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ROPINIROLE 1 MG FILM-COATED TABLETS

Active substance: ROPINIROLE HYDROCHLORIDE

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Ref:

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

1

Trackwise Parent:

N/A

PL Number(s),
MA Holder & Packer:
Reason for revision:

EAN Code:
Pharma Code:
Edge Code:
Third party code:
Fonts:

231-10-06632, 06633, 06643, 06653
and 231-10-06656
N/A
TBC
N/A
TBC
Univers

Base Font Size:

Child:

N/A

PL 00289/1192-1195. Teva UK Limited Licence, Teva Regulatory Team.
Packed at Debrecen, Hungary.
V1: Correction of PL Number and QRD updates.

F. P. Code:

17 April 2013

8 Pt

Dimensions:
L:
W:
Foil Width:
Perforated:

320 mm
160 mm
N/A
N/A

Colours:
(PANTONE® is a registered
trademark of Pantone, Inc.)

PANTONE® GREEN C
BLACK
D5 (PANTONE® 123 C)
S3 (PANTONE® 232 C)

IMPORTANT: Artwork, text and content must not be reset, remade, amended or altered. The only exceptions to this are: bleeds, chokes, spreads or other print related adjustments required for reproduction by the supplier.
We must receive a copy of any 3rd Party Supplier’s Proof before approval to print will be granted.

PAGE 1: FRONT FACE (INSIDE OF REEL)

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.
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

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.
Children and adolescents
Ropinirole is not recommended for use in children
and adolescents below 18 years.
Other medicines and Ropinirole
Talk to your doctor if you are taking any of the
following:
• high doses of oestrogens (hormone
replacement therapy)
• medicines known to inhibit the cytochrome
P450 isoenzyme CYP1A2, such as ciprofloxacin
(an antibiotic), enoxacin (an antibiotic) or
fluvoxamine (used to treat depression)
• stop or start smoking (your dose may need to
be adjusted)
• antipsychotic medicines and other medicines
that block dopamine receptors in the brain,
such as sulpiride (used to treat schizophrenia)
or metoclopramide (used to treat nausea and
vomiting).
Please tell your doctor or pharmacist if you are
taking or have recently taken any other
medicines, including medicines obtained without
a prescription.
Ropinirole with food and drink
Ropinirole should be taken with food to improve
your ability to tolerate this medicine.

