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Package Leaflet: Information for the user

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

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

3.    How to take Repinex XL

4.    Possible side effects

5.    How to store Repinex XL

6.    Contents of the pack and other information

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

The active ingredient in Repinex 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.

Repinex 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 Repinex XL

Do not take Repinex XL

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

•    ifyou 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 Repinex XL.

Tell your doctor if you or your family/carer notice 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 Repinex XL:

•    ifyou are pregnant or think you may be pregnant

•    ifyou are breast-feeding

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

Other medicines and Repinex 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 Repinex XL.

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

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

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

Smoking and Repinex XL

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

Repinex XL with food

You can take Repinex XL with or without food, as you prefer. Pregnancy, breast-feeding and fertility Repinex XL is not recommended if you are pregnant, unless your doctor advises that the benefit to you of taking Repinex XL is greater than the risk to your unborn baby. Repinex XL is not recommended if you are breast-feeding, as it can affect your milk production. Repinex XL is not known to affect human fertility.

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. Your doctor will also advise you if you are breast-feeding or planning to do so. Your doctor may advise you to stop taking Repinex XL.

Driving and using machines

Repinex 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.

Repinex XL 2mg

Repinex XL 2mg contains a sugar called 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.

Repinex XL 4mg

Repinex XL 4mg contains a colouring agent called sunset yellow (E110), which may cause allergic reactions.

3.    How to take Repinex XL

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

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

Repinex XL tablet(s) are designed to release drug over a 24hr period. If you have a condition where your medicine passes through your body too quickly, e.g., diarrhoea, 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 Repinex XL will you need to take?

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

The recommended starting dose is 2mg once daily for the first week. Your doctor may increase your dose to 4mg of Repinex XL prolonged-release tablets once daily, from the second week of treatment. In the very elderly, the doctor may increase the dosage 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 24mg of Repinex 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 Repinex XL to children. Repinex XL is not

normally prescribed for people under 18.

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

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

Taking your dose of Repinex XL Take Repinex XL once a day, at the same time each day. Swallow your Repinex 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 Repinex 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 Repinex XL prolonged-release tablets next morning and do not take any more ropinirole film-coated (immediate-release) tablets.

If you take more Repinex XL than you should Contact a doctor or pharmacist immediately. If possible, show them the Repinex XL pack.

Someone who has taken an overdose of Repinex 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 Repinex XL

Do not take extra prolonged-release tablets or a double

dose to make up for a missed dose.

If you have missed taking Repinex XL for one day or more,

ask your doctor for advice on how to start taking it again.

If you stop taking Repinex XL

Do not stop using Repinex XL suddenly without talking to your doctor. A sudden stop could cause you to develop a medical condition called neuroleptic malignant syndrome which may represent a major health risk. The symptoms include: akinesia (loss of muscle movement), rigid muscles, fever, unstable blood pressure, tachycardia (increased heart rate), confusion, depressed level of consciousness (e.g. coma). Take Repinex XL for as long as your doctor recommends.

Do not stop unless your doctor advises you to.

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

If you need to stop taking Repinex 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 Repinex 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

These may affect more than 1 in 10 people taking Repinex XL:

•    fainting

•    feeling drowsy

•    feeling sick (nausea).

Common side effects

These may affect up to 1 in 10 people taking Repinex XL:

•    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

These may affect up to 1 in 100 people taking Repinex XL:

•    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 side effects

Cannot be estimated from the available data:

•    excessive use of Repinex XL (craving for large doses of dopaminergic drugs in excess of that required to control motor symptoms, known as dopamine dysregulation syndrome)

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 Repinex XL with L-dopa

People who are taking Repinex 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 Repinex 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 (website: 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 Repinex 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 Repinex XL contains

The active substance in Repinex XL is ropinirole.

One prolonged-release tablet contains 2mg, 4mg or 8mg 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:

What Repinex XL looks like and contents of the pack

Repinex XL 2mg:

pink prolonged-release round biconvex tablets 6.8 ± 0.1 mm in diameter and 5.5 ± 0.2 mm in thickness.

Repinex XL 4mg:

light brown prolonged-release oval biconvex tablets, with dimensions 12.6*6.6 ± 0.1 mm in diameter and 5.3 ± 0.2 mm in thickness.

Repinex XL 8mg:

red prolonged-release oval biconvex tablets, with dimensions 19.2*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 Authorisation Holder

Aspire Pharma Ltd,

Bellamy House,

Winton Road,

Petersfield,

Hampshire,

GU32 3HA,

United Kingdom

Manufacturer

Pharmathen SA,

6 Dervenakion Str,

153 51, Pallini Attiki,

Greece

or

Pharmathen International SA,

Industrial Park Sapes,

Rodopi Prefecture,

Block No 5,

Rodopi 69300,

Greece

This leaflet was last revised in

04/2016

Aspire

1010112-P6.4    Pharma