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ROPINIROLE 1 MG FILM-COATED TABLETS

Active substance(s): ROPINIROLE HYDROCHLORIDE

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Teva Pharmaceuticals Europe B.V
Effective Date: 11-Aug-2017

REG0074369

Version 6.0
Effective

BLACK

Template

• falling asleep very suddenly without
feeling sleepy first (sudden sleep onset
episodes)

6 Contents of the pack and other
information

Ropinirole 1 mg: Do not store above 30ºC.
Store in the original container.
Ropinirole 2 mg: Do not store above 30ºC.
Store in the original container.

Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Teva UK Limited, Eastbourne, BN22 9AG

Do not throw away any medicines via
This leaflet was last revised in May 2017.
wastewater or household waste. Ask your
PL 00289/1192, 1193, 1194 & 1195
pharmacist how to throw away medicines
EAS1195a
you no longer use. These measures will help
87084-ZB
protect the environment.
320 x 323

PAGE 1: AFTER FOLDING FRONT FACE (INSIDE OF REEL AFTER FOLDING AND TACKING)

Warnings and precautions
Talk to your doctor or pharmacist before
taking Ropinirole
• if you are pregnant or think you may be
pregnant.
• if you are breast-feeding.

if
you are under 18 years old.
Package leaflet: Information for the patient
• if you have a serious heart complaint.
Read all of this leaflet carefully before you
• if you have a serious mental health
start taking this medicine because it
problem.
contains important information for you.
• if you have experienced any unusual
- Keep this leaflet. You may need to read it
urges and/or behaviours (such as
again.
excessive gambling or excessive sexual
- If you have any further questions, ask your
behaviour).
doctor or pharmacist.
• if you have an intolerance to some sugars
- This medicine has been prescribed for you
(such as lactose).
only. Do not pass it on to others. It may
Tell your doctor if you or your family/carer
harm them, even if their signs of illness
notices that you are developing urges or
are the same as yours.
cravings to behave in ways that are unusual
- If you get any side effects, talk to your
for you and you cannot resist the impulse,
doctor or pharmacist. This includes any
drive or temptation to carry out certain
possible side effects not listed in this
activities that could harm yourself or others.
leaflet. See section 4.
These are called impulse control disorders
What is in this leaflet
and can include behaviours such as
addictive gambling, excessive eating or
1. What Ropinirole is and what it is used for
spending, an abnormally high sex drive or
2. What you need to know before you take an increase in sexual thoughts or feelings.
Ropinirole
Your doctor may need to adjust or stop your
3. How to take Ropinirole
dose.

Ropinirole 0.25 mg Film-Coated Tablets
Ropinirole 0.5 mg Film-Coated Tablets
Ropinirole 1 mg Film-Coated Tablets
Ropinirole 2 mg Film-Coated Tablets
Ropinirole

4. Possible side effects
5. How to store Ropinirole
6. Contents of the pack and other
information

1 What Ropinirole is and what it is
used for

The active ingredient in Ropinirole
Film-Coated Tablets is ropinirole, which
belongs to a group of medicines called
dopamine agonists. Dopamine agonists
affect the brain in a similar way to a natural
substance called dopamine.
Ropinirole is used to treat:
• Parkinson’s disease
• the symptoms of moderate to severe
restless legs syndrome.
People with Parkinson’s disease have low
levels of dopamine in some parts of their
brains. Ropinirole has effects similar to those
of natural dopamine, so it helps to reduce
the symptoms of Parkinson’s disease.
Restless legs syndrome (RLS) is also called
Ekbom syndrome. People with restless legs
syndrome have an irresistible urge to move
their legs, and sometimes their arms and
other parts of their bodies. Usually, they
have unpleasant sensations in their limbs sometimes described as ‘crawling’ or
‘bubbling’ - which can begin as soon as they
sit or lie down, and are relieved only by
movement. So they often have problems
with sitting still, and especially with
sleeping.
Ropinirole relieves the unpleasant
sensations, and so reduces the urge to
move the legs and other limbs.
You must talk to a doctor if you do not feel
better or if you feel worse.

2 What you need to know before
you take Ropinirole

Do not take Ropinirole
• if you are allergic to ropinirole or any of
the other ingredients of this medicine
(listed in section 6)
• if you are allergic to soya or peanut (for
Ropinirole 0.5 mg, 1 mg and 2 mg
film-coated tablets only)
• if you have serious kidney disease
• if you have liver disease.
Tell your doctor if you think any of these
may apply to you.

