Requip modutab

Package leaflet: Information for the user

Requip-Modutab, 2 mg, prolonged-release tablets
Requip-Modutab, 4 mg, prolonged-release tablets
Requip-Modutab, 8 mg, prolonged-release tablets
Ropinirole
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.
 This medicine has been prescribed for a specific individual only. Do not give it to others.
This medicine may harm others, even if their symptoms are the same.
 Keep this leaflet so that you can read it again if necessary.
 If you have any further questions, please consult your doctor or pharmacist.
 If you experience any adverse reactions, including any adverse reactions not listed in
this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents

1. What Requip-Modutab is and what it is used for
2. What you need to know before taking Requip-Modutab
3. How to take Requip-Modutab
4. Possible side effects
5. How to store Requip-Modutab
6. Contents of the pack and other information

1. What Requip-Modutab is and what it is used for

The active substance in Requip-Modutab 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-Modutab 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 acts like naturally occurring dopamine in the brain and thus helps to relieve the symptoms of Parkinson's disease.

2. Important Information Before Using Requip-Modutab

When not to use Requip-Modutab:

• if the patient has hypersensitivity to the active substance or to any of the other components of this medicine (listed in section 6)
• if the patient has severe kidney disease
• if the patient has liver disease. Please inform your doctor if any of these conditions apply.

Warnings and precautions

Before starting treatment with Requip-Modutab, 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 mental disorders
• if the patient has unusual urges or (and) behaviors (see section 4)
• if the patient has sugar intolerance (e.g. lactose intolerance). If the patient experiences 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 the doctor. If symptoms persist for more than a few weeks, the doctor may decide to adjust the dose of the medicine. Inform the doctor if the patient, a family member, or caregiver notices new urges or behaviors not previously observed in the patient, and that the patient cannot resist the impulse, drive, or temptation to carry out certain actions that could harm themselves or others. This condition is known as impulse control disorders and may include behaviors such as compulsive gambling, excessive eating or spending, increased sexual drive, or intensified sexual thoughts or feelings. The doctor may consider it necessary to adjust the dose or discontinue the medicine. Inform the doctor if the patient or their family or caregiver notice episodes of excessive activity, excitement, or irritability (symptoms of mania). These may occur with or without symptoms of impulse control disorders (see above). The doctor may decide to adjust the dose or discontinue the medicine.

Please inform your doctor if any of these conditions occur. The doctor may decide that Requip-Modutab is not suitable for the patient or may recommend additional monitoring tests during treatment.

While taking Requip-Modutab

Contact your doctor if the patient or a family member observes any unusual behaviors during treatment with Requip-Modutab (such as uncontrollable urge to gamble or increased sexual drive and/or excessive sexual activity). The doctor may recommend adjusting the dose or discontinuing the medicine.

Smoking and Requip-Modutab

Please inform your doctor if you start or stop smoking while taking Requip-Modutab. The doctor may need to adjust the dose.

Requip-Modutab and other medicines

Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, including herbal medicines and other medicines available without a prescription.
Remember to inform your doctor or pharmacist if you start taking any other medicine during treatment with Requip-Modutab.
Some medicines may affect the action of Requip-Modutab or increase the risk of side effects. Requip-Modutab may also affect the action of other medicines.

These include:

• fluvoxamine (an antidepressant)
• medicines used for other psychiatric disorders, such as 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. Please inform your doctor if the patient is taking or has recently taken any of these medicines. Additional blood tests should be performed if the patient is taking the following medicines together with Requip-Modutab:
• Vitamin K antagonists (used to reduce blood clotting), such as warfarin (Coumadin).

Requip-Modutab with food and drink

Requip-Modutab can be taken with or without food, according to the patient's preference.

Pregnancy and breastfeeding

Requip-Modutab is not recommended during pregnancy unless the doctor determines that the benefit to the patient outweighs the risk to the unborn child. Requip-Modutab is not recommended during breastfeeding, as it may affect milk production.

Please inform your doctor immediately if the patient is pregnant, suspects she may be pregnant, or plans to become pregnant. The doctor will also provide advice if the patient is breastfeeding or planning to breastfeed. The doctor may recommend discontinuing Requip-Modutab.

Driving and operating machinery

Requip-Modutab may cause drowsiness. Sudden and overwhelming sleepiness may occur, sometimes accompanied by sudden and unexpected sleep attacks without prior warning of drowsiness.

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

If there is suspicion that such symptoms may occur: do not drive, operate machinery, or perform any activities where drowsiness or falling asleep could place the patient (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 concern for the patient.

