Forales
(Formoterol)




COMPOSITION

1 capsule contains: formoterol fumarate (as formoterol fumarate dehydrate) 12 mıcrogram

Active substance:

Excipients: lactose monohydrate.

Capsule composition: hydroxypropyl methyl cellulose.

THERAPEUTIC INDICATIONS

- maintenance treatment and in the prevention of bronchospasm in patients with asthma;

- prevention of exercise-induced, allergen-induced or cold air-induced bronchospasm;

- in the maintenance treatment of bronchoconstriction in patients with Chronic Obstructive

Pulmonary Disease including reversible and non-reversible bronchial obstruction, chronic bronchitis and emphysema.

CONTRAINDICATIONS

- Hypersensitivity to any component of the drug;

- Lactation;

- Children below 6 years old.

ADVERSE EFFECTS

Gastrointestinal disorders: rare – nausea.

Psychiatric disorders and nervous system disorders: common – headache, tremor; uncommon – agitation, anxiety, nervousness, insomnia, dizziness.

Cardiac disorders: common - palpitation, rare – tachycardia, peripheral edema.

Respiratory system disorders: uncommon – bronchial spasm.

Musculoskeletal disorders: uncommon - muscle cramps, myalgia.

Immune system disorders: very rare – hypersensitivity reactions, arterial hypotension, urticaria, angioneurotic edema, itching, exanthema.

Topical reactions: uncommon – pharyngal, laryngal mucosal irritation.

Other: taste disturbances.

DOSAGE AND ADMINISTRATION

Forales is indicated only for inhalative administration in adults and children aged 6 years and older. Do not administer orally. Forales represents the capsules containing the powder for inhalations to be used only by means of special device provided in the package set. Due to the capsule destruction small pieces of coat may enter the mouth or throat. In order to minimize the risk of this event, it is not allowed to puncture the capsule more than once. It is recommended to take the capsule out of blister immediately before the administration.

Adults.

In bronchial asthma:

Regular maintenance therapy: 1 inhalation capsule (equivalent to 12 micrograms formoterol) to be inhaled twice daily. For more severe cases 12-24 microgram to be inhaled twice daily for symptoms relief. The recommended maximum daily dose is 48 micrograms per day.

Forales should not be used to relieve the acute symptoms of an asthma attack. In the event of an acute attack, a short-acting beta2-agonist should be used.

For the prophylaxis of bronchospasm induced by exercise load or by inevitable effect of known allergen, 15 minutes prior to contact with the allergen or prior to exercise 12 micrograms of Forales should be administered (equivalent to 1 capsule). Patients with severe bronchial asthma may require a single dose of 24 micrograms.

In patients with chronic obstructive pulmonary disease the regular maintenance dose is 12 microgram (equivalent to 1 capsule) twice daily.

Children aged 6 and older:

In bronchial asthma:

Regular maintenance therapy: 1 inhalation capsule (equivalent to 12 micrograms formoterol) to be inhaled twice daily. For more severe cases 12-24 microgram to be inhaled twice daily for symptoms relief. The recommended maximum daily dose is 24 micrograms per day.

For the prophylaxis of bronchospasm induced by exercise load or by inevitable effect of known allergen, 15 minutes prior to contact with the allergen or prior to exercise 12 micrograms of Fo-rales should be administered (equivalent to 1 capsule).

For children 6-12 years of age, when treatment with an inhaled corticosteroid and long-acting beta2-agonist (LABA) is required, it is recommended to use a combination product, except in cases where separate inhaled corticosteroid and long-acting beta2-agonist inhalers are more appropriate.

The following rules are required to make inhalations.

A child or adolescent should be shown how to use the inhaler correctly and should only use it with the help of an adult.

Rinsing the mouth with water after the inhalation of formoterol may prevent the mucosal irritation of mouth and throat , as well as decrese the risk of systemic adverse effects.

The following steps for usage of inhalation device.

  1. Pull off the cap from inhalation device.
  2. Hold the base of the inhaler firmly and turn the mouthpiece in the direction of the arrow on the bottom of the mouthpiece to open.
  3. Place the capsule in the capsule-shaped compartment in the base of the inhaler (it is capsule-shaped). It is important that you remove the capsule from the blister pack only immediately before you use it.
  4. Twist the mouthpiece to the closed position.
  5. Keeping the inhaler upright, firmly squeeze the red buttons on the sides once only. This will pierce the capsule. Release the buttons.

On this stage capsule destruction may occur while needling it, resultin in the penetration of small pieces of capsule into mouth or throat. In order to prevent complete destruction of capsule, the following requirements should be followed: capsule should not be punctured more than once, storate conditions should be maintained, the capsule should be taken out of blister immediately before the inhalation.

  1. Breathe out fully.
  2. Place the mouthpiece in your mouth and tilt your head slightly backwards. Close your lips around the mouthpiece and breathe in as quickly and as deeply as you can. As you breathe in, you will inhale the medicine into your lungs. You should hear the capsule spinning in the inhaler. If you do not hear this whirring noise, the capsule may be stuck in the compartment. If this occurs, open the inhaler and loosen the capsule by prising it out of the compartment. Do not try to loosen the capsule by repeatedly pressing the buttons.
  3. If you have heard the whirring noise, hold your breath for as long as you comfortably can while taking the inhaler out of your mouth. Then breathe normally. Open the inhaler to see if any powder is still in the capsule. If there is still powder in the capsule repeat steps 6 to 8.
  4. After use, tip out the empty capsule and close the mouthpiece. Replace the cap. If you need to clean the inhaler, wipe the mouthpiece and capsule compartment with a dry cloth or a clean soft brush.

DRUG INTERACTIONS

Forales, as with other beta2-agonists, should be administered with extreme caution to patients

being treated with quinidine, disopyramide, procainamide, phenotiasines, antihistamines, monamine oxidase inhibitors, tricyclic antidepressants, or drugs known to prolong the QTc interval because the action of adrenergic agonists on the cardiovascular system may be potentiated by these agents. Drugs that are known to prolong the QTc interval have an increased risk

of ventricular arrhythmias. Concomitant administration of other sympathomimetic agents has the potential to produce additive effects in respect of the undesirable effects. Concomitant treatment with xanthine derivatives, steroids, or diuretics such as thiazides and loop diuretics may potentiate a possible hypokalaemic adverse effect of beta2-agonists. Hypokalaemia may increase susceptibility to cardiac arrhythmias in patients treated with digitalis glycosides. Beta-adrenergic blockers may weaken or antagonise the effect of Forales. Therefore Forales should not be given together with beta-adrenergic blockers (including eye drops) unless there are compelling reasons for their use.

PREGNANCY AND LACTATION

Treatment with formoterol may be considered if the expected benefit to the mother is greater than any possible risk to the fetus. It is not known whether formoterol passes into human breast milk. Therefore women who are breast-feeding should withdraw lactation.

MANUFACTURED FORM

Capsules wıth inhalation powder

10 capsules in a blister.

6 blisters with a leaflet and inhaler in a carton box.

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