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ROPINIROLE 2MG FILM-COATED TABLETS

Active substance(s): ROPINIROLE HYDROCHLORIDE

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Package leaflet: Information for the patient

(ropinirole)

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.

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 or
Restless Legs Syndrome.
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

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.
Ropinirole is also used to treat the symptoms
of moderate to severe idiopathic Restless Legs
Syndrome.
Moderate to severe Restless Legs Syndrome
is typically represented by patients who have
difficulty sleeping or severe discomfort in their legs
or arms.
Restless Legs Syndrome is a condition
characterised by an irresistible urge to move
the legs and occasionally the arms, usually
accompanied by uncomfortable sensations such as
tingling, burning or prickling. These feelings occur
during periods of rest or inactivity such as sitting
or lying down, especially in bed, and are worse in
the evening or at night.
Usually the only relief is obtained by walking about
or moving the affected limbs, which often leads to
problems sleeping.
Ropinirole relieves the discomfort and reduces
the urge to move the limbs that disrupts night
time sleep.

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.

Description

Tell your doctor or pharmacist if you are taking or
have recently taken any other medicines, including
any herbal 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.

Ropinirole Hydrochloride 2 mg,1 mg,0.5 mg,0.25 mg
126,84,28,21

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 or Restless
Legs Syndrome. 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.
Swallow the Ropinirole tablet(s) whole with water.
Do not chew or crush the tablet(s).
The exact dose of ropinirole people take can be
different. Your doctor will decide on the dose
you need to take each day and you should
follow the doctors instructions. When you first
start taking Ropinirole, the dose you take will be
increased gradually.

How much Ropinirole will you need to take?
Parkinson’s disease
It may take a while to find out the best dose of
Ropinirole for you.

The recommended starting dose is 0.25 mg of
ropinirole three times each day for the first week.
Then your doctor will increase your dose each
week, for the next three weeks. After that, your
doctor will gradually increase the dose until
you are taking the dose that is best for you. The
recommended dose is 1 mg to 3 mg three times
each day (making a total daily dose of 3 mg to
9 mg). If your Parkinson’s disease symptoms have
not improved enough, your doctor may decide to
gradually increase your dose some more. Some
people take up to 8 mg of Ropinirole three times a
day (24 mg daily altogether).
If you are also taking other medicines for
Parkinson’s disease, your doctor may advise you to
gradually reduce the dose of the other medicine.
Restless Legs Syndrome
Take Ropinirole once a day by mouth, every day
at the same time each day. Ropinirole is usually
taken just before bedtime, but can be taken up to
3 hours before you go to bed.
The starting dose is 0.25 mg once daily. After two
days your doctor will probably increase you dose
to 0.5 mg once daily for the remainder of your
first week of treatment. Then your doctor may
gradually increase your dose over the next three
weeks to a dose of 2 mg per day.

Date: 14 Mar 2016

Component Type Leaflet

Pharma Code TBC

No. of colours

Affiliate Item Code 845642

SAP No. N/A

Colours

Black

Non-Print
Colours

Code
area

Superceded Affiliate Item Code 773347
TrackWise PR No. 845642
MA No. PL 04569/0812-15
Packing Site/Printer N/A
Supplier Code N/A

Vendor Job No. 276377
Trackwise Proof No. 1
Glams Proof No. N/A
Client Market UK
Keyline/Drawing No. N/A
Barcode Info N/A

TBC

TBC

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

Other medicines and Ropinirole

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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

If your symptoms get worse

Occasionally, people taking Ropinirole find that
their Restless Legs Syndrome symptoms get worse.
For example, symptoms may start earlier in the
day, after a shorter time at rest, or the symptoms
may affect other parts of the body, such as the
arms. See your doctor if this happens to you.

Taking your dose of Ropinirole

Swallow your Ropinirole tablets 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 (sncope)
• feeling drowsy
• feeling sick or being sick
• uncontrollable movements (dyskinesia).
Common (may affect up to 1 in 10 people):
• hallucinations (‘seeing’ things that aren’t
really there)
• feeling dizzy (a spinning sensation)
• heartburn
• abdominal pain
• swelling of the legs, feet or hands
• fatigue (mental or physical tiredness)
• nervousness
• worsening of RLS (symptoms may start earlier
than usual or be more intense, or affect other
previously unaffected limbs, such as the arms or
return in the early morning).
Uncommon (may affect up to 1 in 100 people):
• 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)
Not known (frequency cannot be estimated from
the available data):
• changes in the liver function, which have shown
up in blood tests
• 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 Film-coated Tablets contains
The active substance in Ropinirole is ropinirole.

Each film-coated tablet contains 0.25 mg, 0.5 mg,
1 mg or 2 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:
0.25 mg: hypromellose, titanium dioxide (E171),
macrogol, polysorbate
0.5 mg: hypromellose, titanium dioxide (E171),
macrogol, iron oxide yellow (E172)
1mg: hypromellose, macrogol, iron oxide yellow
(E172), titanium dioxide (E171), Indigo carmine (E132)
2mg: hypromellose, titanium dioxide (E171),
macrogol, iron oxide red (E172), iron oxide
yellow (E172)

What Ropinirole looks like and contents of
the pack
Your medicine comes as a film-coated tablet.

Ropinirole 0.25 mg: White to off-white, capsule
shaped biconvex, film-coated tablets with
break-line on both sides.
Ropinirole 0.5 mg: Yellow, capsule shaped
biconvex, film-coated tablets with break-line on
both sides.
Ropinirole 1 mg: Green, capsule shaped biconvex,
film-coated tablets with break-line on both sides.
Ropinirole 2 mg: Light pink, capsule shaped
biconvex, film-coated tablets with break-line 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.

TBC

If your symptoms have not improved, the dose
may be increased gradually up to a maximum of
4 mg daily. After three months of treatment with
Ropinirole, your doctor may adjust your dose or
discontinue your treatment depending on your
symptoms and how you feel.

Mylan Hungary Kft,
H-2900 Komarom,
Mylan utca 1,
Hungary
This leaflet was last revised in 03/2016

845642

Description

Ropinirole Hydrochloride 2 mg,1 mg,0.5 mg,0.25 mg
126,84,28,21

Date: 14 Mar 2016

Component Type Leaflet

Pharma Code TBC

No. of colours

Affiliate Item Code 845642

SAP No. N/A

Colours

Black

Non-Print
Colours

Code
area

Superceded Affiliate Item Code 773347
TrackWise PR No. 845642
MA No. PL 04569/0812-15
Packing Site/Printer N/A
Supplier Code N/A

Vendor Job No. 276377
Trackwise Proof No. 1
Glams Proof No. N/A
Client Market UK
Keyline/Drawing No. N/A
Barcode Info N/A

1

Time: 15:52
Page Count

2/2

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

Body Text Size 9 pt
Min Text Size used 9 pt

Sign-offs

v1/May 2015

Expand view ⇕

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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