Biltricide

Praziquantel.

Each film-coated tablet contains 600 mg praziquantel.
Excipients/Inactive Ingredients: The other ingredients are: macrogol 4000, magnesium stearate, maize starch, microcrystalline cellulose, hypromellose, sodium dodecyl sulphate, povidone 25, titanium dioxide (E171)

Biltricide contains the active substance praziquantel. Bitricide is a medicine for treating diseases caused by flukes (anthelmintic drug; trematode medicine).

Biltricide is used to treat: diseases caused by flukes (trematodes), such as various species of blood flukes (e.g. Schistosoma haematobium, S. mansoni, S. intercalatum, S. japonicum, S. mekongi), liver flukes (e.g. Clonorchis sinensis, Opisthorchis viverrini) and lung flukes (e.g. Paragonimus westermani and other species).

Always take this medicine exactly as the doctor has told. Check with the doctor or pharmacist if not sure.
The recommended dose is: Adults: See Table 1.

Click on icon to see table/diagram/image

Children and adolescents: The safety of Biltricide in children aged under 4 years has not been established. (See Table 2.)

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The duration of administration in individual cases is determined by the treating doctor, and depends on the nature, severity and progress of the disease.
When treating fluke (trematode) infections, the effectiveness and tolerability of the active substance can be enhanced by dividing the total dose and administering it at intervals of 4 hours. To reach the lowest dose necessary (threshold dose), a single dose must be at least 20 mg per kg body weight.
Calculation of the required number of film-coated tablets for one single dose: See Tables 3, 4, 5 and 6.

Click on icon to see table/diagram/image


Click on icon to see table/diagram/image


Click on icon to see table/diagram/image


Click on icon to see table/diagram/image

The film-coated tablet has 3 score lines for dividing into doses of 150 mg each, allowing the dosage to be adjusted exactly to the body weight. If a quarter of a film-coated tablet needs to be taken, the patient should start by breaking off the film-coated tablet at one of the outer score lines.
It is easiest to break the tablet by inserting the thumbnails in the score line.
Method of administration: Oral use.
Take the film-coated tablets whole with a little liquid, preferably during a meal.
If the dose is to be taken once daily, it is advisable to take the tablets in the evening. If multiple doses per day have been prescribed, a minimum of 4 and a maximum of 6 hours should be left between the single doses.
If having the impression that the effect of Biltricide is too strong or too weak, talk to the doctor or pharmacist.

If the patient takes more Biltricide than he/she should: No cases of poisoning have been reported so far.
If there are any further questions on the use of this medicine, ask the doctor or pharmacist.

Do not take Biltricide: if allergic to praziquantel or any of the other ingredients of this medicine (listed in Description); if eyes are infected with larvae from the pork tapeworm (intraocular cysticercosis); if also using rifampicin (an active substance for tuberculosis), since rifampicin can increase the activity of enzymes that break down medicines and, as a result, effective blood concentrations of Biltricide may not be reached (see Interactions).

Talk to the doctor before taking Biltricide.
Impaired liver function: Caution is required with certain types of liver dysfunction (severe liver failure), or if the liver and spleen are infected with blood flukes (hepatosplenic schistosomiasis). Due to reduced breakdown of the medicine in the body, the active substance remains in the blood for longer and thus the effect of the medicine is prolonged. In such cases, appropriate treatment should be administered in hospital.
Impaired kidney function: If kidney function is impaired, the excretion of praziquantel is likely to be delayed.
Heart rhythm abnormalities and digitalis-dependent heart function impairment: If suffering from an abnormal heart rhythm, the treatment should be monitored by a doctor. In the event of heart failure requiring treatment with digitalis (digitalis-dependent heart failure), therapy with Biltricide should likewise be monitored by a doctor since animal studies found the effectiveness of digitalis products to be decreased.
Schistosomiasis (bilharzia): Biltricide is not effective against migratory (immature) blood flukes (schistosomula). Consequently, it is ineffective during acute phases of blood fluke infection (acute schistosomiasis). Study data suggest that treatment with Biltricide in this acute phase of an infection cannot prevent progression to the chronic phase.
In addition, the use of Biltricide in patients with schistosomiasis may be associated with a deterioration in the clinical condition (paradoxical reactions, serum sickness, Jarisch-Herxheimer-type reactions with a sudden inflammatory immune response, probably resulting from destruction of the parasites). Such reactions mostly occur in patients receiving treatment during the acute phase of schistosomiasis. They can lead to potentially life-threatening events, such as lung dysfunction (respiratory failure), inflammation of the heart muscle (myocarditis), inflammation of the brain (encephalitis), non-inflammatory diseases of the brain (encephalopathy) and/or inflammation of the blood vessels in the brain (cerebral vasculitis).
If patients diagnosed as having schistosomiasis or fluke infection live in, or come from, an area in which infections with larvae from the pork tapeworm are common (endemic) in humans, it is advisable to administer Biltricide treatment in a hospital setting. Due to its action against the larvae of the pork tapeworm (Taenia solium), Biltricide may worsen an eye infection with such larvae (intraocular cysticercosis) or symptoms affecting the central nervous system.
Biltricide may worsen symptoms affecting the central nervous system or brain which are caused by blood flukes (schistosomiasis), lung flukes (paragonimiasis) or pork tapeworms (cysticercosis). Therefore, Biltricide should in principle not be used in patients with a history of seizures (epilepsy) or if there are any other signs of central nervous system or brain impairment, such as the nodules under the skin that are characteristic of cysticercosis.
Driving and using machines: Individuals are affected in different ways by this medicine, meaning that reactions to unexpected and sudden events may not be sufficiently rapid and specific. For this reason, the patient should remain at home, especially on starting treatment, as well as for the entire treatment period and for 24 hours after treatment has ended. This applies in particular at the start of treatment as well as in combination with alcohol. Do not drive a car or any other type of vehicle. Do not operate electrical tools or machines. Do not work without a secure foothold.
Use in Children: The safety of Biltricide in children aged under 4 years has not been established.

