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ROPINIROLE 1 MG FILM-COATED TABLETS

Active substance(s): ROPINIROLE HYDROCHLORIDE

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TEVA UK Ref:

231-30-62401-D LEA ROPINIROLE A/S F/C TAB TUK
Version:

1

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

Package leaflet:
Information for the user
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 Teva is and what it is
used for

planning to have a baby, ask your doctor or
pharmacist for advise before taking this
medicine.
Smoking and Ropinirole
Tell your doctor if you start smoking, or give up
smoking, while you are taking Ropinirole. Your
doctor may need to adjust your dose.
Driving and using machines
Ropinirole can make you feel drowsy. In very rare
cases, 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.
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.
Ropinirole contains Lactose
This medicinal product contains Lactose. If you
have been told by your doctor that you have an
intolerance to some sugars, contact your doctor
before taking Ropinirole.

Position for pharmacode

Ropinirole belongs to a group of medicines called
3 How to take Ropinirole Teva
dopamine agonists. Dopamine agonists act in a
similar way to a natural substance called
Always take this medicine exactly as your doctor
dopamine, in the brain.
or pharmacist has told you. You should check with
Ropinirole is used to treat:
your doctor or pharmacist if you are not sure.
• patients with Parkinson’s disease (used alone or
Parkinson’s Disease
in combination with another medicine)
You may be given Ropinirole on its own to treat
• the symptoms of moderate to severe idiopathic
the symptoms of your Parkinson’s disease. Or you
Restless Legs Syndrome.
may be given Ropinirole as well as another
People with Parkinson’s disease have low levels of medicine called L-dopa (also called levodopa).
dopamine in some parts of their brains.
If you are taking L-dopa you may experience some
Ropinirole has effects similar to those of natural
uncontrollable movements (dyskinesias) when
dopamine, so it helps to reduce the symptoms of you first start taking Ropinirole. Tell your doctor if
Parkinson’s disease.
this happens, as your doctor may need to adjust
the dose of the medicines you are taking.
Restless Legs (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 Teva

Do not take Ropinirole
• if you are allergic (hypersensitive) to ropinirole
or any of the other ingredients of this medicine
(listed in section 6)
• if you are allergic (hypersensitive) to soya or
peanut (for Ropinirole 0.5 mg, 1 mg and 2 mg
film-coated tablets only)
• if you have severe kidney problems
• 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 intolerance to some sugars (such as
lactose)

It may take a while to find out the best dose of
Ropinirole for you. The usual 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
usual 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.
Method of administration
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’ll
feel sick (nauseous).

