Co-Beneldopa 100 Mg/25 Mg Capsules

TEVA UK Ref: 231-30-86486-ZB LEA CO-BENELDOPA A/S CAP TUK<DEB Version: 2 02 May 2014

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Do NOT take Co-Beneldopa

• If you are allergic (hypersensitive) to levodopa,

■ benserazide or any of the other ingredients of this medicine

• Ifyou have hyperthyroidism (an overactive thyroid gland), an excessively fast heartbeat, or phaeochromocytoma (a tumour of the adrenal gland that causes hypertension)

• Ifyou have severe hormonal, heart, liver or kidney disease

• Ifyou have psychosis (a psychiatric condition characterised by personality derangement and loss of contact with reality)

• Ifyou have narrow angle glaucoma (high pressure in the eye)

• lfyouareunder25yearsofage • Ifyouarepregnant

• If you are a woman of child-bearing age not using reliable contraception (see section "Pregnancy and breast-feeding")

• Ifyouare taking reserpine or monoamine

oxidase (MAO) inhibitors (e.g. tranylcypromine), which are used to treat high blood pressure and depressed mood. Also do nottake Co-Beneldopa ifyou have taken a MAO inhibitor within the last 2 weeks.

Warnings and precautions

Tell your doctor before you take this medicine:

• If your symptoms were caused by another drug, or if you have another movement disorder called Huntington's chorea, as this medicine may not be appropriate • If you have ever had aheart attack orheart problems

• Ifyou have orthostatic hypotension (low blood pressure associated with changes in posture, which makes you feel light-headed or dizzy)

• Ifyou have ever had a peptic or intestinal ulcer • Ifyou have ever had convulsions (fits)

• Ifyou have ever had osteomalacia (a bone disease similarto rickets)

• If you have wide angle glaucoma (high pressure in the eye)

• Ifyou have diabetes.You should checkyour blood sugar levels more often, and your doctor may need to adjust the dose of your antidiabetic medicine.

• Ifyouareabouttoundergosurgery.

Depression and suicidal thoughts may occur during treatment with Co-Beneldopa, although they can also be caused byyour disease. If you feel depressed whilst on treatment, you should contact your doctor.

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 yourtreatments.

You must continue your treatment as long as your doctor tells you to. Suddenly stopping it could cause potentially life-threatening side effects (see section 3. below, 'Ifyou stoptaking Co-Beneldopa). Your doctor maywish to 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.

■ Other medicines and Co-Beneldopa

Checkwith your doctor if you are taking any of the following:

• Monoamine oxidase (MAO) inhibitors (used to treat depression): the combination ofthese medicines with Co-Beneldopa could cause excessively high blood pressure.This could also occur if you have taken an MAO inhibitor within the last 2 weeks (see 'Do NOT take Co-Beneldopa', above)

• Medicines that could strengthen or weaken the effect of Co-Beneldopa • Other medicines used for the treatment of Parkinson's disease, such as bromocriptine, amantadine, trihexyphenidyl or entacapone • Ferrous sulphate (used to treat iron deficiency)

CO-BENELDOPA 50 mg/12.5 mg, 100 mg/25 mg AND 200 mg/50 mg CAPSULES

(Levodopa/Benserazide)

PACKAGE LEAFLET: INFORMATION FOR THE USER

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 symptoms are the same as yours.

• Ifany of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

IN THIS LEAFLET:

1. What Co-Beneldopa is and what it is used for

2. What you need to know before you take Co-Beneldopa

3. How to take Co-Beneldopa

4. Possible side effects

5. How to store Co-Beneldopa

6. Contents of the pack and other information

OWHAT CO-BENELDOPA IS AND WHAT IT IS USED FOR

• Levodopa is an anti-Parkinson's agent and benserazide is a decarboxylase inhibitorwhich helps levodopa to work better

• Co-Beneldopa is used to treat the symptoms of Parkinson's disease.

WHAT YOU NEED TO KNOW BEFORE YOU TAKE CO-BENELDOPA

• Metoclopramide (used to treat digestive disorders)

• Medicines belonging to a group called opioids, such as codeine, oxycodone, morphine, or tramadol (usedto relieve pain)

• Medicines for high blood pressure that contain reserpine (see 'Do NOT take Co-Beneldopa', above)

• Neuroleptics such as haloperidol, flupenthixol or chlorpromazine (used to treat some psychiatric disorders including severe anxiety and schizophrenia, nausea, sickness and hiccoughs)

• Medicines for high blood pressure: your blood pressure could become too low. Your doctor may need to adjust the dose of yourtreatment for high blood pressure.

• Medicines belonging to a group called sympathomimetics, such as clonidine or salbutamol, should not be used at the same time as Co-Beneldopa: the effect of these medicines could be strengthened. Your doctor may need to adjust the dose of your sympathomimetic treatment.

Co-Beneldopa may interfere with the results of tests for levels of certain chemicals in the blood.

Operations

If you are going to have an operation, tell the doctorthatyou are taking Levodopa/Benserazide. This is because you may need to stop taking it before you have a general anaesthetic.

Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines.

Taking Co-Beneldopa with food and drink

Taking Co-Beneldopa with high-protein meals could reduce its effect.

When possible, you should take Co-Beneldopa 30 minutes to 1 hour after meals.

Pregnancy and breast-feeding

You must nottake Levodopa/Benserazide ifyou are pregnant. If you are of child-bearing age, you must use reliable contraception during treatment with Levodopa/Benserazide.

Nevertheless, if you still become pregnant or think you may be pregnant, you must consult your doctor. He/she will advise you how to stop treatment with Levodopa/Benserazide.

You should not breast-feed during treatmentwith Levodopa/Benserazide. If treatment with Levodopa/Benserazide is necessary during lactation, you should stop breast-feeding your baby.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Levodopa is associatedwith somnolence (excessive drowsiness) and, very rarely, with excessive daytime sleepiness and sudden onset sleep episodes.These can occurwithout warning signs. Ifyou experiencethese symptoms,you must inform your doctor and you must refrain from driving or engaging in activities where impaired alertness may put yourself or others at risk of serious injury (e.g. operating machines), until such recurrent episodes and somnolence have been resolved.

^ HOW TO TAKE CO-BENELDOPA

Always take Co-Beneldopa exactly as your doctor has told you. You should checkwith your doctor or pharmacist ifyou are not sure.

50 mg/12.5 mg strength:

Treatment with Co-Beneldopa is usually started with low doses, e.g. one capsule two to four times a day.

100 mg/25 mg strength:

Treatment with Co-Beneldopa is usually started with low doses. Co-Beneldopa 100 mg/25 mg Capsules are not appropriate for this and the 50 mg/12.5 mg strength is available for this purpose.

200 mg/50 mg strength:

Treatment with Co-Beneldopa is usually started with low doses. Co-Beneldopa 200 mg/50 mg Capsules are not appropriate for this and the 50 mg/12.5 mg strength is available forthis purpose.

50 mg/12.5 mg strength: After three to seven days, your doctor may, if necessary, begin to increase your dose by one or two capsules every third to seventh day, until you achieve suitable control of your symptoms.

100 mg/25 mg strength: After three to seven days, your doctor may, if necessary, begin to increase your dose by one capsule everythird to seventh day, until you achieve suitable control of your symptoms.

200 mg/50 mg strength: After three to seven days, your doctor may, if necessary, begin to increase your dose every third to seventh day, until you achieve suitable control ofyour symptoms. Co-Beneldopa 200 mg/50 mg Capsules are not appropriate for this and other strengths are available to this end.

The maximum dose is generally no more than 50 mg/12.5 mg: sixteen capsules a day.

100 mg/25 mg: eight capsules a day.

200 mg/50 mg: four capsules a day.

The daily dose should be spread out over the day into several smaller doses.The size of individual doses and the way they are spread throughout the day must be adjusted to suit the needs of each individual patient.

It may take several weeks for the full effect of your medicine to become apparent.

Ifyou have previouslytaken levodopa on its own or with another decarboxylase inhibitor, you should stop taking ittwelve hours beforeyou start taking Co-Beneldopa.

When possible, you should take Co-Beneldopa 30 minutes to 1 hour after meals. You must swallow the capsules whole, without chewing them, with a drink.

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If you take more Co-Beneldopa than you should

Ifyou (or someone else) swallow a lot ofthe capsules all together, or if you think a child has swallowed any of the capsules, contact your nearest hospital casualty department or your doctor immediately. Please take this leaflet, any remaining capsules and the container with you to the hospital or doctor so that they know which capsules were consumed.

Overdose may cause a worsening ofyour symptoms, aswell as confusion, hallucinations and sleep disturbances. Nausea and vomiting (feeling and being sick) and abnormal heart rhythms may rarely occur.

If you forget to take Co-Beneldopa

Do not take a double dose to make up for a forgotten dose.Take your next dose as usual; however, you may experience some return of Parkinson's disability in the meantime.

If you stop taking Co-Beneldopa

Your doctor will advise you when you should stop taking Co-Beneldopa. Usually, it is taken for a long time since it replaces a substance, dopamine, which is not produced in sufficient amounts by patientswith Parkinson's disease.

You must tell your doctor if you want to stop taking Co-Beneldopa. Although it is rare, sudden discontinuation oftreatment can cause potentially life-threatening side effects, including a condition called neuroleptic malignant-like syndrome, which involves greatly elevated bodytemperature, muscle stiffness and psychological changes, and akinetic crisis (inability to move).To avoid these, your doctor will advise you how to end your treatment.

If you have any further questions on the use of this product, askyour doctor or pharmacist.

^ POSSIBLE SIDE EFFECTS

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

You may experience the following side effects:

• inability to resist the impulse to perform an action that could be harmful, which may include:

• strong impulse to gamble excessively despite serious personal or family consequences

• altered or increased sexual interest and behaviour of significant concern to you or to others, for example, an increased sexual drive

• uncontrollable excessive shopping or spending

• binge eating (eating large amounts of food in a short time period) or compulsive eating (eating more food than normal and more than is needed to satisfy your hunger).

