Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
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.
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.
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 taking ROPINIROLE 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 intolerance to some sugars (such as lactose)
Tell your doctor if you experience symptoms such as depression, apathy, anxiety, fatigue, sweating or pain after stopping or reducing your Ropinirole treatment ( called dopamine agonist withdrawal syndrome or DAWS ). If the problems persist more than a few weeks, your doctor may need to adjust your dose .
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, or aggressive behaviours. Your doctormay need to adjust or stop your dose.
Tell your doctor if you or your family/carer notices that you are developing episodes of overactivity, elation or irritability (symptoms of mania). These may occur with or without the symptoms of impulse control disorders (see above). 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.
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.
• any other medicine for Parkinson's disease .
• 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).
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 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.
Ropinirole can cause hallucinations (seeing, hearing or feeling things that are not there). If affected do not drive or use machines.
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.
ROPINIROLE contains sodium Ropinirole tablets contain less than 1mmol sodium (23 mg) per tablet, that is to say essentially "sodium free".
Always take this medicine exactly as your doctor or pharmacist 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).
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. 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.
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 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 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.
Do not take any more ROPINIROLE than your doctor has recommended It may take a few weeks for Ropinirole to work for you.
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), feeling drowsy, mental or physical tiredness, fainting and hallucinations.
If you forget to take ROPINIROLE Do not take extra tablets or a double dose to make up for a missed dose . Just take your next dose at the usual time.
Parkinson's disease: If you have missed taking ROPINIROLE for one day or more , 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.
If you stop taking ROPINIROLE Do not stop using ropinirole without advice .
Take ROPINIROLE for as long as your doctor recommends. Do not stop unless your doctor advises you to.
If you suddenly stop taking ROPINIROLE your Parkinson's disease symptoms may quickly get much worse.
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 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.
Like all medicines, this medicine can cause side effects, although not everyone 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 (seeing things that are not real)
• feeling dizzy (a spinning sensation)
• being sick (vomiting)
• heartburn
• swelling of the legs, , feet or hands
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)
• 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)
• hiccups
Some patients may have the following side effects (frequency not known: cannot be estimated from the available data)
• 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)
• aggression
• 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).
• Depression, apathy, anxiety, lack of energy, sweating or pain may occur (called dopamine agonist withdrawal syndrome or DAWS) after stopping or reducing your Ropinirole treatment.
• Changes in liver function, which have shown up in blood tests.
• spontaneous penile erection
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 is needed to satisfy your hunger).
• episodes of overactivity, elation or irritability.
Tell your doctor if you experience any of these behaviours; they will discuss ways of managing or reducing the symptoms.
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. 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 doses of the medicines you are taking.
• Feeling confused is a common side effect
Restless legs Syndrome When ROPINIROLE is used to treat Restless Legs Syndrome, the following effects have been reported:
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.
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).
• hiccups
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; cannot be estimated from the available data):
• 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
• 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)
• After stopping or reducing your ROPINIROLE treatment: Depression, apathy, anxiety, fatigue, sweating or pain may occur (called dopamine agonist withdrawal syndrome or DAWS).
• spontaneous penile erection
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, 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; website www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in Google play or Apple App store. By reporting side effects you can help provide more information on the safety of this medicine.
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.
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 mg film-coated tablets
Blister: 21, 28 and 84
Bottle: 84
1.0 mg film-coated tablets
Blister: 21, 28 and 84
Bottle: 84
2.0 mg film-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 Vysoké Mýto
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 05/2026.
Glenmark Pharmaceuticals Europe Ltd
Address
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+44 (0)1923 202 950
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Ropinirole 1 mg film-coated tablets comes as tablet containing 1mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Ropinirole 1 mg film-coated tablets is ropinirole hydrochloride.
Medicines with the same active substance, strength and form include: Requip 1 mg Film-coated Tablets, Ropinirole 1 mg Film-coated Tablets. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Ropinirole 1 mg film-coated tablets, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Treatment of Parkinson's disease under the following conditions:
Initial treatment as monotherapy, in order to delay the introduction of levodopa.
In combination with levodopa, over the course of the disease, when the effect of levodopa wears off or becomes inconsistent and fluctuations in the therapeutic effect occur ("end of dose" or "on-off" type fluctuations)
Or
Ropinirole is indicated for the symptomatic treatment of moderate to severe idiopathic Restless Legs Syndrome (see section 5.1).
