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RAFOREX 12µg

RAFOREX®12 micrograms
FormoterolFumarate
Suspension for inhalation in pressurized canister

RAFOREX 12µg

RAFOREX®12 micrograms
FormoterolFumarate
Suspension for inhalation in pressurized canister

COMPOSITION

Each inhalation contains:
formoterolfumarate…………………… 12 microgram

Excipients :Anhydrous ethanol, Hydrochloricacid 1N, HFA 134a (Norflurane)

PHARMACEUTICAL FORM AND CONTENT:

Suspension for inhalation in pressurized canister.
Canister contains100 doses.

The product does not containany substance that is harmful for the ozone layer.

Pharmaco- therapeutic class :

Selective beta 2-adrenergic receptors agonist.

Prevention and treatment of bronchospasmsforthe patients that are affected bychronic obstructive pulmonary disease(bronchial asthmaand chronic bronchitis, with or without emphysema), and bronchospasm induced by allergens, stress or cold. The action of thisdrug is considered particularly prolonged (until12 hours), a maintenance treatmentof two doses per day allows to control, at day and night time, the bronchospastic forms arefrequently identified in thechronic obstructive pulmonary disease.

Hypersensitivityregarding the active ingredient, excipents orother substances that are tightly correlatedto the chemical plans. Tachyarrhythmia, atrioventricular blockof third degree idiopathic hypertrophic subaortic stenosis, hypertrophic obstructive cardiomyopathy, syndrome of the extended interval Q-T, idiopathic or inducedby drugs (QTc interval > 0,44 seconds), severe hyperthyroidism, pregnancy and breastfeeding , children under the age of 6 years.

In case of asthma, always use RAFOREX® with an anti-inflammatory drug (such as inhaled corticosteroid) .If this kind of therapy (oral or inhaled corticosteroid) is already provided, it should be continued without modification, even you feel an improvement of symptoms.

If the symptoms persist or areimposingto increase the dosage ofRAFOREX®, the condition of the basis disease can be worsened; so you should consider reviewing the treatment. Using RAFOREX®, including its dosage should be assessed with the utmost caution in patients concomitantly the following pathological conditions:Ischemic heart disease, myocardial infarction, severe hypertension, heart rhythm disorders, Heart failure, diabetesmellius, prostatic adenoma, glaucoma. The beta2-stimulants can determine an increase of theglycaemia,so it is recommended to prescribe additional control for the diabetic patients.

Thebeta2-stimulants drugscan cause a severe hypokalemia, especially for patients who suffer from severe asthma, where this effect will be fosteredby thehypoxiaand by the concomitant treatments. With the presence of condition like this, it is advised to monitor the plasma levelsof potassium.
As for the case of other inhalation treatments, a paradoxicalbronchismuscan be emerged. It is compulsory then to suspend immediately the treatment and change it by another one.

The safety of this drug during pregnancy and breast-feeding has not been established yet, the use in this context should be avoided as much as possible. Like other beta2-stimulants drugs, the Formoterol can, the fact that it causes a feeling of relaxation of smooth muscle of uterus, inhibit the work during the childbirth. It is not known whether Formoterol passes into human milk, but we have found traces in the milk of treated female rats.
So the breast-feeding is not recommended to women who are treated by this drug.

Athletes:

RAFOREX® contains an active ingredient that could produce a positive analytic result in doping controls.

Effects on ability to drive and use machines
The use of RAFOREX® can cause sometimes side effects as tremor and agitation, which may affect the ability to drive and / or to operate machinery.

This drug product containsa small quantity ofethanol. There is a theoretical possibilityof interaction with thedisulfiram or the metronidazole, particularly for the sensitive subjects following a treatment like this one. Drugs such as the quinidine , thedisopyramide, the procainamide, thephenothiazines, the antihistaminesand the tricyclic antidepressants that can causeextension of the Q-T intervaland increase the risk of ventricular arrhythmias ( see : equally « contra-indications »).It is no advisable to administer simultaneouslyother drugswith adrenergic action, because this can increase the collateraleffects affecting the cardio-vascular field. For the patients following a treatment with inhibitors basis of MAO ortricyclic antidepressants, it is compulsory to administer RAFOREX 12 mcg witha big care, because there is a risk that the action of beta-2-stimulants will be increased on the cardio-vascular system.In addition, the treatment that is concomitant with xanthine derivatives, steroids or diuretics can strengthen e effect of beta-2- stimulants in terms of induction ofhypokalemia; it can itself increase the occurrence of cardiac arrhythmias for the patients treated by digitalic drugs.

The beta-blockerscan from their partdecrease or impedethe effect ofRAFOREX 12mcg. Consequently, it is advisable not to administer them at the same time (even in the case ofeye drops), except aneffective need.

Posology

The treatment is reserved to adults, including the elderly, and to children of more than six years old.

Maintenance treatment and prophylaxis:

1 – 2inhalations of 12mcg (12-24mcg) twice per day.
Where required, make one to two additional puffs allduring the day to relieve the symptoms.

In case of more frequent need (For example, more than two days per week), It is possible that there is a worsening of the underlying disease.So consult the doctor to review the disease.
Prophylaxisofexercise-induced bronchospasm oranticipation of an inevitable exposure to known allergen: make a puff of 12mcg (or potentially two forthe patients suffering from serious forms), around a quarter of an hour beforehand. Method of use to get good results, it is essential to use the inhaler in a correct way.
Administration route
Inhalation with a mouth nozzle inhaler.
Exclusive inhaled route
The efficiency of this drug is, in part, depending on good use of the inhalation 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).

-The mouth nozzle should be cleanedbefore and 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 canister was done before the beginning or after the end of expiration, 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.

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 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.

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.
Treatment duration
Follow your doctor’s prescription.

Overdose:

TheoverdoseofRAFOREX®causes the typical symptoms of beta2-stimulants: nausea, vomit, cephalalgia, tremors,drowsiness, palpitations, ventriculararrhythmia, low/ high blood pressure, metabolic acidosis, hypokalemia, hyperglycemia.

Symptomatictreatment: hospitalization in the very serious cases.

We can consider the use of non-selective beta-blockers, but it is necessary to observe extreme caution in this kind of treatment, because there is the risk of the occurrence of an acute asthma attack

Musculoskeletal System:rare : cramps, myalgia.

Cardiovascular system:occasional: palpitations, rare : tachycardia.

Central and peripheral nervous system :occasional : tremors ; headaches; rare : agitations, dizziness, anxiety, nervousness, sleeplessness.

Respiratory system : occasional : exacerbation ofthe asthma, dyspnea, cough ; rare : paradoxical bronchospasm.

Localirritation : rare : irritation of theoropharyngeal cavity.

Others : occasional : fatigue.

In rare cases, we have the following side effects:itching, conjunctival irritationand eyelids edema, dysgeusia, exanthemata, nausea.

To comply with the instructions of use in the leaflet leads to reduce the occurrence of side effects.

Note to your doctor or your pharmacist any side effect, which is not mentioned in this leaflet.

Do not exceed the expiry date printed on the case.

At the pharmacist: keep in a refrigerator (2 ° C to 8 ° C)
After delivery to the patient: keep at a temperature not exceeding 30 ° C for 3 months maximum after the issuance by the pharmacist.

Special precautions:

Pressurized container: Do not pierce, do not place the (even empty) near a heat source, do not freeze and do not put it directly to sunlight.

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List I (TABLE A)