Caramet 50 Mg / 200 Mg Cr Tablets

CARAMET® 25 mg/100 mg & 50 mg/200 mg CR TABLETS CARBIDOPA/LEVODOPA

PACKAGE LEAFLET: INFORMATION FORTHE USER

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.

• Ifyou have anyfurther questions, askyour doctor or pharmacist.

• This medicine has been prescribed foryou 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.

WHAT IS IN THIS LEAFLET:

1. What Caramet is and what it is used for

2. What you need to know before you take Caramet

3. How to take Caramet

4. Possible side effects

5. How to store Caramet

6. Contents of the pack and other information

OWHAT CARAMET IS AND WHAT IT IS USED FOR

• Caramet contains levodopa, which is a dopaminergic agent and carbidopa, which is a dopa-decarboxylase inhibitor • Caramet is used in the therapy of Parkinson's disease

• Parkinson's disease is caused by a lackofa chemical called dopamine in the nervous system. Levodopa is converted in the brain to dopamine, increasing the amount in the brain to a normal level. Carbidopa itself does not enterthe brain but is there to preventthe conversion of levodopa to dopamine outside the brain.This helps to reduce unwanted effects in other parts of the body.The controlled release tablets are generally used if therapy with the normal rapid release tablets orwith levodopa alone does not adequately control your symptoms.

WHAT YOU NEED TO KNOW BEFORE YOU TAKE CARAMET

Do NOT take Caramet:

• Ifyou are allergic (hypersensitive) to carbidopa, levodopa orany ofthe ingredients of this medicine • Ifyou sufferfrom narrow-angle glaucoma (increased pressure in the eye)

• Ifyou sufferfrom severe heart disease • Ifyouhavehadanacutestroke • Ifyou have ever suffered from skin cancer orthinkthat you may have skin cancer • Ifyou are taking or have recently taken medicines known as non-selective monoamine oxidase inhibitors (MAO inhibitors) and selective MAO-A inhibitors, used to treat depression, such as phenelzine, isocarboxazid or moclobemide. These medicines must be discontinued at leasttwo weeks before you start taking Caramet

• Ifyou sufferfrom hallucinations, delusions or mental confusion • Ifyouhaveanabnormalheartbeat • Ifyou knowthat youare not allowed to take sympathomimetic agents e.g. ephedrine (may be present in medicines for colds and nasal stuffiness), adrenaline or noradrenaline.

Warnings and precautions Talk to your doctor:

• Ifyou have previouslytaken levodopafor your illness, as this treatment should be stopped at least 12hours before you startto take Caramet, and you may be more prone to abnormal muscle movements at the beginning oftreatment • Ifyou have previously suffered from severe abnormal muscle movements or mental illness, including depression as you will need to be closely monitored by your doctor in case these symptoms return • Ifyou have heart or lung disease, asthma, kidney or liver problems • Ifyou have beentold byyourdoctorthat you have an endocrine (hormone) disturbance

• Ifyou havea historyofstomach ulcers, coughing up blood or fits • Ifyou have recently suffered a heart attack, as you will require more careful monitoring • Ifyou oryourfamily/carer notices youare developing urges or cravings to behave in ways that are unusual foryou oryou cannot resist the impulse, drive ortemptation 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 orspending,an abnormally high sex drive oran increase in sexual thoughts orfeelings.Your doctor may needto reviewyourtreatments.

Children and adolescents This medicine is not recommended for children and adolescents under 18 years of age.

Other medicines and Caramet:

• Medicines to lower blood pressure, such as an ACE inhibitor (e.g. captopril, enalapril), a thiazide (e.g. bendroflumethiazide), a beta-blocker (e.g. sotalol, propranolol), a calcium-channel blocker (e.g. verapamil), moxonidine or reserpine

• Tricyclicantidepressants, e.g. amitriptyline

• Medicines that help relax muscles and stop shaking, such as atropine sulphate, hyoscine butylbromide or papavarine

• Selegiline or entacapone, used to treat Parkinson's disease

• Amantadine (used to treat Parkinson's disease and viral infections)

• Metoclopramide (used to treat nausea and sickness)

• Sympathomimetic active substances e.g. adrenaline, noradrenaline, orephedrine. Ephedrine may be present in medicines for colds and nasal stuffiness

• Irontabletsforanaemia

• Phenytoin,usedinthetreatmentof epilepsy

• Monoamine oxidase inhibitors (MAOIs) used to treat depression e.g. phenelzine

• An anticholinergic agent (used to treat nerve impulses) e.g. trihexyphenidyl

• Ifyouarealsotakinga neuroleptic/antipsychotic medicinal product (used to treat mental illness) e.g. chlorpromazine

• Isoniazid.

