Ropinirole 2mg Film-Coated Tablets
_Package leaflet: Information for the patient_
Ropinirole 2 mg Film-coated Tablets
Ropinirole
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 Ropinirole is and what it is used for
2. What you need to know before you take Ropinirole
3. How to take Ropinirole
4. Possible side effects
5. How to store Ropinirole
6. Contents of the pack and other information
Q What Ropinirole is and what it is used for
Ropinirole is used to treat
• Parkinson's disease.
• Symptoms of moderate to severe restless legs syndrome.
The active ingredient in Ropinirole is ropinirole, which belongs to a group of medicines called dopamine agonists. Dopamine agonists act in a similar way to a natural substance called dopamine, in the brain. .
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
Restless legs syndrome (RLS) is also called Ekbom syndrome. People with restless legs syndrome have an irresistible urge to move their legs, and sometimes their arms and other parts of their bodies. Usually, they have unpleasant sensations in their limbs - sometimes described as 'crawling' or 'bubbling' - which can begin as soon as they sit or lie down, and are relieved only by movement. So they often have problems with sitting still and especially with sleeping.
Ropinirole relieves the unpleasant sensations, and so reduces the urge to move the legs and other limbs.
^ What you need to know before you take Ropinirole Do not take Ropinirole
- if you are allergic to ropinirole hydrochloride 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 Ropinirole
- 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
- Tell your doctor if you think any of these may apply to you. Your doctor may decide that Ropinirole isn't suitable for you or that you need extra check-ups while you're taking it.
Children and adolescents
Do not give Ropinirole to children .Ropinirole is not normally prescribed for people under 18.
Other medicines and Ropinirole
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. Remember to tell your doctor if you start taking any other medicine while you are taking Ropinirole.
Some medicines can affect the way Ropinirole works or make it more likely that you will have side effects. Ropinirole can also affect the way some other medicines work.
These include:
• the anti-depressent fluvoxamine
• theophylline (used to treat asthma)
• HRT hormone replacement therapy
• the antibiotics ciprofloxacin or enoxacin
• medication for other mental health problems, for example
• metoclopramide, which is used to treat nausea and heartburn
• cimetidine, used in the treatment of stomach ulcers
• any other medicine for Parkinson's disease.
• any other drug which blocks the action of dopamine in the brain
— Tell your doctor if you are taking, or have recently taken, any of these.
You will require additional blood tests if you are taking these medicines with Ropinirole:
• Vitamin K antagonists (used to reduce blood clotting) such as Warfarin (coumadin).
Ropinirole with food and drink
If you take Ropinirole 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.. You should not drink alcohol whilst taking Ropinirole.
Pregnancy and breast-feeding
Ropinirole is not recommended if you are pregnant, unless your doctor advises that the benefit to you of taking Ropinirole is greater than the risk to your unborn baby.
Ropinirole 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 taking this medicine. Your doctor may advise you to stop taking Ropinirole.
Driving and using machines
Ropinirole can make you feel drowsy. In very rare cases, Ropinirole can make people feel extremely sleepy, and it sometimes makes people fall asleep very suddenly without warning.
If you could be affected: do not drive, do not operate machines and do not put yourself in any situation where feeling sleepy or falling asleep could put you (or other people) at risk of serious injury or death. Do not take part in these activities until you are no longer affected.
- Talk to your doctor if this causes problems for you.
If your symptoms get worse
Some people taking Ropinirole find that their RLS symptoms get worse - for example, symptoms may start earlier than usual or be
more intense, or affect other previously unaffected limbs, such as the arms or return in the early morning.
- Tell your doctor as soon as possible if you get any of these symptoms.
Ropinirole contains lactose
Ropinirole contains a small amount of a sugar called lactose monohydrate. If you have an intolerance to lactose or any other sugars, ask your doctor for advice before taking Ropinirole . Smoking and Ropinirole
Tell your doctor if you start smoking, or give up smoking, while you are taking Ropinirole. Your doctor may need to adjust your
^ How to take Ropinirole
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Do not give Ropinirole to children. Ropinirole is not normally prescribed for people under 18.
How to take Ropinirole for Parkinson's disease You may be given Ropinirole on its own to treat the symptoms of your Parkinson's disease. Or you may be given Ropinirole 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 Ropinirole. 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 Ropinirole. Your doctor may need to adjust or stop your dose.
How much Ropinirole will you need to take?
It may take a while to find out what is the best dose of Ropinirole for you.
The recommended starting dose is 0.25mg 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 recommended dose is img to 3mg three times each day (making a total daily dose of 3mg to 9mg). 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 Ropinirole three times a day (24mg 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 Ropinirole than your doctor has recommended.
It may take a few weeks for Ropinirole to work for you.
Taking your dose of Ropinirole
Take Ropinirole three times a day.
Swallow your Ropinirole tablets whole, with a glass of water. It's best to take Ropinirole with food, because that makes it less likely that you'll feel sick (nauseous).
How to take Ropinirole for Restless Legs Syndrome
It may take a while to find out what is the best dose of Ropinirole for you.
The recommended starting dose is 0.25 mg once a day. After two days your doctor will probably increase your dose to 0.5 mg daily for the rest of the week. Then your doctor may gradually increase your dose over the next three weeks, up to a daily dose of 2 mg.
If a 2 mg daily dose does not improve your RLS symptoms enough, your doctor may gradually increase your dose some more, up to a maximum of 4 mg daily. After you have been taking Ropinirole for three months, your doctor may adjust your dose or advise you to stop taking it.
If you feel that the effects of Ropinirole are too strong or too weak, talk to your doctor or your pharmacist. Do not take more Ropinirole than your doctor has recommended.
