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
Please read this leaflet carefully before taking this medicine because it contains important
information for you.

• This medicine has been prescribed for a specific individual. Do not give it to others. This medicine may harm another person, even if their symptoms are the same.
• Keep this leaflet so that you can read it again if necessary.
• If you have any doubts, please consult your doctor or pharmacist.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet
1. What REQUIP is and what it is used for
2. Important information before taking 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 in REQUIP is ropinirole, which belongs to a group of medicines called dopamine
agonists. Dopamine agonists act in the brain similarly to a naturally occurring substance called dopamine.
REQUIP is used in the treatment of Parkinson's disease.
In patients with Parkinson's disease, certain areas of the brain have low levels of dopamine. Ropinirole acts like dopamine and thus helps to relieve the symptoms of Parkinson's disease.

2. Important information before taking REQUIP

Do not take REQUIP:

• if you are allergic to the active substance 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 doctor if any of these conditions apply to you.
Warnings and precautions
Before starting treatment with REQUIP, discuss with your doctor or pharmacist:

• if you are pregnant or think you may be pregnant,
• if you are breast-feeding,
• if you are under 18 years of age,
• if you have severe heart disease,
• if you have severe psychiatric disorders,
• if you have specific urges and/or behaviours (e.g. uncontrollable urge to gamble or increased sexual activity),
• if you have sugar intolerance (e.g. lactose).

If you experience symptoms such as depression, apathy, anxiety, fatigue, sweating or pain (known as
dopamine agonist withdrawal syndrome (DAWS)) after stopping or reducing the dose of ropinirole,
inform your doctor. If symptoms persist for longer than a few weeks, your doctor may decide to adjust
the dose of the medicine.
Inform your treating doctor if you, your family or caregiver notice the occurrence of sudden or any
unusual behaviours in you, and you are unable to resist an impulse, desire or urge to carry out certain
actions that may be harmful to you or others. This condition is known as impulse control disorders,
which may include behaviours such as: gambling addiction, compulsive eating or shopping, increased
sexual activity or more frequent thoughts and feelings with a sexual basis. Your doctor may decide to
adjust the dose or discontinue the medicine.
Tell your doctor if you or your family or caregiver notice episodes of excessive motor activity,
excitement or irritability (symptoms of mania). These may occur with or without symptoms of impulse
control disorders (see above). Your doctor may decide to adjust the dose or discontinue the medicine.
Tell your doctor if any of these conditions apply to you. Your doctor may decide that REQUIP is not
suitable for you or may recommend additional monitoring tests during treatment.
While taking REQUIP
Contact your doctor if you or a family member notice any unusual behaviours during treatment with
REQUIP (such as uncontrollable urge to gamble or increased libido and/or excessive sexual activity).
Your doctor may recommend adjusting the dose or discontinuing the medicine.
Driving and using machines
REQUIP may cause drowsiness. Sudden and uncontrollable drowsiness may occur, as well as sudden
and unexpected sleep attacks, not preceded by drowsiness.
Hallucinations (seeing, hearing or feeling things that are not actually present) may occur during
treatment with REQUIP. If you experience hallucinations, you should not drive or operate machinery.
If you suspect that such symptoms may occur: do not drive, do not operate machinery, or
perform any activity where feeling sleepy or falling asleep could put you or others at risk of serious
injury or death. Do not perform such activities until symptoms have resolved.
Talk to your doctor if this situation is a problem for you.
REQUIP and smoking tobacco
Inform your doctor if you start or stop smoking while taking REQUIP. Your doctor may need to
adjust the dose.
REQUIP and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking or have recently
taken, as well as any medicines you plan to take, including herbal remedies and other medicines
available without a prescription. Remember to inform your doctor if you start taking any other
medicine during treatment with REQUIP.
Some medicines may affect the action of REQUIP or increase the risk of adverse reactions. REQUIP
may also affect the action of other medicines.
These include:

• fluvoxamine (an antidepressant)
• medicines used for other psychiatric disorders, for example sulpiride
• HRT (hormone replacement therapy)
• metoclopramide, a medicine used to treat nausea and heartburn
• antibiotics ciprofloxacin and enoxacin
• any other medicines used for Parkinson's disease. Tell your doctor if you are taking or have recently taken any of these medicines.

Additional blood tests should be performed if you are taking the following medicines together
with REQUIP:

• Medicines belonging to the vitamin K antagonist group (used to reduce blood clotting), such as warfarin (Coumadin).

