PACKAGE LEAFLET: INFORMATION FOR THE USER

Ropinirole 0.25mg, 0.5mg, 1mg and 2mg Film-coated Tablets

(Ropinirole)

(Referred to as Ropinirole Tablets in the remainder of the leaflet)

Read all of this leaflet carefully before you start

to take this medicine.

-    Keep this leaflet. You may need to read it again.

-    If you have any further questions, please ask your doctor or pharmacist.

-    This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

-    If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What Ropinirole Tablets are and what they are used for

2.    Before you take Ropinirole Tablets

3.    How to take Ropinirole Tablets

4.    Possible side effects

5.    How to store Ropinirole Tablets

6.    Further information

1. What Ropinirole Tablets are and what they are used for

The active ingredient in Ropinirole Tablets 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 Tablets are 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.

•    moderate to severe Restless Legs Syndrome. People with Restless Legs Syndrome have an irresistible urge to move their legs, and sometimes their arms and other parts of their body. 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.

breastfeeding, 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 Tablets.

While you are taking Ropinirole Tablets

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 Tablets. Your doctor may need to adjust or stop your dose.

Driving and using machines

Ropinirole Tablets can make you feel drowsy. In very rare cases, Ropinirole Tablets 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 Tablets

Tell your doctor if you start smoking, or give up smoking, while you are taking Ropinirole Tablets. Your doctor may need to adjust your dose.

If your symptoms get worse

Some people taking Ropinirole Tablets find that their Restless Leg Syndrome 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.

Important information about some of the ingredients of Ropinirole Tablets

This medicine contains lactose (a type of sugar). If you have been told by your doctor that you cannot tolerate certain sugars, contact your doctor before taking this medicine.

3. How to take Ropinirole Tablets

2. Before you take Ropinirole Tablets

Do not take Ropinirole Tablets :

•    if you are allergic (hypersensitive) to ropinirole or to any of the other ingredients in this medicine (see Section 4 and 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

Take special care with Ropinirole Tablets

Your doctor needs to know before you take Ropinirole Tablets:

•    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)

•    are taking medicines to treat high blood pressure

•    are taking medicines to control your heart beat

Tell your doctor if you think any of these may apply to you. Your doctor may decide that Ropinirole Tablets aren't suitable for you, or that you need extra check-ups while you are taking them.

Taking other medicines

Please tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines, including any herbal medicines or other medicines you have obtained without a prescription. Remember to tell your doctor or pharmacist if you begin taking a new medicine while you are taking Ropinirole Tablets.

Some medicines can affect the way Ropinirole Tablets work, or make it more likely that you will have side effects. Ropinirole Tablets can also affect the way some other medicines work.

These include:

•    the anti-depressant fluvoxamine

•    medications for other mental health problems, for example sulpiride

•    hormone replacement therapy (HRT)

•    metoclopramide, which is used to treat nausea and heartburn

•    the antibiotics ciprofloxacin or enoxacin

•    any other medicine for Parkinson's disease

•    any other drug which blocks the action of dopamine in the brain

Taking with food and drink

If you take Ropinirole Tablets with food, you may be less likely to feel sick (nauseous) or be sick (Vomit). So it's best to take it with food if you can.

Pregnancy and Breastfeeding

Ropinirole Tablets are not recommended if you are pregnant, unless your doctor advises that the benefit to you of taking Ropinirole Tablets is greater than the risk to your unborn baby. Ropinirole Tablets are not recommended if you are

Always take Ropinirole Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

This medicine is to be swallowed whole with water and preferably with food.

Do not give Ropinirole Tablets to children. Ropinirole Tablets are not normally prescribed for people under 18 years of age.

When you begin taking Ropinirole Tablets your dose will be increased gradually. It may take a while to find the right dose for you.

Treatment of Parkinson's disease:

Adults

The usual starting dose is 0.25mg three times a day. After one week your doctor may increase your dose to 0.5mg three times a day. Then your doctor may increase your dose gradually over the next two weeks, up to a daily dose of 3mg per day.

If a 3mg daily dose does not improve your symptoms enough, your doctor may gradually increase you dose to a maximum of 9mg per day.

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 Tablets. Tell your doctor if this happens, as your doctor may need to adjust the doses of the medicines you are taking.

Treatment of Restless Legs Syndrome Adults

Take Ropinirole Tablets once a day, usually just before bedtime, but you can take it up to 3 hours before you go to bed. After two days your doctor may increase your dose to 0.5mg once a day for the remainder of the week. Then your doctor may gradually increase your dose to 2mg once a day over the next three weeks. In some patients, a 2mg daily dose may not improve Restless Legs Syndrome enough and your doctor may increase the dose up to a maximum of 4mg daily to improve your symptoms.

After three months of taking Ropinirole Tablets, your doctor may adjust your dose or advise you to stop taking this medicine, depending on your symptoms and how you feel.

If you take more Ropinirole Tablets than you should

Contact a doctor or pharmacist or go to your nearest hospital casualty department immediately. Take this leaflet and any unused tablets with you to show the doctor.

The symptoms of overdose includes feeling sick (nausea), being sick (vomiting), dizziness, feeling drowsy, mental or physical tiredness, fainting, hallucinations.

If you forget to take Ropinirole Tablets

If you forget to take your medicine take it as soon as you remember. If it is almost time for your next dose, then do not take the missed dose at all. NEVER take a double dose to make up for the one missed. If you have missed taking Ropinirole Tablets for one day or more, ask your doctor for advice on how to start taking it again.

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Do not stop taking this medicine suddenly

without consulting your doctor.

an unusual urge to gamble or increased sexual urges and/or behaviours

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Ropinirole Tablets can cause side effects, although not everybody gets them. The side effects of Ropinirole Tablets 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.

