ROPINIROLE 0.25MG FILM-COATED TABLETS

Active substance: ROPINIROLE HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER



ROPINIROLE 0.25mg FILM-COATED TABLETS
ROPINIROLE 0.5mg FILM-COATED TABLETS
ROPINIROLE 1.0mg FILM-COATED TABLETS
ROPINIROLE 2.0mg FILM-COATED TABLETS
Ropinirole
Read all of this leaflet carefully before you start
No information is available on alcohol consumption while
taking this medicine because it contains important
taking ropinirole and it should therefore be avoided.
information for you.
Pregnancy and breast-feeding
• Keep this leaflet. You may need to read it again.
If you are pregnant or breast-feeding, think you may be
• If you have any further questions, ask your doctor or
pregnant or planning to have a baby, ask your doctor or
pharmacist.
pharmacist for advice before taking any medicine.
• This medicine has been prescribed for you only. Do not
ROPINIROLE is not recommended if you are pregnant,
pass it on to others. It may harm them, even if their
unless your doctor advises that the benefit to you of taking
signs of illness are the same as yours.
it is greater than the risk to your unborn baby.
• If you get any side effects talk to your doctor or
ROPINIROLE is not recommended if you are breast
pharmacist. This includes any possible side effects not
feeding, as it can affect your milk production.
listed in this leaflet.
Tell your doctor immediately if you are pregnant, if you
What is in this leaflet:
think you might be pregnant, or if you are planning to
1. What ROPINIROLE is and what it is used for
become pregnant. Your doctor will also advise you if you
2. What you need to know before you take ROPINIROLE
are breast feeding or planning to do so. Your doctor may
3. How to take ROPINIROLE
advise you to stop taking ROPINIROLE.
4. Possible side effects
Driving and using machines
5. How to store ROPINIROLE
ROPINIROLE may have an influence on the ability to
6. Contents of the pack and other information
drive and use machines as it may possibly cause dizziness
or a spinning sensation.
1. WHAT ROPINIROLE IS AND WHAT IT IS USED
Also ROPINIROLE can cause extreme sleepiness
FOR
(somnolence) and sudden sleep onset episodes. If you
ROPINIROLE belongs to a group of medicines called
do suffer from these effects, you must not drive or put
dopamine agonists. Dopamine agonists act like a naturally
yourself in a situation where sleepiness or falling asleep
occurring chemical in your brain called dopamine.
may put you at risk of serious injury or death (for example
Ropinirole is used to treat Parkinson’s disease. The
using machinery) until you are no longer affected.
cause of Parkinson’s disease is a lack of the substance
dopamine in the brain. Ropinirole may be used alone or
ROPINIROLE contains lactose
in combination with other medicines against Parkinson’s
This medicinal product contains lactose. If you have an
disease to achieve a more effective treatment.
intolerance to lactose or any other sugars, ask contact
your doctor before taking this medicine.
ROPINIROLE is also used to treat the symptoms of
moderate to severe idiopathic Restless Legs Syndrome
3. HOW TO TAKE ROPINIROLE
(RLS), a condition characterised by an irresistible urge
Always take this medicine exactly as your doctor has told
to move the legs and occasionally the arms, usually
you. Check with your doctor or pharmacist if you are not
accompanied by uncomfortable sensations such as
sure.
tingling, burning or prickling. These feelings occurs
during periods of rest or inactivity such as sitting or lying
Ropinirole is used differently depending on the disease.
down, especially in bed, and are worse in the evening or
Parkinson’s disease
at night. Usually the only relief is obtained by walking
The starting dose is 0.25 mg ropinirole three times per
about or moving the affected limbs, which often leads to
day for one week. Then the dose is gradually increased in
problems sleeping. ROPINIROLE relieves the discomfort
accordance with the following:
and reduces the urge to move the limbs that disrupt night
1st week: 0.25 mg ropinirole 3 times daily
time sleep.