Restless Legs Syndrome
It may take a while to find out the best dose of
Ropinirole for you.
The usual 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
Tell your doctor if you or your family/carer notices Ropinirole for three months, your doctor may
that you are developing urges or cravings to
adjust your dose or advise you to stop taking it.
behave in ways that are unusual for you and you If you feel that the effects of Ropinirole are too
cannot resist the impulse, drive or temptation to
strong or too weak, talk to your doctor or your
carry out certain activities that could harm
pharmacist. Do not take more Ropinirole than
yourself or others. These are called impulse
your doctor has recommended.
control disorders and can include behaviours
Carry on taking Ropinirole as your doctor advises,
such as addictive gambling, excessive eating or
even if you do not feel better. Ropinirole may take
spending, an abnormally high sex drive or an
a few weeks to work for you.
increase in sexual thoughts or feelings. Your
For doses not possible with this medicinal
doctor may need to adjust or stop your dose.
product other strengths of this medicinal product
Tell your doctor if you think any of these may
are available.
apply to you.
Method of administration
Your doctor may need to adjust or stop your
Take your Ropinirole tablet(s) once a day.
dose.
Swallow the tablet(s) whole, with a glass of water.
Do not chew or crush the tablets.
Children and adolescents
You can take Ropinirole with or without food. If
Do not give Ropinirole to children. Ropinirole is
you take it with food, you may be less likely to
not normally prescribed for people under 18.
feel sick (nauseous).
Other medicines and Ropinirole
Ropinirole is usually taken just before bedtime,
Talk to your doctor or pharmacist if you are
but you can take it up to 3 hours before you go to
taking, have recently taken or might take, any
bed.).
other medicines including any herbal remedies or
Use in Children and Adolescents
other medicines you bought without a
Do not give ropinirole to children. Ropinirole is
prescription. Remember to tell your doctor or
not normally prescribed for people under 18.
pharmacist if you begin taking a new medicine
while you are taking Ropinirole.
Older people
Some medicines can affect the way Ropinirole
Ropinirole dose should be individually titrated in
works or make it more likely that you will have
patients over 65 years old, with careful
side effects. Ropinirole can also affect the way
monitoring of tolerability, to the optimal clinical
some other medicines work.
response.
These include:
If you take more Ropinirole than you should
• the anti-depressant fluvoxamine
Contact a doctor or pharmacist immediately. If
• medication for other mental health problems,
possible, show them the Ropinirole pack.
for example sulpiride
Someone who has taken an overdose of
• any other medicine for Parkinson’s disease
Ropinirole may have any of these symptoms:
• any other drug which blocks the action of
feeling sick (nausea), being sick (vomiting),
dopamine in the brain
• metoclopramide, which is used to treat nausea dizziness (a spinning sensation), feeling drowsy,
mental or physical tiredness, fainting,
and heartburn
hallucinations.
• HRT (hormone replacement therapy)
• the antibiotics ciprofloxacin or enoxacin
If you forget to take Ropinirole
• Tell your doctor if you are taking or have
If you forget to take a tablet, just carry on with the
recently taken any of these.
next one as usual. Do not take a double dose to
make up for a forgotten dose.
Ropinirole with food and drink
If you take Ropinirole with food, you may be less If you stop taking Ropinirole
likely to feel sick (nauseous) or be sick (vomit). So Do not take a double dose to make up for a
it may be best to take it with food if you can.
forgotten dose. Just take your next dose at the
usual time.
Pregnancy breast-feeding and fertility
Ropinirole is not recommended if you are
If you have missed taking Ropinirole for more
pregnant, unless your doctor advises that the
than a few days, ask your doctor for advice on
benefit to you of taking ropinirole is greater than how to start taking it again.
the risk to your unborn baby. Ropinirole is not
recommended if you are breast-feeding, as it can If you stop taking Ropinirole
affect your milk production. If you are pregnant or Take Ropinirole for as long as your doctor
breast-feeding, think you may be pregnant or are recommends. Do not stop unless your doctor
advises you to.

07 July 2015

TEVA UK Ref:

231-30-62401-D LEA ROPINIROLE A/S F/C TAB TUK
Version:

1

PAGE 2: REAR FACE (OUTSIDE OF REEL)

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’re worried about side effects, talk to your
doctor.
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 (‘seeing’ things that aren’t really
there)
• being sick (vomiting)
• feeling dizzy (a spinning sensation)
• heartburn
• abdominal pain
• swelling of the legs

5

How to store Ropinirole Teva

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 to 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.

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)

The other ingredients are: lactose monohydrate,
microcrystalline cellulose,
hydroxypropylcellulose, croscarmellose sodium
and magnesium stearate.

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)

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 and 100.
Ropinirole 2 mg comes in pack sizes of 15, 21, 28,
30, 60, 84, 90 and 100.
Not all pack sizes may be marketed.

