Biltricide

New Zealand - English - Medsafe (Medicines Safety Authority)

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Active ingredient:
Praziquantel 600 mg
Available from:
Bayer New Zealand Limited
INN (International Name):
Praziquantel 600 mg
Dosage:
600 mg
Pharmaceutical form:
Film coated tablet
Composition:
Active: Praziquantel 600 mg Excipient: Hypromellose Macrogol 4000 Magnesium stearate Maize starch Microcrystalline cellulose Povidone Purified water   Sodium laurilsulfate Titanium dioxide
Units in package:
Bottle, glass, Type II with PE cap, 8 tablets
Class:
Prescription
Prescription type:
Prescription
Manufactured by:
Merck KGaA
Therapeutic indications:
Treatment of schistosoma infections due to various types of blood fluke (e.g. Schistosoma haematobium, S. japonicum, S. mekongi or S mansoni).
Product summary:
Package - Contents - Shelf Life: Bottle, glass, - brown, Type II with PE cap - 8 tablets - 48 months from date of manufacture stored at or below 25°C
Authorization number:
TT50-8752/1
Authorization date:
2011-06-08

BILTRICIDE

BILTRICIDE

®

(BIL·tra·side)

praziquantel

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.

BILTRICIDE

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.

Body weight

in Kg

No of

tablets

20-25

26-33

34-41

42-48

49-56

57-63

BILTRICIDE

64-70

71-78

79-86

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.

“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

BILTRICIDE

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.

170817 Biltricide DS

Page 1 of 8

DATA SHEET

1.

BILTRICIDE

®

(600 mg film coated tablet)

Biltricide, 600 mg film coated tablet

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION

Each film-coated tablet contains 600 mg praziquantel.

For a full list of excipients, see Section 6.1.

3.

PHARMACEUTICAL FORM

The film-coated 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 (eg 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.

Schistosoma haematobium

20 mg/kg body weight

Schistosoma mansoni

three times a day

Schistosoma japonicum

at four hourly intervals

Schistosoma mekongi

for one day.

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 body weight.

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.

170817 Biltricide DS

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Table 1: Conversion Table

BODY WEIGHT IN KG

20-25

26-33

34-41

42-48

49-56

57-63

64-70

71-78

79-86

No. of tablets

corresponding to

1 x 20 mg/kg

Biltricide should be swallowed whole with a little liquid, preferably after meals.

4.2.1

Paediatric population

See Section 4.4.

4.2.2

Hepatic impairment

See Section 4.4.

4.2.3

Renal impairment

See Section 4.4.

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 P 450 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.

170817 Biltricide DS

Page 3 of 8

As praziquantel 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 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 hospitalized under specialist care.

4.4.1

Renal impairment

Since 80% of praziquantel and its metabolites are excreted in the kidneys, excretion might

be delayed in patients with impaired renal function. Nephrotoxic effects of praziquantel are

not known.

4.4.2

Hepatic impairment

In uncompensated liver insufficiency and in patients with hepatosplenic schistosomiasis

caution should be taken, since due to reduced drug metabolisation in the liver, considerably

higher and longer lasting concentrations of unmetabolised 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.

4.4.3

Paediatric population

Safety in children has not been established.

4.5

Interaction with other medicines and other form of interaction

Praziquantel is believed to be metabolised via the CYP450 enzyme system. Many categories

of medicines are known to inhibit or induce CYP450 enzymes causing an increase or

decrease in serum concentrations or bioavailability. Care must therefore be exercised when

co-administering such medicines.

Concomitant administration of medicines that increase the activity of drug metabolising liver

enzymes (CYP450 inducers), e.g. antiepileptic medicines, dexamethasone may reduce

plasma levels of praziquantel. Concomitant administration of strong inducers of CYP450

such as rifampicin must be avoided. Chloroquine, when taken simultaneously, can lead to

lower concentrations of praziquantel in blood.

Concomitant administration of medicines that decrease the activity of drug metabolising liver

enzymes (CYP450 inhibitors) e.g. cimetidine, ketoconazole, itraconazole, erythromycin, may

increase plasma levels of praziquantel.

When administered concomitantly with grapefruit juice, an increase in praziquantel exposure

of less than twofold was observed in clinical studies.

170817 Biltricide DS

Page 4 of 8

4.6

Fertility, pregnancy and lactation

4.6.1

Pregnancy

Reproduction studies performed so far in rats and rabbits have revealed no evidence of

impaired fertility or harm to the fetus due to praziquantel. An increase in abortion rate was

seen in rats given single doses of 300 mg/kg. There are no adequate and well controlled

studies on the use of praziquantel in pregnant women.

