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

Before taking the medicine, you should read the contents of this leaflet carefully, as it contains important information for the patient.

• You should keep this leaflet, so you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

• 1. What Repirol SR is and what it is used for
• 2. Important information before taking 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 brain function in a similar way to a naturally occurring substance called dopamine.

Repirol SR prolonged-release tablets are used to treat

Parkinson's disease.

In patients with Parkinson's disease, there is a low level of dopamine in some parts of the brain. Ropinirole works in a similar way to natural dopamine and helps to alleviate the symptoms of Parkinson's disease.

2. Important information before taking Repirol SR

When not to take Repirol SR

• if the patient is allergicto ropinirole or any of the other ingredients of Repirol SR (listed in section 6);
• if the patient has severe kidney disease;
• if the patient has liver disease.

The patient should inform their doctor about these circumstances.

Warnings and precautions

Before starting to take Repirol SR, the patient should discuss with their doctor or pharmacist:

• if the patient is pregnantor thinks they may be pregnant;
• if the patient is breast-feeding;
• if the patient is under 18 years old;
• if the patient has severe heart disease;
• if the patient has severe mental disorders;
• if the patient has had unusual impulses and/or behaviors(see section 4);
• if the patient has intolerance to some sugars(e.g., lactose).

The patient should consult their doctor if they, their caregiver, or their family notice that they have developed unusual behaviors (such as an uncontrollable urge or desire to engage in behaviors that may harm themselves or others). This is called impulse control disorder and may include behaviors such as compulsive gambling, overeating, or excessive spending.

While taking Repirol SR

The patient should contact their doctor if they or a family member notice any unusual behaviorswhile taking Repirol SR (such as an uncontrollable urge to gamble or increased libido and/or hypersexuality). The doctor may adjust the dose or stop the medicine.

Repirol SR and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking or have recently taken, including herbal medicines and other medicines available without a prescription.

• antidepressant fluvoxamine
• medicines used in other mental disorders, e.g., sulpiride
• HRT (hormone replacement therapy)
• metoclopramideused to treat nausea and heartburn
• antibiotics ciprofloxacinor enoxacin
• any other medicines used to treat Parkinson's disease.

The patient should inform their doctor if they are taking or have recently taken any of these medicines.

Smoking and Repirol SR

The patient should inform their doctor if they start or stop smoking while taking Repirol SR. The doctor may need to adjust the dose.

Taking Repirol SR with food and drink

Repirol SR can be taken with or without food, as preferred by the patient.

Pregnancy, breast-feeding, and fertility

Repirol SR should not be used during pregnancy, unless the doctor considers that the benefits to the mother outweigh the risks to the unborn child. Repirol SR should not be used during breast-feeding, as it may affect milk production.

It has not been shown that Repirol SR affects fertility in humans. If the patient is pregnant, breast-feeding, thinks they may be pregnant, or plans to have a baby, they should ask their doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Repirol SR may cause drowsiness. Uncontrollable drowsiness may occur, and sometimes sudden and unanticipated episodes of sleep without prior warning of drowsiness. If these symptoms occur, the patient should not drive, operate machinery, and should notperform tasks that could put themselves or others at risk of serious injury or death. The patient should not perform these tasks until the symptoms have resolved.

During treatment with ropinirole, hallucinations (seeing, hearing, or feeling things that are not there) may occur. If the patient experiences hallucinations, they should not drive or operate machinery.

The patient should inform their doctor if they think this situation applies to them.

This medicine contains less than 1 mmol sodium (23 mg) per dose, which is essentially "sodium-free".

3. How to take Repirol SR

This medicine should always be taken exactly as prescribed by the doctor or pharmacist.If the patient is unsure, they should consult their doctor or pharmacist.

Repirol SR can be used to treat the symptoms of Parkinson's disease as a single medicine or in combination with another medicine called L-dopa (also known as levodopa). If the patient is taking L-dopa, they may experience uncontrolled movements (dyskinesias) when starting treatment with Repirol SR. If these symptoms occur, the patient should inform their doctor, who may adjust the doses of the medicines they are taking.

What dose of Repirol SR to take

It may take some time to establish the correct dose of Repirol SR.

The recommended starting doseof Repirol SR is 2 mg once daily for the first week. From the second week onwards, the doctor may increase the dose to 4 mg once daily. If the patient is elderly, the doctor may prescribe a slower dose increase. The doctor will then adjust the dose until the most suitable dose for the patient is found.

Some patients may take doses up to 24 mg of Repirol SR once daily.

If the patient experiences intolerable side effects at the start of treatment, they should inform their doctor. The doctor may recommend changing the treatment to ropinirole immediate-release tablets in smaller doses taken three times a day.

Use in children and adolescents

Repirol SR should not be given to children.Repirol SR is not intended for use in people under 18 years old.

Do not take more Repirol SR than prescribed by the doctor.

It may take several weeks for the beneficial effects of Repirol SR to appear.

Taking the dose of Repirol SR

Repirol SR should be taken once daily at the same time each day.

Repirol SR prolonged-release tablets should be swallowed whole, with a glass of water.

