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ROPILYNZ XL 4 MG PROLONGED-RELEASE TABLETS

Active substance(s): ROPINIROLE HYDROCHLORIDE

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Package leaflet: information for the user
Ropilynz XL 2 mg prolonged-release tablets
Ropilynz XL 4 mg prolonged-release tablets
Ropilynz XL 8 mg prolonged-release tablets

40 mm

Ropilynz XL
2 mg, 4 mg, 8 mg
prolonged-release tablets

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for
Pharmacode

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 Ropilynz XL is and what it is used for
2. What you need to know before you take Ropilynz XL
3. How to take Ropilynz XL
4. Possible side effects
5. How to store Ropilynz XL
6. Contents of the pack and other information
1. What Ropilynz XL is and what it is used for

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Ropinirole

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The active ingredient in Ropilynz 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.
Ropilynz 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 Ropilynz XL
Do not take Ropilynz 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 Ropilynz XL.
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.
Your doctor needs to know before you take Ropilynz 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).

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Tell your doctor if you think any of these may apply to you. Your doctor
may decide that Ropilynz XL is not suitable for you or that you need extra
check-ups while you are taking it.

you have been told by your doctor that you have an intolerance to some
sugars, contact your doctor before taking this medicinal product.

While you are taking Ropilynz XL
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 Ropilynz XL. Your
doctor may need to adjust or stop your dose.

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 Ropilynz XL on its own to treat the symptoms of your
Parkinson’s disease, or you may be given Ropilynz 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 Ropilynz XL. Tell your doctor if this happens,
as your doctor may need to adjust the doses of the medicines you are
taking.
Ropilynz XL tablet(s) are designed to release drug over a 24-hour period.
If you have a condition where your medicine passes through your body
too quickly e.g. diarrhea, 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.

Other medicines and Ropilynz 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 Ropilynz XL.
Some medicines can affect the way Ropilynz XL works, or make it more
likely that you will have side effects. Ropilynz 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 Ropilynz XL:
• Vitamin K antagonists (used to reduce blood clotting) such as
Warfarin (coumarin).
Smoking and Ropilynz XL
Tell your doctor if you start smoking, or give up smoking, while you are
taking Ropilynz XL. Your doctor may need to adjust your dose.
Ropilynz XL with food
You can take Ropilynz XL with or without food, as you prefer.
Pregnancy, breast-feeding and fertility
Ropilynz XL is not recommended if you are pregnant, unless your doctor
advises that the benefit to you of taking Ropilynz XL is greater than the
risk to your unborn baby. Ropilynz XL is not recommended if you are
breast feeding, as it can affect your milk production.
Ropilynz XL is not known to affect human fertility
If you are pregnant or breast-feeding, think you might 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 Ropilynz XL.
Driving and using machines
Ropilynz 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.
Ropilynz XL 2 mg and 4mg contains lactose
Ropilynz XL 2 mg and 4 mg prolonged-release tablets contain lactose. If

3. How to take Ropilynz XL

How much Ropilynz XL will you need to take?
It may take a while to find out the best dose of Ropilynz XL for you.
The recommended starting dose is 2 mg once daily for the first week.
Your doctor may increase your dose to 4 mg of Ropilynz XL prolongedrelease tablets once daily, from the second week of treatment. If you are
very elderly, your doctor may increase the dosage more slowly. After
that, your doctor may adjust your dose until you are taking the dose that
is best for you. Some people take up to 24 mg of Ropilynz 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 Ropilynz XL to children. Ropilynz XL is not normally
prescribed for people under 18.
Do not take any more Ropilynz XL than your doctor has recommended.
It may take a few weeks for Ropilynz XL to work for you.
Taking your dose of Ropilynz XL
Take Ropilynz XL once a day, at the same time each day.
Swallow your Roplynz 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 Ropilynz XL prolonged-release tablets
on the dose of ropinirole film-coated (immediate-release) tablets you
were taking.
Take your ropinirole film-coated (immediate-release) tablets as normal
the day before you switch. Then take your Ropilynz XL prolonged-release
tablets next morning and do not take any more ropinirole film-coated
(immediate-release) tablets.
If you take more Ropilynz XL than you should
Contact a doctor or pharmacist immediately. If possible, show them
the Ropilynz XL pack.
Someone who has taken an overdose of Ropilynz 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 Ropilynz XL
Do not take extra prolonged-release tablets or a double dose to make up
for a missed dose.
If you have missed taking Ropilynz XL for one day or more, ask your
doctor for advice on how to start taking it again.
If you stop taking Ropilynz XL
Do not stop taking Ropilynz XL without advice.
Take Ropilynz XL for as long as your doctor recommends.
Do not stop unless your doctor advises you to.
If you suddenly stop taking Ropilynz XL, your Parkinson’s disease
symptoms may quickly get much worse.
If you need to stop taking Ropilynz 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 Ropilynz 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 (may affect more than 1 in 10 people):
• Fainting
• feeling drowsy
• feeling sick (nausea).
Common side effects (may affect up to 1 in 10 people):
• 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 (may affect up to 1 in 100 people):
• 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.

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- 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 Ropilynz XL with L-dopa
People who are taking Ropilynz 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
Ropilynz 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 (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 Ropilynz 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 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 Ropilynz XL contains
The active substance in Ropilynz XL is ropinirole.
One prolonged-release tablet contains 2 mg, 4 mg or 8 mg 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 prolonged- Hypromellose (E464), iron oxide red (E172), lactose
release tablet
monohydrate, titanium dioxide (E171), triacetin
Macrogol 400, hypromellose (E464), sunset yellow
4mg prolongedaluminium lake (E110), titanium dioxide (E171),
release tablet
indigo carmine aluminium lake (E132)
Hypromellose (E464), iron oxide red (E172), iron
8mg prolongedoxide black (E172), iron oxide yellow (E172),
release tablet
macrogol 400, titanium dioxide (E171)
What Ropilynz XL looks like and contents of the pack
Ropilynz XL 2mg: pink prolonged-release round biconvex tablets 6.8 ±
0.1mm in diameter and 5.5 ± 0.2 mm in thickness.
Ropilynz XL 4mg: light brown prolonged-release oval biconvex tablets

with dimensions 12.6 x 6.6 ± 0.1 mm in diameter and 5.3 ± 0.2 mm in
thickness.
Ropilynz XL 8mg: red prolonged-release oval biconvex tablets, with
dimensions 19.2 x 10.2 ± 0.2 mm in diameter and 5.2 ± 0.2 mm in
thickness.
All strengths are supplied in white opaque PVC/PCTFE-Aluminium 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 Authorization Holder
Lupin (Europe) Ltd
Victoria Court
Bexton Road
Knutsford
Cheshire
WA16 0PF
United Kingdom
Manufacturer
Pharmathen S.A.
6 Dervenakion Str.,
153 51, Pallini Attiki,
Greece
Or
Pharmathen International S.A.
Industrial Park Sapes,
Rodopi Prefecture,
Block No 5, Rodopi 69300,
Greece
This leaflet was last revised in November 2014

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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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