PYRIDOSTIGMINE LIME TM 60MG TABLETS Pyridostigmine bromide

Transcription

1 PACKAGE LEAFLET PYRIDOSTIGMINE LIME TM 60MG TABLETS Pyridostigmine bromide Patient Information Leaflet READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. THE LEAFLET CONTAINS INFORMATION ON: 1. What Pyridostigmine Lime TM tablets are and what they are used for 2. Before you take Pyridostigmine Lime TM tablets 3. How to take Pyridostigmine Lime TM tablets 4. Possible side effects 5. How to store Pyridostigmine Lime TM tablets 6. Further Information 1. WHAT PYRIDOSTIGMINE LIME TM TABLETS ARE AND WHAT THEY ARE USED FOR? Pyridostigmine belongs to a group of medicines known as anticholinesterase inhibitors. It helps messages pass from the brain to the muscles so that the muscle works properly. Pyridostigmine is used to treat: myasthenia gravis, a condition that prevent messages reaching the muscles from the brain. The muscles quickly become tired and weak and, in severe cases may become paralysed. This medicine helps the messages to get through more easily. some rare forms of constipation (paralytic ileus) the inability to pass urine after an operation. 2. BEFORE YOU TAKE PYRIDOSTIGMINE LIME TM TABLETS Do not take Pyridostigmine Lime TM tablets if you: are allergic (hypersensitive) to pyridostigmine bromide or any of the other ingredients. are constipated or cannot urinate, unless your doctor has told you to use this Take special care with Pyridostigmine Lime TM tablets and consult your doctor if you: suffer from asthma have recently had coronary thrombosis (heart attack) have a slow heart beat have low blood pressure have a stomach ulcer have epilepsy have Parkinson's disease have kidney problems

2 suffer from a condition called vagotonia (a condition where over activity of the vagus nerve causes symptoms such as slow heart rate, low blood pressure, constipation, sweating and painful muscle spasms) have had an operation to remove your thymus gland. Take special care with Pyridostigmine Lime TM tablets There is no evidence to suggest that pyridostigmine has any special effects on elderly patients. However, tell your doctor if you are elderly and have any heart condition. Taking other medicine Take special care with pyridostigmine Lime TM tablets and consult your doctor if you are taking any other medicines including those not prescribed by your doctor. This is extremely important, as using more than one medicine at the same time can strengthen or weaken the effect of the The following medicines can prevent your tablets from working: Antimuscarinics e.g. atropine, hyoscine Medicines used to relax muscles during surgery e.g.pancuronium, vencuronium The following medicines can increase the effect of your tablets: Steroids Other muscle relaxants e.g. suxamethonium Immunosuppressant drugs Please tell your doctor or pharmacist if you are taking or have recently taken any other Medicines including medicines obtained without a prescription. Taking Pyridostigmine Lime TM tablets with food or drink Pyridostigmine Lime TM tablets should be taken 30 to 60 minutes before a meal. Pregnancy and breast-feeding The safety of pyridostigmine for use during pregnancy has not been established. Hence, it should be taken only if your doctor advises to do so. Pyridostigmine passes into breast milk in small amounts. Your doctor will decide if it is appropriate for you to continue taking pyridostigmine while breast-feeding. Ask your doctor or pharmacist for advice before taking any Driving and using machines The effects of pyridostigmine on the ability to drive and operate machinery have not been established. Hence do not drive or use machinery when you are on pyridostigmine Lime TM tablets unless you are sure your judgement and co-ordination are not affected. Important information about some of the ingredients of Pyridostigmine Lime TM tablets Pyridostigmine tablets contain lactose. If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicinal product. 3. HOW TO TAKE PYRIDOSTIGMINE LIME TM TABLETS Follow your doctor s directions about when and how to take your tablets and look at the label on the carton. Your pharmacist will also help if you are not sure. You should try to take your medicine so that it can work when your muscles are needed most, for example, when you get up and at meal times. The tablets take 30 to 60 minutes to start working after you have taken them so you should try to take your first dose of the day when you get up and other doses about 30 to 60 minutes before a meal. Swallow the tablets with water or another non-alcoholic drink. If you have difficulty swallowing, you can break the tablets into pieces.

