Ropinirole 0.5mg Film-Coated Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
ROPINIROLE 0.25mg FILM-COATED TABLETS ROPINIROLE 0.5mg FILM-COATED TABLETS ROPINIROLE 1.0mg FILM-COATED TABLETS ROPINIROLE 2.0mg 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 Contents of the pack and other information
1. WHAT ROPINIROLE IS AND WHAT IT IS USED FOR
The active ingredient in ROPINIROLE FILM-COATED TABLETS 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.
Ropinirole is used to treat Parkinson’s disease. 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.
ROPINIROLE is used to treat the symptoms of moderate to severe Restless Legs Syndrome (RLS).
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.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ROPINIROLE
Do not take ROPINIROLE
if you are allergic to the active ingredient , ropinirole, or any of the other ingredients of ROPINIROLE (listed in section 6).
if you have serious liver disease if you have a serious kidney disease
Tell your doctor if you think any of these may apply to you.
Warnings and precautions
Tell your doctor or pharmacist before you start to take this medicine if you:
are pregnant or think you may be pregnant are breast-feeding are under 18 years old have liver disease have a serious heart complaint have a serious mental health problem have experienced any unusual urges and /or behaviours (such as excessive gambling or excessive sexual behaviour)
have an intolerence 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.
Talk to your doctor if any of these may apply to you. If you and your doctor decide that you can take ROPINIROLE, your doctor will probably ask you to have extra check-ups while you are taking it.
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 medicines or other medicines you obtained without a prescription. Remember to tell your doctor or pharmacist if you begin taking a new medicine while you are taking ROPINIROLE.
Remember to tell your doctor if you start taking any other medicine while 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 how some other medicines work. These medicines include:
the anti-depressant fluvoxamine medication for other mental health problems, for example sulpiride
metoclopramide, which is used to treat nausea and heartburn
HRT (hormone replacement therapy) the antibiotics ciprofloxacin or enoxacin. any other drug, which blocks dopamine in the brain. cimetidine, used in treatment of stomach ulcers. any other medicine for Parkinson’s disease.
Talk to your doctor if you think any of these may apply to you. If you and your doctor decide that you can take this medicine, your doctor will probably ask you to have extra check-ups while you are taking it.
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).
Taking ROPINIROLE with food and drink If you take this medicine with food, you may be less likely to feel sick (nauseous) or be sick (vomit). So it may be best to take it with food if you can.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or planning to have a baby, ask your doctor or pharmacist for advice before taking any medicine. ROPINIROLE is not recommended if you are pregnant, unless your doctor advises that the benefit to you of taking it 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.
Tell your doctor immediately if you are pregnant, if you think you might be pregnant, or if you are planning to become pregnant. Your doctor will also advise you if you are breast feeding or planning to do so. Your doctor may advise you to stop taking ROPINIROLE.
While you are taking ROPINIROLE
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.
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. 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 dose.
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
This medicinal product contains lactose. If you have an intolerance to lactose or any other sugars, ask contact your doctor before taking this medicine.
3. 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.
Ropinirole is used differently depending on the disease. 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 the best dose of ROPINIROLE 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 ROPINIROLE 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.
Restless Legs Syndrome
Do not give ROPINIROLE to children.
ROPINIROLE is not normally prescribed for people under 18.
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 usual 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 this medicine 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 this medicine as your doctor advises, even if you do not feel better. Ropinirole may take a few weeks to work for you.
Swallow the ROPINIROLE tablet(s) whole with a glass of water. Do not chew or crush the tablet(s).
You can take ROPINIROLE with or without food. If you take ROPINIROLE with food you may be less likely to feel sick (nauseous).
Parkinson’s disease
Take ropinirole 3 times a day.
Restless Legs Syndrome
Take your ROPINIROLE tablet(s) once a day.
Ropinirole is usually taken just before bedtime, but can be taken up to 3 hours before going to bed.
Use in children and adolescents
ROPINIROLE is not normally prescribed in children and adolescents under 18 years of age.
If you take more ROPINIROLE than you should
Contact your doctor or pharmacist immediately. If possible show them the package.
Someone who has taken an overdose of ROPINIROLE may have any of these symptoms: feeling sick (nausea), being sick (vomiting), dizziness (a spinning sensation), feeling drowsy, mental or physical tiredness, fainting and 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.
Parkinson’s disease: If you have missed taking ROPINIROLE for more than a few days, ask your doctor for advice on how to start taking ROPINIROLE again. Restless Legs Syndrome: If you have missed your dose for more than a few days, ask your doctor for advice on how to start taking ROPINIROLE again.
