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PACKAGE LEAFLET: INFORMATION FOR THE USER Aimpart XL 2mg, 4mg and 8mg prolonged-release 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 Aimpart XL is and what it is used for

2.    What you need to know before you take Aimpart XL

3.    How to take Aimpart XL

4.    Possible side effects

5.    How to store Aimpart XL

6.    Contents of the pack and other information

1.    WHAT AIMPART XL IS AND WHAT IT IS USED FOR

The name of your medicine is Aimpart XL Prolonged Release Tablets (referred to as Aimpart XL throughout this leaflet). The active ingredient in Aimpart XL 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. Aimpart XL prolonged-release tablets are used to treat Parkinson’s disease.

People with Parkinson's disease have low levels of dopamine in some parts of their brains. Aimpart XL has effects similar to those of natural dopamine, so it helps to reduce the symptoms of Parkinson's disease.

2.    WHAT YOU NEED TO KNOW BEFORE YOU TAKE AIMPART XL Do not take Aimpart XL

•    if you are allergic to ropinirole or any of the other ingredients of this medicine (listed in section 6)

•    if you have serious kidney disease

•    if you have liver disease

Tell your doctor if you think any of these may apply to you.

Warnings and precautions

Talk to your doctor or pharmacist before taking Aimpart XL:

•    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 experienced any unusual urges and/or behaviours (such as excessive gambling or excessive sexual behaviour)

•    if you have an intolerance to some sugars (such as lactose).

Tell your doctor if you think any of these may apply to you. Your doctor may decide that Aimpart XL is not suitable for you or that you need extra check-ups while you are taking it.

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 abnormal high sex drive or an increase in sexual thoughts or feelings. Your doctor may need to adjust or stop your dose.

Driving and using machines

Aimpart XL 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.

Smoking and Aimpart XL

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

Other medicines and Aimpart XL

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 Aimpart XL.

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

These include:

•    the anti-depressant fluvoxamine

•    medication for other mental health problems, for example sulpride

•    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.

Aimpart XL with food and drink

You can take Aimpart XL with or without food, as you prefer.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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

as it can affect your milk production.

Aimpart XL 2mg Prolonged Release Tablets contain lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Aimpart XL 4mg prolonged-release tablets contain sunset yellow (E110)

The colouring agent called sunset yellow (E110) may cause allergic reactions.

3. HOW TO TAKE AIMPART XL

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Do not give Aimpart XL to children. Aimpart XL is not normally prescribed for people under 18.

You may be given Aimpart XL on its own to treat the symptoms of your Parkinson's disease. Or you may be given Aimpart XL 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 Aimpart XL. Tell your doctor if this happens, as your doctor may need to adjust the doses of the medicines you are taking.

How much Aimpart XL will you need to take?

It may take a while to find out the best dose of Aimpart XL for you.

The usual starting dose is 2mg once daily for the first week. Your doctor may increase your dose to 4mg of Aimpart XL prolonged-release tablets once daily, from the second week of treatment. In very elderly, the doctor may increase the dosage slowly. After that, the doctor may adjust your dose until you are taking the dose that is best you. Some people take up to 24mg of Aimpart XL prolonged-release tablets each day.

If at the start of your treatment, you experience side effects that you find difficult to tolerate, speak to your doctor. Your doctor may advise you to switch to a lower dose of ropinirole film-coated (immediate-release) tablets which you will take three times a day.

Do not take any more Aimpart XL than your doctor has recommended.

It may take a few weeks for Aimpart XL to work for you.

Taking your dose of Aimpart XL

Take Aimpart XL once a day, at the same time each day.

Swallow your Aimpart XL prolonged-release tablet(s) whole, with a glass of water.

Don't break, chew or crush the prolonged-release tablet(s) - if you do, there is a danger you could overdose, because the medicine will be released into your body too quickly.

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If you are switching from ropinirole film-coated (immediate-release) tablets

Your doctor will base your dose of Aimpart XL prolonged-release tablets on the dose of ropinirole film-coated (immediate-release) tablets you were taking.

