REQUIP XL 8MG PROLONGED-RELEASE TABLETS
Active substance: ROPINIROLE HYDROCHLORIDE
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CUSTOMER: PRODUCT: CODE:
Waymade Requip XL 8mg tabs 06464 2706E
PRE-PRESS NO.: ARTWORKER: DATE OF PROOF:
02-1808 DT 08/10/12
Q.A. APPROVED: DATE:
CUSTOMER APPROVED: DATE:
PROOF HISTORY: v.3 - waymade - 08/10/12
Leaflet Flat Size = 296 x 317
ARIAL REGULAR FONT SIZE 8 ARIAL BOLD FONT SIZE 10 BRIDGED TO TRANSTEC 6464/2327 2328 2329
MANUFACTURER: No: UK PIL DATED OCTOBER 2011 including Dopamine Agonist safety warning Pg 4
Pg 1
You may experience the following side effects: inability to resist the impulse, drive or temptation to perform an action that could be harmful to you or others, which may include: o Strong impulse to gamble excessively despite serious personal or family consequences. o Altered or increased sexual interest and behaviour of significant concern to you or to others, for example, an increased sexual drive. o Uncontrollable excessive shopping or spending o Binge eating (eating large amounts of food in a short time period) or compulsive eating (eating more food than normal and more than is needed to satisfy your hunger) Tell your doctor if you experience any of these behaviours; they will discuss ways of managing or reducing the symptoms If you get side effects If you notice any unwanted effects (even ones not mentioned in this leaflet) or if any of the side effects become troublesome while youre taking Requip XL: Tell your doctor, nurse or pharmacist.
REQUIP XL 8mg PROLONGED RELEASE TABLETS (ropinirole hydrochloride) Patient Information Leaflet
This product will usually be referred to as Requip XL throughout this leaflet. Please note that the leaflet also contains information about other strengths of the medicine Requip XL 2mg and 4mg Prolonged Release Tablets. Information about your medication Please read right through this leaflet before you start taking these tablets. This medicine has been prescribed for you personally. Dont pass it on to other people - it may harm them, even if their symptoms seem to be the same as yours. Keep this leaflet. You may need to read it again. If you have any more questions, ask your Parkinsons disease doctor, Parkinsons disease nurse specialist or pharmacist (chemist). If you have serious side effects, or if you notice any side effects not listed in this leaflet, tell your doctor, nurse or pharmacist. In this leaflet 1. What Requip XL is and what it is for 2. Before you take Requip XL 3. While youre taking Requip XL 4. How to take Requip XL 5. Possible side effects 6. How to store Requip XL 7. Further information
6. How to store Requip XL
Keep Requip XL out of the sight and reach of children. Dont use Requip XL after the expiry date shown on the carton or blister label. Do not store above 25C. Store in the original package in order to protect from light. If you have any unwanted Requip XL tablets, dont dispose of them in waste water or household rubbish. Take them back to your pharmacist, who will dispose of them in a way that wont harm the environment.
7. Further information
What Requip XL contains The active substance in Requip is ropinirole. Each prolonged-release tablet contains 8 mg of ropinirole (as hydrochloride). The other ingredients are: tablet core: hypromellose, hydrogenated castor oil, carmellose sodium, povidone K29-32, maltodextrin (a source of glucose), magnesium stearate, lactose monohydrate, anhydrous colloidal silica, mannitol (E421), ferric oxide yellow (E172), glycerol dibehenate film coat: hypromellose, ferric oxide yellow (E172), titanium dioxide (E171), ferric oxide black (E172), macrogol 400, ferric oxide red (E172).
1. What Requip XL is and what it is for
Requip XL is used to treat Parkinsons disease. The active ingredient in Requip XL is ropinirole, which belongs to a group of medicines called dopamine agonists. Dopamine agonists affect the brain in a similar way to a natural substance called dopamine. People with Parkinsons disease have low levels of dopamine in some parts of their brains. Ropinirole has effects similar to those of natural dopamine, so it helps to reduce the symptoms of Parkinsons disease. You can take Requip XL (like Requip) either on its own or along with L-dopa (see Section 4 of this leaflet for more details). Requip XL should be prescribed and your progress monitored by a doctor with experience in the treatment of Parkinsons disease.
