BERMOXEL Tablet Ref.[49649] Active ingredients: Praziquantel

Bilharziases during invasion phase

Praziquantel lacks efficacy against migrant schistosomula in Schistosomiasis (bilharzia). Consequently, praziquantel is not effective when administered during acute schistosomiasis. In addition, the use of praziquantel in the acute phase of schistosomiasis may be associated with paradoxical reactions (Jarisch-Herxheimer-like reactions: sudden inflammatory immune response probably caused by the release of schistosome antigens). This can lead to potentially life-threatening myocarditis, encephalitis and lung involvement.

Central nervous effects

When schistosomiasis or fluke infection is found in patients living in or coming from areas where cysticercosis is endemic, the patient should be taken up in the hospital for the duration of treatment with praziquantel. As a result of the activity on Taenia solium larvae cysticercosis, praziquantel can worsen the potential of the eye or involvement of the central nervous system. Praziquantel can worsen cysticercosis produced by schistosomiasis, Paragonimiasis or Taenia solium due to the pathological effects on the central nervous system. Therefore, this drug should usually not be administered to patients with a history of epilepsy and/or other signs of potential involvement of the central nervous system, such as subcutaneous nodules indicative of cysticercosis.

Heart rhythm disorders

During treatment with praziquantel, patients with heart rhythm disorders or a history of arrhythmias should be monitored.

Renal failure

Considering that 80% of praziquantel and its metabolites are excreted renally, excretion may be delayed in patients with renal impairment.

Liver failure and hepatosplenic schistosomiasis

Praziquantel must be administered with caution in patients with severe hepatic impairment and in patients with hepatosplenic schistosomiasis; in fact, blood levels substantially higher and persistent un-metabolized praziquantel can be observed because of the decreased hepatic metabolism of praziquantel thus resulting in an extension of plasma half-life.

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say it is essentially “sodium-free”.

Contraindicated combinations

Rifampicin: there is a dramatic decrease in plasma concentrations of praziquantel, with the risk of treatment failure by increasing the hepatic metabolism of praziquantel by rifampicin. The effective plasma concentrations of praziquantel may not be achieved (see section 4.3).

Combinations not recommended

Enzyme inducing anticonvulsants (carbamazepine, phenytoin, Phenobarbital, primidone): due to marked decrease in plasma concentration of praziquantel, with a risk of treatment failure due to increased praziquantel hepatic metabolism.

Combinations subject to precautions for use

Dexamethasone: Decrease in plasma concentrations of praziquantel, with a risk of treatment failure, due to its hepatic metabolism increased by dexamethasone. Treatment with dexamethasone should be discontinued at least one week prior to administration of praziquantel.

When co-administered with grapefruit juice, increases in exposure to praziquantel less than twice the usual concentrations have been observed in a clinical study.

Concomitant administration of cytochrome P450 inhibitors medications, such as cimetidine, ketoconazole and itraconazole may increase plasma concentrations of praziquantel by decreasing hepatic metabolism.

Pregnancy

Animal studies have found no embryotoxic or teratogenic effects.

A large number of women treated without damaging effects has been reported in the literature.

In accordance with WHO publication on praziquantel risk-benefit analysis, it has been shown that the benefits of treating fertile and pregnant women are much greater than the risks to their health and the health of their babies, where schistosomiasis and soil helminthiasis are endemically transmitted. The benefit of praziquantel treatment in pregnant women consists of less anemia in the mothers and improvement of birth weight and survival of the baby. Consequently, praziquantel can be used during pregnancy, as clinically necessary.

Breast-feeding

Praziquantel is excreted 0.0008% in milk.

It is not known if can cause a pharmacological effect in infants.

For a short duration treatment, breast-feeding should be discontinued during treatment and for the subsequent 24 hours.

Fertility

There are no clinical data on fertility.

Praziquantel has shown no effect on fertility in animal studies.

Praziquantel has moderate influence on the ability to drive and use machines. Patients should be aware that side effects such as dizziness, lightheadedness, or drowsiness may occur after taking praziquantel. Therefore it is recommended to avoid driving or operating machinery during the treatment period and for 24 hours after treatment discontinuation (see section 4.8).

Side effects are depending on dosage and duration of treatment, the type of parasite, severity of infection, length of infection and location of the parasites in the body.

The side effects are only observed during post-marketing surveillance and they are based on publications and spontaneous reports.

For the side effects a frequency cannot be determined, they are listed under ‘Not known’ (cannot be estimated from the available data).

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 to Pharmaceutical Services, Ministry of Health, CY-1475 Nicosia, Tel: +357 22608607, Fax: +357 22608669, website: www.moh.gov.cy/phs.

None known.