Orphenadrine Hydrochloride 50mg Tablets
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DISIPAL® 50mg Tablets
(orphenadrine hydrochloride) Patient Information Leaflet
Read all of this leaflet carefully before you start taking this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it onto others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
The name of your medicine is Disipal 50mg Tablets but will be referred to as Disipal Tablets throughout this leaflet.
In this leaflet:
1. What Disipal Tablets are and what they are used for
2. Before you take Disipal Tablets
3. How to take Disipal Tablets
4. Possible side effects
5. How to store Disipal Tablets.
6. Further information
1. What Disipal Tablets are and what they are used for
The active ingredient in Disipal Tablets belongs to the group of medicines called anticholinergic agents.
Disipal Tablets are used in the treatment of all forms of Parkinson's disease, a condition which can cause uncontrollable trembling of the hands, and other difficulties of movement, for example in standing or walking. Anticholinergic agents are also used when other medicines have caused these problems.
2. Before you take Disipal Tablets Do not take Disipal Tablets. Tell your doctor if you:
• are allergic (hypersensitive) to orphenadrine or any of the other ingredients of Disipal Tablets (see list in section 6 ‘Further information')
• have increased pressure in the eye (glaucoma).
• have an enlarged prostate.
• are unable to pass water for any reason.
• Have a blockage in your digestive system or any stomach disorders.
• suffer from a rare inherited disease where the breakdown of haemoglobin (a pigment in the red
blood cells) is affected (porphyria).
• suffer from involuntary movements of the face or body (tardive dyskinesia). Your doctor will take this into consideration before prescribing the tablets for you.
• suffer from a rare hereditary problem of fructose and galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption or sucrase-isomaltase insufficiency.
Disipal Tablets should not be given to children.
Take special care with Disipal Tablets Tell your doctor if you:
• suffer from heart disease
• suffer from liver disorders
• suffer from kidney disorders
• have difficulties passing water
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
If you are taking other anticholinergic agents at the same time as Disipal Tablets, this can lead to an increase in dry mouth and difficulties in passing water. Your doctor or pharmacist will be able to advise you whether any of the medicines you are taking fall into this category.
Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine. Do not use Disipal Tablets during pregnancy or if you are breast-feeding, unless clearly necessary.
Driving and using machines
Do not drive or use any tools or machines if you feel dizzy or have blurred vision whilst taking Disipal Tablets. Important information about some of the ingredients of Disipal Tablets
This medicine contains sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. How to take Disipal Tablets
Always take Disipal Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Dosage
The usual dose for adults and the elderly is three tablets daily in divided doses. Your doctor may increase this dose, if necessary, by one tablet every two to three days up to a maximum of eight tablets in a day. Usually you will need long term treatment with Disipal Tablets.
Use in children
Disipal Tablets should not be given to children.
If you take more Disipal Tablets than you should
Taking more Disipal Tablets than have been prescribed could be dangerous. If you, or anyone else, should accidentally take more tablets than prescribed, you must phone your doctor or go to a hospital casualty department immediately.
If you forget to take Disipal Tablets
Take the forgotten dose as soon as you remember. If it is time for your next dose skip the dose you missed and just continue to follow the dosing schedule as usual. Do not take a double dose to make up for a forgotten one.
If you stop taking Disipal Tablets
If you are to stop taking Disipal Tablets then your doctor will make sure that the dose is gradually reduced over a number of days. You should not stop taking the tablets unless you have been told to do so by your doctor. If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Disipal Tablets can cause side effects, although not everybody gets them.
If you are elderly you may be more likely to get side effects.
Uncommon (fewer than 1 in 100 patients)
allergic reactions may occur while on treatment with Disipal Tablets. Signs of allergy include: rash, wheezing, breathlessness, swollen eye lids, face or lips and in extreme cases collapse. If you get any of these symptoms soon after taking Disipal Tablets, do not take any more.
Tell a doctor immediately and take the packaging and this leaflet with you.
