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MODOPAR 125MG SLOW RELEASE CAPSULES

Active substance(s): BENSERAZIDE HYDROCHLORIDE / LEVODOPA

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CUSTOMER: Waymade
PRODUCT:
CODE:

Modopar 125mg SR caps
6464/0374E

PRE-PRESS NO.:

06 1257

ARTWORKER:

DT

DATE OF PROOF:

07/01/15

Q.A.
APPROVED:

CUSTOMER
APPROVED:

DATE:

DATE:

PROOF HISTORY:
v.1 - waymade - 07/01/15

I¤€-‚œ
Leaflet Flat Size = 296 x 317
ARIAL REGULAR FONT SIZE 8
ARIAL BOLD FONT SIZE 10
BRIDGED TO
TRANSTEC 6464/2327 2328 2329

TVT CHECKED

UK PIL DATED FEBRUARY 2014
REPORTING OF SIDE EFFECTS

Pg 1

Pg 4

5. How to store Modopar 125mg slow release capsules
Store Modopar 125mg slow release capsules in the original container, with the lid closed to protect the
capsules from moisture.
Do not store Modopar 125mg slow release capsules above 25°C
Do not use after the expiry date printed on the pack and carton label.
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
If your doctor tells you to stop taking the capsules, please take them back to the pharmacist for safe disposal.
Only keep the capsules if your doctor tells you to.
If the capsules become discoloured or show any other signs of deterioration, you should seek the advice of
your pharmacist who will advise you what to do.

6. Contents of the pack and other information
Your medicine is called Modopar 125mg slow release capsules. It contains the active ingredients 100mg of
levodopa and 25mg of benserazide (as the hydrochloride).
Each capsule is marked with the name 'Roche' in red on the dark green cap and also on the light blue body.
Modopar 125mg slow release capsules also contain the following inactive ingredients:
Hypromellose (2910/4000 CP), Hypromellose (2910/50 CP), hydrogenated castor oil (sterotex K), calcium
hydrogen phosphate, granulated mannitol, povidone K 90, talc, magnesium stearate.
Capsule shell contains gelatin, indigo carmine (E132), yellow iron oxide (E172), and titanium dioxide (E171),
Modopar 125mg slow release capsules are available as bottles of 60 capsules.
POM

PL No: 18799/2703

This product is manufactured by Roche, 30, Cours de l’lle Seguin, 92100 Boulogne-Billancort, France and is
procured from within the EU and repackaged by the Product Licence holder who is:
B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.
Leaflet revision and issue date (Ref.) 04.06.2015
MODOPAR is a registered trademark

MODOPAR 125MG SLOW RELEASE CAPSULES
(levodopa/benserazide)
Patient Information Leaflet

Please 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. This includes any possible side effects not listed
in this leaflet. See section 4 .
What is in this leaflet
1. What Modopar 125mg slow release capsules are and what they are used for
2. What you need to know before you take Modopar 125mg slow release capsules
3. How to take Modopar 125mg slow release capsules
4. Possible side effects
5. How to store Modopar 125mg slow release capsules
6. Contents of the pack and other information

1. What Modopar 125mg slow release capsules are and what they are used for
Modopar 125mg slow release capsules contain two medicines called levodopa and benserazide. They are
used to treat Parkinson’s disease.
People with Parkinson’s disease do not have enough dopamine in certain parts of their brains. This can result
in slow movements, stiff muscles and tremor.
Modopar 125mg slow release capsules work like this:

In your body the levodopa is changed into dopamine. Dopamine is the active medicine that is
needed in your brain to help Parkinson’s disease.

The benserazide allows more of the levodopa you take to get into your brain, before it is changed
into dopamine.
The capsules are designed to release the medicines into your body slowly. This is why they are called ‘slow
release’.

2. What you need to know before you take Modopar 125mg slow release
capsules
Do not take Modopar 125mg slow release capsules if:

You are allergic (hypersensitive) to levodopa, benserazide or any of the other ingredients of
Modopar 125mg slow release capsules (listed in Section 6: Contents of the pack and other
information).

You have a problem with the pressure in your eyes called ‘narrow-angle glaucoma’.

You have serious problems with your kidneys, liver or heart.

You have a serious problem with your hormones, such as an overactive thyroid gland.

You have a severe mental problem which may make you distressed and anxious, or may make you
lose contact with reality and become unable to think and judge clearly.

You have depression and have taken a medicine called a ‘non-selective monoamine oxidase
inhibitor’ (MAOI) in the last 14 days. These medicines include isocarboxazid and phenelzine. See
the section on ‘Other medicines and Modopar 125mg slow release capsules’.

You are pregnant or trying to become pregnant. See the section on ‘Pregnancy and breast-feeding’.

You are under 25 years of age. This is because your bones may not have finished developing.

You have ever had skin cancer.
Do not take Modopar 125mg slow release capsules if any of the above applies to you. If you are not sure, talk
to your doctor or pharmacist before you take Modopar 125mg slow release capsules.
Warnings and precautions
Talk to your doctor or pharmacist before taking Modopar 125mg slow release capsules if:

You have a problem with the pressure in your eyes called ‘wide-angle glaucoma’.

