Carbi-Levo 25 mg/100 mg/250 mg Tablets

CARBI-LEVO TEVA is 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. Ask your doctor or pharmacist if you need additional information.

Do not take CARBI-LEVO TEVA:

• if you are hypersensitive (allergic) to carbidopa or levodopa or any of the ingredients of CARBI-LEVO TEVA
• if you are pregnant, intending to become pregnant or breastfeeding
• if you are taking any medicines known as ‘monoamine oxidase inhibitors’ (which are used to treat depression) such as phenelzine, tranylcypromine or moclobemide
• if you have narrow-angle glaucoma (that may cause a sudden build-up of pressure in the eye)
• if you ever suffered from skin cancer or think that you may have skin cancer
• if you have heart disease
• if you have any severe mental disorders.

Warnings and precautions:

Take special care with CARBI-LEVO TEVA:

• CARBI-LEVO TEVA should not be used for the treatment of medicine induced effects such as tremor, slurred speech, anxiety or distress.
• Inform your doctor if you have sudden sleep attacks or sometimes feel very sleepy.
• Inform your doctor if you are taking levodopa (a medicine used in the treatment of Parkinson’s disease) or if you have experienced involuntary movements with levodopa treatment.
• If you suffer from open-angle glaucoma; severe heart or lung disease; asthma; kidney, liver or endocrine (gland) disease; or a history of stomach or intestinal ulceration, vomiting blood.
• If you have a history of heart disease.
• If you have a history of seizures (fits).
• If you suffer from diabetes, your blood sugar needs to be monitored and your diabetic medicine dose might be adjusted.
• If you suffer from psychiatric disturbances or psychosis (mental disorders).
• If you experience a form of low blood pressure which causes dizziness on standing-up quickly.
• Tell your doctor if you or your family/care giver notices you are developing addiction-like symptoms leading to cravings for large doses of CARBI-LEVO TEVA and other medicines used to treat Parkinson’s disease.
• Tell your doctor if you or your family/care giver 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 CARBI-LEVO TEVA treatment.
• Your liver, heart and kidney functions should be tested periodically.
• You should not stop taking CARBI-LEVO TEVA without consulting your medical practitioner.

Other medicines and CARBI-LEVO TEVA:

Always tell your healthcare provider if you are taking any other medicine. If you are pregnant or breastfeeding your baby please consult your healthcare provider for advice before taking CARBI-LEVO TEVA. (This includes complementary or traditional medicines.)

Monoamine oxidase inhibitors used in the treatment of depression (e.g. moclobemide) should be discontinued at least 2 weeks prior to initiating therapy with CARBI-LEVO TEVA.

Tell your doctor if you are taking:

• medicines used to treat high blood pressure e.g. reserpine
• tricyclic antidepressant medicine (e.g. amitriptyline, clomipramine, imipramine)
• iron supplements
• antipsychotic medicine called phenothiazines (chlorpromazine, promazine) and butyrophenones (e.g. haloperidol, droperidol)
• isoniazid a medicine used to treat TB (tuberculosis)
• seizure (fits) treatment such as phenytoin and papaverine
• anticholinergic medicines (such as orphenadrine, trihexyphenidyl, benzatropine and procyclidine), since your dose may need to be changed.

CARBI-LEVO TEVA can affect some blood tests performed by laboratories; inform your medical practitioner that you are taking CARBI-LEVO TEVA if you are to undergo blood tests.

Do not share medicines prescribed for you with any other person. Always take CARBI-LEVO TEVA exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure. The tablets should be swallowed with a drink of water.

The usual dosage instructions are given below:

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 CARBI-LEVO TEVA until it is exactly right. It is important to follow your doctor's instructions carefully. If you are not sure of anything, always ask your doctor.