What Requip XL looks like and contents of the pack Requip XL 8mg prolonged-release tablets are provided as red coloured, capsule-shaped, film-coated tablets, marked GS on one side and marked 5CC on reverse side. Requip XL 8mg tablets are available as blister packs of 28 tablets. Marketing authorisation holder and manufacturer This product is manufactured by SmithKline Beecham plc, trading as SmithKline Beecham Pharmaceuticals, Manor Royal, Crawley, West Sussex RH10 9QJ and is procured from within the EU and repackaged by the Product Licence holder: Waymade plc, Miles Gray Road, Basildon, Essex SS14 3FR POM PL No: 06464/2706
2. Before you take Requip XL
Dont take Requip XL: if youre allergic (hypersensitive) to ropinirole or any of the other ingredients of Requip XL (see Section 6) if you have serious kidney disease if you have liver disease Tell your doctor or nurse if you think any of these may apply to you. Take special care with Requip XL Your doctor needs to know before you take Requip XL: if you are pregnant or think you may be pregnant if you are breast feeding if you are under 18 years old if you have a serious heart complaint if you have a history of or currently have a serious mental health problem if you have an intolerance to some sugars (such as lactose). Tell your doctor or nurse if you think any of these may apply to you. Your doctor or nurse may decide that Requip XL isnt suitable for you, or that you need extra check-ups while youre taking it. Tell your doctor if you or your family/carer notices that you are developing urges or cravings to behave in ways that are unusual for you and you cannot resist the impulse, drive or temptation to carry out certain activities that could harm yourself or others. These are called impulse control disorders and can include behaviours such as addictive gambling, excessive eating or spending, an abnormally high sex drive or an increase in sexual thoughts or feelings. Your doctor may need to adjust or stop your dose. You also need to be careful with Requip XL if you drive or operate machinery. Please read the warning in Section 3 of this leaflet. Requip XL contains lactose and sunset yellow Requip XL tablets contain a sugar called lactose. If you have been told that you have an intolerance to some sugars, contact your doctor or nurse before taking Requip XL. The 4 mg tablets contain a colouring called sunset yellow (E110), which may cause allergic reactions. Other medicines and Requip XL Tell your doctor, nurse or pharmacist if youre taking, or have recently taken, any other medicines including any herbal remedies or medicines you bought without a prescription.
Leaflet revision and issue date (Ref.) 8.10.2012 Requip is a registered trademark of SmithKline Beecham plc A number of groups exist to provide further information and support to Parkinson's disease patients and their carers. The main one is the Parkinson's Disease Society, who you can contact at the address given below: Parkinson's Disease Society, 215 Vauxhall Bridge Road, London SW1V 1EJ
Pg 2
WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.
WARNING!
WARNING!
THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.
CUSTOMER: PRODUCT: CODE:
Waymade Requip XL 8mg tabs 06464 2706E
PRE-PRESS NO.: ARTWORKER: DATE OF PROOF:
02-1808 DT 08/10/12
Q.A. APPROVED: DATE:
CUSTOMER APPROVED: DATE:
PROOF HISTORY: v.3 - waymade - 08/10/12
Leaflet Flat Size = 296 x 317
MANUFACTURER: No: UK PIL DATED OCTOBER 2011 including Dopamine Agonist safety warning Pg 2
ARIAL REGULAR FONT SIZE 8 ARIAL BOLD FONT SIZE 10 BRIDGED TO TRANSTEC 6464/2327 2328 2329
Pg 3
Some medicines can affect the way Requip XL works, or make it more likely that youll have side effects. Requip XL can also affect the way some other medicines work. These include: the anti-depressant, fluvoxamine HRT (hormone replacement therapy) medication for other mental health problems, for example sulpiride metoclopramide, which is used to treat nausea and heartburn cimetidine, used in the treatment of stomach ulcers the antibiotics, ciprofloxacin or enoxacin any other medicine for Parkinson's disease. Tell your doctor or nurse if youre taking, or have recently taken, any of these. Remember to tell your doctor or nurse if you start taking any other medicine while youre taking Requip XL. Pregnancy and breast-feeding Requip XL is not recommended if you are pregnant, unless your doctor advises that the benefit of you taking Requip XL is greater than the risk to your unborn baby. Requip XL is not recommended if you are breast feeding, as it can affect your milk production. Tell your doctor or nurse immediately: if youre pregnant, if you think you might be pregnant, or if youre planning to become pregnant if youre breast-feeding or planning to breast-feed. Your doctor or nurse may advise you to stop taking Requip XL. Children Do not give Requip XL to children. Requip XL is not normally prescribed for people under 18.
