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RALNEA XL 2 MG PROLONGED-RELEASE TABLETS

Active substance(s): ROPINIROLE HYDROCHLORIDE

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if you are pregnant or think you might 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 have experienced any unusual urges and/or behaviours (such
as excessive gambling or excessive sexual behaviour)
• if you have an intolerance to some sugars (such as lactose).

In this leaflet:
1. What Ralnea XL is and what it is used for
2. Before you take Ralnea XL
3. How to take Ralnea XL
4. Possible side effects
5. How to store Ralnea XL
6. Further information








Ralnea XL 2 mg

1. WHAT Ralnea XL IS AND WHAT IT IS USED FOR

Ralnea XL 4 mg

prolonged-release tablets

The active substance in Ralnea 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.

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

prolonged-release tablets
Ropinirole

Ralnea XL prolonged-release tablets are used to treat
Parkinson’s disease.

PACKAGE LEAFLET:
INFORMATION FOR THE USER

prolonged-release tablets

Ralnea XL 8 mg

Read all of this leaflet carefully before you start taking
this medicine.
• 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. Do not pass it on to others.
It may harm them, even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects
not listed in this leaflet, please tell your doctor or pharmacist.

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. Before you take Ralnea XL
Do NOT TAKE Ralnea XL if you:
• are allergic (hypersensitive) to ropinirole or any of the other
ingredients of Ralnea XL.
• have serious kidney disease
• have liver disease
Tell your doctor if you think any of these may apply to you.
Take special care with Ralnea XL
Your doctor needs to know before you take Ralnea 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.
Smoking and Ralnea XL
Tell your doctor if you start smoking, or give up smoking, while you are
taking Ralnea XL. Your doctor may need to adjust your dose.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently
taken any other medicines, including medicines obtained without a
prescription.
Remember to tell your doctor or pharmacist if you begin taking a new
medicine while you are taking Ralnea XL.
Some medicines can affect the way Ralnea XL works, or make it more likely
that you will have side effects. Ralnea XL 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.
Taking Ralnea XL with food and drink
You can take Ralnea XL with or without food.
Drinking alcohol while you are taking Ralnea XL is not recommended.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
Ralnea XL is not recommended if you are pregnant, unless your doctor
advises that the benefit to you of taking Ralnea XL is greater than the risk
to the unborn baby. Ralnea XL is not recommended if you are breastfeeding, 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 Ralnea XL.
Driving and using machines
Ralnea 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.

Important information about some of the ingredients of
Ralnea XL
Ralnea XL contains 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.
3. How to take Ralnea XL
Always take Ralnea XL exactly as your doctor has told you.
You should check with your doctor or pharmacist if you are not sure.
Do not give Ralnea XL to children. Ralnea XL is not normally prescribed
for people under 18.
You may be given Ralnea XL on its own to treat the symptoms of your
Parkinson’s disease. Or you may be given Ralnea XL as well as 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 Ralnea XL. Tell your doctor if this happens, as your doctor may
need to reduce the dose of L-dopa you are taking.
How much Ralnea XL will you need to take?
It may take a while to find out the best dose of Ralnea XL for you.
The usual starting dose of Ralnea XL prolonged-release tablets is 2 mg
once daily for the first week. Your doctor may increase your dose to 4 mg
of Ralnea 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
Ralnea XL prolonged-release 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 immediate-release tablets which you
will take three times a day.

Do not take any more Ralnea XL than your doctor has
recommended.
It may take a few weeks for Ralnea XL to work for you.
Taking your dose of Ralnea XL
Take Ralnea XL once a day, at the same time each day.

If you stop taking Ralnea XL
Do not stop taking Ralnea XL without advice.
Take Ralnea XL for as long as your doctor recommends. Do not stop unless
your doctor advises you to.
If you suddenly stop taking Ralnea XL, your Parkinson’s disease symptoms
may quickly get much worse.

Swallow your Ralnea XL prolonged-release
tablet(s) whole, with a glass of water.

If you need to stop taking Ralnea XL, your doctor will reduce your dose
gradually.

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 have any further questions on the use of this product, ask your
doctor or pharmacist.

