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ROPINIROLE 5MG FILM-COATED TABLETS

Active substance(s): ROPINIROLE HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
ROPINIROLE 5 mg film-coated tablets
Ropinirole
Read all of this leaflet carefully before you start
Some medicines can affect the way ropinirole works,
taking this medicine because it contains important
or make it more likely that you will have side effects.
information for you.
Ropinirole can also affect how some other medicines
• Keep this leaflet. You may need to read it again.
work. These include:
• If you have any further questions, ask your doctor or
- the anti-depressant fluvoxamine
pharmacist.
- HRT (hormone replacement therapy)
• This medicine has been prescribed for you only. Do
- the antibiotics ciprofloxacin or enoxacin
not pass it on to others. It may harm them, even if
- medication for other mental health problems, for
their signs of illness are the same as yours.
example sulpiride
• If you get any side effects talk to your doctor or
- metoclopramide, which is used to treat nausea and
pharmacist. This includes any possible side effects not
heartburn
listed in this leaflet.
- cimetidine, used in the treatment of stomach ulcers
- any other medicine for Parkinson’s disease
What is in this leaflet:
1. What ROPINIROLE is and what it is used for
Tell your doctor if you’re taking, or have recently taken
2. What you need to know before you take
any of these medicines.
ROPINIROLE
Remember to tell your doctor if you start taking any
3. How to take ROPINIROLE
other medicine while taking ropinirole.
4. Possible side effects
ROPINIROLE with food and drink
5. How to store ROPINIROLE
If you take this medicine with food, you may be less
6. Contents of the pack and other information
likely to feel sick or be sick (vomit). So it’s best to take it
with food if you can.
1. WHAT ROPINIROLE IS AND WHAT IT IS
USED FOR
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be
ROPINIROLE is used to treat Parkinson’s disease.
pregnant or planning to have a baby, ask your doctor or
The active ingredient in ROPINIROLE 5 mg filmpharmacist for advice before taking this medicine. Your
coated tablets is ropinirole, which belongs to a group of
doctor may advise you to stop taking ROPINIROLE.
medicines called dopamine agonists. Dopamine agonists
ROPINIROLE is not recommended if you are pregnant,
affect the brain in a similar way to a natural substance
unless your doctor advises that the benefit to you taking
called dopamine.
ROPINIROLE is greater than the risk to your unborn
People with Parkinson’s disease have low levels of
baby.
dopamine in some parts of their brains. Ropinirole has
effects similar to those of natural dopamine, so it helps to ROPINIROLE is not recommended if you are breast
feeding, as it can affect your milk production.
reduce the symptoms of Parkinson’s disease.
Driving and using machines
2. WHAT YOU NEED TO KNOW BEFORE YOU
ROPINIROLE can make you feel drowsy. It can make
TAKE ROPINIROLE
people feel extremely sleepy and it sometimes makes
people fall asleep very suddenly without warning.
Do not take ROPINIROLE
If you could be affected: don’t drive, don’t operate
- if you are allergic to ropinirole, or any of the other
machines and don’t put yourself in any situation where
ingredients of this medicine (listed in section 6).
feeling sleepy or falling asleep could put you (or other
- if you have serious kidney disease
people) at risk of serious injury or death. Don’t take part
- if you have serious liver disease.
in these activities until you are no longer affected.
Tell your doctor if you think any of these may apply to
Talk to your doctor if this causes problems for you.
you.
ROPINIROLE contains lactose
Warnings and precautions
This medicinal product contains lactose. If you have
Tell your doctor or pharmacist before you start to take
an intolerance to lactose or any other sugars, ask your
this medicine if you:
doctor for advice before you take this medicine.
- are pregnant or think you may be pregnant
Smoking and ROPINIROLE
- are breast-feeding
Tell your doctor or nurse if you start smoking, or give
- are under 18 years old
up smoking, while you’re taking ROPINIROLE. Your
- have liver disease
doctor or nurse may need to adjust your dose.
- have a serious heart complaint.
