Co-Careldopa 10 mg/100 mg tablets Co-Careldopa 25 mg/100 mg tablets Co-Careldopa 25 mg/250 mg tablets

carbidopa/levodopa

Package leaflet: Information for the patient

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.

What is in this leaflet:

• 1. What Co-Careldopa is and what it is used for

• 2. What you need to know before you take Co-Careldopa

• 3. How to take Co-Careldopa

• 4. Possible side effects

• 5. How to store Co-Careldopa

• 6. Contents of the pack and other information

©■ What Co-Careldopa is and what it is used for

Co-Careldopa 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.

Co-Careldopa 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.

©

H What you need to know before you take Co-Careldopa

Do not take Co-Careldopa:

• – if you are allergic to levodopa, carbidopa or any of the other ingredients of this medicine (listed in section 6)

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

• – if you are taking certain medicines used in the treatment of depression (non-selective monoamine oxidase inhibitors [MAOIs] or selective MAO-A inhibitors). Treatment with these medicines should be discontinued at least two weeks before you start Co-Careldopa (see also section ‘Other medicine and Co-Careldopa’)

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

• – if you have a severe mental disorder

Warnings and precautions

Talk to your doctor or pharmacist before taking Co-Careldopa :

• – if you have a history of fits (convulsions) – if you have had an ulcer in your gut (called ‘duodenal’ or ‘peptic ulcer’) or have vomited blood

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

• – if you have had kidney, liver or hormonal problems

• – if you have had depression or other mental problems

• – if 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.

• – if you are suffering from disorders in which certain medicines, for instance, medicines to treat low blood pressure, circulatory failure, irregular heartbeat and cramps in the lower airways (sympathomimetic agents) may not be used.

Consult your doctor if during the treatment with Co-Careldopa you:

• – notice that your muscles get very rigid or jerk violently, or if you get tremors, agitation, confusion, fever, rapid pulse, or wide fluctuations in your blood pressure. If any of this happens, contact your doctor immediately

• – find yourself suddenly falling asleep, or if you feel very drowsy. If this happens, you should not drive or use any tools or machines (see also section ‚Driving and using machines‘)

• – feel depressed, have suicidal thoughts, or notice unusual changes in your behaviour

• – notice that uncontrolled movements begin or get worse after you started to take Co-Careldopa. If this happens, your doctor may need to change the dose of your antiparkinson medicine

• – are due to have surgery.

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.

Tell your doctor if you or your family/carer notices you are developing addiction-like symptoms leading to craving for large doses of Co-Careldopa and other medicines used to treat Parkinson’s di­sease.

Your doctor may carry out certain periodic tests, such as taking blood and urine samples and checking your heart rate and blood pressure. In addition, your skin should be tested for malignant melanomas on a regular basis.

Co-Careldopa is not recommended to be used for treatment of extrapyramidal symptoms (e.g. involuntary movements, shaking, muscle rigidity and muscle contractions) caused by other medicines.

Other medicines and Co-Careldopa

Tell your doctor or pharmacist if you are taking/using, have recently taken/used or might take/use any other medicines. This includes herbal medicines. This is because Co-Careldopa can affect the way some other medicines work. Also some other medicines can affect the way Co-Careldopa works.

In particular tell your doctor or pharmacist if you are taking any of the following medicines:

• – Medicines for Parkinson’s disease containing levodopa:

o If they are ‘slow release’, you will need to wait 24 hours after your last dose before starting Co-Careldopa.

o If they are ‘normal release’, you will need to wait 12 hours after your last dose before starting Co-Careldopa.

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 blood pressure, circulatory failure, irregular heartbeat and cramps in the lower airways (sympathomimetic agents). Your dose may need to be changed.

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

• – Medicines called ‘MAOIs’ (see also section ‘Do not take Co-Careldopa ’).

• – Anticholinergic medicines (such as orphenadrine, trihexyphenidyl, benzatropine and procyclidine).

• – Medicines to treat difficulty in falling asleep or sleeping through (benzodiazepines).

• – Phenytoin (used to treat fits (convulsions)).

• – Papaverine (used to treat impotence in men).

• – Selegiline (used to treat Parkinson’s di­sease).

• – Metoclopramide (used to treat nausea and vomiting).

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 Co-Careldopa.

Tests while you are taking Co-Careldopa

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 Co-Careldopa and are having any tests.

Co-Careldopa 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) Co-Careldopa may not work as well as it should.

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.

Levodopa, one of the substances in Co-Careldopa , is passed into human milk.

Driving and using machines

Co-Careldopa affects different people in different ways. Some people have side effects which affect their ability to drive or use tools or machines (see section ‘Possible side effects’). Do not drive or use tools or machines if you get these effects.

Co-Careldopa 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.

How to take Co-Careldopa

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Taking this medicine

• – Take this medicine by mouth.