3 The dose will depend on your illness and on your age as follows: For myasthenia gravis: The normal adult dose is ½ to 2 tablets (30 to 120 mg pyridostigmine) to be taken five to six times daily or higher doses if needed as recommended by your doctor. If you have myasthenia gravis, the effect of each dose should last about four hours during the day and about six hours at night. For paralytic ileus and post-operative inability to pass urine: The normal adult dose is 1 to 4 tablets (60 to 240 mg pyridostigmine) daily and for children ¼ to 1 tablet (15 to 60 mg) daily, depending on the needs of the patient. For children For children under 6 years the usual dose is ½ tablet (30 mg). For children aged 6 to 12 years, the usual starting dose is 1 tablet (60 mg). The doctor will then gradually increase the dose until maximum improvement is seen. In children the total dose per day is usually 30 to 360 mg. If you take more Pyridostigmine Lime TM tablets than you should It is important to stick to the dose on the label of the If you or someone else swallows several of these tablets all together, contact your doctor or nearest hospital emergency department immediately. Always take any tablets left over with you and also the box, as this will allow easier identification of the tablets. If you forget to take Pyridostigmine Lime TM tablets If you forget to take a dose, take it as soon as you remember. If it is almost time for your next dose do not take a double dose to make up for a forgotten dose, just carry on as before. If you stop taking Pyridostigmine Lime TM tablets It is important that you keep taking these tablets until your doctor tells you to stop. Do not change the prescribed dose yourself. If you think the effect of your medicine is too weak or too strong, talk to your doctor. Always tell your doctor if you want to stop taking the If you have any further questions on the use of this product ask your doctor or pharmacist. 4. POSSIBLE SIDE EFFECTS Like all medicines, Pyridostigmine Lime TM tablets can have side effects although not everybody gets them. The following side effects have been reported: feeling or being sick diarrhoea or stomach cramps you may produce more saliva than usual. If you are concerned about any of these effects talk to your doctor or pharmacist. 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 HPRA Pharmacovigilance, Earlsfort, Terrace, IRL - Dublin 2; Tel: ; Fax: Website: medsafety@hpra.ie. By reporting side effects you can help provide more information on the safety of this 5. HOW TO STORE PYRIDOSTIGMINE LIME TM TABLETS Keep out of the sight and reach of children. Do not use Pyridostigmine Lime TM tablets after the expiry date. The expiry date refers to the last day of the month. Expiry date can be found on the bottle label and carton. Store your tablets in the original container. Do not store above 25 C.

4 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 Pyridostigmine Lime TM tablets contain The name of your medicine is Pyridostigmine Lime TM 60mg tablets. The active substance in your tablet is pyridostigmine bromide. Each tablet contains 60mg of pyridostigmine bromide. Other ingredients are silicon dioxide, lactose monohydrate, maize starch, purified talc and magnesium stearate. What Pyridostigmine Lime TM tablets look like and contents of the pack Pyridostigmine Lime TM 60mg tablets are white to off white, flat faced, round, bevelled edges, uncoated tablet with cross scoring on one side and debossed NM on the other side. Pyridostigmine Lime TM 60mg tablets are supplied in Type III amber glass bottle with PP childresistant closure or white opaque HDPE bottle, containing HDPE desiccant (silica gel) canister, with a PP child-resistant closure. Each bottle contains 200 tablets. Marketing authorisation holder: Lime Pharma Limited, Whiddon Valley, Barnstaple, North Devon, EX32 8NS, United Kingdom. Manufacturer: Actavis UK Limited, Whiddon Valley, Barnstaple, North Devon, EX32 8NS, United Kingdom. This leaflet was prepared in 02/2016

