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RAPONER XL 8MG PROLONGED-RELEASE TABLETS

Active substance(s): ROPINIROLE HYDROCHLORIDE / ROPINIROLE HYDROCHLORIDE / ROPINIROLE HYDROCHLORIDE

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Package leaflet: Information for the user

Raponer XL 2mg, 3mg, 4mg, 6mg and 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 .
• The full name of this medicine is Raponer XL 2mg, 3mg, 4mg, 6mg
and 8mg Prolonged-release Tablets but within the leaflet it will be
referred to as Raponer XL tablets.

What is in this leaflet:
1 What Raponer XL tablets are and what they are used

for
2 What you need to know before you take Raponer XL
tablets
3 How to take Raponer XL tablets
4 Possible side effects
5 How to store Raponer XL tablets
6 Contents of the pack and other information

1 What Raponer XL tablets are and what they are used

for

The active ingredient in Raponer XL 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.
Raponer XL prolonged-release tablets are 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 Raponer XL

tablets

Do not take Raponer XL tablets if you

• are allergic to ropinirole or any of the other ingredients of this medicine
(listed in section 6)
• have a serious kidney disease
• have a 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 Raponer XL tablets
if you
• are pregnant or think you may be pregnant
• are breast-feeding
• are under 18 years old
• have a serious heart complaint
• have a serious mental health problem
• 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 Raponer XL is not suitable for you, or that you need extra checkups while you are taking it.

While you are taking Raponer XL tablets

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.

Smoking and Raponer XL tablets

Tell your doctor if you start smoking, or give up smoking, while you are
taking Raponer XL tablets. Your doctor may need to adjust your dose.

Children and adolescents

Do not give Raponer XL tablets to children. Raponer XL tablets are not
normally prescribed for people under 18 years of age.

Other medicines and Raponer XL tablets

Tell your doctor or pharmacist if you are taking, have recently taken or
might take any other medicines. Also remember to tell your doctor or
pharmacist if you begin taking a new medicine while you are taking
Raponer XL tablets.
Some medicines can affect the way Raponer XL tablets works, or make it
more likely that you will have side effects. Raponer XL tablets 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 Raponer XL:
• Vitamin K antagonists (used to reduce blood clotting) such as
warfarin
Raponer XL tablets with food and drink

You can take Raponer XL tablets with or without food, as you prefer.

Pregnancy and breast-feeding

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.
Raponer XL tablets is not recommended if you are pregnant, unless your
doctor advises that the benefit to you of taking Raponer XL tablets is
greater than the risk to your unborn baby.
Your doctor will also advise you if you are breast-feeding or planning to
do so. Raponer XL is not recommended if you are breast-feeding, as it can
affect your milk production. Your doctor may advise you to stop taking
Raponer XL tablets.

Driving and using machines

Raponer XL tablets 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.

Raponer XL tablets contain lactose and castor oil

Raponer XL prolonged-release tablets contain a type of 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.
Raponer XL prolonged-release tablets contain castor oil. May cause
stomach upset and diarrhoea.

3 How to take Raponer XL tablets
Always take this medicine exactly as your doctor or pharmacist has told
you. Check with your doctor or pharmacist if you are not sure.
Raponer XL tablets 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 tablets may not dissolve completely and may
not work properly. You may see tablets in your stool. If this happens, let your
doctor know as soon as possible.
You may be given Raponer XL tablets on its own to treat the symptoms of
your Parkinson’s disease. You may also be given Raponer XL tablets with
another medicine called L-dopa (also called levodopa). If you are taking
L-dopa you may experience some uncontrolled jerky movements when
you first start taking Raponer XL tablets. Tell your doctor if this happens, as
your doctor may need to adjust the dose of L-dopa you are taking.

How much Raponer XL tablets will you need to take?

It may take a while to find out the best dose of Raponer XL tablets for you.
The recommended starting dose of Raponer XL prolonged-release tablets
is 2mg once daily for the first week. Your doctor may increase your dose to
4mg of Raponer 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 24mg of
Raponer XL prolonged-release tablets each day.

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S.Anson

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Date received: 16.12.16

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

Use in children and adolescents

Do not give Raponer XL tablets to children. Raponer XL tablets are not
normally prescribed for people under 18 years of age.

Method of administration

Take Raponer XL tablets once a day, at the same time each day.
Swallow your Raponer XL prolonged-release tablet(s) whole, with a glass
of water. Do not break, chew or crush them. If you do so, 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 (immediaterelease) tablets

Your doctor will base your dose of Raponer 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 Raponer XL prolonged-release
tablets next morning and do not take any more ropinirole film-coated
(immediate-release) tablets.

If you take more Raponer XL tablets than you should

Contact a doctor or pharmacist immediately. If possible, show them the
Raponer XL tablets pack.
Someone who has taken an overdose of Raponer XL tablets 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 Raponer XL tablets

Do not take a double dose to make up for a forgotten tablet.
If you have missed taking Raponer XL tablets for one day or more, ask your
doctor for advice on how to start taking it again.

