Levodopa/Carbidopa/Entacapone Teva

Levodopa/Carbidopa/Entacapone Teva

carbidopa + levodopa + entacapone

Manufacturer:

Teva

Distributor:

KLN Pharma
Full Prescribing Info
Contents
Levodopa, carbidopa, entacapone.
Description
Levodopa/Carbidopa/Entacapone Teva Tablets contains three active substances (levodopa, carbidopa and entacapone) in one film-coated tablet.
Action
Parkinson's disease is caused by low levels of a substance called dopamine in the brain. Levodopa increases the amount of dopamine and hence reduces the symptoms of Parkinson's disease. Carbidopa and entacapone improve the antiparkinson effects of levodopa.
Indications/Uses
Levodopa/Carbidopa/Entacapone Teva Tablets is used for the treatment of Parkinson's disease.
Dosage/Direction for Use
Always take this medicine exactly as told by the doctor or pharmacist. Check with the doctor or pharmacist if unsure.
Adults and elderly: The doctor will prescribe exactly how many tablets of Levodopa/Carbidopa/Entacapone Teva Tablets to take each day.
The tablets are not intended to be split or broken into smaller pieces.
Only one tablet should be taken each time.
Depending on treatment response, the doctor may suggest a higher or lower dose.
Do not take more than 10 tablets per day (100/25/200 mg FC tab), or more than 7 tablets per day (200/50/200 mg FC tab).
Talk to the doctor or pharmacist if the effect of Levodopa/Carbidopa/Entacapone Teva Tablets may be too strong or too weak, or if any side effects are experienced.
Use in children and adolescents: Levodopa/Carbidopa/Entacapone Teva Tablets should not be used in children and adolescents under 18 years of age.
Forgotten intake of Levodopa/Carbidopa/Entacapone Teva Tablets: Do not take a double dose to make up for a forgotten tablet.
If it is more than 1 hour until the next dose: Take one tablet as soon as it is remembered, and the next tablet at the normal time.
If it is less than 1 hour until the next dose: Take a tablet as soon as it is remembered, wait 1 hour, then take another tablet. After that, carry on as normal.
Always leave at least an hour between Levodopa/Carbidopa/Entacapone Teva Tablets to avoid possible side effects.
Stopping intake of Levodopa/Carbidopa/Entacapone Teva Tablets: Do not stop taking Levodopa/Carbidopa/Entacapone Teva Tablets unless told to by the doctor. In such a case, the doctor may need to adjust the other antiparkinson medicines, especially levodopa, to give sufficient control of the symptoms. If suddenly stopping intake of Levodopa/Carbidopa/Entacapone Teva Tablets and other antiparkinsonian medicines, it may result in unwanted side effects.
Overdosage
If more Levodopa/Carbidopa/Entacapone Teva Tablets has been accidentally taken, talk to the doctor or pharmacist immediately. In case of an overdose, confusion or agitation may occur, the heart rate may be slower or faster than normal, or the colour of the skin, tongue, eyes or urine may change.
Contraindications
Do not take Levodopa/Carbidopa/Entacapone Teva Tablets if: allergic to levodopa, carbidopa or entacapone; with narrow-angle glaucoma (an eye disorder); with a tumour of the adrenal gland; taking certain medicines for treating depression (combinations of selective MAO-A and MAO-B inhibitors, or non-selective MAO inhibitors); with history of neuroleptic malignant syndrome (NMS, a rare reaction to medicines used to treat severe mental disorders); with history of non-traumatic rhabdomyolysis (a rare muscle disorder); with a severe liver disease.
Special Precautions
Talk to the doctor or pharmacist before taking Levodopa/Carbidopa/Entacapone Teva Tablets if with existing or history of: a heart attack or any other diseases of the heart including cardiac arrhythmias, or of the blood vessels; asthma or any other disease of the lungs; a liver problem, because the dose may need to be adjusted; kidney- or hormone-related diseases; stomach ulcers or convulsions; prolonged diarrhoea, as it may be a sign of inflammation of the colon; any form of severe mental disorder like psychosis; chronic wide-angle glaucoma, because the dose may need to be adjusted and the pressure in the eyes may need to be monitored.
Consult the doctor if currently taking: antipsychotics (medicines used to treat psychosis); a medicine which may cause low blood pressure when rising from a chair or bed [Levodopa/Carbidopa/Entacapone Teva Tablets may make these reactions worse].
