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
Please read the entire leaflet before taking this medicine, as it contains important information
for the patient.

• Keep this leaflet for future reference.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your 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 in Repirol SR is ropinirole, which belongs to a group of medicines called dopamine agonists. Dopamine agonists affect brain function in a similar way to the naturally occurring substance called dopamine.
Repirol SR prolonged-release tablets are used in the treatment of Parkinson's disease.
In patients with Parkinson's disease, certain parts of the brain have low levels of dopamine. Ropinirole works in a similar way to naturally occurring dopamine and thus helps to relieve the symptoms of Parkinson's disease.

2. Important Information Before Using Repirol SR

When not to use Repirol SR

• if the patient is allergic to 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.

You should inform your doctor if any of these circumstances apply.
Warnings and precautions
Before starting treatment with Repirol SR, discuss the following with your doctor or pharmacist:

• if the patient is pregnant or suspects she may be pregnant;
• if the patient is breastfeeding;
• if the patient is under 18 years of age;
• if the patient has severe heart disease;
• if the patient has severe psychiatric disorders;
• if the patient has experienced unusual urges and/or behaviours (see section 4);
• if the patient has intolerance to certain sugars (e.g. lactose).

Contact your doctor if the patient, caregiver, or family members notice the emergence of uncontrollable urges or compulsions to engage in unusual behaviours, and the patient is unable to resist impulses, compulsions, or drives to perform actions that could harm the patient or others. This is known as impulse control disorder and may include behaviours such as gambling addiction, excessive eating or spending, increased sexual drive, or intensified sexual thoughts and feelings. The doctor may recommend adjusting the dose or discontinuing treatment.

If the patient experiences symptoms such as depression, apathy, anxiety, fatigue, sweating, or pain after stopping or reducing the dose of ropinirole—referred to as dopamine agonist withdrawal syndrome (DAWS)—you should inform the doctor. If symptoms persist for longer than a few weeks, the doctor may decide to modify the dosage of the medication.

Before using Repirol SR, inform your doctor:
Inform your doctor if you suspect this situation applies. The doctor may decide that Repirol SR is not suitable for the patient or may recommend additional monitoring during treatment.

While using Repirol SR
Contact your doctor if the patient or a family member observes any unusual behaviours during treatment with Repirol SR (such as uncontrollable urge to gamble or increased drive and/or excessive sexual activity). The doctor may recommend adjusting the dose or discontinuing the medication.

Repirol SR and other medicines
Tell your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines the patient plans to take, including herbal remedies and other over-the-counter medicines.

Remember to inform your doctor or pharmacist if starting a new medicine while taking Repirol SR.

Some medicines may affect how Repirol SR works or increase the likelihood of side effects. Repirol SR may also affect how other medicines work.

These include:

• the antidepressant fluvoxamine
• medicines used for other psychiatric disorders, e.g. sulpiride
• HRT (hormone replacement therapy)
• metoclopramide, used to treat nausea and indigestion
• antibiotics ciprofloxacin or enoxacin
• any other medicines used in the treatment of Parkinson's disease.

Inform your doctor if you are currently or have recently taken any of the above medicines.

When taking the following medicines with Repirol SR, additional blood tests may be required:

• vitamin K antagonists (medicines used to reduce blood clotting), e.g. warfarin (coumarin).

Smoking and Repirol SR
Inform your doctor if you start or stop smoking while taking Repirol SR. The doctor may need to adjust the dose of the medicine.

Taking Repirol SR with food and drink
Repirol SR may be taken with or without food, according to the patient's preference.

Pregnancy, breastfeeding and fertility
Repirol SR is not recommended during pregnancy unless the doctor considers that the benefits to the patient outweigh the risks to the unborn child. Repirol SR is not recommended during breastfeeding, as it may affect milk production.

No effect of Repirol SR on fertility in humans has been observed.

If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine. The doctor will also provide advice regarding breastfeeding or plans to breastfeed. The doctor may recommend discontinuing treatment with Repirol SR.

Driving and operating machinery
Repirol SR may cause drowsiness. Sudden and uncontrollable sleepiness may occur, and sometimes sudden, unexpected episodes of falling asleep without prior warning of sleepiness.