Take your ropinirole film-coated (immediate-release) tablets as normal the day before you switch. Then take your Aimpart XL prolonged-release tablets next morning and do not take any more ropinirole film-coated (immediate-release) tablets.

If you take more Aimpart XL than you should

Contact a doctor or pharmacist immediately. If possible, show them the

Aimpart XL pack.

Someone who has taken an overdose of Aimpart XL 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 Aimpart XL

Do not take a double dose to make up for a forgotten dose.

If you have missed taking Aimpart XL for one day or more, ask your doctor for advice on how to start taking it again.

If you stop taking Aimpart XL

Do not stop taking Aimpart XL without advice.

Take Aimpart XL for as long as your doctor recommends.

Do not stop unless your doctor advises you to.

If you suddenly stop taking Aimpart XL, your Parkinson's disease symptoms may quickly get much worse.

If you need to stop taking Aimpart XL, 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 Aimpart XL 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.

Very common side effects (may affect more than 1 in 10 people):

•    tainting

•    feeling drowsy

•    feeling sick (nausea).

Common side effects (may affect up to 1 in 10 people):

•    hallucinations (“seeing” things that are not really there)

•    being sick (vomiting)

•    feeling dizzy (a spinning sensation)

•    heartburn

•    stomach pain

•    constipation

•    swelling of the legs, feet or hands.

Uncommon side effects (may affect up to 1 in 100 people):

•    feeling dizzy or faint, especially when you stand up suddenly (this is caused by a drop in blood pressure)

•    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)

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).

•    changes in liver function, which have shown up in blood tests.

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.

If you’re taking Aimpart XL with L-dopa

People who are taking Aimpart XL 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 Aimpart XL. 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.

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 at: 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 AIMPART XL

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the blister and on the carton. The expiry date refers to the last day of that month.

Do not store above 25°C.

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 Aimpart XL Prolonged Release Tablets contains

The active substance is ropinirole.

One prolonged-release tablet contains 2mg, 4mg or 8mg of ropinirole (as hydrochloride).

The other ingredients are:

•    Prolonged-release tablet cores: Methacrylic acid copolymer typeRS,HPMC (E464), SLS, Copovidone, Mg stearate (E572).

•    film coats:

What Aimpart XL Prolonged Release Tablets looks like and contents of the pack

Aimpart XL 2mg Prolonged Release Tablets: pink prolonged-release round biconvex tablets 6.8 ± 0.1mm in diameter and 5.5 ± 0.2 mm in thickness. Aimpart XL 4mg Prolonged Release Tablets: light brown prolonged-release oval biconvex tablets with dimensions 12.6*6.6 ± 0.1 mm and 5.3 ± 0.2 mm in thickness. Aimpart XL 8mg Prolonged Release Tablets: red prolonged-release oval biconvex tablets with dimensions 19.2*10.2 ± 0.2 mm and 5.2 ± 0.2 mm in thickness.

All strengths are supplied in white opaque PVC/PCTFE-Aluminium foil blisters Pack Sizes: 21, 28, 42, 84 prolonged-release tablets Not all pack sizes may be marketed.

Marketing Authorization Holder

Zentiva, One Onslow Street, Guildford, Surrey, GU1 4YS, UK

Manufacturer

Pharmathen S.A, 6 Dervanakion str., 153 51, Pallini Attiki, Greece Or

Pharmathen International S.A., Industrial Park Sapes, Rodopi Prefecture,

Block No 5, Rodopi 69300, Greece

This leaflet was last revised in September 2013 Zentiva is a registered trade mark.

©2013 Zentiva    00000

Zentiva

Brand: AIMPART XL 2MG, 4MG AND 8MG PROLONGED RELEASE TABLETS

No. colours and varnish: 1

Artwork Approval

Reason for Circulation:

Zentiva Regulatory

Approved: YesO NoO N/AO

Date:    THESE

Signature:

Zentiva - Head of Regulatory

Approved: YesO No    N/AO

Date:FOR ZENTIvA

Signature:

Other - as required

Approved: YesO NoO Date:

Signature:

00000000

00000000