Consumer medicine information

WHAT IS IN THIS LEAFLET

This leaflet answers some common questions about Biltricide. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you taking Biltricide against the benefits they expect it will have for you.

As Biltricide is a prescription medicine, it should only be used under medical supervision.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine. You may need to read it again.

WHAT BILTRICIDE IS USED FOR

Biltricide is used for the treatment of schistosomiasis or bilharziasis, which is a chronic parasitic infestation in humans caused by blood flukes (worms). The flukes live in freshwater snails and you may have been infected if you swam or waded in water infested by larvae released from the snails. They are found in Africa (including Madagascar and Mauritius), the Middle East, India, Southeast Asia and South America.

The larvae penetrate the skin, most commonly on the feet, and mature into adult worms in the urinary bladder or the gut.

A rash may occur soon after infestation. Common symptoms of acute infestation are fever, night sweats, lethargy, headache, abdominal pain, loss of appetite, weight loss and a non-productive cough. You may pass blood in the urine.

Infestation with schistosoma parasites may cause no symptoms. However, they may also lead to chronic liver disease or chronic disorders of the urinary tract.

Eggs of the adult worms can occasionally be found in the brain or the spinal cord causing paralysis, or in the eyes, affecting your eyesight.

Biltricide kills blood flukes by causing an immediate contraction and paralysis of the parasite; it also stops the parasite from being able to absorb and use sugars. The parasite then disintegrates with the help of the white blood cells and is passed from the body.

Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed it for another reason.

BEFORE YOU TAKE BILTRICIDE

When you must not take it

Do not take Biltricide if you have an allergy to:

• praziquantel, the active ingredient in Biltricide
• any of the ingredients listed at the end of this leaflet.

Some of the symptoms of an allergic reaction may include:

• shortness of breath
• wheezing or difficulty breathing
• swelling of the face, lips, tongue or other parts of the body
• rash, itching or hives on the skin.

Do not take Biltricide if you are taking rifampicin (an antibiotic used to treat tuberculosis or leprosy), dexamethasone (a corticosteroid) or anti-epileptic medicines.

Do not take Biltricide if the infestation is found in your eyes, because killing the parasite may cause blindness.

Do not take this medicine after the expiry date printed on the pack and bottle. The expiry date is printed on the carton and on each vial after “EXP” (e.g. 11 18 refers to November 2018). The expiry date refers to the last day of that month. If it has expired return it to your pharmacist for disposal.

Do not take this medicine if the packaging is torn or shows signs of tampering. If the packaging is damaged, return it to your pharmacist for disposal.

If you are not sure whether you should start taking this medicine, talk to your doctor.

Before you start to take it

Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.

Tell your doctor if you have or have had any of the following medical conditions:

• any heart problems
• any kidney disease that causes you to pass little or no urine
• any problems with your liver, particularly, if your liver has been infected by blood flukes
• history of epilepsy
• skin nodules (slightly elevated lesions on or in the skin).

Use of Biltricide may be associated with deterioration of your medical condition with symptoms similar to an allergic reaction. This is mainly seen in the acute phase of schistosomiasis (where the worms begin to produce eggs). This can lead to potentially life-threatening events such as lung failure, encephalopathy (disease of the brain), and/or cerebral vasculitis (narrowing or blockage of blood vessels in the brain).

If you take Biltricide for an infestation in your brain or spinal cord, you may get severe headaches and fits. If the doctor wants to treat you for your infestation in the brain, you should be taken to hospital so that a specialist can monitor your treatment.

Tell your doctor if you are pregnant or plan to become pregnant. Your doctor can discuss with you the risks and benefits of using Biltricide during pregnancy.

Tell your doctor if you are breastfeeding or intend to breastfeed. The active ingredient in Biltricide passes into breast milk and there is a possibility that your baby may be affected. You should not breastfeed your baby on the day you take Biltricide or for 3 days afterwards.

Your doctor may want to monitor you carefully or hospitalise you while you are taking Biltricide.

If you have not told your doctor or pharmacist about any of the above, tell them before you start taking Biltricide.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including any you have bought at your pharmacy, supermarket or health food shop.

Do not take Biltricide if you are taking:

• rifampicin (an antibiotic used to treat tuberculosis and leprosy).