Animal studies have not indicated that treatment with Biltricide harms an unborn child. According to reports in the literature, a large number of women have been treated to date without harmful effects.
The World Health Organization (WHO) has published a benefit-risk assessment of Biltricide in pregnant women and women of childbearing age in areas where blood fluke infections (schistosomiasis) and worm diseases transmitted by contaminated soil are common. The report states that the benefit of Biltricide treatment outweighs the health risk to the women and their babies. The benefit of treatment in pregnant women can be seen as a reduction in the occurrence of maternal anaemia and increased birth weights as well as a higher survival rate in newborn babies. Consequently, Biltricide can be used during pregnancy if the doctor deems it necessary.
Small quantities of praziquantel are excreted in human milk. It is not known whether the medicine has an effect on the baby as a result. When receiving short-term therapy, the patient should stop breast-feeding during treatment and for a further 24 hours afterwards.
It is unknown whether Biltricide influences human fertility. In animal studies, Biltricide was not found to affect fertility.
If pregnant or breast-feeding, thinking may be pregnant or planning to have a baby, ask the doctor or pharmacist for advice before taking this medicine.

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The side effects are ranked by frequency, using the following convention: Very common: more than 1 in 10 people treated.
Common: 1 to 10 in 100 people treated.
Uncommon: 1 to 10 in 1,000 people treated.
Rare: 1 to 10 in 10,000 people treated.
Very rare: less than 1 in 10,000 people treated.
Not known: cannot be estimated from the available data.
The side effects vary depending on the dose and duration of Biltricide treatment. They also depend on the species of parasite, the extent of the infection, the duration of the infection, and the location of the parasites in the body.
Hypersensitivity reactions: Very rare: Allergic reactions, increase in certain white blood cells (eosinophilia).
Nervous system disorders: Very common: Headache, dizziness.
Common: Vertigo, fatigue and delayed reactions with increased drowsiness.
Very rare: Seizures.
Cardiovascular disorders: Very rare: Heart rhythm disorders.
Gastrointestinal disorders: Very common: Stomach and abdominal pain, nausea, vomiting.
Common: Loss of appetite, diarrhea (very rarely bloody diarrhoea).
Skin disorders: Very common: Hives.
Common: Rash.
Very rare: Itching.
Musculoskeletal and connective tissue disorders: Common: Muscle pain.
General disorders: Very common: Fatigue.
Common: General malaise, fever.
Often it is not clear whether the symptoms have been caused directly by praziquantel (I, direct relationship), should be viewed as a physical reaction to the destruction of the parasites by praziquantel (II, indirect relationship), or are simply characteristic (symptoms caused by the parasitic infection) of the parasitic infection (III, no relationship). It can be difficult to differentiate conclusively between options I, II and III.
Reporting of side effects: If getting any side effects, talk to the doctor or pharmacist. This includes any possible side effects not listed in this monograph.

Tell the doctor or pharmacist if taking/using, have recently taken/used or might take/use any other medicines.
The effect of Biltricide is influenced in the following ways by simultaneous treatment with the medicines listed as follows: Diminished effect: The simultaneous administration of medicines that increase the breakdown of medicines in the liver by cytochrome P450 enzymes, such as rifampicin (an active substance for tuberculosis), antiepileptics (medicines for treating seizures, such as carbamazepine, phenytoin, phenobarbital, primidone), can decrease the concentration of Biltricide in the blood and consequently diminish the effect of Biltricide.
The simultaneous intake of dexamethasone (an active substance for treating inflammation), which increases the breakdown of medicines in the liver by cytochrome P450 enzymes, can decrease the concentration of Biltricide in the blood and consequently diminish the effect of Biltricide.
Dexamethasone should be stopped at least one week prior to taking Biltricide.
Increased effect and possible increase in side effects: The simultaneous administration of medicines that reduce the breakdown of medicines in the liver by cytochrome P450 enzymes, such as cimetidine (an active substance for treating gastrointestinal ulcers), can increase (lead to higher plasma concentrations) and prolong the effect (exposure time) of Biltricide.

Anthelmintics

P02BA01 - praziquantel ; Belongs to the class of quinoline derivatives and related substances used as antitrematodals.

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