Stalevo tablets contain three active ingredients, levodopa, carbidopa and entacapone. These are all medicines used in Parkinson's disease to increase the level of dopamine in the brain.
Dopamine is a substance known as a neurotransmitter. Neurotransmitters are found in the brain and nervous system and are involved in transmitting messages between nerves. These messages allow the normal functioning of the body. The neurotransmitter dopamine is known to be reduced or absent in the brains of people with Parkinson's disease, and this is thought to be the cause of the disease symptoms.
When you take levodopa, it is converted into dopamine in the brain. This replaces the lost dopamine and therefore reduces some of the symptoms of the disease.
Levodopa is also converted into dopamine in the rest of the body, which can cause unwanted side effects such as nausea and palpitations. An extra medicine called a dopa-decarboxylase inhibitor is therefore usually combined with levodopa treatment to prevent this happening. Dopa-decarboxylase inhibitors include the medicines carbidopa (found with levodopa in Sinemet) and benserazide (found with levodopa in Madopar). They block the conversion of levodopa to dopamine outside the brain and so prevent levodopa side effects on the rest of the body. (Carbidopa and benserazide cannot pass into the brain and so do not affect the conversion of levodopa to dopamine in the brain.)
Unfortunately levodopa treatment tends to become less effective over time, and patients tend to experience 'end-of-dose' deterioration, where the duration of benefit after each dose of levodopa becomes progressively shorter. Entacapone is used as an add-on treatment for Parkinson's disease because it prolongs the effect of levodopa.
Entacapone works by inhibiting the action of an enzyme in the body known as COMT. This enzyme normally breaks down levodopa that is left in the body after a dose so that the body can start to remove it. By stopping the action of this enzyme, entacapone increases the amount of levodopa that is available to pass into the brain with every dose of this medicine.
The three active ingredients have been combined in each tablet of this medicine to treat people with Parkinson's disease whose symptoms are not controlled by levodopa/carbidopa (Sinemet) or levodopa/benserazide (Madopar) alone, and who therefore need entacapone to increase the length of time the levodopa controls their symptoms. The medicine should make Parkinson's treatment simpler to remember and take, because all three active ingredients are contained in one tablet.
This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.
Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.
Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect.
The side effects listed above may not include all of the side effects reported by the drug's manufacturer.For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.
It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start treatment with this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while taking this one, to ensure that the combination is safe.
This medicine should not be taken at the same time as, or within two weeks of taking non-selective monoamine oxidase inhibitors (MAOIs), for example the antidepressants phenelzine, isocarboxazid and tranylcypromine, and the antibiotic linezolid. In addition it should not be taken in combination with BOTH a selective MAO-A inhibitor, eg moclobemide, AND a selective MAO-B inhibitor, eg selegiline or rasagiline, though it can be used with either of these on their own.
If this medicine is taken in combination with the MAO-B inhibitor selegiline, the daily selegiline dose should not exceed 10mg.
There may be an increased risk of dizziness when moving from a lying or sitting position to sitting or standing (postural hypotension) if this medicine is taken with other medicines that can have this effect, for example medicines to treat high blood pressure (antihypertensives). Your doctor may need to adjust the dose of your blood pressure medicine.
Iron reduces the absorption of this medicine from the gut. For this reason, if you are taking iron supplements such as ferrous sulphate, you should take them two to three hours before or after this medicine.
Entacapone may enhance the effect of warfarin. If you are taking warfarin your blood clotting time (INR) should be monitored when you start and stop treatment with this medicine.
The following medicines may reduce the effect of levodopa:
Tricyclic antidepressants (eg amitriptyline, imipramine) may decrease the therapeutic effects of this medicine, and may also rarely increase the risk of a dangerous rise in blood pressure (hypertensive crisis).
Anticholinergic medicines, eg procyclidine, atropine, hyoscine, propantheline, orphenadrine, benzhexol, may decrease the absorption of this medicine from the gut and reduce its therapeutic effect.
This medicine can be used with other medicines for Parkinsons disease, eg anticholinergics, amantadine or dopamine agonists, however both the desired effects and side effects of treatment may be intensified. Your doctor may need to adjust the dose of one or more of your medicines to get the correct balance to control your symptoms with minimum side effects.
There are currently no other medicines available in the UK that contain all three active ingredients that are in Stalevo tablets.
Sinemet contains levodopa and carbidopa alone.
Comtess contains entacapone alone.