BAMIFIX Tablet
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1. Name of the medicinal product
Bamifix.
2. Qualitative and quantitative composition
Bamifylline 600mg.
3. Pharmaceutical form
Tablets.
4.1. Therapeutic indications
Bronchial asthma, pulmonary affections with bronchospastic component.
4.2. Posology and method of administration
Usually 1 tablet of BAMIFIX in the morning and one in the evening before meals. Dosage can vary from 900 to 1800 mg daily according to medical advice. Do not administer the drug at short intervals.
4.3. Contraindications
Acute myocardial infarction. Known hypersensitivity to the product and to xanthinic derivatives.
4.4. Special warnings and precautions for use
BAMIFIX tablets should not be administered to neonates and children in the first infancy, patients with severe heart failure, serious hypertension, hepatic and renal insufficiency, gastric ulcer and hyperthyroidism. ...
4.5. Interaction with other medicinal products and other forms of interaction
No interactions with bamifylline are known, however, those known for theophylline should be considered. Erythromycin, TAO lincomycin, clindamycin, allopurinol, cimetidine, antiflu vaccine and propranolol ...
4.6. Pregnancy and lactation
Tests on reproduction showed that bamifylline hydrochloride does not influence fertility, pregnancy, lactation and the embryofoetal development. However, it is advisable not to administer the drug during ...
4.8. Undesirable effects
Cases of headache or gastralgia were seldom reported. Doses higher than the therapeutical ones can induce the onset of nausea and slight distal tremors disappearing with therapy reduction. Allergic reactions ...
5.1. Pharmacodynamic properties
BAMIFIX contains bamifylline, a methylxanthinic derivative with two side chains in position 7 and 8, distinguishing it clearly from theophylline. Bamifylline carries out a bronchospasmolytic action on ...
5.2. Pharmacokinetic properties
Its pharmacokinetic characteristics are very interesting. Its absorption, both by oral and rectal route, is rapid, reaching the plasma peak between the first and the second hour. Its diffusion in the extravascular ...
6.1. List of excipients
Saccharose Calcium carbonate Hydroxypropylmethylcellulose Methylcellulose Magnesium stearate Talc Polyvinylpyrrolidone Titanium dioxide Precipitated silica Aluminum hydroxide Natural waxes
6.4. Special precautions for storage
Store below 30°C in a dry place. Protect from heat and light.
6.5. Nature and contents of container
BAMIFIX: box of 30 tablets (600 mg).
7. Marketing authorization holder
Manufactured by: Hansel Pharmaceuticals (Pvt.) Ltd., Plot No.2, Pharma City, 30 Km. Multan Road, Sundar, Lahore Pakistan Under Licence of: CHIESI FARMACEUTICI S.p.A. - 26/A,Via Palermo PARMA, ITALY ...