Oral use.
Parkinson's disease:
Adults
Individual dose titration against efficacy and tolerability is recommended.
Ropinirole 0.25 mg film-coated tablets should be taken three times a day, preferably with meals to improve gastrointestinal tolerance.
Treatment initiation
The initial dose of ropinirole should be 0.25 mg three times daily for 1 week. Thereafter, the dose of ropinirole can be increased in 0.25 mg three times daily increments, according to the following regimen:
Week
1
2
3
4
Unit dose (mg) of ropinirole
0.25
0.5
0.75
1.0
Total daily dose (mg) of ropinirole
0.75
1.5
2.25
3.0
Therapeutic regimen
After the initial titration, weekly increments of 0.5 to 1 mg three times daily (1.5 to 3 mg/day) of ropinirole may be given.
A therapeutic response may be seen between 3 and 9 mg/day of ropinirole. If sufficient symptomatic control is not achieved, or maintained after the initial titration as described above, the dose of ropinirole may be increased up to 24 mg/day.
Doses of ropinirole above 24 mg/day have not been studied.
If treatment is interrupted for one day or more re-initiation by dose titration should be considered (see above).
When ropinirole is administered as adjunct therapy to levodopa, the concurrent dose of levodopa may be reduced gradually according to the symptomatic response. In clinical trials, the levodopa dose was reduced gradually by around 20% in patients treated with ropinirole as adjunct therapy. In patients with advanced Parkinson's disease receiving ropinirole in combination with levodopa, dyskinesias can occur during the initial titration of ropinirole. In clinical trials it was shown that a reduction of the levodopa dose may ameliorate dyskinesia (see section 4.8).
When switching treatment from another dopamine agonist to ropinirole, the marketing authorisation holder's guidance on discontinuation should be followed before initiating ropinirole.
As with other dopamine agonists, it is necessary to discontinue ropinirole treatment gradually by reducing the number of daily doses over the period of one week (see section 4.4).
Restless Legs Syndrome:
Adults
Individual dose titration against efficacy and tolerability is recommended.
Ropinirole should be taken just before bedtime; however the dose can be taken up to 3 hours before retiring. Ropinirole may be taken with food, to improve gastrointestinal tolerance.
Treatment initiation (week 1)
The recommended initial dose is 0.25 mg once daily (administered as above) for 2 days. If this dose is well tolerated the dose should be increased to 0.5 mg once daily for the remainder of week 1.
Therapeutic regimen (week 2 onwards)
Following treatment initiation, the daily dose should be increased until optimal therapeutic response is achieved. The average dose in clinical trials, in patients with moderate to severe Restless Legs Syndrome, was 2 mg once a day.
The dose may be increased to 1 mg once a day at week 2. The dose may then be increased by 0.5 mg per week over the next two weeks to a dose of 2 mg once a day. In some patients, to achieve optimal improvement, the dose may be increased gradually up to a maximum of 4 mg once a day. In clinical trials the dose was increased by 0.5 mg each week to 3 mg once a day and then by 1 mg up to the maximum recommended dose of 4 mg once a day as shown in table 1.
Doses above 4 mg once daily have not been investigated in Restless Legs Syndrome patients.
Table 1 Dose titration
Week
2
3
4
5*
6*
7*
Dose (mg)/once daily
1
1.5
2
2.5
3
4
* To achieve optimal improvement in some patients.
The efficacy of ropinirole treatment has not been shown beyond 12 weeks (see Section 5.1). Patient response should be evaluated after 12 weeks treatment and the need for treatment continuation reconsidered. If treatment is interrupted for more than a few days it should be re‑initiated by dose titration as noted above.
When switching treatment from another dopamine agonist to ropinirole, the marketing authorisation holder's guidance on discontinuation should be followed before initiating ropinirole.
As with other dopamine agonists, it is necessary to discontinue ropinirole treatment gradually by reducing the daily doses over the period of one week (see section 4.4).
Children and adolescents
Ropinirole Glenmark is not recommended for use in children below 18 years of age due to a lack of data on safety and efficacy.
