FLUSHOF Uncoated caplet Ref.[115656] Active ingredients: Albendazole

Leucopenia may occur when FLUSHOF is used for periods longer than recommended. In order to avoid administering FLUSHOF during early pregnancy, women of childbearing age should initiate treatment during the first week of menstruation or after a negative pregnancy test.

Sub-clinical neurocystercosis may manifest after a single dose of FLUSHOF.

Treatment with albendazole may uncover pre-existing neurocysticercosis, particularly in areas with high taenosis infection. Patients may experience neurological symptoms e.g. seizures, increased intracranial pressure and focal signs as a result of an inflammatory reaction caused by death of the parasite within the brain. Symptoms may occur soon after treatment, appropriate steroid and anticonvulsant therapy should be started immediately.

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Praziquantel increase the plasma levels of the active metabolite of FLUSHOF. Ritonavir, phenytoin, carbamazepine and phenobarbital may reduce plasma concentrations of the active metabolite of FLUSHOF; albendazole sulfoxide. The clinical relevance of this is unknown, but may result in decreased efficacy, especially in the treatment of systemic helminth infections. Patients should be monitored for efficacy and may require alternative dose regimens or therapies.

FLUSHOF should not be administered during pregnancy (refer to CONTRA-INDICATIONS).

Albendazole is known to be teratogenic and embryotoxic in animals.

Adequate human data during lactation are not available.

Since dizziness has been reported following treatment with FLUSHOF, caution is recommended in patients performing skilled tasks.

Data from clinical studies were used to determine the frequency of very common to rare undesirable reactions. The following convention has been used for the classification of frequency: Very common ≥1/10, common ≥1/100 to <1/10, uncommon ≥1/1 000 to <1/100, rare ≥1/10 000 and <1/1 000, very rare <1/10 000.

Immune system disorders

Rare: Hypersensitivity reactions

Nervous system disorders

Uncommon: Headache and dizziness

Gastrointestinal disorders

Uncommon: Upper gastrointestinal symptoms (e.g. epigastric or abdominal pain, nausea, vomiting) and diarrhoea

Hepatobiliary disorders

Rare: Elevations of hepatic enzymes

Skin and subcutaneous tissue disorders

Rare: Rash, pruritus and urticaria.

Post-marketing Side Effects:

Skin and subcutaneous tissue disorders

Unknown: Erythema multiforme, Stevens-Johnson syndrome.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions.

Not applicable.