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ROPINIROLE 2MG TABLETS

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S734 LEAFLET Requip 20121107

These include:

PACKAGE LEAFLET: INFORMATION FOR THE USER



the anti-depressant fluvoxamine

REQUIP 2mg TABLETS
(ropinirole hydrochloride)



HRT (hormone replacement therapy)



the antibiotics ciprofloxacin or enoxacin

Your medicine is called Requip 2mg Tablets but will be referred to
as Requip throughout the remainder of the leaflet.



medication for other mental health problems, for example
sulpiride

Information regarding other strengths are also available in this
leaflet.



metoclopramide, which is used to treat nausea and heartburn



cimetidine, used in the treatment of stomach ulcers

Read right through this leaflet before you start taking these
tablets.



any other medicine for Parkinson’s disease.

This medicine has been prescribed for you personally. Don’t pass it
on to other people — it may harm them even if their symptoms
seem to be the same as yours.
Keep this leaflet. You may need to read it again.
If you have any more questions, ask your doctor or pharmacist
(chemist).
If you have serious side effects, or if you notice any side
effects not listed in this leaflet, tell your doctor or pharmacist.

→ Tell your doctor if you’re taking, or have recently taken, any of
these.
Remember to tell your doctor if you start taking any other
medicine while you’re taking Requip.
Pregnancy and breast-feeding
Requip is not recommended if you are pregnant, unless your
doctor advises that the benefit to you taking Requip is greater than
than risk to your unborn baby. Requip is not recommended if you
are breast feeding, as it can affect your milk production.
Tell your doctor immediately:


if you’re pregnant, if you think you might be pregnant or if you’re
planning to become pregnant

2. Before you take Requip



if you’re breast-feeding or planning to breast-feed.

3. While you’re taking Requip

Your doctor may advise you to stop taking Requip.

4. How to take Requip

Children

5. Possible side effects

Do not give Requip to children. Requip is not normally prescribed
for people under 18.

In this leaflet
1. What Requip is and what it is used for

6. How to store Requip
7. Further information
1. What Requip is and what it is used for
Requip is used to treat Parkinson’s disease.
The active ingredient in Requip 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.
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 Requip
Don’t take Requip:

3. While you’re taking Requip
If you drive or operate machinery
Requip 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: don’t drive, don’t operate machines and
don’t put yourself in any situation where feeling sleepy or falling
asleep could put you (or other people) at risk of serious injury or
death. Don’t take part in these activities until you are no longer
affected.
→ Talk to your doctor if this causes problems for you.
Smoking and Requip



if you’re allergic (hypersensitive) to ropinirole or any of the
other ingredients of Requip (see Section 5 and 7)

Tell your doctor or nurse if you start smoking, or give up smoking,
while you’re taking Requip. Your doctor or nurse may need to adjust
your dose.



if you have serious kidney disease

Food and drink with Requip



if you have liver disease

If you take Requip with food, you may be less likely to feel sick or
be sick (vomit). So it’s best to take it with food if you can.

→ Tell your doctor if you think any of these may apply to you.
Take special care with Requip
Your doctor needs to know before you take Requip:

4. How to take Requip



if you are pregnant or think you may be pregnant



if you are breast feeding

Always take Requip exactly as your doctor has told you to.
Check with your doctor or pharmacist if you’re not sure.



if you are under 18 years old



if you have a serious heart complaint



if you have a serious mental health problem



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.



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 Requip isn’t suitable for you or that
you need extra check-ups while you’re taking it.
You also need to be careful with Requip if you drive or operate
machinery. Please read the warning in Section 3 of this leaflet.
Requip contains lactose
Requip tablets contain a small amount of a sugar called lactose. If
you have an intolerance to lactose or any other sugars, ask your
doctor for advice before you take Requip.

