Document: leaflet MAH BRAND_PL 00025-0269 change

• leaflet MAH BRAND_PL 00025-0269
• leaflet MAH BRAND_PLPI 20636-2683
• leaflet MAH BRAND_PLPI 30900-2280

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PACKAGE LEAFLET: INFORMATION FOR THE USER

SINEMET® CR 50 mg/200 mg Prolonged-Release Tablets HALF SINEMET® CR 25 mg/100 mg Prolonged-Release Tablets

(Carbidopa/levodopa)

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 get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1    What Sinemet CR is and what it is used for

2    Before you take Sinemet CR

3    How to take Sinemet CR

4    Possible side effects

5    How to store Sinemet CR

6    Further information

1 What Sinemet CR is and what it is used for

Sinemet CR improves the signs of Parkinson's disease. Parkinson's disease is a long-term illness where:

•    you become slow and unsteady

•    your muscles feel stiff

•    you may develop shaking or trembling (called 'tremor').

If not treated, Parkinson's disease can make it hard for you to continue your normal daily activities.

Sinemet CR contains two different medicines called: levodopa and carbidopa.

•    levodopa turns into a material called 'dopamine' in your brain. The dopamine helps to improve the signs of your Parkinson's disease.

•    carbidopa belongs to a group of medicines called 'aromatic amino acid decarboxylase inhibitors'. It helps levodopa work more effectively by slowing the speed at which levodopa is broken down in your body.

2 Before you take Sinemet CR

Do not take Sinemet CR if:

•    you are allergic (hypersensitive) to carbidopa or levodopa or any of the other ingredients of Sinemet CR (listed in Section 6)

•    you have ever had skin cancer or you have any unusual moles which have not been examined by your doctor

•    you are taking certain medicines called 'MAOIs' (Monoamine Oxidase Inhibitors) used for depression. You need to stop using these medicines at least two weeks before you start Sinemet CR (see also under 'Taking other medicines' below)

•    you have a condition called 'narrow-angle glaucoma' that may cause a sudden build up of pressure in the eye

•    you have a severe mental disorder

•    you are pregnant, might become pregnant, or are breast-feeding.

Do not take Sinemet CR if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist

before taking Sinemet CR.

Take special care with Sinemet CR

Check with your doctor or pharmacist before taking your medicine if:

•    you have a history of fits (convulsions)

•    you have had an ulcer in your gut (called 'duodenal' or 'peptic ulcer') or have vomited blood

•    you have had a heart attack, heart beat problems, circulation or breathing problems

•    you have had kidney, liver or hormonal problems

•    you have had depression or other mental problems

•    you have a condition called 'chronic wide-angle glaucoma' that may cause a build up of pressure in the eye. You will need to have regular checks on the pressure in your eye

•    you sometimes have sudden sleep attacks or sometimes feel very sleepy

•    you are due to have surgery.

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Sinemet CR.

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.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This includes herbal medicines. This is because Sinemet CR can affect the way some other medicines work. Also some other medicines can affect the way Sinemet CR works. In particular tell your doctor or pharmacist if you are taking any of the following medicines:

•    Medicines for Parkinson's disease containing levodopa:

- If they are 'slow release, you will need to wait 24 hours after your last dose before starting Sinemet CR.

-    If they are 'normal release', you will need to wait 12 hours after your last dose before starting Sinemet CR.

-    Tell the doctor or pharmacist even if you have only taken them in the past.

Medicines for Parkinson's disease which do not contain levodopa will usually be continued. However, your dose may be changed.

•    Medicines for mental problems (including depression), tuberculosis (TB), high blood pressure, muscle spasms, epilepsy or other diseases related to involuntary movements. Your dose may need to be changed.

•    Medicines to treat low iron. Your dose may need to be changed.

•    Medicines called 'MAOIs' (see also 'Do not take Sinemet CR if').

•    Anticholinergic medicines (such as orphenadrine, trihexyphenidyl, benzatropine and procyclidine). Your dose may need to be changed.

•    Phenytoin which is used to treat fits (convulsions).

•    Papaverine which is used to treat impotence in men.

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking this medicine. Your doctor or pharmacist has a more complete list of medicines to avoid while taking Sinemet CR.

Tests while you are taking Sinemet CR

This medication can affect some laboratory tests that your doctor may perform on blood or urine samples. Please remind your doctor if you are taking Sinemet CR and are having any tests.

Taking Sinemet CR with food and drink

Try to avoid taking your tablets with a heavy meal. If your diet contains too much protein (meat, eggs, milk, cheese) Sinemet CR may not work as well as it should.

Pregnancy and breast-feeding

Do not take Sinemet CR if you are pregnant, might become pregnant or are breast-feeding. Levodopa, one of the substances in Sinemet CR, is passed into human milk.

Ask your doctor or pharmacist for advice before taking any medicine, if you are pregnant or breast-feeding.

Driving and using machines

•    Sinemet CR affects different people in different ways. Some people have side effects which affect their ability to drive or use tools or machines (see Section 4 Possible side effects). Do not drive or use tools or machines if you get these effects.

•    Sinemet CR can also make you sleepy or cause 'sudden sleep attacks'. If this happens to you, you must not drive or use tools or machines. Your doctor will tell you if you can start driving again if these attacks stop.

3 How to take Sinemet CR

Always take Sinemet CR exactly as your doctor has told you. You should check with your doctor or pharmacist

if you are not sure.

Taking this medicine

•    Take this medicine by mouth. You must swallow your tablets whole. Do not break, crush or chew the tablets.

•    Although your medicine can have an effect after one day, it may take up to seven days to work.

•    Take them at regular time intervals according to your doctor's instructions.

•    Do not change the times at which you take your tablets or take any other medicines for Parkinson's disease without first consulting your doctor. You should not take Sinemet CR or Half Sinemet CR tablets at intervals of less than 4 hours apart.

•    Try to avoid taking your tablets with a heavy meal.

If you have not had levodopa before

The usual starting dose for Sinemet CR is one tablet twice a day.

If you have had levodopa before

• your doctor will ask you to stop taking your medicine for Parkinson's disease for 8 hours before you start taking Sinemet CR.

The usual starting dose for Sinemet CR is one tablet twice a day. Your doctor may ask you to take Half Sinemet CR to help in determining the correct dose.

A combination of more than one Sinemet or Sinemet CR product may be prescribed by your doctor. If you have been given different Sinemet or Sinemet CR tablets to take make sure that you are taking the correct one at the right time. Remember: Half Sinemet CR is a lower dose tablet than Sinemet CR.

Children under 18 years of age

Sinemet CR is not suitable for children under the age of 18 years.

5 If you take more Sinemet CR than you should

If you take too many tablets see your doctor immediately.