Skip to Content

UK Edition. Click here for US version.

ROPIQUAL XL 2 MG PROLONGED-RELEASE TABLETS

Active substance(s): ROPINIROLE HYDROCHLORIDE

View full screen / Print PDF » Download PDF ⇩
Transcript
Package leaflet: Information for the user

ROPIQUAL XL 2 mg prolonged-release tablets
ROPIQUAL XL 4 mg prolonged-release tablets
ROPIQUAL XL 8 mg prolonged-release tablets
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 more questions, ask your
doctor or pharmacist.
- This medicine has been prescribed for
you only. Don’t pass it on to other people.
It may harm them even if their signs of
illness seem to be 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 ROPIQUAL XL is and what it is
used for
2. What you need to know before you take
ROPIQUAL XL
3. How to take ROPIQUAL XL
4. Possible side effects
5. How to store ROPIQUAL XL
6. Contents of the pack and other
information
1. What ROPIQUAL XL is and what it is
used for
ROPIQUAL XL prolonged-release tablets
are used to treat Parkinson’s disease. The
active ingredient in ROPIQUAL XL 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.
People with Parkinson’s disease have low
levels of dopamine in some parts of their
brains. 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 ROPIQUAL XL
Do not take ROPIQUAL XL





if you are allergic to ropinirole or any of
the other ingredients of this medicine
(listed in section 6)
if you have serious kidney disease
if you have liver disease.

Tell your doctor if you think any of these may
apply to you.
Warnings and precautions
Your doctor needs to know before you take
ROPIQUAL XL:
• 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 mental health problem
• if you have a history of any unusual urges
and/or behaviours (such as excessive
gambling or excessive sexual behaviour)
Tell your doctor if you think any of these may
apply to you. Your doctor may decide that
ROPIQUAL XL isn’t suitable for you or that
you need extra check-ups while you’re
taking it.
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.
Other medicines and ROPIQUAL XL
Tell your doctor or pharmacist if you are
taking, have recently taken or might take
any other medicines
Some medicines can affect the way
ROPIQUAL XL works, or make it more likely
that you will have side effects. ROPIQUAL
XL can also affect the way some other
medicines work.








the anti-depressant fluvoxamine
HRT (hormone replacement therapy)
the antibiotic ciprofloxacin or enoxacin
medication for other mental health
problems, for example sulpiride
metoclopramide, which is used to treat
nausea and heartburn
cimetidine, used in the treatment of
stomach ulcers
theophylline, used for asthma, bronchitis
or air trapped in the body (emphysema)

Black



any other medicine for Parkinson’s
disease.

Tell your doctor if you are taking, or have
recently taken, any of these.
Taking ROPIQUAL XL with food, drink
and alcohol
Swallow the tablets whole with a glass of
water. You can take ROPIQUAL XL with or
without food, as you prefer.
You should not drink alcohol while you are
taking ROPIQUAL XL
Tell your doctor or nurse if you start
smoking, or give up smoking, while you’re
taking ROPIQUAL XL. Your doctor or nurse
may need to adjust your dose.
Pregnancy, breast-feeding and fertility
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
ROPIQUAL XL.
If you are pregnant or breast-feeding, think
you may be pregnant or are planning to
have a baby, ask your doctor or pharmacist
for advice before taking this medicine.
ROPIQUAL XL is not recommended if you
are pregnant, unless the doctor advises that
the benefit of you taking ROPIQUAL XL is
greater than the risk to your unborn baby.
ROPIQUAL XL is not recommended if you
are brest feeding, as it can affect your milk
production.
Driving and using machines
Do not drive because ROPIQUAL XL can
make you feel drowsy. It can make people
feel extremely sleepy and it sometimes
makes people fall asleep very suddenly
without warning.
Do not operate or use any tools or
machinery. 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. Don’t take part in
these activities until you are no longer
affected.
Talk to your doctor if this causes problems
for you.
ROPIQUAL XL 2 mg prolonged-release
tablets contain a sugar called lactose. If you
have been told by your doctor that you have
an intolerance to some sugars, contact your
doctor before taking this medicinal product.
ROPIQUAL XL4 mg prolonged-release
tablet contain the colouring agent sunset
yellow, which may cause allergic reactions.
3. How to take ROPIQUAL XL
Always take this medicine exactly as your
doctor or pharmacist has told you to. Check
with your doctor or pharmacist if you’re not
sure.
The product is a prolonged-release tablet
and should not be taken if the tablet is
broken or damaged.
You may be given ROPIQUAL XL on its own
to treat the symptoms of your Parkinson’s
disease or you may be given ROPIQUAL XL
as well as another medicine called L-dopa
(also called levodopa). If you are taking Ldopa you may experience some
uncontrollable movements (dyskinesias)
when you first start taking ROPIQUAL XL.
Tell your doctor if this happens, as your
doctor may need to adjust the dose of the
medicines you are taking.
The usual starting dose of ROPIQUAL XL
prolonged-release tablets is 2 mg once daily
for the first week. Your doctor may increase
your dose to 4 mg of ROPIQUAL XL
prolonged-release tablets once daily, from
the second week of treatment. If you are
very elderly, your doctor may increase your
dose more slowly. After that, the doctor may
adjust your dose until you are taking the
dose that is best for you. Some people take
up to 24 mg of ROPIQUAL XL prolongedrelease tablets each day.
Do not give ROPIQUAL XL to children.
ROPIQUAL XL is not normally prescribed for
people under 18.
It may take a while to find out the best dose
of ROPIQUAL XL for you.
Taking your dose of ROPIQUAL XL
Take ROPIQUAL XL once a day, at the
same time each day.
Swallow your ROPIQUAL XL prolongedrelease tablet(s) whole, with a glass of
water.
Do not break, chew or crush the prolongedrelease tablet(s) - if you do, there is a
danger you could overdose, because the
medicine will be released into your body too
quickly.