Tell your doctor if you think any of these
may apply to you.
Your doctor may decide that Ropinirole isn't
suitable for you or that you need extra
check-ups while you are taking it.
Tell your doctor if you experience symptoms
such as depression, apathy, anxiety, fatigue,
sweating or pain after stopping or reducing
your ropinirole treatment. If the problems
persist more than a few weeks, your doctor
may need to adjust your treatment.
Children
Do not give Ropinirole to children.
Ropinirole is not normally prescribed for
people under 18.
Other medicines and Ropinirole
Tell your doctor or pharmacist if you are
taking, have recently taken or might take
any other medicines including any herbal
remedies or other medicines you bought
without a prescription.
Some medicines can affect the way
Ropinirole works or make it more likely that
you will have side effects. Ropinirole can
also affect the way some other medicines
work.
These include:
• the anti-depressant fluvoxamine
• HRT (hormone replacement therapy)
• the antibiotics ciprofloxacin or enoxacin
• medication for other mental health
problems, for example sulpiride
• metoclopramide, which is used to treat
nausea and heartburn
• cimetidine, used in the treatment of
stomach ulcers
• any other medicine for Parkinson’s disease
• any other drug which blocks the action of
dopamine in the brain
Tell your doctor if you are taking or have
recently taken any of these.
Remember to tell your doctor if you start
taking any other medicine while you’re
taking Ropinirole.
You will require additional blood tests if you
are taking these medicines with Ropinirole:
• Vitamin K antagonists (used to reduce
blood clotting) such as Warfarin
(coumadin).

Peel Here To Open

06-Oct-2017

Page 1 of 4

Pharma code :644
First bar is 105mm from top edge.

What Ropinirole contains
The active substance is ropinirole
hydrochloride.
• Each Ropinirole 0.25 mg film-coated tablet
contains 0.285 mg ropinirole
hydrochloride, equivalent to 0.25 mg
ropinirole.
• Each Ropinirole 0.5 mg film-coated tablet
contains 0.57 mg ropinirole hydrochloride,
equivalent to 0.5 mg ropinirole.
• Each Ropinirole 1 mg film-coated tablet
contains 1.14 mg ropinirole hydrochloride,
equivalent to 1 mg ropinirole.
• Each Ropinirole 2 mg film-coated tablet
contains 2.28 mg ropinirole hydrochloride,
Possible side effects in treatment of Restless
equivalent to 2 mg ropinirole.
Legs Syndrome and Parkinson’s disease
The other ingredients are lactose
Some patients may have the following side
monohydrate, microcrystalline cellulose,
effects:
hydroxypropylcellulose, croscarmellose
• inability to resist the impulse, drive or
sodium and magnesium stearate.
temptation to perform an action that could
The tablet coating contains:
be harmful to you or others, which may
• Ropinirole 0.25 mg (Opadry II 85F18422):
include:
poly (vinyl alcohol) – partially hydrolyzed,
• strong impulse to gamble excessively
titanium dioxide (E171), macrogol 3350
despite serious personal or family
and talc.
consequences.
• Ropinirole 0.5 mg (Opadry II 85G32558):
• altered or increased sexual interest and
poly(vinyl alcohol) – partially hydrolyzed,
behaviour of significant concern to you
titanium dioxide (E171), macrogol 3350,
or to others, for example, an increased
talc, lecithin (soya) (E322), iron oxide
sexual drive.
yellow (E172) and iron oxide black (E172).
• uncontrollable excessive shopping or
• Ropinirole 1 mg (Opadry II 85G11948):
spending
poly(vinyl alcohol) – partially hydrolyzed,
• binge eating (eating large amounts of
titanium dioxide (E171), macrogol 3350,
food in a short time period) or
talc, lecithin (soya) (E322), FD&C Blue #2/
compulsive eating (eating more food
Indigo Carmine Aluminium (E132) and
than normal and more than is needed to
iron oxide yellow (E172).
satisfy your hunger)
• Ropinirole 2 mg (Opadry II 85G34363):
• excessive use of Ropinirole (craving for
poly(vinyl alcohol) – partially hydrolyzed,
large doses of dopaminergic drugs in
titanium dioxide (E171), macrogol 3350,
excess of that required to control motor
talc, lecithin (soya) (E322), carmine (E120),
symptoms, known as dopamine
iron oxide yellow (E172) and iron oxide
dysregulation syndrome)
black (E172).
Tell your doctor if you experience any of
What Ropinirole looks like and contents of
these behaviours; they will discuss ways of
the pack
managing or reducing the symptoms
Ropinirole 0.25 mg is a white, round slightly
Ropinirole 0.5/1/2 mg film-coated tablets:
arched film-coated tablet, debossed “R 0.25”
lecithin (soya) may cause very rarely allergic on one side and plain on the other.
reactions.
Ropinirole 0.5 mg is a yellow, round slightly
Reporting of side effects
arched film-coated tablet, debossed “R 0.5”
If you get any side effects, talk to your
on one side and plain on the other.
doctor or pharmacist. This includes any
Ropinirole 1 mg is a green, round slightly
possible side effects not listed in this leaflet.
arched film-coated tablet, debossed “R 1”
You can also report side effects directly via
on one side and plain on the other.
the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard. By reporting Ropinirole 2 mg is a pink, round slightly
arched film-coated tablet, debossed “R 2”
side effects you can help provide more
on one side and plain on the other.
information on the safety of this medicine.
Ropinirole 0.25 mg comes in pack sizes of
12, 15, 21, 24, 30, 60, 81, 84, 90, 100, 126, 210
5 How to store Ropinirole
and 50 unit dose blisters (hospital
Keep this medicine out of the sight and
presentation pack).
reach of children.
Ropinirole 0.5 mg comes in pack sizes of 15,
Do not use this medicine after the expiry
21, 28, 30, 60, 84, 90, 100 and 126.
date which is stated on the blister foil and
Ropinirole 1 mg comes in pack sizes of 15,
carton after EXP. The expiry date refers to
21, 30, 60, 84, 90, 100 and 50 unit dose
the last day of that month
blisters (hospital pack).
Ropinirole 0.25 mg: Do not store above
Ropinirole 2 mg comes in pack sizes of 15,
25ºC. Store in the original container.
Ropinirole 0.5 mg: Do not store above 25ºC. 21, 28, 30, 60, 84, 90 and 100 and 50 unit
dose blisters (hospital pack).
Store in the original container.