If you have an allergic reaction to Ropinirole Tablets, tell your doctor straight away. The signs of an allergic reaction include:

•    swelling of your face

•    low blood pressure (feeling faint, dizzy or light headed)

•    difficulty breathing

•    itchy lumpy rash.

Treatment of Parkinson's disease:

The following side-effects may be experienced when taking Ropinirole Tablets:

Very common (affects more than 1 in 10 people):

•    feeling drowsy or sleepy (somnolence)

•    feeling sick (nausea)

•    fainting.

Common (affects up to 10 users in 100):

•    seeing or hearing things that are not there (hallucinations)

•    dizziness (or a spinning sensation)

•    stomach pains

•    being sick (vomiting)

•    indigestion or heartburn

•    swelling of your legs

Uncommon (affects up to 10 users in 1000):

•    feeling dizzy or faint, especially when standing up from a sitting down or lying position (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 (affects up to one in 10,000)

•    a very small number of people taking Ropinirole Tablets 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).

•    urges to behave in a way unusual for them such as an unusual urge to gamble or increased sexual urges and/or behaviours

If you are taking Ropinirole Tablets with L-dopa

People who are taking Ropinirole Tablets 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 Tablets. 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

The following side effects may be experienced when taking Ropinirole Tablets:

Very common (affects more than 1 in 10 people):

•    being sick (vomiting)

•    feeling sick (nausea)

Common (affects up to 10 users in 100):

•    feeling nervous

•    fainting

•    feeling drowsy

•    fatigue (mental or physical tiredness)

•    dizziness

•    stomach pain

•    worsening of RLS (symptoms may start earlier than usual or be more intense, or affect other parts of the body, such as the arms or return in the early morning)

You should seek advice from your doctor if you

notice that your symptoms become worse, start

earlier in the day or

after less time at rest

whilst taking

Ropinirole Tablets.

Your doctor may adjust your dose.

If any of the side effects get serious, or if you notice any

side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. How to store Ropinirole Tablets

Keep out of the reach and sight of children.

Do not use Ropinirole Tablets after the expiry date stated on the blister or carton. The expiry date refers to the last day of that month.

For tablets packed in plastic bottles: Ropinirole Tablets can be used for one month after first opening of the container.

Blisters: Store below 25°C. Store in the original package (blister) in order to protect from moisture. HDPE bottles: Store below 25°C. Keep the bottle tightly closed in order to protect from moisture.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Further information

What Ropinirole tablets contain

The active ingredient is: ropinirole hydrochloride.

The other ingredients are: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hypromellose (6cps), magnesium stearate.

Film coating:

Ropinirole 0.25mg Film-Coated tablets: opadry white 03B28796 (hypromellose 6cps, titanium dioxide (E171), macrogol).

Ropinirole 0.5mg Film-Coated tablets: opadry yellow 03B52117 (hypromellose 6cps, titanium dioxide (E171), macrogol, iron oxide yellow (E172)). Ropinirole 1mg Film-Coated tablets: opadry green 03B21595 (hypromellose 6cps, titanium dioxide (E171), macrogol, iron oxide yellow (E172), indigo carmine aluminium lake (E132)).

Ropinirole 2mg Film-Coated tablets: opadry pink 03B84727 (hypromellose 6cps, titanium dioxide (E171), macrogol, iron oxide red (E172), iron oxide yellow (E172)).

What Ropinirole Film-coated tablets look like and the contents of the pack Ropinirole 0.25mg Film-coated tablets are white irregular hexagonal shape film-coated tablets, debossed 'W' on one side and '154' on the other. Ropinirole 0.5mg Film-coated tablets: are yellow irregular hexagonal shape film-coated tablets, debossed 'W' on one side and '155' on the other. Ropinirole 1mg Films-coated tablets: are green irregular hexagonal shape film-coated tablets, debossed 'W' on one side and '171' on the other. Ropinirole 2mg Film-coated tablets: are pale yellowish pink irregular hexagonal shape film-coated tablets, debossed 'W' on one side and '172' on the other.

These tablets are available in:

•    blister packs of 12, 28 or 100 tablets

•    HDPE container with child resistant cap of 30 or 84 tablets

Not all pack sizes may be marketed.

Marketing Authorisation Holder: Wockhardt UK Ltd, Ash Road North, Wrexham, LL13 9UF, UK. Manufacturer: CP Pharmaceuticals Ltd,

Ash Road North, Wrexham, LL13 9UF, UK.

These medicinal products are authorised in the Member States of the EEA under the following names:

UK: Ropinirole 0.25, 0.5, 1 and 2mg Film-Coated Tablets

Germany: Ropinirole Wockhardt 0,25/0,5/1/2mg Filmtabletten

Cyprus: Ropinirole 0.25, 0.5, 1 and 2mg Film-Coated Tablets

Malta: Ropinirole 0.25, 0.5, 1 and 2mg Film-Coated Tablets

Uncommon (affects up to 10 users in 1000):

•    feeling confused

•    hallucinations ('seeing' things that are not really there)

•    low blood pressure which can make you feel dizzy or faint especially when standing up from a sitting down or lying position.

Very rare side effects(affects up to one in 10,000)

A very small number of people taking Ropinirole

Tablets have had:

•    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

•    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)

•    urges to behave in a way unusual for them such as

Other formats:

To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:

0800 198 5000 (UK Only).

Please be ready to give the following information:

This is a service provided by the Royal National Institute of Blind People

For the Republic of Ireland please call +353 52 6186000 Leaflet prepared: January 2011

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WOCKHARDT

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