- have a serious mental health problem
3. HOW TO TAKE ROPINIROLE
- if you have experienced any unusual urges and / or
behaviours (such as excessive gambling or
Always take this medicine exactly as your doctor has
excessive sexual behaviour)
told you. Check with your doctor or pharmacist if you
- if you have an intolerance to some sugars (such as
are not sure.
lactose)
You may be given ROPINIROLE on its own to treat the
Talk to your doctor if you think any of these may apply
symptoms of your Parkinson’s disease, or you may be
to you. If you and your doctor decide that you can take
given ROPINIROLE as well as another medicine called
ropinirole, your doctor will probably ask you to have
L-dopa (also called levodopa). If you are taking L-dopa
extra check-ups while you are taking it.
you may experience some uncontrollable movements
Take special care with this medicine
(dyskinesias) when you first start taking ROPINIROLE.
Tell your doctor if you or your family/carer notices that
Tell your doctor if this happens, as your doctor may need
you are developing urges or cravings to behave in ways
to adjust the dose of the medicines you are taking.
that are unusual for you or you cannot resist the impulse,
Tell your doctor if you or your family notices that you
drive or temptation to carry out certain activities that
are developing any unusual behaviours (such as an
could harm yourself or others. These are called impulse
unusual urge to gamble or increased sexual urges and/or
control disorders and can include behaviours such as
behaviours) while you are taking ROPINIROLE. Your
addictive gambling, excessive eating or spending, an
doctor may need to adjust or stop your dose.
abnormally high sex drive or an increase in sexual
How much ROPINIROLE will you need to take?
thoughts or feelings. Your doctor may need to adjust or
It may take a while to find out the best dose of
stop your dose.
ROPINIROLE for you.
Tell your doctor if you think any of these may apply to
The usual starting dose is 0.25 mg ropinirole three
you. Your doctor may decide that ROPINIROLE isn’t
times each day for the first week. Then your doctor will
suitable for you or that you need extra check-ups while
increase your dose each week, for the next three weeks.
you’re taking it.
After that, your doctor will gradually increase the dose
Children
Do not give ROPINIROLE to children. ROPINIROLE is until you are taking the dose that is best for you. The
usual is 1 mg to 3 mg three times each day (making a
not normally prescribed for people under 18.
total daily dose of 3 mg to 9 mg). If your Parkinson’s
Other medicines and ROPINIROLE
disease symptoms have not improved enough, your
Tell your doctor or pharmacist if you are taking, have
doctor may decide to gradually increase your dose some
recently taken or might take any other medicines
more.
including any herbal remedies or other medicines you
Some people take up to 8 mg of ROPINIROLE three
bought without a prescription.
times a day (24 mg daily altogether).

If you are also taking other medicines for Parkinson’s
disease, your doctor may advise you to gradually reduce
the dose of the other medicine.
Don’t take any more ROPINIROLE than your doctor
has recommended. It may take a few weeks for
ROPINIROLE to work for you.
Take ropinirole 3 times a day.
Swallow the ROPINIROLE tablet(s) whole with a glass
of water. It’s best to take ROPINIROLE with food,
because that makes it less likely that you’ll feel sick
(nauseous).
If you take more ROPINIROLE than you should
Contact a doctor or pharmacist immediately. If possible,
show them the ROPINIROLE pack.
Someone who has taken an overdose of ROPINIROLE
may have any of these symptoms: feeling sick (nausea)
or being sick (vomiting), dizziness (a spinning
sensation), feeling drowsy, mental or physical tiredness,
fainting and hallucinations.
If you forget to take ROPINIROLE
Do not take a double dose to make up for a forgotten
dose. Just take your next dose at the usual time.
If you have missed taking ROPINIROLE for more than
a few days, ask your doctor for advice on how to start
taking ROPINIROLE again.
If you stop taking ROPINIROLE
Do not stop taking ROPINIROLE without advice. Take
ropinirole for as long as your doctor recommends. Don’t
stop unless your doctor advises you to.
If you suddenly stop taking ropinirole your Parkinson’s
disease symptoms may quickly get much worse.
If you need to stop taking ropinirole your doctor will
reduce your dose gradually.
If you have any further questions on the use of this
product, 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 ropinirole are more likely to happen
when you first start taking it, or when your dose has just
been increased. They are usually mild, and may become
less troublesome after you have taken the dose for a
while.
If you are worried about side effects, talk to your doctor.