Not known: frequency cannot be estimated
from the available data
Some patients may have the following side
effects
• other psychotic reactions in addition to
hallucinations, such as severe confusion
(delirium), irrational ideas (delusions)
and irrational suspiciousness (paranoia)
• aggression
• after stopping or reducing your
Ropinirole treatment: Depression,
apathy, anxiety, fatigue, sweating or
pain may occur (called dopamine
agonist withdrawal syndrome or DAWS)

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Teva Pharmaceuticals Europe B.V
Effective Date: 11-Aug-2017

REG0074369

Version 6.0
Effective

BLACK

Template

PAGE 2: LEFT HAND INSIDE FACE AFTER FOLDING AND TACKING

How much Ropinirole will you need to take?
Ropinirole with food and drink
If you take Ropinirole with food, you may be It may take a while to find out the best dose
less likely to feel sick or be sick (vomit). So
of Ropinirole for you.
it‘s best to take it with food if you can.
The recommended starting dose is 0.25 mg
Pregnancy and breast-feeding
of ropinirole three times each day for the
Ropinirole is not recommended if you are
first week. Then your doctor will increase
pregnant, unless your doctor advises that the your dose each week, for the next three
benefit to you taking Ropinirole is greater than weeks. After that your doctor will gradually
the risk to your unborn baby. Ropinirole is not increase the dose until you are taking the
recommended if you are breast-feeding, as it dose that is best for you. The recommended
can affect your milk production.
dose is 1 mg to 3 mg three times each day
If you are pregnant or breast-feeding, think (making a total daily dose of 3 mg to 9 mg).
If your Parkinson’s disease symptoms have
you may be pregnant or are planning to
have a baby, ask your doctor or pharmacist not improved enough, your doctor may
decide to gradually increase your dose
for advice before taking this medicine.
some more.
Your doctor may advise you to stop taking
Some people take up to 8 mg of Ropinirole
Ropinirole.
three times a day (24 mg daily altogether).
Driving and using machines
Ropinirole can make you feel drowsy. It can If you are also taking other medicines for
Parkinson’s disease, your doctor may advise
make people feel extremely sleepy and it
you to gradually reduce the dose of the
sometimes makes people fall asleep very
other medicine.
suddenly without warning.
Don’t take any more Ropinirole than your
If you could be affected: don’t drive, don’t
doctor has recommended.
operate machines and don’t put yourself in
It may take a few weeks for Ropinirole to
any situation where feeling sleepy or falling
work for you.
asleep could put you (or other people) at
Taking your dose of Ropinirole
risk of serious injury or death. Don’t take
part in these activities until you are no
Take Ropinirole three times a day.
longer affected.
Swallow your Ropinirole tablets whole, with
Talk to your doctor if this causes problems
a glass of water. It’s best to take Ropinirole
for you.
with food, because that makes it less likely
Ropinirole can cause hallucinations (seeing, that you will feel sick (nauseous).
hearing or feeling things that are not there). Restless Legs Syndrome
If affected, do not drive or use machines.
How much Ropinirole will you need to take?
If your symptoms get worse
It may take a while to find out what is the
Some people taking Ropinirole find that
best dose of Ropinirole for you.
their RLS symptoms get worse - for
example, symptoms may start earlier than
The recommended starting dose is 0.25 mg
usual or be more intense, or affect other
once a day. After two days, your doctor will
previously unaffected limbs, such as the
probably increase your dose to 0.5 mg daily
arms or return in the early morning.
for the rest of the week. Then your doctor
Tell your doctor as soon as possible if you
may gradually increase your dose over the
get any of these symptoms.
next three weeks, up to a daily dose of 2 mg.
Ropinirole contains lactose
If a 2 mg daily dose does not improve your
Ropinirole tablets contain a small amount of RLS symptoms enough, your doctor may
a sugar called lactose. If you have an
gradually increase your dose some more,
intolerance to lactose or any other sugars,
up to a maximum of 4 mg daily. After you
ask your doctor for advice before you take
have been taking Ropinirole for three
Ropinirole.
months, your doctor may adjust your dose
or advise you to stop taking it.
Smoking and Ropinirole
Tell your doctor or nurse if you start
If you feel that the effects of Ropinirole are
smoking, or give up smoking, while you are too strong or too weak, talk to your doctor
taking Ropinirole. Your doctor may need to
or your pharmacist. Do not take more
adjust your dose.
Ropinirole than your doctor has
recommended.