Pregnancy, breast-feeding and fertility
Ropinirole is not recommended if you are
pregnant, unless your doctor advises that the
benefit to you of taking ropinirole is greater than
the risk to your unborn baby. Ropinirole is not
Ropinirole is used to treat:
recommended if you are breast-feeding, as it can
• patients with Parkinson’s disease (used alone or affect your milk production. Tell your doctor
in combination with another medicine)
immediately if you are pregnant, if you think you
• the symptoms of moderate to severe idiopathic might be pregnant, or if you are planning to
Restless Legs Syndrome.
become pregnant. Your doctor will also advise you
if you are breast-feeding or planning to do so. Your
Restless Legs Syndrome is a condition
doctor may advise you to stop taking ropinirole.
characterised by an irresistible urge to move the
legs and occasionally the arms, usually
Driving and using machines
accompanied by uncomfortable sensations such
Ropinirole may cause some people to become
as tingling, burning or prickling. These feelings
sleepy or drowsy and/or develop sudden sleep
occur during periods of rest or inactivity such as
episodes. If this happens to you, do not drive or
sitting or lying down, especially in bed, and are
take on activities where impaired alertness may
worse in the evening or at night. Usually the only put you or others at risk of serious injury or death
relief is obtained by walking about or moving the (e.g. operating machines) until the sleepiness or
affected limbs, which often leads to problems
drowsiness and/or sudden sleep episodes have
sleeping.
disappeared.
Ropinirole relieves the discomfort and reduces
Important information about some of the
the urge to move the limbs that disrupts night
ingredients of Ropinirole
time sleep.
This medicinal product contains lactose. If you
WHAT YOU NEED TO KNOW BEFORE YOU have been told by your doctor that you have an
2 TAKE ROPINIROLE
intolerance to some sugars, contact your doctor
before taking Ropinirole.
Do not take Ropinirole
• if you are allergic (hypersensitive) to ropinirole
3 HOW TO TAKE ROPINIROLE
or any of the other ingredients of Ropinirole
Always take Ropinirole exactly as your doctor has
• if you are allergic (hypersensitive) to soya or
told you. You should check with your doctor or
peanut (for Ropinirole 0.5 mg, 1 mg and 2 mg
pharmacist if you are not sure.
film-coated tablets only)
• if you have severe kidney problems
Parkinson’s Disease
• if you have liver problems.
The initial dose is 0.25 mg three times a day for
1 week (0.75 mg/day). Afterwards, your doctor
Warnings and precautions
may increase the dose according to the following
Talk to your doctor before taking Ropinirole
• if you have neuroleptic akathisia (an inability to schedule:
sit still or remain motionless caused by an
Week
antipsychotic medicine), tasikinesia (a
compulsive tendency to walk caused by an
1
2
3
4
antipsychotic medicine), or secondary Restless
Unit dose (mg), to be
Legs Syndrome (caused by kidney problems,
0.25
0.5
0.75
1.0
taken 3 times a day
low iron anaemia or pregnancy)
• if your Restless Legs Syndrome symptoms
Total daily dose (mg) 0.75
1.5
2.25 3.0
become worse earlier in the day or there is a
reoccurrence of the symptoms in the early
Following this, your doctor may continue to
morning hours (your dosage may need to be
gradually increase the dose, up to a maximum of
adjusted or treatment stopped)
24 mg/day.
• if you become sleepy or drowsy, or have
episodes of sudden sleep onset (your dosage
Restless Legs Syndrome
may need to be adjusted or treatment stopped) The dose should be taken just before bedtime,
• if you have major psychiatric or psychotic
but can be taken up to 3 hours before retiring.
disorders
The initial dose is 0.25 mg once a day for 2 days.
• if you have severe heart disease (blood
Afterwards, the dose can be increased in the
pressure monitoring is recommended).
following weeks to a maximum of 4 mg once a day.
• if you are taking any medicines used to treat
For doses not possible with this medicinal
high blood pressure and medicines used to
product other strengths of this medicinal product
suppress fast rhythms of the heart.
are available.
Tell your doctor if you or your family/carer notices
Use in Children and Adolescents
that you are developing urges or cravings to
behave in ways that are unusual for you and you Ropinirole is not recommended for use in children
below 18 years.
cannot resist the impulse, drive or temptation to
carry out certain activities that could harm
yourself or others. These are called impulse
Ropinirole belongs to a group of medicines called
dopamine agonists. This group of medicines
mimics the effect of dopamine (a compound in
the brain), which activates dopamine receptors.

Position for pharmacode

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

Position for pharmacode

Ref:

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

1

N/A

Trackwise Parent:

PL Number(s),
MA Holder & Packer:
Reason for revision:

EAN Code:
Pharma Code:
Edge Code:
Third party code:
Fonts:

231-10-06632, 06633, 06643, 06653
and 231-10-06656
N/A
TBC
N/A
TBC
Univers

Base Font Size:

Child:

N/A

PL 00289/1192-1195. Teva UK Limited Licence, Teva Regulatory Team.
Packed at Debrecen, Hungary.
V1: Correction of PL Number and QRD updates.

F. P. Code:

17 April 2013

8 Pt

Dimensions:
L:
W:

320 mm
160 mm

Foil Width:
Perforated:

Colours:
(PANTONE® is a registered
trademark of Pantone, Inc.)

PANTONE® GREEN C
BLACK
D5 (PANTONE® 123 C)

N/A
N/A

S3 (PANTONE® 232 C)

IMPORTANT: Artwork, text and content must not be reset, remade, amended or altered. The only exceptions to this are: bleeds, chokes, spreads or other print related adjustments required for reproduction by the supplier.
We must receive a copy of any 3rd Party Supplier’s Proof before approval to print will be granted.

PAGE 2: REAR FACE (OUTSIDE OF REEL)

Elderly
The dose should be increased in those over
65 years. This increase should be gradual.

