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SPIROCO XL 8 MG PROLONGED-RELEASE TABLETS

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

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Ropinirole

Package leaflet:
Information for the user
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.

BLACK

Template

PANTONE® GREEN C

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

1

Version:

SPIROCO 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.

Colours Used:
420 mm
148 mm

Warnings and precautions
Talk to your doctor or pharmacist before
taking SPIROCO 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)
(see 4“Possible side effects”)
• if you have an intolerance to some sugars
(such as lactose)

Length:
Width:

Dimensions:

TEVA UK Ref:

Teva Pharmaceuticals Europe B.V
Effective Date: TBD

What you need to know before
you take SPIROCO XL

Do NOT TAKE SPIROCO XL if you:
• are allergic to ropinirole or any of the other
ingredients of this medicine (listed in
section 6).
• have serious kidney disease
• have liver disease
Tell your doctor if you think any of these may
apply to you.

Tell your doctor if you think any of these may
apply to you. Your doctor may decide that
SPIROCO XL is not suitable for you, or that
you need extra check-ups while you are
taking it.
MINI Pharma code 23906

231-30-88247-H LEA ROPINIROLE (SPIROCO XL) A/S TAB TUK (RAT)
2

You will require additional blood tests if you
are taking these medicines with SPIROCO XL:
• Vitamin K antagonists (used to reduce
blood clotting) such as Warfarin
(coumadin).
SPIROCO XL with food, drink and alcohol
You can take SPIROCO XL with or without
food.
Concomitant intake of alcoholic beverages
and SPIROCO 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.
SPIROCO XL is not recommended if you are
pregnant, unless your doctor advises that the
benefit to you of taking SPIROCO XL is
greater than the risk to the unborn baby.
SPIROCO XL is not recommended if you are
breast-feeding, as it can affect your milk
production.
Your doctor will advise you if you are breast
feeding or planning to do so. Your doctor
may advise you to stop taking SPIROCO XL.
Driving and using machines
SPIROCO XL can make you feel drowsy. It
can make people feel extremely sleepy, and
it sometimes makes people fall asleep very
suddenly without warning.

What SPIROCO XL is and what it is
If you could be affected: do not drive, do not
used for

The active substance in SPIROCO 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.

1

13 December 2016

What is in this leaflet:

• any other medicine for Parkinson’s disease.
Tell your doctor if you are taking or have
recently taken any of these.

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.
SPIROCO 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 SPIROCO XL

Always take this medicine exactly as your
doctor has told you. Check with your doctor
or pharmacist if you are not sure.
Do not give SPIROCO XL to children.
SPIROCO XL is not normally prescribed for
people under 18.
You may be given SPIROCO XL on its own to
treat the symptoms of your Parkinson’s
disease. Or you may be given SPIROCO XL
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 SPIROCO XL. Tell
your doctor if this happens, as your doctor
may need to adjust the doses of the
medicines you are taking.
SPIROCO 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 SPIROCO XL will you need to
take?
It may take a while to find out the best dose
of SPIROCO XL for you.

The recommended starting dose of SPIROCO
XL prolonged-release tablets is 2 mg once
daily for the first week. Your doctor may
While you are taking SPIROCO XL
increase your dose to 4 mg of SPIROCO XL
Tell your doctor if you or your family/carer
prolonged-release tablets once daily, from
notices that you are developing urges or
the second week of treatment. If you are very
cravings to behave in ways that are unusual
elderly, your doctor may increase your dose
for you and you cannot resist the impulse,
more slowly. After that, the doctor may
drive or temptation to carry out certain
activities that could harm yourself or others. adjust your dose until you are taking the
dose that is best for you. Some people take
These are called impulse control disorders
and can include behaviours such as addictive up to 24 mg of SPIROCO XL
prolonged-release tablets each day.
gambling, excessive eating or spending, an
abnormally high sex drive or an increase in
If at the start of your treatment, you
sexual thoughts or feelings. Your doctor may
experience side effects that you find difficult
need to adjust or stop your dose.
to tolerate, speak to your doctor. Your doctor
may advise you to switch to a lower dose of
Smoking and SPIROCO XL
Tell your doctor if you start smoking, or give ropinirole immediate-release tablets which
you will take three times a day.
up smoking, while you are taking SPIROCO
XL. Your doctor may need to adjust your
Do not take any more SPIROCO XL than your
dose.
doctor has recommended.
Other medicines and SPIROCO XL
It may take a few weeks for SPIROCO XL to
Tell your doctor or pharmacist if you are
work for you.
taking, have recently taken or might take any
other medicines.
Taking your dose of SPIROCO XL
Remember to tell your doctor or pharmacist
Take SPIROCO XL once a day, at the same
if you begin taking a new medicine while you time each day.
are taking SPIROCO XL
Swallow your
Some medicines can affect the way
SPIROCO XL
SPIROCO XL works, or make it more likely
prolonged-release
that you will have side effects. SPIROCO
tablet(s) whole,
XL can also affect the way some other
with a glass of
medicines work.
water.
These include:
Do not break, chew
• the anti-depressant fluvoxamine;
or crush the
• medicines for other mental health
prolonged-release
problems, for example sulpiride;
tablet(s). If you do,
• HRT (hormone replacement therapy);
there is a danger
• metoclopramide, which is used to treat
you could overdose,
nausea and heartburn;
because the medicine will be released into
• the antibiotics ciprofloxacin or enoxacin;
your body too quickly.

