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ROPINIROLE 0.25MG TABLETS

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S0034 LEAFLET Requip 20120903

These include:

PACKAGE LEAFLET: INFORMATION FOR THE USER



the anti-depressant fluvoxamine

STARTER PACK



HRT (hormone replacement therapy)

REQUIP 0.25mg TABLETS
ROPINIROLE 0.25mg TABLETS
(ropinirole hydrochloride)



the antibiotics ciprofloxacin or enoxacin



medication for other mental health problems, for example
sulpiride



metoclopramide, which is used to treat nausea and heartburn



cimetidine, used in the treatment of stomach ulcers any
other medicine for Parkinson’s disease.

Your medicine is called Requip 0.25mg Tablets but will be referred
to as Requip throughout the remainder of the leaflet.
Information regarding other strengths are also available in this
leaflet.
Read right through this leaflet before you start taking these
tablets.
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

In this leaflet



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

1. What Requip is and what it is used for

Your doctor may advise you to stop taking Requip.

2. Before you take Requip

Children

3. While you’re taking Requip

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

4. How to take Requip
5. Possible side effects
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:


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



if you have serious kidney disease



if you have liver disease

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
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.
Food and drink with Requip
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

4. HOW TO TAKE REQUIP – STARTER PACK

Your doctor needs to know before you take Requip:

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 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 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 Requip isn’t suitable for you or that
you need extra check-ups while you’re taking it.
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.

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 three times a day for the first week.
This dose is then gradually increased each week.
The Requip Starter Pack contains four blister strips of tablets —
one strip for each of the first four weeks of your treatment. The four
strips are marked with Week 1, Week 2, Week 3 and Week 4, and
also with the treatment day (Day 1 to Day 28).

Requip contains lactose

You must take the tablets in the order of the day number printed on
the strips, starting at Day 1 and finishing at Day 28. The daily dose
you take of Requip increases each week. There is one tablet in
each blister pocket for you to take during weeks 1, 2 and 4, and
two tablets for you to take during week 3.

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.

Morning

You also need to be careful with Requip if you drive or operate
machinery. Please read the warning in Section 3 of this leaflet.

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.
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.

Week 1

Week 2

Week 3

Week 4

0.25 mg
1 white
tablet

0.5 mg 1
pale
yellow
tablet

0.75 mg 1
white tablet 1
pale yellow
tablet

1 mg 1
green
tablet

(about 1
pm)

0.25 mg
1 white
tablet

0.5 mg 1
pale
yellow
tablet

0.75 mg 1
white tablet 1
pale yellow
tablet

1 mg 1
green
tablet

Evening
(about 6
pm)

0.25 mg
1 white
tablet

0.5 mg 1
pale

0.75 mg 1
white tablet 1
pale yellow
tablet

1 mg 1
green
tablet

(about 8
am)
After lunch

yellow
tablet

Keep taking Requip until you have finished this four-week Starter
Pack. After that, your doctor may gradually increase or decrease
the dose until you’re taking what’s best for you. Some people take
up to 8 mg of Requip three times a day (24 mg daily altogether).

You may experience the following side effects:


If you are also taking medicines for Parkinson’s disease, your
doctor may advise you to gradually reduce the dose of the other
medicine.

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.

It may take a few weeks for Requip to work for you.

o

Uncontrollable excessive shopping or spending

Taking your dose of Requip

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)

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

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.

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

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.

→ Tell your doctor or pharmacist.


KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

If you forget to take Requip



Do not store above 25°C. Store in a dry place protected from
light.



Do not use Requip after the expiry date shown on the carton or
blister strips.



If you have any unwanted Requip, don’t dispose of them in
waste water or household rubbish. Take them back to your
pharmacist, who will dispose of them in a way that won’t harm
the environment.



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.

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.
If you have missed taking Requip for more than a few days, ask
your doctor for advice on how to start taking it again.
Don’t stop taking Requip without advice

6. HOW TO STORE REQUIP

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

7. FURTHER INFORMATION
What Requip contains


Each film-coated tablet contains 0.25mg of the active ingredient
ropinirole (as the hydrochloride).



Requip also contains the following: lactose monohydrate,
microcrystalline cellulose, croscarmellose sodium, magnesium
stearate, hypromellose, macrogol 400, titanium dioxide (E171)
and polysorbate 80.



The sodium content of each tablet is 0.1mg.

What Requip looks like and contents of the pack

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

Requip is a white pentagonal tablet marked ‘SB’ on one side and
‘4890’ on the other.



fainting

Requip is available in blister packs of 21 or 210 tablets.



feeling drowsy

Product Licence holder



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:

Manufacturer



hallucinations (sensing things that are not real)



being sick (vomiting)



feeling dizzy (a spinning sensation)



heartburn



stomach pain

Leaflet revision date: 03 September 2012



swelling of the legs

Requip is a registered trade mark of GlaxoSmithKline group of
companies.

Uncommon side effects

Requip is manufactured by SmithKline Beecham Pharmaceuticals,
Manor Royal, Crawley, RH10 2QJ UK.
POM

PL No. 19488/0034

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


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)



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)

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

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:
Parkinson’s Disease Society
215 Vauxhall Bridge Rd
London SW1V 1EJ
S0034 LEAFLET Requip 20120903

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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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