You may be given Requip on its own to treat the symptoms of your
Parkinson’s disease. Or you may be given Requip as well as
another medicine called L-dopa (also called levodopa).
If you are taking L-dopa you may experience some uncontrollable
movements (dyskinesias) when you first start taking Requip. Tell
your doctor if this happens, as your doctor may need to adjust the
dose of the medicines you are taking.
Tell your doctor if you or your family notices that you are developing
any unusual behaviours (such as an unusual urge to gamble or
increased sexual urges and/or behaviours) while you are taking
Requip. Your doctor may need to adjust or stop your dose.
How much Requip will you need to take?
It may take a while to find out the best dose of Requip for you.
The usual starting dose is 0.25 mg of ropinirole three times each
day for the first week. Then your doctor will increase your dose
each week, for the next three weeks. After that, your doctor will
gradually increase the dose until you are taking the dose that is
best for you. The usual is 1 mg to 3 mg three times each day
(making a total daily dose of 3 mg to 9 mg). If your Parkinson’s
disease symptoms have not improved enough, your doctor may
decide to gradually increase your dose some more.
Some people take up to 8 mg of Requip three times a day (24 mg
daily altogether).
If you are also taking other medicines for Parkinson’s disease, your
doctor may advise you to gradually reduce the dose of the other
medicine.

Other medicines and Requip
Tell your doctor or pharmacist if you’re taking, or have recently
taken, any other medicines including any herbal remedies or
other medicines you bought without a prescription.

Don’t take any more Requip than your doctor has
recommended.

Some medicines can affect the way Requip works or make it more
likely that you’ll have side effects. Requip can also affect the way
some other medicines work.

Taking your dose of Requip

It may take a few weeks for Requip to work for you.
Take Requip three times a day.
Swallow your Requip tablets whole, with a glass of water.
It’s best to take Requip with food, because that makes it less likely
that you’ll feel sick (nauseous).

If someone takes too much Requip
Contact a doctor or pharmacist immediately. If possible, show
them the Requip pack.
Someone who has taken an overdose of Requip 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 Requip
Don’t take extra tablets or a double dose to make up for a
missed dose. Just take your next dose at the usual time.

Tell your doctor if you experience any of these behaviours;
they will discuss ways of managing or reducing the symptoms
If you get side effects
If you notice any unwanted effects (even ones not mentioned in
this leaflet) or if any of the side effects becomes troublesome while
you’re taking Requip
→ Tell your doctor or pharmacist.
6. How to store Requip


KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Do not store the tablets above 25°C.



Keep in a dry place protected from light.

Don’t stop taking Requip without advice



Do not take the tablets after the date shown on the pack.

Take Requip for as long as your doctor recommends. Don’t
stop unless your doctor advises you to.



If your doctor tells you to stop using the medicine, please take it
back to the pharmacist for safe disposal. Only keep the
medicine if your doctor tells you to.



If the medicine becomes discoloured or shows any other signs
of deterioration, you should seek the advice of your pharmacist
who will tell you what to do.

If you have missed taking Requip for more than a few days, ask
your doctor for advice on how to start taking it again.

If you suddenly stop taking Requip your Parkinson’s disease
symptoms may quickly get much worse.
If you need to stop taking Requip your doctor will reduce your dose
gradually.
If you have any further questions on the use of this product, ask
your doctor or pharmacist.
5. Possible side effects
Like all medicines, Requip can have side effects, but not everyone
gets them.
The side effects of Requip 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’re worried about side effects, talk to your doctor.

7. Further information
What Requip contains


Each film-coated tablet contains 2mg of the active ingredient
ropinirole (as the hydrochloride).



Each tablet contains the inactive ingredients lactose
monohydrate, microcrystalline cellulose, croscarmellose
sodium, magnesium stearate, hypromellose, macrogol 400,
titanium dioxide (E171), yellow ferric oxide (E172) and red ferric
oxide (E172).

What Requip looks like and contents of the pack

Very common side effects

Each tablet is a pink, pentagonal shaped tablet marked ‘SB’ on one
side and ‘4893’ on the other.

These may affect more than 10 in 100 people taking Requip:

Requip Tablets are available in blister packs of 21 or 84 tablets.



fainting

Product Licence holder



feeling drowsy



feeling sick (nausea)

Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House, Alperton
Lane, Wembley, HA0 1DX.