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,
Not known: frequency cannot be estimated from
lecithin (soya) (E322), iron oxide yellow (E172)
the available data
and iron oxide black (E172)
• a very small number of people have had
• Ropinirole 1 mg (Opadry II 85G11948):
changes in liver function, which have shown up
poly(vinyl alcohol) – partially hydrolyzed,
in blood tests
titanium dioxide (E171), macrogol 3350, talc,
• allergic reactions such as red, itchy swellings on
lecithin (soya) (E322), FD&C Blue #2/ Indigo
the skin (hives), swelling of the face, lips,
Carmine Aluminium (E132) and iron oxide
mouth, tongue or throat which may cause
yellow (E172)
difficulty in swallowing or breathing, rash or
• Ropinirole 2 mg (Opadry II 85G34363):
intense itching
poly(vinyl alcohol) – partially hydrolyzed,
titanium dioxide (E171), macrogol 3350, talc,
If you are taking Ropinirole with L-dopa
lecithin (soya) (E322), carmine (E120), iron
People who are taking Ropinirole with L-dopa may
oxide yellow (E172) and iron oxide black (E172).
develop other side effects over time:
• Uncontrollable movements (dyskinesia) are a
What Ropinirole looks like and contents of the
very common side effect. If you are taking
pack
L-dopa you may experience some
Ropinirole 0.25 mg is a white, round slightly
uncontrollable movements (dyskinesia) when
arched film-coated tablet, debossed “R 0.25” on
you first start taking Ropinirole. Tell your doctor one side and plain on the other.
if this happens, as your doctor may need to
Ropinirole 0.5 mg is a yellow, round slightly
adjust the doses of the medicines you are
arched film-coated tablet, debossed “R 0.5” on
taking
one side and plain on the other.
• Feeling confused is a common side effect
Possible side effects in treatment of Restless Legs Ropinirole 1 mg is a green, round slightly arched
film-coated tablet, debossed “R 1” on one side
Syndrome:
and plain on the other.
Very common: may affect more than 1 in 10
Ropinirole 2 mg is a pink, round slightly arched
people
film-coated tablet, debossed “R 2” on one side
• feeling sick (nausea)
and plain on the other.
• being sick (vomiting).

Marketing Authorisation Holder and Manufacturer
Teva UK Limited, Eastbourne, BN22 9AG
Uncommon: may affect up to 1 in 100 people
• confusion
This leaflet was last revised in March 2015
• hallucinations (‘seeing’ things that are not
PL 00289/1192, 1193, 1194 & 1195
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)
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)
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)
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.

62401-D

07 July 2015

TEVA UK Ref:

231-30-87084-Y LEA ROPINIROLE A/S F/C TAB TUK

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.

Marketing Authorisation Holder and
Manufacturer
Teva UK Limited, Eastbourne, BN22 9AG
This leaflet was last revised in March 2015
PL 00289/1192, 1193, 1194 & 1195

6 Contents of the pack and other
information

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

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

Warnings and precautions
Talk to your doctor or pharmacist before
taking Ropinirole
• if you are pregnant or think you may be
Ropinirole
pregnant
• if you are breast-feeding
Package leaflet:
Information for the user
• if you are under 18 years old
• 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.
• This medicine has been prescribed for you • if you have intolerance to some sugars
(such as lactose)
only. Do not pass it on to others. It may
harm them, even if their signs of illness
Tell your doctor if you or your family/carer
are the same as yours.
notices that you are developing urges or
• If you get any side effects, talk to your
cravings to behave in ways that are unusual
doctor or pharmacist. This includes any
for you and you cannot resist the impulse,
possible side effects not listed in this
drive or temptation to carry out certain
leaflet. See section 4.
activities that could harm yourself or others.
These are called impulse control disorders
What is in this leaflet:
1. What Ropinirole is and what it is used for and can include behaviours such as
addictive gambling, excessive eating or
2. What you need to know before you take
spending, an abnormally high sex drive or
Ropinirole
an increase in sexual thoughts or feelings.
3. How to take Ropinirole
Your doctor may need to adjust or stop your
4. Possible side effects
dose.
5. How to store Ropinirole
6. Contents of the pack and other
information