5

HOW TO STORE ROPINIROLE

Keep out of the sight and reach of children.
Do not use Ropinirole after the expiry date that 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
If you take more Ropinirole than you should
in the original container.
If you (or someone else) swallow a lot of the
Ropinirole 1 mg: Do not store above 30ºC. Store
tablets all together or if you think a child has
swallowed any of the tablets, contact your nearest in the original container.
Ropinirole 2 mg: Do not store above 30ºC. Store
hospital casualty department or your doctor
in the original container.
immediately. Please take this leaflet, any
remaining tablets and the container with you to
Do not throw away any medicines via wastewater
the hospital or doctor so that they know which
or household waste. Ask your pharmacist how to
tablets were consumed.
throw away medicines you no longer use. These
measures will help to protect the environment.
If you forget to take Ropinirole
If you forget to take a tablet, just carry on with the
next one as usual. Do not take a double dose to
6 CONTENTS OF THE PACK AND OTHER
INFORMATION
make up for a forgotten dose.
If you stop taking Ropinirole
Contact your doctor if your symptoms get worse
when you stop taking Ropinirole.
If you have any further questions on the use of
this product, ask your doctor or pharmacist.

4

POSSIBLE SIDE EFFECTS

Like all medicines, Ropinirole can cause side
effects, although not everybody gets them.
The following side effects have been reported at
the approximate frequencies shown:
Very common (affecting more than one person
in 10):
• Sleepiness
• Fainting
• Abnormal muscular movements
• Feeling sick (nausea)
• Being sick (vomiting).
Common (affecting fewer than one person in 10
but more than one person in 100):
• Hallucinations (seeing things that are not really
there)
• Confusion
• Dizziness (including vertigo)
• Abdominal pain
• Heartburn
• Swollen legs
• Nervousness
• Fainting (in Restless Legs Syndrome)
• Sleepiness
• Fatigue (mental or physical tiredness).
Uncommon (affecting fewer than one person in
100 but more than one person in 1,000):
• Psychotic reactions (other than hallucinations)
including delirium, delusions and paranoia
• Excessive daytime sleepiness and sudden
onset of sleep (in Parkinson’s Disease)
• Low blood pressure
• A fall in blood pressure on standing up which
causes dizziness, light-headedness or fainting.

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).

Position for pharmacode

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
Very rare (affecting fewer than one person in
one side and plain on the other.
10,000):
• Liver reactions and increased liver enzymes.
Ropinirole 0.5 mg is a yellow, round slightly
arched film-coated tablet, debossed “R 0.5” on
Some patients may have the following side
one side and plain on the other.
effects:
• Inability to resist the impulse, drive or
Ropinirole 1 mg is a green, round slightly arched
temptation to perform an action that could be
film-coated tablet, debossed “R 1” on one side
harmful to you or others, which may include:
and plain on the other.
• strong impulse to gamble excessively despite Ropinirole 2 mg is a pink, round slightly arched
serious personal or family consequences.
film-coated tablet, debossed “R 2” on one side
• altered or increased sexual interest and
and plain on the other.
behaviour of significant concern to you or to
Ropinirole 0.25 mg comes in pack sizes of 12, 15,
others, for example, an increased sexual
21, 24, 30, 60, 81, 84, 90, 100, 126, 210 and 50 unit
drive.
dose blisters (hospital presentation pack).
• uncontrollable excessive shopping or
Ropinirole 0.5 mg comes in pack sizes of 15, 21,
spending
• binge eating (eating large amounts of food in 28, 30, 60, 84, 90, 100 and 126.
Ropinirole 1 mg comes in pack sizes of 15, 21, 30,
a short time period) or compulsive eating
60, 84, 90 and 100.
(eating more food than normal and more
Ropinirole 2 mg comes in pack sizes of 15, 21, 28,
than is needed to satisfy your hunger).
30, 60, 84, 90 and 100.
• Ropinirole 0.5/1/2 mg film-coated tablets:
Not all pack sizes may be marketed.
lecithin (soya) may cause very rarely allergic
reactions.
Marketing Authorisation Holder and Manufacturer
If any of the side effects get serious, or if you
notice any side effects not listed in this leaflet or
if you experience any of these behaviours, please
tell your doctor or pharmacist; they will discuss
ways of managing or reducing the symptoms.

Teva UK Limited, Eastbourne, BN22 9AG
This leaflet was last revised in October 2012
PL 00289/1192, 1193, 1194 & 1195

62401-B

Position for pharmacode

Method of administration
The film-coated tablets should be swallowed
whole with liquid and should be taken with food,
to reduce the chance of feeling or being sick.

