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EPPINIX XL 3 MG PROLONGED-RELEASE TABLETS

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Information for the user

Eppinix® XL 2 mg prolonged-release tablets
Eppinix® XL 3 mg prolonged-release tablets
Eppinix® XL 4 mg prolonged-release tablets
Eppinix® XL 6 mg prolonged-release tablets
Eppinix® 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.
- The full name of this medicine is Eppinix® XL 2 mg, 3 mg,
4 mg, 6 mg and 8 mg Prolonged-release Tablets but within
the leaflet it will be referred to as Eppinix® XL.
What is in this leaflet
1. What Eppinix® XL is and what it is used for
2. What you need to know before you take Eppinix® XL
3. How to take Eppinix® XL
4. Possible side effects
5. How to store Eppinix® XL
6. Contents of the pack and other information

1. What Eppinix® XL is and what it is used for
The active ingredient in Eppinix® 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.
Eppinix® 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 Eppinix® XL
Do not take Eppinix® XL
- if you are allergic (hypersensitive) to ropinirole or any of the
other ingredients of this medicine (listed in section 6)
- if you have a serious kidney disease
- if you have a liver disease
Tell your doctor if you think any of these may apply to you.
Warnings and precautions
Take special care with Eppinix® XL 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 Eppinix® XL is not suitable for you, or
that you need extra check-ups while you are taking it.
While you are taking Eppinix® 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 Eppinix® XL
Tell your doctor if you start smoking, or give up smoking, while you
are taking Eppinix® XL. Your doctor may need to adjust your dose.
Other medicines and Eppinix® XL
Tell your doctor or pharmacist if you are taking or have recently
taken or might take any other medicines, including medicines
obtained without a prescription. Also remember to tell your
doctor or pharmacist if you begin taking a new medicine while
you are taking Eppinix® XL.
Some medicines can affect the way Eppinix® XL works, or make
it more likely that you will have side effects. Eppinix® 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.

Eppinix® XL with food and drink
You can take Eppinix® XL 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.
Eppinix® XL is not recommended if you are pregnant, unless
your doctor advises that the benefit to you of taking Eppinix® XL
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. Eppinix® XL is not recommended if you are
breast-feeding, as it can affect your milk production. Your doctor
may advise you to stop taking Eppinix® XL.
Driving and using machines
Eppinix® 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.
Eppinix® XL contain lactose and castor oil
Eppinix® XL contains 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 Eppinix® XL.
Eppinix® XL contains castor oil. May cause stomach upset and
diarrhoea.

3. How to take Eppinix® 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.
Use in children and adolescents
Do not give Eppinix® XL to children. Eppinix® XL is not normally
prescribed for people under 18 years of age.
You may be given Eppinix® XL on its own to treat the symptoms
of your Parkinson’s disease. You may also be given Eppinix® XL
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 Eppinix® XL. Tell
your doctor if this happens, as your doctor may need to adjust
the dose of L-dopa you are taking.
How much Eppinix® XL will you need to take?
It may take a while to find out the best dose of Eppinix® XL for you.
The recommended starting dose of Eppinix® XL is 2 mg once
daily for the first week. Your doctor may increase your dose
to 4 mg of Eppinix® XL 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 Eppinix® XL 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.
It may take a few weeks for Eppinix® XL to work for you. Do not
take any more Eppinix® XL than your doctor has recommended.
Method of administration
Take Eppinix® XL once a day, at the same time each day.
Swallow your Eppinix® XL 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 Eppinix® XL 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 Eppinix® XL
the next morning and do not take any more ropinirole
film-coated (immediate-release) tablets.
If you take more Eppinix® XL than you should
Contact a doctor or pharmacist immediately. If possible, show
them the Eppinix® XL pack.
Someone who has taken an overdose of Eppinix® 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.
Continued over page

If you forget to take Eppinix® XL
Do not take a double dose to make up for a forgotten tablet.
If you have missed taking Eppinix® XL for one day or more, ask
your doctor for advice on how to start taking it again.
If you stop taking Eppinix® XL
Do not stop taking Eppinix® XL without advice. Take Eppinix® XL
for as long as your doctor recommends.
Do not stop unless your doctor advises you to. If you suddenly
stop taking Eppinix® XL, your Parkinson’s disease symptoms may
quickly get much worse.
If you need to stop taking Eppinix® 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
Like all medicines, this medicine can cause side effects, although
not everybody gets them.
The side effects of Eppinix® 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: (affects more than 1 user in 10)
- fainting
- feeling drowsy
- feeling sick (nausea).
Common: (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: (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 feeling sleepy first
(sudden sleep onset episodes)
- mental problems such as delirium (severe confusion),
delusions (unreasonable ideas) or paranoia (unreasonable
suspicions).
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.
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.
If you are taking Eppinix® XL with L-dopa
People who are taking Eppinix® XL with L-dopa may develop
other side effects over time:
- uncontrolled 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
Eppinix® 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, 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

Ropinirole (Eppinix® XL) 2mg, 3mg, 4mg, 6mg and 8mg PIL - UK
Dimensions: 190mm x 380mm
Proof Date: 02/10/14

5. How to store Eppinix® 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 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 Eppinix® XL contains
- The active substance is ropinirole. Each prolonged-release
tablet contains 2 mg, 3 mg, 4 mg, 6 mg or 8 mg of ropinirole
(as hydrochloride).
- The other ingredients are: hypromellose, croscarmellose
sodium, maltodextrin; lactose monohydrate, hydrogenated
castor oil, colloidal anhydrous silica, magnesium stearate;
pigment blend :
2 mg tablets: iron oxide red (E172), iron oxide yellow (E172),
lactose monohydrate,
3 mg tablets: lactose monohydrate, indigo carmine
aluminium lake (E132), carmine (E120),
4 mg & 8 mg tablets: iron oxide red (E172), iron oxide yellow
(E172), lactose monohydrate, iron oxide black (E172).
6 mg tablets: do not contain pigment blend.
What Eppinix® XL looks like and contents of the pack
Eppinix® XL 2 mg prolonged-release tablets are pink, mottled
and oval with 2x debossed on one side.
Eppinix® XL 3 mg prolonged-release tablets are purple,
mottled and oval with 3x debossed on one side.
Eppinix® XL 4 mg prolonged-release tablets are brown,
mottled and oval with 4x debossed on one side.
Eppinix® XL 6 mg prolonged-release tablets are white and
oval with 6x debossed on one side.
Eppinix® XL 8 mg prolonged-release tablets are dark pink,
mottled and oval with 8x debossed on one side.
Pack sizes:
Eppinix® XL prolonged-release tablets are available in blister
packs of 21, 28, 30, 42, 56, 84 and 90 prolonged release tablets.
Not all pack sizes may be available.
Marketing Authorisation Holder
DB Ashbourne Limited
The Rectory, Braybrooke Road, Arthingworth,
Market Harborough
LE16 8JT United Kingdom
Manufacturer
Actavis Ltd
BLB 016 Bulebel Industrial Estate,
Zejtun ZTN 3000,
Malta
This leaflet was last revised in 09/2014.

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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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