If at the start of your treatment, you experience side effects that you find difficult to tolerate, speak to your doctor. Your doctor may advise you to switch to a lower dose of Requip film-coated (immediate release) tablets which you will take three times a day. Dont take more Requip XL than your doctor or nurse has recommended. It may take a few weeks for Requip XL to work for you. Taking your dose of Requip XL Take Requip XL once a day, at the same time each day. Swallow your Requip XL tablets whole, with a glass of water. Dont break, chew or crush the tablets - if you do, theres a danger you could overdose, because the medicine will be released into your body too quickly. If someone takes too much Requip XL Contact a doctor, nurse or pharmacist immediately. If possible, show them the Requip XL pack. Someone who has taken an overdose of Requip XL may have any of these symptoms: feeling sick (nausea), being sick (vomiting), dizziness (a spinning sensation), feeling drowsy, mental or physical tiredness, fainting, hallucinations. If you forget to take Requip XL Dont take extra tablets or a double dose to make up for a missed dose. If you have missed taking Requip XL for one day or more, ask your doctor or nurse for advice on how to start taking it again. Dont stop taking Requip XL without advice Take Requip XL for as long as your doctor or nurse recommends. Dont stop unless your doctor or nurse advises you to. If you suddenly stop taking Requip XL, your Parkinsons disease symptoms may quickly get much worse. If you need to stop taking Requip XL, your doctor or nurse will reduce your dose gradually. If you have any further questions on the use of this product, ask your doctor or pharmacist.
3. While youre taking Requip XL
If you drive or operate machinery Requip XL can make you feel drowsy or dizzy. It can make people feel extremely sleepy, and it sometimes makes people fall asleep very suddenly without warning. If you could be affected: dont drive, dont operate machines and dont put yourself in any situation where feeling sleepy or falling asleep could put you (or other people) at risk of serious injury or death. Dont take part in these activities until you are sure youre not affected. Talk to your doctor or nurse if this causes problems for you. Smoking and Requip XL Tell your doctor or nurse if you start smoking, or give up smoking, while youre taking Requip XL. Your doctor or nurse may need to adjust your dose. Food and drink with Requip XL You can take Requip XL with or without food, as you prefer. Because high fat foods might increase the amount of ropinirole absorbed by your body, its recommended that you do not take Requip XL at the same time as a high fat meal.
5. Possible side effects
Like all medicines, Requip XL can have side effects, but not everyone gets them. The more common side effects of Requip XL are more likely to happen when you first start taking it, or when your dose has just been increased. They are usually mild, and may become less troublesome after youve taken the dose for a while. If youre worried about side effects, talk to your doctor or nurse. Very common side effects These may affect more than 1 in 10 people taking Requip XL: fainting feeling drowsy feeling sick (nausea). Common side effects These may affect more than 1 in 100 people taking Requip XL: hallucinations (sensing things that are not real) being sick (vomiting) feeling dizzy (a spinning sensation) heartburn stomach pain constipation swelling of the legs, feet or hands. Uncommon side effects These may affect more than 1 in 1,000 people taking Requip XL: feeling dizzy or faint, especially when you stand up suddenly (this is caused by a drop in blood pressure) feeling very sleepy during the day falling asleep very suddenly without feeling sleepy first (sudden sleep onset episodes) mental problems such as delirium (severe confusion), delusions (unreasonable ideas) or paranoia (unreasonable suspicions). Very rare side effects A very small number of people taking Requip XL (less than 1 in 10,000) have experienced: changes in liver function, which have shown up in blood tests allergic reactions such as red, itchy swellings on the skin (hives), swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing, rash or intense itching. If youre taking Requip XL with L-dopa People who are taking Requip XL with L-dopa may develop other side effects over time: uncontrollable movements (dyskinesias) are a very common side effect. If you are taking L-dopa you may experience some uncontrollable movements (dyskinesias) when you first start taking Requip XL. Tell your doctor if this happens, as your doctor may need to adjust the dose of the medicines you are taking feeling confused is a common side effect.
