PRAZIQUANTEL Tablets Ref.[8692] Active ingredients:

Caution should be exercised in administering the usual recommended dose of praziquantel to hepatosplenic schistosomiasis patients with moderate to severe liver impairment (Child Pugh Class B and C). Reduced metabolism of praziquantel in these patients may lead to considerably higher and longer lasting plasma concentrations of unmetabolized praziquantel.

Approximately 80% of a dose of praziquantel is excreted in the kidneys, almost exclusively (>99%) in the form of metabolites. Excretion may be delayed in patients with impaired renal function, but accumulation of unchanged drug would not be expected. Therefore dose adjustment for renal impairment is not considered necessary. Nephrotoxic effects of praziquantel or its metabolites are not known.

Patients suffering from cardiac arrhythmias or cardiac insufficiency treated with digoxin should be monitored during treatment.

Praziquantel should not be used in patients with a history of or suffering from epilepsy and/or other signs of potential central nervous system involvement due to schistosomiasis, paragonimiasis or Taenia solium cysticercosis such as subcutaneous nodules of cysticercosis.

Patients with neurocysticercosis should always be treated in hospital because of the risk of pericystic oedema.

The intensity and the severity of the undesirable effects that appear after administration of Praziquantel 600mg Tablets may be associated with the level of worm burden (see section 4.8).

Concomitant use of rifampicin should be avoided (see section 4.3). Rifampicin should be discontinued 4 weeks before administration of praziquantel. Rifampicin can be restarted one day after praziquantel treatment.

Concomitant administration of drugs that increase the activity of drug metabolizing liver enzymes (Cytochrome P450), e.g. antiepileptic drugs (phenytoin, phenobarbital and carbamazepine), dexamethasone may reduce plasma levels of praziquantel and concomitant use is not recommended.

Concomitant administration of drugs that decrease the activity of drug metabolizing liver enzymes (Cytochrome P450), e.g. cimetidine, ketoconazole, itraconazole, or erythromycin may increase plasma levels of praziquantel.

Chloroquine, when taken simultaneously, may lead to lower concentrations of praziquantel in blood. The mechanism of this drug-drug interaction is unclear.

Patients should be advised not to drink grapefruit juice on the day of administration of Praziquantel 600mg Tablets.

Pregnancy

In areas where schistosomiasis is endemic, risk-benefit analyses have revealed that the health advantages of treating women of reproductive age and pregnant women far outweigh the risk to their health and to their babies. Evidence also shows that women can be treated with praziquantel at any stage of pregnancy or lactation.

Breastfeeding

Praziquantel has been reported to be excreted in the milk of nursing women. Women should not breastfeed on the day of treatment with Praziquantel 600mg Tablets and during the subsequent 24 hours.

Fertility

Reproduction studies performed so far in rat and rabbits have revealed no evidence of impaired fertility (see section 5.3).

No studies on the effects on the ability to drive or use machines have been performed. Patients should be warned about the potential for dizziness, somnolence or seizures (see section 4.8) while taking Praziquantel 600mg Tablets and should be advised not to drive or operate machines if any of these symptoms occur on the day of treatment.

The following adverse reactions have been observed and reported during treatment with praziquantel with the following frequencies: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).

The most frequently (>1/10) reported adverse reactions are headache, dizziness, fatigue, abdominal pain, nausea, vomiting, and urticaria.

Immune system disorders

Very Rare: Allergic reaction, Polyserositis, Eosinophilia

Nervous system disorders*

Very common: Headache, Dizziness

Common: Vertigo, Somnolence

Very Rare: Seizures

Cardiac disorders

Very Rare: Unspecified Arrhythmias

Gastrointestinal disorders

Very common: Gastrointestinal and abdominal pains, Nausea, Vomiting

Common: Anorexia, Diarrhoea

Very Rare: Bloody diarrhoea

Hepatobiliary disorders

Rare: Liver function tests increased

Skin and subcutaneous tissue disorders

Very common: Urticaria

Musculoskeletal and connective tissue disorders

Common: Myalgia

General disorders and administration site conditions

Very common: Fatigue

Common: Feeling unwell (asthenia, malaise), Fever

* In cysticercosis, death of the cysts results in local inflammation and oedema. Within the brain, this oedema can simulate an acute space-occupying lesion.

Side effects may be more frequent and/or serious in patients with a heavy worm burden. It is often not clear whether the complaints reported by patients or the undesirable effects reported by the health care provider are caused by praziquantel itself, or may be considered to be an endogenous reaction to the death of the parasites produced by praziquantel, or are symptomatic observations of the infestation.

Reporting 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 via the local reporting system.

Not applicable.