BAMIFIX Tablet Ref.[49515] Active ingredients: Bamifylline

Publisher: 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 ...

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.

BAMIFIX should not be administered to children.

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 can increase the serum concentration of theophylline; phenytoin, other anticonvulsants and cigarette’s smoking can decrease theophylline serum levels.

The product should not be administered with other xanthinic compounds.

Caution should be taken in case of combination with ephedrine or other sympathomimetic bronchodilators.

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 the first months of pregnancy, as a precautionary measure.

Under treatment with bamifylline, during pregnancy, no cases of neonatal toxicity were observed.

However, it is advisable not to take the drug during the last days of pregnancy and during lactation.

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 such as urticaria, itching, rash, dermatitis have been observed.

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