Requip Xl 4 Mg Prolonged-Release Tablets
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501013/PL1 f
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor, nurse specialist or pharmacist.
- This medicine has been prescribed for you only. Don't pass it on to others. It may harm them, even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor, nurse or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
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2) WHAT Y |
OU NEED TO KNOW BEFORE YOU TAKE | |
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REQUIP® XL |
Do not take Requip® XL:
• if you are allergic (hypersensitive) to ropinirole or any
3) HOW TO TAKE REQUIP® XL
®
Requip XL 2 mg Prolonged Release Tablets Requip® XL 4 mg Prolonged Release Tablets Requip® XL 8 mg Prolonged Release Tablets
(ropinirole hydrochloride)
Patient Information Leaflet
The name of your medicine is Requip® XL 2 mg Prolonged Release Tablets, Requip® XL 4 mg Prolonged Release Tablets or Requip® XL 8 mg Prolonged Release Tablets. Throughout this leaflet it will be referred to as Requip® XL.
What is in this leaflet
1) What Requip® XL is and what it is used for
2) What you need to know before you take Requip® XL
3) How to take Requip® XL
4) Possible side effects
5) How to store Requip XL
6) Contents of the pack and other information
1) WHAT REQUIP® XL IS AND WHAT IT IS USED FOR
Requip XL is used to treat Parkinson's 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 Parkinson's 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 Parkinson's 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 Parkinson's disease.
of the other ingredients of this medicine (listed in 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.
Warnings and Precautions
Talk to your doctor or pharmacist before taking 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 a history of or have experienced any unusual urges and/or behaviours (such as excessive gambling or excessive sexual behaviour, see section 4)
• if you have an intolerance to some sugars (such as lactose).
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.
^ Tell your doctor or nurse if you think any of these may apply to you. Your doctor or nurse may decide that Requip® XL isn't suitable for you, or that you need extra check-ups while you're taking it.
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.
Other medicines and Requip® XL
Tell your doctor, nurse or pharmacist if you are taking, have recently taken, or might take any other medicines -
including any herbal remedies or medicines you bought without a prescription.
Some medicines can affect the way Requip® XL works, or make it more likely that you'll 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 you're taking, or have recently taken, any of these.
Remember to tell your doctor or nurse if you start taking any other medicine while you're taking Requip® XL.
Requip® XL with food and drink
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, it is recommended that you do not take Requip® XL at the same time as a high fat meal.
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 breastfeeding, as it can affect your milk production.
If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
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: don't drive, don't operate machines and don't put yourself in any situation where feeling sleepy or falling asleep could put you (or other people) at risk of serious injury or death. Don't take part in these activities until you are sure you're not affected.
^ Talk to your doctor or nurse if this causes problems for you.
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.
Smoking and Requip® XL
Tell your doctor or nurse if you start smoking, or give up smoking, while you're taking Requip® XL. Your doctor or nurse may need to adjust your dose.
Always take this medicine exactly as your doctor or nurse or pharmacist has told you. Check with your doctor, nurse or pharmacist if you are not sure.
Do not give Requip® XL to children. Requip® XL is not normally prescribed for people under 18.
You may be given Requip® XL on its own to treat the symptoms of your Parkinson's 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 Parkinson's 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 don't 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 recommended 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.
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.
Don't 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.
Don't break, chew or crush the tablets - if you do, there's a danger you could overdose, because the medicine will be released into your body too quickly.
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|4) POSSIBLE SIDE EFFECTS|
5) HOW TO STORE REQUIP® XL
Requip® XL tablets are designed to release the drug into your body over a 24 hour period. If the tablets pass through your body in less than 24 hours the medicine may not be completely released. You may see tablets in your stool. If this happens, let your doctor know.
If you take more Requip® XL than you should
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
Do not take a double dose to make up for a forgotten 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.
Don't stop taking Requip® XL without advice Take Requip® XL for as long as your doctor or nurse recommends. Don't stop unless your doctor or nurse advises you to.
If you suddenly stop taking Requip® XL, your Parkinson's 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 medicine, ask your doctor, nurse or pharmacist.
Like all medicines, this medicine 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 you've taken the dose for a while. If you're worried about side effects, talk to your doctor or nurse.
Very common side effects:
may affect more than 1 in 10 people:
• fainting
• feeling drowsy
• feeling sick (nausea).
Common side effects:
may affect up to 1 in 10 people:
• 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:
may affect up to 1 in 100 people:
• 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).
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:
• strong impulse to gamble excessively despite serious personal or family consequences
• altered or increased sexual interest and behaviour of significant concern to you or to others, for example, an increased sexual drive
• uncontrollable excessive shopping or spending
• 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
Very rare side effects:
may affect up to 1 in 10,000 people
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.
Some patients may have the following side effects (frequency not known)
• act in an aggressive manner.
If you're 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.
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 the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.
• Keep out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the blister and the carton. The expiry date refers to the last day of that month.
• Do not store above 25°C.
• Store in the original package.
• If you notice any sign of deterioration or discolouration of the tablets, please tell your pharmacist immediately.
• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use.
6) CONTENTS OF THE PACK AND OTHER INFORMATION
What Requip® XL contains
The active ingredient in Requip® XL is ropinirole.
Each prolonged release tablet contains either 2 mg, 4 mg or 8 mg of ropinirole (as hydrochloride).
The other ingredients are:
• tablet cores: hypromellose, hydrogenated castor oil, carmellose sodium, povidone K29-32, maltodextrin, magnesium stearate, lactose monohydrate, colloidal anhydrous silica, mannitol (E421), ferric oxide yellow (E172) and glycerol dibehenate.
• film coats:
2 mg tablet: hypromellose, ferric oxide yellow (E172), titanium dioxide (E171), macrogol 400, ferric oxide red (E172)
4 mg tablet: hypromellose, titanium dioxide (E171), macrogol 400, sunset yellow (E110), indigo carmine (E132)
8 mg tablet: hypromellose, ferric oxide yellow (E172), titanium dioxide (E171), ferric oxide black (E172), macrogol 400, ferric oxide red (E172)
What Requip® XL looks like and contents of the pack
Requip® XL 2 mg: pink capsule shaped, film coated tablets marked 'GS' on one side and '3V2' on the other side.
Requip® XL 4 mg: light brown capsule shaped, film coated tablets marked 'GS' on one side and 'WXG' on the other side. Requip® XL 8 mg: red capsule shaped, film coated tablets marked 'GS' on one side and '5CC' on the other side.
All strengths are available as blister packs of 28 tablets. Product Licence Holder
Procured from within the EU. Product Licence Holder Ginova Ltd and repackager Ginova UK Ltd both at St James' House, 8 Overcliffe, Gravesend, Kent, DA11 0HJ.
Manufacturers:
SmithKline Beecham Pharmaceuticals, Manor Royal, Crawley, West Sussex RH10 9QJ, UK.
Glaxo Wellcome S.A., Avenida de Extremadura 3, 09400 Aranda de Duero, Burgos, Spain.
Requip® XL 2 mg Prolonged Release Tablets
PL No: 18067/0331
Requip® XL 4 mg Prolonged Release Tablets
PL No: 18067/0332
Requip® XL 8 mg Prolonged Release Tablets _
PL No: 18067/0333 |POM|
Other formats:
To request a copy of this leaflet in Braille, large print or audio please call 01622 690172.
This leaflet was revised on 15th July 2014.
Requip® is a registered trademark of the GlaxoSmithKline group of companies.
501013/PL1f