Ropinirole 0.5 Mg Film-Coated Tablets
Out of date information, search anotherPackage leaflet: Information for the user Ropinirole 0.25 mg Film-coated tablets Ropinirole 0.5 mg Film-coated tablets Ropinirole 1 mg Film-coated tablets 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.
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
1. What Ropinirole is and what it is used for
The active ingredient in Ropinirole 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.
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 also used to treat the symptoms of moderate to severe Restless Legs Syndrome.
Restless Legs Syndrome (RLS) is also called Ekbom syndrome. People with restless leg syndrome have an irresistible urge to move their legs, and sometimes their arms and other parts of their bodies. Usually, they have unpleasant sensation in their limbs - sometimes described as ‘crawling’ or ‘bubling’ - which can begin as soon as they sit or lie down, and are relieved only by movement. So they often have problem 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 ropinirole or to any of the other ingredients in this medicine (listed in section 6)
• have liver disease
• have serious kidney disease.
If you are unsure, talk to your doctor.
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 breastfeeding
• 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).
^ 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 are taking it.
Take special care with Ropinirole
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.
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.
Other medicines and Ropinirole
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. 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 the way some other medicines work.
These include:
• the anti-depressant fluvoxamine
• medication for other mental health problems, for example sulpiride
• HRT (hormone replacement therapy)
• metoclopramide, which is used to treat nausea and heartburn
• the antibiotics ciprofloxacin or enoxacin
• any other medicine for Parkinson’s disease
^ Tell your doctor if you are taking, or have recently taken, any of these.
Ropinirole with food and drink
Swallow Ropinirole tablets whole with water and preferably with food. Do not chew them.
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.
Pregnancy, breast-feeding and fertility
Ropinirole is not recommended if you are pregnant, unless your doctor advises that the benefit to you 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.
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.
Driving and using machines
Ropinirole 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: 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.
Ropinirole tablet contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. How to take Ropinirole
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose of Ropinirole people take can be different. Your doctor will decide on the dose you need to take each day and you should follow the doctor's instructions. When you first start taking Ropinirole, the dose you take will be increased gradually.
For doses not realizable/practicable with this strength other strengths of this medicinal product are available.
If you are taking Ropinirole for Parkinson’s disease, your doctor will increase or decrease the amount of Ropinirole that you are taking to get the best effect.
The usual starting dose is 0.25 mg of Ropinirole three times each day for the first week. Then your doctor may 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 dose is 1 mg to 3 mg three times each day (making a total 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 to a maximum of 8 mg three times each day (making a total dose of 24 mg).
If you are 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 Ropinirole for Restless Leg Syndrome you will take one tablet a day which should be taken about the same time each day, usually before bedtime, but can be taken up to 3 hours before going to bed.
The exact dose of Ropinirole tablets people take can be different. Your doctor will decide on the dose you need to take each day and you should follow the doctor’s instructions. When you first start taking Ropinirole, the dose you take will be increased gradually.
The starting dose is 0.25 mg once daily. After two days your doctor will probably increase your dose to 0.5 mg once daily for the remainder of your first week of treatment.
After the first week your doctor may increase your dose by 0.5 mg per week over three weeks to a dose of 2 mg per day. In some patients, the dose may be increased gradually up to a maximum of 4 mg daily. After three months of treatment with Ropinirole tablets, your doctor may adjust your dose or discontinue your treatment depending on the symptoms and how you feel.
You should always check with your doctor or pharmacist if you are not sure how to take your tablets.
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, hallucinations.
If you forget to take Ropinirole, Do not take take a double dose to make up for a forgotten tablet, leave that dose out completely. Take the next dose at the normal time.
If you stop taking Ropinirole
Do not stop taking 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. 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.
4. 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’re worried about side effects, talk to your doctor.
Very common side effects
These may affect more than 1 in 10 people taking Ropinirole:
• fainting
• feeling drowsy
• feeling sick (nausea)
Common side effects
These may affect up to 1 in 10 people taking Ropinirole:
• hallucinations (‘seeing’ things that aren’t really there)
• being sick (vomiting)
• feeling dizzy (a spinning sensation)
• heartburn
• abdominal pain
• swelling of the legs
• fatigue (mental or physical tiredness)
• nervousness
Uncommon side effects
These may affect up to 1 in 100 people taking Ropinirole:
• 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)
Very rare side effects
A very small number of people taking Ropinirole (up to 1 in 10,000) have had changes in liver function, which have shown up in blood tests.
Some patients may have the following side effects
• 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).
• 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)
Tell your doctor if you experience any of these behaviors; they will discuss ways of managing or reducing the symptoms
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. 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
If you get side effects
If any of the side effects become serious or troublesome, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. How to store Ropinirole
Keep this medicine out of the sight and reach of children.
Store below 25°C.
Store in the original package in order to protect from moisture.
Do not use this medicine after the expiry date which is stated on the carton/ and blister foil after EXP. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information What Ropinirole contains
- The active substance is ropinirole hydrochloride. Each film-coated tablet contains 0.25 mg, 0.5 mg,
1 mg or 2 mg of ropinirole (as ropinirole hydrochloride).
- The other ingredients are lactose monohydrate; cellulose, microcrystalline; croscarmellose sodium and magnesium stearate.
The film-coating of the 0.25 mg tablets also contains; hypromellose, titanium dioxide (E171), macrogol (PEG 400) and polysorbate 80
The film-coating of the 0.5 mg tablets also contains; hypromellose, titanium dioxide (E171), macrogol (PEG 400), iron oxide yellow (E172) and iron oxide red (E172)
The film-coating of the 1 mg tablets also contains; hypromellose, titanium dioxide (E171), macrogol (PEG 400), iron oxide yellow (E172) and indigo carmine aluminium lake (E132)
The film-coating of the 2 mg tablets also contains; hypromellose, titanium dioxide (E171), macrogol (PEG 400), iron oxide yellow (E172) and iron oxide red (E172)
What Ropinirole looks like and contents of the pack
Ropinirole 0.25 mg Film-Coated Tablets
White to off-white, circular, biconvex, film-coated tablets debossed with ‘F’ on one side and ‘61’ on the other side.
Ropinirole 0.5 mg Film-Coated Tablets
Yellow coloured, circular, biconvex, film-coated tablets debossed with ‘F’ on one side and ‘62’ on the other side.
Ropinirole 1 mg Film-Coated Tablets
Green coloured, circular, biconvex, film-coated tablets debossed with ‘F’ on one side and ‘63’ on the other side.
Ropinirole 2 mg Film-Coated Tablets
Pink coloured, circular, biconvex, film-coated tablets debossed with ‘F’ on one side and ‘64’ on the other side.
Ropinirole tablets are available in Polyamide/ Aluminium/ PVC/Aluminium blister packs and HDPE bottle packs.
Ropinirole 0.25mg, 0.5mg, 1mg & 2mg Tablets
Aluminium foil blister: 12, 14, 20, 21, 28, 30, 42, 50, 56, 60, 63, 84, 90, 100, 126 or 210 film-coated tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Amneal Pharma Europe Limited 70 Sir John Rogerson’s Quay Dublin 2 Ireland
Manufacturer:
Pfizer Service Company BVBA
Hoge Wei 10 , 1930 Zaventem Belgium or
Pfizer PGM
Zone Industrielle 29, route des Industries 37530 Poce -Sur-Cisse France or
Pfizer Italia s.r.l.
Localita Marino Del Tronto 63100 - Ascoli Piceno (AP)_
Italy
This leaflet was last revised in 07/2013
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