5 PACKAGE LEAFLET PYRIDOSTIGMINE LIME TM 60MG TABLETS Pyridostigmine bromide Patient Information Leaflet READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. THE LEAFLET CONTAINS INFORMATION ON: 1. What Pyridostigmine Lime TM tablets are and what they are used for 2. Before you take Pyridostigmine Lime TM tablets 3. How to take Pyridostigmine Lime TM tablets 4. Possible side effects 5. How to store Pyridostigmine Lime TM tablets 6. Further Information 1. WHAT PYRIDOSTIGMINE LIME TM TABLETS ARE AND WHAT THEY ARE USED FOR? Pyridostigmine belongs to a group of medicines known as anticholinesterase inhibitors. It helps messages pass from the brain to the muscles so that the muscle works properly. Pyridostigmine is used to treat: myasthenia gravis, a condition that prevent messages reaching the muscles from the brain. The muscles quickly become tired and weak and, in severe cases may become paralysed. This medicine helps the messages to get through more easily. some rare forms of constipation (paralytic ileus) the inability to pass urine after an operation. 2. BEFORE YOU TAKE PYRIDOSTIGMINE LIME TM TABLETS Do not take Pyridostigmine Lime TM tablets if you: are allergic (hypersensitive) to pyridostigmine bromide or any of the other ingredients. are constipated or cannot urinate, unless your doctor has told you to use this Take special care with Pyridostigmine Lime TM tablets and consult your doctor if you: suffer from asthma have recently had coronary thrombosis (heart attack) have a slow heart beat have low blood pressure have a stomach ulcer have epilepsy have Parkinson's disease have kidney problems

6 suffer from a condition called vagotonia (a condition where over activity of the vagus nerve causes symptoms such as slow heart rate, low blood pressure, constipation, sweating and painful muscle spasms) have had an operation to remove your thymus gland. Take special care with Pyridostigmine Lime TM tablets There is no evidence to suggest that pyridostigmine has any special effects on elderly patients. However, tell your doctor if you are elderly and have any heart condition. Taking other medicine Take special care with pyridostigmine Lime TM tablets and consult your doctor if you are taking any other medicines including those not prescribed by your doctor. This is extremely important, as using more than one medicine at the same time can strengthen or weaken the effect of the The following medicines can prevent your tablets from working: Antimuscarinics e.g. atropine, hyoscine Medicines used to relax muscles during surgery e.g.pancuronium, vencuronium The following medicines can increase the effect of your tablets: Steroids Other muscle relaxants e.g. suxamethonium Immunosuppressant drugs Please tell your doctor or pharmacist if you are taking or have recently taken any other Medicines including medicines obtained without a prescription. Taking Pyridostigmine Lime TM tablets with food or drink Pyridostigmine Lime TM tablets should be taken 30 to 60 minutes before a meal. Pregnancy and breast-feeding The safety of pyridostigmine for use during pregnancy has not been established. Hence, it should be taken only if your doctor advises to do so. Pyridostigmine passes into breast milk in small amounts. Your doctor will decide if it is appropriate for you to continue taking pyridostigmine while breast-feeding. Ask your doctor or pharmacist for advice before taking any Driving and using machines The effects of pyridostigmine on the ability to drive and operate machinery have not been established. Hence do not drive or use machinery when you are on pyridostigmine Lime TM tablets unless you are sure your judgement and co-ordination are not affected. Important information about some of the ingredients of Pyridostigmine Lime TM tablets Pyridostigmine tablets contain lactose. If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicinal product. 3. HOW TO TAKE PYRIDOSTIGMINE LIME TM TABLETS Follow your doctor s directions about when and how to take your tablets and look at the label on the carton. Your pharmacist will also help if you are not sure. You should try to take your medicine so that it can work when your muscles are needed most, for example, when you get up and at meal times. The tablets take 30 to 60 minutes to start working after you have taken them so you should try to take your first dose of the day when you get up and other doses about 30 to 60 minutes before a meal. Swallow the tablets with water or another non-alcoholic drink. If you have difficulty swallowing, you can break the tablets into pieces.