Please also tell your doctor or pharmacist if you are taking or have recentlytaken any other medicines, including medicines obtained without a prescription.

Caramet with food and drink

Tell your doctor if you are on a high-protein

diet, as it may affect the effectiveness of

Caramet.

Caramet should be taken 30 minutes before a meal.

Pregnancy, breast-feeding and fertility

Do nottake Caramet ifyou are pregnant, planning to become pregnant or breast-feeding.

Women of child-bearing age must use a reliable form of contraception whilst taking Caramet.

Askyour doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Some people treated with Caramet may sufferfrom light-headedness or drowsiness and sudden onset ofsleepwithout any prior warning. If this side effect happens to you, you must not drive oroperate machinery. This applies until you are sure that these recurrent episodes orthe drowsiness have subsided.

© HOW TO TAKE CARAMET

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

The tablets should be swallowed whole, with a drinkofwater and be taken 30 minutes before a meal.

The usual dosage instructions are given below:

The number of tablets you should take each day will depend uponyourpersonal needs. Your doctorwill tell you how many tablets to take each day. During the first fewweeks your doctor may change your dose of Caramet until it is exactly right. It is important to followyour doctor's instructions carefully. Ifyou are not sure of anything, always askyour doctor.

Depending on your needs, the dosage may be as low as one prolonged-release tablet taken twice daily. Higher dosages should not normally exceed 8 tablets per day, taken in three or more divided doses, at intervals of between 4 and 12 hours.

If you are taking levodopa with another medicine,thistreatmentwill be discontinued at least 12 hours before starting treatment with Caramet.

Use in children and adolescents This medicine is not recommended for children and adolescents under 18 years of age.

If you take more Caramet than you should

Ifyou (or someone else) swallow a lot ofthe tablets all together, or ifyou think a child has swallowed any of the tablets, contact your nearest hospital casualty department or your doctor immediately.

If you forget to take Caramet Ifyou forget to take a dose,take it as soon as you remember, unless it is nearlytime to take the next one. Nevertake two doses together.Take the remaining doses at the correct time.

If you stop taking Caramet

You should continue to take these tablets for as long as your doctor tells you to. Do not stop taking your medicine unless yourdoctor tells you to. If this is the first time you are taking this type of medicine foryour symptoms, it may be upto 6 months before you can see the full benefit of your treatment. Ifyourtreatment is discontinued or reduced abruptlyyouwill require careful monitoring by yourdoctor.

Ifyou have anyfurther questions on the use of this product, askyour doctor or pharmacist.

Q POSSIBLE SIDE EFFECTS

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

If the following happens, stop taking Caramet and tell yourdoctor immediately or go to the casualty department at your nearest hospital:

• Feverand serious deterioration ofyour general condition

• An allergic reaction: swelling ofthe face, hands, feet, lips, tongue or throat, or difficulty in breathing orswallowing. This is a very serious but rare side effect. You may need urgent medical attention or hospitalisation.

The following side effects have been reported at the approximate frequencies shown: Common (affecting fewer than one person in 10 but more than one person in 100):

• Lossofappetite

• Hallucinations,confusion, light-headedness

• Nightmares, drowsiness, exhaustion

• Problemssleeping,depression

• Abnormalfeelingofwell-being

• Memory loss, periods of mental illness

• Abnormal muscle movements, including uncontrolled movements that seem to move around the body, abnormal muscle rigidity

• Impairment ofvoluntary movement i.e. tremors, tics, changes in muscle tone, slowness of movement, problems with speech

• Palpitations, irregular heart beat

• Problems with balance, feeling faint and fainting

• Nausea,vomiting, dry mouth and bitter taste in the mouth.

