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reQuip
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 or pharmacist.
This medicine has been prescribed for you only. Do not 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1 What ReQuip is and what it is used for
2 What you need to know before you take ReQuip
3 How to take ReQuip
4 Possible side effects
5 How to store ReQuip
6 Contents of the pack and other information
1 What ReQuip is and what it is used for
ReQuip is used to treat Parkinson's disease.
The active ingredient in ReQuip 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.
2 What you need to know before you take ReQuip
Do not take ReQuip:
• if you are allergic to ropinirole or any of the other ingredients of this medcine (listed in section 6).
• if you have serious kidney disease
• if you have liver disease
Tell your doctor if you think any of these may apply to you.
Warnings and precautions
Talk to your doctor or pharmacist before taking ReQuip:
• 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 serious mental health problem
• if you have experienced any unusual urges and/or behaviours (such as excessive gambling or excessive sexual behaviour)
• 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 if you think any of these may apply to you. Your doctor may decide that ReQuip isn't suitable for you or that you need extra check-ups while you're taking it.
Children
Do not give ReQuip to children. ReQuip is not normally prescribed for people under 18
Other medicines and ReQuip
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines including
any herbal remedies or other medicines you bought without a
prescription.
Some medicines can affect the way ReQuip works or make it more likely that you'll have side effects. ReQuip can also affect the way some other medicines work.
These include:
• the anti-depressant fluvoxamine
• HRT (hormone replacement therapy)
• the antibiotics ciprofloxacin or enoxacin
• medication for other mental health problems, for example sulpiride
• metodopramide, which is used to treat nausea and heartburn
• cimetidine, used in the treatment of stomach ulcers
• any other medicine for Parkinson's disease.
Tell your doctor if you're taking, or have recently taken, any of these.
Remember to tell your doctor if you start taking any other medicine while you're taking ReQuip.
ReQuip with food and drink
If you take ReQuip with food, you may be less likely to feel sick or be sick (vomit). So it's best to take it with food if you can.
Pregnancy and breast-feeding
ReQuip is not recommended if you are pregnant, unless your doctor advises that the benefit to you taking ReQuip is greater than the risk to your unborn baby. ReQuip is not recommended if you are breast-feeding, as it can affect your milk production.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before thaking this medicine.
Your doctor may advise you to stop taking ReQuip.
Driving and using machines
ReQuip can make you feel drowsy. 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 no longer affected.
Talk to your doctor if this causes problems for you.
ReQuip contains lactose
ReQuip tablets contain a small amount of a sugar called lactose. If you have an intolerance to lactose or any other sugars, ask your doctor for advice before you take ReQuip.
Smoking and ReQuip
Tell your doctor or nurse if you start smoking, or give up smoking, while you're taking ReQuip. Your doctor or nurse may need to adjust your dose.
3 How to take ReQuip
Always take this medicine exactly as your doctor or pharmacisthas told you to. Check with your doctor or pharmacist if you're not sure.
You may be given ReQuip on its own to treat the symptoms of your Parkinson's disease or you may be given ReQuip as well as another medicine called L-dopa (also called levodopa).
If you are taking L-dopa you may experience some uncontrollable movements (dyskinesias) when you first start taking ReQuip. 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. Your doctor may need to adjust or stop your dose.
How much ReQuip will you need to take?
It may take a while to find out the best dose of ReQuip for you. The usual starting dose is 0.25 mg three times a day for the first week. This dose is then gradually increased each week.
|
Week 1 |
Week 2 |
Week 3 |
Week 4 | |
|
Morning (about 8 am) |
0.25 mg 1 white tablet |
0.5 mg 1 pale yellow tablet |
0.75 mg 1 white tablet 1 pale yellow tablet |
1 mg 1 green tablet |
|
After lunch (about 1 pm) |
0.25 mg 1 white tablet |
0.5 mg 1 pale yellow tablet |
0.75 mg 1 white tablet 1 pale yellow tablet |
1 mg 1 green tablet |
|
Evening (about 6 pm) |
0.25 mg 1 white tablet |
0.5 mg 1 pale yellow tablet |
0.75 mg 1 white tablet 1 pale yellow tablet |
1 mg 1 green tablet |
V2
The ReQuip Starter Pack contains four blister strips of tablets -one strip for each of the first four weeks of your treatment. The four strips are marked with Week 1, Week 2, Week 3 and Week 4, and also with the treatment day (Day 1 to Day 28).
You must take the tablets in the order of the day number printed on the strips, starting at Day 1 and finishing at Day 28. The daily dose you take of ReQuip increases each week. There is one tablet in each blister pocket for you to take during Weeks 1, 2 and 4, and two tablets for you to take during Week 3.
