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CYVAX 125µg/25µg/dose

CYVAX125micrograms/25 micrograms
Fluticasone Propionate/Salmeterol
Suspension for inhalation in pressurized canister

CYVAX 125µg/25µg/dose

CYVAX125micrograms/25 micrograms
Fluticasone Propionate/Salmeterol
Suspension for inhalation in pressurized canister

DRUG IDENTIFICATION

Compositions:

Fluticasone Propionate…125mcg
Salmeterol.. 25mcg

Quantity corresponding to Salmeterol Xinafoate… 36,8 mcg

Excipients: Oleic Acid, propellant gas norflurane (tetrafluoroethane or HFA 134a)

Excipient with known effect: anhydrous ethanol

s.q.f. one dose.

Pharmaceutical form:

Suspension for inhalation
Canister of 120 doses.

Pharmacological therapeutic class:
– X +
Holder
BERG life sciences
I.A. of Hammam Zriba,1152 Zaghouan – Tunisia.

Manufacturer

BERG life sciences
I.A. of Hammam Zriba,1152 Zaghouan – Tunisia.

WHEN TO USE CYVAX 125 mcg/25 mcg?
CYVAX is recommended for the continuous asthma treatment, when the administration via inhaled route of a medicine combining a corticosteroid and long-actingbeta-2 mimetic bronchodilator is justified for:
-Patients not adequately controlled by inhaled corticosteroids and taking a short –acting inhaled beta-2 mimetic bronchodilator “on demand”.
or
-Patients controlled by the administration of inhaled corticosteroid combined with continuous treatment with long-acting inhaled beta-2 mimetic.

Hypersensitivity to Fluticasone Propionate, Salmeterol Xinafoate or one of its excipients
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.

  • Cardiac pathology including arrhythmias (tachycardia or bradycardia).
  • Hyperthyroidism
  • Hypertension
  • Diabetes ( Cyvax could cause high level of glucose )
  • Hypokalemia
  • Tuberculosis in the current course of evolution or has occurred in the past.

Once you have already one of those problems, tell your doctor about it before using CYVAX.

If you are pregnant, or you are planning to be, or you are breast feeding inform your doctor before taking CYVAX®. Your doctor will assess with you whether CYVAX®is the best treatment adapted to your state or not.
In general, during pregnancy or breast feeding, it is best to always ask for doctor or pharmacist opinion before taking any medication.

This drug product contains two active ingredients which can induce a positive reaction during anti-doping control.

Posology

– Use CYVAX every day until your doctor tells you otherwise.
– Always use CYVAX beta 2 mimetic as prescribed by your doctor

Adults and adolescents over 12
• Two inhalations twice a day (morning and evening).

Your symptoms should be well controlled using CYVAX twice daily. If so, your doctor may decide to reduce your doses to a single one per day.

Your dose could therefore be reduced to:
• 01 inhalation at night if you have symptoms at night,
Or
•01 inhalation in the morning if you have symptoms during the day,

It is very important to follow the indications prescribed by your doctor concerning the number of puffs to inhale or the time interval between intakes

If you are using CYVAX for the treatment of your asthma, your doctor will want to regularly check your clinical condition.

If your asthma or shortness of breath worsens, consult your doctor immediately. If you experience more severe bronchial whistles, more chest tightness, or more need to use your emergency bronchodilator treatment, continue to use CYVAX without increasing the number of puffs.

If your condition worsens, consult your doctor as you may need additional treatment.

IN ALL CASES YOU HAVE TO CONFORM STRICTLY TO THE PRESCRIPTION OF YOUR DOCTOR.

IN CASE OF PERSISTENCE OR AGGRAVATION OF YOUR STATE, CONSULT YOUR DOCTOR IMPERATIVELY.

Inhalation with a mouth nozzle inhaler.
Exclusively inhaled route
The efficiency of this drug is, in part, depending on good use of the inhalation device.therefore, you need to read attentively the method of use . when needed, don’t hesitate to ask your doctor for more detailed information.

Method of use

-After shaking the actuator with the canister, take off the cap (fig. 1).

-Empty your lungs by a forced expiration (fig. 2).
-Present the mouth nozzle to your mouth, the back of the canister to the top (fig. 3).