Taking REQUIP with food and drink
Taking REQUIP with food may reduce the likelihood of nausea and vomiting. Therefore, it is best to
take REQUIP with food.
Pregnancy and breast-feeding
REQUIP is not recommended during pregnancy, unless your doctor determines that the benefit to
the patient outweighs the risk to the unborn child. REQUIP is not recommended during breast-feeding,
as it may affect milk production in the patient.
Inform your doctor immediately if you are pregnant, think you may be pregnant, or plan to become
pregnant. Your doctor will also advise you if you are breast-feeding or plan to breast-feed. Your doctor
may recommend discontinuing REQUIP.
Important information about certain ingredients of REQUIP
REQUIP contains a small amount of a sugar called lactose. If you have previously been diagnosed
with intolerance to certain sugars, you should contact your doctor before taking this medicine.
Requip contains less than 1 mmol (23 mg) of sodium per tablet, i.e. the medicine is considered to be
"essentially sodium-free".

3. How to use REQUIP

This medicine should always be taken exactly as instructed by your doctor or pharmacist. If you
are unsure, consult your doctor or pharmacist again.
REQUIP may be used in the treatment of symptoms of Parkinson's disease either as monotherapy or
in combination with another medicine called L-dopa (also known as levodopa).
REQUIP must not be used in children. REQUIP is not intended for use in patients under 18 years of age.
What dose of REQUIP should be taken?
Finding the optimal dose may take time.
The usual starting dose is 0.25 mg of ropinirole three times a day for the first week. Then your doctor
will increase the dose weekly over a period of three weeks. Afterwards, your doctor will gradually
increase the dose until the optimal dose for you is reached. The usual dose is 1 mg to 3 mg three times
a day (total daily dose 3 mg to 9 mg). If sufficient control of symptoms of Parkinson's disease has not
been achieved, your doctor may decide to gradually increase the dose. Some patients receive up to
8 mg of REQUIP three times a day (total 24 mg per day).
If you are taking other medicines for Parkinson's disease, your doctor may recommend gradually
reducing the doses of those medicines. If you are taking L-dopa, involuntary movements (dyskinesias)
may occur when starting REQUIP. If these symptoms occur, inform your doctor, who may adjust the
doses of your medicines.
Do not take a higher dose of REQUIP than prescribed by your doctor.
It may take several weeks before the beneficial effect of REQUIP becomes apparent.
How to take REQUIP
REQUIP should be taken three times a day.
The tablet(s) should be swallowed with a glass of water. It is recommended to take REQUIP with
food, as this may reduce the likelihood of nausea.
Taking more REQUIP than prescribed
Seek immediate advice from your doctor or pharmacist. If possible, show the medicine packaging.
In a person who has taken more than the prescribed dose of REQUIP, symptoms such as nausea,
vomiting, dizziness, drowsiness, fatigue (mental or physical), fainting, or hallucinations may occur.
If you miss a dose of REQUIP
Do not take extra tablets or a double dose to make up for a missed dose. Take the next dose at the
usual time.
If you have not taken REQUIP for a day or longer, consult your doctor about restarting treatment
with REQUIP.
Stopping REQUIP treatment
Do not stop taking REQUIP unless your doctor tells you to do so.
REQUIP should be taken for as long as your doctor recommends. Do not stop unless instructed by
your doctor.
If REQUIP is stopped suddenly, symptoms of Parkinson's disease may worsen significantly. Abrupt
discontinuation may lead to a condition known as neuroleptic malignant syndrome, which can be a
serious health risk. Symptoms include: akinesia (loss of muscle movement), muscle rigidity, fever,
unstable blood pressure, tachycardia (rapid heartbeat), confusion, and reduced level of consciousness
(e.g. coma).
If it becomes necessary to discontinue REQUIP, your doctor will gradually reduce the dose.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although they do not occur in everyone.
Adverse effects of REQUIP may most commonly occur when starting treatment or
shortly after increasing the dose. Adverse effects are usually mild and tend to become less bothersome
after a short period of using the medicine. If you have any concerns about adverse effects, consult your doctor.