• – 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.

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

Adults (including the elderly) The number of tablets which you should take each day will depend on your personal needs. Your doctor will tell you how many tablets to take each day. During the first few weeks your doctor may change your dose of Co-Careldopa until it is exactly right. You may also be given Co-Careldopa in combination with other medicines.

Please always attend the regular routine appointments with your doctor, as the symptoms of Parkinson’s disease change with time. A subsequent dose adjustment may therefore become necessary during the course of treatment.

Patients already being treated with levodopa, either on its own or in combination with another medicine

If you are taking levodopa, either on its own or in combination with another medicine, it will be discontinued at least 12 hours before starting treatment with Co-Careldopa.

Use in children and adolescents

Co-Careldopa should not be used in children and adolescents.

If you take more Co-Careldopa than you should

If you (or someone else) swallow a lot of the tablets all together, or if you think a child has swallowed any of the tablets, contact your nearest hospital casualty department or your doctor immediately. An overdose is likely to cause irregular heart beats. Please take this leaflet, any remaining tablets and the container with you to the hospital or doctor so that they know which tablets were consumed.

If you forget to take Co-Careldopa

You should continue to take these tablets for as long as your doctor tells you to. If you forget to take a tablet, take one as soon as you remember, unless it is nearly time to take the next one. Do not take a double dose to make up for a forgotten dose. Take the remaining doses at the correct time.

If you stop taking Co-Careldopa

Do not stop taking your medicine or change your dose without talking to your doctor first even if you feel better.

Do not stop taking Co-Careldopa suddenly as this can cause muscle problems, fever and mental changes to occur. When your doctor decides that you should stop taking Co-Careldopa they will reduce your dose gradually over a period of time.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

^4

Possible side effects

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

Stop taking Co-Careldopa and see your doctor straight away, or go to the nearest hospital if you notice any of the following side effects:

• - allergic reaction: the signs may include hives (nettle rash), itching, rash, swelling of your face, lips, tongue or throat. This may cause difficulty in breathing or swallowing.

• - mental changes including delusions, hallucinations, paranoia and depression. If you have thought of harming or killing yourself at any time, contact your doctor or go to a hospital straight away.

• - neuroleptic malignant syndrome (characterised by sweating, fast heart rate, high body temperature, stiff muscles, coma).

• - blood problems : the signs may include pale skin (pallor), tiredness, fever, sore throat or mild bruising and prolonged bleeding after injury.

• - bleeding from your gut which may be seen as blood in your faeces or darkened faeces (gastro-intestinal bleeding)

• - fits (convulsions).

Other side effects that may occur:

Common (may affect up to 1 in 10 people)

• – loss of appetite

• – difficulty sleeping, feeling high (euphoria), dementia, increased energy or activity, dream abnormalities, confusion

• – abnormal movements such as unwanted jerky movements of the body (which may or may not be like your Parkinson’s sym­ptoms

• – on-off phenomenon, characteristic of some people with long-standing Parkinson’s di­sease. This is when you can have unpredictable changes from being mobile -“on” – to a sudden inability to move – “off”. “Off” to “on” can occur just as suddenly.

• – dizziness

• – uneven (irregular) heart beat or palpitations

• – a fall in blood pressure on standing up which causes dizziness, fainting

• – nausea, being sick (vomiting), dry mouth, bitter taste

• – feeling tired or faint.

Uncommon (may affect up to 1 in 100 people)

• – weight gain or loss

• – lack of coordination, increased hand tremor

• – high blood pressure

• – hoarseness

• – constipation, diarrhoea, excessive production of saliva, difficulty swallowing, wind

• – swelling in the limbs

• – muscle cramp

• – dark urine

• – chest pain, feeling weak, general feeling of being unwell, hot flushes.

Rare (may affect up to 1 in 1,000 people)

• – feeling agitated or anxious, reduced thinking capacity, disorientation, increased sexual desire

• – headache, numbness, pins and needles, falling, abnormal walking patterns, lockjaw (difficulty opening the mouth), eyelid twitching

• – activation of a previously unrecognised disease (latent Horner’s syndrome characterised by following symptoms: narrowing of the pupils, hanging down of the upper eyelid)

• – double vision, blurred vision, dilated pupils, irregular movement of the eye (oculogyric crisis)

• – inflammation of the veins

• – shortness of breath, unusual breathing pattern

• – indigestion, abdominal pain and distress, dark saliva, grinding of the teeth, hiccups, burning sensation of the tongue, gut ulcer

• – flushing, increased sweating, hair loss, dark sweat

• – in children, allergy-related bleeding in the skin and gastrointestinal tract wall (Schonlein-Henoch purpura)

• – difficulty passing urine or incontinence (inability to control urine flow)

• – persistent abnormal erection of the penis

Very rare (may affect up to 1 in 10,000 people)

• – sleepiness (including excessive daytime drowsiness or sudden sleep onset episodes)

Not known (frequency cannot be estimated from the available data)

• – craving for large doses of Co-Careldopa in excess of that required to control motor symptoms, known as dopamine dysregulation syndrome. Some patients experience severe abnormal involuntary movements (dyskinesias), mood swings or other side effects after taking large doses of Co-Careldopa.