2nd week: 0.5 mg ropinirole 3 times daily
3rd week: 0.75 mg ropinirole 3 times daily
2. WHAT YOU NEED TO KNOW BEFORE YOU
4th week: 1.0 mg ropinirole 3 times daily
TAKE ROPINIROLE
Hereafter your doctor may increase or decrease the dose
Do not take ROPINIROLE
that you are taking to get the best effect. The usual dose is
- if you are allergic (hypersensitive) to the active
between 1 mg to 3 mg ropinirole taken three times daily (a
ingredient , ropinirole, or any of the other
total daily dose of 3 mg to 9 mg), but if sufficient effects
ingredients of ROPINIROLE (see sections 4 and 6).
are not achieved or maintained, the total daily dose may
- if you have serious liver disease
be gradually increased up to 24 mg.
- if you have a serious kidney disease
This medicine may also be used in combination with
If you are unsure, it is essential that you talk to your
other medicines for Parkinson’s disease. If you are using
doctor.
other medicines for Parkinson’s disease your doctor may
Warnings and precautions
eventually reduce its dose when you use this medicine.
Tell your doctor before you start to take this medicine if
Restless Legs Syndrome
you:
Take ROPINIROLE once a day, every day at the same
- are pregnant or think you may be pregnant
time. ROPINIROLE is usually taken just before bedtime,
- are breast-feeding
but can be taken up to 3 hours before going to bed. The
- are under 18 years old
exact dose of ROPINIROLE people take can be different.
- have liver disease
Your doctor will decide on the dose you need to take
- have a serious heart complaint (Your doctor may want
each day and you should follow the doctor’s instructions.
to monitor your blood pressure, especially when you
When you first start taking ROPINIROLE, the dose you
first start taking ropinirole)
take will be increased gradually.
- have a serious mental health problem
The starting dose is 0.25 mg once daily. After two days
- have experienced any unusual urges and /or behaviours
your doctor will probably increase your dose to 0.5
(such as excessive gambling or excessive sexual
mg once daily for the remainder of your first week of
behaviour)
treatment. Then your doctor may gradually increase your
- have an intolerence to some sugars (such as lactose)
dose over the next three weeks up to a dose of 2 mg per
Talk to your doctor if you think any of these may apply to
day.
you. If you and your doctor decide that you can take this
If a 2 mg daily dose does not improve your RLS symptoms
medicine, your doctor will probably ask you to have extra
enough, your doctor may gradually increase your dose
check-ups while you are taking it.
some more, up to a maximum of 4 mg daily. After you
Take special care with this medicine
have been taking X for three months, your doctor may
Tell your doctor if you or your family/carer notices
adjust your dose or advise you to stop taking it.
that you are developing urges or cravings to behave in
If you feel that the effects of this medicine are too strong
ways that are unusual for you and you cannot resist the
or too weak, talk to your doctor or your pharmacist. Do not
impulse, drive or temptation to carry out certain activities
take more ropinirole than your doctor has recommended.
that could harm yourself or others. These are called
Carry on taking this medicine as your doctor advises,
impulse control disorders and can include behaviours
even if you do not feel better. Ropinirole may take a few
such as addictive gambling, excessive eating or spending,
weeks to work for you.
an abnormally high sex drive or an increase in sexual
Method of administration
thoughts or feelings. Your doctor may need to adjust or
Swallow the ROPINIROLE tablet(s) whole with a glass
stop your dose.
of water. Do not chew or crush the tablet(s).
If during treatment of Restless Legs Syndrome, your
You can take ROPINIROLE with or without food. If you
symptoms become much worse, start earlier in the day
take ROPINIROLE with food you may be less likely to
or after less time at rest or effect other parts of your body
feel sick (nauseous).
such as your arms, you should contact your doctor who
Parkinson’s disease
may adjust the dose of ROPINIROLE that you are taking.
Take ropinirole 3 times a day.