3 How to take Ropinirole
Always take this medicine exactly as your
doctor or pharmacist has told you. Check
with your doctor or pharmacist if you are
not sure.
Parkinson’s disease
You may be given Ropinirole on its own to
treat the symptoms of your Parkinson’s
disease, or you may be given Ropinirole as
well as another medicine called L-dopa (also
called levodopa).
If you are taking L-dopa you may experience
some uncontrollable movements
(dyskinesias) when you first start taking
Ropinirole. Tell your doctor if this happens,
as your doctor may need to adjust the dose
of the medicines you are taking.

Carry on taking Ropinirole as your doctor
advises, even if you do not feel better.
Ropinirole may take a few weeks to work for
you.
For doses not possible with this medicinal
product other strengths of this medicinal
product are available.
Taking your dose of Ropinirole
Take your Ropinirole tablet once a day.
Swallow the Ropinirole tablets whole, with a
glass of water. Do not chew or crush the
tablets.

You can take Ropinirole with or without
food. If you take it with food, you may be
less likely to feel sick (nauseous).
Ropinirole is usually taken just before
bedtime, but you can take it up to 3 hours
Tell your doctor if you or your family notices before you go to bed.
that you are developing any unusual
Use in children and adolescents
behaviours (such as an unusual urge to
Do not give ropinirole to children. Ropinirole
gamble or increased sexual urges and/or
behaviours) while you are taking Ropinirole. is not normally prescribed for people under
Your doctor may need to adjust or stop your 18.
dose.

06-Oct-2017

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Elderly
Ropinirole dose should be individually
titrated in patients over 65 years old, with
careful monitoring of tolerability, to the
optimal clinical response.

Possible side effects in treatment of
Parkinson’s disease
Very common: may affect more than 1 in 10
people
• fainting
• feeling drowsy
If you take more Ropinirole than you should

feeling sick (nausea)
Contact a doctor or pharmacist immediately.
If possible, show them the Ropinirole pack. Common: may affect up to 1 in 10 people
Someone who has taken an overdose of
• hallucinations (‘sensing’ things that are
Ropinirole may have any of these
not real)
symptoms: feeling sick (nausea), being sick
• being sick (vomiting)
(vomiting), dizziness (a spinning sensation),
• feeling dizzy (a spinning sensation)
feeling drowsy, mental or physical tiredness,
• heartburn
fainting, hallucinations.
• stomach pain
• swelling of the legs, feet and hands
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.

Uncommon: may affect up to 1 in 100
people
• feeling dizzy or faint, especially when
you stand up suddenly (this is caused
Parkinson’s disease: If you have missed
by a drop in blood pressure)
taking Ropinirole for one day or more, ask
feeling
very sleepy during the day

your doctor for advice on how to start taking
(extreme somnolence)
it again.
• falling asleep very suddenly without
Restless Legs Syndrome: If you have missed
feeling sleepy first (sudden sleep onset
taking Ropinirole for more than a few days,
episodes)
ask your doctor for advice on how to start
• mental problems such as delirium
taking it again.
(severe confusion), delusions
(unreasonable ideas) or paranoia
Do not stop taking Ropinirole without
(unreasonable suspicions)
advice.
Take Ropinirole for as long as your doctor
recommends.
Do not stop using Ropinirole suddenly
without talking to your doctor. A sudden
stop could cause you to develop a medical
condition called neuroleptic malignant
syndrome which may represent a major
health risk. The symptoms include: akinesia
(loss of muscle movement), rigid muscles,
fever, unstable blood pressure, tachycardia
(increased heart rate), confusion, depressed
level of consciousness (e.g. coma).

