Consumer Medicine Information
DISIPAL®
50 mg Orphenadrine hydrochloride
Tablet
What is in this leaflet
This leaflet answers some common questions about DISIPAL. 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 this medicine against the expected benefits.
Use DISIPAL as instructed. If you have any concerns about taking this medicine, ask your doctor or pharmacist.
Keep this leaflet. You may need to read it again.
What DISIPAL is used for
This medicine is used to treat a type of movement disorder caused by changes in the brain. This is called Parkinson's Syndrome and includes all forms of Parkinsonism.
This medicine belongs to a group of medicines called anticholinergics.
This medicine works in the central nervous system (CNS). It relaxes muscles affected by Parkinson's Syndrome. Your doctor may have prescribed DISIPAL for another reason. Ask your doctor why this medicine has been prescribed for you.
This medicine is available only with a doctor's prescription.
Before you take DISIPAL
When you must not take DISIPAL.
Do not take this medicine if you are allergic to:
- orphenadrine
- any of the ingredients listed at the end of this leaflet (see Product Description)
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 this medicine if you have, or have had, any of the following medical conditions:
- Myasthenia gravis (a disease of the muscles causing drooping eyelids, double vision, difficulty in speaking and swallowing and sometimes muscle weakness in the arms or legs).
- Enlarged prostate
- Acute (or narrow angle) glaucoma (high pressure in the eye).
- Untreated urinary retention (difficulty passing water).
- Gastrointestinal obstruction (a blockage in the digestive system).
- Tardive dyskinesia (repeated involuntary muscle movements).
- Porphyria (a rare inherited disorder which affects the breakdown of the red blood cell pigment, haemoglobin).
If you are unsure whether any of the above conditions apply to you, ask your doctor.
Do not take this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering. If it has expired or 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 DISIPAL
Tell your doctor if you have a known allergy to DISIPAL or any ingredients listed at the end of this leaflet.
Tell your doctor if:
- you have or have had any medical conditions, particularly:
- arrhythmia or tachycardia (changes in heart rate either fast, slow or irregular)
- liver or kidney function disorders
- micturition disturbances (problems in passing urine)
- you have an allergy to DISIPAL or any of the ingredients listed at the end of this leaflet
- you have any allergies to any other medicines or any other substances, such as food, preservatives or dyes
- you are pregnant or plan to become pregnant or are breast-feeding. Your doctor can discuss with you the risks and benefits involved.
If you have not told your doctor about any of the above, tell him/her before you start taking this medicine.
This medicine is not addictive
Warning: The sodium benzoate E211 used in the sugar coat can be mildly irritating to the skin, eyes and mucous membrane.
Taking other medicines
Do not take this medicine if you are also using chlorpromazine (a major tranquilliser, also used in severe nausea and vomiting).
Taking the following medicines together with DISIPAL increases the chance of adverse effects:
- other anticholinergic medicines to treat Parkinsonism
- tricyclic antidepressants (medicines used to treat depression)
- phenothiazines (tranquillisers)
- amantadine (antiviral and antiparkinsonian medicine)
- disopyramide or quinidine (medications for treatment of irregular heart rate)
- some antihistamines (medicine used to prevent or relieve the symptoms of allergy)
Tell your doctor or pharmacist if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop. Some medicines may interfere with DISIPAL.
These medicines may be affected by DISIPAL 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 DISIPAL
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 on the pack, ask your doctor or pharmacist for help.
How much to take
Start with a low dose: eg. 50 mg three times daily.
Increase this slowly by 50 mg every 2-3 days, up to a maintenance dose of 150-250 mg (maximum 400 mg) daily, divided into three doses.
Do not discontinue DISIPAL abruptly. Withdraw DISIPAL gradually.
If you stop taking it suddenly, your condition may worsen or you may have unwanted side effects.
If it is necessary for you to stop taking DISIPAL, your doctor will advise you how to gradually reduce the amount you take each day, before stopping the medicine completely.
How to take DISIPAL
Swallow the tablets whole, with a full glass of water.
When to take DISIPAL
Take your medicine at about the same time each day. This will help you remember when to take it.
It does not matter if you take this medicine before or after food.
Do not take DISIPAL with alcohol.
How long to take DISIPAL
Follow carefully all directions given to you by your doctor and the pharmacist. These directions may differ from the information contained in this leaflet.
Continue taking your medicine for as long as your doctor advises you. This medicine helps control your condition. It is important to keep taking your medicine even if you feel well.
If you forget to take DISIPAL
If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to. Otherwise, take it as soon as you remember, and then go back to taking your medicine as you would normally.