Other possible side effects:
Common (fewer than 1 in 10 patients)
• Dry mouth, stomach upsets
• Dizziness
• Difficulty in seeing clearly
Uncommon (fewer than 1 in 100 patients)
• Rapid heart beat
• Changes of mood such as highly elevated mood, confusion, sleepiness, hallucinations, difficulty in sleeping, nervousness, seizure (fits)
• Difficulty in passing water
Rare (fewer than 1 in 1000 patients)
• Memory disturbance
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Disipal Tablets
• Keep out of the sight and reach of children.
• Store at room temperature (15°C-25°C).
• Do not use this medicine after the expiry date (Exp) printed on the package. The expiry date refers to the last day of that month.
• Medicines should not be disposed of via waste water or house hold waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
• If your medicine becomes discoloured or show any sings of deterioration, seek the advice of your pharmacist.
6. Further information
What Disipal Tablets contain
Each tablet contains 50mg orphenadrine hydrochloride.
Other ingredients are microcrystalline cellulose, maize starch granulated, stearic acid, magnesium stearate, silicon dioxide. Excipients for sugar-coating are shellac, acacia, talc, beta-carotene E160a, sucrose.
What Disipal Tablets look like and contents of the pack
Disipal 50mg Tablets are round, yellow, sugar coated tablets with no markings.
Disipal 50mg Tablets are available in blister packs of 100 and 250 tablets.
Manufacturer and Product Licence Holder
POM PL No: 06464/3060
This product is manufactured by Mipharm S.p.A, Via B.Quaranta, 12-20141, Milan, Italy, and procured from within the EU and repackaged by the Product Licence holder:
Waymade plc, Miles Gray Road, Basildon, Essex SS14 3FR.
Leaflet revision date (Ref.) 24.6.2014
Disipal is a registered trademark of Astellas Pharma Europe B.V.
Orphenadrine Hydrochloride 50mg Tablets
Patient Information Leaflet
Read all of this leaflet carefully before you start taking this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it onto others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
The name of your medicine is Orphenadrine Hydrochloride 50mg Tablets but will be referred to as Orphenadrine Hydrochloride Tablets throughout this leaflet.
In this leaflet:
1. What Orphenadrine Hydrochloride Tablets are and what they are used for
2. Before you take Orphenadrine Hydrochloride Tablets
3. How to take Orphenadrine Hydrochloride Tablets
4. Possible side effects
5. How to store Orphenadrine Hydrochloride Tablets.
6. Further information
1. What Orphenadrine Hydrochloride Tablets are and what they are used for
The active ingredient in Orphenadrine Hydrochloride Tablets belongs to the group of medicines called anticholinergic agents.
Orphenadrine Hydrochloride Tablets are used in the treatment of all forms of Parkinson's disease, a condition which can cause uncontrollable trembling of the hands, and other difficulties of movement, for example in standing or walking. Anticholinergic agents are also used when other medicines have caused these problems.
2. Before you take Orphenadrine Hydrochloride Tablets Do not take Orphenadrine Hydrochloride Tablets. Tell your doctor if you:
• are allergic (hypersensitive) to orphenadrine or any of the other ingredients of Orphenadrine Hydrochloride Tablets (see list in section 6 ‘Further information')
• have increased pressure in the eye (glaucoma).
• have an enlarged prostate.
• are unable to pass water for any reason.
• Have a blockage in your digestive system or any stomach disorders.
• suffer from a rare inherited disease where the breakdown of haemoglobin (a pigment in the red
blood cells) is affected (porphyria).
• suffer from involuntary movements of the face or body (tardive dyskinesia). Your doctor will take this into consideration before prescribing the tablets for you.
• suffer from a rare hereditary problem of fructose and galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption or sucrase-isomaltase insufficiency.
Orphenadrine Hydrochloride Tablets should not be given to children.
Take special care with Orphenadrine Hydrochloride Tablets Tell your doctor if you:
• suffer from heart disease
• suffer from liver disorders
• suffer from kidney disorders
• have difficulties passing water
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
If you are taking other anticholinergic agents at the same time as Orphenadrine Hydrochloride Tablets, this can lead to an increase in dry mouth and difficulties in passing water. Your doctor or pharmacist will be able to advise you whether any of the medicines you are taking fall into this category.
Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine. Do not use Orphenadrine Hydrochloride Tablets during pregnancy or if you are breast-feeding, unless clearly necessary.
Driving and using machines
Do not drive or use any tools or machines if you feel dizzy or have blurred vision whilst taking Orphenadrine Hydrochloride Tablets.
Important information about some of the ingredients of Orphenadrine Hydrochloride Tablets
This medicine contains sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. How to take Orphenadrine Hydrochloride Tablets
Always take Orphenadrine Hydrochloride Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Dosage
The usual dose for adults and the elderly is three tablets daily in divided doses. Your doctor may increase this dose, if necessary, by one tablet every two to three days up to a maximum of eight tablets in a day. Usually you will need long term treatment with Orphenadrine Hydrochloride Tablets.
Use in children
Orphenadrine Hydrochloride Tablets should not be given to children.
If you take more Orphenadrine Hydrochloride Tablets than you should
Taking more Orphenadrine Hydrochloride Tablets than have been prescribed could be dangerous. If you, or anyone else, should accidentally take more tablets than prescribed, you must phone your doctor or go to a hospital casualty department immediately.
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If you forget to take Orphenadrine Hydrochloride Tablets
Take the forgotten dose as soon as you remember. If it is time for your next dose skip the dose you missed and just continue to follow the dosing schedule as usual. Do not take a double dose to make up for a forgotten one.
If you stop taking Orphenadrine Hydrochloride Tablets
If you are to stop taking Orphenadrine Hydrochloride Tablets then your doctor will make sure that the dose is gradually reduced over a number of days. You should not stop taking the tablets unless you have been told to do so by your doctor. If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Orphenadrine Hydrochloride Tablets can cause side effects, although not everybody gets them.
If you are elderly you may be more likely to get side effects.
Uncommon (fewer than 1 in 100 patients)
allergic reactions may occur while on treatment with Orphenadrine Hydrochloride Tablets. Signs of allergy include: rash, wheezing, breathlessness, swollen eye lids, face or lips and in extreme cases collapse. If you get any of these symptoms soon after taking Orphenadrine Tablets, do not take any more.
Tell a doctor immediately and take the packaging and this leaflet with you.
Other possible side effects:
Common (fewer than 1 in 10 patients)
• Dry mouth, stomach upsets
• Dizziness
• Difficulty in seeing clearly
Uncommon (fewer than 1 in 100 patients)
• Rapid heart beat
• Changes of mood such as highly elevated mood, confusion, sleepiness, hallucinations, difficulty in sleeping, nervousness, seizure (fits)
• Difficulty in passing water
Rare (fewer than 1 in 1000 patients)
• Memory disturbance
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Orphenadrine Hydrochloride Tablets
• Keep out of the sight and reach of children.
• Store at room temperature (15°C-25°C).
• Do not use this medicine after the expiry date (Exp) printed on the package. The expiry date refers to the last day of that month.
• Medicines should not be disposed of via waste water or house hold waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
• If your medicine becomes discoloured or show any sings of deterioration, seek the advice of your pharmacist.
6. Further information
What Orphenadrine Hydrochloride Tablets contain
Each tablet contains 50mg orphenadrine hydrochloride.
Other ingredients are microcrystalline cellulose, maize starch granulated, stearic acid, magnesium stearate, silicon dioxide. Excipients for sugar-coating are shellac, acacia, talc, beta-carotene E160a, sucrose.
What Orphenadrine Hydrochloride Tablets look like and contents of the pack
Orphenadrine Hydrochloride 50mg Tablets are round, yellow, sugar coated tablets with no markings.
Orphenadrine Hydrochloride 50mg Tablets are available in blister packs of 100 and 250 tablets. Manufacturer and Product Licence Holder
POM PL No: 06464/ 3060
This product is manufactured by Mipharm S.p.A, Via B.Quaranta, 12-20141, Milan, Italy, and procured from within the EU and repackaged by the Product Licence holder:
Waymade plc, Miles Gray Road, Basildon, Essex SS14 3FR.
Leaflet revision date (Ref.) 24.6.2014
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