Consult the doctor in case of the following during treatment with Levodopa/Carbidopa/Entacapone Teva Tablets: noticing that muscles get very rigid or jerk violently, or if tremors, agitation, confusion, fever, rapid pulse, or wide fluctuations in blood pressure occur [if any of this happens, contact the doctor immediately]; feeling depressed, having suicidal thoughts, or noticing unusual changes in behaviour; suddenly falling asleep, or feeling very drowsy [if this happens, do not drive or use any tools or machines (see also Driving and using machines as follows)]; noticing that uncontrolled movements begin or get worse after starting to take Levodopa/Carbidopa/Entacapone Teva Tablets [if this happens, the doctor may need to change the dose of the antiparkinson medicine]; experiencing diarrhoea [monitoring of weight is recommended in order to avoid potentially excessive weight loss]; experiencing progressive anorexia, asthenia (weakness, exhaustion) and weight decrease within a relatively short period of time [if this happens, a general medical evaluation including liver function should be considered]; feeling the need to stop using Levodopa/Carbidopa/Entacapone Teva Tablets (see Stopping intake of Levodopa/Carbidopa/Entacapone Teva Tablets under Dosage & Administration).
Tell the doctor if developing addiction-like symptoms leading to craving for large doses of Levodopa/Carbidopa/Entacapone Teva Tablets and other medicines used to treat Parkinson's disease.
Tell the doctor if developing urges or cravings to behave in ways that are unusual, or the impulse, drive or temptation to carry out certain activities that could be harmful cannot be resisted. These behaviours are called impulse control disorders and can include addictive gambling, excessive eating or spending, an abnormally high sex drive or a preoccupation with an increase in sexual thoughts or feelings. The doctor may need to review the treatments. The doctor may take some regular laboratory tests during a long-term treatment with Levodopa/Carbidopa/Entacapone Teva Tablets.
If undergoing surgery, tell the doctor that Levodopa/Carbidopa/Entacapone Teva Tablets is being used.
Levodopa/Carbidopa/Entacapone Teva Tablets is not recommended to be used for treatment of extrapyramidal symptoms (e.g. involuntary movements, shaking, muscle rigidity and muscle contractions) caused by other medicines.
Driving and using machines: Levodopa/Carbidopa/Entacapone Teva Tablets may lower blood pressure, which may cause lightheadedness or dizziness. Therefore, be particularly careful when driving or when using any tools or machines.
If feeling very drowsy, or if suddenly falling asleep sometimes, wait until feeling fully awake again before driving or doing anything else that requires alertness. Otherwise, there may be a risk of serious injury or death.
Use in Children: Experience with Levodopa/Carbidopa/Entacapone Teva Tablets in patients under 18 years is limited. Therefore, the use of Levodopa/Carbidopa/Entacapone Teva Tablets in children is not recommended.
Use In Pregnancy & Lactation
If pregnant or breast-feeding, possibly pregnant or planning to have a baby, ask the doctor or pharmacist for advice before taking this medicine. Do not breast-feed during treatment with Levodopa/Carbidopa/Entacapone Teva Tablets.
Side Effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Many of the side effects can be relieved by adjusting the dose.
If the following symptoms are experienced during treatment with Levodopa/Carbidopa/Entacapone Teva Tablets, contact the doctor immediately: Muscles get very rigid or jerk violently, or tremors, agitation, confusion, fever, rapid pulse, or wide fluctuations in blood pressure occur [these can be symptoms of neuroleptic malignant syndrome (NMS, a rare severe reaction to medicines used to treat disorders of the central nervous system) or rhabdomyolysis (a rare severe muscle disorder)]; Allergic reaction, the signs may include hives (nettle rash), itching, rash, swelling of face, lips, tongue or throat [this may cause difficulties in breathing or swallowing].
Very common (may affect more than 1 in 10 people): uncontrolled movements (dyskinesias); feeling sick (nausea); harmless reddish-brown discoloration of urine; muscle pain; diarrhoea.
