Package leaflet: information for the user

Ropilynz XL 2 mg prolonged-release tablets Ropilynz XL 4 mg prolonged-release tablets Ropilynz XL 8 mg 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 Ropilynz XL is and what it is used for

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

3.    How to take Ropilynz XL

4.    Possible side effects

5.    How to store Ropilynz XL

6.    Contents of the pack and other information

1.    What Ropilynz XL is and what it is used for

The active ingredient in Ropilynz 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.

Ropilynz XL 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.

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

Do not take Ropilynz 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 Ropilynz 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.

Your doctor needs to know before you take Ropilynz XL:

•    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 experienced any unusual urges and/or behaviours (such as excessive gambling or excessive sexual behaviour) (see section 4)

•    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 Ropilynz XL is not suitable for you or that you need extra check-ups while you are taking it.

While you are taking Ropilynz XL

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 Ropilynz XL. Your doctor may need to adjust or stop your dose.

Other medicines and Ropilynz 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 Ropilynz XL.

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

You will require additional blood tests if you are taking these medicines with Ropilynz XL:

•    Vitamin K antagonists (used to reduce blood clotting) such as Warfarin (coumarin).

Smoking and Ropilynz XL

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

Ropilynz XL with food

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

Pregnancy, breast-feeding and fertility

Ropilynz XL is not recommended if you are pregnant, unless your doctor advises that the benefit to you of taking Ropilynz XL is greater than the risk to your unborn baby. Ropilynz XL is not recommended if you are breast feeding, as it can affect your milk production.

Ropilynz XL is not known to affect human fertility If you are pregnant or breast-feeding, think you might be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Your doctor will also advise you if you are breast feeding or planning to do so. Your doctor may advise you to stop taking Ropilynz XL.

Driving and using machines

Ropilynz 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.

Ropilynz XL 2 mg and 4mg contains lactose

Ropilynz XL 2 mg and 4 mg 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.

3. How to take Ropilynz XL

Always take this medicine exactly as your doctor has told you. You

should check with your doctor or pharmacist if you are not sure. You may be given Ropilynz XL on its own to treat the symptoms of your Parkinson’s disease, or you may be given Ropilynz 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 Ropilynz XL. Tell your doctor if this happens, as your doctor may need to adjust the doses of the medicines you are taking.

Ropilynz XL tablet(s) are designed to release drug over a 24-hour period. If you have a condition where your medicine passes through your body too quickly e.g. diarrhea, the tablet(s) may not dissolve completely and may not work properly. You may see tablet(s) in your stool. If this happens, let your doctor know as soon as possible.

How much Ropilynz XL will you need to take?

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

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

Use in children and adolescents

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

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

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

Taking your dose of Ropilynz XL

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

Swallow your Roplynz 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.

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

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

If you take more Ropilynz XL than you should

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

Someone who has taken an overdose of Ropilynz 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 Ropilynz XL

Do not take extra prolonged-release tablets or a double dose to make up for a missed dose.

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

If you stop taking Ropilynz XL

Do not stop taking Ropilynz XL without advice.

Take Ropilynz XL for as long as your doctor recommends.

Do not stop unless your doctor advises you to.

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

If you need to stop taking Ropilynz XL, your doctor will reduce your dose gradually.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

The side effects of Ropilynz 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):

•    Fainting

•    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.

•    act in an aggressive manner

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 Ropilynz XL with L-dopa

People who are taking Ropilynz 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 Ropilynz 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 (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 Ropilynz 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, on the bottle and on the carton. The expiry date refers to the last day of that month.

Do not store above 25°C.

HDPE bottle: Shelf life after first opening is 60 days.

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 Ropilynz XL contains

The active substance in Ropilynz XL is ropinirole.

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

The other ingredients are:

•    Prolonged-release tablet cores: Ammonio Methacrylate Copolymer Type B, Hypromellose (E464), Sodium lauryl sulfate, Copovidone, Magnesium stearate (E572).

•    film coats:

with dimensions 12.6 x 6.6 ± 0.1 mm in diameter and 5.3 ± 0.2 mm in thickness.

Ropilynz XL 8mg: red prolonged-release oval biconvex tablets, with dimensions 19.2 x 10.2 ± 0.2 mm in diameter and 5.2 ± 0.2 mm in thickness.

All strengths are supplied in white opaque PVC/PCTFE-Aluminium foil blisters and white opaque HDPE bottles with white cylindrical caps of polypropylene with three break points on the tamper-evident ring and aperture of desiccant insert.

Pack sizes of

Blister: 7, 21, 28, 30, 42, 84, 90,100 prolonged-release tablets Bottle: 7, 21, 28,30, 42, 84, 90,100 prolonged-release tablets Not all pack sizes may be marketed.

Marketing Authorization Holder

Lupin (Europe) Ltd Victoria Court Bexton Road Knutsford Cheshire WA16 0PF United Kingdom

Manufacturer

Pharmathen S.A.

6 Dervenakion 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 November 2014    ID#: xxxxxx