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 other people, 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, please inform your doctor or pharmacist. See section 4.

Contents of the leaflet

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 areas of the brain have low levels of dopamine. Ropinirole works 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 a hypersensitivity to the active substance or to any of the other ingredients of this medicine (listed in section 6)
• if the patient has severe kidney disease
• if the patient has liver disease. The doctor should be informed if any of these conditions occur.

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 impulsive tendencies and (or) behaviors (see section 4)
• if the patient has sugar intolerance (e.g. lactose intolerance). If, after stopping or reducing the dose of ropinirole, the patient experiences symptoms such as: depression, apathy, anxiety, fatigue, sweating, or pain (known as dopamine agonist withdrawal syndrome (DAWS)), inform the doctor. If symptoms persist for longer than a few weeks, the doctor may decide to modify the dose of the medicine. Inform the doctor if the patient, a family member, or caregiver notices the emergence of new tendencies or behaviors not previously observed in the patient, and that the patient cannot resist the urge, drive, or temptation to carry out certain actions that could harm him 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 his 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). The doctor may decide to adjust the dose or discontinue the medicine.

Inform your doctor if any of these conditions occur. The doctor may
decide that Requip-Modutab is not an appropriate medicine for the patient or may
recommend additional monitoring tests during treatment.
While using Requip-Modutab
Contact your doctor if the patient or a family member observes the occurrence of any
unusual behaviors during treatment with Requip-Modutab (such as: uncontrollable urge to gamble
or increased drive and (or) excessive sexual activity). The doctor may recommend adjusting the dose or discontinuing the medicine.
Smoking and using Requip-Modutab
Inform your doctor about starting or stopping smoking while using Requip-Modutab. The doctor may find it necessary 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, as well as any medicines the patient plans to take, including herbal medicines and other over-the-counter medicines.
Remember to inform your doctor or pharmacist when starting any other medicine during treatment with Requip-Modutab.
Some medicines may affect the action of Requip-Modutab or increase the risk of
adverse effects. Requip-Modutab may also affect the action of other
medicines.
These include:

• fluvoxamine (an antidepressant)
• medicines used for other mental 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 in Parkinson's disease. 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 in the patient.
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 plans to breastfeed. The doctor may recommend discontinuing Requip-Modutab.
Driving and operating machinery
Requip-Modutab may cause drowsiness. Sudden and overwhelming sleepiness may occur, and sometimes sudden and unexpected sleep attacks without prior warning of sleepiness.
Hallucinations (seeing, hearing, or sensing things that are not actually present) may occur during treatment with Requip-Modutab. If the patient experiences hallucinations, he should not drive or operate machinery.
If there is suspicion that such symptoms may occur: do not drive,
operate machinery, or perform any activities in which 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.
Talk to your doctor if this situation is a problem for the patient.
Important information about certain 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 contact the doctor before taking this medicine.
The 4 mg prolonged-release tablets contain the colour orange-yellow FCF (E110),
which may cause allergic reactions.
Requip-Modutab contains less than 1 mmol (23 mg) of sodium per tablet; therefore, the medicine is considered "sodium-free".

3. How to use Requip-Modutab

This medicine must always be used exactly as directed by the doctor. If in doubt, consult the
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 treatment. If such symptoms occur, inform the doctor, who may adjust the doses
of medicines being taken.
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, contact the 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 time.
The recommended starting dose of Requip-Modutab prolonged-release tablets is 2 mg once daily
for the first week. The 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.
The doctor may then adjust the dose until the optimal dose for the patient is reached. Some patients
take up to 24 mg of Requip-Modutab prolonged-release tablets per day.
If intolerable side effects occur at the beginning of treatment, inform the 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 daily.
Do not take a higher dose of Requip-Modutab than that prescribed by the 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 tablet(s) – doing so may lead to overdose
due to too rapid release of the medicine into the body.

Switching treatment in patients taking ropinirole in the form of coated tablets
(immediate-release)
The doctor will determine the dose of Requip-Modutab prolonged-release tablets based on the
previously used dose of ropinirole in the form of coated tablets (immediate-release).
Continue taking the current dose of ropinirole in the form of coated tablets (immediate-release) on
the day before switching treatment. The next morning, take Requip-Modutab prolonged-release
tablets and do not take any further doses of ropinirole in the form of coated tablets (immediate-release).
Taking more Requip-Modutab than prescribed
Seek immediate medical advice from a doctor or pharmacist. If possible, show the Requip-Modutab
packaging.
In a person who has taken more than the prescribed dose of Requip-Modutab, symptoms such as
nausea, vomiting, dizziness, drowsiness, mental or physical fatigue, fainting, or hallucinations may occur.
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 one day or longer, consult the doctor about resuming
treatment with Requip-Modutab.
Stopping Requip-Modutab treatment
Do not stop taking Requip-Modutab unless instructed by the doctor.
Requip-Modutab should be taken for as long as the doctor recommends. Do not stop taking it unless
the doctor advises.
If Requip-Modutab is stopped suddenly, symptoms of Parkinson's disease may worsen rapidly.
Sudden discontinuation may lead to a condition known as neuroleptic malignant syndrome, which
may be life-threatening. 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-Modutab, the doctor will gradually reduce the dose.
If there are any further doubts about using this medicine, consult the doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects with Requip-Modutab may occur most often when starting treatment 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 up to 1 in 10 patients taking Requip-Modutab:

• sudden sleep attacks without prior warning signs (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 up to 1 in 100 patients taking Requip-Modutab:

• dizziness or fainting, particularly when changing position suddenly to standing (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 intense itching (see section 2).
• liver function abnormalities detected in blood tests.
• aggressive behaviour.
• excessive use of Requip-Modutab (uncontrollable urge to take large 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 carry out activities 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 interest in sex and behaviour that is particularly troubling to the patient or others, for example 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 (known 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, other 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 being taken.
• feeling disoriented is a common side effect.

Reporting of side effects
If any side effects occur, including any side effects not listed in this leaflet, tell 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 marketing authorisation holder.
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 cardboard
container. 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. Such measures 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), polyethylene glycol 400, iron oxide red (E 172))
  4 mg prolonged-release tablet: Opadry Light Brown OY-27207 (hypromellose, titanium dioxide (E 171), polyethylene glycol 400, Orange-Yellow FCF, as lake (E 110), indigo carmine, as 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), polyethylene glycol 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 with "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 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:
France: Ropinirole GSK LP
Malta, Lithuania and Poland: Requip-Modutab

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