Tell your doctor if you experience any of these behaviours; they will discuss ways of managing or reducing the symptoms.

The following side effects have been reported at the approximate frequencies shown:

Very common (may affect more than 1 in 10 people)

• Sleep disturbances, especially in the elderly

• Depressed mood*, especially in the elderly

• Loss of appetite

• Fluctuations in response such as 'freezing' (movement suddenly becoming difficult), 'end-of-dose' (a return of symptoms before the next dose of medicine is due) and 'on-off' phenomena (sudden changes from periods of good symptom control to periods where symptoms are less controlled)*

• Distorted or impaired voluntary movement (dyskinesia)

• Involuntary movements.

In the later stages of treatment, and in many cases after the medicine has been taken for many years, uncontrollable, unusual movements of the arms, legs, face and tongue can occur. These may disappear if the daily dose is changed or if the spread of doses throughout the day can be improved.

• Nausea*

• Vomiting*

• Diarrhoea*

• Increased levels ofthe substance alkaline phosphatase in blood

• Increased levels ofthe substances uric acid or urea nitrogen in blood.

Common (may affect up to 1 in 10 people):

• Hallucinations, especially in the elderly

• Anxiety, especially in the elderly

• Abnormal heart rhythm

• Changes in blood pressure, which can be improved by reducing the dose

• Taste alterations*.

Uncommon (may affect up to 1 in 100 people):

• Taste loss*.

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

• Decreasedwhitebloodcellcounts.

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

• Decreased red blood cell or platelet counts

• Disorientation in time, especially in the elderly

• Agitation, especially in the elderly

• Delusions, especially in the elderly

• Mild elation

• Drowsiness

• Aggression

• 'Unmasking¹ of psychosis (a psychiatric condition characterised by personality derangement and loss of contact with reality)

• Dopamine dysregulation syndrome

• Confusion

• Excessive daytime sleepiness

• Sleep episodes

• Discoloured urine, usually red-tinged*

• Illness accompanying kidneyfailure (uraemia)

• Increasedlevelsofthesubstances transaminases in blood

• Allergic skin reactions such as itching and rash

• Irresistible urge to move your legs to stop uncomfortable or odd sensations

• Bleeding in digestivetract

• Discoloured saliva, tongue, tooth or mouth

• Flushing and sweating.

**These side effects typically occur at the beginning oftreatment and can usually be controlled by taking Co-Beneldopa with food or drink and by increasing the dose more slowly.

Reporting of side effects

If you get any side effects, talktoyour doctor, pharmacist or nurse.This includes any possible side effects not listed in this leaflet. You can also report side effects directly via theYellow Card Scheme at: www.mhra.gov.uk/yellowcard By reporting side effects you can help provide more information on the safety of this medicine.

HOW TO STORE CO-BENELDOPA

Keep out of the sight and reach of children.

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

This medicinal product does not require any special storage conditions.

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

What Co-Beneldopa contains

• The active substances are levodopa and benserazide.

• One capsule contains 50/100/200 mg of

levodopa and 12.5/25/50 mg of benserazide (as hydrochloride).

• The other ingredients are as follows:

Capsule contents: mannitol, cellulose microcrystalline, povidone K-30, talc, magnesium stearate.

Capsule shell: gelatin, titanium dioxide (El71), black iron oxide (El72), 200/50 mg: red iron oxide (El72), erythrosin (El 27), indigo carmine (El 32).

Printing ink: shellac, propylene glycol, potassium hydroxide, blackiron oxide.

What Co-Beneldopa looks like and contents of the pack

• Co-Beneldopa 50 mg/12.5 mg Capsules are hard gelatin capsules with an opaque grey cap imprinted '62.5' axially in black ink, and an opaque blue body imprinted 'BL' axially in black ink, and filled with off-white to brownish white granules. Available in white opaque bottles with a white cap with desiccant containing 30, 50,

60, 90 and 100 capsules.

• Co-Beneldopa 100 mg/25 mg Capsules are hard gelatin capsules with an opaque pink cap imprinted '125' axially in black ink, and an opaque blue body imprinted 'BL' axially in black ink, and filled with off-white to brownish white granules. Available in white opaque bottles with white cap with desiccant containing 20, 30, 50, 60, 90 and 100 capsules in container.

• Co-Beneldopa 200 mg/50 mg Capsules are hard gelatin capsules with an opaque maroon cap imprinted '250' axially in black ink, and an opaque blue body imprinted 'BL' axially in black ink, and filled with off-white to brownish white granules. Available in white opaque bottles with white cap with desiccant containing 30, 60 and 100 capsules in container.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

TEVA UK Limited, Eastbourne, BN22 9AG

This leaflet was last revised in 03/2014.

PL 00289/0992 PL 00289/0993 PL 00289/0994

TEVA UK Limited 86486-ZB