If such symptoms occur: do not drive, operate machinery, or perform any activities where drowsiness or falling asleep could put the patient (or others) at risk of serious injury or death. Do not perform such activities until symptoms have resolved.

Hallucinations (seeing, hearing, or sensing things that are not actually present) may occur during treatment with ropinirole. If the patient experiences hallucinations, they should not drive or operate machinery.

Inform your doctor if you suspect this situation applies.

This medicine contains less than 1 mmol sodium (23 mg) per dose, therefore it can be considered essentially "sodium-free".

Repirol SR 2 mg
Repirol SR 2 mg prolonged-release tablets contain a sugar called lactose. If the patient has previously been diagnosed with intolerance to certain sugars, consult a doctor before taking this medicine.

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

3. How to use Repirol SR
This medicine should always be used exactly as prescribed by the doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Repirol SR may be used in the treatment of Parkinson's disease symptoms either as monotherapy or in combination with another medicine called L-dopa (also known as levodopa). If the patient is taking L-dopa, uncontrolled movements (dyskinesias) may occur at the beginning of treatment with Repirol SR. If such symptoms occur, inform the doctor, who may adjust the doses of the medicines the patient is taking.

Repirol SR prolonged-release tablets have been designed to release the medicine over 24 hours. If the patient has a condition that may cause the medicine to pass through the body too quickly, e.g. diarrhoea, the tablet may not dissolve completely and the medicine may not work properly. Tablets may then be visible in the stool. If this occurs, inform your doctor immediately.

What dose of Repirol SR should be taken
Finding the appropriate dose of Repirol SR may take time.

The recommended starting dose of Repirol SR prolonged-release tablets is 2 mg once daily during the first week of treatment. From the second week of therapy, the doctor may increase the dose of Repirol SR prolonged-release tablets to 4 mg once daily. If the patient is elderly, the doctor may recommend a slower dose escalation. The doctor may then adjust the dose until the most appropriate dose for the patient is reached. Some patients may require doses up to 24 mg of Repirol SR prolonged-release tablets per day.

If intolerable side effects occur at the beginning of treatment, inform the doctor. The doctor may recommend switching treatment to ropinirole immediate-release tablets taken in smaller doses three times daily.

Use in children and adolescents
Repirol SR must not be given to children. Repirol SR is not intended for use in individuals under 18 years of age.

Do not take a higher dose of Repirol SR than prescribed by the doctor.
It may take several weeks before the beneficial effects of Repirol SR become apparent.

How to take Repirol SR
Repirol SR should be taken once daily at the same time each day.
Repirol SR prolonged-release tablets must be swallowed whole with a glass of water.
Do not break, chew, or crush prolonged-release tablets due to the risk of overdose, as this would cause the medicine to be released too quickly into the body.

Switching from immediate-release coated tablets to prolonged-release tablets
The doctor will determine the dose of Repirol SR prolonged-release tablets based on the total previous daily dose of ropinirole taken as immediate-release tablets. On the day before switching treatment, take the usual dose of immediate-release ropinirole tablets. The next morning, take the first dose of Repirol SR prolonged-release tablets and discontinue further use of immediate-release ropinirole tablets.

Taking more Repirol SR than prescribed
Contact your doctor or pharmacist immediately. If possible, show the Repirol SR packaging.

Symptoms of overdose may include: nausea, vomiting, dizziness (spinning sensation), drowsiness, mental fatigue or physical exhaustion, fainting, hallucinations.

Missing a dose of Repirol SR
Do not take an extra or double dose of the prolonged-release tablets to make up for a missed dose.
If a dose of Repirol SR has been missed for one day or longer, consult your doctor for advice on resuming treatment.

Stopping treatment with Repirol SR
Do not suddenly stop taking Repirol SR without first consulting your doctor. Repirol SR should be taken for as long as prescribed by the doctor. Do not discontinue treatment without medical advice.

Suddenly stopping Repirol SR may cause a rapid and significant worsening of Parkinson's disease symptoms. Abrupt discontinuation may also lead to a condition known as neuroleptic malignant syndrome, which can be life-threatening. Symptoms include: akinesia (lack of muscle movement), muscle rigidity, fever, unstable blood pressure, tachycardia (rapid heartbeat), disorientation, and disturbances in consciousness (e.g. coma).