Carry on taking Ropinirole as your doctor advises, even if you do not feel better. Ropinirole may take a few weeks to work for you. Taking your dose of Ropinirole Take your Ropinirole tablet(s) once a day.
Swallow the tablet(s) whole, with a glass of water. Do not chew or crush the tablets.
You can take Ropinirole with or without food. If you take it with food, you may be less likely to feel sick (nauseous).
Ropinirole is usually taken just before bedtime, but you can take it up to 3 hours before you go to bed.
If you take more Ropinirole than you should Contact a doctor or pharmacist immediately. If possible, show them the Ropinirole pack. Someone who has taken an overdose of Ropinirole may have any of these symptoms: feeling sick (nausea), being sick (vomiting), dizziness (a spinning sensation),
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feeling drowsy, mental or physical tiredness, fainting, hallucinations.
If you forget to take Ropinirole
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 Ropinirole for more than a few days,ask your doctor for advice on restarting Ropinirole how to start taking it again.
If you stop taking Ropinirole
Do not stop taking Ropinirole without advice.
Take Ropinirole for as long as your doctor recommends.
Do not stop using Ropinirole suddenly without talking to your doctor. A sudden stop could cause you to develop a medical condition called neuroleptic malignant syndrome which may represent a major health risk. The symptoms include: akinesia (loss of muscle movement), rigid muscles, fever, unstable blood pressure, tachycardia (increased heart rate), confusion, depressed level of consciousness (e.g. coma).
If you suddenly stop taking Ropinirole your Parkinson's disease symptoms may quickly get much worse.
If you need to stop taking Ropinirole your doctor will reduce your dose gradually.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Q Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The side effects of Ropinirole 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.
Serious side effects
If you experience the following, tell your doctor immediately or go to the casualty department at your nearest hospital:
Not known: frequency cannot be estimated from the available
• 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 (see section 2).
Other side effects
Tell your doctor if you experience:
unusual worsening of symptoms (e.g. symptoms become worse, start earlier in the day or after less time at rest, or affect other parts of your body such as your arms) during treatment for restless legs syndrome . Your doctor may adjust the dose of Ropinirole that you are taking.
Possible side effects in treatment of Parkinson's disease Very common side effects:may affect more than 1 in 10 people
• fainting
• feeling drowsy
• feeling or being 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)
• 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)
• low blood pressure (hypotension)
• 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).
Very rare side effects: may affect up to 1 in 10,000 people
• changes in liver function (abnormal blood tests), which have shown up in(blood test)
Not known: frequency cannot be estimated from the available data
• aggression
If you are taking Ropinirole with L-dopa
People who are taking Ropinirole 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
Possible side effects in treatment of Restless Legs Syndrome: Very common: may affect more than 1 in 10 people
■ feeling sick (nausea)
■ being sick (vomiting).
Common: may affect up to 1 in 10 people
■ nervousness
■ fainting
■ drowsiness
■ fatigue (mental or physical tiredness)
■ dizziness (a 'spinning' sensation)
■ stomach pain
■ worsening of RLS (symptoms may start earlier than usual or be more intense, or affect other previously unaffected limbs, such as the arms or return in the early morning)
■ swelling of the legs, feet or hands Uncommon: may affect up to 1 in 100 people
■ confusion
■ hallucinations ('seeing' things that are not really there)
■ feeling dizzy or faint, especially when you stand up suddenly (this is caused by a drop in blood pressure)
Very rare: may affect up to 1 in 10,000 people
■ changes in liver function, which have shown up in blood tests
■ feeling very sleepy during the day (extreme somnolence)
■ falling asleep very suddenly without feeling sleepy first (sudden sleep onset episodes)
Not known: frequency cannot be estimated from the available data
■ other psychotic reactions in addition to hallucinations, such as severe confusion (delirium), irrational ideas (delusions) and irrational suspiciousness (paranoia)
■ aggression
Possible side effects in treatment of Restless Legs Syndrome and Parkinson's disease
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)
excessive use of Ropinirole (craving for large doses of dopaminergic drugs in excess of that required to control motor symptoms, known as dopamine dysregulation syndrome)
Tell your doctor if you experience any of these behaviours; they will discuss ways of managing or reducing the symptoms 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.
Q How to store Ropinirole
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 the carton after EXP:. The expiry date refers to the last day of that month.
Do not store above 250 C. Store in the original package in order to protect from moisture.
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.
Q Contents of the pack and other information What Ropinirole contains
- The active substance is ropinirole. Each film-coated tablet contains 2.0mg of ropinirole (as hydrochloride)
- The other ingredients of the tablet core are lactose monohydrate, cellulose, microcrystalline, maize starch, silica colloidal anhydrous, magnesium stearate.
The film-coating contains:
2 mg film-coated tablets: Opadry II 31F58914 White consisting of: Hypromellose 15 cp (E464), Lactose monohydrate, Titanium dioxide (E171), Macrogol 4000, Sodium citrate dihydrate (E331C) What Ropinirole looks like and contents of the pack
Ropinirole is supplied as film-coated tablets.
Ropinirole 2 mg Film-coated Tablets are white, round, biconvex tablets embossed with ’’RO’’ on one side and "2" on the other side. They are available in blister packs of 21, 28 and 84 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder
Pliva Pharma Ltd
Ridings Point, Whistler Drive
Castleford, West Yorkshire,
WF10 5HX, UK Manufacturer
Teva Operations Poland Sp. z.o.o. ul. Mogilska 80 31-456 Krakow Poland.
This leaflet was last revised in May 2016
PL 10622/0322
@ PLIVA
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