Requip

Package Leaflet: Information for the User

REQUIP 0.25 mg coated tablets

REQUIP 0.5 mg coated tablets

REQUIP 1 mg coated tablets

REQUIP 2 mg coated tablets

REQUIP 5 mg coated tablets

Ropinirole

Read all of this leaflet carefully before taking this medicine because it contains important information for you.

• 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.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• 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 REQUIP is and what it is used for

2. Before you take REQUIP

3. How to take REQUIP

4. Possible side effects

5. How to store REQUIP

6. Contents of the pack and other information

1. What REQUIP is and what it is used for

The active substance of REQUIP is ropinirole, which belongs to a group of medicines called dopamine agonists. Dopamine agonists work in the brain in a similar way to a natural substance called dopamine.

REQUIP is used to treat Parkinson's disease.

In patients with Parkinson's disease, certain parts of the brain become less active and there is a decrease in the amount of dopamine. Ropinirole works by stimulating the brain to make more dopamine to help control the symptoms of Parkinson's disease.

2. Before you take REQUIP

Do not take REQUIP:

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

Tell your doctorif you have any of these conditions.

Warnings and precautions

Before taking REQUIP, 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 severe mental health problems
• you have a history of unusual impulses or behaviours
• you have intolerance to some sugars (e.g. lactose)

If you experience any of the following side effects after stopping or reducing the dose of REQUIP, tell your doctor: depression, apathy, anxiety, fatigue, sweating, or pain (called dopamine agonist withdrawal syndrome or DAWS). If these symptoms persist for more than a few weeks, your doctor may decide to adjust your dose.

While taking REQUIP

Tell your doctor if you or a family member notice any unusual behaviours while taking REQUIP, such as an uncontrollable urge to gamble or increased sexual desire.

Driving and using machines

REQUIP can cause drowsiness. Excessive drowsinessand sudden sleep attacks can occur. If you experience hallucinations, do not drive or operate machinery.

Taking REQUIP with food and drink

Taking REQUIP with food may reduce the chance of feeling sick or being sick.

Pregnancy and breast-feeding

REQUIP is not recommended during pregnancyunless your doctor advises that the benefits outweigh the risks. REQUIP is not recommended during breast-feedingas it may affect milk production.

Important information about some of the ingredients of REQUIP

REQUIP contains a small amount of 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 medicine.

3. How to take REQUIP

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

How much REQUIP to take:

The usual starting dose is 0.25 mg of ropinirole three times a day for the first week. Your doctor will then increase your dose every week for three weeks. Your doctor will then adjust your dose until you reach the dose that is best for you.

What to do if you take more REQUIP than you should:

See a doctor or pharmacist immediately. If possible, show them the REQUIP pack. If you take more REQUIP than you should, you may experience nausea, vomiting, dizziness, drowsiness, confusion, or hallucinations.

What to do if you forget to take REQUIP:

Do not take a double dose to make up for a forgotten dose. Take your next dose at the usual time.

What to do if you stop taking REQUIP:

Do not stop taking REQUIP without talking to your doctor first. If you stop taking REQUIP, your Parkinson's symptoms may get worse.

4. Possible side effects

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

Very common side effects:

May affect more than 1 in 10 people taking REQUIP:

• dizziness
• drowsiness
• nausea

Common side effects:

May affect up to 1 in 10 people taking REQUIP:

• hallucinations
• vomiting
• dizziness
• heartburn
• abdominal pain
• swelling of the legs, feet, and hands

Uncommon side effects:

May affect up to 1 in 100 people taking REQUIP:

• dizziness or fainting, especially when standing up
• low blood pressure
• excessive drowsiness
• sudden sleep attacks
• mental health problems such as confusion, delusions, or paranoia
• hiccups

Other side effects:

• impulse control disorders such as strong urges to gamble, increased sexual desire, or uncontrolled spending
• episodes of excessive excitement, agitation, or aggression

Tell your doctor immediately if you experience any of these behaviours

Taking REQUIP with L-dopa

When taking REQUIP with L-dopa, you may experience other side effects:

• involuntary movements (dyskinesias) are very common
• feeling disoriented 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 REQUIP

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 carton.

Do not store above 25°C. Store in the original package to protect from light.

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 REQUIP contains

The active substance is ropinirole.

• Core:lactose monohydrate, microcrystalline cellulose, croscarmellose sodium (type A), magnesium stearate
• Coating:hypromellose, macrogol 400, titanium dioxide (E171), polysorbate 80 (E433)

What REQUIP looks like and contents of the pack

REQUIP 0.25 mg: white tablets with "4890" on one side.

REQUIP 0.5 mg: yellow tablets with "4891" on one side.

REQUIP 1 mg: green tablets with "4892" on one side.

REQUIP 2 mg: pink tablets with "4893" on one side.

REQUIP 5 mg: blue tablets with "4894" on one side.

Marketing Authorisation Holder and Manufacturer

GlaxoSmithKline Trading Services Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, D24 YK11, Ireland

Glaxo Wellcome S.A., Avenida de Extremadura 3, 09400 Aranda de Duero, Burgos, Spain

This medicine is authorised in the Member States of the European Economic Area

Austria, Belgium, France, Germany, Ireland, Italy, Luxembourg, Malta, Netherlands, Poland, Spain, and Sweden: REQUIP

Date of last revision:January 2025