Tell your doctor if you think any of these
may apply to you.
Your doctor may need to adjust or stop your
1 What Ropinirole Teva is and what it dose.
is used for
Children and adolescents
Ropinirole belongs to a group of medicines Do not give Ropinirole to children.
Ropinirole is not normally prescribed for
called dopamine agonists. Dopamine
people under 18.
agonists act in a similar way to a natural
substance called dopamine, in the brain.
Other medicines and Ropinirole
Talk to your doctor or pharmacist if you are
Ropinirole is used to treat:
taking, have recently taken or might take,
• patients with Parkinson’s disease (used
any other medicines including any herbal
alone or in combination with another
remedies or other medicines you bought
medicine)
without a prescription. Remember to tell
• the symptoms of moderate to severe
your doctor or pharmacist if you begin
idiopathic Restless Legs Syndrome.
taking a new medicine while you are taking
People with Parkinson’s disease have low
Ropinirole.
levels of dopamine in some parts of their
Some medicines can affect the way
brains. Ropinirole has effects similar to
Ropinirole works or make it more likely that
those of natural dopamine, so it helps to
you will have side effects. Ropinirole can
reduce the symptoms of Parkinson’s
also affect the way some other medicines
disease.
work.
Restless Legs (RLS) is also called Ekbom
These include:
syndrome. People with restless legs
• the anti-depressant fluvoxamine
syndrome have an irresistible urge to move • medication for other mental health
their legs, and sometimes their arms and
problems, for example sulpiride
other parts of their bodies. Usually, they
• any other medicine for Parkinson’s disease
have unpleasant sensations in their limbs • any other drug which blocks the action of
sometimes described as ‘crawling’ or
dopamine in the brain
‘bubbling’ - which can begin as soon as they • metoclopramide, which is used to treat
sit or lie down, and are relieved only by
nausea and heartburn
movement. So they often have problems
• HRT (hormone replacement therapy)
with sitting still, and especially with
• the antibiotics ciprofloxacin or enoxacin
sleeping.
• Tell your doctor if you are taking or have
Ropinirole relieves the unpleasant
recently taken any of these.
sensations, and so reduces the urge to
Ropinirole with food and drink
move the legs and other limbs.
If you take Ropinirole with food, you may be
You must talk to a doctor if you do not feel
less likely to feel sick (nauseous) or be sick
better or if you feel worse.
(vomit). So it may be best to take it with

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.

2 What you need to know before

food if you can.

Pregnancy breast-feeding and fertility
Ropinirole is not recommended if you are
Do not take Ropinirole
pregnant, unless your doctor advises that
• if you are allergic (hypersensitive) to
the benefit to you of taking ropinirole is
ropinirole or any of the other ingredients
greater than the risk to your unborn baby.
of this medicine (listed in section 6)
Ropinirole is not recommended if you are
• if you are allergic (hypersensitive) to soya breast-feeding, as it can affect your milk
or peanut (for Ropinirole 0.5 mg, 1 mg and production. If you are pregnant or
2 mg film-coated tablets only)
breast-feeding, think you may be pregnant
• if you have severe kidney problems
or are planning to have a baby, ask your
• if you have liver disease.
doctor or pharmacist for advise before
Tell your doctor if you think any of these
taking this medicine.
may apply to you.

you take Ropinirole Teva

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 and 100.
Ropinirole 2 mg comes in pack sizes of 15,
21, 28, 30, 60, 84, 90 and 100.
Not all pack sizes may be marketed.

02 July 2015

87084-Y
320 x 323

Peel Here To Open

Pharma code :34
First bar is 105mm from top edge.

Pharma code: 34

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.

1

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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.

Version:

TEVA UK Ref:

231-30-87084-Y LEA ROPINIROLE A/S F/C TAB TUK

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Smoking and Ropinirole
Tell your doctor if you start smoking, or give
up smoking, while you are taking Ropinirole.
Your doctor may need to adjust your dose.
Driving and using machines
Ropinirole can make you feel drowsy. In
very rare cases, 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.
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.
Ropinirole contains Lactose
This medicinal product contains Lactose. If
you have been told by your doctor that you
have an intolerance to some sugars, contact
your doctor before taking Ropinirole.

