Inhalation powder in hard capsules: 12 micrograms of formoterol fumarate 2H2O. One delivered dose contains 9 micrograms of formoterol fumarate 2 H2O.
Indication & Usage
Formagal is a selective long acting beta-2-receptor agonist that dilates the bronchi and makes breathing easier.
Formagal 12 micrograms inhalation powder is a medicine used for long-term therapy of moderate to severe persistent bronchial asthma in patients who need regular bronchodilator therapy in addition to long-term anti-inflammatory therapy. The treatment with glucocorticoids must be continued regularly.
Formagal is also indicated for the relief of symptoms of bronchial obstruction (breathlessness as a result of constriction of the bronchi) in patients with chronic obstructive airway disease. It is recommended that the therapy be initiated by a lung specialist.
Dosage & Administration
For adults, including elderly patients, the following recommendations apply:
Long-term use: one inhalation once or twice per day. In individual cases the use of two inhalations once or twice per day may be necessary.
Prevention of effort-induced bronchoconstriction:
One inhalation before the expected effort.
The daily dose should not exceed four inhalations.
Not more than two inhalations should be taken at one time.
Chronic obstructive airway disease (COPD)
Long-term use: one inhalation once or twice per day.
In cases of regular use should not be inhaled more than twice daily.
For relief of the symptoms, additional inhalations extra to the regular therapy may be taken if necessary, up to a maximum daily dose of four inhalations (regular plus additionally necessary dose).
Not more than two inhalations should be taken at one time.
For oral inhalation only. DO NOT swallow Formagal capsule. Formagal capsule should be always used with inhaler ONLY.
In the evaluation of side effects the following frequency conventions are taken as the basis:
- Very Common: affects more than 1 user in 10
- Common: affects 1 to 10 users in 100
- Uncommon: affects 1 to 10 users in 1000
- Rare: affects 1 to 10 users in 10000
- Very rare: affects less than 1 user in 10000
- Not known: frequency cannot be estimated from the available data
No side effects occur very commonly.
- Musculoskeletal and connective tissue disorders; Common: Tremor, Uncommon: Muscle cramps, Myalgia
- Cardiovascular system; Common: Palpitations, accelerated heartbeat (tachycardia), Uncommon: Disturbances of heart rhythm, Rare: Atrial fibrillation, supraventricular tachycardia, extra systoles, Very rare: Angina pectoris, prolongation of the QTc interval, oscillations in blood pressure
- Metabolism disorders; Rare: Potassium deficiency (hypokalemia), Very rare: Raised blood sugar (hyper-glycaemia), increase in insulin, free fatty acids, glycerol and ketone bodies in the blood
- Skin and subcutaneous tissue, immune system; Rare: Hypersensitivity reactions such as e.g. pronounced fall in blood pressure, exanthema, urrticaria, pruritus, angioedema or peripheral edema
- Nervous system; Common: Headache, Uncommon: Excitation, confusion, anxiety, nervousness, insomnia, agitation, restlessness
- Respiratory tract; Uncommon: Severe bronchospasm
- Digestion; Rare: Nausea
- Local irritation; Uncommon: Irritation in mouth and pharynx, Rare: Altered taste
Lactose contains small amounts of milk protein, and can therefore cause allergic reactions.
Hypersensitivity to formoterol fumarate or any components of this product (such as Lactose) or milk protein.
- In cases of concomitant therapy with some medicines for disturbances of heart rhythm (quinidine, disopyramide, procainamide), heart failure (digitalis-containing preparations), malaria (quinidine), allergies or schizophrenia (phenothiazines) or depression (tricyclic antidepressants), side effects in the form of disturbances of heart rhythm and/or specific ECG changes (prolongation of the QT interval) may occur.
- Adrenergic agents: Use with caution. Additional adrenergic drugs may potentiate sympathetic effects.
- Xanthine derivatives, systemic corticosteroids, and non-potassium sparing diuretics: Use with caution. May potentiate hypokalemia or ECG changes. In patients receiving treatment with digitalis glycosides, hypokalemia can increase susceptibility to disturbances of heart rhythm.
- MAO inhibitors, tricyclic antidepressants, macrolides, and drugs that prolong QTc interval: Use with extreme caution. May potentiate effect on cardiovascular system.
- Beta-blockers: Use with caution and only when medically necessary. May decrease effectiveness and produce severe bronchospasm.
- Halogenated hydrocarbons: There is an elevated risk of arrhythmias in patients receiving concomitant anesthesia with halogenated hydrocarbons.
Warnings & Precaution
- Asthma-related deaths and asthma-related hospitalizations: LABA increase the risk. Prescribe for asthma only as concomitant therapy with a long-term control medication such as an inhaled corticosteroid.
- Deterioration of asthma and acute episodes: Do not initiate during acutely deteriorating asthma. Do not use to treat acute symptoms.
- Corticosteroids: Not a substitute for corticosteroids. Corticosteroids should not be stopped or reduced when Formagal is initiated.
- Use with additional long-acting beta2-agonist: Do not use in combination because of risk of overdose.
- Paradoxical bronchospasm: Discontinue Formagal and institute alternative therapy if paradoxical bronchospasm occurs.
- Patients with cardiovascular or central nervous system disorders: Use with caution because of beta-adrenergic stimulation.
- Coexisting conditions: Use with caution in patients with convulsive disorders, thyrotoxicosis, diabetes mellitus, ketoacidosis, aneurysm, and pheochromocytoma.
- Metabolic effects: Be alert to hypokalemia and hyperglycemia.
- Anti-Doping: the use of Formagal may produce positive results in doping controls.
Pregnancy & Lactation
Especially in the first 3 months of pregnancy and shortly before delivery, Formagal 12 micrograms inhalation powder may only be used after careful consideration of the benefit-risk ratio following discussion with the doctor responsible for treatment.
As it is not known whether the active substance passes into human breast-milk, as a precaution breast- feeding mothers should not use Formagal 12 micrograms inhalation powder.
- Do not store above 25° C.
- Store in the original package in order to protect the contents from moisture.
- Do not use Formagal 12 micrograms inhalation powder after the expiry date which is stated on the carton and on the container.
- The expiry date refers to the last day of that month.
- Keep out of the reach and sight of children.
- Medicines should not be disposed of via wastewater or household waste.
HDPE bottle, closed with a polypropylene screw cap, which contains drying agent (silica gel). The inhaler is made of plastic.
Formagal is supplied in packs of 60 hard capsules with powder for inhalation and one inhaler.
SMB Laboratories/ Belgium
Marketing Authorization Holder in IRAN