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REPINEX XL 8 MG PROLONGED-RELEASE TABLETS

Active substance(s): ROPINIROLE HYDROCHLORIDE

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Package Leaflet: Information for the user

Repinex XL 2mg prolonged-release tablets
Repinex XL 4mg prolonged-release tablets
Repinex XL 8mg 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 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 Repinex XL is and what it is used for
2. What you need to know before you take Repinex XL
3. How to take Repinex XL
4. Possible side effects
5. How to store Repinex XL
6. Contents of the pack and other information

1. What Repinex XL is and what it is used for
The active ingredient in Repinex 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.
Repinex XL is used to treat Parkinson’s disease.
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
Repinex XL
Do not take Repinex 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
Talk to your doctor or pharmacist before taking Repinex XL.
Tell your doctor if you or your family/carer notice 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.
Your doctor needs to know before you take Repinex 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 serious mental health problem
if you experienced any unusual urges and/or behaviours
(such as excessive gambling or excessive sexual behaviour)
(see section 4)
if you have an intolerance to some sugars (such as lactose).
Tell your doctor if you think any of these may apply to you.
Your doctor may decide that Repinex XL is not suitable for you
or that you need extra check-ups while you are taking it.









While you are taking Repinex XL
Tell your doctor if you or your family notice 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 Repinex XL. Your doctor may need to
adjust or stop your dose.
Other medicines and Repinex XL
Tell your doctor or pharmacist if you are taking, have recently
taken or might take, any other medicines.
Remember to tell your doctor or pharmacist if you begin
taking a new medicine while you are taking Repinex XL.
Some medicines can affect the way Repinex XL works, or make
it more likely that you will have side effects. Repinex XL can
also affect the way some other medicines work.
These include:
the anti-depressant fluvoxamine
medication for other mental health problems,
for example sulpride
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 Repinex XL:
Vitamin K antagonists (used to reduce blood clotting)
such as Warfarin (coumarin).









Smoking and Repinex XL
Tell your doctor if you start smoking, or give up smoking,
while you are taking Repinex XL. Your doctor may need to
adjust your dose.
Repinex XL with food and drink
You can take Repinex XL with or without food, as you prefer.
Pregnancy, breast-feeding and fertility
Repinex XL is not recommended if you are pregnant, unless
your doctor advises that the benefit to you of taking Repinex XL
is greater than the risk to your unborn baby. Repinex XL is not
recommended if you are breast-feeding, as it can affect
your milk production. Repinex XL is not known to affect
human fertility.

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. Your doctor
will also advise you if you are breast-feeding or planning to do
so. Your doctor may advise you to stop taking Repinex XL.
Driving and using machines
Repinex XL 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.
Repinex XL 2mg
Repinex XL 2mg contains 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.
Repinex XL 4mg
Repinex XL 4mg contains a colouring agent called sunset
yellow (E110), which may cause allergic reactions.

3. How to take Repinex XL
Always take this medicine exactly as your doctor has
told you. You should check with your doctor or pharmacist if
you are not sure.
You may be given Repinex XL on its own to treat the symptoms
of your Parkinson’s disease. Or you may be given Repinex XL as
well as another medicine called L-dopa (also called levodopa).
If you are taking L-dopa you may experience some
uncontrollable movements (dyskinesias) when you first start
taking Repinex XL. Tell your doctor if this happens, as your doctor
may need to adjust the doses of the medicines you are taking.
Repinex XL tablet(s) are designed to release drug over a 24hr
period. If you have a condition where your medicine passes
through your body too quickly, e.g., diarrhoea, the tablet(s) may
not dissolve completely and may not work properly. You may
see tablet(s) in your stool. If this happens, let your doctor know
as soon as possible.
How much Repinex XL will you need to take?
It may take a while to find out the best dose of Repinex XL
for you.
The recommended starting dose is 2mg once daily for the
first week. Your doctor may increase your dose to 4mg of
Repinex XL prolonged-release tablets once daily, from the
second week of treatment. In the very elderly, the doctor may
increase the dosage 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 24mg of Repinex XL prolongedrelease tablets each day.
If at the start of your treatment, you experience side effects
that you find difficult to tolerate, speak to your doctor. Your
doctor may advise you to switch to a lower dose of ropinirole
film-coated (immediate-release) tablets which you will take
three times a day.
Use in children and adolescents
Do not give Repinex XL to children. Repinex XL is not
normally prescribed for people under 18.
Do not take any more Repinex XL than your doctor has
recommended.
It may take a few weeks for Repinex XL to work for you.
Taking your dose of Repinex XL
Take Repinex XL once a day, at the same time each day.
Swallow your Repinex XL prolonged-release tablet(s)
whole, with a glass of water.
Don’t break, chew or crush the prolonged-release 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 from ropinirole film-coated
(immediate-release) tablets
Your doctor will base your dose of Repinex XL prolonged release
tablets on the dose of ropinirole film-coated (immediaterelease) tablets you were taking.
Take your ropinirole film-coated (immediate-release) tablets as
normal the day before you switch. Then take your Repinex XL
prolonged-release tablets next morning and do not take any
more ropinirole film-coated (immediate-release) tablets.
If you take more Repinex XL than you should
Contact a doctor or pharmacist immediately. If possible,
show them the Repinex XL pack.
Someone who has taken an overdose of Repinex 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 Repinex XL
Do not take extra prolonged-release tablets or a double
dose to make up for a missed dose.
If you have missed taking Repinex XL for one day or more,
ask your doctor for advice on how to start taking it again.
If you stop taking Repinex XL
Do not stop taking Repinex XL without advice.
Take Repinex XL for as long as your doctor recommends.
Do not stop unless your doctor advises you to.
If you suddenly stop taking Repinex XL, your Parkinson’s
disease symptoms may quickly get much worse.
If you need to stop taking Repinex XL, your doctor will reduce
your dose gradually.
If you have any further questions on the use of this product,
ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause side effects,
although not everyone gets them.
The side effects of Repinex XL 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 are worried about
side effects, talk to your doctor.

