ROPIRAL 2 mg Extended-Release Tablet

Зміст інструкції

1. Ropiral 2 mg, 4 mg, 8 mg prolonged-release tablets
   1. What is Ropiral and what it is used for
   2. What you need to know before taking Ropiral
   3. How to take Ropiral
   4. Possible side effects
   5. How to store Ropiral
   6. Contents of the pack and other information

Ropiral 2 mg, 4 mg, 8 mg prolonged-release tablets

Ropinirole
Equivalent medicine
Read this leaflet carefully before you start to take this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not give it to other people, even if their symptoms are the same as yours, because it could be dangerous.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Ropiral and what it is used for

The active ingredient of Ropiral is ropinirole, which belongs to a group of medicines known as dopamine
agonists. Dopamine agonists act on the brain in a similar way to a natural substance
called dopamine.

Ropiral prolonged-release tablets are used to treat Parkinson's disease.
People with Parkinson's disease have low levels of dopamine in certain areas of the brain. Ropinirole has
effects similar to those of natural dopamine, in this way it helps to reduce the symptoms of
Parkinson's disease.

2. What you need to know before taking Ropiral

Do not take Ropiral

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

Tell your doctor if you think any of these apply to you.

Warnings and precautions
Talk to your doctor or pharmacist before taking Ropiral:

• if you are pregnantor think you may be;
• if you are breast-feeding;
• if you are under 18 years of age;
• if you have a serious heart problem;
• if you have a serious mental health problem;
• if you have experienced any unusual urges and/or behaviours(see section 4);
• if you are intolerant to some sugars(such as lactose).

Tell your doctor if you experience symptoms such as depression, apathy, anxiety, feeling tired,
sweating or painafter stopping treatment or reducing the dose of Ropiral. If the symptoms
persist for more than a few weeks, your doctor may need to adjust the therapy.
Tell your doctor if you or a family member/caregiver notices that you are
developing impulses or desires to behave in a way that is unusual for you and you cannot resist the urge, desire or temptation to carry out certain activities that could be harmful to yourself or to
others. These are called impulse control disorders and can include behaviours such as gambling, overeating or excessive shopping, an abnormally high sexual drive, or increased thoughts or sensations related to sex. Your doctor may need to adjust or stop your
dose.

Tell your doctorif you think any of these apply to you. Your doctor may decide that Ropiral is not
suitable for you, or that further checks are needed while you are taking it.

During treatment with Ropiral
Tell your doctor if you or your family members notice that you are developing any unusual behaviour
(such as an unusual urge to gambleor an increased urge and/or behaviour
related to sex) while taking Ropiral. Your doctor may need to adjust the dose or stop
taking it.

Smoking and Ropiral
Tell your doctorif you start or stop smoking while taking Ropiral. Your
doctor may need to adjust the dose.

Other medicines and Ropiral
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, including herbal remedies or medicines available without a prescription.

Remember to tell your doctoror pharmacist if you are starting to take any new medicine while you are
taking Ropiral.
Some medicines can affect the way Ropiral works, or make side effects more likely. Ropiral can also affect the way other medicines work.
These medicines include:

• the antidepressant fluvoxamine;
• medicines for the treatment of other mental health problems, for example sulpiride;
• hormone replacement therapy(HRT);
• metoclopramide, used to treat nauseaand heartburn;
• the antibiotics ciprofloxacinor enoxacin;
• any other medicine for the treatment of Parkinson’s disease.

Tell your doctorif you are taking, or have recently taken, any of these medicines.

You will need further blood testsif you are taking these medicines with Ropiral:

• vitamin K antagonists (used to reduce blood clotting) such as warfarin (Coumadin).

Ropiral with food and drink
You can take Ropiral with or without food, as you prefer.

Pregnancy, breast-feeding and fertility
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.

Ropiral is not recommended during pregnancyunless your doctor considers that the benefit of taking
Ropiral is greater than the risk to the unborn baby.

Ropiral is not recommended if you are breast-feedingas it may affect milk production.

Tell your doctor immediatelyif you are pregnant, think you may be or are planning a
pregnancy. Your doctor will advise you if you are breast-feeding or intend to do so. Your doctor may advise you to stop taking Ropiral.

Driving and using machines
Ropiral can cause drowsiness. It can make people feel very sleepyand sometimes causes
people to fall asleep suddenly, without any warning signs.
Ropinirole can cause hallucinations (seeing, hearing or feeling things that are not there). If you experience these, do not drive and
do not use machines.
If you experience these symptoms: do not drive, do not use machines and do notput yourself in a situation
where drowsiness or falling asleep could put you (or others) at risk of serious injury or death.
Do not engage in these activities until these effects have worn off.

Talk to your doctorif this causes you problems.
This medicine contains less than 1 mmol (23 mg) of sodium per prolonged-release capsule, i.e. it is
essentially ‘sodium-free’.