Restless Legs Syndrome
It may take a while to find out the best dose
of Ropinirole for you.
The usual 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.

Method of administration
Take your Ropinirole tablet(s) once a day.
Swallow the tablet(s) 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
3 How to take Ropinirole Teva
less likely to feel sick (nauseous).
Ropinirole is usually taken just before
Always take this medicine exactly as your
doctor or pharmacist has told you. You should bedtime, but you can take it up to 3 hours
before you go to bed.).
check with your doctor or pharmacist if you
Use in Children and Adolescents
are not sure.
Do not give ropinirole to children. Ropinirole
Parkinson’s Disease
is not normally prescribed for people under
You may be given Ropinirole on its own to
18.
treat the symptoms of your Parkinson’s
disease. Or you may be given Ropinirole as Older people
well as another medicine called L-dopa (also Ropinirole dose should be individually
titrated in patients over 65 years old, with
called levodopa).
If you are taking L-dopa you may experience careful monitoring of tolerability, to the
optimal clinical response.
some uncontrollable movements
(dyskinesias) when you first start taking
If you take more Ropinirole than you should
Ropinirole. Tell your doctor if this happens,
Contact a doctor or pharmacist immediately.
as your doctor may need to adjust the dose If possible, show them the Ropinirole pack.
of the medicines you are taking.
Someone who has taken an overdose of
It may take a while to find out the best dose Ropinirole may have any of these
symptoms: feeling sick (nausea), being sick
of Ropinirole for you. The usual starting
(vomiting), dizziness (a spinning sensation),
dose is 0.25 mg of ropinirole three times
each day for the first week. Then your doctor feeling drowsy, mental or physical
tiredness, fainting, hallucinations.
will increase your dose each week, for the
next three weeks. After that your doctor will If you forget to take Ropinirole
gradually increase the dose until you are
If you forget to take a tablet, just carry on
taking the dose that is best for you. The
with the next one as usual. Do not take a
usual is 1 mg to 3 mg three times each day
double dose to make up for a forgotten
(making a total daily dose of 3 mg to 9 mg). dose.
If your Parkinson’s disease symptoms have
If you stop taking Ropinirole
not improved enough, your doctor may
Do not take a double dose to make up for a
decide to gradually increase your dose
forgotten dose. Just take your next dose at
some more.
the usual time.
Some people take up to 8 mg of Ropinirole
If you have missed taking Ropinirole for
three times a day (24 mg daily altogether).
more than a few days, ask your doctor for
If you are also taking other medicines for
advice on how to start taking it again.
Parkinson’s disease, your doctor may advise
If you stop taking Ropinirole
you to gradually reduce the dose of the
Take Ropinirole for as long as your doctor
other medicine.
recommends. Do not stop unless your
Don’t take any more Ropinirole than your
doctor advises you to.
doctor has recommended.
If you suddenly stop taking Ropinirole your
It may take a few weeks for Ropinirole to
Parkinson’s disease symptoms may quickly
work for you.
get much worse.
Method of administration
If you need to stop taking Ropinirole your
Take Ropinirole three times a day.
doctor will reduce your dose gradually.
Swallow your Ropinirole tablets whole, with
If you have any further questions on the use
a glass of water. It’s best to take Ropinirole
of this medicine, ask your doctor or
with food, because that makes it less likely
pharmacist.
that you’ll feel sick (nauseous).