If treatment with Repirol SR needs to be discontinued, the doctor will gradually reduce the dose.

If you have any further questions about using this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
The likelihood of adverse effects associated with the use of Repirol SR is increased at the beginning of initial treatment and immediately after increasing the dose of the medicine.
Adverse effects are usually mild and may become less troublesome over time after starting treatment.
If you have any concerns about adverse effects, consult your doctor.

Very common adverse effects
Adverse effects that may occur in more than 1 out of 10 people taking Repirol SR:

• fainting;
• drowsiness;
• nausea.

Common adverse effects
Adverse effects that may occur in up to 1 out of 10 people taking Repirol SR:

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

Uncommon adverse effects
Adverse effects that may occur in up to 1 out of 100 people taking Repirol SR:

• dizziness or fainting, particularly when suddenly changing to an upright position (due to low blood pressure);
• hiccups;
• excessive daytime sleepiness (severe somnolence);
• psychiatric disorders such as: delirium (severe confusion), delusions (irrational thoughts), or paranoia (unfounded suspicion).

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

• allergic reactions such as: red, itchy skin rash with swelling (urticaria), swelling of the face, lips, mouth, tongue, or throat, which may cause difficulty in swallowing or breathing; skin rash or severe itching (see section 2);
• liver function abnormalities detected in blood tests;
• spontaneous erection;
• aggressive behaviour;
• excessive use of Repirol SR (craving for high doses of dopaminergic drugs, exceeding what is necessary to control motor symptoms, known as dopamine dysregulation syndrome);
• inability to resist an impulse, urge, or compulsion to perform acts that may be harmful to the patient or others; this includes:
  • a strong urge to engage in uncontrolled gambling, despite serious personal or family consequences;
  • altered or increased sexual interests and behaviours of significance to the patient or others, e.g. increased libido;
  • uncontrolled spending or shopping;
  • binge eating (consuming large amounts of food in a short time) or compulsive eating (eating more food than normal and more than needed to satisfy hunger);
• upon stopping or reducing the dose of Repirol SR, symptoms such as depression, apathy, anxiety, fatigue, sweating, or pain may occur (referred to as dopamine agonist withdrawal syndrome or DAWS).

You should inform your doctor if the patient exhibits any of these behaviours, so that ways of managing or reducing the symptoms can be discussed.

Use of Repirol SR in combination with L-dopa
Over time, the following additional adverse effects may occur in patients taking Repirol SR together with L-dopa:

• uncontrolled movements (dyskinesias) – a very common adverse effect. These may occur at the beginning of initial treatment with Repirol SR in patients taking L-dopa. In such cases, inform your doctor, who may adjust the doses of the medicines being taken;
• feeling of disorientation (confusion) – a common adverse effect.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products.
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store Repirol SR

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister, on the bottle, and on the
cardboard box. The expiry date refers to the last day of the specified month.
Do not store above 25°C.
HDPE bottle: the shelf life after first opening is 60 days.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Repirol SR contains
The active substance in Repirol SR is ropinirole.
One prolonged-release tablet contains 2 mg, 4 mg, or 8 mg of ropinirole (as ropinirole hydrochloride).
Other ingredients in the medicine are:

• core of the prolonged-release tablet: methacrylic acid 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 tablets
with a diameter of 6.8 ± 0.1 mm and thickness of 5.5 ± 0.2 mm.
Repirol SR, 4 mg, prolonged-release tablets: light brown, oval, biconvex tablets
with dimensions of 12.6 x 6.6 ± 0.1 mm and thickness of 5.3 ± 0.2 mm.
Repirol SR, 8 mg, prolonged-release tablets: red, oval, biconvex tablets
with dimensions of 19.2 x 10.2 ± 0.2 mm and thickness of 5.2 ± 0.2 mm.
Repirol SR in all strengths is available in PVC/PCTFE/Aluminium blisters and in HDPE bottles
with a PP screw cap, security seal, and desiccant.
Pack 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 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 European Economic Area countries under the following names:
Poland: Repirol SR