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ERVA 250µg/dose

ERVA® 250 micrograms
Fluticasone propionate
Suspension for inhalation in pressurized canister
DRUG IDENTIFICATION

ERVA 250µg/dose

ERVA® 250 micrograms
Fluticasone propionate
Suspension for inhalation in pressurized canister
DRUG IDENTIFICATION

Composition

Fluticasone propionate 250 micrograms

Excipients: oleic acid, anhydrous ethanol,Propellant: norflurane (HFA 134a) s.q.f one dose.

Pharmaceutical form

Suspension for inhalation.
Canister containing 120 doses.

Pharmacotherapeutic class:

Inhaled glucocorticoid. Anti-asthmatic.
Code ATC : R03BA05

Holder

BERG life sciences

Address :Z.I. Hammam Zriba 1152 Zaghouan- Tunisia

Manufacturer

BERG life sciences

Address :Z.I. Hammam Zriba 1152 Zaghouan- Tunisia

Manufacturer

– This drug is a corticosteroid that is administered by inhalation.

– It is an anti-inflammatory medication recommended in regular doses for the continuous treatment of persistent asthma *.

* Persistent asthma is defined by the existence of daytime symptoms lasting several weeks and / or nighttime symptoms more than twice a month.

– It should not be interrupted without medical advice, even in the event of a marked improvement in symptoms.

Warning : This medication is not a bronchodilator.
It does not allow the treatment of an asthma attack.

– It does not bring immediate relief. It is in particular without action on the declared asthma attack. Its effectiveness only manifests itself after several days and depends on the strict observance of the dosage (dose and number of doses) prescribed by your doctor and adapted to your case.

This drug should not be used if:
– Hypersensitivity to any of the compounds.
– In case of an increase in respiratory discomfort following inhalation of this product, don’t take again, but contact your doctor.
IN CASE OF DOUBT, IT IS ESSENTIAL TO FOLLOW THE ADVICE OF YOUR DOCTOR OR PHARMACIST.

In case of asthma attack or breathing difficulties, you should use another drug “short-acting short-acting inhaled beta-2 bronchodilator” that your doctor has prescribed for this purpose.

The relief usually obtained with the inhaled beta-2 bronchodilator should then be observed quickly.
IN CASE OF FAILURE CONSULT A DOCTOR IMMEDIATELY.

If the usually effective dose of this drug becomes insufficient, if attacks or episodes of respiratory discomfort become more frequent, there is a fear of worsening of the disease, consult your doctor quickly who will reassess your treatment.

If you have diabetes, your doctor will monitor your treatment more carefully

Contact your doctor in case of blurred vision or visual disturbances

– This product, administered by inhalation must reach the extremity of small bronchi to act effectively.

In case of obstruction of the respiratory tract (by profuse mucus) or infection, its effectiveness may be reduced.

Your doctor should be consulted quickly so that he can initiate appropriate treatment for you.

IN CASE OF DOUBT DO NOT HESITATE TO ASK FOR THE OPINION OF YOUR DOCTOR OR PHRMACIST.

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription, including certain medicines made with ketoconazole, cobicistat or ritonavir.

This medication will only be used during pregnancy on the advice of your doctor. If you discover that you are pregnant during treatment, consult your doctor as only he can judge the treatment best suited to your case.

In general, it is advisable during pregnancy and breast-feeding to follow the advice of your doctor or pharmacist before taking any medicine.

Please note this specialty contains an active ingredient which can induce a positive reaction from the tests carried out during doping controls.

Inhalation with a mouth nozzle inhaler.
Exclusive inhaled route.

The efficiency of this drug is partly dependent on the proper use of the dispensing device. The instructions for use should therefore be read very carefully. If necessary, don’t hesitate to ask your doctor for detailed explanations.

-Check the absence of foreign bodies inside and outside the aerosol including in the mouthpiece
-After shaking the appliance, remove the cap (fig. 1).
– Empty your lungs while breathing out deeply (fig. 2)
– Present the mouthpiece at the entrance to the mouth, the bottom of the metal cartridge facing up (fig. 3).
– Start to inhale and press on 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).
-Check your inhalation technique in front of a mirror. If a large quantity of product escapes through the nose or mouth, the following points should be monitored: either the pressure on the metal cartridge took place before the start or after the end of inspiration, or inspiration n was not deep enough.

– For hygienic reasons, the mouthpiece should be cleaned after each use.
– Your metered dose inhaler should be cleaned at least once a week.

Like any active product, this medication can cause side effects, although not everybody gets them:

– As with other inhaled products; there may rarely be an increase in respiratory discomfort following inhalation of the product. In this case don’t take it again but contact your doctor.
– In case of persistent discomfort in the mouth or throat, tell your doctor, do not modify or stop the treatment without his advice.

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Very frequently: oral and pharyngeal candidiasis. It does not necessarily require a cessation of this treatment but the initiation of a specific treatment. It can be prevented by rinsing your mouth after inhaling the product.

– Frequently:

-Hoarseness of voice and bruises
-Cases of allergic rashes

Uncommon
– Hypersensitivity skin reactions

Rarely
-sophageal candidiasis, possibility of sleep disturbance anxiety, agitation, feeling of nervousness, behavioral disorder, such as hyperexcitation or irritability. These effects occur mainly in children.

Very rarely

-Angioedema (mainly facial and oropharyngeal edema), respiratory symptoms (dyspnea and / or bronchospasm) and anaphylactic reactions

-Cushing’s syndrome, cushingoid symptoms, inhibition of adrenal function, decreased bone mineral density, slower growth in children and adolescents.
– Hyperglycemia
-Anxiety, sleep disturbances and behavioral changes including psychomotor hyperactivity and irritability (mainly in children).

-Possibility of glaucoma (Eye condition linked to increased pressure inside the eye), or cataract (clouding of the lens of the eye, usually causing visual discomfort).

-Possibility of glaucoma (Eye condition linked to increased pressure inside the eye), or cataract (clouding of the lens of the eye, usually causing visual discomfort).

In case of blurred vision or eye pain, see your doctor.

Indefinite Frequency: Possibility of depression (Especially in children).

Unknown frequency: Epistaxis

IF IN DOUBT, DO NOT HESITATE TO PREVENT YOUR DOCTOR.
TELL YOUR PHYSICIAN OR PHRMACIST OF ANY UNWANTED AND UNSUITABLE EFFECT THAT WOULD NOT BE MENTIONED IN THIS MANUAL.

HOW TO STORE THIS MEDICINE?

Keep out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the box.
Do not store above 25 ° C.
Pressurized container: do not expose to a temperature above + 50 ° C, nor in the sun, do not pierce, or throw into a fire, even empty.

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