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MODOPAR DISPERSIBLE TABLETS 125MG

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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 works 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.

DATE:
DATE:
03/09/12
DATE OF PROOF:

UK PIL DATED NOVEMBER 2008
INCLUDING LEVODOPA
CONTAINING SAFETY WARNING

6464/0837F

DT

Do not take Modopar 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 and ask your
doctor or pharmacist for advice.

CODE:

Q.A.
APPROVED:
04-1957

Taking other medicines
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 can affect the way some medicines work. Also some other medicines can affect the way Modopar works.

Modopar dispersible tabs

ARTWORKER:

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 treatment.

PRE-PRESS NO.:

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Take special care with Modopar
Check with your doctor or pharmacist before you take Modopar 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.
If any of the above apply to you, or if you are not sure, talk to your doctor or pharmacist before you take Modopar.

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 prochlorperazine (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.
Operations
If you are going to have an operation, tell the doctor that you are taking Modopar. This is because you may need to stop taking it
before you have a general anaesthetic.
Tests
If you need to have tests on your blood or urine, tell the doctor or nurse that you are taking Modopar. This is because the medicine
may affect the results of some tests.
Pregnancy and breast-feeding
Do not take Modopar if you are pregnant, trying to get pregnant or breast-feeding. This is because Modopar may affect your baby.
It is important for women to use contraception while taking the medicine.
If you get pregnant while taking Modopar, 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. This is because one of the medicines in
Modopar, 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
Always take Modopar 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.
• Either swallow the tablets whole with a little water or
• Dissolve in a little water or orange squash (not fresh orange juice). Use at least 25 ml liquid for each tablet.
• Take them with or just after food.
Patients NOT already treated with levodopa:
• The usual starting dose is one 50mg/12.5mg tablets (50 mg levodopa), three or four times a day.
• Your doctor will then increase your dose every 2 to 3 days until they find the right dose for you.

WARNING!

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ARIAL BOLD
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BRIDGED TO
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1. What Modopar is and what it is used for
Modopar dispersible tablets contain two medicines called levodopa and benserazide. They are used to treat Parkinson’s disease.

PROOF HISTORY:
v.3 - waymade - 03/09/12

Leaflet Flat Size = 180 x 429

In this leaflet:
1. What Modopar is and what it is used for
2. Before you take Modopar
3. How to take Modopar
4. Possible side effects
5. How to store Modopar
6. Further information

2. Before you take Modopar:
Do not take Modopar if:
• You are allergic (hypersensitive) to levodopa, benserazide or any of the other ingredients of Modopar (listed in Section 6:
Further 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 ‘Taking other medicines’.
• 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 if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before you take
Modopar.

PRODUCT:

CUSTOMER: Waymade

Please read all of this leaflet carefully before you start taking this medicine.
• 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. Do not pass it on to others. It may harm them even if their symptoms are the same as
yours.
• If any of the side effects become serious or troublesome, or if you notice any side effects not listed in this leaflet, please tell your
doctor or pharmacist.

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.

Your medicine is called Modopar Dispersible tablets 125mg but will be referred to as Modopar throughout this leaflet.
27mm

WARNING!

MODOPAR DISPERSIBLE TABLETS 125mg
(Levodopa/benserazide hydrochloride)
Patient Information Leaflet

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.

000-0000F

If someone else takes your Modopar 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 can cause side effects, although not everyone will get them.
You may experience the following side effects:
• inability to resist the impulse to perform an action that could be harmful, 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)
Tell your doctor if you experience any of these behaviours; they will discuss ways of managing or reducing the symptoms

Skin:
DATE:

CUSTOMER
APPROVED:

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 with some food or drink or increase your dose more slowly.
• 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).


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

Heart and circulation:
• Heart beat may be uneven or go faster or slower.
• Feeling dizzy when you stand up. This usually gets better if your dose is lowered.

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.
• Being unable to stop gambling even if this causes serious personal or family problems.
• An increase in your levels of sexual desire or sex drive (libido) which may be worrying to you or to others.

UK PIL DATED NOVEMBER 2008
INCLUDING LEVODOPA
CONTAINING SAFETY WARNING

6464/0837F

03/09/12
DATE OF PROOF:
CODE:

DT

DATE:

04-1957

ARTWORKER:
Modopar dispersible tabs
PRODUCT:

CUSTOMER: Waymade

PRE-PRESS NO.:

Q.A.
APPROVED:

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.
• Low numbers of all types of white blood cells. The signs include infections of your mouth, gums, throat and lungs.
• Low numbers of platelets in your blood. The signs include bruising easily and nose bleeds.
• Changes to your liver or blood – shown in a blood test.

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 to help with these
effects.
• 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.
If any of the side effects become serious or troublesome, or if you notice any side effects not listed in this leaflet, please tell your
doctor or pharmacist.







5. How to store Modopar
Do not use after the expiry date printed on the pack and carton label.
Modopar dispersible tablets 125mg should be stored in a dry place below 25°C. Keep in the original container, with the
container lid tightly closed.
Keep all medicines out of the sight and reach of children.
If your doctor tells you to stop taking the tablets, please take them back to the pharmacist for safe disposal. Only keep the
tablets if your doctor tells you to.
If the tablets become discoloured or show any other signs of deterioration, you should seek the advice of your pharmacist
who will advise you what to do.
Do not throw away any left over tablets. Instead, return them to your pharmacist so that they can be disposed of carefully.
Only keep them if your doctor tells you to.

6. Further information
Your medicine is called Modopar dispersible tablets 125mg. Each white round tablet contains the active ingredients 100mg of
levodopa and 25mg of benserazide (as the hydrochloride).
Each tablet is marked with the name 'Roche' and ‘125’ on one side and with a breakline on the reverse.
Modopar dispersible tablets 125mg also contain the following inactive ingredients:
Microcrystalline cellulose, citric acid, modified maize starch, and magnesium stearate.
Modopar dispersible tablets 125mg are available as bottles of 60 tablets.
POM

PL No: 6464/0837

This product is manufactured by Produits Roche SA, 94120 Fontenay-sous-Bois, France and is procured from within the EU and
repackaged by the Product Licence holder:
Waymade plc Miles Gray Road, Basildon Essex SS14 3FR
Leaflet revision and issue date (Ref.) 17.8.2012

WARNING!

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD
FONT SIZE 8
BRIDGED TO
CRESTOR 6464/2069 2070

If you take more Modopar than you should
If you take more Modopar 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 tablets 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.

PROOF HISTORY:
v.3 - waymade - 03/09/12

Leaflet Flat Size = 180 x 429

Stopping Modopar
You must not stop taking your tablets without talking to your doctor first.
This is because if you stop taking the tablets suddenly it can cause something called ‘neuroleptic malignant-like syndrome’ This
can be life threatening.

WARNING!

If you forget to take Modopar
• 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.

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.

Patients already treated with a combined levodopa/decarboxylase inhibitor:
• The usual starting dose is one 50 mg/12.5 mg tablet (50 mg levodopa), three or four times a day.
• Your doctor will then increase your dose every 2 to 3 days until they find the right dose for you.

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.

27mm

Patients already treated with levodopa:
• Your starting dose of Modopar will be one less 125 mg tablet than the number of levodopa 500 mg capsules or tablets you
take each day.
For example if you take four levodopa tablets (2000 mg levodopa) each day, your doctor will start by giving you three
Modopar tablets 125 mg daily.
• After one week your doctor may then start to increase your dose every 2 to 3 days until they find the right dose for you.

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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