Common side effects
These may affect more than 1 in 100 people taking Requip:


hallucinations (sensing things that are not real)



being sick (vomiting)



feeling dizzy (a spinning sensation)



heartburn



stomach pain



swelling of the legs

Uncommon side effects

Manufacturer
This product is manufactured by SmithKline Beecham
Pharmaceuticals, Magpie Wood, Manor Royal, Crawley, RH10 2QJ
England.
POM

PL 19488/0734 Requip 2mg Tablets

Leaflet revision date: 07 November 2012
Requip is a registered trade mark of GlaxoSmithKline group of
companies.



feeling dizzy or faint, especially when you stand up suddenly
(this caused by a drop in blood pressure)

A number of groups exist to provide further information and support
to Parkinson’s disease patients and their carers. The main one is
the Parkinson’s Disease Society, who you can contact at the
address given below:



feeling very sleepy during the day (extreme somnolence)

Parkinson’s Disease Society



falling asleep very suddenly without feeling sleepy first (sudden
sleep onset episodes)

These may affect more than 1 in 1,000 people taking Requip:



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

Some people taking Requip have had a compulsive urge to
gamble or increased sexual urges and/or behaviours.
Very rare side effects
A very small number of people taking Requip (less than 1 in
10,000) have had:


changes in liver function, which have shown up in blood tests



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

If you’re taking Requip with L-dopa
People who are taking Requip with L-dopa may develop other side
effects over time:


uncontrollable movements (dyskinesias) are a very common
side effect. 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

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:
o

Strong impulse to gamble excessively despite serious
personal or family consequences.

o

Altered or increased sexual interest and behaviour of
significant concern to you or to others, for example, an
increased sexual drive.

o

Uncontrollable excessive shopping or spending

o

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)

215 Vauxhall Bridge Rd
London SW1V 1EJ
S734 LEAFLET Requip 20121107

S734 LEAFLET Ropinirole 20121107

These include:

PACKAGE LEAFLET: INFORMATION FOR THE USER



the anti-depressant fluvoxamine

ROPINIROLE 2mg TABLETS
(ropinirole hydrochloride)



HRT (hormone replacement therapy)



the antibiotics ciprofloxacin or enoxacin

Your medicine is called Ropinirole 2mg Tablets but will be referred
to as Ropinirole throughout the remainder of the leaflet.



medication for other mental health problems, for example
sulpiride

Information regarding other strengths are also available in this
leaflet.



metoclopramide, which is used to treat nausea and heartburn



cimetidine, used in the treatment of stomach ulcers

Read right through this leaflet before you start taking these
tablets.



any other medicine for Parkinson’s disease.

This medicine has been prescribed for you personally. Don’t pass it
on to other people — it may harm them even if their symptoms
seem to be the same as yours.
Keep this leaflet. You may need to read it again.
If you have any more questions, ask your doctor or pharmacist
(chemist).

→ Tell your doctor if you’re taking, or have recently taken, any of
these.
Remember to tell your doctor if you start taking any other
medicine while you’re taking Ropinirole.
Pregnancy and breast-feeding

If you have serious side effects, or if you notice any side
effects not listed in this leaflet, tell your doctor or pharmacist.

Ropinirole is not recommended if you are pregnant, unless your
doctor advises that the benefit to you taking Ropinirole is greater
than than risk to your unborn baby. Ropinirole is not
recommended if you are breast feeding, as it can affect your milk
production.

In this leaflet

Tell your doctor immediately:

1. What Ropinirole is and what it is used for



if you’re pregnant, if you think you might be pregnant or if you’re
planning to become pregnant



if you’re breast-feeding or planning to breast-feed.

2. Before you take Ropinirole
3. While you’re taking Ropinirole
4. How to take Ropinirole
5. Possible side effects
6. How to store Ropinirole
7. Further information
1. What Ropinirole is and what it is used for
Ropinirole is used to treat Parkinson’s disease.
The active ingredient in Ropinirole 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.

Your doctor may advise you to stop taking Ropinirole.
Children
Do not give Ropinirole to children. Ropinirole is not normally
prescribed for people under 18.
3. While you’re taking Ropinirole
If you drive or operate machinery
Ropinirole can make you feel drowsy. It can make people feel
extremely sleepy and it sometimes makes people fall asleep very
suddenly without warning.