• – changed patches of pigmented skin, including, irritated or irregular moles, or moles in which you have noticed changes (melanoma)

• – muscle twitching

• – 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; he/she will discuss ways of managing or reducing the symptoms.

If any symptoms persist or you experience any other side effects please tell your doctor or pharmacist. It will help if you make a note of what you experienced, when it started and how long it lasted.

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 via theYellow Card Scheme at: , or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects, you can help provide more information on the safety of this medicine.

How to store Co-Careldopa

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the outer packaging after EXP. The expiry date refers to the last day of that month.

Do not store above 25°C. Store in the original package.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

©

■ Contents of the pack and other information

What Co-Careldopa contains

Co-Careldopa 10 mg/100 mg tablets – The active substances are carbidopa (as monohydrate) and levodopa.

Each tablet contains 10 mg carbidopa (as monohydrate) and 100 mg levodopa.

• – The other ingredients are maize starch, pregelatinised maize starch, microcrystalline cellulose, magnesium stearate and indigo carmine (E132).

Co-Careldopa 25 mg/100 mg tablets – The active substances are carbidopa (as monohydrate) and levodopa.

Each tablet contains 25 mg carbidopa (as monohydrate) and 100 mg levodopa.

• – The other ingredients are maize starch, pregelatinised maize starch, microcrystalline cellulose, magnesium stearate and quinoline yellow aluminium lake (E104).

Co-Careldopa 25 mg/250 mg tablets – The active substances are carbidopa (as monohydrate) and levodopa.

Each tablet contains 25 mg carbidopa (as monohydrate) and 250 mg levodopa.

• – The other ingredients are maize starch, pregelatinised maize starch, microcrystalline cellulose, magnesium stearate and indigo carmine (E132).

What Co-Careldopa looks like and contents of the pack

Co-Careldopa 10 mg/100 mg tablets The tablets are mottled blue, round, flat-bevelled, 9.1 mm in diameter, plain and with breakline on each side. They can be divided into equal doses.

Co-Careldopa is available in pack sizes of 50, 100, 500 and 1000 tablets.

Not all pack sizes may be marketed.

Co-Careldopa 25 mg/100 mg tablets The tablets are mottled yellow, round, flat-bevelled, 9.1 mm in diameter, plain and with breakline on each side. They can be divided into equal doses.

Co-Careldopa is available in pack sizes of 20, 30, 50, 60, 100, 200, 500 and 1000 tablets. Not all pack sizes may be marketed.

Co-Careldopa 25 mg/250 mg tablets The tablets are mottled blue, round, flat-bevelled, 10.3 mm in diameter, plain on each side and with breakline on one side. They can be divided into equal doses.

Co-Careldopa is available in pack sizes of 20, 30, 50, 60, 100, 120, 200, 500 and 1000 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder

TEVA UK Limited, Eastbourne, BN22 9AG, UK

Manufacturer

TEVA Pharmaceutical Works Private Limited Company

Pallagi Street 13, Debrecen, H-4042, Hungary

This leaflet was last revised: September 2018

PL 00289/0783–5

TTTTTI EAS4563a

TEVA UK LIMITED

PAGE 1: FRONT FACE (INSIDE OF REEL)

Co-Careldopa 10 mg/100 mg tablets

Co-Careldopa 25 mg/100 mg tablets

Co-Careldopa 25 mg/250 mg tablets

carbidopa/levodopa

Package leaflet: Information for the patient

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.

What is in this leaflet:

• 1. What Co-Careldopa is and what it is used for

• 2. What you need to know before you take Co-Careldopa

• 3. How to take Co-Careldopa

• 4. Possible side effects

• 5. How to store Co-Careldopa

• 6. Contents of the pack and other information

^ 1^ What Co-Careldopa is and what it is used for

Co-Careldopa 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 H continue your normal daily activities.

Co-Careldopa 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.

©

What you need to know before you take Co-Careldopa

Do not take Co-Careldopa:

• – if you are allergic to levodopa, carbidopa or any of the other ingredients of this medicine (listed in section 6)

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

• – if you are taking certain medicines used in the treatment of depression (non-selective monoamine oxidase inhibitors [MAOIs] or selective MAO-A inhibitors). Treatment with these medicines should be discontinued at least two weeks before you start Co-Careldopa (see also section ‘Other medicine and Co-Careldopa’)

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

• – if you have a severe mental disorder

Warnings and precautions

Talk to your doctor or pharmacist before taking Co-Careldopa :

• – if you have a history of fits (convulsions)

• – if you have had an ulcer in your gut (called ‘duodenal’ or ‘peptic ulcer’) or have vomited blood

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

• – if you have had kidney, liver or hormonal problems

• – if you have had depression or other mental problems – if 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.