Uncommon (affecting fewer than one person in 100 but more than one person in 1,000):

• Weightlossorweightgain

• Lethargy, increased tremorand shaking in the hands

• High blood pressure

• Hoarseness,chestpain

• Constipation,diarrhoea,excess production of saliva

• Difficultyinswallowing,wind

• Generalised swelling

• Musclespasms

• Darkdiscolourationoftheurine

• Feeling of weakness, a general feeling of being unwell

• AnapparentworseningofParkinson symptoms ("flare-ups").

Rare (affecting fewer than one person in 1,000 but more than one person in 10,000):

• Agitation,fear, difficultythinking

• Blooddisorderswhichmaybe characterised by fever or chills, sore throat, ulcers inyour mouth orthroat, unusual tiredness or unusual bleeding or unexplained bruising

• Disorientation, headache, sluggishness, fits

• A reaction to an active substance characterised by fever, muscle rigidity, feeling dizzy or faint, tremor, drowsiness and confusion. Other symptoms can include fits and changes in heart rate

• Pins and needles and numbness,falling over, problems walking

• Restriction in the opening of the mouth, blurred vision, a dysfunction ofthe nerves in the face and around the eye which causes uncontrollable prolonged blinking

• Horner'ssyndromewhichcausesa constricted pupil, drooping eyelids and facial dryness

• Eye problems including double vision and dilation ofthe pupils in the eye

• lnflammationofavein(sometimes accompanied by a clot)

• Shortness of breath and other breathing problems

• Increasedsexualdesire

• Heartburn/indigestion, stomach pain, a dark discolouration of the saliva

• Teeth clenching, hiccups,stomach ulcers, darktarry stools, burning sensation in the mouth

• Nettle rash, itching, flushing, hair loss, redness and swelling

• Increased sweating, a darkdiscolouration of the sweat

• Activation ofskin cancer, a rash caused by inflammation and leaking of blood vessels

• Difficulty in passing urine or incontinence

• Serious, painful, persistenterection

• Pathological gambling (failure to resist gambling impulses despite serious personal orfamily consequences)

• Increasedsexdrive

• Hypersexuality (altered sexual interest and behaviour of significant concern to the patient or others)

• Uncontrollable excessive shopping or spending

• Binge eating (eating large amounts offood in a short time period) or compulsive eating (eating more food than normal and more than is needed to satisfyyour hunger).

Very rare (affecting fewer than one person in 10,000):

• Severe reduction in the numberofwhite blood cells, which makes infections more likely

• Extreme daytime drowsiness and sudden on-set ofsleep.

If any ofthe side effects get serious, ifyou notice any side effects not listed in this leaflet or ifyou experience any ofthese unusual behaviours mentioned before, please tell your doctoror pharmacist; they will discuss ways of managing or reducing the symptoms.

^5) HOWTO STORE CARAMET

Keep out ofthe reach and sight of children.

Do not take after the expiry date that is stated on the outer packaging.This medicinal product does not require any special storage instructions.

Do notthrow away any medicines via wastewater or household waste. Askyour pharmacist how to throw away medicines you no longer use.These measures will help protect the environment.

What Caramet contains:

• The active ingredients are levodopa and carbidopa

• Each 25 mg/100 mg prolonged-release tablet contains 100 mg of levodopa and 25 mg of carbidopa as carbidopa monohydrate

• Each 50 mg/200 mg prolonged-release tablet contains 200 mg of levodopa and 50 mg of carbidopa as carbidopa monohydrate

• Theotheringredientsare:

In the core: fumaric acid, hypromellose, sodium stearyl fumarate, colloidal silica anhydrous, and quinoline yellow (E104)

In the coating: hypromellose, macrogol, iron oxides (E172) and titanium dioxide (E171).

What Caramet looks like and contents of the pack:

• Caramet 25 mg/100 mg CR tablets are orange-brown, round, biconcave prolonged-release tablets • Caramet 50 mg/ 200 mg CR tablets are orange-brown, round, biconvex prolonged-release tablets • The 25 mg/100 mg product is available in pack sizes of 20,30,50, 60 & 100 tablets • The 50 mg/200 mg product is available in pack sizes of 20, 25,30, 60 & 100 tablets. Marketing Authorisation Holder and Manufacturer

The Marketing Authorisation holder isTEVA UK Limited, Eastbourne, BN22 9AG and the company responsible for manufacture is Pharmachemie B.V., Haarlem,The Netherlands.

This leaflet was last revised: October 2012

PL00289/0924-5.

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