The tablets (tablets) should not be broken, chewed, or crushed, as this may lead to overdosing, as the medicine is released too quickly into the body.

Switching from immediate-release tablets

The doctor will determine the dose of Repirol SR based on the total daily dose of ropinirole previously taken in the form of immediate-release tablets. On the day before switching, the patient should take their usual dose of ropinirole immediate-release tablets. The next morning, they should take Repirol SR and not take ropinirole immediate-release tablets anymore.

Taking more Repirol SR than prescribed

The patient should immediately consult their doctor or pharmacist.If possible, they should show the packaging of Repirol SR.

Symptoms of overdosing on Repirol SR may include: nausea (vomiting), vomiting, dizziness (feeling of spinning), drowsiness, mental fatigue, or physical fatigue, fainting, hallucinations.

Missing a dose of Repirol SR

The patient should not takean extra dose or a double dose of the prolonged-release tablets to make up for a missed dose.

If the patient misses a dose of Repirol SR for a day or longer, they should consult their doctor for advice on restarting Repirol SR.

Stopping treatment with Repirol SR

The patient should not suddenly stop taking Repirol SR without consulting their doctor first.

Repirol SR should be taken for as long as the doctor recommends.The patient should not stop taking the medicine without their doctor's advice.

If the patient suddenly stops taking Repirol SR, their Parkinson's disease symptoms may worsen rapidly. Suddenly stopping this medicine may cause a condition called neuroleptic malignant syndrome, which can be life-threatening. Symptoms include: akinesia (inability to move), muscle stiffness, fever, unstable blood pressure, tachycardia (rapid heart rate), disorientation, and impaired consciousness (e.g., coma).

If the doctor needs to stop Repirol SR, they will gradually reduce the dose.

If the patient has any further doubts about taking the medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Repirol SR can cause side effects, although not everybody gets them. The risk of side effects is higher at the start of the first treatment and immediately after increasing the dose.

Side effects are usually mild and may become less troublesome after some time on the medicine. If the patient is concerned about side effects, they should talk to their doctor.

Very common side effects

• fainting;
• drowsiness;
• nausea (vomiting).

Common side effects

• sudden onset of sleep without prior warning of drowsiness (sudden sleep attacks);
• hallucinations (seeing things that are not there);
• vomiting;
• dizziness (feeling of spinning);
• heartburn;
• abdominal pain;
• constipation;
• swelling of the feet, ankles, or hands.

Uncommon side effects

• dizziness or fainting, especially when standing up quickly (due to low blood pressure);
• hiccups;
• excessive drowsiness during the day (extreme drowsiness);
• mental disorders, such as: confusion (severe confusion), delusions (unreasonable thoughts), or paranoia (unjustified suspicion).

Side effects with unknown frequency

• allergic reactions, such as: red, itchy skin changes with swelling (hives), swelling of the face, lips, mouth, tongue, or throat, which may cause difficulty swallowing or breathing; rash or severe itching (see section 2);
• changes in liver functionshown in blood tests;
• spontaneous erections;
• aggressive behavior.
• excessive use of Repirol SR (desire to take large doses of dopaminergic medicines in excess of those needed to control motor symptoms, called dopamine dysregulation syndrome);
• inability to resist an impulse, temptation, or drive to perform an action that may be harmful to the patient or others; this includes: strong impulse to gamble excessively, despite significant personal or family consequences; altered or increased sexual interest and behavior of importance to the patient or others, e.g., increased libido; uncontrolled spending; binge eating (eating large amounts of food in a short time) or compulsive eating (eating more food than normal and more than needed to satisfy hunger);
• after stopping or reducing the dose of Repirol SR, the following may occur: depression, apathy, anxiety, fatigue, sweating, or pain (known as dopamine agonist withdrawal syndrome or DAWS).

The patient should inform their doctor if they exhibit any of these behaviors to discuss ways to control or limit the symptoms.

Taking Repirol SR with L-dopa

Over time, patients taking Repirol SR with L-dopa may experience other side effects, including:

• uncontrolled movements (dyskinesias) - a very common side effect. In patients taking L-dopa, these may occur at the start of treatment with Repirol SR. If these symptoms occur, the patient should inform their doctor, who may adjust the doses of the medicines they are taking;
• feeling disoriented (confused) - a common side effect.

Reporting side effects

If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Ministry of Health, via the website https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder.

5. How to store Repirol SR

The medicine should be stored out of sight and reach of children.

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

Do not store above 25°C.

HDPE bottle: the shelf life after first opening is 60 days.

Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer need. This 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 tablet core: ammonio methacrylate copolymer type B, hypromellose (E464), sodium lauryl sulfate, 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 thick.

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 thick.

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 thick.

Repirol SR in all strengthsis available in PVC/PCTFE/Aluminum blisters and HDPE bottles with a PP cap and a desiccant.

Package sizes:

Blister: 21, 28, 42, 56, 84 prolonged-release tablets

Bottle: 21, 28, 42, 56, 84 prolonged-release tablets

Not all pack sizes may be marketed.

Marketing authorization 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 authorized 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