Ref:

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

Version:

1

06 March 2013

163970

Trackwise Parent:

PL Number(s),
MA Holder & Packer:
Reason for revision:

231-10-06633/06643/06653
34 (00011)
TBC
Univers
8 Pt

188102

PL 00289/1192-5. TEVA UK Limited Licence (Post Licence Regulatory Team),
Packed at TEVA UK Limited, Eastbourne. Packing line: Uhlmann.
Leaflet PL correction.

F. P. Code:
Pharma Code:
Third party code:
Fonts:
Base Font Size:

Child:

Dimensions:
L:
W:

323 mm
160 mm

Colours:
(PANTONE® is a registered
trademark of Pantone, Inc.)

PANTONE® GREEN C
BLACK

Please refer to the latest version of
the full base material specification:
92653, 92655, 92651

IMPORTANT: Artwork, text and content must not be reset, remade, amended or altered. The only exceptions to this are: bleeds, chokes, spreads or other print related adjustments required for reproduction by the supplier.
We must receive a copy of any 3rd Party Supplier’s Proof before approval to print will be granted.

PAGE 1: FRONT FACE (INSIDE OF REEL)

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.
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
Pharma code: 34

1 WHAT ROPINIROLE IS AND WHAT IT IS
USED FOR

Ropinirole belongs to a group of medicines called
dopamine agonists. This group of medicines mimics
the effect of dopamine (a compound in the brain),
which activates dopamine receptors.

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.
Children and adolescents
Ropinirole is not recommended for use in children
and adolescents below 18 years.
Other medicines and Ropinirole
Talk to your doctor if you are taking any of the
following:
• high doses of oestrogens (hormone replacement
therapy)
• medicines known to inhibit the cytochrome P450
isoenzyme CYP1A2, such as ciprofloxacin (an
antibiotic), enoxacin (an antibiotic) or fluvoxamine
(used to treat depression)
• stop or start smoking (your dose may need to be
adjusted)
• antipsychotic medicines and other medicines that
block dopamine receptors in the brain, such as
sulpiride (used to treat schizophrenia) or
metoclopramide (used to treat nausea and
vomiting).
Please tell your doctor or pharmacist if you are
taking or have recently taken any other medicines,
including medicines obtained without a prescription.
Ropinirole with food and drink
Ropinirole should be taken with food to improve
your ability to tolerate this medicine.

Pregnancy breast-feeding and fertility
Ropinirole is not recommended if you are pregnant,
unless your doctor advises that the benefit to you of
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
Restless Legs Syndrome is a condition characterised
production. Tell your doctor immediately if you are
by an irresistible urge to move the legs and
pregnant, if you think you might be pregnant, or if
occasionally the arms, usually accompanied by
you are planning to become pregnant. Your doctor
uncomfortable sensations such as tingling, burning
will also advise you if you are breast-feeding or
or prickling. These feelings occur during periods of
planning to do so. Your doctor may advise you to
rest or inactivity such as sitting or lying down,
stop taking ropinirole.
especially in bed, and are worse in the evening or at
night. Usually the only relief is obtained by walking Driving and using machines
Ropinirole may cause some people to become sleepy
about or moving the affected limbs, which often
or drowsy and/or develop sudden sleep episodes. If
leads to problems sleeping.
this happens to you, do not drive or take on activities
Ropinirole relieves the discomfort and reduces the
where impaired alertness may put you or others at
urge to move the limbs that disrupts night time
risk of serious injury or death (e.g. operating
sleep.
machines) until the sleepiness or drowsiness and/or
sudden sleep episodes have disappeared.
WHAT YOU NEED TO KNOW BEFORE
Ropinirole is used to treat:
• patients with Parkinson’s disease (used alone or in
combination with another medicine)
• the symptoms of moderate to severe idiopathic
Restless Legs Syndrome.