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02 July 2015

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Possible side effects

• stomach pain
• worsening of RLS (symptoms may start
earlier than usual or be more intense, or
Like all medicines, this medicine can cause
affect other previously unaffected limbs,
side effects, although not everybody gets
such as the arms or return in the early
them.
morning)
The side effects of Ropinirole are more likely
to happen when you first start taking it, or
Uncommon: may affect up to 1 in 100
when your dose has just been increased.
people
They are usually mild, and may become less • confusion
troublesome after you have taken the dose
• hallucinations (‘seeing’ things that are not
for a while.
really there)
If you’re worried about side effects, talk to
• feeling dizzy or faint, especially when you
your doctor.
stand up suddenly (this is caused by a
drop in blood pressure)
The following side effects have been
reported at the approximate frequencies
Very rare: may affect up to 1 in 10,000
shown:
people
• changes in liver function, which have
Possible side effects in treatment of
shown up in blood tests
Parkinson’s disease
Very common: may affect more than 1 in 10 • feeling very sleepy during the day
(extreme somnolence)
people
• falling asleep very suddenly without
• fainting
feeling sleepy first (sudden sleep onset
• feeling drowsy
episodes)
• feeling sick (nausea)
Some patients may have the following side
Common: may affect up to 1 in 10 people
effects
• hallucinations (‘seeing’ things that aren’t
• allergic reactions such as red, itchy
really there)
swellings on the skin (hives), swelling of
• being sick (vomiting)
the face, lips, mouth, tongue or throat
• feeling dizzy (a spinning sensation)
which may cause difficulty in swallowing
• heartburn
or breathing, rash or intense itching (see
• abdominal pain
Section 2)
• swelling of the legs
• other psychotic reactions in addition to
Uncommon: may affect up to 1 in 100
hallucinations, such as severe confusion
people
(delirium), irrational ideas (delusions) and
• feeling dizzy or faint, especially when you
irrational suspiciousness (paranoia)
stand up suddenly (this is caused by a
drop in blood pressure)
Possible side effects in treatment of
• feeling very sleepy during the day
Restless Legs Syndrome and Parkinson’s
(extreme somnolence)
disease
• falling asleep very suddenly without
Some patients may have the following side
feeling sleepy first (sudden sleep onset
effects:
episodes)
• Inability to resist the impulse, drive or
• mental problems such as delirium (severe
temptation to perform an action that could
confusion), delusions (unreasonable
be harmful to you or others, which may
ideas) or paranoia (unreasonable
include:
suspicions)
• strong impulse to gamble excessively
despite serious personal or family
Not known: frequency cannot be estimated
consequences
from the available data
• altered or increased sexual interest and
• a very small number of people have had
behaviour of significant concern to you
changes in liver function, which have
or to others, for example, an increased
shown up in blood tests
sexual drive
• allergic reactions such as red, itchy
• uncontrollable excessive shopping or
swellings on the skin (hives), swelling of
spending
the face, lips, mouth, tongue or throat
• binge eating (eating large amounts of
which may cause difficulty in swallowing
food in a short time period) or
or breathing, rash or intense itching
compulsive eating (eating more food
If you are taking Ropinirole with L-dopa
than normal and more than is needed to
People who are taking Ropinirole with
satisfy your hunger)
L-dopa may develop other side effects over
Ropinirole 0.5/1/2 mg film-coated tablets:
time:
lecithin (soya) may cause very rarely allergic
• Uncontrollable movements (dyskinesia)
reactions.
are a very common side effect. If you are
Reporting of side effects
taking L-dopa you may experience some
If you get any side effects, talk to your
uncontrollable movements (dyskinesia)
when you first start taking Ropinirole. Tell doctor or pharmacist. This includes any
your doctor if this happens, as your doctor possible side effects not listed in this leaflet.
You can also report side effects directly via
may need to adjust the doses of the
the Yellow Card Scheme at:
medicines you are taking
• Feeling confused is a common side effect www.mhra.gov.uk/yellowcard. By reporting
side effects you can help provide more
Possible side effects in treatment of
information on the safety of this medicine.
Restless Legs Syndrome:

4

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)

5 How to store Ropinirole Teva
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.

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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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