Do not take a double dose to make up for the dose that you missed. This may increase the chance of you getting an unwanted side effect.
If you are not sure what to do, ask your doctor or pharmacist.
If you have trouble remembering to take your medicine, ask your doctor or pharmacist for some hints.
While you are using DISIPAL
Things you must do
If you are about to be started on any new medicine, tell your doctor and pharmacist that you are taking this medicine.
Tell any other doctors, dentists, and pharmacists who treat you that you are taking this medicine.
If you are going to have surgery, tell the surgeon or anaesthetist that you are taking this medicine. It may affect other medicines used during surgery.
If you become pregnant while taking this medicine, tell your doctor immediately.
If you are about to have any blood tests, tell your doctor that you are taking this medicine. It may interfere with the results of some tests.
Keep all of your doctor's appointments so that your progress can be checked.
Things you must not do
Do not take alcohol whilst taking Disipal.
Do not take this medicine to treat any other complaints unless your doctor tells you to.
Do not give your medicine to anyone else, even if they seem to 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 such as movement disturbances, agitation and/or confusion, diarrhoea and an increased sweating. This is particularly apparent in elderly patients.
Things to be careful of
Be careful driving or operating machinery until you know how this medicine affects you. This medicine may cause dizziness, drowsiness, visual disturbances and a slow reaction time in some people. If you have any of these symptoms, do not drive, operate machinery or do anything else that could be dangerous.
Side-Effects
Like all medicines, DISIPAL can cause some side effects. Side effects not listed in this leaflet may occur in some patients.
Tell your doctor or pharmacist if you have any unpleasant effects while you are taking DISIPAL even if you do not think the effect is connected with the medicine or is not listed in this leaflet.
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 if you notice any of the following and they worry you:
- dry mouth
- blurred vision or dilated pupils
- dizziness
- drowsiness
- intolerance to heat, with decreased sweating
The above list includes the more common side effects of your medicine
Tell your doctor as soon as possible if you notice any of the following:
- constipation or difficulty passing urine
- changes in heart rate
- nausea and vomiting
- extremely high body temperature
- sedation
- confusion
- agitation
- hallucinations
- difficulty in sleeping
- changes in mood
- any kind of skin rash, irritation or redness
- concentration problems and memory loss
- convulsions or fits
The above list includes serious side effects which may require medical attention.
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.
In Case of Overdose
If you take too much
Immediately telephone your doctor or the Poisons Information Centre (0800 POISON and 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 of this medicine. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.
Symptoms of an overdose may include:
- excitation
- nervousness
- delirium
- unconsciousness
- increased heart rate
- convulsions or fits
- difficulty passing urine
- difficulty in breathing (NOTE this may occur 2 -3 hours after taking DISIPAL)
After using DISIPAL
Keep DISIPAL in the pack until required.
Storage
Keep your tablets in a cool dry place at normal room temperature (not more than 25°C).
Do not store this medicine or any other medicine in the bathroom or near a sink. Do not leave it on a window sill or in the car. Heat and dampness can destroy some medicines.
Keep DISIPAL 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.
Do not use DISIPAL after the expiry date on the package.
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.
Product description
What DISIPAL looks like
DISIPAL tablets are yellow sugar-coated tablets, imprinted with 'I'.
Ingredients
Active ingredients:
Each DISIPAL tablet contains 50 mg of orphenadrine hydrochloride as the active ingredient.
Inactive ingredients:
DISIPAL also contains:
- lactose
- sucrose
- maize starch
- tribasic calcium phosphate
- magnesium stearate
- calcium carbonate
- kaolin
- talc
- stearic acid
- gelatin
- titanium dioxide
- acacia
- Opaseal P-17-0200 (containing IMS, polyvinylacetate phthalate and stearic acid)
- Opalux yellow AS 3026 (containing sucrose, titanium dioxide, tartrazine E102, sunset yellow E110, povidone, amaranth E123 and sodium benzoate E211)
- Opaglos 6000 (containing ethanol, shellac, beeswax and yellow carnuba wax)
- black printing ink.
This medicine does not contain gluten.
This is not all the information available on DISIPAL. If you have any more questions or are unsure about anything, ask your doctor or pharmacist.
Supplier
DISIPAL is supplied in New Zealand by:
CSL Biotherapies (NZ) Ltd
666 Great South Road
Penrose
Auckland 6
NEW ZEALAND
Telephone: 0800 502 757
This leaflet was prepared in July 2007.
DISIPAL® is a registered trademark of Astellas Pharma Europe B.V.