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 pass it on to others. The 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 further questions, please consult your doctor or pharmacist.
 If you experience any adverse effects, including any not listed in this leaflet, 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 acts like naturally occurring dopamine in the brain and thereby 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 known 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 physician should be informed 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 impulse control disorders and (or) unusual 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 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 impulses, urges, or behaviors that were not previously observed and that the patient cannot resist the urge or compulsion to carry out certain activities that may 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 physical 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 apply. 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 use of Requip-Modutab
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 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 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 reactions. 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 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 benefits to the patient outweigh the risks 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, irresistible drowsiness may occur, and sometimes sudden and unexpected sleep attacks without prior warning of sleepiness.
Hallucinations (seeing, hearing, or feeling 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 activity where drowsiness or falling asleep could place the patient (or others) at risk of serious injury or death. Such activities should not be performed until symptoms resolve.
Talk to your doctor if this situation is a concern 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 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, the medicine is considered "sodium-free".

3. How to use Requip-Modutab

This medicine should always be used exactly as your doctor has told you. If in doubt,
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 Parkinson’s disease either as monotherapy 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, inform your doctor, who may adjust the doses of the 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 be visible in the stool. In such a case, contact your doctor as soon as possible.
What dose of Requip-Modutab should be used?
Finding the right 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. 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.
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 the patient experiences intolerable side effects at the beginning of treatment, inform the doctor.
The doctor may recommend switching therapy to a lower dose of ropinirole in coated tablets
(immediate-release formulation), to be taken three times daily.
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
Take Requip-Modutab 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 rapid release of the medicine in the body.

Switching treatment in patients currently 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 current 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 further doses of ropinirole immediate-release tablets.
Taking more than the prescribed dose of Requip-Modutab
Contact your doctor or pharmacist immediately. 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 double dose or extra tablets to make up for a missed dose.
If Requip-Modutab has not been taken for a day or longer, consult your doctor about how to
resume treatment with Requip-Modutab.
Stopping Requip-Modutab treatment
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 instructed by your doctor.
If Requip-Modutab is stopped suddenly, Parkinson’s disease symptoms may worsen rapidly.
Sudden discontinuation may lead to a condition called 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-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 adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Adverse reactions to Requip-Modutab may occur most frequently when starting treatment or shortly after increasing the dose. Adverse reactions are usually mild and become less troublesome after a short period of treatment. If you have any concerns about adverse reactions, consult your doctor.

Very common adverse reactions
May occur in more than 1 in 10 patients taking Requip-Modutab:

• fainting
• feeling sleepy
• nausea

Common adverse reactions
May occur in up to 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 legs, feet or hands

Uncommon adverse reactions
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 disturbances such as delirium, hallucinations (irrational thoughts) or paranoia (unjustified suspicion)
• hiccups

In some patients, the following adverse reactions may occur (frequency not known: 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).
• liver function abnormalities, detected in blood tests.
• aggressive behaviour.
• excessive use of Requip-Modutab (compulsive craving to take high doses of dopaminergic medication, higher than necessary to control motor symptoms, known as dopamine dysregulation syndrome).
• inability to resist the impulse, urge or temptation to carry out behaviours that could 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 distressing to the patient or others, such as increased libido.
  - Uncontrolled, excessive shopping or spending.
  - 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, other adverse reactions may occur:

• involuntary movements (dyskinesias) are a very common adverse reaction. 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 adverse reaction.

Reporting of adverse reactions
If any symptoms of adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at the 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 reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps to 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 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-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), ferric oxide yellow (E 172), glycerol dibehenate
• Coating:
  2 mg prolonged-release tablet: Opadry Pink OY-S-24900 (hypromellose, ferric oxide yellow (E 172), titanium dioxide (E 171), macrogol 400, ferric 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, ferric oxide yellow (E 172), titanium dioxide (E 171), ferric oxide black (E 172), macrogol 400, ferric 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: pack 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 Marketing Authorisation Holder:
GSK Services Sp. z o.o.
Tel. +48 22 576 90 00