Orphenadrine Hydrochloride 50mg Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
DISIPAL® 50mg TABLETS Revision date: 15.09.2014
(orphenadrine hydrochloride) Leafiet Ref: dis50mg
The name of your medicine is Disipal® 50mg Tablets but will be referred to as Disipal® Tablets throughout this 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 ® TABLETSTABLETS 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 lactose and sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. The colours tartrazine (E102), sunset yellow (E110) and amaranth (E123) used in the sugar coat may cause allergic reactions (see section 6 for the list of ingredients).
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.
Keep the tablets at normal room temperature (15°C - 25°C).
Do not use 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.
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 contains:
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, silicon dioxide, shellac, acacia, talc, sucrose, beta-carotene E160.
What Disipal® Tablets look like and contents of the pack
Disipal® Tablets are round, yellow, sugar coated tablets with no markings. Disipal® Tablets come in blister packs. Disipal® Tablets are available in packs of 250 tablets.
Who manufactured your medicine
Disipal® Tablets are manufactured by by Mipharm S.p.A. - Via B. Quaranta, 12 - 20141 Milano, Italy and is procured from within the EU and repackaged by Product Licence Holder Beachcourse Limited, 20 Alliance Court, Alliance Road, London W3 0RB.
PL 16378/0556 |POM|
Revision date: 15.09.2014 Leaflet reference: DIS50MG
Disipal® is a trademark of Astellas group of companies.
PACKAGE LEAFLET: INFORMATION FOR THE USER ORPHENADRINE HYDROCHLORIDE 50mg TABLETS Revision date: 15.09.2014
Leaflet Ref: ORP50MG
The name of your medicine is Orphenadrine Hydrochloride 50mg Tablets but will be referred to as Orphenadrine Hydrochloride Tablets throughout this 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 Hydrochloride Tablets are and what they are used for
2. Before you take Orphenadrine Hydrochloride Tablets
3. How to take Orphenadrine Hydrochloride T ablets
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 TABLETSTABLETS
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 breast-feeding
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 lactose and sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. The colours tartrazine (E102), sunset yellow (E110) and amaranth (E123) used in the sugar coat may cause allergic reactions (see section 6 for the list of ingredients).
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.
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 T ablets 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 eyelids, face or lips and in extreme cases collapse. If you get any of these symptoms soon after taking Orphenadrine Hydrochloride 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 HYDROCHLORIDE TABLETS
Keep out of the sight and reach of children.
Keep the tablets at normal room temperature (15°C - 25°C).
Do not use Orphenadrine Hydrochloride Tablets after the expiry date which is stated on the label after EXP.
The expiry date refers to the last day of that month.
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 Hydrochloride Tablets contains:
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, silicon dioxide, shellac, acacia, talc, sucrose, beta-carotene E160.
What Orphenadrine Hydrochloride Tablets look like and contents of the pack
Orphenadrine Hydrochloride Tablets are round, yellow, sugar coated tablets with no markings. Orphenadrine Hydrochloride Tablets come in blister packs. Orphenadrine Hydrochloride Tablets are available in packs of 250 tablets.
Who manufactured your medicine
Orphenadrine Hydrochloride Tablets are manufactured by by Mipharm S.p.A. - Via B. Quaranta, 12 - 20141 Milano, Italy and is procured from within the EU and repackaged by Product Licence Holder Beachcourse Limited, 20 Alliance Court, Alliance Road, London W3 0RB.
PL 16378/0556 |POM|
Revision date: 15.09.2014 Leaflet reference: ORP50MG
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