Because animal reproduction studies are not always predictive of human response, for

safety reasons praziquantel should not be used in pregnancy unless clearly needed.

4.6.2

Lactation

Praziquantel has been reported to be excreted in the milk of nursing women. Women

should not nurse on the day of Biltricide treatment and during the subsequent 72 hours.

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

Undesirable effects

4.8.1

Summary of the safety profile

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.

4.8.2

Tabulated list of adverse reactions

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.

Table 2: Adverse reactions

Very Common

Common

Uncommon

Rare

Very Rare

Immune System

Disorders

Allergic

reaction

Polyserositis

Eosinophilia

Nervous System

Disorders

Headache

Dizziness

Vertigo

Somnolence

Seizures

Cardiac Disorders

Unspecified

arrhythmias

170817 Biltricide DS

Page 5 of 8

Gastrointestinal

Disorders

Gastrointestinal

and abdominal

pains

Nausea

Vomiting

Anorexia

Diarrhoea

(very rarely

bloody

diarrhoea)

Skin and

Subcutaneous

Tissue Disorders

Urticaria

Rash

Pruritus

Musculoskeletal,

Connective

Tissue and Bone

Disorders

Myalgia

General Disorders

and

Administrative

Site Conditions

Fatigue

Feeling

unwell

(asthenia,

malaise)

Fever

It is often not clear whether the complaints reported by patients or the undesirable effects

reported by the physician are caused by praziquantel itself (I, direct relation), or may be

considered to be an endogenous reaction to the death of the parasites produced by

praziquantel (II, indirect relation), or are symptomatic observations of the infestation (III, no

relation). It may be difficult to differentiate between the possible variations I, II and III.

4.8.3

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. Healthcare

professionals are asked to report any suspected adverse reactions to

https://nzphvc.otago.ac.nz/reporting/

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 medicine 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 advice on the management of overdose please contact the National Poisons Centre on

0800 POISON (0800 764 766).

5.

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties

Pharmacotherapeutic group: Antihelmintics, ATC code: P02BA01

170817 Biltricide DS

Page 6 of 8

Praziquantel is 2-(cyclohexylcarbonyl)-1,2,3,6,7,11b-hexahydro-4H-pyrazino

(2,1a) isoquinolin-4-one. CAS Number: 55268-74-1

Praziquantel is a white crystalline powder of bitter taste. The compound is stable under

normal conditions and melts at 136°C-140°C with decomposition. The active substance is

hygroscopic. Praziquantel is easily soluble in chloroform and dimethylsulfoxide, soluble in

ethanol and very slightly soluble in water. The molecular formula is C

. The

structural formula is as follows:

5.1.1

Pharmacodynamic effects

Animal studies show that praziquantel induces a rapid contraction of schistosomes by a

specific effect on the permeability of the cell membrane. The medicine further causes

vacuolisation and disintegration of the schistosome tegument. The effect is more marked on

the adult than on young worms.

5.2

Pharmacokinetic properties

5.2.1

Absorption

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 medicine in serum is in the unmetabolised form. Both the unchanged medicine

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

Preclinical data reveal no special hazard for humans based on studies of systemic toxicity,

genotoxicity, carcinogenic potential, toxicity to reproduction.

6.

PHARMACEUTICAL PARTICULARS

6.1

List of excipients

Maize starch, magnesium stearate, microcrystalline cellulose, povidone 25, sodium lauryl

sulfate, macrogol 4000, hypromellose, titanium dioxide (CI77891).

170817 Biltricide DS

Page 7 of 8

6.2

Incompatibilities

Not applicable.

6.3

Shelf life

48 months.

6.4

Special precautions for storage

Not applicable.

6.5

Nature and contents of container

Each brown glass bottle contains 8 tablets.

6.6

Special precautions for disposal

Any unused medicine or waste material should be disposed of in accordance with local

requirements.

7.

MEDICINE SCHEDULE

Prescription Medicine

8.

SPONSOR

Bayer New Zealand Limited

3 Argus Place

Hillcrest, North Shore

Auckland 0627

Free phone: 0800 233 988

9.

DATE OF FIRST APPROVAL

13 September 2012

170817 Biltricide DS

Page 8 of 8

10. DATE OF REVISION OF THE TEXT

17 August 2017

Registered Trademark of the Bayer Group, Germany

Summary table of changes

Section changed

Summary of new information

All sections

Data Sheet reformatted

Addition of interaction with grapefruit juice

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