Quantimak 600 600 mg Fim-coated tablets

QUANTIMAK 600 is indicated for the treatment of: Infections due to organisms of the following species pathogenic to man: Schistosoma haematobium; Schistosoma mansoni

Posology 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 Renal and Hepatic impairment: Refer to Section 4.4 Paediatric population Post-marketing experience indicates that children (1 u2013 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. QUANTIMAK 600 should be swallowed whole with a little liquid, preferably during or after meals. With single daily doses it is recommended to take QUANTIMAK 600 in the evening. If ingestion of QUANTIMAK 600 several times a day is prescribed, the interval between administrations should not be less than 4 hours and not more than 6 hours. When broken each of the segments of the tablet contains 300 mg of praziquantel, so that the dosage can be easily adjusted to the patient's body weight.

QUANTIMAK 600 is contraindicated:

• in patients with a known hypersensitivity to praziquantel or to any of the excipients listed in section 6.1.
• 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 QUANTIMAK 600
• with concomitant administration of strong inducers of Cytochrome P 450 such as rifampicin must be avoided as therapeutically effective plasma levels may not be achieved (see Section 4.5)

Since 80 % of praziquantel as in QUANTIMAK 600 and its metabolites are excreted in the kidneys, excretion might be delayed in patients with impaired renal function, but accumulation of unchanged drug would not be expected. Therefore, dosage adjustment for renal impairment is not considered necessary. Nephrotoxic effects of praziquantel or its metabolites are not known.

In uncompensated liver insufficiency and in patients with hepatosplenic schistosomiasis, caution should be taken, since due to reduced drug metabolism in the liver, considerably higher and longer lasting concentrations of unmetabolized praziquantel 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.

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 QUANTIMAK 600 can exacerbate central nervous system pathology due to schistosomiasis, paragonimiasis or Taenia solium 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.

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 QUANTIMAK 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 P 450) e.g. cimetidine, ketoconazole, itraconazole, erythromycin, may increase plasma levels of QUANTIMAK 600

Chloroquine, when taken simultaneously, can lead to lower concentrations of QUANTIMAK 600 in blood. The mechanism of this drug-drug interaction in unclear.

Grapefruit juice was reported to produce a 1, 6 fold increase in the C max and a 1, 9 fold increase in the AUC of praziquantel. However, the effect of this exposure increase on the therapeutic effect and safety of praziquantel has not been systemically evaluated.

Pregnancy Safety in pregnancy has not been established. (see section 4.3)

Breast feeding Praziquantel appears in the milk of breastfeeding women at a concentration of 20-25 % of 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.

Fertility There is no data currently available.

The patient's ability to drive or to operate, machinery may be temporarily impaired. Dizziness, vertigo and drowsiness may occur with QUANTIMAK 600, and this may affect the patientu2019s ability to drive and operate machinery (see section 4.8)

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).

Summary of the safety profile Side effects vary according to dose and duration of QUANTIMAK 600; furthermore, they are dependent on the parasite species, extent of parasitisation, duration of infection and localisation of the parasites in the body. Adverse reactions are based on publications and on spontaneous reports sorted by CIOMS III categories of frequency and MedDRA System Organ Classes (in internationally agreed order). Frequencies of adverse reactions are mainly based on data from medical literature.

Tabulated summary of adverse reactions

System organ class Frequent Less frequent Frequency unknown

Immune system disorders - Allergic reactions, Polyserositis, Eosinophilia

Nervous system disorders Headache, Dizziness Vertigo, Somnolence (including drowsiness) Seizures

Cardiac disorders - Unspecified dysrhythmias (bradycardia, ectopic rhythms, ventricular fibrillation, AV blocks).

Gastrointestinal disorders Gastro-intestinal and abdominal pains, Nausea, Vomiting bloody diarrhoea

Anorexia, Diarrhoea

Skin and subcutaneous tissue disorders Urticaria Pruritis

Musculoskeletal connective tissue and bone disorders Myalgia

General disorders and administration site conditions Asthenia, Feeling unwell, Rise in temperature

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 to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on SAHPRA website or to Macleods Pharmaceuticals SA (Pty) Ltd. at [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.