Other medicines and ropinirole
Restless Legs Syndrome
Tell your doctor or pharmacist if you are taking, have
Ropinirole is usually taken just before bedtime, but can
recently taken or might take any other medicines.
be taken up to 3 hours before going to bed.
Some medicines can affect the way ropinirole works,
or make it more likely that you will have side effects.
Use in children and adolescents
Ropinirole can also affect how some other medicines
ROPINIROLE is not normally prescribed in children and
work. These medicines include:
adolescents under 18 years of age.
− the antibiotics ciprofloxacin or enoxacin.
If you take more ROPINIROLE than you should
− The anti-depressant fluvoxamine
Someone who has taken an overdose may have any of
− HRT (hormone replacement therapy)
these symptoms: feeling sick (nausea) or being sick
− medication for other mental health problems, for
(vomiting), dizziness (a spinning sensation), feeling
example sulpride.
drowsy, mental or physical tiredness, stomach pain,
− any other drug, which blocks dopamine in the brain.
fainting and hallucinations.
− metoclopramide, which is used to treat nausea and
If you take more ROPINIROLE than you should or if
heartburn.
someone else has taken your medicine, tell a doctor or
− cimetidine, used in treatment of stomach ulcers.
pharmacist immediately. Show them the package.
− any other medicine for Parkinson’s disease.
If you forget to take ROPINIROLE
Talk to your doctor if you think any of these may apply to
Do not take a double dose to make up for a forgotten dose.
you. If you and your doctor decide that you can take this
When you do remember to take ROPINIROLE, take your
medicine, your doctor will probably ask you to have extra
next dose of ROPINIROLE at the usual time.
check-ups while you are taking it.
Parkinson’s disease: If you have missed taking
Remember to tell your doctor if you start taking any other
ROPINIROLE for one or more day consult your doctor
medicine while taking ropinirole.
for advice on how to start taking ROPINIROLE again.
Taking ROPINIROLE with food and drink
Restless Legs Syndrome: If you have missed taking
If you take this medicine with food, you may be less
ROPINIROLE for more than a few days consult your
likely to feel sick (nauseous) or be sick (vomit). So it may
doctor for advice on how to start taking ROPINIROLE
be best to take it with food if you can.
again.

If you stop taking ROPINIROLE
Ropinirole may take a few weeks to work for you. 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 symptoms
may quickly get much worse.
If you need to stop taking ropinirole your doctor will
reduce your dose gradually.
If your symptoms worsen after you stop treatment with
ROPINIROLE, you should contact your doctor.
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.
STOP taking Ropinirole and seek immediate medical
attention if you experience any of the following symptoms
of a severe allergic reaction:
• swelling of the face, lips, tongue or throat
• difficultly in swallowing
• difficulty breathing or wheezing
• itchy skin or nettle rash (hives)
• dizziness
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.
Parkinson’s disease
When ROPINIROLE is used to treat Parkinson’s disease,
the following side effects have been reported:
Very common: may affect more than 1 in 10 people
• feeling sick (nausea)
• feeling drowsy
• fainting
Common: may affect up to 1 in 10 people
• fainting, feeling faint or dizzy especially when standing
up
• hallucinations (sensing things that are not real)
• feeling confused
• feeling dizzy (a spinning sensation)
• being sick (vomiting), heartburn, stomach ache
or upset stomach (with indigestion or bloating),
abdominal 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)
Some people taking this medicine have had a
compulsive urge to gamble or increased sexual urges
and / or behaviours.
Not known (cannot be estimated from the available data)
• changes in liver function, which have shown up in
blood tests
• allergic 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.
If you are taking this medicine with L-dopa
People who are taking this medicine 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
If you get any side effects talk to your doctor or pharmacist
as soon as possible. This includes any side effects not
listed in this leaflet.