If you are switching from ropinirole immediate-release tablets
Your doctor will base your dose of Ralnea XL prolonged-release tablets on
the dose of ropinirole immediate-release tablets you were taking.
Take your ropinirole immediate-release tablets as normal the day before
you switch. Then take your Ralnea XL prolonged-release tablets next
morning and do not take any more ropinirole immediate-release tablets.
If you take more Ralnea XL than you should
Contact a doctor or pharmacist immediately. If possible, show them
the Ralnea XL pack.
Someone who has taken an overdose of Ralnea 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 Ralnea XL
Do not take a double dose to make up for a forgotten dose.
If you have missed taking Ralnea XL for one day or more, ask your doctor
for advice on how to start taking it again.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Ralnea XL can cause side effects, although not
everybody gets them.
The side effects of Ralnea 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 (affects more than 1 user in 10)
• fainting
• feeling sleepy (somnolence)
• feeling sick (nausea).
Common side effects (affects 1 to 10 users in 100)
• 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 (affects 1 to 10 users in 1,000)
• 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 apparent warning

(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
• changes in liver function, which have shown up on blood tests.
• 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 behaviors; they will
discuss ways of managing or reducing the symptoms.
If you are taking Ralnea XL with L-dopa
People who are taking Ralnea XL with L-dopa may develop other side
effects over time:
• uncontrolled jerky movements (very common side effect),
• feeling confused is a common side effect.

If any of the side effects gets serious or troublesome, or if you
notice any side effects not listed in this leaflet, please tell your
doctor or pharmacist.
5. How to store Ralnea XL

Keep out of the reach and sight of children.
Do not use Ralnea XL after the expiry date which is stated on the blisters
and carton after EXP. The expiry date refers to the last day of that month.
Do not store above 30°C.
Store in the original package in order to protect from moisture.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required.
These measures will help to protect the environment.
6. FURTHER INFORMATION
What Ralnea XL contains
• The active substance is ropinirole.
Ralnea XL 2 mg prolonged-release tablets:
Each prolonged-release tablet contains 2 mg ropinirole
(as hydrochloride).
Ralnea XL 4 mg prolonged-release tablets:
Each prolonged-release tablet contains 4 mg ropinirole
(as hydrochloride).
Ralnea XL 8 mg prolonged-release tablets:
Each prolonged-release tablet contains 8 mg ropinirole
(as hydrochloride).
• The other ingredients are:
Ralnea XL 2 mg prolonged-release tablets:



hypromellose type 2208, lactose monohydrate, colloidal anhydrous
silica, carbomers 4,000-11,000 mPa.s, hydrogenated castor oil,
magnesium stearate in the tablet core and hypromellose type 2910,
titanium dioxide (E171), macrogol 400, red iron oxide (E172), yellow
iron oxide (E172) in the film coating.
Ralnea XL 4 mg and 8 mg prolonged-release tablets:
hypromellose type 2208, lactose monohydrate, colloidal anhydrous
silica, carbomers 4,000-11,000 mPa.s, hydrogenated castor oil,
magnesium stearate in the tablet core and hypromellose type 2910,
titanium dioxide (E171), macrogol 400, red iron oxide (E172), yellow
iron oxide (E172), black iron oxide (E172) in the film coating.
What Ralnea XL looks like and contents of the pack
Ralnea XL 2 mg prolonged-release tablets:
Tablets are pink, biconvex and oval.
Ralnea XL 4 mg prolonged-release tablets:
Tablets are light off-brown, biconvex and oval.
Ralnea XL 8 mg prolonged-release tablets:
Tablets are brownish-red, biconvex and oval.
Tablets are available in boxes of 21, 28, 42 and 84 prolonged-release
tablets in blisters (OPA/Al/PVC//Al).
Not all pack sizes may be marketed.
Marketing Authorisation Holder
KRKA, d.d, Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
Manufacturers
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501, Novo mesto, Slovenia
TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany
Distributed by
Consilient Health (UK) Ltd., 500 Chiswick High Road, London. W4 5RG. UK
This leaflet was last revised in January 2013
P0184

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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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