iMedi.co.uk

Madopar 200mg/50mg Hard Capsules

Document: leaflet MAH BRAND_PL 00031-0074 change

Madopar Test 3_GB 04.12.2007    14:08 Uhr -sej- te 1


Patient Information Leaflet


Madopar Test 3 GB 0712.10 75


Madopar ® 50 mg/12.5 mg    s

Madopar ® 100 mg/25 mg Dispersible Tablets

Levodopa and benserazide (as hydrochloride)



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.

In this leaflet:

1.    What Madopar is and what it is used for

2.    Before you take Madopar

3.    How to take Madopar

4.    Possible side effects

5.    How to store Madopar

6.    Further information


1. What Madopar is and what it is used for


Madopar dispersible tablets 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.

Madopar 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.


2. Before you take Madopar


Do not take Madopar if:

•    You are allergic (hypersensitive)

to levodopa, benserazide or any of the other ingredients of Madopar (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 Madopar if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before you take Madopar.

Take special care with Madopar Check with your doctor or pharmacist before you take Madopar 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 Madopar.

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 Madopar can affect the way some medicines work. Also some other medicines can affect the way Madopar works.



Do not take Madopar 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 Madopar 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.

Operations

If you are going to have an operation, tell the doctor that you are taking Madopar. 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 Madopar. This is because the medicine may affect the results of some tests.

Pregnancy and breast-feeding

Do not take Madopar if you are pregnant, trying to get pregnant or breast-feeding. This is because Madopar may affect your baby. It is important for women to use contraception while taking the medicine.

If you get pregnant while taking Madopar, talk to your doctor straight away.

Driving and using machines

Talk to your doctor about driving and using machines or tools, when you take Madopar. This is because one of the medicines in Madopar, 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 Madopar


Always take Madopar 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 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.

Patients already treated with levodopa:

•    Your starting dose of Madopar will be one less 100 mg/25 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 Madopar 100 mg/25 mg tablets 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.


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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.

If you forget to take Madopar

•    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.

Stopping Madopar

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.

If you take more Madopar than you should

If you take more Madopar 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.

If someone else takes your Madopar tablets 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 Madopar can cause side effects, although not everyone will get them.

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 Madopar 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).

5. How to store Madopar

•    Store Madopar dispersible tablets in their bottle, with the lid closed to protect the capsules from moisture.

•    Do not store Madopar tablets above 25 °C.

•    Keep out of the reach and sight of children.

•    Do not use Madopar after the expiry date printed on the pack.

•    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

What Madopar contains

There are two active substances in Madopar dispersible tablets, and there are two different strengths of tablet available

•    Each Madopar 50 mg/12.5 mg Dispersible Tablet contains 50 mg levodopa and 12.5 mg benserazide as the hydrochloride.

•    Each Madopar 100 mg/25 mg Dispersible Tablet contains 100 mg levodopa and 25 mg benserazide as the hydrochloride.

Other ingredients in the tablets are, citric acid anhydrous (E 330), pregelatinised starch, microcrystalline cellulose (E 460) and magnesium stearate (E 572).

What Madopar dispersible tablets look like and contents of the pack

Madopar 50 mg/12.5 mg Dispersible Tablets are round and white in colour, have Roche 62.5 marked one side and a score line on the other. Madopar 100 mg/25 mg Dispersible Tablets are round and white in colour, have Roche 125 marked one side and a score line on the other.

Madopar dispersible tablets are supplied in amber coloured glass bottles containing 100 tablets.

Marketing Authorisation Holder and Manufacturer

Roche Products Limited 6 Falcon Way Shire Park

Welwyn Garden City, AL7 1TW United Kingdom

This leaflet was last approved in

<month and year of approval date to be inserted here>.

Skin:



• 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.

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.

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.

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 Madopar 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.

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