Caramet® 25 mg/100 mg Prolonged-release Tablets – patient leaflet, side effects, dosage

WHAT CARAMET IS AND WHAT IT IS USED FOR

• Carament belongs to a class of drugs used to treat Parkinson’s disease. The symptoms of this disease are probably caused by a lack of dopamine a substance that is normally produced by the brain. Dopamine plays a role in controlling muscle movement. A lack of it causes problems in muscle movement. Levodopa compensates for the lack of dopamine, whilst carbidopa ensures that enough levodopa reaches the brain.
• Caramet is used in the treatment of Parkinson’s disease. It reduces the ‘off’ time (a sudden onset of muscle stiffness that can last for minutes or even hours) if you are being treated with levodopa alone, levodopa/decarboxylase inhibitor tablets with an immediate-release formulation (e.g. carbidopa) and if you suffer from sudden uncontrolled movements.

WHAT YOU NEED TO KNOW BEFORE YOU TAKE CARAMET

Do not take Caramet:

• if you are allergic to carbidopa, levodopa or any of the ingredients of this medicine (listed in section 6)
• if you 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 least two weeks before you start taking Caramet. Caramet may be co-administered with the recommended dose of a MAO inhibitor which is selective for MAO type B (e.g. selegiline)
• if you have suspicious, undiagnosed skin changes or a known history of melanoma, because levodopa can activate malignant melanoma
• if you suffer from narrow-angle glaucoma (increased pressure in the eye).

Warnings and precautions

Talk to your doctor before taking Caramet

• if you have a severe cardiovascular condition or have had an acute stroke
• if you have a severe lung disease or if you experience sudden attacks of breathlessness caused by muscular spasms and swelling of the mucous membrane inside the airways, often accompanied by coughing and the production of phlegm (bronchial asthma)
• if you have a kidney or liver disorder
• if you have problems with your endocrine system (glands that secrete hormones internally into the blood stream) such as hyperthyroidism (an overactive thyroid gland) or phaeochromocytoma (a tumour of the adrenal gland that causes hypertension)
• if you have ever had stomach or intestinal ulcers, as there is a greater risk of stomach bleeding
• if you have ever had seizures convulsions
• if you suffer from a fast heartbeat (tachycardia)
• if you have a severe disorder of the haematopoietic (blood-forming) system
• if you know that you are not allowed to take sympathomimetic agents e.g. ephedrine (may be present in medicines for colds and nasal stuffiness), epinephrine or norepinephrine
• if you have ever had a psychotic episode or suffered from psychosis. Psychosis is a severe mental illness whereby control over one’s own conduct and behaviour is impaired.
• if you have ever had a heart attack and you are still suffering from heart rhythm disorders
• if you are currently being, or have ever been, treated with levodopa on its own. You must wait for at least 12 hours before you can start taking Caramet
• if you suffer from chronic wide-angle glaucoma (increased eye pressure)
• if you have an hereditary disease characterised by sudden involuntary but coordinated movements (Huntington’s chorea). Use of Caramet is not recommended. Consult your doctor if during the treatment with Caramet
• you suffer from movement disorders such as facial muscle twitches, muscle rigidity and stiffness, difficulties in starting to move, trembling of the fingers or hands. It may be necessary to reduce the dose

• you are constantly tired and/or prone to falling asleep without warning. You must not drive or operate machines; your doctor will adjust your dose if necessary, or stop your treatment altogether

• you feel depressed, have suicidal thoughts, or notice unusual changes in your behaviour. Very rarely, there have been reports of patients who became depressed and who later developed suicidal tendencies. If you think that this also applies to you, you are advised to contact your doctor immediately
• are due to have surgery.

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

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. After many years of treatment with levodopa/carbidopa, sudden withdrawal or a reduction in Caramet can lead to levodopa withdrawal symptoms (known as malignant levodopa withdrawal syndrome or neuroleptic malignant syndrome). This applies especially when medicines for treating psychoses are being used at the same time. A very high fever, muscle stiffness, complete loss of movement and mental abnormalities can occur. These conditions are life-threatening. Contact a doctor immediately. Caramet may cause abnormalities in several laboratory tests. These include:

catecholamines, creatinine, uric acid, glucose, alkaline phosphatase, SGOT, SGPT, lactic acid dehydrogenase, bilirubin, blood urea nitrogen

• decreased haemoglobin and haemotocrit, elevated serum glucose and detection of white blood cells, bacteria and blood in the urine
• false positive result when a test strip is used to determine urinary ketone bodies (This reaction is not altered by boiling the urine sample.)
• false negative results in the examination of glycosuria with the use of glucose oxidase methods
• a false positive Coombs test

Notes on monitoring treatment

Checks on liver, heart, circulation and kidney function as well as blood counts need to be carried out at regular intervals.

