BIOFARM

BIOFLU 16 SOFT CAPSULES

Composition

The active substances are paracetamol, pseudoephedrine hydrochloride and dextromethorphan hydrobromide as dextromethorphan hydrobromide anhydrous. A soft capsule contains paracetamol 250.00 mg, pseudoephedrine hydrochloride 30.00 mg and dextromethorphan hydrobromide 10.51 mg corresponding to dextromethorphan hydrobromide anhydrous 10.00 mg

Therapeutic indications

Symptomatic treatment of nasal congestion, non-productive cough and fever associated with respiratory tract diseases (eg sinusitis, rhinitis, pharyngitis, bronchitis).

Symptomatic treatment in colds and flu.

Dosage and method of administration

Adults and adolescents: the usual dose is 1-2 soft capsules 4 times a day.

The maximum dose of 8 soft capsules per day should not be exceeded.

Bioflu soft capsules should not be administered to children under 12 years of age.

The duration of treatment should be short (maximum 5 days).

Precautions

This medicine is recommended only for adults and adolescents.

Productive cough is a fundamental component of the bronchopulmonary defense mechanism and should therefore not be suppressed. The combination of an expectorant or mucolytic with an antitussive is not recommended. Before prescribing an antitussive, cases where the cough requires appropriate etiological treatment should be identified, especially bronchial asthma, bronchiectasis, bronchial obstruction, left ventricular failure of known causes, pulmonary embolism, cardiac cough, cancer and endobronchial conditions.

Due to the pseudoephedrine in its composition, Bioflu soft capsules should be used with caution in patients suffering from mild or moderate hypertension. Similar to other sympathomimetics, pseudoephedrine should be used with caution in patients with heart disease, increased intraocular pressure, prostatic hypertrophy, pyloroduodenal obstruction.

Administration should be done with caution in case of mild or moderate renal impairment (especially in association with cardiovascular conditions).

Special warnings

Pregnancy, lactation, fertility

Ask your doctor or pharmacist for advice before taking any medicine.

Due to the possible relationship between the occurrence of fetal malformations and exposure to pseudoephedrine in the first trimester of pregnancy on the one hand, and on the other hand the fact that during the last three months of pregnancy, all inhibitors of prostaglandin synthesis can expose the fetus to cardiopulmonary toxicity (pulmonary hypertension with closure of the ductus arteriosus) and renal or may inhibit uterine contractions, the medicine should not be administered during pregnancy.

Pseudoephedrine is excreted in large amounts in breast milk and can cause cardiovascular and neurological adverse reactions in infants. Also, dextromethorphan is excreted in breast milk. There have been a few cases of muscle hypotonia and apnea in infants after administration to mothers of other central antitussives in doses higher than therapeutic doses. Therefore, as a precautionary measure, administration of the medicine to breastfeeding women is contraindicated.

Driving and using machines

Bioflu soft capsules has little or moderate influence on the ability to drive or use machines. Drivers and those using machines should be warned of the risk of drowsiness and dizziness associated with the use of the medicine.

Packaging

Box with 2 PVC/Al blisters of 8 soft capsules each

 

Page updated on: 09.06.2021