Consumer medicine information

What is in this leaflet

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

All medicines have risks and benefits. Your doctor has weighed the risks of you being given Benzatropine Injection against the benefits they expect it will have for you.

If you have any concerns about being given this medicine, ask your doctor.

Keep this leaflet in a safe place. You may need to read it again.

What Benzatropine Injection is used for

Benzatropine Injection is used to treat some of the symptoms of parkinsonism.

The symptoms of parkinsonism include slow and unsteady movement, muscle stiffness and shaking (tremors). If untreated, parkinsonism can cause difficulty in performing normal daily activities.

Symptoms of parkinsonism can be caused by certain diseases of the brain affecting movement, such as Parkinson’s disease. They can also be caused by some medicines that are used to treat certain mental conditions.

Benzatropine Injection is most helpful in improving muscle stiffness and shaking.

Benzatropine Injection belongs to a group of medicines called anticholinergics. It comes as an injection.

Benzatropine Injection works by blocking the effects of acetylcholine, a naturally occurring chemical produced by brain cells that can interfere with the regions of the brain that control muscle movement. In many patients, this reduces the symptoms of shaking and muscle stiffness.

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.

This medicine is available only with a doctor’s prescription.

Before you are given Benzatropine Injection

When you must not be given it

You should not be given Benzatropine Injection if you have an allergy to:

• any medicine containing benzatropine mesilate
• 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 give this medicine to a child under three years old. Also, it should be used with caution in older children.

You should not be given Benzatropine Injection if the solution is discoloured, cloudy, turbid, or a precipitate is present. The solution is normally a clear, particle free solution.

The doctor or nurse will check to ensure the medicine is not past its expiry date and has not been tampered with.

If you are not sure whether you should be given this medicine, talk to your doctor.

Before you are given it

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

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

• heart problems, such as fast heart beat
• enlarged prostate
• mental illness
• glaucoma
• uncontrolled movements of hands, mouth or tongue.

Tell your doctor if you are pregnant, plan to become pregnant or are breast-feeding. Your doctor can discuss with you the risks and benefits involved.

Tell your doctor if you consume large quantities of alcohol.

If you have not told your doctor about any of the above, tell him/her before you are given Benzatropine Injection.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket, health food shop, naturopath or herbalist.

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

• some medicines used to treat mental illness or psychotic disorders
• a group of medicines called tricyclic antidepressants used to treat depression
• other anticholinergic medicines, such as benzhexol, biperiden, procyclidine, orphenadrine.

These medicines may be affected by Benzatropine Injection or may affect how well it works. Being given Benzatropine Injection with these medicines may cause fever, heat intolerance, and stomach or bowel problems. You may need different amounts of your medicines, or you may need to take different medicines.

Your doctor has more information on medicines to be careful with or avoid while being given this medicine.

How Benzatropine Injection is given

Benzatropine Injection must only be given by a doctor or nurse.

How it is given

The dose is given as an injection into a vein or a muscle.

How much is given

Your doctor will decide what dose of Benzatropine Injection you will receive and how long you will receive it for. This depends on your medical condition and other factors, such as your weight, age and whether you are taking other medicines.

If you are given too much (overdose)

Symptoms of an overdose are the same as side effects but may be more severe. The symptoms of a side effect are listed under Side effects below. You may also have other effects, including decreased or increased reaction time, dizziness, poor coordination, muscle weakness, inability to perspire, hot and dry flushed skin, headache, breathing difficulties, fits and unconsciousness.

Also, symptoms of existing mental illness may worsen after taking an overdose.

If you notice any symptoms of an overdose immediately contact your doctor or go to the Emergency Department at the nearest hospital.

Contact the Poisons Information Centre on 13 11 26 for further advice on overdose management.

While you are being given Benzatropine Injection

Things you must do

If you are about to be started on any new medicine, remind your doctor and pharmacist that you have been given Benzatropine Injection.

If you become pregnant while being given this medicine, tell your doctor immediately.

If you experience problems with sweating while using Benzatropine Injection tell your doctor immediately.

Under certain conditions Benzatropine Injection may make you perspire or sweat less, which may cause heat stroke. This may happen during hot weather, especially if you:

• drink large quantities of alcohol
• are being treated with other anticholinergic medicines for a chronic illness
• have a nervous (neurological) disorder
• will be working in a hot environment
• have an existing problem with sweating.

Your doctor may need to reduce your dose of Benzatropine Injection.

Try to avoid becoming overheated during exercise or hot weather while you are using this medicine. Benzatropine Injection may make you sweat less, causing your body temperature to increase. If you overheat during exercise or hot weather you may get heat stroke.

Things to be careful of

Be careful driving or operating machinery until you know how Benzatropine Injection affects you. This medicine may cause some people to have blurred vision or to become less alert than normal. If you have any of these symptoms, do not drive, operate machinery or do anything else that could be dangerous.