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.

If you could be affected: don’t drive, don’t operate machines and
don’t put yourself in any situation where feeling sleepy or falling
asleep could put you (or other people) at risk of serious injury or
death. Don’t take part in these activities until you are no longer
affected.

2. Before you take Ropinirole

→ Talk to your doctor if this causes problems for you.

Don’t take Ropinirole:

Smoking and Ropinirole



if you’re allergic (hypersensitive) to ropinirole or any of the
other ingredients of Ropinirole (see Section 5 and 7)



if you have serious kidney disease

Tell your doctor or nurse if you start smoking, or give up smoking,
while you’re taking Ropinirole. Your doctor or nurse may need to
adjust your dose.



if you have liver disease

Food and drink with Ropinirole

→ Tell your doctor if you think any of these may apply to you.
Take special care with Ropinirole

If you take Ropinirole with food, you may be less likely to feel sick
or be sick (vomit). So it’s best to take it with food if you can.

Your doctor needs to know before you take Ropinirole:
4. How to take Ropinirole



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



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.

If you are taking L-dopa you may experience some uncontrollable
movements (dyskinesias) when you first start taking Ropinirole. Tell
your doctor if this happens, as your doctor may need to adjust the
dose of the medicines you are taking.

if you have an intolerance to some sugars (such as lactose).

It may take a while to find out the best dose of Ropinirole for you.



→ Tell your doctor if you think any of these may apply to you.
Your doctor may decide that Ropinirole isn’t suitable for you or
that you need extra check-ups while you’re taking it.
You also need to be careful with Ropinirole if you drive or operate
machinery. Please read the warning in Section 3 of this leaflet.
Ropinirole contains lactose
Ropinirole tablets contain a small amount of a sugar called lactose.
If you have an intolerance to lactose or any other sugars, ask your
doctor for advice before you take Ropinirole.
Other medicines and Ropinirole
Tell your doctor or pharmacist if you’re taking, or have recently
taken, any other medicines including any herbal remedies or
other medicines you bought without a prescription.
Some medicines can affect the way Ropinirole works or make it
more likely that you’ll have side effects. Ropinirole can also affect
the way some other medicines work.

Always take Ropinirole exactly as your doctor has told you to.
Check with your doctor or pharmacist if you’re not sure.
You may be given Ropinirole on its own to treat the symptoms of
your Parkinson’s disease. Or you may be given Ropinirole as well
as another medicine called L-dopa (also called levodopa).

Tell your doctor if you or your family notices that you are developing
any unusual behaviours (such as an unusual urge to gamble or
increased sexual urges and/or behaviours) while you are taking
Ropinirole. Your doctor may need to adjust or stop your dose.
How much Ropinirole will you need to take?
The usual starting dose is 0.25 mg of ropinirole three times each
day for the first week. Then your doctor will increase your dose
each week, for the next three weeks. After that, your doctor will
gradually increase the dose until you are taking the dose that is
best for you. The usual is 1 mg to 3 mg three times each day
(making a total daily dose of 3 mg to 9 mg). If your Parkinson’s
disease symptoms have not improved enough, your doctor may
decide to gradually increase your dose some more.
Some people take up to 8 mg of Ropinirole three times a day (24
mg daily altogether).
If you are also taking other medicines for Parkinson’s disease, your
doctor may advise you to gradually reduce the dose of the other
medicine.
Don’t take any more Ropinirole than your doctor has
recommended.
It may take a few weeks for Ropinirole to work for you.
Taking your dose of Ropinirole
Take Ropinirole three times a day.
Swallow your Ropinirole tablets whole, with a glass of water.
It’s best to take Ropinirole with food, because that makes it less
likely that you’ll feel sick (nauseous).

If someone takes too much Ropinirole
Contact a doctor or pharmacist immediately. If possible, show
them the Ropinirole pack.
Someone who has taken an overdose of Ropinirole 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
Don’t take extra tablets or a double dose to make up for a
missed dose. Just take your next dose at the usual time.