Some medicines and Biltricide may interfere with each other. These include:

• dexamethasone (an anti-inflammatory and immunosuppressant)
• medicines for treating epilepsy
• cimetidine (a medicine used to treat high acid levels in your stomach, reflux and ulcers)
• chloroquine (an antimalarial medicine)
• ketoconazole or itraconazole (medicines used to treat fungal infections)
• erythromycin (an antibiotic used to treat bacterial infections)
• grapefruit juice.

These medicines may be affected by Biltricide or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.

Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking this medicine.

HOW TO TAKE BILTRICIDE

How much to take

Follow all directions given to you by your doctor or pharmacist carefully. They may differ from the information contained in this leaflet.

If you do not understand the instructions printed on the pharmacist label, ask your doctor or pharmacist for help.

You must take all the Biltricide tablets prescribed by your doctor or pharmacist to kill the type of blood fluke you have. Your doctor will prescribe a dose specifically for you. It is important to take all the tablets your doctor prescribed.

The dose prescribed will usually be 20 mg for every kg of your body weight taken three times in the one day every four hours.

How to take it

Swallow the tablets with a full glass of water.

The tablet can be divided into 4 parts.

Each part of the tablet has 150 mg of the active ingredient, allowing a precise dose to be given, depending on your weight.

If you need to take ¼ of a tablet, it is easier if you break the tablet at one of the outer grooves. The simplest way to break the tablet is to put your thumbnail in the groove of the tablet.

When to take it

Take your medicine at about the same time each day. Taking it at the same time each day will have the best effect. It will also help you remember when to take it.

Swallow the tablets preferably after eating a meal.

If you forget to take it

Take the dose as soon as you remember.

If it is almost time for the next dose, wait until it is time for your next dose, take your next dose when you are meant to and seek your doctor’s advice.

Do not take a double dose to make up for the dose that you missed. If you have trouble remembering when to take your medicine, ask your doctor or pharmacist for some hints.

If you take too much (overdose)

Immediately telephone your doctor or the Poisons Information Centre (Australia: 13 11 26 or New Zealand: 0800 POISON or 0800 764 766) for advice, or go to Accident and Emergency at the nearest hospital, if you think that you or anyone else may have taken too much Biltricide. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

If you take too many Biltricide tablets, you should take a laxative, which works quickly.

WHILE YOU ARE TAKING BILTRICIDE

Things you must do

If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking Biltricide.

Tell all the doctors, dentists and pharmacists who are treating you that you are taking Biltricide.

If you are on corticosteroid therapy or if you are about to start taking any new medicine, especially medicines used to treat tuberculosis, leprosy, epilepsy, malaria, stomach acidity, reflux or ulcers, tell your doctor or pharmacist that you are taking Biltricide. See “BEFORE YOU TAKE BILTRICIDE” for examples of these medicines.

Things you must not do

Do not take Biltricide to treat any other complaints unless your doctor tells you to.

Do not give your medicine to anyone else, even if they have the same condition as you.

Do not stop taking your medicine or lower the dosage without checking with your doctor. If you stop taking it suddenly, your condition may worsen or you may have unwanted side effects.

Things you should be careful of

You should not drive or operate machinery on the day of treatment and for the next 24 hours because you may feel tired or dizzy after taking Biltricide.

Seek your doctor’s advice before taking any other medicines with Biltricide.

SIDE EFFECTS

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Biltricide.

All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.

Do not be alarmed by the following lists of side effects. You may not experience any of them.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Biltricide, whether or not they are mentioned below. You may need medical treatment in some cases.

Tell your doctor if you notice any of the following and they worry you:

• vomiting
• nausea
• diarrhoea
• loss of appetite
• stomach pains
• drowsiness, sleepiness
• general feeling of being unwell, unusual tiredness or weakness
• aching muscles, muscle tenderness or weakness
• headache
• dizziness, spinning sensation
• hives (redness and itchiness of the skin) or rash
• fever.

These are the more common side effects. It is often not clear, whether the side effects you experience are a result of taking Biltricide, caused by the death of the parasites or are symptoms caused by the parasite.

Tell your doctor immediately, or go to accident and emergency at your nearest hospital if you notice any of the following:

• signs of an allergic reaction e.g. rash, swelling of the face, lips, tongue or other parts of the body, shortness of breath, wheezing or trouble breathing
• itching
• seizures
• palpitations and or chest pain
• bloody diarrhoea.