4. How to take Requip XL
Always take Requip XL exactly as your Parkinsons disease doctor or nurse has told you to. Check with your doctor, nurse or pharmacist if youre not sure. You may be given Requip XL on its own to treat the symptoms of your Parkinsons disease. Or you may be given Requip XL as well as another medicine called L-dopa (also called levodopa). Requip XL should be prescribed and your progress monitored by a doctor with experience in the treatment of Parkinsons disease. If you are taking L-dopa you may experience some uncontrollable movements (dyskinesias) when you first start taking Requip XL. Tell your doctor if this happens, as your doctor may need to adjust the dose of the medicines you are taking. Tell your doctor if you or your family notices that you are developing any unusual behaviours (such as an unusual urge to gamble or increased sexual urges and/or behaviours) while you are taking Requip XL. Your doctor may need to adjust your dose. If you are switching from Requip film-coated (immediate release) tablets Your doctor or nurse will base your dose of Requip XL on the dose of Requip you were taking. You will take the same or similar daily dose of Requip XL to your previous dose of Requip but you will only take Requip XL once a day. Take your Requip as normal the day before you switch. Then take your Requip XL on the next day and dont take any more Requip. Your doctor or nurse will be monitoring your progress closely after switching to Requip XL. If there is any change in the control of your symptoms before your next appointment, talk to your doctor or nurse as soon as possible in case dose adjustment is needed. How much Requip XL will you need to take? It may take a while to find out the best dose of Requip XL for you. The usual starting dose of Requip XL tablets is 2 mg once daily for the first week. Your doctor may increase your dose to 4 mg of Requip XL tablets once daily, from the second week of treatment. If you are very elderly your doctor may increase your dose more slowly. After that, the doctor may adjust your dose until you are taking the dose that is best for you. Some people take up to 24 mg of Requip XL tablets each day.
Pg 3
Pg 4
WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.
WARNING!
WARNING!
THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.
Waymade Requip XL 8mg tabs 06464 2706E
PRE-PRESS NO.: ARTWORKER: DATE OF PROOF:
02-1808 DT 08/10/12
Q.A. APPROVED: DATE:
CUSTOMER APPROVED: DATE:
PROOF HISTORY: v.3 - waymade - 08/10/12
Leaflet Flat Size = 296 x 317
ARIAL REGULAR FONT SIZE 8 ARIAL BOLD FONT SIZE 10 BRIDGED TO TRANSTEC 6464/2327 2328 2329
MANUFACTURER: No: UK PIL DATED OCTOBER 2011 including Dopamine Agonist safety warning Pg 4
Pg 1
You may experience the following side effects: inability to resist the impulse, drive or temptation to perform an action that could be harmful to you or others, which may include: o Strong impulse to gamble excessively despite serious personal or family consequences. o Altered or increased sexual interest and behaviour of significant concern to you or to others, for example, an increased sexual drive. o Uncontrollable excessive shopping or spending o Binge eating (eating large amounts of food in a short time period) or compulsive eating (eating more food than normal and more than is needed to satisfy your hunger) Tell your doctor if you experience any of these behaviours; they will discuss ways of managing or reducing the symptoms If you get side effects If you notice any unwanted effects (even ones not mentioned in this leaflet) or if any of the side effects become troublesome while youre taking Requip XL: Tell your doctor, nurse or pharmacist.