Tell your doctor if you experience any of these behaviours;
they will discuss ways of managing or reducing the symptoms
If you get side effects
If you notice any unwanted effects (even ones not mentioned in
this leaflet) or if any of the side effects becomes troublesome while
you’re taking Ropinirole
→ Tell your doctor or pharmacist.
6. How to store Ropinirole


KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Do not store the tablets above 25°C.



Keep in a dry place protected from light.

Don’t stop taking Ropinirole without advice



Do not take the tablets after the date shown on the pack.

Take Ropinirole for as long as your doctor recommends. Don’t
stop unless your doctor advises you to.



If your doctor tells you to stop using the medicine, please take it
back to the pharmacist for safe disposal. Only keep the
medicine if your doctor tells you to.



If the medicine becomes discoloured or shows any other signs
of deterioration, you should seek the advice of your pharmacist
who will tell you what to do.

If you have missed taking Ropinirole for more than a few days,
ask your doctor for advice on how to start taking it again.

If you suddenly stop taking Ropinirole your Parkinson’s disease
symptoms may quickly get much worse.
If you need to stop taking Ropinirole your doctor will reduce your
dose gradually.
If you have any further questions on the use of this product, ask
your doctor or pharmacist.
5. Possible side effects
Like all medicines, Ropinirole can have side effects, but not
everyone gets them.
The side effects of Ropinirole 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’re worried about side effects, talk to your doctor.

7. Further information
What Ropinirole contains


Each film-coated tablet contains 2mg of the active ingredient
ropinirole (as the hydrochloride).



Each tablet contains the inactive ingredients lactose =
monohydrate, microcrystalline cellulose, croscarmellose
sodium, magnesium stearate, hypromellose, macrogol 400,
titanium dioxide (E171), yellow ferric oxide (E172) and red ferric
oxide (E172).

What Ropinirole looks like and contents of the pack

Very common side effects

Each tablet is a pink, pentagonal shaped tablet marked ‘SB’ on one
side and ‘4893’ on the other.

These may affect more than 10 in 100 people taking Ropinirole:

Ropinirole Tablets are available in blister packs of 21 or 84 tablets.



fainting

Product Licence holder



feeling drowsy



feeling sick (nausea)

Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House, Alperton
Lane, Wembley, HA0 1DX.

Common side effects

Manufacturer

These may affect more than 1 in 100 people taking Ropinirole:

This product is manufactured by SmithKline Beecham
Pharmaceuticals, Magpie Wood, Manor Royal, Crawley, RH10 2QJ
England.



hallucinations (sensing things that are not real)



being sick (vomiting)



feeling dizzy (a spinning sensation)



heartburn



stomach pain



swelling of the legs

Uncommon side effects
These may affect more than 1 in 1,000 people taking Ropinirole:

POM

PL 19488/0734 Ropinirole 2mg Tablets

Leaflet revision date: 07 November 2012
A number of groups exist to provide further information and support
to Parkinson’s disease patients and their carers. The main one is
the Parkinson’s Disease Society, who you can contact at the
address given below:



feeling dizzy or faint, especially when you stand up suddenly
(this caused by a drop in blood pressure)



feeling very sleepy during the day (extreme somnolence)

215 Vauxhall Bridge Rd



falling asleep very suddenly without feeling sleepy first (sudden
sleep onset episodes)

London SW1V 1EJ



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

Some people taking Ropinirole have had a compulsive urge to
gamble or increased sexual urges and/or behaviours.
Very rare side effects
A very small number of people taking Ropinirole (less than 1 in
10,000) have had:


changes in liver function, which have shown up in blood tests



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

If you’re taking Ropinirole with L-dopa
People who are taking Ropinirole with L-dopa may develop other
side effects over time:


uncontrollable movements (dyskinesias) are a very common
side effect. 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

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:
o

Strong impulse to gamble excessively despite serious
personal or family consequences.

o

Altered or increased sexual interest and behaviour of
significant concern to you or to others, for example, an
increased sexual drive.

o

Uncontrollable excessive shopping or spending

o

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)

Parkinson’s Disease Society

S734 LEAFLET Ropinirole 20121107

Expand view ⇕

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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