REG0075198
Valid For 7 Days from 21-Dec-2016

Version 5.2

Approved
Page 1 of 3

MINI Pharma code 23906

SPIROCO XL
2 mg, 4 mg and 8 mg
prolonged-release tablets

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

If you are taking SPIROCO XL with L-dopa
People who are taking SPIROCO XL with
L-dopa may develop other side effects over
time:
• uncontrollable movements (dyskinesias)
If you take more SPIROCO XL than you
are a very common side effect. If you are
should
taking L-dopa you may experience some
Contact a doctor or pharmacist immediately.
uncontrollable movements (dyskinesias)
If possible, show them the SPIROCO XL pack.
when you first start taking SPIROCO XL.
Someone who has taken an overdose of
Tell your doctor if this happens, as your
SPIROCO XL may have any of these
doctor may need to adjust the doses of the
symptoms: feeling sick (nausea), being sick
medicines you are taking.
(vomiting), dizziness (a spinning sensation),
• feeling confused (a common side effect).
feeling drowsy, mental or physical tiredness,
Reporting of side effects
fainting, hallucinations.
If you get any side effects, talk to your doctor,
If you forget to take SPIROCO XL
pharmacist. This includes any possible side
Do not take extra prolonged-release tablets or effects not listed in this leaflet. You can also
a double dose to make up for a forgotten dose. report side effects directly via the Yellow Card
If you have missed taking SPIROCO XL for
Scheme at: www.mhra.gov.uk/yellowcard. By
one day or more, ask your doctor for advice
reporting side effects you can help provide
on how to start taking it again.
more information on the safety of this
medicine.
If you stop taking SPIROCO XL
Do not stop using SPIROCO XL suddenly
How to store SPIROCO XL
without talking to your doctor. A sudden stop
could cause you to develop a medical
Keep this medicine out of the sight and reach
condition called neuroleptic malignant
of children.
syndrome which may represent a major
health risk. The symptoms include: akinesia
Do not use this medicine after the expiry date
(loss of muscle movement), rigid muscles,
which is stated on the blisters and carton
fever, unstable blood pressure, tachycardia
after EXP. The expiry date refers to the last
(increased heart rate), confusion, depressed
day of that month.
level of consciousness (e.g. coma).
Take SPIROCO XL for as long as your doctor Do not store above 30°C.
recommends. Do not stop unless your doctor
Store in the original package in order to
advises you to.
protect from moisture.
If you suddenly stop taking SPIROCO XL,
your Parkinson’s disease symptoms may
Do not throw away any medicines via
quickly get much worse.
wastewater or household waste. Ask your
If you need to stop taking SPIROCO XL, your pharmacist how to throw away medicines
you no longer use. These measures will help
doctor will reduce your dose gradually.
protect the environment.
If you have any further questions on the use
Contents of the pack and other
of this medicine, ask your doctor or
information
pharmacist.

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PANTONE® GREEN C

5

Version:

1

13 December 2016

Take your ropinirole immediate-release
tablets as normal the day before you switch.
Then take your SPIROCO XL
prolonged-release tablets next morning and
do not take any more ropinirole
immediate-release tablets.

- 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)

6

Possible side effects

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

Colours Used:

The side effects of SPIROCO 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.

420 mm
148 mm

Very common side effects:
These may affect more than 1 in 10 people
taking SPIROCO XL
• fainting
• feeling sleepy (somnolence)
• feeling sick (nausea).

Length:
Width:

Dimensions:

Common side effects:
These may affect up to 1 in 10 people taking
SPIROCO XL
• 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.

