Package leaflet: Information for the patient

Ropinirole Mylan XL 2 mg, 4 mg, 8 mg Prolonged-release Tablets

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 Mylan XL is and what it is used for

2.    What you need to know before you take Ropinirole Mylan XL

3.    How to take Ropinirole Mylan XL

4.    Possible side effects

5.    How to store Ropinirole Mylan XL

6.    Contents of the pack and other information

1.    What Ropinirole Mylan XL is and what it is used for

The active ingredient in Ropinirole Mylan XL Prolonged-release 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 Mylan 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. Ropinirole 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 Ropinirole Mylan XL

Do not take Ropinirole Mylan XL:

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

•    if you have a serious kidney disease

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

Your doctor may decide that Ropinirole Mylan XL is not suitable for you, or that you need extra check-ups while you are taking it.

While you are taking Ropinirole Mylan XL

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 Mylan XL

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

Other medicines and Ropinirole XL

Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines. Also remember to tell your doctor or pharmacist if you begin taking a new medicine while you are taking Ropinirole Mylan XL.

Some medicines can affect the way Ropinirole Mylan XL works, or make it more likely that you will have side effects. Ropinirole Mylan XL 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.

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.

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

Your doctor will also advise you if you are breastfeeding or planning to do so. Ropinirole Mylan XL is not recommended if you are breast-feeding, as it can affect your milk production. Your doctor may advise you to stop taking Ropinirole Mylan XL.

Driving and using machines

Ropinirole Mylan 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.

Ropinirole Mylan XL contains lactose

Ropinirole Mylan XL prolonged-release tablets contain a type of sugar called lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Ropinirole Mylan XL.

3. How to take Ropinirole Mylan 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.

You may be given Ropinirole Mylan XL on its own to treat the symptoms of your Parkinson's disease. You may also be given Ropinirole Mylan XL with another medicine called L-dopa (also called levodopa). If you are taking L-dopa you may experience some uncontrolled jerky movements when you first start taking Ropinirole Mylan XL. Tell your doctor if this happens, as your doctor may need to adjust the dose of L-dopa you are taking.

Use in children and adolescents

Do not give Ropinirole Mylan XL to children. Ropinirole Mylan XL is not normally prescribed for people under 18 years of age.

How much Ropinirole Mylan XL will you need to take?

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

The recommended starting dose of Ropinirole Mylan XL is 2 mg once daily for the first week. Your doctor may increase your dose to 4 mg of Ropinirole Mylan XL once daily, from the second week of treatment. If you are very elderly, your doctor may increase your dose more slowly. After that, the doctor may adjust your dose until you are taking the dose that is best for you. Some people take up to 24 mg of Ropinirole Mylan XL 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.

It may take a few weeks for Ropinirole Mylan XL to work for you. Do not take any more Ropinirole Mylan XL than your doctor has recommended.

Method of administration

Take Ropinirole Mylan XL once a day, at the same time each day. You can take Ropinirole Mylan XL with or without food, as you prefer.

Swallow your Ropinirole Mylan XL prolonged-release tablet(s) whole, with a glass of water. Do not break, chew or crush them. If you do so, there is a danger you could overdose, because the medicine will be released into your body too quickly.

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

Your doctor will base your dose of Ropinirole Mylan 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 Ropinirole Mylan XL prolonged-release tablets next morning and do not take any more ropinirole film-coated (immediate-release) tablets.

If you take more Ropinirole Mylan XL than you should

Contact a doctor or pharmacist immediately. If possible, show them the Ropinirole Mylan XL pack.

Someone who has taken an overdose of Ropinirole Mylan 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 Ropinirole Mylan XL

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

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

If you stop taking Ropinirole Mylan XL

Do not stop taking Ropinirole Mylan XL without advice. Take Ropinirole Mylan XL for as long as your doctor recommends.

Do not stop unless your doctor advises you to. If you suddenly stop taking Ropinirole Mylan XL, your Parkinson's disease symptoms may quickly get much worse.

If you need to stop taking Ropinirole Mylan 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 Ropinirole Mylan 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.

If any of the following happen, do not take more Ropinirole Mylan XL. Tell your doctor immediately or go to the casualty department at your nearest hospital:

Not known (frequency cannot be estimated from the available data):

•    hypersensitivity reactions including itchy skin rash, swollen face, lips, throat or tongue which may cause difficulty swallowing or breathing, rash and itching.

Other side effects are:

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

•    fainting

•    feeling drowsy

•    feeling sick (nausea).

Common (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 (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).

Not known (frequency cannot be estimated from the available data):

•    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 are taking Ropinirole Mylan XL with L-dopa

People who are taking Ropinirole Mylan XL with L-dopa may develop other side effects over time:

•    uncontrolled jerky movements are a very common side effect. If you are taking L-dopa you may experience some uncontrollable movements when you first start taking Ropinirole Mylan 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 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 Ropinirole Mylan 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 carton and blister foil after EXP. The expiry date refers to the last day of that month.

Do not store above 30°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 Ropinirole XL contains:

•    The active substance is ropinirole. Each prolonged-release tablet contains 2 mg, 4 mg or 8 mg of ropinirole (as hydrochloride).

•    The other ingredients are: hypromellose, croscarmellose sodium, maltodextrin, lactose monohydrate, hydrogenated castor oil, colloidal anhydrous silica, magnesium stearate, pigment blend: [2 mg prolonged release tablets:] iron oxide red (E172), iron oxide yellow (E172), lactose monohydrate, [4 mg & 8 mg prolonged release tablets:] iron oxide red (E172), iron oxide yellow (E172), lactose monohydrate, iron oxide black (E172).

What Ropinirole XL looks like and contents of the pack

Ropinirole Mylan XL 2 mg prolonged-release tablets are pink, mottled and oval with 2x debossed on one side. Ropinirole Mylan XL 4 mg prolonged-release tablets are brown, mottled and oval with 4x debossed on one side. Ropinirole Mylan XL 8 mg prolonged-release tablets are dark pink, mottled and oval with 8x debossed on one side.

Pack sizes:

Ropinirole Mylan XL prolonged-release tablets are available in blister packs of 21,28, 30, 42, 56, 84 and 90 prolonged-release tablets.

Not all pack sizes may be available.

Marketing Authorisation Holder

Mylan, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom

Manufacturer

Actavis Ltd, BLB016, Bulebel Industrial Estate, Zejtun,

ZTN 3000, Malta

This leaflet was last revised in 11/2016

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