These may be more serious side effects of Biltricide. You may need urgent medical attention. Serious side effects are uncommon.

Side effects seem to happen more often and be more noticeable if you are infected with a large number of the parasites. Some patients may experience mild liver problems.

Tell your doctor or pharmacist if you notice anything that is making you feel unwell.

Other side effects not listed above may also occur in some people.

AFTER TAKING BILTRICIDE

Storage

Keep your tablets in the bottle until it is time to take them. If you take the tablets out of the bottle they may not keep well.

Keep your tablets in a cool dry place where the temperature stays below 25°C.

Do not store it or any other medicine in the bathroom, near a sink, or on a window-sill.

Do not leave it in the car. Heat and dampness can destroy some medicines.

Keep it where children cannot reach it. A locked cupboard at least one-and-a half metres above the ground is a good place to store medicines.

Disposal

If your doctor tells you to stop taking this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.

Return any unused medicine to your pharmacist.

PRODUCT DESCRIPTION

What it looks like

Biltricide is available in bottles of 8 tablets. They are white to pale yellow oblong tablets, with three score lines, marked with ‘BAYER’ on one side and ‘LG’ on the reverse.

Ingredients

Active Ingredient per tablet:
Biltricide - 600 mg praziquantel

Inactive ingredients:

• maize starch
• povidone
• sodium lauryl sulfate
• cellulose
• magnesium stearate
• hypromellose
• macrogol 4000
• titanium dioxide

Supplier

Made in Germany for:

Bayer Australia Ltd
ABN 22 000 138 714
875 Pacific Highway
Pymble NSW 2073

Bayer New Zealand Limited
3 Argus Place, Hillcrest
North Shore AUCKLAND 0627

Australian Registration Number

Biltricide - AUST R 18845

Date of preparation

July 2017

See TGA website (www.ebs.tga.gov.au) for latest Australian Consumer Medicine Information.

See MEDSAFE website (www.medsafe.govt.nz) for the latest New Zealand Consumer Medicine Information.

® Registered Trademark of Bayer AG, Germany

© Bayer Australia Ltd.

All rights reserved.

Published by MIMS December 2017

1 Name of Medicine

Praziquantel.

2 Qualitative and Quantitative Composition

Biltricide lacquer coated tablets are available as 600 mg of praziquantel.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Biltricide tablets contain 600 mg praziquantel. The tablets are white to pale yellow lacquer-coated oblong shaped tablets with three scores with Bayer on one side and "LG" on the reverse.

4 Clinical Particulars

4.1 Therapeutic Indications

Treatment of schistosoma infections due to various types of blood fluke (e.g. Schistosoma haematobium, S. japonicum, S. mekongi, S. mansoni).

4.2 Dose and Method of Administration

The doctor must prescribe individual doses for individual cases, according to the diagnosis.
20 mg/kg bodyweight three times daily at four hourly intervals for one day, for Schistosoma haematobium, Schistosoma mansoni, Schistosoma japonicum, Schistosoma mekongi.
The tablet has 3 score marks, each fragment contains 150 mg active substance, thus allowing a precise dose to be given, corresponding to the patient's bodyweight. See Table 1.
If 1/4 of a tablet is required, it is convenient to begin by breaking the tablet at one of the outer grooves. The simplest way to break the tablet is to place the thumbnail in the groove.
Biltricide should be swallowed whole with a little liquid, preferably after meals.

4.3 Contraindications

Known hypersensitivity to praziquantel or any of the excipients.
Ocular cysticercosis - parasite destruction within the eye may cause irreparable damage.
The concomitant administration of strong inducers of cytochrome P450 such as rifampicin must be avoided as therapeutically effective plasma levels may not be achieved.

4.4 Special Warnings and Precautions for Use

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 praziquantel can exacerbate central nervous system pathology due to schistosomiasis, paragonimiasis or Taenia solium cysticercosis, as a general rule this drug should not be administered to individuals reporting a history of epilepsy and/or other signs of potential central nervous system involvement such as subcutaneous nodules suggestive of cysticercosis.
Neurocysticercosis is not an approved indication due to insufficient data. In animals, venous thrombosis and the development of granulomas at the site of worm attachment has been observed following treatment with praziquantel. Patients treated with praziquantel (for neurocysticercosis) have had a high incidence of severe headache and seizures. Some patients also developed intracranial hypertension. Because of the potential for undiagnosed neurocysticercosis to be present in patients originating from endemic areas, extra care is necessary in managing such patients. If cerebral cysticercosis is present and treatment is still considered essential, the patient should be hospitalised under specialist care.
The concomitant administration of praziquantel with efavirenz, a strong inducer of cytochrome P 450 should be avoided as therapeutically effective plasma levels of praziquantel may not be achieved (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).