Not known: frequency cannot be estimated
from the available data
• changes in liver function, which have
shown up in blood tests.
• aggression
• after stopping or reducing your Ropinirole
treatment: Depression, apathy, anxiety,
fatigue, sweating or pain may occur
(called dopamine agonist withdrawal
syndrome or DAWS)

If you are taking Ropinirole with L-dopa
People who are taking Ropinirole with
L-dopa may develop other side effects over
If you suddenly stop taking Ropinirole your time:
Parkinson’s disease symptoms may quickly • uncontrollable movements (dyskinesias)
get much worse.
are a very common side effect. Tell your
doctor if this happens, as your doctor may
If you need to stop taking Ropinirole your
need to adjust the doses of the medicines
doctor will reduce your dose gradually .
you are taking
If you have any further questions on the use

feeling confused is a common side effect
of 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 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 tell your doctor
immediately or go to the casualty
department at your nearest hospital, if the
following happens:
• 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).
These are very serious but rare side effects
with unknown frequency. You may need
urgent medical attention or hospitalisation.
The following side effects have been
reported at the approximate frequencies
shown:

Possible side effects in treatment of
Restless Legs Syndrome:
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
• fainting
• drowsiness
• fatigue (mental or physical tiredness)
• dizziness (a ‘spinning’ sensation)
• 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
• hallucinations (‘seeing’ things that are
not really there)
• feeling dizzy or faint, especially when
you stand up suddenly (this is caused
by a drop in blood pressure)
Very rare: may affect up to 1 in 10,000
people
• changes in liver function, which have
shown up in blood tests
• feeling very sleepy during the day
(extreme somnolence)

Page 2 of 4

Teva Pharmaceuticals Europe B.V
Effective Date: 11-Aug-2017
ZINC Ref:

REG0114445

EAS1196a LEA ROPINEROLE 0.25MG, 0.5MG, 1MG & 2MG FC TAB TUK
Version:

2

26 June 2017

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PANTONE® GREEN C

Version 4.0
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PAGE 1: FRONT FACE (INSIDE OF REEL)

Ropinirole 0.25 mg Film-Coated Tablets
Ropinirole 0.5 mg Film-Coated Tablets
Ropinirole 1 mg Film-Coated Tablets
Ropinirole 2 mg Film-Coated Tablets

Ropinirole with food and drink
If you take Ropinirole with food, you may be less
likely to feel sick or be sick (vomit). So it‘s best to
take it with food if you can.

Ropinirole

Pregnancy and breast-feeding
Ropinirole is not recommended if you are
pregnant, unless your doctor advises that the
benefit to you taking Ropinirole is greater than
the risk to your unborn baby. Ropinirole is not
recommended if you are breast-feeding, as it can
affect your milk production.

Package leaflet:
Information for the patient
Read all of this leaflet carefully before you start
taking this medicine because it contains
important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your
doctor or pharmacist.
- This medicine has been prescribed for you only.
Do not pass it on to others. It may harm them,
even if their signs of illness are the same as
yours.
- If you get any side effects, talk to your doctor
or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Ropinirole is and what it is used for
2. What you need to know before you take
Ropinirole
3. How to take Ropinirole
4. Possible side effects
5. How to store Ropinirole
6. Contents of the pack and other information

1

What Ropinirole is and what it is used
for

The active ingredient in Ropinirole Film-Coated
Tablets is ropinirole, which belongs to a group of
medicines called dopamine agonists. Dopamine
agonists affect the brain in a similar way to a
natural substance called dopamine.

Your doctor may advise you to stop taking
Ropinirole.
Driving and using machines
Ropinirole can make you feel drowsy. It can make
people feel extremely sleepy and it sometimes
makes people fall asleep very suddenly without
warning.
If you could be affected: don’t drive, don’t operate
machines and don’t put yourself in any situation
where feeling sleepy or falling asleep could put
you (or other people) at risk of serious injury or
death. Don’t take part in these activities until you
are no longer affected.
Talk to your doctor if this causes problems for you.
Ropinirole can cause hallucinations (seeing,
hearing or feeling things that are not there). If
affected, do not drive or use machines.

Position for pharmacode

Ropinirole is used to treat:
• Parkinson’s disease
• the symptoms of moderate to severe restless
legs syndrome.

If your symptoms get worse
Some people taking Ropinirole find that their RLS
symptoms get worse - for example, 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.
Tell your doctor as soon as possible if you get any
of these symptoms.

