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ROPINIROLE 5 MG FILM-COATED TABLETS

Active substance(s): ROPINIROLE HYDROCHLORIDE

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Ropinirole 5 mg
Film-coated Tablets
(ropinirole)

TBC

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

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 have a 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. Medicines are not always
suitable for everyone. Your doctor needs to
know before you take Ropinirole if you suffer
from or have suffered in the past from any of
the following conditions:
• you are pregnant or think you may
be pregnant
• you are breast feeding
• you are under 18 years old
• you have a serious heart complaint
• you have a serious mental health problem.
Your doctor will then decide if Ropinirole is
suitable for you, or whether you need extra
check-ups while you are taking it.
Tell your doctor if you or your family/carer
notices you are developing urges or cravings
to behave in ways that are unusual for you
or 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 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.

While you are taking Ropinirole
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.
Ropinirole can make you feel drowsy. It can
make people feel extremely sleepy, and it
sometimes makes people fall asleep very
suddenly without warning. This can occur
most commonly with people with Parkinson’s
disease. If you experience this, then do not
drive or operate machinery.

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

Description Ropinirole Hydrochloride 5 mg 126,84,28,21

medicines or other medicines you obtained
without a prescription. Remember to tell
your doctor or pharmacist if you begin taking
any new medicines while you are taking
Ropinirole.
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
• medication for other mental health
problems, for example sulpiride
• HRT (hormone replacement therapy)
• metoclopramide, which is used to treat
nausea and heartburn
• the antibiotics ciprofloxacin or enoxacin
• any other medicine for Parkinson’s disease.
Tell your doctor if you are taking, or have
recently taken, any of these.
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.

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.
Ropinirole with food and drink
If you take Ropinirole with food, you may
be less likely to feel sick (nauseous) or be
sick (vomit). So it’s best to take it with food if
you can.
Pregnancy and breast-feeding
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 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: do not drive, do not
operate machines and do not put yourself in
any situation where feeling sleepy or falling
asleep could put you (or other people) at
risk of serious injury or death. Do not take
part in these activities until you are no
longer affected.
Talk to your doctor if this causes problems
for you.

Ropinirole 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 this medicine exactly as your
doctor or pharmacist has told you to. Check
with your doctor or pharmacist if you are
not sure.
You may be given Ropinirole on its own
to treat the symptoms of your Parkinson’s
disease. You may be given Ropinirole as well
as another medicine called L-dopa (also
called levodopa).
Do not give Ropinirole to children. Ropinirole
is not normally prescribed for people
under 18.

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).

Date: 14 Mar 2016

Component Type Leaflet

Pharma Code TBC

No. of colours

Affiliate Item Code 845638

SAP No. N/A

Colours

Black

Non-Print
Colours

Code
area

Superceded Affiliate Item Code 771672
TrackWise PR No. 845638
MA No. PL 04569/0816
Packing Site/Printer N/A
Supplier Code N/A

Vendor Job No. 276376
Trackwise Proof No. 1
Glams Proof No. N/A
Client Market UK
Keyline/Drawing No. N/A
Barcode Info N/A

1

TBC

Package leaflet: Information for the patient

Time: 15:37
Page Count

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Main Font Myriad Pro
Dimensions 160 x 450 mm

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Do not take any more Ropinirole than your
doctor has recommended.
It may take a few weeks for Ropinirole to work
for you.

TBC

Taking your dose of Ropinirole
Swallow your Ropinirole tablet(s) whole, with
a glass of water. It is best to take Ropinirole
with food, because that makes it less likely
that you will feel sick (nauseous).
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,
seeing, feeling or hearing things that are not
there (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.
If you have missed taking Ropinirole for one
day or more, 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 unless your doctor
advises you to.
If you suddenly stop taking Ropinirole, your
symptoms may quickly get much worse. A
sudden stop could also 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 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.
If you notice any of the following serious
side effects, stop taking ropinirole and
contact a doctor immediately:
• swelling of the face, lips, mouth, tongue
or throat which may cause difficulty in
swallowing or breathing - frequency not
known (frequency cannot be estimated from
the available data).

Other possible side effects:
Very common (may affect more than 1 in
10 people):
• fainting
• feeling sick (nausea)
• feeling drowsy.
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, feet or hands
Uncommon (may affect up to 1 in
100 people):
• low blood pressure
• 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)

• allergic reactions such as red, itchy swellings
on the skin (hives), rash or intense itching
• aggression
• craving for large doses of dopaminergic
drugs in excess of that required to control
motor symptoms, known as dopamine
dysregulation syndrome
• inability to resist the impulse, drive or
temptation to perform an action that
could be harmful to you or others, which
may include:
* strong impulse to gamble excessively
despite serious personal or family
consequences.
* altered or increased sexual interest and
behaviour of significant concern to you
or to others, for example, an increased
sexual drive.
* uncontrollable excessive shopping
or spending
* binge eating (eating large amounts of
food in a short time period) or compulsive
eating (eating more food than normal
and more than is needed to satisfy
your hunger)
Tell your doctor if you experience any of
these behaviours; they will discuss ways of
managing or reducing the symptoms.

If you’re taking Ropinirole with L-dopa
People who are taking Ropinirole with L-dopa
may develop other side effects over time:
• uncontrolled jerky movements are a very
common side effect
• feeling confused is a common side effect.
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 label and outer carton
after EXP. The expiry date refers to the last day
of that month.
This medicine does not require any special
storage conditions.
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 in Ropinirole Film-coated
Tablets is ropinirole.
Each film-coated tablet contains 5 mg
ropinirole (as hydrochloride)
The other ingredients are: microcrystalline
cellulose, lactose monohydrate (see section 2,
“Ropinirole contains lactose”), croscarmellose
sodium, hypromellose, magnesium stearate.
The coating includes: hypromellose, titanium
dioxide (E171), macrogol, polysorbate, Indigo
carmine (E132)

What Ropinirole looks like and contents of
the pack
Your medicine comes as blue, capsule shaped,
biconvex, film-coated tablets with a breakline on both sides.
The tablet can be divided into equal halves.
Ropinirole is available in a HDPE multidose
container with a child resistant closure (PP) of
21, 28, 84 and 126 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Mylan, Potters Bar, Hertfordshire, EN6 1TL,
United Kingdom
Manufacturer
Generics [UK] Ltd, Station Close, Potters Bar,
Herts, EN6 1TL, UK
Gerard Laboratories, 35/36 Baldoyle Industrial
Estate, Grange Road, Dublin 13, Ireland.
Mylan Hungary Kft, H-2900 Komarom,
Mylan utca 1, Hungary
This leaflet was last revised in 03/2016

Not known (frequency cannot be estimated
from the available data):
• changes in the liver function, which have
shown up in blood tests

Description Ropinirole Hydrochloride 5 mg 126,84,28,21

845638

Date: 14 Mar 2016

Component Type Leaflet

Pharma Code TBC

No. of colours

Affiliate Item Code 845638

SAP No. N/A

Colours

Black

Non-Print
Colours

Code
area

Superceded Affiliate Item Code 771672
TrackWise PR No. 845638
MA No. PL 04569/0816
Packing Site/Printer N/A
Supplier Code N/A

Vendor Job No. 276376
Trackwise Proof No. 1
Glams Proof No. N/A
Client Market UK
Keyline/Drawing No. N/A
Barcode Info N/A

TBC

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.

1

Time: 15:37
Page Count

2/2

Equate CMYK
with
Main Font Myriad Pro
Dimensions 160 x 450 mm

Body Text Size 10 pt
Min Text Size used 10 pt

Sign-offs

v1/May 2015

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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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