Elderly
The clearance of ropinirole is decreased by approximately 15% in patients aged 65 years or above. Although a dose adjustment is not required, ropinirole dose should be individually titrated, with careful monitoring of tolerability, to the optimal clinical response.
Renal impairment
No dosage adjustment is necessary in patients with mild to moderate renal impairment (creatinine clearance 30-50 ml/min).
A study into the use of ropinirole in patients with end stage renal disease (patients on haemodialysis) has shown that a dose adjustment in these patients is required as follows: the recommended initial dose of ropinirole is 0.25 mg once daily for Restless Legs Syndrome and 0.25 mg three times a day for Parkinson's disease. Further dose escalations should be based on tolerability and efficacy. The recommended maximum dose of ropinirole is 3 mg/day when it is prescribed for Restless Legs Syndrome and 18 mg/day when it is prescribed for Parkinson's disease in patients receiving regular haemodialysis. Supplemental doses after haemodialysis are not required (see section 5.2).
The use of ropinirole in patients with severe renal impairment (creatinine clearance less than 30 ml/min) without regular haemodialysis has not been studied.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Severe renal impairment (creatinine clearance <30ml/min) without regular haemodialysis.
Severe hepatic impairment.
Ropinirole should not be used to treat neuroleptic akathisia, tasikinesia (neuroleptic-induced compulsive tendency to walk), or secondary Restless Legs Syndrome (e.g. caused by renal failure, iron deficiency anaemia or pregnancy).
Paradoxical worsening of Restless Legs Syndrome symptoms described as augmentation (either earlier onset, increased intensity, or spread of symptoms to previously unaffected limbs), or early morning rebound (reoccurrence of symptoms in the early morning hours), have been observed during treatment with ropinirole. If this occurs, the adequacy of ropinirole treatment should be reviewed and dosage adjustment or discontinuation of treatment may be considered (see section 4.8).
In Parkinson's disease, ropinirole has been associated uncommonly with somnolence and episodes of sudden sleep onset (see section 4.8) however, in Restless Legs Syndrome, this phenomenon is very rare. Nevertheless, patients must be informed of this phenomenon and advised to exercise caution while driving or operating machines during treatment with ropinirole. Patients who have experienced somnolence and/or an episode of sudden sleep onset must refrain from driving or operating machines. A reduction of dosage or termination of therapy may be considered.
Psychiatric or psychotic disorders
Patients with major psychiatric or psychotic disorders, or a history of these disorders should only be treated with dopamine agonists if the potential benefits outweigh the risks.
Impulse control disorders
Patients should be regularly monitored for the development of impulse control disorders. Patients and carers should be made aware that behavioural symptoms of impulse control disorders including pathological gambling, increased libido, hypersexuality, aggressive behaviours, compulsive spending or buying, binge eating and compulsive eating can occur in patients treated with dopamine agonists including ropinirole. Dose reduction/tapered discontinuation should be considered if such symptoms develop.
Mania
Patients should be regularly monitored for the development of mania. Patients and carers should be made aware that symptoms of mania can occur with or without the symptoms of impulse control disorders in patients treated with Ropinirole. Dose reduction/tapered discontinuation should be considered if such symptoms develop.
Neuroleptic malignant syndrome
Symptoms suggestive of neuroleptic malignant syndrome have been reported with abrupt withdrawal of dopaminergic therapy. Therefore it is recommended to taper treatment (see section 4.2).
Hypotension
Due to the risk of hypotension, blood pressure monitoring is recommended, particularly at the start of treatment, in patients with severe cardiovascular disease (in particular coronary insufficiency).
Dopamine agonist withdrawal syndrome (DAWS)
DAWS has been reported with dopamine agonists, including ropinirole (see section 4.8). To discontinue treatment in patients with Parkinson's disease, ropinirole should be tapered off (see section 4.2). Limited data suggests that patients with impulse control disorders and those receiving high daily dose and/or high cumulative doses of dopamine agonists may be at higher risk for developing DAWS. Withdrawal symptoms may include apathy, anxiety, depression, fatigue, sweating and pain and do not respond to levodopa. Prior to tapering off and discontinuing ropinirole, patients should be informed about potential withdrawal symptoms. Patients should be closely monitored during tapering and discontinuation. In case of severe and/or persistent withdrawal symptoms, temporary re-administration of ropinirole at the lowest effective dose may be considered.