Keep taking ReQuip until you have finished this four-week Starter Pack. After that, your doctor may gradually increase or decrease the dose until you're taking what's best for you. Some people take up to 8 mg of ReQuip three times a day (24 mg daily altogether).
If you are also taking other medicines for Parkinson's disease, your doctor may advise you to gradually reduce the dose of the other medicine.
Don't take any more ReQuip than your doctor has recommended.
It may take a few weeks for ReQuip to work for you.
Taking your dose of ReQuip
Take ReQuip three times a day.
Swallow your ReQuip tablet(s) whole, with a glass of water. It's best to take ReQuip with food, because that makes it less likely that you'll feel sick (nauseous).
If you take more ReQuip than you should
Contact a doctor or pharmacist immediately. If possible,
show them the ReQuip pack.
Someone who has taken an overdose of ReQuip 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
Do not take a double dose to make up for a forgotten dose. Just take your next dose at the usual time.
If you have missed taking ReQuip for more than a few
days, ask your doctor for advice on how to start taking it again.
Do not stop taking ReQuip without advice
Take ReQuip for as long as your doctor recommends. Don't
stop unless your doctor advises you to.
If you suddenly stop taking ReQuip your Parkinson's disease symptoms may quickly get much worse.
If you need to stop taking ReQuip your doctor will reduce your dose gradually.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4 Possible side effects
Like all medicines, this medicine can have side effects, but not everyone gets them.
The side effects of ReQuip 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 have taken the dose for a while.
If you're worried about side effects, talk to your doctor.
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 taking ReQuip:
• hallucinations (sensing things that are not real)
• being sick (vomiting)
• feeling dizzy (a spinning sensation)
• heartburn
• stomach pain
• swelling of the legs
Uncommon side effects:
may affect up to 1 in 100 people taking ReQuip:
• feeling dizzy or faint, especially when you stand up suddenly (this caused by a drop in blood pressure)
• feeling very sleepy during the day (extreme somnolence)
• 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
• 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)
• aggression
If you're taking ReQuip with L-dopa
People who are taking ReQuip with L-dopa may develop other side effects over time:
• uncontrollable movements (dyskinesias) are a very common side effect. Tell your doctor if this happens, as your doctor may need to adjust the doses 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.
5 How to store ReQuip
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and on the carton.The expiry date refers to the last day of that month.
Do not store this medicine above 25°C. Keep in a dry place, away from light.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6 Contents of the pack and other information
What ReQuip contains
The active substance in the ReQuip Starter Pack is ropinirole (as the hydrochloride) as 0.25 mg, 0.5 mg and 1 mg tablets.
The other ingredients are:
• tablet cores: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, magnesium stearate
• film coats:
0.25 mg tablet: hypromellose, macrogol 400, titanium dioxide (E171), polysorbate 80 (E433).
0.5 mg tablet: hypromellose, macrogol 400, titanium dioxide (E171), iron oxide yellow (E172), iron oxide red (E172), indigo carmine aluminium (E132).
1 mg tablet: hypromellose, macrogol 400, titanium dioxide (E171), iron oxide yellow (E172), indigo carmine aluminium (E132).
What ReQuip looks like and contents of the pack
ReQuip (all strengths) is provided as pentagonal, film-coated tablets, marked 'SB' on one side.
ReQuip 0.25 mg: white tablets marked '4890' on reverse side. ReQuip 0.5 mg: pale yellow tablets marked '4891' on reverse side.
ReQuip 1 mg: green tablets marked '4892' on reverse side.
0.25 mg, 0.5 mg and 1 mg tablets are supplied in a Starter blister pack of 105 tablets.
The Marketing Authorisation Holder is SmithKIine Beecham Limited, Stockley Park West, Uxbridge, Middlesex UB11 1BT
The Manufacturer is Catalent UK Packaging Limited, Lancaster Way, Wingates Industrial Estate, Westhoughton, Bolton, Lancashire BL5 3XX
Other formats
To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:
0800 198 5000 (UK Only)
Please be ready to give the following information:
Product name ReQuip 0.25 mg
ReQuip 0.5 mg ReQuip 1 mg
Reference number 10592/0085
This is a service provided by the Royal National Institute of Blind People.
Leaflet date: January 2014
ReQuip and the ReQuip tablet shape are registered trademarks of the GlaxoSmithKline group of companies © 2014 GlaxoSmithKline group of companies. All rights reserved.
DEVCOMP-0003108