Important information about some ingredients of Requip-Modutab

Requip-Modutab contains a sugar called lactose. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult their doctor before taking this medicine.

The 4 mg prolonged-release tablets contain the colouring agent E110 (Orange-Yellow FCF), which may cause allergic reactions.

Requip-Modutab contains less than 1 mmol (23 mg) of sodium per tablet; therefore, this medicine is considered "sodium-free".

3. How to use Requip-Modutab

This medicine should always be used exactly as directed by your doctor. If you have any doubts,
you should consult your doctor or pharmacist.
Requip-Modutab must not be used in children. Requip-Modutab is not intended for use in patients
under 18 years of age.
Requip-Modutab may be used in the treatment of symptoms of Parkinson's disease either as the only
medicine or in combination with another medicine called L-dopa ( also known as levodopa ). If the
patient is taking L-dopa, involuntary movements (dyskinesias) may occur when starting Requip-Modutab.
If such symptoms occur, you should inform your doctor, who may adjust the doses of medicines the
patient is taking.
Requip-Modutab tablets are designed to release the medicine gradually over a period of more than
24 hours. If, due to the patient's condition (e.g. during diarrhoea), the medicine passes through the
body too quickly, the tablets may not dissolve completely and may not work as intended. The tablets
may possibly be visible in the stool. In such a case, you should contact your doctor as soon as possible.
What dose of Requip-Modutab should be used?
Determining the appropriate dose of Requip-Modutab for the patient may take some time.
The recommended starting dose of Requip-Modutab prolonged-release tablets is 2 mg once daily
during the first week. Your doctor may increase the dose to 4 mg of Requip-Modutab once daily from
the second week of treatment. If the patient is elderly, the doctor may increase the dose more slowly.
Thereafter, the doctor may adjust the dose until the optimal dose for the patient is reached. Some
patients may take up to 24 mg of Requip-Modutab prolonged-release tablets per day.
If intolerable side effects occur at the beginning of treatment, you should inform your doctor. The
doctor may recommend changing the therapy to treatment with a lower dose of ropinirole in the form
of coated tablets (immediate-release), to be taken three times a day.
Do not take more Requip-Modutab than prescribed by your doctor.
It may take several weeks before the beneficial effect of the medicine becomes apparent.
How to take Requip-Modutab
Requip-Modutab should be taken once daily, at the same time each day.
The prolonged-release tablet(s) of Requip-Modutab must be swallowed whole,
with a glass of water.
Do not break, chew or crush the prolonged-release tablets – doing so may result in an overdose
due to too rapid release of the medicine in the body.

Switching treatment in patients taking ropinirole immediate-release tablets
Your doctor will determine the dose of Requip-Modutab prolonged-release tablets based on the
previously used dose of ropinirole immediate-release tablets.
Continue taking your usual dose of ropinirole immediate-release tablets on the day before switching
treatment. The next morning, take Requip-Modutab prolonged-release tablets and do not take any more
ropinirole immediate-release tablets.
Taking more than the recommended dose of Requip-Modutab
Seek immediate advice from your doctor or pharmacist. If possible, show the Requip-Modutab
packaging.
In a person who has taken more than the recommended dose of Requip-Modutab, the following
symptoms may occur: nausea, vomiting, dizziness, drowsiness, mental or physical fatigue, fainting,
hallucinations.
If a dose of Requip-Modutab is missed
Do not take a larger number of prolonged-release tablets or a double dose to make up for a missed dose.
If Requip-Modutab has not been taken for a day or longer, you should consult your doctor about
resuming treatment with Requip-Modutab.
Stopping Requip-Modutab
Do not stop taking Requip-Modutab unless your doctor tells you to.
Requip-Modutab should be taken for as long as your doctor recommends. Do not stop taking it unless
your doctor advises you to do so.
If Requip-Modutab is stopped suddenly, symptoms of Parkinson's disease may worsen significantly
within a short time. Abrupt discontinuation may cause the patient to develop a condition known as
neuroleptic malignant syndrome, which may be a serious health risk. Symptoms include: akinesia
(loss of muscle movement), muscle rigidity, fever, unstable blood pressure, tachycardia (rapid heart
rate), confusion, and reduced level of consciousness (e.g. coma).
If it becomes necessary to discontinue Requip-Modutab, 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 side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Side effects with Requip-Modutab may most commonly occur when treatment is started or shortly after increasing the dose. Side effects are usually mild and become less bothersome after a short period of taking the medicine. If you have any concerns about side effects, consult your doctor.

