DISIPAL 50MG TABLETS
Active substance: ORPHENADRINE HYDROCHLORIDE
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PACKAGE LEAFLET: INFORMATION FOR THE USER
DISIPAL 50mg Tablets
(orphenadrine hydrochloride) 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. 2. 3. 4. 5. 6. What Disipal Tablets are and what they are used for Before you take Disipal Tablets How to take Disipal Tablets Possible side effects How to store Disipal Tablets. Further information
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.
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 Parkinsons 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, glucosegalactose malabsorption or sucrase-isomaltase insufficiency.
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 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. 5. HOW TO STORE DISIPAL TABLETS Keep out of the sight and reach of children. Store at room temperature (15C-25C). 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 are round, yellow, sugar coated tablets with no markings. Tablets come in blister pack. Dispal Tablets are available in packs of 50 tablets. Manufactured by: Mipharm S.p.A, - Via B.Quaranta, 1220141, Milan, Italy. Procured from within the EU and repackaged by the Product Licence holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK. Disipal 50mg Tablets PL No: 18799/2162 Leaflet dated: 23.10.2012 POM
DISIPAL 50mg Tablets
(orphenadrine hydrochloride) 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. 2. 3. 4. 5. 6. What Disipal Tablets are and what they are used for Before you take Disipal Tablets How to take Disipal Tablets Possible side effects How to store Disipal Tablets. Further information
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.
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 Parkinsons 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, glucosegalactose malabsorption or sucrase-isomaltase insufficiency.
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 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. 5. HOW TO STORE DISIPAL TABLETS Keep out of the sight and reach of children. Store at room temperature (15C-25C). 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 are round, yellow, sugar coated tablets with no markings. Tablets come in blister pack. Dispal Tablets are available in packs of 50 tablets. Manufactured by: Mipharm S.p.A, - Via B.Quaranta, 1220141, Milan, Italy. Procured from within the EU and repackaged by the Product Licence holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK. Disipal 50mg Tablets PL No: 18799/2162 Leaflet dated: 23.10.2012 POM
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