If you stop taking Raponer XL tablets

Do not stop taking Raponer XL tablets without advice. Take Raponer XL
tablets for as long as your doctor recommends.
Do not stop unless your doctor advises you to. If you suddenly stop taking
Raponer XL tablets, your Parkinson’s disease symptoms may quickly get
much worse.
If you need to stop taking Raponer XL tablets, your doctor will reduce your
dose gradually.
Do not stop using Raponer XL tablets suddenly without talking to your
doctor. A sudden stop could 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, and depressed level of consciousness (e.g. coma).
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 Raponer XL tablets 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)

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:
• S trong impulse to gamble excessively despite serious personal or family
consequences.
•A
 ltered 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
• B inge 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 behaviors; they
will discuss ways of managing or reducing the symptoms.
If you are taking Raponer XL tablets with L-dopa

People who are taking Raponer XL tablets with L-dopa may develop other
side effects over time:
• u ncontrolled jerky movements are a very common side effect. If you are
taking L-dopa you may experience some uncontrollable movements
when you first start taking Raponer XL tablets. 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, pharmacist or nurse.
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 Raponer XL tablets
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 carton
and blister foil after EXP. The expiry date refers to the last day of that month.
Do not store above 30°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 Raponer XL tablets contains

• T he active substance is ropinirole. Each prolonged-release tablet contains
2mg, 3mg, 4mg, 6mg or 8mg of ropinirole (as hydrochloride).
• The other ingredients are: hypromellose, croscarmellose sodium,
maltodextrin; lactose monohydrate, hydrogenated castor oil, colloidal
anhydrous silica, magnesium stearate; pigment blend: (2mg tablets:) iron
oxide red (E172), iron oxide yellow (E172), lactose monohydrate, (3mg
tablets:) lactose monohydrate, indigo carmine aluminium lake (E132),
carmine (E120), (4mg & 8mg tablets:) iron oxide red (E172), iron oxide
yellow (E172), lactose monohydrate, iron oxide black (E172), not applicable
(6mg tablets:)

What Raponer XL tablets looks like and contents of the pack

Raponer XL 2mg prolonged-release tablets are pink, mottled and oval with
2x debossed on one side.
Raponer XL 3mg prolonged-release tablets are purple, mottled and oval
with 3x debossed on one side.
Raponer XL 4mg prolonged-release tablets are brown, mottled and oval
with 4x debossed on one side.
Raponer XL 6mg prolonged-release tablets are white and oval with 6x
debossed on one side.
Raponer XL 8mg prolonged-release tablets are dark pink, mottled and oval
with 8x debossed on one side.
Pack sizes:
Raponer XL prolonged-release tablets are available in blister packs of 28
prolonged‑release tablets.

Common side effects (may affect up to 1 in 10 people):
• falling asleep very suddenly without feeling sleepy first (sudden sleep
onset episodes)
• 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 very sleepy during the day (extreme somnolence)
• mental problems such as delirium (severe confusion), delusions
(unreasonable ideas) or paranoia (unreasonable suspicions).
• feeling dizzy or faint, especially when you stand up suddenly (this is
caused by a drop in blood pressure)

Marketing Authorisation Holder
Actavis Group PTC ehf.
Reykjavíkurvegi 76-78
220 Hafnarfjörður
Iceland
Manufacturer
Actavis Ltd.
BLB 016 Bulebel Industrial Estate,
Zejtun ZTN 3000
Malta
This leaflet was last revised in March 2017

Not known (frequency cannot be estimated from the available data):
• changes in liver function, which have shown up in blood tests.
• hypersensitivity reactions including itchy skin rash, swollen face, lips,
throat or tongue which may cause difficulty swallowing or breathing, rash
and itching.
• excessive use of Raponer XL tablets (craving for large dose of
dopaminergic drugs in excess of that required to control motor
symptoms, known as dopamine dysregulation syndrome)
• acting in an aggressive manner

If you would like a leaflet
with larger text,
please contact
01271 385257.

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Ropinirole (Raponer XL) 2mg, 3mg, 4mg, 6mg & 8mg 28 Tablets PIL -UK
approved for print/date

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UK-Eire-Artwork-Support@Actavis.com

Item no:

BBBA0365

Originator:
Origination Date:
Revision Date:
Revised By:

Technical
Approval

S.Anson
16.12.16
17.03.17
S.Anson

Date sent:
16.12.16
Date received: 16.12.16

Dimensions:
190 x 380
Min Body Text Size: 9pts
Supplier:
Actavis Malta Zejtun

Colours

Non Printing Colours

1. Black

1.

2.

2.

3.

3.

4.
5.
6.

* Please note that only Artwork Studio is permitted to make changes to the above artwork.
No changes are permitted by any 3rd party other than added notes and mark ups for required changes.

Expand Transcript

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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