REQUIP XL 8mg PROLONGED RELEASE TABLETS (ropinirole hydrochloride) Patient Information Leaflet
This product will usually be referred to as Requip XL throughout this leaflet. Please note that the leaflet also contains information about other strengths of the medicine Requip XL 2mg and 4mg Prolonged Release Tablets. Information about your medication Please read right through this leaflet before you start taking these tablets. This medicine has been prescribed for you personally. Dont pass it on to other people - it may harm them, even if their symptoms seem to be the same as yours. Keep this leaflet. You may need to read it again. If you have any more questions, ask your Parkinsons disease doctor, Parkinsons disease nurse specialist or pharmacist (chemist). If you have serious side effects, or if you notice any side effects not listed in this leaflet, tell your doctor, nurse or pharmacist. In this leaflet 1. What Requip XL is and what it is for 2. Before you take Requip XL 3. While youre taking Requip XL 4. How to take Requip XL 5. Possible side effects 6. How to store Requip XL 7. Further information
6. How to store Requip XL
Keep Requip XL out of the sight and reach of children. Dont use Requip XL after the expiry date shown on the carton or blister label. Do not store above 25C. Store in the original package in order to protect from light. If you have any unwanted Requip XL tablets, dont dispose of them in waste water or household rubbish. Take them back to your pharmacist, who will dispose of them in a way that wont harm the environment.
7. Further information
What Requip XL contains The active substance in Requip is ropinirole. Each prolonged-release tablet contains 8 mg of ropinirole (as hydrochloride). The other ingredients are: tablet core: hypromellose, hydrogenated castor oil, carmellose sodium, povidone K29-32, maltodextrin (a source of glucose), magnesium stearate, lactose monohydrate, anhydrous colloidal silica, mannitol (E421), ferric oxide yellow (E172), glycerol dibehenate film coat: hypromellose, ferric oxide yellow (E172), titanium dioxide (E171), ferric oxide black (E172), macrogol 400, ferric oxide red (E172).
1. What Requip XL is and what it is for
Requip XL is used to treat Parkinsons disease. The active ingredient in Requip XL is ropinirole, which belongs to a group of medicines called dopamine agonists. Dopamine agonists affect the brain in a similar way to a natural substance called dopamine. People with Parkinsons disease have low levels of dopamine in some parts of their brains. Ropinirole has effects similar to those of natural dopamine, so it helps to reduce the symptoms of Parkinsons disease. You can take Requip XL (like Requip) either on its own or along with L-dopa (see Section 4 of this leaflet for more details). Requip XL should be prescribed and your progress monitored by a doctor with experience in the treatment of Parkinsons disease.
What Requip XL looks like and contents of the pack Requip XL 8mg prolonged-release tablets are provided as red coloured, capsule-shaped, film-coated tablets, marked GS on one side and marked 5CC on reverse side. Requip XL 8mg tablets are available as blister packs of 28 tablets. Marketing authorisation holder and manufacturer This product is manufactured by SmithKline Beecham plc, trading as SmithKline Beecham Pharmaceuticals, Manor Royal, Crawley, West Sussex RH10 9QJ and is procured from within the EU and repackaged by the Product Licence holder: Waymade plc, Miles Gray Road, Basildon, Essex SS14 3FR POM PL No: 06464/2706
2. Before you take Requip XL
Dont take Requip XL: if youre allergic (hypersensitive) to ropinirole or any of the other ingredients of Requip XL (see Section 6) if you have serious kidney disease if you have liver disease Tell your doctor or nurse if you think any of these may apply to you. Take special care with Requip XL Your doctor needs to know before you take Requip XL: if you are pregnant or think you may be pregnant if you are breast feeding if you are under 18 years old if you have a serious heart complaint if you have a history of or currently have a serious mental health problem if you have an intolerance to some sugars (such as lactose). Tell your doctor or nurse if you think any of these may apply to you. Your doctor or nurse may decide that Requip XL isnt suitable for you, or that you need extra check-ups while youre taking it. Tell your doctor if you or your family/carer notices that you are developing urges or cravings to behave in ways that are unusual for you and you cannot resist the impulse, drive or temptation to carry out certain activities that could harm yourself or others. These are called impulse control disorders and can include behaviours such as addictive gambling, excessive eating or spending, an abnormally high sex drive or an increase in sexual thoughts or feelings. Your doctor may need to adjust or stop your dose. You also need to be careful with Requip XL if you drive or operate machinery. Please read the warning in Section 3 of this leaflet. Requip XL contains lactose and sunset yellow Requip XL tablets contain a sugar called lactose. If you have been told that you have an intolerance to some sugars, contact your doctor or nurse before taking Requip XL. The 4 mg tablets contain a colouring called sunset yellow (E110), which may cause allergic reactions. Other medicines and Requip XL Tell your doctor, nurse or pharmacist if youre taking, or have recently taken, any other medicines including any herbal remedies or medicines you bought without a prescription.