Depending on your needs, the dosage may be as low as one tablet a day or every other day, or as high as eight tablets of CARBI-LEVO 25/250 TEVA a day. If you are taking levodopa with another medicine, this treatment will be discontinued at least 12 hours before starting treatment with CARBI-LEVO TEVA. You should continue to take CARBI-LEVO TEVA for as long as your doctor tells you to. If you have the impression that the effect of CARBI-LEVO TEVA is too strong or too weak, tell your doctor or pharmacist.

If you take more CARBI-LEVO TEVA than you should:

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre.

If you forget to take a dose of CARBI-LEVO TEVA:

If you forget to take a tablet, take one as soon as you remember, unless it is nearly time to take the next one. Never take two doses together. Take the remaining doses at the correct time.

If you stop taking CARBI-LEVO TEVA:

Do not stop taking CARBI-LEVO TEVA or change your dose without checking with your doctor. When you stop taking CARBI-LEVO TEVA the following symptoms can occur: muscle stiffness, high temperature (fever) and mental changes.

CARBI-LEVO TEVA can have side effects. Not all side effects reported for CARBI-LEVO TEVA are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking CARBI-LEVO TEVA, please consult your healthcare provider for advice.

If any of the following happens, stop taking CARBI-LEVO TEVA and tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of the hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing
• rash or itching.

These are all very serious side effects. If you have them, you may have had a serious reaction to CARBI-LEVO TEVA. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• chest pain, irregular heartbeat or palpitations
• dizziness on standing up quickly
• bleeding from your gut which may be seen as blood in your faeces or darkened faeces (gastro-intestinal bleeding)
• blood problems, the signs may include pale skin (pallor), tiredness, fever, sore throat or mild bruising and prolonged bleeding after injury
• stiff muscles, high fever
• mental changes including delusions, hallucinations and depression
• fits (convulsions)
• abnormal movements such as twitching or spasms
• abnormal involuntary tight closure of the eyelids
• changed patches of pigmented skin, including irritated or irregular moles, or moles in which you have noticed changes (melanoma).

These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following which may occur frequently:

• urinary tract infections (bladder infections)
• loss of appetite
• confusion, nightmares, abnormal thinking, hallucinations, depression with or without suicidal behaviour, difficulty sleeping, changes in your mood or thoughts, tiredness
• dizziness, headache, feeling of pins and needles, loss of control over voluntary movements
• fainting
• shortness of breath
• nausea (feeling sick), vomiting, stomach pain, constipation, loose stools, dry mouth, heartburn, teeth grinding
• muscle cramps
• weakness, feeling ill.

Tell your doctor if you notice any of the following which may occur less frequently:

• weight loss or weight gain
• agitation, anxiety, fear, disorientation, aggression, paranoia, delirium, confusion, increased sex drive, lethargy, compulsive gambling, compulsive spending/shopping, excessive eating
• falling, abnormal walking patterns, sleepiness (including excessive drowsiness or sudden sleep onset episodes), numbness, increased hand tremor, muscle twitching, irregular movement of jaw muscles resulting in difficulty opening the mouth
• blurred vision, irregular movement of the eye
• hot flushes, high blood pressure (with symptoms such as headaches and dizziness)
• irregular breathing pattern, hoarseness
• bitter taste, hiccups, burning sensation of the tongue, dark saliva, difficulty swallowing, flatulence, increased saliva
• increased sweating, itching, hair loss, dark sweat
• difficulty passing urine or incontinence (inability to control urine flow), discoloured urine
• persistent abnormal erection of the penis.

Tell your doctor if you notice any of the following which may also occur:

• cravings for large doses of CARBI-LEVO TEVA 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 CARBI-LEVO TEVA.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects: If you get any side effects, talk to your doctor or pharmacist. You can also report side effects to SAHPRA via the 6.04 Adverse Drug Reaction Reporting Form, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of CARBI-LEVO TEVA.

Do not use after the expiry date shown on the pack. Store at or below 25 °C and keep the tablets in the package or container supplied. Do not transfer them to another container. Return all unused medicines to your pharmacist for safe disposal. STORE ALL MEDICINES OUT OF REACH OF CHILDREN. Do not store in a bathroom. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).