• – if you are suffering from disorders in which certain medicines, for instance, medicines to treat low blood pressure, circulatory failure, irregular heartbeat and cramps in the lower airways (sympathomimetic agents) may not be used.

Consult your doctor if during the treatment with Co-Careldopa you: – notice that your muscles get very rigid or jerk violently, or if you get tremors, agitation, confusion, fever, rapid pulse, or wide fluctuations in your blood pressure. If any of this happens, contact your doctor immediately

• – find yourself suddenly falling asleep, or if you feel very drowsy. If this happens, you should not drive or use any tools or machines (see also section ‚Driving and using machines‘)

• – feel depressed, have suicidal thoughts, or notice unusual changes in your behaviour

• – notice that uncontrolled movements begin or get worse after you started to take Co-Careldopa. If this happens, your doctor may need to change the dose of your antiparkinson medicine

• – are due to have surgery.

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.

Tell your doctor if you or your family/carer notices you are developing addiction-like symptoms leading to craving for large doses of Co-Careldopa and other medicines used to treat Parkinson’s di­sease.

Your doctor may carry out certain periodic tests, such as taking blood and urine samples and checking your heart rate and blood pressure. In addition, your skin should be tested for malignant melanomas on a regular basis.

Co-Careldopa is not recommended to be used for treatment of extrapyramidal symptoms (e.g. involuntary movements, shaking, muscle rigidity and muscle contractions) caused by other medicines.

Other medicines and Co-Careldopa

Tell your doctor or pharmacist if you are taking/using, have recently taken/used or might take/use any other medicines. This includes herbal medicines. This is because Co-Careldopa can affect the way some other medicines work. Also some other medicines can affect the way Co-Careldopa works.

In particular tell your doctor or pharmacist if you are taking any of the following medicines:

• – Medicines for Parkinson’s disease containing levodopa:

o If they are ‘slow release’, you will need to wait 24 hours after your last dose before starting Co-Careldopa.

o If they are ‘normal release’, you will need to wait 12 hours after your last dose before starting Co-Careldopa.

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 blood pressure, circulatory failure, irregular heartbeat and cramps in the lower airways (sympathomimetic agents). Your dose may need to be changed.

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

• – Medicines called ‘MAOIs’ (see also section ‘Do not take Co-Careldopa ’).

• – Anticholinergic medicines (such as orphenadrine, trihexyphenidyl, benzatropine and procyclidine).

• – Medicines to treat difficulty in falling asleep or sleeping through (benzodiazepines).

• – Phenytoin (used to treat fits (convulsions)).

• – Papaverine (used to treat impotence in men).

• – Selegiline (used to treat Parkinson’s di­sease).

• – Metoclopramide (used to treat nausea and vomiting).

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 Co-Careldopa.

Tests while you are taking Co-Careldopa

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 Co-Careldopa and are having any tests.

Co-Careldopa 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) Co-Careldopa may not work as well as it should.

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.

Levodopa, one of the substances in Co-Careldopa , is passed into human milk.

Driving and using machines

Co-Careldopa affects different people in different ways. Some people have side effects which affect their ability to drive or use tools or machines (see section ‘Possible side effects’). Do not drive or use tools or machines if you get these effects.

Co-Careldopa 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.

How to take Co-Careldopa

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Taking this medicine

• – Take this medicine by mouth.

• – 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.

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

Adults (including the elderly)

The number of tablets which you should take each day will depend on your personal needs. Your doctor will tell you how many tablets to take each day. During the first few weeks your doctor may change your dose of Co-Careldopa until it is exactly right. You may also be given Co-Careldopa in combination with other medicines. Please always attend the regular routine appointments with your doctor, as the symptoms of Parkinson’s disease change with time. A subsequent dose adjustment may therefore become necessary during the course of treatment.

Patients already being treated with levodopa, either on its own or in combination with another medicine

If you are taking levodopa, either on its own or in combination with another medicine, it will be discontinued at least 12 hours before starting treatment with Co-Careldopa.

Use in children and adolescents

Co-Careldopa should not be used in children and adolescents.

PAGE 2: REAR FACE (OUTSIDE OF REEL)

If you take more Co-Careldopa than you should

If you (or someone else) swallow a lot of the tablets all together, or if you think a child has swallowed any of the tablets, contact your nearest hospital casualty department or your doctor immediately. An overdose is likely to cause irregular heart beats. Please take this leaflet, any remaining tablets and the container with you to the hospital or doctor so that they know which tablets were consumed.

