Co-careldopa tablets 25/100 – patient leaflet, side effects, dosage

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.

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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 a contraindication for sympathomimetics, e.g. epinephrine (used for anaphylactic shocks and cardiac arrest) and isoprenaline (used for cardiac arrest and bronchospasms)

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

Warnings and precautions

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

• if you have a severe condition affecting your heart and blood circulation
• 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 had kidney or liver disorder
• if you have problems with your endocrine system (glands that secrete hormones internally into the blood stream)
• if you have had an ulcer in your gut (called ‘duodenal’ or ‘peptic ulcer’) or have vomited blood
• if you have a history of fits (convulsions)
• if you have ever had depression or other mental problems
• if you have ever had a heart attack and you are still suffering from heart rhythm disorders
• if you suffer from 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 have an hereditary disease characterised by sudden involuntary but coordinated movements (Huntington’s chorea). Use of Co-Careldopa is not recommended.
• if you experienced extrapyramidal symptoms (e.g. involuntary movements, shaking, muscle rigidity and muscle contractions) caused by other medicines. Use of Co-Careldopa is not recommended. Consult your doctor if during the treatment with Co-Careldopa:
• you 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
• 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
• you find yourself suddenly falling asleep, or if you feel very drowsy. If this happens, you must not drive or use any tools or machines (see also section ‘Driving and using machines’)
• you feel depressed, have suicidal thoughts, or notice unusual changes in your behaviour. If you think that this also applies to you, you are advised to contact your doctor immediately
• you 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 Co-Careldopa 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.

Don’t stop or reduce your levodopa/carbidopa dose on your own, particularly if you are receiving medicines to treat psychosis. This may lead to very high fever, muscle rigidity and a change in your mental condition; symptoms resembling a malignant neuroleptic syndrome. If any of this happens, contact your doctor immediately.

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.

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 used to treat high blood pressure; your doctor may need to adjust the dosage
• medicines used to treat depression (see also section ‘Do not take Co-Careldopa ’)

• medicines that act on the central nervous system (anticholinergics; such as orphenadrine, trihexyphenidyl,

  benzatropine and procyclidine). The effect of levodopa may be reduced; your doctor may adjust the dosage

• medicines to treat low iron. Your dose may need to be changed.
• selegiline (used to treat Parkinson’s disease); when used at the same time as Co-Careldopa, severe low blood pressure may occur

• 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 used to treat psychosis (e.g. phenothiazine, butyrophenones, risperidone)
• medicines to treat difficulty in falling asleep or sleeping through (benzodiazepines).
• isoniazid (used to treat tuberculosis)
• phenytoin (used in the treatment of epilepsy); the effect of Co-Careldopa may be reduced
• papaverine (used to treat impotence in men), the effect of Co-Careldopa may be reduced
• dopamine-depleting agents (e.g. reserpine, tetrabenazine)
• metoclopramide (used to treat nausea and sickness)

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. Co-Careldopa should not be used during pregnancy, unless your doctor considers it strictly necessary.

Levodopa is excreted into breast milk. You must therefore not breastfeed during treatment with Co-Careldopa.

Driving and using machines

Co-Careldopa affects different people in different ways. Some people have side effects, such as dizziness, confusion or drowsiness, 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. Otherwise, you may put yourself or others at risk of serious injury or death. Your doctor will tell you if you can start driving again if these attacks stop.

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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.

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

If you are currently being treated with other medicines containing levodopa, you must wait for at least 12 hours (24 hours for

prolonged-release products) before you can start taking 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. A spasm of the eyelid may be an early sign of overdose. 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.

(Schönlein-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:

  • 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)

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

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

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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 (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, sore throat or 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 that may occur:

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
• 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
• ulcer in the duodenum, the part of the gut leading out of the stomach
• flushing, increased sweating, hair loss, dark sweat

• in children, allergy-related bleeding in the skin and gastrointestinal tract wall

  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: http://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.

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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 carton and blister/bottle 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.

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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, Ridings Point, Whistler Drive, Castleford, WF10 5HX, United Kingdom

Manufacturer

TEVA Pharmaceutical Works Private Limited Company

Pallagi Street 13, Debrecen, H-4042, Hungary This leaflet was last revised July 2023.

PL 00289/0783-5

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