken large doses of inhaled corticosteroids during pregnancy should be carefully observed for possible hyposigenralism.


Studies on the effects of HFA 134a propellant on reproduction and embryo-fetal development in animals did not reveal any significant adverse effects. It is therefore unlikely that adverse effects will be detected in humans.

Be careful, this drug contains an active ingredient which can induce a positive reaction in anti-dumping control tests.
How to use this drug
Posology

Posology is strictly individual and will be adjusted by your doctor depending on the severity of the disease.

– In mild or moderate persistent asthma, the recommended dose is between:

Adults: 500 to 1000 mcg daily equivalent to 2 – 4 inhalations per day.

Children: 250 to 500 mcg daily equivalent to 1 – 2 inhalations per day.

– In severe persistent asthma, the recommended dose is:

Adults: 2000 mg per day equivalent to 8 inhalations per day.
Children: 1000 mcg daily equivalent to 4 inhalations per day.
Treatment with Cortis® should not be abruptly interrupted.

Inhalation with a mouth nozzle inhaler.
Exclusive respiratory route
The efficiency of this drug is, in part, depending on good use of the inhaler device.

– After shaking the appliance, remove the cap (Fig. 1).
– Drain your lungs by exhaling deeply (Fig. 2).
– Place the mouthpiece at the entrance of the mouth with the bottom of the metal cartridge facing up (Fig. 3).

– Begin to breathe in and squeeze the metal cartridge while continuing to inhale slowly and deeply (Fig. 3).

– Remove the mouthpiece from the mouth and hold your breath for at least 10 seconds (Fig. 4).

– For hygiene reasons, the mouthpiece must be cleaned after use.

– For hygiene reasons, the mouthpiece must be cleaned after use.

Control your inhalation technique in front of a mirror, if an important amount of product gets out from the mouth or the nose, these points are to be monitored: either the pressure on the metallic cartridge was done before the beginning or after the end of expiration, or the inspiration was not deep enough.

Follow your doctor’s prescription.

What to do in case of overdosing

Consult a doctor

Undesirable side effects

Systemic side effects are quite unlikely at the recommended doses; Patients should be under strict control during prolonged treatment to detect the onset of systemic manifestations (osteoporosis, peptic ulcer, signs of secondary adrenocortical insufficiency, such as hypotension and weight loss) in a timely manner. ), and avoid, in the latter case, very serious accidents of acute hyposigenalism.

Inhalation of high doses (≥ 1500mcg / day) for long periods may cause adrenal weakness.

As with any inhaled drug, there is a risk of paradoxical bronchial spasm.

Following the instructions in the package leaflet reduces the risk of adverse effects. It is important to tell your doctor or pharmacist if you have any side effects, even if they are not listed in the package leaflet.

Do not exceed the expiry date indicated on the external packaging.
Special precautions for storage

Pressurized container: do not expose to excessive heat (≤ 30 ° C)
Do not pierce or throw in fire even if empty