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Cyvax 250µg/25µg

CYVAX® 250 micrograms/25 micrograms
CFC-FREE INHALER Fluticasone Propionate/Salmeterol
Suspension for inhalation in pressurized canister

Cyvax 250µg/25µg

CYVAX® 250 micrograms/25 micrograms
CFC-FREE INHALER Fluticasone Propionate/Salmeterol
Suspension for inhalation in pressurized canister

DRUG IDENTIFICATION

Compositions

Fluticasone Propionate..250mcg
Salmeterol Xinafoate…36,8 mcg
Quantity corresponding to Salmeterol .. 25mcg

Excipients: Oleic Acid, anhydrous Ethanol, propellant gas norflurane (tetrafluoroethane or HFA 134a) s.q.f. one dose.
This product does not contain the CFC (harmful substance for the ozone layer).

Pharmaceutical form and contents

Suspension for inhalation in pressurized canister.
Canister of 120 doses.

Pharmacological therapeutic class:

Cyvax® is a bronchodilator – anti-asthmatic, associating two active substances:

Salmeterol Xinafoate: beta-2 mimetic bronchodilator of long duration of action.

Fluticasone Propionate:anti-inflammatory steroidal. (R: Respiratory system)

WHEN TO USE CYVAX® 250 mcg/25 mcg?

This drug is recommended for the continuous asthma treatment, in the following situations:

– Patients not adequately controlled by inhaled corticosteroids and taking an inhaled beta-2 mimetic bronchodilator short-acting “on demand”.

-Patients controlled by the administration of inhaled corticosteroid combined with continuous treatment with inhaled beta-2 mimetic long-acting.

Over-sensitiveness (allergy) known in Fluticasone Propionate, Salmeterol Xinafoate or with the one of its excipients
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.

In the case of occurence of crises or respiratory difficulty, it is necessary to use another drug “bronchodilator beta2 mimetic by inhaled way with fast action and of short duration” that your doctor will have prescribed you to this aim. If a patient develops in a few days a fast increase in his consumption as a mimetic bronchodilator beta-2 of fast action and short duration by inhaled way to treat the symptoms, it is a sign of a destabilization of your disease. In this case, the patient will have to consult his doctor.

The doctors must remain vigilant on the possible occurrence of a low pneumonia or other respiratory infections among patients who were affected by the chronic obstructive pulmonary disease (COPD).

The treatment by CYVAX® 250mcg/25mcg should not be initiated during an exacerbation phase, nor in the case of significant aggravation or of acute deterioration of asthma.

This product, active by inhalation route, must reach the extremity of small bronchi. In case of respiratory airways obstruction (mucosal hyper secretion) or infection, its efficiency can be decreased. It is advised to consult your doctor rapidly, in order to initiate an adapted treatment.

Your doctor will watch over more attentively your treatment whether you have medical problems such as:

•An adrenal function impaired, or slowed down by the long corticotherapy.
•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 take or have recently taken any other medicine, tell your doctor or pharmacist about it.
Before start using Cyvax® , inform your doctor that you have taken the following drugs:
-The other beta-adrenergic that can potentiate the effects of beta-2 mimetics.

-Antiviral and antifungal treatments (such as the treatments containing the ritonavir, the ketoconazole and the itraconazole). Some of these drugs can increase the rate of Fluticasone Propionate or the Salmeterol in your body. This can increase the risk of having unwanted effects with Cyvax® .

-Corticoids (by oral or injectable route). If you have recently taken these drugs , there is a risk that this drug has an effect on the suprarenal glands of your body.

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.

This drug product contains two active ingredients which can induce a positive reaction in anti-dumping control tests.

Posology

Posology is strictly individual and will be adapted by your doctor according to the severity of your asthma.

This drug is reserved only for the adults and 12 year old teenagers and more.

Moderate asthma:
An inhalation of 250mcg of Fluticasone Propionate and 25mcg of Salmeterol Xinafoate twice per day ( in the morning and evening).
Severe asthma:

Two inhalations of 250mcg of Fluticasone Propionate and 25mcg of Salmeterol Xinafoate twice per day ( in the morning and evening).
If you use Cyvax® for the treatment of your asthma, your doctor will wish to verify regularly your clinical state.

IN ALL CASES YOU HAVE TO CONFORM STRICTLY TO THE PRESCRIPTION OF YOUR DOCTOR.
IN CASE OF PERSISTENCE OR DISORDERS, CONSULT YOUR DOCTOR IMPERATIVELY.

Inhalation with a mouth nozzle inhaler.
Exclusive inhaled route.
The efficiency of this drug is in part depending on good use of the inhaler device.
Mode 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).
-Rinse your mouth with water and spit it. This will prevent the occurrence of candidacies and hoarse voice.

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 canister was done before the beginning or after the end of expiration, or the inspiration was not deep enough.

In case you have difficulty 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 the canister 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.

The use of 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.

Overdose

In case of accidental taking of a dose to an amount higher than the dose recommended, contact your doctor and your pharmacist. You can feel an acceleration in the heart rhythm , tremors, headaches, a muscular weakness and joint pains.

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In case of the administration of higher doses during a long period, a decrease of the steroidal hormones secreted by suprarenal glands is possible. If this is your case tell your doctor or your pharmacist about it.

In case of infection or stress conditions, similar unwanted effects can be felt.
UNDESIRABLE SIDE EFFECTS:

As for all active products, this drug can give to some persons, some side effects.

Very Frequent undesirable effects (≥1/10):
-Headache.
-Rhinopharyngitis.

Frequent undesirable effects (between 1/100 and 1/10):

-Candidose of the mouth and the throat. Also tongue and throat are irritated, and the rasping voice. Rinse your mouth with some water and spit it immediately after every taking this can avoid those effects.

-Decrease of the quantity of potassium in your blood (which can be manifested by the palpitations, a muscular weakness, and cramps).
-Muscular cramps, arthralgia and myalgia
– Pneumonia and bronchiti. Contact your doctor in case where there is: increasing of quantity of spits, change in the coloring of spits, fever, shivers, increase of the cough, and increase of the respiratory problems.
-Sinusitis
-Bruises and traumatic fractures.

Uncommon undesirable effects (between 1/1000 and 1/100):

-Cutaneous hypersensitivity reaction (urticaria).
-Accelerated heart rhythm.
-Hyperglycemia. If you are a diabetic, more frequent controls of glycemia and a possible adjustment of your anti-diabetic treatment can be necessary.
-Cataract
-Anxiety, sleeping disorders

Rare undesirable effects (between 1/10000 and 1/1000):

-Hypersensitivity reaction of angioedema type (facial and oropharyngeal edema), anaphylactic reaction including the anaphylactic shock, bronchospasm

-Inhibition of the adrenal function syndrome of Cushing and Cushing-like table.

-Slowing down of the growth of child and teenager and a thinning down of the osseous weft

-Glaucoma

-Irregularity of the heart rhythm (arrhythmia)

-Behaviour modifications with hyperactivity and irritability.

IN CASE OF DOUBT, DO NOT HESITATE TO CONTACT YOUR DOCTOR.

If you notice undesirable side effects not mentioned in this leaflet, or if certain undesirable side effects have become serious, please inform your doctor or your pharmacist.

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•Do not exceed the expiration date indicated on the external packaging.
• To preserve in a temperature not exceeding 25°C.
• Do not store this drug in a very cold place, as it may not be effective

Particular precautions of storage:

Canister under pressure: Do not expose to excessive heat and freeze.
Do not break, pierce, nor throw even empty.
To preserve in a temperature < 25°C AMM N°: 928 304 1 10