In patients with a medical history of heart attacks, arrythmias (irregular heartbeat) or coronary ischaemia (reduced blood flow through the coronary arteries), circulation and ECG checks (measurement of current flows in the heart) should be carried out regularly. Patients with Parkinson's disease are at increased risk of developing malignant melanoma. Patients and relatives/carers should therefore check the skin often and regularly for signs of melanoma during treatment with Caramet. Ideally, regular skin examinations should be carried out be a dermatologist.

Patients with a previous history of peptic ulcers should also be kept under close medical observation. In the case of patients with glaucoma, regular checks of intraocular pressure are necessary.

It is important for you to attend all the follow-up appointments that your doctor arranges with you. Children and adolescents

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

Other medicines and Caramet

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes herbal medicines. This is because Caramet can affect the way some other medicines work. Also some other medicines can affect the way Caramet works. In particular tell your doctor or pharmacist if you are taking any of the following medicines:

• medicines used to treat high blood pressure; your doctor will need to adjust the dosage
• medicines used to treat depression (see also section ‘Do not take Caramet’)
• medicines that act on the central nervous system (anticholinergics; bronchodilators used in asthma), such as ipratropium and tiotropium. The effect of levodopa may be reduced; your doctor will adjust the dosage if necessary
• dopamine-depleting agents (e.g. reserpine, tetrabenazine)
• tolcapone and entacapone (COMT inhibitors used in Parkinson’s disease); when used at the same time as Caramet, the levels of levodopa reaching the brain may increase. The Caramet dose may need to be adjusted.
• selegiline (used to treat Parkinson’s disease); when used at the same time as Caramet, severe low blood pressure may occur
• amantadine (used to treat Parkinson’s disease). The side effects of levodopa may increase. The dosage of Caramet may need to be adjusted.
• medicines used to treat psychosis (e.g. phenothiazine, butyrophenones, risperodone)
• benzodiazepines (certain sleeping pills and tranquilisers), such as diazepam, oxazepam and lormetazepam; the effect of Caramet may be reduced
• isoniazid (used to treat tuberculosis)
• phenytoin (used in the treatment of epilepsy); the effect of Caramet may be reduced
• papavarine (used to treat spasms in the gastrointestinal tract); the effect of Caramet may be reduced
• opioids (used to treat severe pain)
• sympathomimetics such as epinephrine, norepinephrine, ephedrine, apraclonidine, dipivefrin and brimonidine. Cardiovascular-related side effects may increase.
• medicines containing ferrous sulphate or ferrous glouconate. Levodopa absorption may decrease.
• metoclopramide (used to treat nausea and sickness)
• anaesthetics (e.g. halothane, cyclopropane) Caramet with food and drink

The effect of levodopa can sometimes be impaired in patients on a high-protein diet.

Pregnancy, breast-feeding and fertility

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 any medicine. Any woman of childbearing potential who is receiving Caramet must practise effective contraception. Not enough is known about the use of Caramet during human pregnancies. It was shown to be harmful in animal experiments. Do not take Caramet if you are pregnant, or trying to conceive.

Levodopa is excreted into breast milk. You must therefore not breastfeed during treatment with Caramet. Driving and using machines

Caramet can cause side effects such as dizziness, drowsiness and double vision which may affect your ability to react.

What is in this leaflet

Package leaflet: Information for the user

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You should bear this in mind if you intend driving or using machines. Patients who are known to be prone to drowsiness and falling asleep without warning may not drive or use machines.

Caramet contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per prolonged-release tablet, that is to say essentially ‘sodium-free’.

HOW TO TAKE CARAMET

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.
• Take the tablets 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.

• Your doctor will tell you how long you must keep using Caramet. Do not stop treatment before you should; otherwise, your symptoms may return. Swallow the tablet whole with a glass of water 30 min before a meal or 90 min after a meal; do not break, chew or crush the tablet.