If you forget to take Co-Careldopa

You should continue to take these tablets for as long as your doctor tells you to. If you forget to take a tablet, take one as soon as you remember, unless it is nearly time to take the next one. Do not take a double dose to make up for a forgotten dose. Take the remaining doses at the correct time.

If you stop taking Co-Careldopa

Do not stop taking your medicine or change your dose without talking to your doctor first even if you feel better.

Do not stop taking Co-Careldopa suddenly as this can cause muscle problems, fever and mental changes to occur. When your doctor decides that you should stop taking Co-Careldopa they will reduce your dose gradually over a period of time.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Possible side effects

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

Stop taking Co-Careldopa and see your doctor straight away, or go to the nearest hospital if you notice any of the following side effects:

• - allergic reaction: the signs may include hives (nettle rash), itching, rash, swelling of your face, lips, tongue or throat. This may cause difficulty in breathing or swallowing.

• - mental changes including delusions, hallucinations, paranoia and depression. If you have thought of harming or killing yourself at any time, contact your doctor or go to a hospital straight away.

• - neuroleptic malignant syndrome (characterised by sweating, fast heart rate, high body temperature, stiff muscles, coma).

• - blood problems : the signs may include pale skin (pallor), tiredness, fever, sore throat or mild bruising and prolonged bleeding after injury.

• - bleeding from your gut which may be seen as blood in your faeces or darkened faeces (gastro-intestinal bleeding)

• - fits (convulsions).

Other side effects that may occur:

Common (may affect up to 1 in 10 people)

• – loss of appetite

• – difficulty sleeping, feeling high (euphoria), dementia, increased energy or activity, dream abnormalities, confusion

• – abnormal movements such as unwanted jerky movements of the body (which may or may not be like your Parkinson’s sym­ptoms

• – on-off phenomenon, characteristic of some people with long-standing Parkinson’s di­sease. This is when you can have unpredictable changes from being mobile – “on” – to a sudden inability to move – “off”. “Off” to “on” can occur just as suddenly.

• – dizziness

• – uneven (irregular) heart beat or palpitations

• – a fall in blood pressure on standing up which causes dizziness, fainting

• – nausea, being sick (vomiting), dry mouth, bitter taste

• – feeling tired or faint.

Uncommon (may affect up to 1 in 100 people)

• – weight gain or loss

• – lack of coordination, increased hand tremor

• – high blood pressure

• – hoarseness

• – constipation, diarrhoea, excessive production of saliva, difficulty swallowing, wind

• – swelling in the limbs

• – muscle cramp

• – dark urine

• – chest pain, feeling weak, general feeling of being unwell, hot flushes.

Rare (may affect up to 1 in 1,000 people)

• – feeling agitated or anxious, reduced thinking capacity, disorientation, increased sexual desire

• – headache, numbness, pins and needles, falling, abnormal walking patterns, lockjaw (difficulty opening the mouth), eyelid twitching

• – activation of a previously unrecognised disease (latent Horner’s syndrome characterised by following symptoms: narrowing of the pupils, hanging down of the upper eyelid)

• – double vision, blurred vision, dilated pupils, irregular movement of the eye (oculogyric crisis)

• – inflammation of the veins

• – shortness of breath, unusual breathing pattern

• – indigestion, abdominal pain and distress, dark saliva, grinding of the teeth, hiccups, burning sensation of the tongue, gut ulcer

• – flushing, increased sweating, hair loss, dark sweat

• – in children, allergy-related bleeding in the skin and gastrointestinal tract wall (Schonlein-Henoch purpura)

• – difficulty passing urine or incontinence (inability to control urine flow)

• – persistent abnormal erection of the penis

Very rare (may affect up to 1 in 10,000 people)

• – sleepiness (including excessive daytime drowsiness or sudden sleep onset episodes)

Not known (frequency cannot be estimated from the available data) – craving for large doses of Co-Careldopa in excess of that required to control motor symptoms, known as dopamine dysregulation syndrome. Some patients experience severe abnormal involuntary movements (dyskinesias), mood swings or other side effects after taking large doses of Co-Careldopa.

• – changed patches of pigmented skin, including, irritated or irregular moles, or moles in which you have noticed changes (melanoma)

• – muscle twitching

• – 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; he/she will discuss ways of managing or reducing the symptoms.

If any symptoms persist or you experience any other side effects please tell your doctor or pharmacist. It will help if you make a note of what you experienced, when it started and how long it lasted.

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 via the Yellow Card Scheme at: , or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects, you can help provide more information on the safety of this medicine.

How to store Co-Careldopa

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the outer packaging after EXP. The expiry date refers to the last day of that month.

