Zentel 400 mg Tablets

ZENTEL 400 is indicated in the treatment indicated in the treatment of single or mixed intestinal parasites u2013 roundworm; whipworm; pinworm; hookworm; tapeworm, for single dose use.

Posology: 400 mg (one ZENTEL 400 tablet) as a single dose in both adults and children over two years of age. Note: If the patient is still symptomatic after a single course of treatment, they must consult a healthcare professional for further treatment. No special procedures, such as fasting or purging, are required. Do not exceed the maximum daily dose and treatment duration recommended. Not to be used in children aged under 1-year. Elderly: Experience in patients 65 years of age or older is limited. Reports indicate that no dosage adjustment is required; however, ZENTEL 400 should be used with caution in elderly patients with evidence of hepatic dysfunction (see Hepatic Impairment below). Renal impairment: Since renal elimination of albendazole and its primary metabolite, albendazole sulfoxide, is negligible, it is unlikely that clearance of these compounds would be altered in these patients. No dosage adjustment is required; however, patients with evidence of renal impairment should be carefully monitored. Hepatic impairment: Since albendazole is rapidly metabolised by the liver to the primary pharmacologically active metabolite, albendazole sulfoxide, hepatic impairment would be expected to have significant effects on the pharmacokinetics of albendazole sulfoxide. Patients with abnormal liver function test results (transaminases) prior to commencing ZENTEL 400 therapy should be carefully monitored.

ZENTEL 400 should not be administered during pregnancy or in women thought to be pregnant (see section 4.6). ZENTEL 400 is contra-indicated in patients with a known history of hypersensitivity to albendazole or constituents of ZENTEL 400.

Leucopenia may occur when ZENTEL 400 is used for periods longer than recommended. In order to avoid administering ZENTEL 400 during early pregnancy, women of childbearing age should initiate treatment during the first week of menstruation or after a negative pregnancy test. Sub-clinical neurocysticercosis may manifest after a single dose of ZENTEL 400. 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. Patients experiencing such symptoms, after taking this medicine must seek advice from a healthcare professional. Excipient warnings: Contains lactose/fructose. Patients with the rare hereditary conditions of galactose intolerance e.g., galactosaemia, Lapp lactase deficiency, glucose-galactose malabsorption or fructose intolerance should not take ZENTEL 400. Lactose may have an effect on the glycaemic control of patients with diabetes mellitus. ZENTEL 400 tablets contain sunset yellow FCF (E110 or FD&C Yellow No 6) which may cause allergic-type reactions.

Praziquantel increase the plasma levels of the active metabolite of ZENTEL 400. Ritonavir, phenytoin, carbamazepine and phenobarbital may reduce plasma concentrations of the active metabolite of ZENTEL 400; 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.

Pregnancy: ZENTEL 400 should not be administered during pregnancy or in women thought to be pregnant (refer to section 4.3). Albendazole is known to be teratogenic and embryotoxic in animals. Breastfeeding: Adequate human data during lactation are not available.

Since dizziness has been reported following treatment with ZENTEL 400, 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 ( u2265 1/10), common ( u2265 1/100 to < 1/10), uncommon ( u2265 1/1 000 to < 1/100), rare ( u2265 1/10 000 to < 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.

In overdose, side effects can be precipitated and/or be of increased severity (refer to section 4.8).