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 Caramet until it is exactly right. You may also be given Caramet 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 Caramet. If you take more Caramet 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. A spasm of the eyelid may be an early sign of overdose. If you forget to take Caramet

Do not take a double dose of Caramet to make up for a forgotten dose. If you have forgotten a dose, you can still take it unless it is almost time for your next dose. If this occurs, continue on your normal dosage schedule. If you stop taking Caramet

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 Caramet suddenly as this can cause muscle problems, fever and mental changes. When your doctor decides that you should stop taking Caramet 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 Caramet 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) (may affect up to 1 in 100 people),
  • itching, rash, swelling of your face, lips, tongue or throat. This may cause difficulty in breathing or swallowing. (may affect up to 1 in 1,000 people)
• mental changes including delusions, hallucinations, paranoia and depression (may affect up to 1 in 10 people). 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) (may affect up to 1 in 1,000 people)
• blood problems: the signs may include pale skin (pallor), tiredness, fever, chills, sore throat, ulcers in your mouth or throat, mild bruising and prolonged bleeding after injury. (may affect up to 1 in 1,000 people)
• bleeding from your gut which may be seen as blood in your faeces or darkened faeces (gastro-intestinal bleeding) (may affect up to 1 in 1,000 people)
• fits (convulsions). (may affect up to 1 in 1,000 people) Other side effects:

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

• urinary tract infections

Common (may affect up to 1 in 10 people)

• loss of appetite
• periods of mental illness, during which control over one's own conduct and behaviour is impaired (psychosis), dementia, abnormal feeling of well-being (euphoria), confusion, dizziness, nightmares, sleepiness, problems sleeping, light-headedness, increased drive
• movement disorders (dyskinesia)
• a disorder characterised by sudden involuntary movements (chorea)
• muscle tone disorder (dystonia)
• movement disorders caused from outside the nervous system (extrapyramidal)
• 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.
• headache, pins and needles (paraesthesia), fainting/tendency to faint, bitter taste in the mouth
• palpitations, irregular heartbeat

• a drop in blood pressure caused e.g. by getting up too quickly from a sitting or lying position, sometimes accompanied by dizziness (postural hypotension)

  • shortness of breath
  • constipation, diarrhoea, indigestion, nausea, vomiting, dry mouth
  • muscle cramps
  • chest pain, fatigue, feeling of weakness

Uncommon (may affect up to 1 in 100 people)

• weight loss or weight gain
• agitation, fear, disorientation
• difficulty thinking, ataxia, increased tremor and shaking in the hands
• high blood pressure
• hoarseness
• stomach pain, difficulty in swallowing, wind, excess production of saliva
• nettle rash
• dark discolouration of the urine
• problems walking, hot flushes, fluid accumulation (oedema), general feeling of being unwell (malaise)
• falling

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

• teeth clenching, increased sexual desire
• Horner’s syndrome which causes a constricted pupil, drooping eyelids and facial dryness
• numbness, restriction in the opening of the mouth (lockjaw)
• blurred vision, a dysfunction of the nerves in the face and around the eye which causes uncontrollable prolonged blinking
• eye problems including double vision and dilation of the pupils in the eye
• irregular movement of the eye (oculogyric crisis)
• facial redness, inflammation of a vein (sometimes accompanied by a clot)
• unusual breathing pattern
• dark discolouration of the saliva, burning tongue, ulcers in the duodenum, hiccups
• hair loss, dark discolouration of the sweat, increased sweating, itching, rash
• skin cancer
• in children, allergy-related bleeding in the skin and gastrointestinal tract wall (Schönlein-Henoch purpura)
• difficulty in passing urine or incontinence
• serious, painful, persistent erection

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

• extreme daytime drowsiness and sudden onset of sleep Not known (cannot be estimated from the available data)
• muscle twitching
• craving for large doses of Caramet in excess of that required to control motor symptoms, known as dopamine dysregulation syndrome. Some patients experience severe abnormal involuntary movements (dyskinesia), mood swings or other side effects after taking large doses of Caramet.

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

  • Pathological gambling (failure to resist gambling impulses despite serious personal or family consequences)
  • Increased sex drive
  • Hypersexuality (altered sexual interest and behaviour of significant concern to the patient or others)
  • 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; he/she will discuss ways of managing or reducing the symptoms.

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 Yellow Card Scheme Website:

www.mhra.gov.uk/yellowcard 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 CARAMET

Keep this medicine out of the sight and reach of children. Do not this medicine after the expiry date which is stated on the blister or carton after EXP. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

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 Caramet contains:

• The active substances 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

• The other ingredients are:

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

  In the tablet coating: hypromellose, macrogol, iron oxides yellow and red (E172) and titanium dioxide (E171). What Caramet looks like and contents of the pack:

• Caramet 25 mg/ 100 mg prolonged-release tablets are orange-brown, round, biconcave prolonged-release tablets
• The 25 mg/100 mg product is available in pack sizes of 20, 30, 50, 60 & 100 tablets

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

The Marketing Authorisation holder is Teva UK Limited, Ridings Point, Whistler Drive, Castleford, WF10 5HX, United Kingdom and the company responsible for manufacture is Acino Estonia, Jaama str 55b, Põlva, 63308 Põlva county, Estonia.

This leaflet was last revised in July 2025

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