Hallucinations
Hallucinations are known as a side effect of treatment with dopamine agonists and levodopa. Patients should be informed that hallucinations can occur.
Ropinirole should be administered with caution to patients with moderate hepatic impairment. Undesirable effects should be closely monitored.
Lactose
This medicinal product also contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Sodium
Each Ropinirole Tablets contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially 'sodium free'.
There is no pharmacokinetic interaction between ropinirole and L-dopa or domperidone which would necessitate dosage adjustment of these medicinal products.
Ropinirole is principally metabolised by the cytochrome P450 enzyme CYP1A2. A pharmacokinetic study (with a ropinirole dose of 2 mg, three times a day in patients with Parkinson's disease) revealed that ciprofloxacin increased the Cmax and AUC of ropinirole by 60% and 84% respectively, with a potential risk of adverse events. Hence, in patients already receiving ropinirole, the dose of ropinirole may need to be adjusted when medicinal products known to inhibit CYP1A2, e.g. ciprofloxacin, enoxacin or fluvoxamine, are introduced or withdrawn.
A pharmacokinetic interaction study in patients with Parkinson's disease between ropinirole (at a dose of 2 mg, three times a day) and theophylline, a substrate of CYP1A2, revealed no change in the pharmacokinetics of either ropinirole or theophylline. Therefore, it is not expected that ropinirole will compete with the metabolism of other medicinal products which are metabolised by CYP1A2.
Based on in-vitro data, ropinirole has little potential to inhibit cytochrome P450 at therapeutic doses. Hence, ropinirole is unlikely to affect the pharmacokinetics of other medicinal products, via a cytochrome P450 mechanism.
Smoking is known to induce CYP1A2 metabolism, therefore if patients stop or start smoking during treatment with ropinirole, dose adjustment maybe required.
Increased plasma concentrations of ropinirole have been observed in patients treated with hormone replacement therapy. In patients already receiving hormone replacement therapy, ropinirole treatment may be initiated in the usual manner. However, it may be necessary to adjust the ropinirole dose, in accordance with clinical response, if hormone replacement therapy is stopped or introduced during treatment with ropinirole.
No pharmacokinetic interaction has been seen between ropinirole and domperidone (a medicinal product used to treat nausea and vomiting) that would necessitate dosage adjustment of either medicinal product. Domperidone antagonises the dopaminergic actions of ropinirole peripherally and does not cross the blood-brain barrier. Hence its value as an anti-emetic in patients treated with centrally acting dopamine agonists.
Neuroleptics and other centrally active dopamine antagonists, such as sulpiride or metoclopramide, may diminish the effectiveness of ropinirole and, therefore, concomitant use of these medicinal products with ropinirole should be avoided.
In patients receiving the combination of vitamin K antagonists and ropinirole, cases of unbalanced INR have been reported. Increased clinical and biological surveillance (INR) is warranted.
Pregnancy
There are no adequate data from the use of ropinirole in pregnant women. Ropinirole concentrations may gradually increase during pregnancy (see section 5.2).
Studies in animals have shown reproductive toxicity (see section 5.3). As the potential risk for humans is unknown, it is recommended that ropinirole is not used during pregnancy unless the potential benefit to the patient outweighs the potential risk to the foetus.
Breast feeding
Ropinirole-related material was shown to transfer into the milk of lactating rats. It is unknown whether ropinirole and its metabolites are excreted in human milk. A risk to the suckling child cannot be excluded.
Ropinirole should not be used in nursing mothers as it may inhibit lactation.
Fertility
There are no data on the effects of ropinirole on human fertility. In female fertility studies in rats, effects were seen on implantation but no effects were seen on male fertility (see Section 5.3).
Patients being treated with ropinirole and presenting with hallucinations, somnolence and/or sudden sleep episodes must be informed to refrain from driving or engaging in activities where impaired alertness may put themselves or others at risk of serious injury or death (e.g. operating machines) until such recurrent episodes and somnolence episodes and somnolence have resolved (see also Section 4.4).
Undesirable effects reported are listed below by system organ class and frequency. It is noted if these undesirable effects were reported in clinical trials as monotherapy or adjunct therapy to levodopa.
Frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000) very rare (<1/10,000), not known (cannot be estimated from the available data).