7 The dose will depend on your illness and on your age as follows: For myasthenia gravis: The normal adult dose is ½ to 2 tablets (30 to 120 mg pyridostigmine) to be taken five to six times daily or higher doses if needed as recommended by your doctor. If you have myasthenia gravis, the effect of each dose should last about four hours during the day and about six hours at night. For paralytic ileus and post-operative inability to pass urine: The normal adult dose is 1 to 4 tablets (60 to 240 mg pyridostigmine) daily and for children ¼ to 1 tablet (15 to 60 mg) daily, depending on the needs of the patient. For children For children under 6 years the usual dose is ½ tablet (30 mg). For children aged 6 to 12 years, the usual starting dose is 1 tablet (60 mg). The doctor will then gradually increase the dose until maximum improvement is seen. In children the total dose per day is usually 30 to 360 mg. If you take more Pyridostigmine Lime TM tablets than you should It is important to stick to the dose on the label of the If you or someone else swallows several of these tablets all together, contact your doctor or nearest hospital emergency department immediately. Always take any tablets left over with you and also the box, as this will allow easier identification of the tablets. If you forget to take Pyridostigmine Lime TM tablets If you forget to take a dose, take it as soon as you remember. If it is almost time for your next dose do not take a double dose to make up for a forgotten dose, just carry on as before. If you stop taking Pyridostigmine Lime TM tablets It is important that you keep taking these tablets until your doctor tells you to stop. Do not change the prescribed dose yourself. If you think the effect of your medicine is too weak or too strong, talk to your doctor. Always tell your doctor if you want to stop taking the If you have any further questions on the use of this product ask your doctor or pharmacist. 4. POSSIBLE SIDE EFFECTS Like all medicines, Pyridostigmine Lime TM tablets can have side effects although not everybody gets them. The following side effects have been reported: feeling or being sick diarrhoea or stomach cramps you may produce more saliva than usual. If you are concerned about any of these effects talk to your doctor or pharmacist. 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 HPRA Pharmacovigilance, Earlsfort, Terrace, IRL - Dublin 2; Tel: ; Fax: Website: medsafety@hpra.ie. By reporting side effects you can help provide more information on the safety of this 5. HOW TO STORE PYRIDOSTIGMINE LIME TM TABLETS Keep out of the sight and reach of children. Do not use Pyridostigmine Lime TM tablets after the expiry date. The expiry date refers to the last day of the month. Expiry date can be found on the bottle label and carton. Store your tablets in the original container. Do not store above 25 C.

8 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 Pyridostigmine Lime TM tablets contain The name of your medicine is Pyridostigmine Lime TM 60mg tablets. The active substance in your tablet is pyridostigmine bromide. Each tablet contains 60mg of pyridostigmine bromide. Other ingredients are silicon dioxide, lactose monohydrate, maize starch, purified talc and magnesium stearate. What Pyridostigmine Lime TM tablets look like and contents of the pack Pyridostigmine Lime TM 60mg tablets are white to off white, flat faced, round, bevelled edges, uncoated tablet with cross scoring on one side and debossed NM on the other side. Pyridostigmine Lime TM 60mg tablets are supplied in Type III amber glass bottle with PP childresistant closure or white opaque HDPE bottle, containing HDPE desiccant (silica gel) canister, with a PP child-resistant closure. Each bottle contains 200 tablets. Marketing authorisation holder: Lime Pharma Limited, Whiddon Valley, Barnstaple, North Devon, EX32 8NS, United Kingdom. Manufacturer: Auden Mckenzie (Pharma Division) Ltd, Mckenzie House, Bury Street, Ruislip, Middlesex, HA4 7TL, United Kingdom. This leaflet was prepared in 02/2016