You have problems with your hormones, kidneys, lungs or liver.

You have diabetes (high blood sugar).

You have heart problems, particularly an uneven heart beat (arrhythmia) or you have had a heart
attack.

You have any mental illness, such as depression.

You have a ‘peptic ulcer’, an ulcer in your stomach, or in the tube leading from it (‘duodenal ulcer’).

You have something called ‘osteomalacia’ which causes problems with the strength of your bones.
Tell your doctor if you or your family/carer notices you are developing urges or cravings to behave in ways that
are unusual for you or you cannot resist the impulse, drive or temptation to carry out certain activities that
could harm yourself or others. These behaviours are called impulse control disorders and can include addictive
gambling, excessive eating or spending, an abnormally high sex drive or an increase in sexual thoughts or
feelings. Your doctor may need to review your treatments.
If any of the above apply to you, or if you are not sure, talk to your doctor or pharmacist before you take
Modopar 125mg slow release capsules.

Pg 2 !

WARNING!

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

:G»GUN
G­¥$<

h»­$Ã

WARNING!

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

CUSTOMER:

Waymade

PRE-PRESS NO.:

06 1257

PRODUCT:

Modopar 125mg SR caps

ARTWORKER:

DT

DATE OF PROOF:

07/01/15

CODE:

6464/0374E

Q.A.
APPROVED:

CUSTOMER
APPROVED:

DATE:

DATE:

PROOF HISTORY:
v.1 - waymade - 07/01/15

I¤€-‚œ
Leaflet Flat Size = 296 x 317
ARIAL REGULAR FONT SIZE 8
ARIAL BOLD FONT SIZE 10
BRIDGED TO
TRANSTEC 6464/2327 2328 2329

TVT CHECKED

UK PIL DATED FEBRUARY 2014
REPORTING OF SIDE EFFECTS

Pg 2

Other medicines and Modopar 125mg slow release capsules
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This
includes medicines that you buy without a prescription and herbal medicines. This is because Modopar 125mg
slow release capsules can affect the way some medicines work. Also some other medicines can affect the
way Modopar 125mg slow release capsules work.
Do not take Modopar 125mg slow release capsules if you have taken a medicine for depression called a
‘non-selective monoamine oxidase inhibitor’ (MAOI) in the last 14 days.
These medicines include isocarboxazid and phenelzine. If this applies to you, do not take Modopar 125mg
slow release capsules and ask your doctor or pharmacist for advice.
In particular, tell your doctor or pharmacist if you are taking the following medicines:

Other medicines for Parkinson’s disease, such as amantadine, ‘anticholinergics’ called orphenadrine
and benzhexol, ‘dopamine agonists’ called pergolide and ropinirole and a ‘COMT inhibitor’ called
entacaprone.

Ferrous sulphate (used to treat low levels of iron in the blood).

Antacids (used for stomach acid if you have indigestion).

Metoclopramide (used to treat problems with digestion).

Phenothiazines – such as chlorpromazine, promazine and prochloroperazine (used to treat mental
illness).

Thioxanthenes – such as flupentixol and zuclopenthixol (used to treat mental illness).

Butyrophenones – such as haloperidol and benperidol (used to treat mental illness).

Diazepam (used to treat anxiety and insomnia).

Tetrabenazine (used to help problems controlling your muscle movement).

Papaverine (used to improve blood flow around the body).

Treatment for high blood pressure (hypertension), in particular reserpine.

‘Sympathomimetics’ – such as epinephrine, norepinephrine and isoproterenol (used to treat
problems with your heart or asthma).

Amphetamines – medicines used for attention deficit disorder, feeling sleepy during the day
(narcolepsy) or to help control appetite and weight gain.

Strong painkillers – such as codeine or morphine.
Operations
If you are going to have an operation, tell the doctor that you are taking Modopar 125mg slow release
capsules. This is because you may need to stop taking it before you have a general anaesthetic.

Pg 3

If you take more Modopar 125mg slow release capsules than you should
If you take more Modopar 125mg slow release capsules than you should, talk to a doctor or go to a hospital
straight away. Take the medicine pack with you. The following effects may happen if you have taken more
capsules than you should: changes in your heart beat, confusion, difficulty sleeping, feeling or being sick and
unusual movements of different parts of the body that you cannot control.
If someone else takes your Modopar 125mg slow release capsules by mistake, they should talk to a doctor or
go to a hospital straight away.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines Modopar 125mg slow release capsules can cause side effects, although not everyone will
get them.
See your doctor as soon as possible if you get the following side effects:

Allergic reactions. The signs include a rash and feeling itchy.

Heart beat that is uneven or is faster or slower than normal.

Bleeding in your stomach or intestines. You may see blood in your stools (they may look black and
tarry) or blood when you are sick (this may look like coffee grounds).