Use of ropinirole in Parkinson's disease
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Immune system disorders
Not known: Hypersensitivity reactions (including urticaria, angioedema, rash, pruritus).
Psychiatric disorders
Common: hallucinations.
Uncommon: psychotic reactions (other than hallucinations) including delirium, delusion and paranoia.
Not known: aggression*, dopamine dysregulation syndrome, mania (see section 4.4.), impulse control disorders** (see section 4.4.).
* Aggression has been associated with psychotic reactions as well as compulsive symptoms.
** Impulse control disorders: pathological gambling, increased libido, hypersexuality, aggression, compulsive spending or buying, binge eating, and compulsive eating can occur in patients treated with dopamine agonists including Ropinirole (see section 4.4).
Use in adjunct therapy studies:
Common: confusion.
Nervous system disorders
Very common: somnolence
Common: dizziness (including vertigo).
Uncommon: sudden onset of sleep, excessive daytime somnolence.
Ropinirole is associated with somnolence and has been associated uncommonly with excessive daytime somnolence and sudden sleep onset episodes.
Use in monotherapy studies:
Very common: syncope.
Use in adjunct therapy studies:
Very common: dyskinesia. In patients with advanced Parkinson's disease, dyskinesias can occur during the initial titration of ropinirole. In clinical trials it was shown that a reduction of the levodopa dose may ameliorate dyskinesia (see section 4.2).
Vascular disorders
Uncommon: postural hypotension, hypotension.
postural hypotension or hypotension is rarely severe.
Respiratory, thoracic and mediastinal disorders
Uncommon: hiccups
Gastrointestinal disorders
Very common: nausea.
Common: heartburn.
Use in monotherapy studies:
Common: vomiting, abdominal pain.
Hepatobiliary disorders
Not known: hepatic reactions, mainly increased liver enzymes.
Reproductive system and breast disorders
Not known: spontaneous penile erection
General disorders
Use in monotherapy studies:
Common: Oedema peripheral (including leg oedema)
Not known: Dopamine agonist withdrawal syndrome (including apathy, anxiety, depression, fatigue, sweating and pain).
Dopamine agonist withdrawal syndrome
Non-motor adverse effects may occur when tapering or discontinuing dopamine agonists including ropinirole (see section 4.4).
Use of ropinirole in Restless Legs Syndrome
In Restless Legs Syndrome clinical trials the most common adverse drug reaction was nausea (approximately 30% of patients). Undesirable effects were normally mild to moderate and experienced at the start of therapy or on increase of dose and few patients withdrew from the clinical studies due to undesirable effects.
Table 2 lists the adverse drug reactions reported for ropinirole in the 12-week clinical trials at ≥1.0% above the placebo rate or those reported uncommonly but known to be associated with ropinirole.
Table 2 Adverse drug reactions reported in 12-week Restless Legs Syndrome clinical trials (ropinirole n=309, placebo n=307) and other clinical trials*
Psychiatric disorders
Common
Nervousness
Uncommon
Confusion
Uncommon
*Hallucinations
Nervous system disorders
Common
Syncope, somnolence, dizziness (including vertigo)
Common
*Augmentation, Early morning rebound (see section 4.4)
Vascular disorders
Uncommon
Postural hypotension, hypotension
Gastrointestinal disorders
Very common
Vomiting, nausea
Common
Abdominal pain
General disorders and administration site conditions
Common
Fatigue
Post marketing reports
Psychiatric disorders: Dopamine dysregulation syndrome (frequency not known).
Dopamine agonist withdrawal syndrome (frequency not known)
Including apathy, anxiety, depression, fatigue, sweating and pain. Non-motor adverse effects may occur when tapering or discontinuing dopamine agonists including ropinirole (see section 4.4).'
Management of undesirable effects
Dose reduction should be considered if patients experience significant undesirable effects. If the undesirable effect abates, gradual up-titration can be re-instituted. Anti-nausea medicinal products that are not centrally active dopamine antagonists, such as domperidone, may be used, if required.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in Google play or Apple App store.
The symptoms of ropinirole overdose are related to its dopaminergic activity. These symptoms may be alleviated by appropriate treatment with dopamine antagonists such as neuroleptics or metoclopramide.
Ask anything about Ropinirole 1 mg film-coated tablets. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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