Common (may affect up to 1 in 10 people): lightheadedness or fainting due to low blood pressure, high blood pressure; worsening of Parkinson's symptoms, dizziness, drowsiness; vomiting, abdominal pain and discomfort, heartburn, dry mouth, constipation; inability to sleep, hallucinations, confusion, abnormal dreams (including nightmares), tiredness; mental changes including problems with memory, anxiety and depression (possibly with thoughts of suicide); heart or artery disease events (e.g. chest pain), irregular heart rate or rhythm; more frequent falling; shortness of breath; increased sweating, rashes; muscle cramps, swelling of legs; blurred vision; anaemia; decreased appetite, decreased weight; feeling of weakness, fatigue; abnormal gait; headache, joint pain; urinary tract infection.
Uncommon (may affect up to 1 in 100 people): heart attack; bleeding in the gut; changes in blood cell count which may result in bleeding, abnormal liver function tests; convulsions; feeling agitated; psychotic symptoms; colitis (inflammation of the colon); discolourations other than urine (e.g. skin, nail, hair, sweat); swallowing difficulties; inability to urinate; feeling unwell.
The following side effects have also been reported: hepatitis (inflammation of the liver); itching.
The following side effects may be experienced: Craving for large doses of Levodopa/Carbidopa/Entacapone Teva Tablets 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 Levodopa/Carbidopa/Entacapone Teva Tablets]; 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 (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 hunger).
Tell the doctor if any of these behaviours are experienced; they will discuss ways of managing or reducing the symptoms.
Reporting of side effects: If any side effects are experienced, talk to the doctor, pharmacist or nurse. This includes any possible side effects not previously listed. By reporting side effects, more information can be provided on the safety of this medicine.
Drug Interactions
Other medicines and Levodopa/Carbidopa/Entacapone Teva Tablets: Tell the doctor or pharmacist if taking, have recently taken or might take any other medicines.
Do not take Levodopa/Carbidopa/Entacapone Teva Tablets if taking certain medicines for treating depression (combinations of selective MAO-A and MAO-B inhibitors, or non-selective MAO inhibitors).
Levodopa/Carbidopa/Entacapone Teva Tablets may increase the effects and side effects of certain medicines. These include: medicines used to treat depression such as moclobemide, amitriptyline, desipramine, maprotiline, venlafaxine and paroxetine; rimiterol and isoprenaline, used to treat respiratory diseases; adrenaline, used for severe allergic reactions; noradrenaline, dopamine and dobutamine, used to treat heart diseases and low blood pressure; alpha-methyldopa, used to treat high blood pressure; apomorphine, used to treat Parkinson's disease.
The effects of Levodopa/Carbidopa/Entacapone Teva Tablets may be weakened by certain medicines. These include: dopamine antagonists, used to treat mental disorders, nausea and vomiting; phenytoin, used to prevent convulsions; papaverine, used to relax the muscles.
Levodopa/Carbidopa/Entacapone Teva Tablets may make it harder to digest iron. Therefore, do not take Levodopa/Carbidopa/Entacapone Teva Tablets and iron supplements at the same time. After taking one of them, wait at least 2 to 3 hours before taking the other.
Levodopa/Carbidopa/Entacapone Teva Tablets with food and drink: Levodopa/Carbidopa/Entacapone Teva Tablets may be taken with or without food. For some patients, Levodopa/Carbidopa/Entacapone Teva Tablets may not be well absorbed if it is taken with, or shortly after eating protein-rich food (such as meats, fish, dairy products, seeds and nuts).
Caution For Usage
Do not throw away any medicines via wastewater or household waste. Ask the pharmacist how to throw away medicines no longer used. These measures will help protect the environment.
MIMS Class
Antiparkinsonian Drugs
ATC Classification
N04BA03 - levodopa, decarboxylase inhibitor and COMT inhibitor ; Belongs to the class of dopa and dopa derivative dopaminergic agents. Used in the management of Parkinson's disease.
Presentation/Packing
Form
Levodopa/Carbidopa/Entacapone Teva 100/25/200 mg FC tab
Packing/Price
100's
Form
Levodopa/Carbidopa/Entacapone Teva 200/50/200 mg FC tab
Packing/Price
100's
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