Low numbers of all types of white blood cells. The signs include infections of your mouth, gums,
throat and lungs.

Reduced numbers of red blood cells, white blood cells and platelets in your blood. This may make
you feel tired, get infections more easily, or bruise more easily or have nose bleeds.
Other possible side effects:
Not known (frequency cannot be estimated from the available data)
Stomach and gut:

Loss of appetite, feeling sick or being sick or diarrhoea, particularly at the start of your treatment. To
help with this, your doctor may tell you to take Modopar 125mg slow release capsules with some
food or drink or increase your dose more slowly.

A change in the colour of your saliva, tongue, teeth or inside of your mouth.
Heart and circulation:

Feeling dizzy when you stand up. This usually gets better if your dose is lowered.

Tests
If you need to have tests on your blood or urine, tell the doctor or nurse that you are taking Modopar 125mg
slow release capsules. This is because the medicine may affect the results of some tests.
Pregnancy and breast-feeding
Do not take Modopar 125mg slow release capsules if you are pregnant, trying to get pregnant or breastfeeding. This is because Modopar 125mg slow release capsules may affect your baby. It is important for
women to use contraception while taking the medicine.
If you get pregnant while taking Modopar 125mg slow release capsules, talk to your doctor straight away.
Driving and using machines
Talk to your doctor about driving and using machines or tools, when you take Modopar 125mg slow release
capsules. This is because one of the medicines in Modopar 125mg slow release capsules, levodopa, can
make you feel very sleepy. This can happen very quickly, even during the day.
You must not drive or use machines if this happens to you. If you are in any doubt about whether you can do a
particular activity, talk to your doctor.

3. How to take Modopar 125mg slow release capsules
Always take Modopar 125mg slow release capsules exactly as your doctor has told you. You should check
with your doctor if you are not sure. How much you take and when you take it is different for different people.

Swallow the capsules whole with a little water (do not crush or chew them).

Take them with or without food.
Patients NOT already treated with levodopa:

The usual starting dose is 1 capsule (100 mg levodopa), three times a day with meals.

The starting dose should not be more than 6 capsules (600 mg levodopa) a day.

Your doctor will then increase your dose every 2 to 3 days until they find the right dose for you.

Some people may also need to take another medicine for Parkinson’s disease with their first
morning dose of Modopar 125mg slow release capsules. This is because Modopar 125mg slow
release capsules releases the medicines slowly into the body.
Patients already treated with levodopa:

Your doctor will start by giving you one Modopar 125mg slow release capsule to replace each
100 mg of levodopa you have been taking.

Your doctor will then increase your dose every 2 to 3 days until they find the right dose for you. This
may take up to 4 weeks.

At the start of treatment your condition may become worse, until the right dose is found for you.
Your doctor may want to supervise you closely during this time.
If you forget to take Modopar 125mg slow release capsules

If you forget to take a dose, skip the missed dose. Then take the next dose when it is due.

Do not take a double dose (two doses at the same time) to make up for a forgotten dose.
If you stop taking Modopar 125mg slow release capsules
You must not stop taking your capsules without talking to your doctor first. This is because if you stop taking
the capsules suddenly it can cause something called ‘neuroleptic malignant-like syndrome’ (NMLS). Early signs
include increased shaking, sudden high body temperature and muscle problems including stiffness and trouble
with balance and keeping upright (postural instability) especially if seen with sweating, paleness and fast heart
beat.
NMLS can be life threatening.

Blood:



Low numbers of red blood cells (anaemia). The signs include feeling tired, pale skin, palpitations (a
fluttering sensation in your heart) and being short of breath.
Changes to your liver or blood – shown in a blood test.

Mental problems:

Feeling excited, anxious, agitated, depressed, aggressive or disorientated (the feeling of being lost).

Believing things which are not true, hallucinations (seeing and possibly hearing things that are not
really there) or losing contact with reality.

Feeling sleepy, sometimes during the daytime.

Falling asleep suddenly.

Having difficulty sleeping.
Impulse Control Disorders:
You may experience an inability to resist the impulse to perform an action that could be harmful, 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
Others:

Unusual movements of different parts of your body which you cannot control. This may affect your
hands, feet, face or tongue. Your doctor may change your dose of Modopar 125mg slow release
capsules to help with these effects.

You may experience ‘on-off’ effects. This is where you can switch quite suddenly between being ‘on’
and able to move, and being ‘off’ and immobile.

An irresistible urge to move the legs and sometimes the arms.

Changes to how things taste or a loss of taste.

Redness of the face or neck.

Sweating.

Your urine (water) may become slightly red. This is not a cause for concern. It is caused by your
body getting rid of the medicine.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed
in this leaflet. You can also report side effects directly (see details below).
By reporting side effects you can help provide more information on the safety of this medicine.
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard.

If the above apply to you, talk to a doctor or go to a hospital straight away.
Pg 4 !

Pg 3 !

WARNING!

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

:G»GUN
G­¥$<

h»­$Ã

WARNING!

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

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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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