2

YOU TAKE ROPINIROLE

Do not take Ropinirole
• if you are allergic (hypersensitive) to ropinirole or
any of the other ingredients of Ropinirole
• 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 problems.
Warnings and precautions
Talk to your doctor before taking Ropinirole
• if you have neuroleptic akathisia (an inability to sit
still or remain motionless caused by an
antipsychotic medicine), tasikinesia (a compulsive
tendency to walk caused by an antipsychotic
medicine), or secondary Restless Legs Syndrome
(caused by kidney problems, low iron anaemia or
pregnancy)
• if your Restless Legs Syndrome symptoms
become worse earlier in the day or there is a
reoccurrence of the symptoms in the early
morning hours (your dosage may need to be
adjusted or treatment stopped)
• if you become sleepy or drowsy, or have episodes
of sudden sleep onset (your dosage may need to
be adjusted or treatment stopped)
• if you have major psychiatric or psychotic
disorders
• if you have severe heart disease (blood pressure
monitoring is recommended)
• if you are taking any medicines used to treat high
blood pressure and medicines used to suppress
fast rhythms of the heart.

Important information about some of the
ingredients of Ropinirole
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.

3

HOW TO TAKE ROPINIROLE

Always take Ropinirole exactly as your doctor has
told you. You should check with your doctor or
pharmacist if you are not sure.
Parkinson’s Disease
The initial dose is 0.25 mg three times a day for
1 week (0.75 mg/day). Afterwards, your doctor may
increase the dose according to the following schedule:
Week
1

2

3

4

Unit dose (mg), to be
taken 3 times a day

0.25

0.5

0.75

1.0

Total daily dose (mg)

0.75

1.5

2.25

3.0

Following this, your doctor may continue to
gradually increase the dose, up to a maximum of
24 mg/day.
Restless Legs Syndrome
The dose should be taken just before bedtime, but
can be taken up to 3 hours before retiring. The initial
dose is 0.25 mg once a day for 2 days. Afterwards,
the dose can be increased in the following weeks to
a maximum of 4 mg once a day.

Top of page cut-off to middle of registration mark: 44 mm.

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

Ref:

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

Version:

1

Trackwise Parent:

163970

PL Number(s),
MA Holder & Packer:
Reason for revision:

231-10-06633/06643/06653
34 (00011)
TBC
Univers
8 Pt

Child:

188102

PL 00289/1192-5. TEVA UK Limited Licence (Post Licence Regulatory Team),
Packed at TEVA UK Limited, Eastbourne. Packing line: Uhlmann.
Leaflet PL correction.

F. P. Code:
Pharma Code:
Third party code:
Fonts:
Base Font Size:

06 March 2013

Dimensions:
L:
W:

323 mm
160 mm

Colours:
(PANTONE® is a registered
trademark of Pantone, Inc.)

PANTONE® GREEN C
BLACK

Please refer to the latest version of
the full base material specification:
92653, 92655, 92651

IMPORTANT: Artwork, text and content must not be reset, remade, amended or altered. The only exceptions to this are: bleeds, chokes, spreads or other print related adjustments required for reproduction by the supplier.
We must receive a copy of any 3rd Party Supplier’s Proof before approval to print will be granted.

PAGE 2: REAR FACE (OUTSIDE OF REEL)

For doses not possible with this medicinal product
other strengths of this medicinal product are available.
Use in Children and Adolescents
Ropinirole is not recommended for use in children
below 18 years.
Elderly
The dose should be increased in those over 65
years. This increase should be gradual.
Method of administration
The film-coated tablets should be swallowed whole
with liquid and should be taken with food, to reduce
the chance of feeling or being sick.
If you take more Ropinirole than you should
If you (or someone else) swallow a lot of the tablets
all together or if you think a child has swallowed any
of the tablets, contact your nearest hospital casualty
department or your doctor immediately. Please take
this leaflet, any remaining tablets and the container
with you to the hospital or doctor so that they know
which tablets were consumed.
If you forget to take Ropinirole
If you forget to take a tablet, just carry on with the
next one as usual. Do not take a double dose to
make up for a forgotten dose.
If you stop taking Ropinirole
Contact your doctor if your symptoms get worse
when you stop taking Ropinirole.
If you have any further questions on the use of this
product, ask your doctor or pharmacist.

4

POSSIBLE SIDE EFFECTS

Like all medicines, Ropinirole can cause side effects,
although not everybody gets them.
The following side effects have been reported at the
approximate frequencies shown:

5

HOW TO STORE ROPINIROLE

Keep out of the sight and reach of children.
Do not use Ropinirole after the expiry date that 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.
The other ingredients are: lactose monohydrate,
microcrystalline cellulose, hydroxypropylcellulose,
croscarmellose sodium and magnesium stearate.

