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CO-CARELDOPA 10/100 mg, 25/100 mg AND 25/250 mg TABLETS carbidopa/levodopa

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.

•    Ifyou have any further questions, askyour 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.

•    Ifyou get any side effects, talkto your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See sections

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

OWHAT CO-CARELDOPA IS AND WHAT IT IS USED FOR

Co-Careldopa is known as a dopaminergic medicine. Co-Careldopa Tablets are used to treat Parkinson's disease, which is caused by a lack of a chemical, called dopamine in the nervous system. The tablets will help to restore the level of dopamine and help to reduce the signs and symptoms of the disease.

OWHAT YOU NEED TO KNOW BEFORE YOU TAKE CO-CARELDOPA

Do NOT take Co-Careldopa if you:

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

• are pregnant, planning to become pregnant or breast-feeding

• are taking any medicines known as "mono-amine oxidase inhibitors" MAOIs, (which are used to treat depression) or have taken these within the last 2 weeks (seeTaking other medicines, Do NOT take Co-Careldopa in combination with)

• have narrow-angle glaucoma (loss ofvision due to abnormally high pressure in the eye)

• have ever suffered from skin cancer orthink that you may have skin cancer • have severe heart problems which can cause shortness of breath or ankle swelling • sufferfrommentalillness • areunder18yearsold.

Warnings and precautions

Talk to your doctor or pharmacist before taking

Co-Careldopa if you:

• havekidneyproblems • have heart problems including history of a heart attack and irregular heart beats • have lung problems • havebreathingdifficulties • have liver problems • have hormone problems • haveahistoryoffits • have ever had ulcers ofthe stomach orgut • havepreviouslytakenlevodopa • have wide-angle glaucoma (loss ofvision due to abnormally high pressure in the eye)

• arefollowingahigh-proteindiet.

Your doctor will want to monitor you during your treatment with Co-Careldopa for the development of mental changes, depression with suicidal tendencies, and other changes in personality (see Section 4, Possible Side Effects).

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.

Children and adolescents

Co-Careldopa should not be used in children and adolescents under 18 years old.

Other medicines and Co-Careldopa

Do NOT take Co-Careldopa in combination with,

or if you have taken in the last 14 days:

•    antidepressants known as MAOIs e.g. phenelzine, isocarboxazid, tranylcypromine or moclobemide.

Talk to your doctor if you are taking any of the following:

•    anti-psychotic drugs e.g. benperidol, haloperidol, chlorpromazine, flupentixol, fluphenazine

•    antidepressants e.g. amitriptyline

•    drugstocontrolbloodpressure

•    anaesthetics

•    benzodiazepinese.g.nitrazepam

•    anti-convulsantse.g. phenytoin

•    anti-cholinergics e.g. benzatropine, orphenadrine

•    papaverine.

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

Pregnancy, breast-feeding and fertility

Do NOT take Co-Careldopa if you are pregnant, or breast-feeding, think you may be pregnant or are planning to have a baby. Ask your doctor for advice before taking any medicine.

Driving and using machines

Co-Careldopa can very rarely cause somnolence (excessive drowsiness) and sudden sleep onset episodes (where you may fall asleep very suddenly, sometimes without prior warning). If affected, do NOT drive or operate machinery.

^ HOW TO TAKE CO-CARELDOPA

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

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.

The tablets should be swallowed preferably with a drink of water.

The recommended dose is:

•    Adults (including the elderly)

Your doctor will calculate your dose for you depending on your needs.

•    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 under 18 years old.

If you take more Co-Careldopa than you should Ifyou (or someone else) swallow a lot ofthe 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 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 the tablets and tell your doctor immediately or go to the casualty department at your nearest hospital if the following happens:

•    an allergic reaction (swelling ofthe lips, face or neck leading to severe difficulty in breathing; skin rash or hives).

This is a very serious but rare side effect. You may need urgent medical attention or hospitalisation.

The following serious side effects have been reported commonly (may affect up to 1 in 10 people):

•    mental problems including depression, feeling suicidal, paranoia, reduction in cognition.

If you have thoughts 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). If you experience these symptoms, contact your doctor straight away.

•    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 also been reported commonly (may affect up to 1 in 10 people):

•    muscle twitching, shaking or other unwanted jerky movements of the body, eyelid twitching

•    feeling sick.

The following side effects have been reported less frequently (may affect up to 1 in 100 people):

•    slow heart rate, palpitations

•    a fall in blood pressure on standing up which causes dizziness, light-headedness or fainting

•    lossofappetite

•    vomiting

•    dizziness

•    drowsiness.

The following side effects have been reported rarely (may affect up to 1 in 1,000 people):

•    bleeding in the stomach

•    gut ulcers

•    high blood pressure

•    inflammation of a vein

•    anaemiaorblooddisorders

•    chest pain

•    difficultybreathing

•    tinglingornumbness

•    fits.

The following side effects have also been reported

(frequency cannot be estimated from the available

data):

•    lack of coordination, falling and difficulty in walking normally, hand shaking, muscle cramp, lockjaw

•    confusion, delusions, agitation, anxiety

•    difficulty sleeping, nightmares, hallucinations

•    abnormalfeelingofwell-being

•    dry mouth, bitter taste, excess saliva, difficulty in swallowing, grinding of teeth, burning sensation of the tongue

•    hiccups, stomach pain, constipation, diarrhoea, wind

•    changes in body weight, water retention causing swelling in the limbs

•    flushing, hot flushes, increased sweating, dark sweat

•    hair loss

•    problems with passing water, dark urine

•    painful and prolonged erection

•    drooping ofeyelids, problems with yourvision

•    weakness,tiredness,headache

•    hoarseness, a general feeling of being unwell

•    sense of stimulation, abnormal breathing

•    very rarely, somnolence (excessive drowsiness) or falling asleep suddenly may also occur.

Reporting of side effects

If you get 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: 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-CARELDOPA

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

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

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

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 Tablets contain:

• The active ingredients are carbidopa monohydrate and levodopa.

• The 10/100 mg tablets contain 10.8 mg carbidopa monohydrate (corresponding to 10 mg carbidopa anhydrous) and 100 mg levodopa.

• The 25/100 mg tablets contain 27 mg carbidopa monohydrate (corresponding to 25 mg carbidopa anhydrous) and 100 mg levodopa.

• The 25/250 mgtablets contain 27 mg carbidopa monohydrate (corresponding to 25 mg carbidopa anhydrous) and 250 mg levodopa.

• The other ingredients are maize starch,

pregelatinised maize, microcrystalline cellulose, magnesium stearate. The 10/100 mg and 25/250 mg tablets also contain indigo carmine (E132).The 25/100 mgtablets also contain quinoline yellow aluminium lake (E104).

What Co-Careldopa Tablets look like and contents of the pack:

• The 10/100 mg tablets are mottled blue, round, flat-bevelled tablets, 9.1 mm in diameter, plain and breakline on each side.

• The 25/100 mg tablets are mottled yellow, round, flat-bevelled tablets, 9.1 mm in diameter, plain and breakline on each side.

• The 25/250 mg tablets are mottled blue, round, flat-bevelled tablets, 10.3 mm in diameter, plain on each side and breakline on one side.

• The product is available in pack sizes of 20, 30, 50, 60, 100, 200, 500 and 1000 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

The Marketing Authorisation holder and company responsible for manufacture isTEVA UK Limited, Eastbourne, BN22 9AG.

This leaflet was last revised: May 2014

PL 00289/0783-5

TFWTI