If you are switching form ropinirole filmcoated (immediate release) tablets
Your doctor or nurse will base your dose of
ROPIQUAL XL on the dose of ropinirole you
were taking. You will take the same or
similar daily dose of ROPIQUAL XL to your
previous dose of ropinirole but you will only
take ROPIQUAL XL once a day.
Take your ropinirole as normal the day
before you switch. Then take your
ROPIQUAL XL on the next day and don’t
take any more ropinirole.
If you take more ROPIQUAL XL than you
should
Contact a doctor or pharmacist immediately.
If possible, show them the ROPIQUAL XL
pack.
Someone who has taken an overdose of
ROPIQUAL XL may have any of these
symptoms: feeling sick (nausea), being sick
(vomiting), dizziness (a spinning sensation),
feeling drowsy, mental or physical tiredness,
fainting, hallucinations.
If you forget to take ROPIQUAL XL
Don’t 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 ROPIQUAL XL for
more than a few days, ask your doctor for
advice on how to start taking it again.
If you stop taking ROPIQUAL XL
Do not stop taking ROPIQUAL XL without
advice.
Take ROPIQUAL XL for as long as your
doctor recommends. Don’t stop unless your
doctor advises you to.
If you suddenly stop taking ROPIQUAL XL
your Parkinson’s disease symptoms may
quickly get much worse.
If you need to stop taking ROPIQUAL XL
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 have
side effects, although not everyone gets
them.
Very common side effects (affects more
than 1 in 10 people taking ROPIQUAL XL):
• fainting
• feeling drowsy
• feeling sick (nausea)
Common side effects (affects more than 1
in 100 people taking ROPIQUAL XL:
• hallucinations (sensing things that are
not real)
• being sick (vomiting)
• feeling dizzy (a spinning sensation)
• heartburn
• stomach pain
• constipation
• swelling of the legs, feet or hands
Uncommon side effects (affects more than
1 in 1,000 people taking ROPIQUAL XL:
• feeling dizzy or faint, especially when you
stand up suddenly (this is caused by a
drop in blood pressure)
• 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)
• feeling very sleepy during the day
(extreme somnolence)
Tell your doctor if you experience any of
these behaviors; they will discuss ways
of managing or reducing the symptoms
If you’re taking ROPIQUAL XL with Ldopa (for Parkinson’s disease)
People who are taking ROPIQUAL XL with
L-dopa may develop other side effects over
time:
• uncontrollable movements (dyskinesia)
are a very common side effect. Tell your
doctor if this happens, as your doctor
may need to adjust the doses of the
medicines you are taking
• feeling confused is a common side effect
Not known (cannot be estimated from the
available data):
• changes in liver function, which have
shown up in blood tests
• 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.
• 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)

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 ROPIQUAL XL
Keep this medicine out of the sight and
reach of children.
Do not use this medicine after the expiry
date (EXP) shown on the carton, blister and
bottle. The expiry date refers to the last day
of that month.
Store ROPIQUAL XL below 25°C.
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 ROPIQUAL XL contains
The active substance in ROPIQUAL XL is
ropinirole.
Each prolonged release tablet contains
ropinirole hydrochloride equivalent to 2 mg,
4mg or 8 mg ropinirole.
The other ingredients are:
Tablet core: Ammonio methacrylate
copolymer, type B, hypromellose, sodium
lauryl sulfate, copovidone, magnesium
stearate.
Tablet coating:
2mg: Hypromellose (E464), iron oxide red
(E172), lactose monohydrate, titanium
dioxide (E171), triacetin.
4mg: Macrogol 400, hypromellose (E464),
sunset yellow (E110), titanium dioxide
(E171), indigo carmine (E132).
8mg: Hypromellose (E464), iron oxide red
(E172), iron oxide black (E172), iron oxide
yellow (E172), macrogol 400, titanium
dioxide (E171).
What ROPIQUAL XL looks like and
contents of the pack
ROPIQUAL XL 2mg : pink prolongedrelease round biconvex tablets 6.8 ± 0.1mm
in diameter and 5.5 ± 0.2 mm in thickness.
ROPIQUAL XL 4mg : light brown prolongedrelease oval biconvex tablets with
dimensions 12.6*6.6 ± 0.1 and 5.3 ± 0.2 mm
in thickness.
ROPIQUAL XL 8mg : red prolonged-release
oval biconvex tablets with dimensions
19.2*10.2 ± 0.2 mm and 5.2 ± 0.2 mm in
thickness .
All strengths are supplied in white opaque
PVC/PCTFE-Aluminium foil blisters.
Pack sizes:
For 2 mg: 28, 30, 42 and 84 tablets
For 4 mg & 8 mg: 28, 30 and 84 tablets
Not all pack sizes may be marketed.
Marketing Authorization Holder:
Milpharm Limited
Ares Block
Odyssey Business Park
West End Road
Ruislip HA4 6QD
United Kingdom
Manufacturer:
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
or
Pharmathen S.A 6th Dervanakion Str
Athens, Pallini 15351
Greece.
or
Pharmathen International S.A.
Industrial Park Sapes
Rodopi Prefecture, Block No 5
Rodopi 69300
Greece
This leaflet was last revised in 03/2015.

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.

Hide