People with Parkinson’s disease have low levels of
dopamine in some parts of their brains.
Ropinirole has effects similar to those of natural
dopamine, so it helps to reduce the symptoms of
Parkinson’s disease.

Ropinirole contains lactose
Ropinirole tablets contain a small amount of a
sugar called lactose. If you have an intolerance to
lactose or any other sugars, ask your doctor for
advice before you take Ropinirole.

Restless legs syndrome (RLS) is also called
Ekbom syndrome. People with restless legs
syndrome have an irresistible urge to move their
legs, and sometimes their arms and other parts of
their bodies. Usually, they have unpleasant
sensations in their limbs - sometimes described
as ‘crawling’ or ‘bubbling’ - which can begin as
soon as they sit or lie down, and are relieved only
by movement. So they often have problems with
sitting still, and especially with sleeping.
Ropinirole relieves the unpleasant sensations,
and so reduces the urge to move the legs and
other limbs.
You must talk to a doctor if you do not feel better
or if you feel worse.

Smoking and Ropinirole
Tell your doctor or nurse if you start smoking, or
give up smoking, while you are taking Ropinirole.
Your doctor may need to adjust your dose.

2

What you need to know before you
take Ropinirole

Do not take Ropinirole
• if you are allergic to ropinirole or any of the other
ingredients of this medicine (listed in section 6)
• if you are allergic to soya or peanut (for
Ropinirole 0.5 mg, 1 mg and 2 mg film-coated
tablets only)
• if you have serious kidney disease
• if you have liver disease.
Tell your doctor if you think any of these may
apply to you.
Warnings and precautions
Talk to your doctor or pharmacist before taking
Ropinirole
• if you are pregnant or think you may be pregnant.
• if you are breast-feeding.
• if you are under 18 years old.
• if you have a serious heart complaint.
• if you have a serious mental health problem.
• if you have experienced any unusual urges
and/or behaviours (such as excessive gambling
or excessive sexual behaviour).
• if you have an intolerance to some sugars (such
as lactose).
Tell your doctor if you or your family/carer notices
that you are developing urges or cravings to
behave in ways that are unusual for you and you
cannot resist the impulse, drive or temptation to
carry out certain activities that could harm
yourself or others. These are called impulse
control disorders and can include behaviours
such as addictive gambling, excessive eating or
spending, an abnormally high sex drive or an
increase in sexual thoughts or feelings. Your
doctor may need to adjust or stop your dose.
Tell your doctor if you think any of these may
apply to you.
Your doctor may decide that Ropinirole isn't
suitable for you or that you need extra check-ups
while you are taking it.
Tell your doctor if you experience symptoms such
as depression, apathy, anxiety, fatigue, sweating
or pain after stopping or reducing your ropinirole
treatment. If the problems persist more than a
few weeks, your doctor may need to adjust your
treatment.
Children
Do not give Ropinirole to children. Ropinirole is
not normally prescribed for people under 18.
Other medicines and Ropinirole
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines including any herbal remedies or other
medicines you bought without a prescription.
Some medicines can affect the way Ropinirole
works or make it more likely that you will have
side effects. Ropinirole can also affect the way
some other medicines work.
These include:
• the anti-depressant fluvoxamine
• HRT (hormone replacement therapy)
• the antibiotics ciprofloxacin or enoxacin
• medication for other mental health problems,
for example sulpiride
• metoclopramide, which is used to treat nausea
and heartburn
• cimetidine, used in the treatment of stomach
ulcers
• any other medicine for Parkinson’s disease
• any other drug which blocks the action of
dopamine in the brain
Tell your doctor if you are taking or have recently
taken any of these.
Remember to tell your doctor if you start taking
any other medicine while you’re taking
Ropinirole.
You will require additional blood tests if you are
taking these medicines with Ropinirole:
• Vitamin K antagonists (used to reduce blood
clotting) such as Warfarin (coumadin).

06-Oct-2017

If you are pregnant or breast-feeding, think you
may be pregnant or are planning to have a baby,
ask your doctor or pharmacist for advice before
taking this medicine.