Side effects

Tell your doctor or nurse as soon as possible if you do not feel well while you are being given Benzatropine Injection

This medicine helps most people with certain symptoms of parkinsonism, but it may have unwanted side effects in a few people. 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.

If you are over 65 years of age you may have an increased chance of getting side effects.

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

Ask your doctor to answer any questions you may have.

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

• constipation
• dry mouth, or difficulty swallowing or speaking due to dry mouth
• feeling sick, also called nausea, vomiting
• loss of appetite, weight loss
• blurred vision, dilated pupils
• increased heart rate.

These are possible side effects of Benzatropine Injection. These are usually mild.

Tell your doctor as soon as possible if you notice any of the following:

• difficult or painful urination
• an allergic reaction, for example skin rash
• mood or mental changes such as depression, nervousness, unusual laziness or sleepiness, confusion, disorientation, memory loss
• numb fingers
• seeing things that are not there, also called visual hallucinations
• worsening symptoms of existing mental illness.

The above list includes serious side effects that may require medical attention. Serious side effects are generally rare.

If any of the following happen, tell your doctor immediately or go to the Emergency Department at your nearest hospital:

• heat stroke, fever, raised body temperature
• it becomes impossible to empty your bladder (urinary retention).

The above list includes very serious side effects. You may need urgent medical attention or hospitalisation. These side effects are very rare.

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

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

After being given Benzatropine Injection

Storage

Benzatropine Injection will be stored in the surgery, pharmacy or ward of a hospital. The injection is kept in a cool dry place protected from light where the temperature stays below 30°C.

Benzatropine Injection will only be opened when it is time for you to have the injection.

Product description

What it looks like

Benzatropine Injection is a clear, particle free solution in a clear glass vial sealed with a grey rubber stopper and aluminium seal with a blue plastic flip off cap.

Benzatropine Injection is available in a 2mL vial.

Ingredients

Benzatropine Injection contains 2 mg of benzatropine mesilate in water for injection.

It also contains sodium chloride.

This medicine does not contain lactose, sucrose, gluten, tartrazine, alcohol, dyes or preservatives.

Manufacturer

Benzatropine Injection is made in Australia by:

Phebra Pty Ltd
19 Orion Road, Lane Cove West,
NSW 2066, Australia.
Telephone: 1800 720 020

Benzatropine Injection 2 mg/2 mL.

AUST R 276242

Phebra product code- INJ187, INJ197

Date prepared: 27 June 2017

Phebra and the Phi symbol are trademarks of Phebra Pty Ltd, 19 Orion Road, Lane Cove West, NSW 2066, Australia.

Published by MIMS November 2017

1 Name of Medicine

Benzatropine mesilate.

2 Qualitative and Quantitative Composition

Benzatropine Injection is available as 2 mg in 2 mL vials.
Benzatropine Injection contains benzatropine mesilate as the active ingredient.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Benzatropine Injection, 2 mg in 2 mL, clear, colourless, particle free solution.

4 Clinical Particulars

4.1 Therapeutic Indications

Benzatropine Injection is recommended for all forms of parkinsonism - including arteriosclerotic, post-encephalitic, idiopathic, as well as drug-induced extrapyramidal disorders (except tardive dyskinesia). It can be effective at any stage of the disease, even when a patient has become bedridden. Benzatropine Injection often is helpful in patients who have become unresponsive to other agents. Benzatropine Injection is a powerful anticholinergic agent which is mainly effective in relieving tremor and rigidity. Therapy is directed toward control of disturbing symptoms to permit the patient maximum integration of function with minimum discomfort.
In non-drug-induced parkinsonism, partial control of symptoms is usually achieved.

4.2 Dose and Method of Administration

Benzatropine Injection is available as an injection for intravenous and intramuscular use. Each mL of the injection contains: benzatropine mesilate 1.0 mg; sodium chloride 9.0 mg; water for injection q.s 1.0 mL.
Because Benzatropine Injection is cumulative in action, therapy should be initiated with a small dose which then can be increased gradually at five- or six-day intervals. Increases in dosage should be made in increments of 0.5 mg, to a maximum of 6 mg.
The injection is especially useful for psychotic patients with acute dystonic reactions or other reactions that make oral medication difficult or impossible.
There is no significant difference in the onset of effect following intravenous or intramuscular injection. Improvement is noticeable within a few minutes after injection.
In emergency situations, when the patient's condition is alarming, administration of 1 to 2 mL of Benzatropine Injection will provide quick relief. If the signs of parkinsonism begin to return, the dose can be repeated.
Some patients experience greatest relief when taking the entire dose at bedtime; others react more favourably to divided doses, two to four times a day.
The long duration of action of Benzatropine Injection makes it particularly suitable for administration at bedtime when the effects may persist throughout the night. Consequently, Benzatropine Injection enables the patient to turn in bed more easily and to rise in the morning.
Therapy with other agents in parkinsonism should not be terminated abruptly when Benzatropine Injection is started, but reduced or discontinued gradually. Many patients obtain the greatest relief with a combination of Benzatropine Injection and other drugs.
Benzatropine Injection may be used concomitantly with combinations of carbidopa/ levodopa, or with levodopa in which case periodic dosage adjustment may be required in order to maintain optimum response.