TEVA UK Ref:

231-30-88247-H LEA ROPINIROLE (SPIROCO XL) A/S TAB TUK (RAT)
4

What SPIROCO XL contains
- The active substance is ropinirole. Each
prolonged-release tablet contains 2 mg,
4 mg or 8 mg ropinirole (as hydrochloride).
- The other ingredients are:
SPIROCO XL 2 mg prolonged-release
tablets:
hypromellose, lactose monohydrate,
colloidal anhydrous silica, carbomers
4,000-11,000 mPa.s, hydrogenated castor
oil, magnesium stearate in the tablet core
and hypromellose, titanium dioxide (E171),
macrogol 400, red iron oxide (E172),
yellow iron oxide (E172) in the filmcoating.
SPIROCO XL 4 mg and 8 mg
prolonged-release tablets:
hypromellose, lactose monohydrate,
colloidal anhydrous silica, carbomers
4,000-11,000 mPa.s, hydrogenated castor
oil, magnesium stearate in the tablet core
and hypromellose, titanium dioxide (E171),
macrogol 400, red iron oxide (E172),
yellow iron oxide (E172), black iron oxide
(E172) in the film-coating.
What SPIROCO XL looks like and contents of
the pack

MINI Pharma code 23906

SPIROCO XL 2 mg prolonged-release tablets:
Tablets are pink, oval, biconvex tablets.
SPIROCO XL 4 mg prolonged-release tablets:
Uncommon side effects:
These may affect up to 1 in 100 people taking Tablets are light off-brown, biconvex, oval
tablets.
SPIROCO XL
SPIROCO XL 8 mg prolonged-release tablets:
• feeling dizzy or faint, especially when you
Tablets are brownish-red, biconvex, oval
stand up suddenly (this is caused by a
tablets.
drop in blood pressure)
• feeling very sleepy during the day
Tablets are available in boxes of 7, 21, 28, 42,
(extreme somnolence)
56, 84 and 100 prolonged-release tablets in
• falling asleep very suddenly without
OPA/Al/PVC//Al blisters.
apparent warning (sudden sleep onset
Not all pack sizes may be marketed.
episodes)
• mental problems such as delirium (severe Marketing Authorisation Holder
confusion), delusions (unreasonable ideas)
Ratiopharm GmbH, Graf-Arco-Strasse 3,
or paranoia (unreasonable suspicions).
89079 Ulm, Germany.
Some patients may have the following side
effects
Manufacturer
Frequency not known: frequency cannot be
Merckle GmbH, Ludwig-Merckle-Str, 3,
estimated from the available data
Weiler, 89143 Blaubeuren, Germany.
• allergic reactions such as red, itchy
swellings on the skin (hives), swelling of
This leaflet was last amended November
the face, lips, mouth, tongue or throat
2016.
which may cause difficulty in swallowing
PL 15773/0886-88
or breathing, rash or intense itching
• changes in liver function, which have
shown up in blood tests.
• act in an aggressive manner
• excessive use of SPIROCO XL (craving for
large doses of dopaminergic drugs in
excess of that required to control motor
symptoms, known as dopamine
dysregulation syndrome)
• 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
88247-H
spending
XXXXXXXX
XXXXXX

Teva Pharmaceuticals Europe B.V
Effective Date: TBD

REG0075198
Valid For 7 Days from 21-Dec-2016

Version 5.2

Approved
Page 2 of 3

MINI Pharma code 23906

If you are switching from ropinirole
immediate-release tablets
Your doctor will base your dose of SPIROCO
XL prolonged-release tablets on the dose of
ropinirole immediate-release tablets you
were taking.

THIS IS A REPRESENTATION OF AN ELECTRONIC RECORD THAT WAS SIGNED ELECTRONICALLY AND THIS
PAGE IS THE MANIFESTATION OF THE ELECTRONIC SIGNATURE

Teva Pharmaceuticals Europe B.V
1.3.2
mockup-pil-uk-pl-15773-0886-0887-0889-spiroco-xl-2mg-4mg-8mg-prolonge
d-release-tablets-ropinirole

APPROVALS
Signed by
Abby Mitchell

Meaning of Signature
Regulatory Affairs Approval

Teva Pharmaceuticals Europe B.V
Effective Date: TBD

Server Date

REG0075198

21-Dec-2016 12:56:42 PM

Version 5.2

Valid For 7 Days from 21-Dec-2016

Approved
Page 3 of 3

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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