Leaflet revision and issue date (Ref.) 8.10.2012 Requip is a registered trademark of SmithKline Beecham plc A number of groups exist to provide further information and support to Parkinson's disease patients and their carers. The main one is the Parkinson's Disease Society, who you can contact at the address given below: Parkinson's Disease Society, 215 Vauxhall Bridge Road, London SW1V 1EJ
Pg 2
WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.
WARNING!
WARNING!
THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.
CUSTOMER: PRODUCT: CODE:
Waymade Requip XL 8mg tabs 06464 2706E
PRE-PRESS NO.: ARTWORKER: DATE OF PROOF:
02-1808 DT 08/10/12
Q.A. APPROVED: DATE:
CUSTOMER APPROVED: DATE:
PROOF HISTORY: v.3 - waymade - 08/10/12
Leaflet Flat Size = 296 x 317
MANUFACTURER: No: UK PIL DATED OCTOBER 2011 including Dopamine Agonist safety warning Pg 2
ARIAL REGULAR FONT SIZE 8 ARIAL BOLD FONT SIZE 10 BRIDGED TO TRANSTEC 6464/2327 2328 2329
Pg 3
Some medicines can affect the way Requip XL works, or make it more likely that youll have side effects. Requip XL can also affect the way some other medicines work. These include: the anti-depressant, fluvoxamine HRT (hormone replacement therapy) medication for other mental health problems, for example sulpiride metoclopramide, which is used to treat nausea and heartburn cimetidine, used in the treatment of stomach ulcers the antibiotics, ciprofloxacin or enoxacin any other medicine for Parkinson's disease. Tell your doctor or nurse if youre taking, or have recently taken, any of these. Remember to tell your doctor or nurse if you start taking any other medicine while youre taking Requip XL. Pregnancy and breast-feeding Requip XL is not recommended if you are pregnant, unless your doctor advises that the benefit of you taking Requip XL is greater than the risk to your unborn baby. Requip XL is not recommended if you are breast feeding, as it can affect your milk production. Tell your doctor or nurse immediately: if youre pregnant, if you think you might be pregnant, or if youre planning to become pregnant if youre breast-feeding or planning to breast-feed. Your doctor or nurse may advise you to stop taking Requip XL. Children Do not give Requip XL to children. Requip XL is not normally prescribed for people under 18.
If at the start of your treatment, you experience side effects that you find difficult to tolerate, speak to your doctor. Your doctor may advise you to switch to a lower dose of Requip film-coated (immediate release) tablets which you will take three times a day. Dont take more Requip XL than your doctor or nurse has recommended. It may take a few weeks for Requip XL to work for you. Taking your dose of Requip XL Take Requip XL once a day, at the same time each day. Swallow your Requip XL tablets whole, with a glass of water. Dont break, chew or crush the tablets - if you do, theres a danger you could overdose, because the medicine will be released into your body too quickly. If someone takes too much Requip XL Contact a doctor, nurse or pharmacist immediately. If possible, show them the Requip XL pack. Someone who has taken an overdose of Requip XL may have any of these symptoms: feeling sick (nausea), being sick (vomiting), dizziness (a spinning sensation), feeling drowsy, mental or physical tiredness, fainting, hallucinations. If you forget to take Requip XL Dont take extra tablets or a double dose to make up for a missed dose. If you have missed taking Requip XL for one day or more, ask your doctor or nurse for advice on how to start taking it again. Dont stop taking Requip XL without advice Take Requip XL for as long as your doctor or nurse recommends. Dont stop unless your doctor or nurse advises you to. If you suddenly stop taking Requip XL, your Parkinsons disease symptoms may quickly get much worse. If you need to stop taking Requip XL, your doctor or nurse will reduce your dose gradually. If you have any further questions on the use of this product, ask your doctor or pharmacist.
