Famotin (powder)

Famotidinum

Each vial of powder contains famotidine 20 mg. Excipient with known effect: sodium.

Famotin powder and solvent for solution for injection 20 mg: each vial of powder contains famotidine 20 mg; each ampoule (5 ml) of solvent contains a solution with sodium chloride 9 mg/ml. Excipient with known effect: sodium.

Indication: Famotin (powder for solution for injection) is indicated for duodenal ulcer, benign gastric ulcer, gastro-oesophageal reflux disease, other conditions with gastric acid hypersecretion (e.g. Zollinger-Ellison syndrome), and for prophylaxis of aspiration syndrome (Mendelson's syndrome) under general anaesthesia. Famotin powder and solvent for solution for injection is indicated, when oral administration is not possible, for treatment of gastric and duodenal ulcer, gastro-oesophageal reflux and other hypersecretory states (e.g. Zollinger-Ellison syndrome), prevention of relapse associated with gastro-oesophageal reflux disease, and prophylaxis of aspiration syndrome (Mendelson's syndrome) under general anaesthesia.

Famotin powder for solution for injection — Contraindications (SmPC sec. 4.3): Hypersensitivity to famotidine or to any component of the preparation. Contraindicated in children, pregnant women and during breast-feeding (due to the lack of clinical experience).

Famotin powder and solvent for solution for injection — Contraindications (SmPC sec. 4.3): Hypersensitivity to famotidine or to any of the excipients listed in section 6.1.

Special warnings and precautions (SmPC sec. 4.4, excerpt, both forms): 4.4 Special warnings and precautions for use In patients with gastric ulcer, it is recommended to confirm the benign nature of the lesion before starting treatment and, if necessary, during it. Improvement of symptoms after treatment with famotidine does not exclude the malignant nature of the condition. Renal impairment Since famotidine is excreted mainly via the kidneys, caution and dose adjustment are necessary in patients with severe renal impairment (see section 4.2). Hepatic impairment — for Famotin powder for solution for injection: Famotidine is administered with caution, at a reduced dose, in patients with hepatic impairment. Since cross-reactions have been described with H2-receptor antagonists, Famotin should be given with caution to patients with a history of hypersensitivity to other H2-receptor antagonists. This medicine contains sodium […] — for Famotin powder and solvent for solution for injection: Plasma concentrations and urinary excretion of famotidine in patients with liver cirrhosis were similar to those in subjects without hepatic impairment. This medicine contains sodium less than 1 mmol (23 mg) per dose, i.e. essentially "sodium-free". This medicine contains 0.8 mmol (18 mg) sodium in one dose (5 ml of 9 mg/ml sodium chloride solution for injection).