Do not store above 25°C. Store in the original package.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

Contents of the pack and other information

What Co-Careldopa contains

Co-Careldopa 10 mg/100 mg tablets

• – The active substances are carbidopa (as monohydrate) and levodopa.

Each tablet contains 10 mg carbidopa (as monohydrate) and 100 mg levodopa.

• – The other ingredients are maize starch, pregelatinised maize starch, microcrystalline cellulose, magnesium stearate and indigo carmine (E132).

Co-Careldopa 25 mg/100 mg tablets

• – The active substances are carbidopa (as monohydrate) and levodopa.

Each tablet contains 25 mg carbidopa (as monohydrate) and 100 mg levodopa.

• – The other ingredients are maize starch, pregelatinised maize starch, microcrystalline cellulose, magnesium stearate and quinoline yellow aluminium lake (E104).

Co-Careldopa 25 mg/250 mg tablets

• – The active substances are carbidopa (as monohydrate) and levodopa.

Each tablet contains 25 mg carbidopa (as monohydrate) and 250 mg levodopa.

• – The other ingredients are maize starch, pregelatinised maize starch, microcrystalline cellulose, magnesium stearate and indigo carmine (E132).

What Co-Careldopa looks like and contents of the pack

Co-Careldopa 10 mg/100 mg tablets The tablets are mottled blue, round, flat-bevelled, 9.1 mm in diameter, plain and with breakline on each side. They can be divided into equal doses.

Co-Careldopa is available in pack sizes of 50, 100, 500 and 1000 tablets.

Not all pack sizes may be marketed.

Co-Careldopa 25 mg/100 mg tablets The tablets are mottled yellow, round, flat-bevelled, 9.1 mm in diameter, plain and with breakline on each side. They can be divided into equal doses.

Co-Careldopa is available in pack sizes of 20, 30, 50, 60, 100, 200, 500 and 1000 tablets. Not all pack sizes may be marketed.

Co-Careldopa 25 mg/250 mg tablets The tablets are mottled blue, round, flat-bevelled, 10.3 mm in diameter, plain on each side and with breakline on one side. They can be divided into equal doses.

Co-Careldopa is available in pack sizes of 20, 30, 50, 60, 100, 120, 200, 500 and 1000 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder

TEVA UK Limited, Eastbourne, BN22 9AG, UK

Manufacturer

TEVA Pharmaceutical Works Private Limited Company

Pallagi Street 13, Debrecen, H-4042, Hungary

This leaflet was last revised: September 2018

PL 00289/0783–5

TTTTTI EAS4563a

TEVA UK LIMITED

PAGE 1: FRONT FACE (INSIDE OF REEL)

Co-Careldopa 10 mg/100 mg tablets

Co-Careldopa 25 mg/100 mg tablets

Co-Careldopa 25 mg/250 mg tablets

carbidopa/levodopa

Package leaflet: Information for the patient

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.

What is in this leaflet:

• 1. What Co-Careldopa is and what it is used for

• 2. What you need to know before you take Co-Careldopa

• 3. How to take Co-Careldopa

• 4. Possible side effects

• 5. How to store Co-Careldopa

• 6. Contents of the pack and other information

• ^ 1^ What Co-Careldopa is and what it is used for

  Co-Careldopa 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 H continue your normal daily activities.

Co-Careldopa 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.

©

What you need to know before you take Co-Careldopa

Do not take Co-Careldopa:

• – if you are allergic to levodopa, carbidopa or any of the other ingredients of this medicine (listed in section 6)

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

• – if you are taking certain medicines used in the treatment of depression (non-selective monoamine oxidase inhibitors [MAOIs] or selective MAO-A inhibitors). Treatment with these medicines should be discontinued at least two weeks before you start Co-Careldopa (see also section ‘Other medicine and Co-Careldopa’)

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

• – if you have a severe mental disorder

Warnings and precautions

Talk to your doctor or pharmacist before taking Co-Careldopa :

• – if you have a history of fits (convulsions)

• – if you have had an ulcer in your gut (called ‘duodenal’ or ‘peptic ulcer’) or have vomited blood

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

• – if you have had kidney, liver or hormonal problems

• – if you have had depression or other mental problems – if 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.

• – if you are suffering from disorders in which certain medicines, for instance, medicines to treat low blood pressure, circulatory failure, irregular heartbeat and cramps in the lower airways (sympathomimetic agents) may not be used.

Consult your doctor if during the treatment with Co-Careldopa you: – notice that your muscles get very rigid or jerk violently, or if you get tremors, agitation, confusion, fever, rapid pulse, or wide fluctuations in your blood pressure. If any of this happens, contact your doctor immediately

• – find yourself suddenly falling asleep, or if you feel very drowsy. If this happens, you should not drive or use any tools or machines (see also section ‚Driving and using machines‘)

• – feel depressed, have suicidal thoughts, or notice unusual changes in your behaviour

• – notice that uncontrolled movements begin or get worse after you started to take Co-Careldopa. If this happens, your doctor may need to change the dose of your antiparkinson medicine

• – are due to have surgery.