Very common side effects
These may affect more than 1 in 10 people taking Repinex XL:
fainting
feeling drowsy
feeling sick (nausea).
Common side effects
These may affect up to 1 in 10 people taking Repinex XL:
hallucinations (‘seeing’ things that are not really there)
being sick (vomiting)
feeling dizzy (a spinning sensation)
heartburn
stomach pain
constipation
swelling of the legs, feet or hands.
Uncommon side effects
These may affect up to 1 in 100 people taking Repinex XL:
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)
Some patients may have the following side effects
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 (see Section 2).
changes in liver function, which have shown up in
blood tests.
act in an aggressive manner.
You may experience 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).
Tell your doctor if you experience any of these
behaviours; they will discuss ways of managing or reducing
the symptoms.




















Repinex XL 4mg :
light brown prolonged-release oval biconvex tablets, with
dimensions 12.6*6.6 ± 0.1 mm in diameter and 5.3 ± 0.2 mm
in thickness.
Repinex XL 8mg :
red prolonged-release oval biconvex tablets, with dimensions
19.2*10.2 ± 0.2 mm in diameter and 5.2 ± 0.2 mm in thickness.
All strengths are supplied in white opaque PVC/PCTFEAluminium foil blisters and white opaque HDPE bottles with
white cylindrical caps of polypropylene with three break points
on the tamper-evident ring and aperture of desiccant insert.
Pack sizes of
Blister: 7, 21, 28, 30, 42, 84, 90, 100 prolonged-release tablets
Bottle: 7, 21, 28, 30, 42, 84, 90, 100 prolonged-release tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Aspire Pharma Ltd,
Bellamy House,
Winton Road,
Petersfield,
Hampshire,
GU32 3HA,
United Kingdom
Manufacturer
Pharmathen SA,
6 Dervenakion Str,
153 51, Pallini Attiki,
Greece
or
Pharmathen International SA,
Industrial Park Sapes,
Rodopi Prefecture,
Block No 5,
Rodopi 69300,
Greece
This leaflet was last revised in
08/2014






If you’re taking Repinex XL with L-dopa
People who are taking Repinex XL with L-dopa may develop
other side effects over time:
uncontrollable movements (dyskinesias) are a very common
side effect. If you are taking L-dopa you may experience
some uncontrollable movements (dyskinesias) when you
first start taking Repinex XL. 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.





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 (website: 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 Repinex XL
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 blister, on the bottle and on the carton. The expiry date
refers to the last day of that month.
Do not store above 25°C.
HDPE bottle: Shelf life after first opening is 60 days.
Do not throw away any medicines via wasterwater or
household waste. Ask you 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 Repinex XL contains
The active substance in Repinex XL is ropinirole.
One prolonged-release tablet contains 2mg, 4mg or 8mg of
ropinirole (as hydrochloride).
The other ingredients are:
Prolonged-release tablet cores: Ammonio Methacrylate
Copolymer Type B, Hypromellose (E464), Sodium lauryl
sulfate, Copovidone, Magnesium stearate (E572).
film coats:
2mg
Hypromellose (E464),
prolonged-release iron oxide red (E172),
tablet
lactose monohydrate,

titanium dioxide (E171),

triacetin
4mg
Macrogol 400,
prolonged-release hypromellose (E464),
tablet
sunset yellow aluminium lake (E110),

titanium dioxide (E171),

indigo carmine aluminium lake (E132)
8mg
Hypromellose (E464),
prolonged-release iron oxide red (E172),
tablet
iron oxide black (E172),

iron oxide yellow (E172),

macrogol 400,

titanium dioxide (E171)




What Repinex XL looks like and contents of the pack
Repinex XL 2mg :
pink prolonged-release round biconvex tablets 6.8 ± 0.1 mm in
diameter and 5.5 ± 0.2 mm in thickness.

1010112-P5.4

Artwork for:
Aspire Pharma Limited
Product name:
Repinex XL 2mg, 4mg & 8mg
Size:
PL/PA no:
Type: Leaflet
Artwork dimensions: 480mm x 170mm
Profile supplied:
Dimensions supplied
Date of first artwork: 10 November 2011
Reason for request: Text edits and additions
Version no: 5.4
Date of revision:
6 August 2014
Colours:
As swatch(es)
Font(s):
9pt Strada Condensed
Artwork software:
InDesign CS6
BAC ref: R622

Black

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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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