3. While youre taking Requip XL
If you drive or operate machinery Requip XL can make you feel drowsy or dizzy. It can make people feel extremely sleepy, and it sometimes makes people fall asleep very suddenly without warning. If you could be affected: dont drive, dont operate machines and dont put yourself in any situation where feeling sleepy or falling asleep could put you (or other people) at risk of serious injury or death. Dont take part in these activities until you are sure youre not affected. Talk to your doctor or nurse if this causes problems for you. Smoking and Requip XL Tell your doctor or nurse if you start smoking, or give up smoking, while youre taking Requip XL. Your doctor or nurse may need to adjust your dose. Food and drink with Requip XL You can take Requip XL with or without food, as you prefer. Because high fat foods might increase the amount of ropinirole absorbed by your body, its recommended that you do not take Requip XL at the same time as a high fat meal.
5. Possible side effects
Like all medicines, Requip XL can have side effects, but not everyone gets them. The more common side effects of Requip XL are more likely to happen when you first start taking it, or when your dose has just been increased. They are usually mild, and may become less troublesome after youve taken the dose for a while. If youre worried about side effects, talk to your doctor or nurse. Very common side effects These may affect more than 1 in 10 people taking Requip XL: fainting feeling drowsy feeling sick (nausea). Common side effects These may affect more than 1 in 100 people taking Requip XL: hallucinations (sensing things that are not real) being sick (vomiting) feeling dizzy (a spinning sensation) heartburn stomach pain constipation swelling of the legs, feet or hands. Uncommon side effects These may affect more than 1 in 1,000 people taking Requip XL: feeling dizzy or faint, especially when you stand up suddenly (this is caused by a drop in blood pressure) feeling very sleepy during the day falling asleep very suddenly without feeling sleepy first (sudden sleep onset episodes) mental problems such as delirium (severe confusion), delusions (unreasonable ideas) or paranoia (unreasonable suspicions). Very rare side effects A very small number of people taking Requip XL (less than 1 in 10,000) have experienced: changes in liver function, which have shown up in blood tests allergic reactions such as red, itchy swellings on the skin (hives), swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing, rash or intense itching. If youre taking Requip XL with L-dopa People who are taking Requip XL with L-dopa may develop other side effects over time: uncontrollable movements (dyskinesias) are a very common side effect. If you are taking L-dopa you may experience some uncontrollable movements (dyskinesias) when you first start taking Requip XL. Tell your doctor if this happens, as your doctor may need to adjust the dose of the medicines you are taking feeling confused is a common side effect.
4. How to take Requip XL
Always take Requip XL exactly as your Parkinsons disease doctor or nurse has told you to. Check with your doctor, nurse or pharmacist if youre not sure. You may be given Requip XL on its own to treat the symptoms of your Parkinsons disease. Or you may be given Requip XL as well as another medicine called L-dopa (also called levodopa). Requip XL should be prescribed and your progress monitored by a doctor with experience in the treatment of Parkinsons disease. If you are taking L-dopa you may experience some uncontrollable movements (dyskinesias) when you first start taking Requip XL. Tell your doctor if this happens, as your doctor may need to adjust the dose of the medicines you are taking. Tell your doctor if you or your family notices that you are developing any unusual behaviours (such as an unusual urge to gamble or increased sexual urges and/or behaviours) while you are taking Requip XL. Your doctor may need to adjust your dose. If you are switching from Requip film-coated (immediate release) tablets Your doctor or nurse will base your dose of Requip XL on the dose of Requip you were taking. You will take the same or similar daily dose of Requip XL to your previous dose of Requip but you will only take Requip XL once a day. Take your Requip as normal the day before you switch. Then take your Requip XL on the next day and dont take any more Requip. Your doctor or nurse will be monitoring your progress closely after switching to Requip XL. If there is any change in the control of your symptoms before your next appointment, talk to your doctor or nurse as soon as possible in case dose adjustment is needed. How much Requip XL will you need to take? It may take a while to find out the best dose of Requip XL for you. The usual starting dose of Requip XL tablets is 2 mg once daily for the first week. Your doctor may increase your dose to 4 mg of Requip XL tablets once daily, from the second week of treatment. If you are very elderly your doctor may increase your dose more slowly. After that, the doctor may adjust your dose until you are taking the dose that is best for you. Some people take up to 24 mg of Requip XL tablets each day.
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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.