Very common: may affect more than 1 in 10 people
• fainting
• feeling drowsy
• feeling sick (nausea)
Common: may affect up to 1 in 10 people
• hallucinations (sensing things that are not real)
• being sick (vomiting)
• feeling dizzy (a spinning sensation)
• heartburn
• stomach pain
• swelling of the legs
Uncommon: may affect up to 1 in 100 people
• feeling dizzy or faint, especially when you stand up
suddenly (this is caused by a drop in blood pressure)
• feeling very sleepy during the day (extreme
somnolence)
• falling asleep very suddenly without feeling sleepy
first (sudden sleep onset episodes)
• mental problems such as delirium (severe confusion),
delusions (unreasonable ideas) or paranoia
(unreasonable suspicions)
You may experience the following side effects:
• inability to resist the impulse, drive or temptation to
perform an action that could be harmful to you or
others, which may include:
- strong impulse to gamble excessively despite
serious personal or family consequences
- altered or increased sexual interest and behaviour
of significant concern to you or to others, for
example, an increased sexual drive
- uncontrollable excessive shopping or spending
- binge eating (eating large amounts of food in a
short time period) or compulsive eating (eating
more food than normal and more than is needed to
satisfy your hunger).
Tell your doctor if you experience any of these
behaviours; they will discuss ways of managing or
reducing the symptoms.
Very rare side effects:may affect up to 1 in 10,000 people
• changes in liver function, which have shown up in
blood tests

• a llergic reactions such as red, itchy swellings on the
skin (hives), swelling of the face, lips, mouth, tongue
or throat which may cause difficulty in swallowing or
breathing, rash or intense itching.
Some patients may have the following side effects
(frequency not known)
• aggression
People who are taking ROPINIROLE with L-dopa may
develop other side effects over time:
• uncontrollable movements (dyskinesias) are a very
common side effect. Tell your doctor if this happens,
as your doctor may need to adjust the doses of the
medicines you are taking
• feeling confused is a common side effect.
Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects not
listed in this leaflet. You can also report side effects
directly via the Yellow Card Scheme, website:
www.mhra.gov.uk/yellowcard. By reporting side effects
you can help provide more information on the safety of
this medicine.
5. HOW TO STORE ROPINIROLE
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 blister/bottle and the outer carton after Exp.
The expiry date refers to the last day of that month.
Do not store above 30°C.
Blisters:
Store in the original package in order to protect from
moisture.
Bottles:
Keep the bottle tightly closed in order to protect from
moisture.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw away
medicines you no longer use. These measures will help to
protect the environment.
6. CONTENTS OF THE PACK AND OTHER
INFORMATION
What ROPINIROLE contains
• The active substance is ropinirole. Each film-coated
tablet contains ropinirole hydrochloride
equivalent to 5.0 mg of ropinirole.
The other ingredients are:
Tablet Cores
Lactose, Anhydrous
Lactose Monohydrate
Cellulose, microcrystalline (E460)
Citric acid, anhydrous (E330)
Croscarmellose sodium (E468)
Magnesium Stearate (E572)
Film Coating
5.0 mg Hypromellose (E464), Titanium dioxide
(E171), Macrogol 400, Talc, Indigo carmine
aluminium lake (E132), Brilliant blue FCF
Aluminium lake (E133)
What ROPINIROLE looks like and contents of the
pack
Film-coated tablet.
5.0 mg Blue, circular, bevelled edged, biconvex film
coated tablets with ‘259’ debossed on one side
and ‘G’ on the other side.
The tablets are packed in either plain Aluminium/
Aluminium blisters, white, opaque Triplex(PVC/PE/
Aclar)/Aluminium blisters or white opaque HDPE
bottles with polypropylene child-resistant closure
Pack Sizes
Blister: 21 and 84
Bottle: 84
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Glenmark Pharmaceuticals Europe Limited,
Laxmi House, 2-B Draycott Avenue,
Kenton, Harrow, Middlesex
HA3 0BU
United Kingdom.
Manufacturer
Glenmark Pharmaceuticals s.r.o, Fibichova 143
56617 Vysoké Mýto, Czech Republic
Glenmark Pharmaceuticals Europe Limited, Building
2, Croxley Green Business Park, Croxley Green,
Hertfordshire, WD18 8 YA, United Kingdom
This leaflet was last revised in 03/2015.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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