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RALNEA XL 8 MG PROLONGED-RELEASE TABLETS

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

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

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.

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.

Tell your doctor if you experience symptoms such as depression, apathy,
anxiety, fatigue, sweating or pain after stopping or reducing your
ropinirole treatment. If the problems persist more than a few weeks, your
doctor may need to adjust your treatment.

1. What Ralnea XL is and what it is used for
CONSILIENT HEALTH

Package leaflet:
Information for the patient

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

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.

2. What you need to know before you take
Ralnea XL
Do NOT TAKE Ralnea 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
Tell to your doctor or pharmacist before taking Ralnea XL:
• 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).
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.

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.
Other medicines and Ralnea 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 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.
you will require additional blood tests if you are taking these
medicines with Ralnea XL:

• Vitamin K antagonists (used to reduce blood clotting) such as Warfarin
(coumadin).
Ralnea XL with food, drink and alcohol
You can take Ralnea XL with or without food.
Drinking alcohol while you are taking Ralnea XL is not recommended.
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.
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.
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. Ropinirole can cause hallucinations (seeing, hearing or
feeling things that are not there). If affected, do not drive or use machines.
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.
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 this medicine exactly as your doctor or pharmacist has told
you. Check with your doctor or pharmacist if you are not sure.

DPMockUp066459_2

CONFIDENTIAL

Use in children and adolescents
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 (dyskinesias)
when you first start taking Ralnea XL. Tell your doctor if this happens, as
your doctor may need to adjust the doses of the medicines you are taking.
Ralnea 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 Ralnea XL will you need to take?
It may take a while to find out the best dose of Ralnea XL for you.
The recommended 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.
Swallow your Ralnea XL prolonged-release
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 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.
If you stop taking Ralnea XL
Do not stop taking Ralnea XL without talking to your doctor.
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.
A sudden stop could also cause you to develop a medical condition called
neuroleptic malingnant 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, depressed level of consiousness (e.g. coma).
If you need to stop taking Ralnea 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

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 (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

CONFIDENTIAL

• constipation
• swelling of the legs, feet or hands.

Tell your doctor if you experience any of these behaviours; they will
discuss ways of managing or reducing the symptoms

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).

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 (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 Ralnea 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.

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 aggressive manner
• excessive use of this medicine (craving for large doses of dopaminergic
drugs in excess of that required to control motor symptoms, known as
dopamine dysregulation syndrome)
• after stopping or reducing your Ralnea XL treatment: depression,
apathy, anxiety, fatigue, sweating or pain may occur (called dopamine
agonist withdrawal syndrome or DAWS)
• 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: 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 Ralnea 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
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.
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 Ralnea XL contains
• The active substance is ropinirole.
Each prolonged-release tablet contains 8 mg ropinirole (as
hydrochloride).
• The other ingredients are:
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. See
section 2.
What Ralnea XL looks like and contents of the pack
Tablets are brownish-red, biconvex and oval.
Tablets are available in cartons of 21, 28, 42 and 84 prolonged-release
tablets in blisters (OPA/Alu/PVC//Alu).
Not all pack sizes may be marketed.
Marketing Authorisation Holder
KRKA, d.d, Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
Manufacturer
KRKA, d.d, Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
TAD Pharma GmbH, Heinz-Lohmann-Str. 5, 27472 Cuxhaven, Germany
Distributed by
Consilient Health (UK) Ltd., No.1 Church Road, Richmond upon Thames,
Surrey. TW9 2QE.
this leaflet was last revised in 07/2017

P0634

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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