Ropiral 2 mg prolonged-release tablets containsa sugar called lactose. If your doctor has
diagnosed you as having intolerance to some sugars, contact him/her before taking this medicine.

Ropiral 4 mg prolonged-release tablets containsthe colourant sunset yellow, which may
cause allergic reactions.

3. How to take Ropiral

Always take this medicine exactly as your doctor has told you. If you have any doubts, ask your doctor or pharmacist.

Do not give Ropiral to children. Ropiral is not normally prescribed to people under the age of 18 years.
Ropiral may be prescribed to you alone to treat the symptoms of Parkinson's disease, or it may be given to you
together with another medicine called L-dopa (also known as levodopa). If you are taking L-dopa you may
experience some uncontrollable movements (dyskinesia) when you start taking Ropiral. Tell your doctor if this
happens, as your doctor may need to adjust the dose of the medicines you are taking.
Ropiral prolonged-release tablets are formulated to release the drug over a period of 24 hours. If you have a
condition in which the medicine passes through the body too quickly, for example in the case of diarrhoea, the
tablets may not dissolve completely and may not work properly. You may find tablet residue in your stools. If
this happens, tell your doctor as soon as possible.

How much Ropiral should you take?
It may take some time to find the optimal dose of Ropiral for you.

The recommended starting doseof Ropiral prolonged-release tablets is 2 mg once a day for the first
week. Your doctor may increase the dose to 4 mg of Ropiral prolonged-release tablets once a day, from the
second week of treatment. If you are very elderly, your doctor may increase your dose more slowly. After that,
your doctor may adjust your dose until the optimal dose for you is reached. Some people take up to 24 mg of
Ropiral prolonged-release tablets per day.
If you experience undesirable effects at the beginning of treatment that you find difficult to tolerate, talk to your
doctor. Your doctor may advise you to switch to a lower dose of ropinirole film-coated tablets (immediate
release) to be taken three times a day.

Do not take more Ropiral than recommended by your doctor.
It may take several weeks for Ropiral to work.

How to take your dose of Ropiral
Take Ropiral once a day, at the same time each day.
Swallow the Ropiral prolonged-release tablet whole, with a glass of water.
Do not break, crush or chew the prolonged-release tablets. If you do, there is a risk of
overdose because the medicine will be released into your body too quickly.

If you are switching from treatment with ropinirole film-coated tablets (immediate release)
Your doctor will base the dose of Ropiral prolonged-release tablets on the dose of ropinirole film-coated
tablets (immediate release) that you are taking.
The day before the switch, take ropinirole film-coated tablets (immediate release) as normal. Then, the
morning after, take Ropiral prolonged-release tablets and stop taking ropinirole film-coated tablets
(immediate release).

If you take more Ropiral than you should
Contact your doctor or pharmacist immediately. If possible, show them the Ropiral packaging.
Someone who has taken an overdose of Ropiral may experience some of these symptoms: feeling
unwell (nausea), feeling sick (vomiting), dizziness (a feeling of spinning), feeling sleepy,
physical or mental fatigue, fainting, hallucinations.

If you forget to take Ropiral
Do not take a double dose to make up for a missed dose.

If you have forgotten to take Ropiral for one day or more, ask your doctor for advice on how to
resume taking it.

If you stop taking Ropiral
Do not stop taking Ropiral without consulting your doctor.
Take Ropiral for the entire time recommended by your doctor. Do not stop unless your doctor
tells you to.
If you stop taking Ropiral suddenly, the symptoms of Parkinson's disease may worsen
rapidly. Sudden discontinuation could induce the development of a medical condition called
neuroleptic malignant syndrome, which can pose a serious health risk. Symptoms include:
akinesia (loss of muscle movement), muscle rigidity, fever, unstable blood pressure,
tachycardia (increased heart rate), confusion, decreased level of consciousness (e.g. coma).
If you need to stop Ropiral therapy, your doctor will reduce your dose gradually.
If you have any doubts about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The side effects of Ropiral are more likely to appear when treatment is started or
when the dose is increased. Side effects are generally mild and may cause fewer
problems after you have taken the medicine for a short period. If you are concerned about side effects, speak
to your doctor.

Very common side effects
May affect more than 1 in 10people taking Ropiral:

• fainting;
• feeling sleepy;
• feeling unwell (nausea).

Common side effects
May affect up to 1 in 10people taking Ropiral:

• falling asleep suddenly without feeling sleepy beforehand (sleep attack);
• hallucinations (“seeing” things that are not really there);
• feeling unwell (vomiting);
• dizziness (feeling of spinning);
• heartburn;
• stomach pain;
• constipation;
• swelling of the legs, feet and hands.