Arteriosclerotic, idiopathic and postencephalitic parkinsonism.

Drug-induced parkinsonism.

4.3 Contraindications

Because of the atropine-like side effects, Benzatropine Injection is contraindicated in children under three years of age, and should be used with caution in older children.
Benzatropine Injection is contraindicated in patients who are hypersensitive to any component of this product.

4.4 Special Warnings and Precautions for Use

Since benzatropine mesilate has cumulative action, continued supervision is advisable. Patients with a tendency to tachycardia and patients with prostatic hypertrophy, should be closely observed during treatment.
In large doses, the drug may cause complaints of weakness and inability to move particular muscle groups. For example, if the neck has been rigid and suddenly relaxes, it may feel weak, causing some concern. In this event, dosage adjustment may be required.
Mental confusion and excitement may occur with large doses, or in susceptible patients. Visual hallucinations have been reported occasionally. Furthermore, in the treatment of extrapyramidal symptoms due to central nervous system drugs, such as phenothiazines and reserpine, in patients with mental disorders, occasionally there may be intensification of mental disorders. In such cases antiparkinsonian drugs can precipitate a toxic psychosis.
Patients with mental disorders should be kept under careful observation, especially at the beginning of treatment or if dosage is increased.
Tardive dyskinesia may appear in some patients on long-term therapy with phenothiazines and related agents, or may occur after therapy when these drugs have been discontinued. Antiparkinsonian agents usually do not alleviate their symptoms of tardive dyskinesia, and in some instances may aggravate or unmask such symptoms. Benzatropine Injection is not recommended in tardive dyskinesia.
Since benzatropine mesilate contains structural features of atropine, it may produce anhydrosis. For this reason, it should be given with caution during hot weather, especially when given concomitantly with other atropine-like drugs to the chronically ill, the alcoholic, those who have central nervous system disease and those who do manual labour in a hot environment.
Anhydrosis may occur more readily when some disturbance of sweating already exists. If there is evidence of anhydrosis, the possibility of hyperthermia should be considered. Dosage should be decreased at the discretion of the physician so that the ability to maintain body heat equilibrium by perspiration is not impaired. Severe anhydrosis and fatal hyperthermia have occurred.
The physician should be aware of the possible occurrence of glaucoma. Although the drug does not appear to have any adverse effect on simple glaucoma, Benzatropine Injection probably should not be used in narrow-angle glaucoma.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

When Benzatropine Injection is given concomitantly with phenothiazines, haloperidol or other drugs with anticholinergic or antidopaminergic activity, patients should be advised to report fever, heat intolerance and gastrointestinal complaints promptly. Paralytic ileus, sometimes fatal, has occurred in patients taking anticholinergic-type antiparkinsonism drugs, including Benzatropine Injection, in combination with phenothiazines and/or tricyclic antidepressants.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

4.7 Effects on Ability to Drive and Use Machines

Benzatropine mesilate may impair mental and/or physical abilities required for performance of hazardous tasks, such as operating machinery or driving a motor vehicle.

4.8 Adverse Effects (Undesirable Effects)

Adverse reactions, most of which are anticholinergic or antihistaminic in nature are listed below by body system in order of decreasing severity.

Cardiovascular.

Digestive.

Nervous system.

Special senses.

Urogenital.

Metabolic/immune and skin.

Other.

Reporting suspected adverse effects.

4.9 Overdose

Symptoms.

Treatment.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Clinical trials.

5.2 Pharmacokinetic Properties

Absorption.

Distribution.

Metabolism.

Excretion.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Each Benzatropine Injection contains: sodium chloride 18.0 mg, water for injections q.s 2.0 mL.

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)¹. The expiry date can be found on the packaging.
¹ AUST R 276242.

6.4 Special Precautions for Storage

Protect from light. Do not freeze. Store below 30°C.

6.5 Nature and Contents of Container

Benzatropine Injection is supplied as 2 mg/2 mL glass vials.
Phebra product code: INJ197 2 mL vial supplied in a carton containing 5 vials;
INJ187 2 mL vial supplied in a carton containing 10 vials.
Not all pack sizes may be marketed.

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

Benzatropine mesilate is a synthetic compound resulting from the combination of the active portions of atropine and diphenhydramine.
Benzatropine mesilate is a crystalline white powder and is very soluble in water.

Chemical structure.

CAS number.

7 Medicine Schedule (Poisons Standard)

S4.

Summary Table of Changes