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ROPINIROLE MYLAN XL 4 MG PROLONGED-RELEASE TABLETS

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

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Package leaflet: Information for the patient

Ropinirole Mylan XL
2 mg, 4 mg, 8 mg
Prolonged-release tablets
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.
What is in this leaflet
1. What Ropinirole Mylan XL is and what it is used for
2. What you need to know before you take Ropinirole Mylan XL
3. How to take Ropinirole Mylan XL
4. Possible side effects
5. How to store Ropinirole Mylan XL
6. Contents of the pack and other information

1. What Ropinirole Mylan XL is and what it is
used for
The active ingredient in Ropinirole Mylan XL Prolonged-release
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.
Ropinirole Mylan 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
Ropinirole Mylan XL
Do not take Ropinirole Mylan XL:
• if you are allergic 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

• 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 may require additional blood tests if you are taking these
medicines with Ropinirole Mylan XL:
• vitamin K antagonists (used to reduce blood clotting) such as
warfarin

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.
Ropinirole Mylan XL is not recommended if you are pregnant,
unless your doctor advises that the benefit to you of taking
Ropinirole Mylan 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. Ropinirole Mylan XL is not recommended
if you are breast-feeding, as it can affect your milk production.
Your doctor may advise you to stop taking Ropinirole Mylan XL.

Driving and using machines
Ropinirole Mylan 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.

Ropinirole Mylan XL contains lactose
Ropinirole Mylan 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 Ropinirole Mylan XL.

3. How to take Ropinirole Mylan 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.
You may be given Ropinirole Mylan XL on its own to treat the
symptoms of your Parkinson’s disease. You may also be given
Ropinirole Mylan 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
Ropinirole Mylan XL. Tell your doctor if this happens, as your
doctor may need to adjust the dose of L-dopa you are taking.

Talk to your doctor or pharmacist before taking Ropinirole
Mylan 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 have an intolerance to some sugars (such as lactose).

Ropinirole Mylan XL prolonged-release tablets are designed
to release your medicine over a 24-hour period. If you have
a condition where the tablet passes through your body
too quickly (e.g. diarrhoea), the tablet(s) may not dissolve
completely and may not work properly. You may also see
undissolved parts of the tablet(s) in your stool. If this happens,
let your doctor know as soon as possible.

Your doctor may decide that Ropinirole Mylan XL is not suitable
for you, or that you need extra check-ups while you are taking it.

Do not give Ropinirole Mylan XL to children. Ropinirole Mylan
XL is not normally prescribed for people under 18 years of age.

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

Other medicines and Ropinirole XL

Use in children and adolescents

How much Ropinirole Mylan XL will you need to take?
It may take a while to find out the best dose of Ropinirole
Mylan XL for you.
The recommended starting dose of Ropinirole Mylan XL is 2 mg
once daily for the first week. Your doctor may increase your dose
to 4 mg of Ropinirole Mylan 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 Ropinirole Mylan 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.

Tell your doctor or pharmacist if you are taking or 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 Ropinirole Mylan XL.

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

Some medicines can affect the way Ropinirole Mylan XL works,
or make it more likely that you will have side effects. Ropinirole
Mylan 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

Take Ropinirole Mylan XL once a day, at the same time each day.
You can take Ropinirole Mylan XL with or without food, as you
prefer.

Description Ropinirole Hydrochloride_2mg_4mg_8mg_24
Component Type Leaflet (Insert) Pharma Code N/A
Affiliate Item Code 1062884
Superceded Affiliate Item Code 940066
TrackWise PR No. 1062884
MA No. N/A
Packing Site/Printer Actavis Ltd (Zejtun - MT)
Supplier Code TBC

SAP No. N/A
Vendor Job No. 470884
Trackwise Proof No. 4
Glams Proof No. N/A
Client Market United Kingdom

Method of administration

Swallow your Ropinirole Mylan 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.

Date: 20 May 17
No. of colours
Colours

1

Time: 17:00
Page Count

1/2

Black

Non-Print
Colours
Equate CMYK
with

Keyline/Drawing No. N/A

Main Font

Barcode Info N/A

Dimensions

Myriad Pro
190 x 380 mm

Body Text Size 9 pt
Min Text Size used 9 pt

Sign-offs

v1/May 2015

If you are switching from ropinirole film-coated
(immediate-release) tablets
Your doctor will base your dose of Ropinirole Mylan 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 Ropinirole
Mylan XL prolonged-release tablets next morning and do
not take any more ropinirole film-coated (immediate-release)
tablets.