Use in hepatic impairment.

Use in renal impairment.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Praziquantel is believed to be metabolised via the CYP450 enzyme system. Many categories of drugs are known to inhibit or induce CYP450 enzymes causing an increase or decrease in serum concentrations or bioavailability. Care must therefore be exercised when coadministering such drugs.
Concomitant administration of drugs that increase the activity of drug metabolising liver enzymes (CYP450 inducers), e.g. antiepileptic drugs and dexamethasone may reduce plasma levels of praziquantel. Concomitant administration of strong inducers of CYP450 such as rifampicin must be avoided (see Section 4.3 Contraindications). Chloroquine, when taken simultaneously, can lead to lower concentrations of praziquantel in blood.
Concomitant administration with efavirenz should be avoided as therapeutically effective plasma levels of praziquantel may not be achieved (see Section 4.4 Special Warnings and Precautions for Use) and no dosage recommendation for praziquantel can be given due to missing pharmacokinetic and safety data. Therapeutic alternatives to praziquantel should be considered.
Concomitant administration of drugs that decrease the activity of drug metabolising liver enzymes (CYP450 inhibitors) e.g. cimetidine, ketoconazole, itraconazole, erythromycin and ritonavir may increase plasma levels of praziquantel.
Coadministration of grapefruit juice and praziquantel is not recommended. Coadministration has been reported to increase praziquantel C_max by 1.6 (90% CI: 1.05, 2.0) and AUC by 1.9 (90% CI: 1.03, 2.47). The effect of this increase in exposure on efficacy and safety of praziquantel has not been studied.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

4.7 Effects on Ability to Drive and Use Machines

Patients should be warned not to drive or operate machinery on the day of treatment (and during the subsequent 24 hours), as their ability to do so may be temporarily impaired by the use of praziquantel.

4.8 Adverse Effects (Undesirable Effects)

Side effects vary according to dose and duration of praziquantel medication; furthermore they are dependent on the parasite species, extent of parasitisation, duration of infection and localisation of the parasites in the body. Side effects occur earlier and are more frequent and pronounced in patients with severe parasitic infestation. Mild increases in liver enzymes have been reported in some patients.
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. See Table 2.
It is often not clear whether the complaints reported by patients or the undesirable effects reported by the physician are caused by praziquantel itself (1. direct relation), or may be considered to be an endogenous reaction to the death of the parasites produced by praziquantel (2. indirect relation), or are symptomatic observations of the infestation (3. no relation). It may be difficult to differentiate between the possible variations 1, 2 and 3.

Reporting suspected adverse effects.

4.9 Overdose

Information on overdosage in humans is not available. Treatment should be supportive and provide symptomatic care.
Activated charcoal may reduce absorption of the drug if given within one to two hours after ingestion. In patients who are not fully conscious or have impaired gag reflex, consideration should be given to administering activated charcoal via a nasogastric tube, once the airway is protected.
For information on the management of overdose, contact the Poison Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Clinical trials.

5.2 Pharmacokinetic Properties

After oral administration praziquantel is rapidly absorbed (80%). It is, however, subject to first pass effect and extensive metabolism. One hour after administration approximately 6% only of the drug in serum is in the unmetabolised form. Both the unchanged drug and the metabolites are excreted primarily by the kidneys.
Maximal serum concentration is achieved 1-3 hours after dosing. The half-life of praziquantel in serum is 0.8-1.5 hours.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Besides the active ingredient, Biltricide tablets also contain the following excipients: hypromellose, macrogol 4000, magnesium stearate, maize starch, microcrystalline cellulose, povidone K25, sodium lauryl sulfate, titanium dioxide (CI77891).

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 25 degrees Celsius.

6.5 Nature and Contents of Container

Biltricide is sold in bottles of 8 tablets.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

Chemical structure.

CAS number.

7 Medicine Schedule (Poisons Standard)

Schedule 4 (Prescription Only Medicine).

Summary Table of Changes