-Begin to inspire and press on the canister and continue to inspire slowly and deeply (fig. 3).

-Retire the mouth nozzle from your mouth and hold your breath for 10 seconds at least (fig. 4).

-The mouth nozzle should be cleaned before and after use.

Check your inhalation technique in front of a mirror, if a large quantity of product escapes through your 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 inspiration, or the inspiration was not deep enough.

In case you have difficulty in using the inhalation system (especially for young children), your doctor may advise you to use an inhalation chamber.

The product must be inhaled immediately after each puff or after each series of successive puffs of the metered dose inhaler in the inhalation chamber.

How to clean your metered dose inhaler?
Your actuator should be cleaned at least once a week.

-Separate thecanister from the actuator and take off the cap.
-Rinse carefully the actuator with lukewarm water.
-Dry carefully the actuator from inside and outside.
-Once these operations are finished, replace the canister and the cap.
-Do not plunge the canister in water.

As for all active products, this drug can give to some persons, some effects more or less uncomfortable. In order to prevent undesirable effects, your doctor will prescribe the minimum dose able to control your asthma

Allergic reaction: you may notice that a worsening of your shortness of breath immediately after using Cyvax. You may experience bronchial whistles and caugh. You may also experience itching and swelling (generally face,lips, tongue, and throat).
If you experience these symptoms or they appear immediately after taking cyvax , consult your doctor immediately.

Allergic reactions of cyvax are very rare, affecting 1 person on 10000.

Other undesirable effects:

Very Frequent undesirable effects (≥1/10):

-Headache , generally decreasing after continuing the treatment

-Cold

Frequent undesirable effects (less than 1/10):

-Candidacies of the mouth and the throat (sometimes dolorous). Also tongue and throat are irritated, and rasping voice. Rinse your mouth with some water and spit it immediately after every taking this can avoid those effects. Your doctor will prescribe an antifungal treatment to treat the Candidaciesb

-Dither and irregular or rapid heartbeat (palpitations) which appears when starting the treatment
This is generally mild and disappears while continuing the treatment.

– Muscular cramps,arthralgia and myalgia.

The following undesirable effects mmay appear in case of patients with chronic obstructive pulmonary disease ( COPD):

-Pneumonia and bronchitis (respiratoryinfection) Contact your doctor in case of : sputum production increase, change of sputum color, fever, chills, cough increased, of the respiratory difficulties increase .

-Bruises and traumatic fractures.

-Inflammation of sinus ( sensation of tension or heaviness in the face , cheeks and behind the eyes, sometimes with a throbbing pain)
-Hypokalemia ( maybe experienced by palpitations , muscles weakness, cramps)

Infrequent effects (less than 1/100):

-Cutaneous hypersensitivity reaction (urticaria).
-Increased heart rate ( tachycardia)

Very rare effects (less than 1/10000)

-Abrupt onset of respiratory difficulties or bronchial whistles immediately after Cyvax inhalation. In this case , stop using Cyvax , instead, use your rescue bronchodilator medicine to help you breath and contact your doctor immediately.

-Cyvax may affect the organism normal production of steroid hormones (produced by adrenal glands), particularly if you have used high doses over extended periods of time. The effects are :

• Reduced growth in adolescents
• Bone –thinning
• Cataract ( clouding of the eye’s lens causing visual difficulties) , and glaucoma ( increase of the intraocular pressure )
• Weight gain
• Rounding of the face (Moon shape ) ( Cushing syndrome)
Your doctor will make sure regularly that you don’t experience any of the side effects by prescribing the minimum sufficient dose to control your asthma

– In case of arrhythmia, contact your doctor, but no need to systematically stop your treatment unless told by your doctor.

– In case of diabetes, more frequent glucose level controls and adjustment of your anti-diabetic treatment might be necessary

-Arthralgia and myalgia may appear.

If you notice other side effects not mentioned in this leaflet, please inform your doctor or your pharmacist.

Do not exceed the expiration date indicated on the external packaging.
Store at temperature not exceeding 25°C.
Canister under pressure: Do not expose to temperature exceeding +50°C nor to sun
Do not break, pierce, nor burn even empty.

AMM N°: 928 304 2