Very common side effects
May occur in more than 1 in 10 patients taking Requip-Modutab:

• fainting
• feeling sleepy
• nausea

Common side effects
May occur in no more than 1 in 10 patients taking Requip-Modutab:

• sudden sleep attacks without prior warning of sleepiness (sudden onset of sleep)
• hallucinations (seeing things that are not real)
• vomiting
• dizziness
• heartburn
• abdominal pain
• constipation
• swelling of the legs, feet or hands

Uncommon side effects
May occur in no more than 1 in 100 patients taking Requip-Modutab:

• dizziness or fainting, particularly when suddenly standing up (related to low blood pressure)
• low blood pressure (hypotension)
• excessive daytime sleepiness (excessive somnolence)
• psychiatric disorders such as delirium, hallucinations (irrational thoughts) or paranoia (unfounded suspicion)
• hiccups

In some patients the following side effects may occur (frequency unknown: cannot be estimated from the 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 severe itching (see section 2).
• liver function abnormalities detected in blood tests.
• aggressive behaviour.
• excessive use of Requip-Modutab (uncontrolled desire to take high doses of dopaminergic medicines, higher than necessary to control motor symptoms, known as dopamine dysregulation syndrome).
• inability to resist the impulse, urge or temptation to perform actions that may harm the patient or others. Symptoms may include:
  - Uncontrollable urge to gamble, despite significant consequences for the patient or their family.
  - Change or increase in sexual interest and behaviour that is particularly troubling to the patient or others, such as increased sexual drive.
  - Uncontrolled, excessive shopping or spending money.
  - Binge eating (consuming large amounts of food in a short time), compulsive eating (eating more food than needed to satisfy hunger).
• episodes of excessive physical activity, excitement and irritability.
• after stopping or reducing the dose of Requip-Modutab, symptoms such as depression, apathy, anxiety, lack of energy, sweating or pain may occur (referred to as dopamine agonist withdrawal syndrome or DAWS).
• spontaneous erection.

If any of these behaviours occur, inform your doctor so that appropriate treatment or symptom relief can be arranged.

Taking Requip-Modutab with L-dopa
In patients taking Requip-Modutab with L-dopa, the following additional side effects may occur:

• involuntary movements (dyskinesias) are a very common side effect. When a patient is taking L-dopa, involuntary movements (dyskinesias) may occur when starting treatment with Requip-Modutab. If these symptoms occur, inform your doctor, who may adjust the doses of medicines the patient is taking.
• feeling disoriented is a common side effect.

Reporting of side effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the 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
Side effects can also be reported to the responsible entity.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Requip-Modutab

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack and the cardboard
box. The expiry date refers to the last day of the specified 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. This will help protect the
environment.

6. Contents of the pack and other information

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

• Core of the prolonged-release tablet: hypromellose, hydrogenated castor oil, sodium carmellose, povidone (K29-32), maltodextrin, magnesium stearate, lactose monohydrate, colloidal anhydrous silica, mannitol (E 421), iron oxide yellow (E 172), glycerol dibehenate
• Coating:
  2 mg prolonged-release tablet: Opadry Pink OY-S-24900 (hypromellose, iron oxide yellow (E 172), titanium dioxide (E 171), macrogol 400, iron oxide red (E 172))
  4 mg prolonged-release tablet: Opadry Light Brown OY-27207 (hypromellose, titanium dioxide (E 171), macrogol 400, orange-yellow FCF, as aluminium lake (E 110), indigo carmine, as aluminium lake (E 132))
  8 mg prolonged-release tablet: Opadry Red 03B25227 (hypromellose, iron oxide yellow (E 172), titanium dioxide (E 171), iron oxide black (E 172), macrogol 400, iron oxide red (E 172))

What Requip-Modutab looks like and contents of the pack
Requip-Modutab (all strengths) is a prolonged-release tablet in capsule shape, marked “GS” on one side.
Requip-Modutab 2 mg: pink prolonged-release tablets marked ‘3V2’ on the other side.
Requip-Modutab 4 mg: light brown prolonged-release tablets marked ‘WXG’ on the other side.
Requip-Modutab 8 mg: red prolonged-release tablets marked ‘5CC’ on the other side.
All strengths: packaging containing 28 or 84 prolonged-release tablets in blisters. 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:
France: Ropinirole GSK LP
Malta, Lithuania and Poland: Requip-Modutab

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