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.

Tell your doctor if you or your family/carer notices you are developing addiction-like symptoms leading to craving for large doses of Co-Careldopa and other medicines used to treat Parkinson’s di­sease.

Your doctor may carry out certain periodic tests, such as taking blood and urine samples and checking your heart rate and blood pressure. In addition, your skin should be tested for malignant melanomas on a regular basis.

Co-Careldopa is not recommended to be used for treatment of extrapyramidal symptoms (e.g. involuntary movements, shaking, muscle rigidity and muscle contractions) caused by other medicines.

Other medicines and Co-Careldopa

Tell your doctor or pharmacist if you are taking/using, have recently taken/used or might take/use any other medicines. This includes herbal medicines. This is because Co-Careldopa can affect the way some other medicines work. Also some other medicines can affect the way Co-Careldopa works.

In particular tell your doctor or pharmacist if you are taking any of the following medicines:

• – Medicines for Parkinson’s disease containing levodopa:

o If they are ‘slow release’, you will need to wait 24 hours after your last dose before starting Co-Careldopa.

o If they are ‘normal release’, you will need to wait 12 hours after your last dose before starting Co-Careldopa.

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 blood pressure, circulatory failure, irregular heartbeat and cramps in the lower airways (sympathomimetic agents). Your dose may need to be changed.

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

• – Medicines called ‘MAOIs’ (see also section ‘Do not take Co-Careldopa ’).

• – Anticholinergic medicines (such as orphenadrine, trihexyphenidyl, benzatropine and procyclidine).

• – Medicines to treat difficulty in falling asleep or sleeping through (benzodiazepines).

• – Phenytoin (used to treat fits (convulsions)).

• – Papaverine (used to treat impotence in men).

• – Selegiline (used to treat Parkinson’s di­sease).

• – Metoclopramide (used to treat nausea and vomiting).

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 Co-Careldopa.

Tests while you are taking Co-Careldopa

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 Co-Careldopa and are having any tests.

Co-Careldopa 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) Co-Careldopa may not work as well as it should.

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.

Levodopa, one of the substances in Co-Careldopa , is passed into human milk.

Driving and using machines

Co-Careldopa affects different people in different ways. Some people have side effects which affect their ability to drive or use tools or machines (see section ‘Possible side effects’). Do not drive or use tools or machines if you get these effects.

Co-Careldopa 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.

How to take Co-Careldopa

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Taking this medicine

• – Take this medicine by mouth.

• – 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.

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

Adults (including the elderly)

The number of tablets which you should take each day will depend on your personal needs. Your doctor will tell you how many tablets to take each day. During the first few weeks your doctor may change your dose of Co-Careldopa until it is exactly right. You may also be given Co-Careldopa in combination with other medicines. Please always attend the regular routine appointments with your doctor, as the symptoms of Parkinson’s disease change with time. A subsequent dose adjustment may therefore become necessary during the course of treatment.

Patients already being treated with levodopa, either on its own or in combination with another medicine

If you are taking levodopa, either on its own or in combination with another medicine, it will be discontinued at least 12 hours before starting treatment with Co-Careldopa.

Use in children and adolescents

Co-Careldopa should not be used in children and adolescents.

PAGE 2: REAR FACE (OUTSIDE OF REEL)

If you take more Co-Careldopa than you should

If you (or someone else) swallow a lot of the tablets all together, or if you think a child has swallowed any of the tablets, contact your nearest hospital casualty department or your doctor immediately. An overdose is likely to cause irregular heart beats. Please take this leaflet, any remaining tablets and the container with you to the hospital or doctor so that they know which tablets were consumed.

If you forget to take Co-Careldopa

You should continue to take these tablets for as long as your doctor tells you to. If you forget to take a tablet, take one as soon as you remember, unless it is nearly time to take the next one. Do not take a double dose to make up for a forgotten dose. Take the remaining doses at the correct time.

If you stop taking Co-Careldopa

Do not stop taking your medicine or change your dose without talking to your doctor first even if you feel better.

Do not stop taking Co-Careldopa suddenly as this can cause muscle problems, fever and mental changes to occur. When your doctor decides that you should stop taking Co-Careldopa they will reduce your dose gradually over a period of time.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Possible side effects

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

Stop taking Co-Careldopa and see your doctor straight away, or go to the nearest hospital if you notice any of the following side effects:

• - allergic reaction: the signs may include hives (nettle rash), itching, rash, swelling of your face, lips, tongue or throat. This may cause difficulty in breathing or swallowing.

• - mental changes including delusions, hallucinations, paranoia and depression. If you have thought of harming or killing yourself at any time, contact your doctor or go to a hospital straight away.

