Repirol Sr

Package Leaflet: Information for the User

Repirol SR, 2 mg, prolonged-release tablets

Repirol SR, 4 mg, prolonged-release tablets

Repirol SR, 8 mg, prolonged-release tablets

Ropinirole

You should read this leaflet carefully before taking this medicine, as it contains important information for you.

• You should 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 symptoms 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.

Contents of the pack and other information:

• 1. What Repirol SR is and what it is used for
• 2. Before you take Repirol SR
• 3. How to take Repirol SR
• 4. Possible side effects
• 5. How to store Repirol SR
• 6. Contents of the pack and other information

1. What Repirol SR is and what it is used for

The active substance of Repirol SR 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.

Repirol SR prolonged-release tablets are used to treat Parkinson's disease.

Parkinson's disease.

In patients with Parkinson's disease, certain parts of the brain become less active and there is a decrease in dopamine. Ropinirole works in a similar way to dopamine and helps to alleviate the symptoms of Parkinson's disease.

2. Before you take Repirol SR

Do not take Repirol SR

• if you are allergic to ropinirole or any of the other ingredients of Repirol SR (listed in section 6);
• if you have severe kidney disease;
• if you have liver disease.

Tell your doctor if any of these apply to you.

Warnings and precautions

Before taking Repirol SR, tell your doctor or pharmacist if:

• you are pregnant or think you may be pregnant;
• you are breast-feeding;
• you are under 18 years old;
• you have severe heart disease;
• you have serious mental health problems;
• you have had uncontrolled urges or behaviours (see section 4);
• you have intolerance to some sugars (e.g. lactose).

Tell your doctor if you or your family/carer notice that you are developing urges or cravings for unusual behaviours such as:

gambling more than is normal for you;

increased sex drive;

excessive spending or buying;

binge eating or compulsive eating;

Tell your doctor if you experience any of these behaviours; they will discuss ways of managing or stopping the behaviour.

While taking Repirol SR

Tell your doctor or pharmacist if you or your family/carer notice that you are developing any unusual behaviours (such as those described above) while taking Repirol SR. Your doctor may need to adjust or stop your treatment.

Repirol SR with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those obtained without a prescription, herbal remedies and other medicines for Parkinson's disease.

• the antidepressant fluvoxamine;
• medicines for other mental health problems, such as sulpiride;
• hormone replacement therapy (HRT);
• metoclopramide, used to treat nausea and vomiting;
• the antibiotics ciprofloxacin or enoxacin;
• any other medicines for Parkinson's disease.

Tell your doctor or pharmacist if you are taking any of these medicines.

If you are taking any of these medicines, your doctor may need to do blood tests to check how the medicine is affecting you.

Smoking and Repirol SR

Tell your doctor if you start or stop smoking while taking Repirol SR. Your doctor may need to adjust your dose.

Taking Repirol SR with food and drink

Repirol SR can be taken with or without food.

Pregnancy, breast-feeding and fertility

Do not take Repirol SR if you are pregnant, unless your doctor advises it is necessary. Do not take Repirol SR if you are breast-feeding.

Repirol SR is not likely to affect your ability to have children. 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.

Driving and using machines

Repirol SR can make you feel drowsy. It can also cause sudden sleep attacks or drowsiness without warning. Do not drive or operate machinery until you know how Repirol SR affects you.

Tell your doctor if you experience this. You should not drive or operate machinery if you have fallen asleep without warning or if you experience excessive drowsiness or sedation.

Repirol SR contains less than 1 mmol sodium (23 mg) per tablet, i.e. essentially 'sodium-free'.

Repirol SR 2 mg

Repirol SR 2 mg prolonged-release tablets contain 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.

Repirol SR 4 mg

Repirol SR 4 mg prolonged-release tablets contain a colouring called orange yellow S (E110), which may cause allergic reactions.

3. How to take Repirol SR

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

Repirol SR can be taken with or without food. Repirol SR is usually taken once a day, at the same time each day.

Swallow the tablets whole, with a glass of water.

Do not break, chew or crush the tablets, as this could affect the way the medicine works.

Changing from immediate-release tablets to prolonged-release tablets

Your doctor will advise you how to take Repirol SR prolonged-release tablets, based on the dose of ropinirole you are already taking.

If you take more Repirol SR than you should

Seek medical advice immediately. If possible, show the doctor the pack or this leaflet.

Symptoms of overdose may include nausea, vomiting, dizziness, drowsiness, mental fatigue or exhaustion, fainting, hallucinations.