If you take more Ropinirole Mylan XL than you should
Contact a doctor or pharmacist immediately. If possible, show
them the Ropinirole Mylan XL pack.
Someone who has taken an overdose of Ropinirole Mylan 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 Ropinirole Mylan XL
Do not take a double dose to make up for a forgotten tablet.
If you have missed taking Ropinirole Mylan XL for one day or
more, ask your doctor for advice on how to start taking it again.

If you stop taking Ropinirole Mylan XL
Do not stop taking Ropinirole Mylan XL without advice. Take
Ropinirole Mylan XL for as long as your doctor recommends.
Do not stop unless your doctor advises you to. If you suddenly
stop taking Ropinirole Mylan 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 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,depressed level of
consciousness (e.g. coma).
If you need to stop taking Ropinirole Mylan XL, your doctor will
reduce your dose gradually.

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 Ropinirole Mylan XL with L-dopa
People who are taking Ropinirole Mylan 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
Ropinirole Mylan 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 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 Ropinirole Mylan XL
Keep this medicine out of the sight and reach of children.

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

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.

4. Possible side effects

Do not store above 30°C.

Like all medicines, this medicine can cause side effects, although
not everybody gets them.

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.

The side effects of Ropinirole Mylan 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.

6. Contents of the pack and other information
What Ropinirole XL contains:

Other side effects are:

• The active substance is ropinirole. Each prolonged-release
tablet contains 2 mg, 4 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 prolonged release tablets:] iron oxide
red (E172), iron oxide yellow (E172), lactose monohydrate,
[4 mg & 8 mg prolonged release tablets:] iron oxide red
(E172), iron oxide yellow (E172), lactose monohydrate, iron
oxide black (E172).

Very common (may affect more than 1 in 10 people):

What Ropinirole XL looks like and contents of the pack

• fainting
• feeling drowsy
• feeling sick (nausea).

Ropinirole Mylan XL 2 mg prolonged-release tablets are pink,
mottled and oval with 2x debossed on one side.
Ropinirole Mylan XL 4 mg prolonged-release tablets are brown,
mottled and oval with 4x debossed on one side.
Ropinirole Mylan XL 8 mg prolonged-release tablets are dark
pink, mottled and oval with 8x debossed on one side.

If any of the following happen, do not take more Ropinirole
Mylan XL. Tell your doctor immediately or go to the casualty
department at your nearest hospital

Not known (frequency cannot be estimated from the
available data):
• hypersensitivity reactions including itchy skin rash, swollen
face, lips, throat or tongue which may cause difficulty
swallowing or breathing, rash and itching.

Common (may affect up to 1 in 10 people):









hallucinations (“seeing” things that are not really there)
being sick (vomiting)
feeling dizzy (a spinning sensation)
falling asleep very suddenly without feeling sleepy first
(sudden sleep onset episodes)
heartburn
stomach pain
constipation
swelling of the legs, feet or hands.

Uncommon (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)
• mental problems such as delirium (severe confusion),
delusions (unreasonable ideas) or paranoia (unreasonable
suspicions).

Pack sizes
Ropinirole Mylan 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
Mylan, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom

Manufacturer
Actavis Ltd, BLB016, Bulebel Industrial Estate, Zejtun, ZTN 3000,
Malta
This leaflet was last revised in 05/2017

Not known (frequency cannot be estimated from the
available data):
• changes in liver function, which have shown up in blood tests.
• craving for large doses of dopaminergic drugs in excess
of that required to control motor symptoms, known as
dopamine dysregulation syndrome.

Description Ropinirole Hydrochloride_2mg_4mg_8mg_24
Component Type Leaflet (Insert) Pharma Code N/A
Affiliate Item Code 1062884
Superceded Affiliate Item Code 940066
TrackWise PR No. 1062884
MA No. N/A
Packing Site/Printer Actavis Ltd (Zejtun - MT)
Supplier Code TBC

SAP No. N/A
Vendor Job No. 470884
Trackwise Proof No. 4
Glams Proof No. N/A
Client Market United Kingdom

1062884

Date: 20 May 17
No. of colours
Colours

1

Time: 17:00
Page Count

2/2

Black

Non-Print
Colours
Equate CMYK
with

Keyline/Drawing No. N/A

Main Font

Barcode Info N/A

Dimensions

Myriad Pro
190 x 380 mm

Body Text Size 9 pt
Min Text Size used 9 pt

Sign-offs

v1/May 2015

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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