3

How to take Ropinirole

Always take this medicine exactly as your doctor
or pharmacist has told you. Check with your
doctor or pharmacist if you are not sure.
Parkinson’s disease
You may be given Ropinirole on its own to treat
the symptoms of your Parkinson’s disease, or you
may be given Ropinirole as well as another
medicine called L-dopa (also called levodopa).
If you are taking L-dopa you may experience some
uncontrollable movements (dyskinesias) when
you first start taking Ropinirole. Tell your doctor if
this happens, as your doctor may need to adjust
the dose of the medicines you are taking.
Tell your doctor if you or your family notices that
you are developing any unusual behaviours (such
as an unusual urge to gamble or increased sexual
urges and/or behaviours) while you are taking
Ropinirole. Your doctor may need to adjust or stop
your dose.
How much Ropinirole will you need to take?
It may take a while to find out the best dose of
Ropinirole for you.
The recommended starting dose is 0.25 mg of
ropinirole three times each day for the first week.
Then your doctor will increase your dose each week,
for the next three weeks. After that your doctor will
gradually increase the dose until you are taking the
dose that is best for you. The recommended dose is
1 mg to 3 mg three times each day (making a total
daily dose of 3 mg to 9 mg). If your Parkinson’s
disease symptoms have not improved enough, your
doctor may decide to gradually increase your dose
some more.
Some people take up to 8 mg of Ropinirole three
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.
Taking your dose of Ropinirole
Take Ropinirole three times a day.
Swallow your Ropinirole tablets whole, with a
glass of water. It’s best to take Ropinirole with
food, because that makes it less likely that you
will feel sick (nauseous).
Restless Legs Syndrome
How much Ropinirole will you need to take?
It may take a while to find out what is the best
dose of Ropinirole for you.
The recommended starting dose is 0.25 mg once
a day. After two days, your doctor will probably
increase your dose to 0.5 mg daily for the rest of
the week. Then your doctor may gradually
increase your dose over the next three weeks, up
to a daily dose of 2 mg.
If a 2 mg daily dose does not improve your RLS
symptoms enough, your doctor may gradually
increase your dose some more, up to a maximum
of 4 mg daily. After you have been taking
Ropinirole for three months, your doctor may
adjust your dose or advise you to stop taking it.
If you feel that the effects of Ropinirole are too
strong or too weak, talk to your doctor or your
pharmacist. Do not take more Ropinirole than
your doctor has recommended.
Carry on taking Ropinirole as your doctor advises,
even if you do not feel better. Ropinirole may take
a few weeks to work for you.
For doses not possible with this medicinal
product other strengths of this medicinal product
are available.
Taking your dose of Ropinirole
Take your Ropinirole tablet once a day.
Swallow the Ropinirole tablets whole, with a glass
of water. Do not chew or crush the tablets.
You can take Ropinirole with or without food. If
you take it with food, you may be less likely to
feel sick (nauseous).
Ropinirole is usually taken just before bedtime,
but you can take it up to 3 hours before you go to
bed.

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Use in children and adolescents
Do not give ropinirole to children. Ropinirole is
not normally prescribed for people under 18.
Elderly
Ropinirole dose should be individually titrated in
patients over 65 years old, with careful monitoring
of tolerability, to the optimal clinical response.
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), being sick (vomiting), dizziness (a
spinning sensation), feeling drowsy, mental or
physical tiredness, fainting, 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.
Parkinson’s disease: If you have missed taking
Ropinirole for one day or more, ask your doctor
for advice on how to start taking it again.
Restless Legs Syndrome: If you have missed taking
Ropinirole for more than a few days, ask your
doctor for advice on how to start taking it again.
Do not stop taking Ropinirole without advice.
Take Ropinirole for as long as your doctor
recommends.
Do not stop using Ropinirole suddenly without
talking to your doctor. A sudden stop could cause
you to develop a medical condition called
neuroleptic malignant syndrome which may
represent a major health risk. The symptoms
include: akinesia (loss of muscle movement), rigid
muscles, fever, unstable blood pressure,
tachycardia (increased heart rate), confusion,
depressed level of consciousness (e.g. coma).
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 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 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 tell your doctor
immediately or go to the casualty department at
your nearest hospital, if the following happens:
• 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).
These are very serious but rare side effects with
unknown frequency. You may need urgent
medical attention or hospitalisation.
The following side effects have been reported at
the approximate frequencies shown:
Possible side effects in treatment of Parkinson’s
disease
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, feet and hands
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)
Not known: frequency cannot be estimated from
the available data
• changes in liver function, which have shown up
in blood tests.
• aggression
• after stopping or reducing your Ropinirole
treatment: Depression, apathy, anxiety, fatigue,
sweating or pain may occur (called dopamine
agonist withdrawal syndrome or DAWS)
If you are taking Ropinirole with L-dopa
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
Possible side effects in treatment of Restless Legs
Syndrome:
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
• fainting
• drowsiness
• fatigue (mental or physical tiredness)
• dizziness (a ‘spinning’ sensation)
• 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
• hallucinations (‘seeing’ things that are not
really there)
• feeling dizzy or faint, especially when you
stand up suddenly (this is caused by a drop
in blood pressure)
Very rare: may affect up to 1 in 10,000 people
• changes in liver function, which 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)

