Requip 1mg Tablets
Package Leaflet: Information for the User
REQUIP® 1mg Tablets
(ropinirole hydrochloride)
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.
• The name of your medicine is ReQuip 1mg Tablets, but will be referred to as ReQuip through the remainder of this leaflet. ReQuip Tablets are also available in 0.25mg, 2mg and 5mg strengths.
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 medicine (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
• metoclopramide, 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 breastfeeding, 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 taking 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 pharmacist has told you. Check with your doctor or pharmacist if you are 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 of ropinirole three times each day for the first week. Then your doctor will increase your dose each week, for the next three weeks. After that, your doctor will gradually increase the dose until you are taking the dose that is best for you. The usual is 1 mg to 3 mg three times each day (making a total daily dose of 3 mg to 9 mg). If your Parkinson's disease symptoms have not improved enough, your doctor may decide to gradually increase your dose some more.
Some people take up to 8 mg of ReQuip three times a day (24 mg daily altogether).
POM
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 tablets 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 cause side effects, although 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 are 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
• 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
• 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 (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 are 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
• The expiry date of these tablets is printed on the label.
• Do not use the medicine after this date.
• Store your tablets in their original container (with this leaflet) to protect them from direct sunlight and humidity.
• Do not store above 25°C.
• You should keep the pack in a place where children cannot see or reach it - preferably in a locked cupboard.
• Never offer these tablets to anyone else. They may not be suitable for them, even if their symptoms seem to be the same as yours.
• If your medicine becomes discoloured or shows any sign of deterioration, return it to your pharmacist.
• 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) CONTENTS OF THE PACK AND OTHER INFORMATION
What ReQuip contains
Your tablets contain the active ingredient ropinirole hydrochloride.
Requip 1mg Tablets are green film-coated pentagonal shape tablets marked with a pentagon symbol and 'SB' on one side and with a pentagon symbol and '4892' on the other side.
Each tablet contains 1mg ropinirole.
The tablets also contain inactive ingredients. These are lactose, microcrystalline cellulose (E460), croscarmellose sodium, magnesium stearate (E572), hydroxypropyl methylcellulose (E464), polyethylene glycol, titanium dioxide (E171),iron oxides (E172) and indigo carmine(E132).
The sodium content of each tablet is 0.1 mg Each pack contains either 21 or 84 tablets.
ReQuip is made by SmithKline Beecham Pharmaceuticals, Manor Royal, Crawley, West Sussex RH10 9QJ.
Procured from within the EU by the Product Licence holder:
MPT Pharma Ltd, Westgate business Park, Unit 5-7 Tintagel way, Aldridge, Walsall WS9 8ER.
Repackaged by XXXXXXXX
PL: 33532/0080
ReQuip and the ReQuip tablet shape are registered trademarks of the GlaxoSmithKline group of companies.
Leaflet dated: 05th June 2014 Leaflet code xxxxxxxxx