• - neuroleptic malignant syndrome (characterised by sweating, fast heart rate, high body temperature, stiff muscles, coma).

• - blood problems : the signs may include pale skin (pallor), tiredness, fever, sore throat or mild bruising and prolonged bleeding after injury.

• - bleeding from your gut which may be seen as blood in your faeces or darkened faeces (gastro-intestinal bleeding)

• - fits (convulsions).

Other side effects that may occur:

Common (may affect up to 1 in 10 people)

• – loss of appetite

• – difficulty sleeping, feeling high (euphoria), dementia, increased energy or activity, dream abnormalities, confusion

• – abnormal movements such as unwanted jerky movements of the body (which may or may not be like your Parkinson’s sym­ptoms

• – on-off phenomenon, characteristic of some people with long-standing Parkinson’s di­sease. This is when you can have unpredictable changes from being mobile – “on” – to a sudden inability to move – “off”. “Off” to “on” can occur just as suddenly.

• – dizziness

• – uneven (irregular) heart beat or palpitations

• – a fall in blood pressure on standing up which causes dizziness, fainting

• – nausea, being sick (vomiting), dry mouth, bitter taste

• – feeling tired or faint.

Uncommon (may affect up to 1 in 100 people)

• – weight gain or loss

• – lack of coordination, increased hand tremor

• – high blood pressure

• – hoarseness

• – constipation, diarrhoea, excessive production of saliva, difficulty swallowing, wind

• – swelling in the limbs

• – muscle cramp

• – dark urine

• – chest pain, feeling weak, general feeling of being unwell, hot flushes.

Rare (may affect up to 1 in 1,000 people)

• – feeling agitated or anxious, reduced thinking capacity, disorientation, increased sexual desire

• – headache, numbness, pins and needles, falling, abnormal walking patterns, lockjaw (difficulty opening the mouth), eyelid twitching

• – activation of a previously unrecognised disease (latent Horner’s syndrome characterised by following symptoms: narrowing of the pupils, hanging down of the upper eyelid)

• – double vision, blurred vision, dilated pupils, irregular movement of the eye (oculogyric crisis)

• – inflammation of the veins

• – shortness of breath, unusual breathing pattern

• – indigestion, abdominal pain and distress, dark saliva, grinding of the teeth, hiccups, burning sensation of the tongue, gut ulcer

• – flushing, increased sweating, hair loss, dark sweat

• – in children, allergy-related bleeding in the skin and gastrointestinal tract wall (Schonlein-Henoch purpura)

• – difficulty passing urine or incontinence (inability to control urine flow)

• – persistent abnormal erection of the penis

Very rare (may affect up to 1 in 10,000 people)

• – sleepiness (including excessive daytime drowsiness or sudden sleep onset episodes)

Not known (frequency cannot be estimated from the available data) – craving for large doses of Co-Careldopa in excess of that required to control motor symptoms, known as dopamine dysregulation syndrome. Some patients experience severe abnormal involuntary movements (dyskinesias), mood swings or other side effects after taking large doses of Co-Careldopa.

• – changed patches of pigmented skin, including, irritated or irregular moles, or moles in which you have noticed changes (melanoma)

• – muscle twitching

• – 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; he/she will discuss ways of managing or reducing the symptoms.

If any symptoms persist or you experience any other side effects please tell your doctor or pharmacist. It will help if you make a note of what you experienced, when it started and how long it lasted.

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 via the Yellow Card Scheme at: , or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects, you can help provide more information on the safety of this medicine.

How to store Co-Careldopa

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the outer packaging after EXP. The expiry date refers to the last day of that month.

Do not store above 25°C. Store in the original package.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

Contents of the pack and other information

What Co-Careldopa contains

Co-Careldopa 10 mg/100 mg tablets

• – The active substances are carbidopa (as monohydrate) and levodopa.

Each tablet contains 10 mg carbidopa (as monohydrate) and 100 mg levodopa.

• – The other ingredients are maize starch, pregelatinised maize starch, microcrystalline cellulose, magnesium stearate and indigo carmine (E132).

Co-Careldopa 25 mg/100 mg tablets

• – The active substances are carbidopa (as monohydrate) and levodopa.

Each tablet contains 25 mg carbidopa (as monohydrate) and 100 mg levodopa.

• – The other ingredients are maize starch, pregelatinised maize starch, microcrystalline cellulose, magnesium stearate and quinoline yellow aluminium lake (E104).

Co-Careldopa 25 mg/250 mg tablets

• – The active substances are carbidopa (as monohydrate) and levodopa.

Each tablet contains 25 mg carbidopa (as monohydrate) and 250 mg levodopa.

• – The other ingredients are maize starch, pregelatinised maize starch, microcrystalline cellulose, magnesium stearate and indigo carmine (E132).