06-Oct-2017

Not known: frequency cannot be estimated from
the available data
Some patients may have the following side effects
• other psychotic reactions in addition to
hallucinations, such as severe confusion
(delirium), irrational ideas (delusions) and
irrational suspiciousness (paranoia)
• aggression
• after stopping or reducing your Ropinirole
treatment: Depression, apathy, anxiety, fatigue,
sweating or pain may occur (called dopamine
agonist withdrawal syndrome or DAWS)
Possible side effects in treatment of Restless Legs
Syndrome and Parkinson’s disease
Some patients may have 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)
• excessive use of Ropinirole (craving for large
doses of dopaminergic drugs in excess of that
required to control motor symptoms, known
as dopamine dysregulation syndrome)
Tell your doctor if you experience any of these
behaviours; they will discuss ways of managing
or reducing the symptoms
Ropinirole 0.5/1/2 mg film-coated tablets: lecithin
(soya) may cause very rarely allergic reactions.
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 at:
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 foil and carton after EXP. The
expiry date refers to the last day of that month
Ropinirole 0.25 mg: Do not store above 25ºC.
Store in the original container.
Ropinirole 0.5 mg: Do not store above 25ºC. Store
in the original container.
Ropinirole 1 mg: Do not store above 30ºC. Store
in the original container.
Ropinirole 2 mg: Do not store above 30ºC. Store
in the original container.
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 protect the environment.

6

Contents of the pack and other
information

What Ropinirole contains
The active substance is ropinirole hydrochloride.
• Each Ropinirole 0.25 mg film-coated tablet
contains 0.285 mg ropinirole hydrochloride,
equivalent to 0.25 mg ropinirole.
• Each Ropinirole 0.5 mg film-coated tablet
contains 0.57 mg ropinirole hydrochloride,
equivalent to 0.5 mg ropinirole.
• Each Ropinirole 1 mg film-coated tablet
contains 1.14 mg ropinirole hydrochloride,
equivalent to 1 mg ropinirole.
• Each Ropinirole 2 mg film-coated tablet
contains 2.28 mg ropinirole hydrochloride,
equivalent to 2 mg ropinirole.
The other ingredients are lactose monohydrate,
microcrystalline cellulose, hydroxypropylcellulose,
croscarmellose sodium and magnesium stearate.
The tablet coating contains:
• Ropinirole 0.25 mg (Opadry II 85F18422): poly
(vinyl alcohol) – partially hydrolyzed, titanium
dioxide (E171), macrogol 3350 and talc.
• Ropinirole 0.5 mg (Opadry II 85G32558):
poly(vinyl alcohol) – partially hydrolyzed,
titanium dioxide (E171), macrogol 3350, talc,
lecithin (soya) (E322), iron oxide yellow (E172)
and iron oxide black (E172).
• Ropinirole 1 mg (Opadry II 85G11948):
poly(vinyl alcohol) – partially hydrolyzed, titanium
dioxide (E171), macrogol 3350, talc, lecithin
(soya) (E322), FD&C Blue #2/ Indigo Carmine
Aluminium (E132) and iron oxide yellow (E172).
• Ropinirole 2 mg (Opadry II 85G34363):
poly(vinyl alcohol) – partially hydrolyzed,
titanium dioxide (E171), macrogol 3350, talc,
lecithin (soya) (E322), carmine (E120), iron
oxide yellow (E172) and iron oxide black (E172).
What Ropinirole looks like and contents of the pack
Ropinirole 0.25 mg is a white, round slightly
arched film-coated tablet, debossed “R 0.25” on
one side and plain on the other.
Ropinirole 0.5 mg is a yellow, round slightly
arched film-coated tablet, debossed “R 0.5” on
one side and plain on the other.
Ropinirole 1 mg is a green, round slightly arched
film-coated tablet, debossed “R 1” on one side
and plain on the other.
Ropinirole 2 mg is a pink, round slightly arched
film-coated tablet, debossed “R 2” on one side
and plain on the other.
Ropinirole 0.25 mg comes in pack sizes of 12, 15,
21, 24, 30, 60, 81, 84, 90, 100, 126, 210 and 50 unit
dose blisters (hospital presentation pack).
Ropinirole 0.5 mg comes in pack sizes of 15, 21,
28, 30, 60, 84, 90, 100 and 126.
Ropinirole 1 mg comes in pack sizes of 15, 21, 30, 60,
84, 90, 100 and 50 unit dose blisters (hospital pack).
Ropinirole 2 mg comes in pack sizes of 15, 21, 28,
30, 60, 84, 90 and 100 and 50 unit dose blisters
(hospital pack).
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Teva UK Limited, Eastbourne, BN22 9AG
This leaflet was last revised in May 2017.
PL 00289/1192, 1193, 1194 & 1195

EAS1196a

Page 2 of 4

+ Expand Transcript

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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