Uncommon side effects
May affect up to 1 in 100people taking Ropiral:

• feeling faint or dizzy, especially when getting up quickly (this is caused by a drop in blood pressure);
• feeling very sleepy during the day (excessive somnolence);
• mental problems such as delirium (severe confusion), illusions (irrational beliefs) or paranoia (unfounded suspicious attitudes).

Some patients may experience the following side effects (frequency not known: cannot be
defined on the basis of the available data)

• allergic reactions, such as redness, itchy skin swelling (urticaria), swelling of the face, lips, mouth, tongue or throat which can cause difficulty swallowing or breathing, skin rashor intense itching (see section 2);
• changes in liver function, which have been observed with blood tests;
• acting aggressively;
• excessive use of Ropiral (an uncontrollable urge to use dopaminergic drugs at doses higher than those needed to control motor symptoms, known as dopamine dysregulation syndrome);
• inability to resist the impulse, urge or temptation to perform actions that may be harmful to you or others, which may include:
• a strong urge to gamble excessively despite serious personal or family consequences;
• altered or increased sexual interest and behaviour of significant concern to you or others, for example an increased sexual drive;
• uncontrollable excessive shopping or spending;
• overeating (eating large amounts of food in a short period of time) or compulsive eating (eating more food than necessary to satisfy hunger);
• after stopping or reducing the dosage of Ropiral, depression, apathy, anxiety, feeling tired, sweating or pain may occur (dopamine agonist withdrawal syndrome or DAWS).

Tell your doctor if you experience any of these behaviours; ways to manage or reduce the symptoms will be discussed.
If you are taking Ropiral with L-dopa
Patients taking Ropiral with L-dopa may develop other side effects over time:

• uncontrollable movements (dyskinesia) are a very common side effect. If you are taking L-dopa you may experience some uncontrollable movements (dyskinesia) when you start taking Ropiral. If this happens, tell your doctor, as they may need to adjust the doses of the medicines you are taking;
• feeling confused, which is a common side effect.

Reporting of side effects
If you get any side effect, even if not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national
reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Ropiral

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 package and on the blister after EXP. The
expiry date refers to the last day of that month.
Store Ropiral at a temperature below 25˚C.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Ropiral contains
The active ingredient of Ropiral is ropinirole.
Each prolonged-release tablet contains ropinirole as hydrochloride equivalent to 2 mg, 4 mg or 8 mg of
ropinirole.
The other ingredients are:

• Tablet core:ammonium methacrylate copolymer Type B, hypromellose, sodium lauryl sulfate, copovidone, magnesium stearate.
• Tablet coating:

Description of the appearance of Ropiral and contents of the pack
Ropiral 2 mg: pink, round, biconvex, prolonged-release tablets with a diameter of 6.8 ± 0.1 mm and
thickness of 5.5  0.2 mm.
Ropiral 4 mg: light brown, oval, biconvex, prolonged-release tablets with dimensions of 12.6 x 6.6 ±
0.1 mm and thickness of 5.3  0.2 mm.
Ropiral 8 mg: red, oval, biconvex, prolonged-release tablets with dimensions of 19.2 x 10.2 ± 0.2 mm
and thickness of 5.2  0.2 mm.
All dosages are provided in blister packs in white opaque PVC/PCTFE-aluminium.
Packs:
2 mg prolonged-release tablets:
White opaque PVC/PCTFE-aluminium blister packs of 28, 30, 42 and 84 tablets.
4 mg prolonged-release tablets:
White opaque PVC/PCTFE-aluminium blister packs of 28, 30 and 84 tablets.
8 mg prolonged-release tablets:
White opaque PVC/PCTFE-aluminium blister packs of 28, 30 and 84 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Aurobindo Pharma (Italia) S.r.l.
via San Giuseppe, 102

• 21047 - Saronno (VA) Italy

Manufacturers
Pharmathen S.A,. 6 Dervanakion Str, Athens, Pallini 15351, Greece
Pharmathen International S.A., Industrial Park Sapes, Rodopi Prefecture, Block No 5, Rodopi 69300,
Greece
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far, Birzebbugia, BBG 3000 - Malta

This medicinal product is authorised in the Member States of the European Economic Area with the following
denominations:
France: Ropinirole Arrow LP 2mg/ 4mg/ 8mg prolonged-release tablet
Germany: Ropinirol PUREN 2 mg/ 4mg/ 8mg Retardtabletten
Italy: Ropiral
Netherlands: Ropinirole Aurobindo 2 mg/ 4mg/ 8mg tablets with prolonged release
Portugal: Ropinirol Aurobindo LP
Romania: Ropinirol Aurobindo 2 mg/ 4mg/ 8mg comprimate cu eliberare prelungita
Spain: Ropinirol Aurobindo 2 mg/ 4mg/ 8mg prolonged-release tablets EFG
United Kingdom: ROPIQUAL XL 2 mg/ 4mg/ 8mg prolonged release tablets