Restless legs Syndrome
When ROPINIROLE is used to treat Restless Legs
Syndrome, the following effects have been reported:
Very common: may affect more than 1 in 10 people
• feeling sick (nausea)
• being sick (vomiting)
Common: may affect up to 1 in 10 people
• nervousness
• dizziness (or a spinning sensation)
• fainting
• drowsiness
• extreme sleepiness (somnolence)
• fatigue (mental or physical tiredness)
• stomach pain
• worsening of RLS (symptoms may start earlier than
usual or be more intense, or affect other
previously unaffected limbs, such as the arms or return
in the early morning)
Uncommon: may affect up to 1 in 100 people
• confusion
• feeling dizzy or faint, especially when you stand up
suddenly (this is caused by a drop in blood pressure)
• hallucinations (‘seeing’ things that are not really there)
• Very rare: may affect up to 1 in 10,000 people
• changes in liver function, which may have shown up in
blood tests



• feeling very sleepy during the day (extreme
somnolence)
• falling asleep very suddenly without feeling sleepy first
(sudden sleep onset episodes)
Some patients may have the following side effects:
• allergic 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 (see section 2)
• other psychotic reactions in addition to hallucinations,
such as severe confusion (delirium), irrational ideas
(delusions) and irrational suspiciousness (paranoia)
• urges to behave in a way unusual for them such as an
unusual urge to gamble or increased sexual urges and/
or behaviours
During treatment with ROPINIROLE you may experience
unusual worsening of symptoms (e.g. symptoms become
worse, start earlier in the day or after less time at rest, or
affect other parts of your body such as your arms). If this
occurs, you should see your doctor.
If you get any side effects talk to your doctor or pharmacist
as soon as possible. This includes any side effects not
listed in this leaflet.
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 0.25 / 0.5 / 1.0/2.0 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
0.25 mg Hypromellose (E464), Titanium dioxide
(E171), Macrogol 400, Talc (E553b)
0.50 mg Hypromellose (E464), Titanium dioxide
(E171), Macrogol 400, Talc (E553b),
Iron oxide yellow (E172), Indigo carmine
aluminium lake (E132), Iron oxide red
(E172)
1.0 mg Hypromellose (E464), Titanium
dioxide(E171), Macrogol 400, Talc (E553b),
Iron oxide yellow (E172), Indigo carmine
aluminium lake (E132), Iron oxide black
(E172)
2.0 mg Hypromellose (E464), Titanium dioxide
(E171), Macrogol 400, Talc, Iron oxide red
(E172)
What ROPINIROLE looks like and contents of the
pack
Film-coated tablet.
0.25 mg: White to off-white, circular, bevelled edged,
biconvex film coated tablets with ‘253’ debossed on one
side and ‘G’ on the other side.
0.50 mg Pale Yellow to Yellow, circular, bevelled edged,
biconvex film coated tablets with ‘254’ debossed on one
side and ‘G’ on the other side.
1.0 mg Pale Green to Green, circular, bevelled edged,
biconvex film coated tablets with ‘255’ debossed on one
side and ‘G’ on the other side.
2.0 mg Pale Pink to Pink, circular, bevelled edged,
biconvex film coated tablets with ‘256’ 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
0.25 mg film-coated tablets:
Blister: 12, 21, 84 and 126
Bottle: 84
0.5 mg film-coated tablets
Blister: 21, 28 and 84
Bottle: 84
1.0 mg film-coated tablets
Blister: 21 and 84
Bottle: 84
2.0 mg film-coated tablets
Blister: 21, 28 and 84
Bottle: 84
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Glenmark Generics (Europe) Ltd,
Laxmi House, 2-B Draycott Avenue,
Kenton, Harrow, Middlesex HA3 0BU
United Kingdom.
Manufacturer
Glenmark Pharmaceuticals s.r.o Hvězdova 1716/2b, 140
78 Praha 4, Czech Republic
Glenmark Generics (Europe) Limited, The Old Sawmill,
Hatfield Park, Hatfield, Hertfordshire, AL9 5PG, United
Kingdom
This leaflet was last revised in 03/2013.

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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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