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ROPINIROLE 5 MG FILM-COATED TABLETS

Active substance(s): ROPINIROLE HYDROCHLORIDE

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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

Ropinirole belongs to a group of medicines
called dopamine agonists. This group of
medicines mimicks the effect of dopamine (a
compound in the brain), which activates
dopamine receptors.
Ropinirole is used to treat patients with
Parkinson’s disease (used alone or in
combination with another medicine).

2

WHAT YOU NEED TO KNOW BEFORE
YOU TAKE ROPINIROLE

Do not take Ropinirole
• if you are allergic (hypersensitive) to
ropinirole, Ponceau 4R or any of the other
ingredients of Ropinirole
• if you have severe kidney problems
• if you have liver problems.
Warnings and precautions
Talk to your doctor before taking Ropinirole
• 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.

Position for pharmacode

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
ciprofloxacine (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 production. Tell your
doctor immediately if you are pregnant, if you
think you might be pregnant, or if you are
planning to become pregnant. Your doctor will
also advise you if you are breast-feeding or
planning to do so. Your doctor may advise you
to stop taking ropinirole.
Driving and using machines
Ropinirole may cause some people to become
sleepy or drowsy and/or develop sudden sleep
episodes. If this happens to you, do not drive or
take on activities where impaired alertness may
put you or others at risk of serious injury or
death (e.g. operating machines) until the
sleepiness or drowsiness and/or sudden sleep
episodes have disappeared.
Important information about some of the
ingredients of Ropinirole
If you have been told by your doctor that you
have an intolerance to some sugars (lactose),
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.
The initial dose is 0.25 mg three times a day for
1 week (0.75 mg/day). Afterwards, the dose can
be increased by 0.25 mg three times a day in
the following weeks. The dose may be increased
up to a maximum of 24 mg/day.
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 and adolescents 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.
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.

Position for pharmacode

ROPINIROLE 5 mg
FILM-COATED TABLETS

PAGE 2: REAR FACE (OUTSIDE OF REEL)

POSSIBLE SIDE EFFECTS

Like all medicines, Ropinirole can cause side
effects, although not everybody gets them.

6

CONTENTS OF THE PACK AND OTHER
INFORMATION

What Ropinirole contains
The following side effects have been reported at The active substance is ropinirole hydrochloride.
Each Ropinirole 5 mg film-coated tablet
the approximate frequencies shown:
contains 5.70 mg ropinirole hydrochloride,
Very common (affecting more than one person equivalent to 5 mg ropinirole.
in 10):
The other ingredients are: lactose monohydrate,
• fainting
microcrystalline cellulose,
• feeling drowsy
hydroxypropylcellulose, croscarmellose sodium
• feeling sick (nausea).
and magnesium stearate.
Common (affecting fewer than one person in 10
The tablet coating (Opadry II 85F30590)
but more than one person in 100):
contains: poly(vinyl alcohol) – partially
• hallucinations (seeing things that are not
hydrolyzed, titanium dioxide (E171), macrogol
really there)
3350, talc, FD&C Blue #2/ Indigo Carmine
• being sick (vomiting)
Aluminium E132 and Ponceau 4R Aluminium
• feeling dizzy (a spinning sensation)
Lake E124.
• heartburn
What Ropinirole looks like and contents of the
• abdominal pain
pack
• swelling of the legs.
Uncommon (affecting fewer than one person in Ropinirole 5 mg is a blue, round slightly arched
film-coated tablet, debossed “R 5” on one side
100 but more than one person in 1,000):
and plain on the other.
• 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).
Very rare (affecting fewer than one person in
10,000):
• a very small number of people have had
changes in liver function, which have shown
up in blood tests.

Ropinirole 5 mg comes in pack sizes of 15, 21,
30, 60, 84, 90 and 100.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Teva UK Limited, Eastbourne, BN22 9AG
This leaflet was last revised in October 2012
PL 00289/1196

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).
• Ponceau 4 R may cause allergic reactions.
When Ropinirole is taken with Levodopa/L-Dopa
you may also experience the following side
effects:
Very common:
• uncontrollable jerky movement.
Common:
• feeling confused.

Position for pharmacode

If any of the side effects get serious, if you
notice any side effects not listed in this leaflet or
if you experience any of these behaviors, please
tell your doctor or pharmacist they will discuss
ways of managing or reducing the symptoms.

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.
Do not store above 30°C. 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.
62407-B

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4

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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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