Orphenadrine Hydrochloride 50mg Tablets
(r)
Disipal® 50mg Tablets
(orphenadrine hydrochloride)
Your medicine is known by the above name, but will be referred to as Disipal Tablets throughout this:
_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 on to 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.
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 breast-feeding
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 eyelids, 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 or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly via: Yellow Card Scheme Website: 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.
• Do not take Disipal Tablets after the expiry date which is stated on the label after EXP. The expiry date refers to the last day of that month.
• Store at room temperature (15°C-25°C).
• If the tablets become discoloured or shows any other signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6) Further information What Disipal Tablets contain
• The active ingredient is orphenadrine hydrochloride.
Each tablet contains 50mg orphenadrine hydrochloride.
• The other ingredients are microcrystalline cellulose, maize starch granulated, stearic acid, magnesium stearate, amorphous silica.
Excipients for sugar-coating are shellac, acacia, talc, beta carotene E160a sucrose.
What Disipal Tablets looks like and contents of the pack
Disipal tablets are round, yellow, sugar-coated tablets with no markings.
Disipal Tablets are available in blister packs of 50 tablets.
PL10383/2083 POM
Who makes and repackages your medicine:
Your medicine is manufactured by Mipharm S.p.A., Via B. Quaranta, 1220141, Milan, Italy. Procured from within the EU and repackaged by the Product Licence Holder: Primecrown Ltd, 4/5 Northolt Trading Estate, Belvue Road, Northolt, Middlesex UB5 5QS.
Leaflet date: 07.02.2014
Disipal is a registered trademark of Astellas Pharma Europe B.V., The Netherlands.
Orphenadrine Hydrochloride 50mg Tablets
Your medicine is known by the above name, but will be referred to as Orphenadrine Tablets throughout this:
_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 on to 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.
In this leaflet
1) What Orphenadrine Tablets are and what they are used for
2) Before you take Orphenadrine Tablets
3) How to take Orphenadrine Tablets
4) Possible side effects
5) How to store Orphenadrine Tablets
6) Further information
1) What Orphenadrine Tablets are and what they are used for
The active ingredient in Orphenadrine Tablets belongs to the group of medicines called anticholinergic agents.
Orphenadrine 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 Tablets
Do not take Orphenadrine Tablets. Tell your doctor if you:
• are allergic (hypersensitive) to orphenadrine or any of the other ingredients of Orphenadrine 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 Tablets should not be given to children.
Take special care with Orphenadrine 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 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 breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine. Do not use Orphenadrine 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 Tablets.
Important information about some of the ingredients of Orphenadrine 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 Tablets
Always take Orphenadrine 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 Tablets.
Use in children
Orphenadrine Tablets should not be given to children.
If you take more Orphenadrine Tablets than you should
Taking more Orphenadrine 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 Orphenadrine 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 Tablets
If you are to stop taking Orphenadrine 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 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 Tablets. Signs of allergy include: rash - wheezing - breathlessness - swollen eyelids, 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 or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly via: Yellow Card Scheme Website: 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 Tablets
• Keep out of the sight and reach of children.
• Do not take Orphenadrine Tablets after the expiry date which is stated on the label after EXP. The expiry date refers to the last day of that month.
• Store at room temperature (15°C-25°C).
• If the tablets become discoloured or shows any other signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6) Further information
What Orphenadrine Tablets contain
• The active ingredient is orphenadrine hydrochloride.
Each tablet contains 50mg orphenadrine hydrochloride.
• The other ingredients are microcrystalline cellulose, maize starch granulated, stearic acid, magnesium stearate, amorphous silica.
Excipients for sugar-coating are shellac, acacia, talc, beta carotene E160a sucrose.
What Orphenadrine Tablets looks like and contents of the pack
Orphenadrine Tablets are round, yellow, sugar-coated tablets with no markings.
Orphenadrine Tablets are available in blister packs of 50 tablets.
PL10383/2083 |pOM
Who makes and repackages your medicine:
Your medicine is manufactured by Mipharm S.p.A., Via B. Quaranta, 1220141, Milan, Italy. Procured from within the EU and repackaged by the Product Licence Holder: Primecrown Ltd, 4/5 Northolt Trading Estate, Belvue Road, Northolt, Middlesex UB5 5QS.