Very common adverse effects:
May occur in more than 1 in 10 patients taking REQUIP:

• fainting
• drowsiness
• nausea

Common adverse effects:
May occur in up to 1 in 10 patients taking REQUIP:

• hallucinations (seeing things that are not real)
• vomiting
• dizziness
• heartburn
• abdominal pain
• swelling of legs, feet and hands

Uncommon adverse effects:
May occur in up to 1 in 100 patients taking REQUIP:

• dizziness or fainting, especially when suddenly changing to an upright position (related to low blood pressure)
• low blood pressure (hypotension)
• severe daytime sleepiness (irresistible sleepiness)
• sudden onset of sleep without prior warning signs (sudden sleep attacks)
• psychiatric disorders such as delirium (acute confusion), delusions (irrational thoughts) or paranoia (unfounded suspicion)
• hiccups

In some patients the following adverse effects may occur (frequency unknown:
cannot be estimated from available data):

• allergic reactions such as red, itchy swellings on the skin (urticaria), swelling of the face, lips, mouth, tongue or throat, which may cause difficulty in swallowing or breathing, rash or intense itching (see section 2)
• aggression
• compulsive use of REQUIP (uncontrollable urge to take high doses of dopaminergic medicines, higher than necessary to control motor symptoms, known as dopamine dysregulation syndrome)
• after stopping or reducing the dose of REQUIP, symptoms such as depression, apathy, anxiety, lack of energy, sweating or pain may occur (referred to as dopamine agonist withdrawal syndrome or DAWS)
• changes in liver function observed in blood tests
• spontaneous erection

The following adverse effects may also occur:

• inability to resist impulses, urges or desires to perform actions that may be harmful to oneself or others, including:
  • strong urge to gamble despite serious personal or family consequences.
  • altered or increased interest in sex and behaviors causing concern to the patient and others, e.g. increased sexual drive.
  • uncontrollable urge to shop and spend money.
  • excessive eating (consuming large amounts of food in a short time) or compulsive eating (eating more food than needed to satisfy hunger).
• episodes of excessive physical activity, excitement and irritability

Contact your doctor immediately if any of these behaviors occur in the patient,
to discuss ways to reduce or eliminate these symptoms.

Taking REQUIP in combination with L-dopa
In patients taking REQUIP with L-dopa, other adverse effects may occur over time:

• involuntary movements (dyskinesias) are a very common adverse effect. If the patient is taking L-dopa, involuntary movements (dyskinesias) may occur when starting REQUIP. If these symptoms occur, inform your doctor, who may adjust the doses of medicines being taken.
• feeling of disorientation is a common adverse effect.

Reporting of adverse effects
If any adverse effects occur, including any not listed
in this leaflet, tell 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, tel.: +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 authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store REQUIP

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Do not store above 25 °C. Store in the original packaging to protect from light.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What REQUIP contains
The active substance in REQUIP is ropinirole.
Each coated tablet contains 0.25 mg, 0.5 mg, 1 mg, 2 mg, or 5 mg of ropinirole (as hydrochloride).
Other ingredients in the medicine are:

• Tablet core: lactose monohydrate, microcrystalline cellulose, sodium croscarmellose (type A), magnesium stearate.
• Coating: 0.25 mg tablets: hypromellose, polyethylene glycol 400, titanium dioxide (E171), polysorbate 80 (E433). 0.5 mg tablets: hypromellose, polyethylene glycol 400, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), indigo carmine (E132). 1 mg tablets: hypromellose, polyethylene glycol 400, titanium dioxide (E171), yellow iron oxide (E172), indigo carmine (E132). 2 mg tablets: hypromellose, polyethylene glycol 400, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172).

5 mg tablets: hypromellose, polyethylene glycol 400, titanium dioxide (E171), indigo carmine (E132),
polysorbate 80 (E433).

What REQUIP looks like and contents of the pack
Film-coated pentagon-shaped tablets with the imprint “SB” on one side.
REQUIP 0.25 mg: white tablets with the imprint “4890” on the other side.
REQUIP 0.5 mg: yellow tablets with the imprint “4891” on the other side.
REQUIP 1 mg: green tablets with the imprint “4892” on the other side.
REQUIP 2 mg: pink tablets with the imprint “4893” on the other side.
REQUIP 5 mg: blue tablets with the imprint “4894” on the other side.
0.25 mg tablets: packs containing 21, 84, or 210 tablets in blister packs.
0.5 mg tablets: packs containing 21 tablets in blister packs.
1 mg, 2 mg, and 5 mg tablets: packs containing 21 or 84 tablets in blister packs.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
GlaxoSmithKline Trading Services Limited
12 Riverwalk
Citywest Business Campus
Dublin 24
D24 YK11
Ireland

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

This medicinal product is authorised in the European Economic Area under the following names:
Austria, Belgium, France, Germany, Ireland, Italy, Luxembourg, Malta, Netherlands, Poland, Spain, and Sweden: REQUIP.

For further information, please contact the Marketing Authorisation Holder's representative:
GSK Services Sp. z o.o.
tel. +48 22 576 90 00

Date of latest revision: January 2025