Prazibil 600 600 mg FC tablets.

Infections due to organisms of the following species pathogenic to man: Schistosoma haematobium; Schistosoma mansoni.

For the treatment of Schistosomiasis, caused by S. haematobium and S. mansoni, the intake of 40 mg/kg body mass once or 20 mg/kg body mass twice, on a single day is recommended.

Special populations

• Patients with renal impairment: See section 4.4.
• Patients with hepatic impairment: See section 4.4.
• Paediatric population: Post-marketing experience indicates that children (1 - 17 years of age) may experience similar side effects as adults during praziquantel treatment. The safety profile of children younger than 1 year of age has not been established.

Method of administration

For oral use. The tablets should be swallowed whole with a little liquid, preferably during or after meals. With single daily doses it is recommended to take the tablets in the evening. If ingestion of tablets several times a day is prescribed, the interval between administrations should not be less than 4 hours and not more than 6 hours.

Special monitoring advice: When broken, each of the four segments contains 150 mg of active ingredient, so that the dosage can be easily adjusted to the patient's bodyweight.

• Known hypersensitivity to praziquantel or to any of the excipients of PRAZIBIL 600 (see section 6.1).
• PRAZIBIL 600 should not be taken during the first trimester of pregnancy (see section 4.6).
• Since parasite destruction within the eye may cause irreversible lesions, ocular cysticercosis must not be treated with this compound.
• The concomitant administration of strong inducers of Cytochrome P450 such as rifampicin must be avoided as therapeutically effective plasma levels may not be achieved (see section 4.5).

Since 80 % of PRAZIBIL 600 and its metabolites are excreted in the kidneys, excretion might be delayed in patients with impaired renal function.

In uncompensated liver insufficiency and in patients with hepatosplenic schistosomiasis, caution should be taken, since due to reduced drug metabolisation in the liver, considerably higher and longer lasting concentrations of unmetabolised PRAZIBIL 600 can occur in vascular and/or collateral circulation, leading to prolonged plasma half-life. If necessary, the patient may be hospitalised for the duration of the treatment.

Published in vitro data have shown a potential lack of efficacy of praziquantel against migrating schistosomulae. Data from two observational cohort studies in patients indicate that treatment with praziquantel in the acute phase of infection may not prevent progression into chronic phase. In addition, the use of praziquantel in patients with schistosomiasis may be associated with clinical deterioration (paradoxical reactions, serum sickness Jarisch-Herxheimer like reactions: sudden inflammatory immune response suspected to be caused by the release of schistosomal antigens). These reactions predominantly occur in patients treated during the acute phase of schistosomiasis. They may lead to potentially life-threatening events, e.g. respiratory failure, encephalopathy, and/or cerebral vasculitis.

Patients suffering from cardiac irregularities should be monitored during treatment.

When schistosomiasis or fluke infection is found in patients living in or coming from areas with endemic human cysticercosis, it is advised to hospitalise the patient for the duration of treatment.

As PRAZIBIL 600 can exacerbate central nervous system pathology due to schistosomiasis, paragonimiasis or Taenia sodium cysticercosis, as a general rule this medicine should not be administered to individuals reporting a history of epilepsy and/or other signs of potential central nervous systems involvement such as subcutaneous nodules suggestive of cysticercosis.

The patient ability to drive or to operate machinery may be temporarily impaired. Caution should be exercised where there is a possibility of a simultaneous occurrence of both Schistosomiasis and CNS-cysticercosis infection, as cerebral cysticercosis requires hospital-based treatment by a specialist.

Concomitant administration of medicines increasing the activity of drug metabolising liver enzymes (Cytochrome P450), e.g. antiepileptic medicines, dexamethasone may reduce plasma levels of PRAZIBIL 600. Concomitant administration of strong inducers of Cytochrome P450 such as rifampicin must be avoided (see section 4.3). Concomitant administration of medicines decreasing the activity of drug metabolising liver enzymes (Cytochrome P450) e.g. cimetidine, ketoconazole, itraconazole, and erythromycin may increase plasma levels of PRAZIBIL 600. When administered concomitantly with grapefruit juice, an increase in praziquantel exposure of less than twofold was observed in clinical studies.

Pregnancy: Safety in pregnancy has not been established.

Breastfeeding: PRAZIBIL 600 appears in the milk or breastfeeding women at a concentration of 20 u2013 25 % or maternal serum. It is not known, whether a pharmacological effect is likely to occur in children. For short-term therapy breastfeeding should be discontinued for the day(s) of treatment and the following 24 hours.

Because of possible effects on vigilance patients should be warned not to drive a car and not to operate machinery on the day of treatment (and during the subsequent 24 hours).

Side effects vary according to dose and duration of PRAZIBIL 600; furthermore, they are dependent on the parasite species, extent of parasitisation, duration of infection and localisation of the parasites in the body.

b) Tabulated summary of adverse reactions

• Immune system disorders
• Less frequent: Allergic reaction polyserositis, eosinophilia
• Nervous system disorders
• Frequent: Headache, dizziness, vertigo, somnolence (including drowsiness)
• Less frequent: Seizures
• Cardiac disorders
• Less frequent: Unspecific dysrhythmias
• Gastrointestinal disorders
• Frequent: Gastrointestinal and abdominal pains, nausea, vomiting, anorexia, diarrhoea
• Less frequently: Bloody diarrhoea
• Skin and subcutaneous tissue disorders
• Frequent: Urticaria, rash
• Less frequent: Pruritus
• Musculoskeletal and connective tissue disorders
• Frequent: Myalgia
• General disorders and administration site conditions
• Frequent: Asthenia, Fatigue, feeling unwell

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Health care providers are asked to report any suspected adverse reactions via the u201c6.04 Adverse Drug Reactions Reporting Formu201d, found online under SAHPRAu2019s publications: https://www.sahpra.org.za and to the Holder of certificate of registration through the mail: [email protected]

Pronounced dizziness, u201chang-overu201d feelings. There is no specific antidote and symptomatic measures should be applied. No data are available in humans. In the event of overdose a fast acting laxative should be given.