If you forget to take Repirol SR

Do not take a double dose to make up for a forgotten dose. If you have missed a dose, ask your doctor for advice on how to proceed.

If you stop taking Repirol SR

Do not stop taking Repirol SR without consulting your doctor. You should only stop taking Repirol SR when your doctor tells you to.

If you suddenly stop taking Repirol SR, your Parkinson's symptoms may quickly get much worse.

When stopping Repirol SR, your doctor will reduce your dose gradually to prevent these symptoms.

4. Possible side effects

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

The risk of side effects is higher when you first start taking this medicine or when your dose is increased.

Side effects are usually mild and may become less troublesome after a few days of treatment.

If you are concerned about side effects, talk to your doctor.

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

• fainting;
• drowsiness;
• nausea.

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

• sudden onset of sleep;
• hallucinations;
• vomiting;
• dizziness;
• heartburn;
• abdominal pain;
• constipation;
• swelling of the legs, feet or hands.

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

• dizziness or fainting, especially when standing up (due to low blood pressure);
• hiccups;
• excessive drowsiness;
• mental health problems, such as confusion, delusions or paranoia.

Side effects with unknown frequency (frequency cannot be estimated from the available data)

• allergic reactions, such as a rash, itching or hives, swelling of the face, lips, tongue or throat, which may cause difficulty in breathing or swallowing;
• changes in liver function, which have been identified by blood tests;
• spontaneous erections;
• aggressive behaviour;
• excessive use of Repirol SR (an overwhelming desire to take more tablets than prescribed to control your movements, known as dopamine dysregulation syndrome);
• impulse control disorders, such as an overwhelming urge to gamble, excessive shopping or spending, binge eating or compulsive eating, or an increased sex drive, which may affect some people taking dopamine agonists like ropinirole;
• after stopping or reducing the dose of Repirol SR, you may experience side effects such as depression, apathy, anxiety, fatigue, sweating or pain (known as dopamine agonist withdrawal syndrome or DAWS).

Tell your doctor if you experience any of these behaviours, so that your doctor can discuss ways of managing or stopping the behaviour.

Taking Repirol SR with L-dopa

When taking Repirol SR with L-dopa, you may experience additional side effects, including:

• uncontrolled movements (dyskinesias), which are very common. These may occur when you first start taking Repirol SR. Tell your doctor, who may adjust the dose of your medicines;
• confusion (disorientation), which is common.

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.

5. How to store Repirol SR

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, bottle and carton after 'EXP'. The expiry date refers to the last day of that month.

Store in a cool, dry place, below 25°C.

HDPE bottle: after first opening, the shelf life 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 Repirol SR contains

The active substance of Repirol SR is ropinirole.

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

The other ingredients are:

• prolonged-release core: ammonio methacrylate copolymer type B, hypromellose (E464), sodium lauryl sulphate, copovidone, magnesium stearate (E572).
• coating:

What Repirol SR looks like and contents of the pack

Repirol SR 2 mg prolonged-release tablets: pink, round, biconvex, 6.8 ± 0.1 mm in diameter and 5.5 ± 0.2 mm in thickness.

Repirol SR 4 mg prolonged-release tablets: light brown, oval, biconvex, 12.6 x 6.6 ± 0.1 mm in diameter and 5.3 ± 0.2 mm in thickness.

Repirol SR 8 mg prolonged-release tablets: red, oval, biconvex, 19.2 x 10.2 ± 0.2 mm in diameter and 5.2 ± 0.2 mm in thickness.

Repirol SR is available in blisters (PVC/PCTFE/Aluminium) and HDPE bottles with a PP cap and a desiccant.

Repirol SR is available in pack sizes of 21, 28, 42, 56, 84 prolonged-release tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Bausch Health Ireland Limited

3013 Lake Drive

Citywest Business Campus

Dublin 24, D24PPT3

Ireland

Manufacturer

Pharmathen S.A.

6 Dervenakion Str,

153 51, Pallini, Attiki

Greece

Pharmathen International S.A.

Industrial Park Sapes

Rodopi Prefecture

Block No 5, Rodopi 69300

Greece

Bausch Health Poland sp. z o.o.

ul. Przemysłowa 2

35-959 Rzeszów

Bausch Health Poland sp. z o.o.

• ul. Kosztowska 21

41 – 409 Mysłowice

Poland

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Poland: Repirol SR

Date of last revision of the leaflet: June 2023