Do not stop taking ROPINIROLE without advice Take ROPINIROLE for as long as your doctor recommends. Don’t stop unless your doctor advises you to.
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 product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The side effects with this medicine 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. Parkinson’s disease
When ROPINIROLE is used to treat Parkinson’s disease, the following side effects have been reported:
Very common: may affect more than 1 in 10 people
• feeling sick (nausea)
• feeling drowsy
• fainting
Common: may affect up to 1 in 10 people
• hallucinations (sensing things that are not real)
• feeling dizzy (a spinning sensation)
• being sick (vomiting)
• heartburn
• swelling of the legs
Uncommon: 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 this medicine with L-dopa
People who are taking this medicine 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
If you get any side effects, talk to your doctor or pharmacist as soon as possible. This includes any side effects not listed in this leaflet.
Restless legs Syndrome
When ROPINIROLE is used to treat Restless Legs Syndrome, the following effects have been reported:
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 fainting, 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).
Some patients may have the following side effects (frequency not known):
• 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 psychotic reactions in addition to hallucinations, such as severe confusion (delirium), irrational ideas (delusions) and irrational suspiciousness (paranoia)
• aggression
You may experience the following side effects:
- inability to resist that 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 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.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme; website 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 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/bottle and the outer carton after Exp. The expiry date refers to the last day of that month.
Do not store above 30°C.
Blisters:
Store in the original package in order to protect from moisture.
Bottles:
Keep the bottle tightly closed 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 to protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What ROPINIROLE contains
• The active substance is ropinirole. Each film-coated tablet contains ropinirole hydrochloride equivalent to 0.25 / 0.5 / 1.0/2.0 mg of ropinirole.
The other ingredients are:
Tablet Cores Lactose, Anhydrous Lactose Monohydrate Cellulose, microcrystalline (E460)
Citric acid, anhydrous (E330)
Croscarmellose sodium (E468)
Magnesium Stearate (E572)
Film Coating
0.25 mg Hypromellose (E464), Titanium dioxide (E171), Macrogol 400, Talc (E553b)
0.50 mg Hypromellose (E464), Titanium dioxide (E171), Macrogol 400, Talc (E553b), Iron oxide yellow (E172), Indigo carmine aluminium lake (E132), Iron oxide red (E172)
1.0 mg Hypromellose (E464), Titanium dioxide(E171),
Macrogol 400, Talc (E553b), Iron oxide yellow (E172), Indigo carmine aluminium lake (E132), Iron oxide black (E172)
2.0 mg Hypromellose (E464), Titanium dioxide (E171),
Macrogol 400, Talc, Iron oxide red (E172)
What ROPINIROLE looks like and contents of the pack Film-coated tablet.
0.25 mg: White to off-white, circular, bevelled edged,
biconvex film coated tablets with ‘253’ debossed on one side and ‘G’ on the other side.
0.50 mg Pale Yellow to Yellow, circular, bevelled edged, biconvex film coated tablets with ‘254’ debossed on one side and ‘G’ on the other side.
1.0 mg Pale Green to Green, circular, bevelled edged,
biconvex film coated tablets with ‘255’ debossed on one side and ‘G’ on the other side.
2.0 mg Pale Pink to Pink, circular, bevelled edged,
biconvex film coated tablets with ‘256’ debossed on one side and ‘G’ on the other side.
The tablets are packed in either plain Aluminium/ Aluminium blisters, white, opaque Triplex(PVC/PE/Aclar)/ Aluminium blisters or white opaque HDPE bottles with polypropylene child-resistant closure.
Pack sizes
0.25 mg film-coated tablets:
Blister: 12, 21, 84 and 126 Bottle: 84
0.5 mgfilm-coated tablets Blister: 21, 28 and 84 Bottle: 84
1.0 mgfilm-coated tablets Blister: 21 and 84 Bottle: 84
2.0 mgfilm-coated tablets Blister: 21, 28 and 84 Bottle: 84
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Glenmark Pharmaceuticals Europe Ltd,
Laxmi House, 2-B Draycott Avenue,
Kenton, Harrow, Middlesex HA3 0BU United Kingdom.
Manufacturer
Glenmark Pharmaceuticals s.r.o, Fibichova 143
56617 Vysoke Myto, Czech Republic
Glenmark Pharmaceuticals Europe Limited, Building 2,
Croxley Green Business Park, Croxley Green, Hertfordshire,
WD18 8YA, United Kingdom
This leaflet was last revised in 03/2015.