Very common (affecting more than one person in 10):
The tablet coating contains:
• Sleepiness
• Ropinirole 0.25 mg (Opadry II 85F18422):
• Fainting
poly(vinyl alcohol) – partially hydrolyzed, titanium
• Abnormal muscular movements
dioxide (E171), macrogol 3350 and talc.
• Feeling sick (nausea)
• Ropinirole 0.5 mg (Opadry II 85G32558): poly(vinyl
• Being sick (vomiting).
alcohol) – partially hydrolyzed, titanium dioxide
Common (affecting fewer than one person in 10 but
(E171), macrogol 3350, talc, lecithin (soya) (E322),
more than one person in 100):
iron oxide yellow (E172) and iron oxide black (E172).
• Hallucinations (seeing things that are not really
• Ropinirole 1 mg (Opadry II 85G11948): poly(vinyl
there)
alcohol) – partially hydrolyzed, titanium dioxide
• Confusion
(E171), macrogol 3350, talc, lecithin (soya) (E322),
• Dizziness (including vertigo)
FD&C Blue #2/ Indigo Carmine Aluminium (E132)
• Abdominal pain
and iron oxide yellow (E172).
• Heartburn
• Ropinirole 2 mg (Opadry II 85G34363): poly(vinyl
• Swollen legs
alcohol) – partially hydrolyzed, titanium dioxide
• Nervousness
(E171), macrogol 3350, talc, lecithin (soya) (E322),
• Fainting (in Restless Legs Syndrome)
carmine (E120), iron oxide yellow (E172) and iron
• Sleepiness
oxide black (E172).
• Fatigue (mental or physical tiredness).
What Ropinirole looks like and contents of the pack:
Uncommon (affecting fewer than one person in 100 Ropinirole 0.25 mg is a white, round slightly arched
but more than one person in 1,000):
film-coated tablet, debossed “R 0.25” on one side
• Psychotic reactions (other than hallucinations)
and plain on the other.
including delirium, delusions and paranoia
Ropinirole 0.5 mg is a yellow, round slightly arched
• Excessive daytime sleepiness and sudden onset
film-coated tablet, debossed “R 0.5” on one side and
of sleep (in Parkinson’s Disease)
plain on the other.
• Low blood pressure
Ropinirole 1 mg is a green, round slightly arched
• A fall in blood pressure on standing up which
film-coated tablet, debossed “R 1” on one side and
causes dizziness, light-headedness or fainting.
plain on the other.
Very rare (affecting fewer than one person in 10,000): Ropinirole 2 mg is a pink, round slightly arched
film-coated tablet, debossed “R 2” on one side and
• Liver reactions and increased liver enzymes.
plain on the other.
Some patients may have the following side effects:
• Inability to resist the impulse, drive or temptation Ropinirole 0.25 mg comes in pack sizes of 12, 15, 21,
to perform an action that could be harmful to you 24, 30, 60, 81, 84, 90, 100, 126, 210 and 50 unit dose
blisters (hospital presentation pack).
or others, which may include:
Ropinirole 0.5 mg comes in pack sizes of 15, 21, 28,
• strong impulse to gamble excessively despite
30, 60, 84, 90, 100 and 126.
serious personal or family consequences
Ropinirole 1 mg comes in pack sizes of 15, 21, 30, 60,
• altered or increased sexual interest and
84, 90 and 100.
behaviour of significant concern to you or to
Ropinirole 2 mg comes in pack sizes of 15, 21, 28, 30,
others, for example, an increased sexual drive
• uncontrollable excessive shopping or spending 60, 84, 90 and 100.
• binge eating (eating large amounts of food in a Not all pack sizes may be marketed.
short time period) or compulsive eating (eating
Marketing Authorisation Holder and Manufacturer
more food than normal and more than is
Teva UK Limited, Eastbourne, BN22 9AG
needed to satisfy your hunger).
• Ropinirole 0.5/1/2 mg film-coated tablets: lecithin This leaflet was last revised in October 2012
(soya) may cause very rarely allergic reactions.
PL 00289/1192, 1193, 1194 & 1195
If any of the side effects get serious, or if you notice
any side effects not listed in this leaflet or if you
experience any of these behaviours, please tell your
doctor or pharmacist; they will discuss ways of
managing or reducing the symptoms.
87084-W

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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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