Comtess 200 mg film-coated tablets
Entacapone
Read all of this leaflet carefully before you start taking this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
- 1. What Comtess is and what it is used for
- 2. Before you take Comtess
- 3. How to take Comtess
- 4. Possible side effects
- 5. How to store Comtess
- 6. Further information
What Comtess Is And What It Is Used For
Comtess is used together with levodopa to treat Parkinson’s disease. Comtess improves the therapeutic effect of levodopa in relieving the symptoms of Parkinson's disease. Comtess has no antiparkinsonian activity without levodopa.
Before You Take Comtess
Do not take Comtess
- if you are allergic (hypersensitive) to entacapone or any of the other ingredients of Comtess;
- if you have a tumour of the adrenal gland (known as pheochromocytoma; this may increase the risk of severe high blood pressure);
- if you are taking certain antidepressants (ask your doctor or pharmacist whether your antidepressive medicine can be taken together with Comtess);
- if you have liver disease;
- if you have ever suffered from a rare reaction to antipsychotic medicines called neuroleptic malignant syndrome (NMS) and/or a rare muscle disorder called non-traumatic rhabdomyolysis.
Take special care with Comtess
- if you are taking a medicine which may cause low blood pressure when rising from a chair or bed;
- if you experience diarrhoea, monitoring of your weight is recommended in order to avoid potentially excessive weight loss;
- if you experience excessive gambling or excessive sexual activity.
- if you experience progressive anorexia, asthenia (weakness, exhaustion) and weight decrease within a relatively short period of time, a general medical evaluation including liver function should be considered.
The dose of other antiparkinsonian medicines may need to be adjusted when you start taking Comtess. Follow the instructions that your doctor has given you.
Entacapone taken with levodopa may cause drowsiness and may cause you to sometimes suddenly fall asleep. If this happens, you should not drive or use any tools or machines (see section ”Driving and using machines”).
There have been isolated cases of neuroleptic malignant syndrome (NMS), especially when treatment with both entacapone and other dopaminergic medicines has been abruptly discontinued or reduced. For the characteristics of NMS see section 4. Your doctor may advise you to slowly discontinue the treatment with entacapone and other dopaminergic medicines.
Children
Experience with Comtess in patients under 18 years is limited. Therefore, the use of Comtess in children cannot be recommended.
Taking other medicines
Comtess may increase the effects of other medicinal products (e.g. those containing rimiterol, isoprenaline, adrenaline, noradrenaline, dopamine, dobutamine, alpha-methyldopa, and apomorphine). Please tell your doctor or pharmacist if you are taking or have recently taken other medicines, including medicines obtained without a prescription or herbal medicines.
Comtess may make it harder for you to digest iron. Therefore, do not take Comtess and iron supplements at the same time. After taking one of them, wait at least 2 to 3 hours before taking the other.
Pregnancy and breast-feeding
Do not use Comtess during pregnancy or if you are breast-feeding.
Driving and using machines
Comtess taken together with levodopa may lower your blood pressure, which may make you feel light-headed or dizzy. Be particularly careful when you drive or when you use tools or machinery.
Comtess taken with levodopa may make you feel very drowsy, or cause you to sometimes find yourself suddenly falling asleep. If this happens, you must not drive or do anything else that requires you to be alert (e.g. using tools or machines) until you are clear of such problems. Otherwise you may put yourself and others at risk of serious injury or even death.
How To Take Comtess
Always take Comtess exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Comtess is taken together with preparations containing levodopa (either levodopa/carbidopa preparations or levodopa/benserazide preparations). You may also use other antiparkinsonian medicines at the same time.
The usual dose of Comtess is one 200 mg tablet with each levodopa dose. If you are receiving dialysis for renal insufficiency, your doctor may tell you to extend the interval between doses. The maximum recommended dose is 10 tablets per day, i.e. 2,000 mg of Comtess.
If you take more Comtess than you should
In the event of an overdose, consult your doctor or the nearest hospital immediately.
If you forget to take Comtess
If you forget to take the Comtess tablet with your levodopa dose, you should continue the treatment by taking the next Comtess tablet with your next levodopa dose.
Do not take a double dose to make up for a forgotten tablet.
If you stop taking Comtess
Do not stop taking Comtess unless your doctor tells you to. In such a case your doctor may need to re-adjust the dosage of your other antiparkinsonian medicines. Abrupt discontinuation of both Comtess and other antiparkinsonian medicines may result in unwanted side effects.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible Side Effects
Like all medicines, Comtess can cause side effects, although not everybody gets them. Usually side effects caused by Comtess are mild to moderate.
The frequencies are defined as:
Very common (affects more than 1 patient in 10)
Common (affects 1 to 10 patients in 100)
Uncommon (affects 1 to 10 patients in 1,000)
Rare (affects 1 to 10 patients in 10,000)
Very rare (affects less than 1 patient in 10,000)
Not known (frequency cannot be estimated from the available data).
Very common
Uncontrollable movements (dyskinesias), feeling sick (nausea) and harmless reddish-brown discoloration of urine.
Common
Uncontrollable movements (hyperkinesias), being sick (vomiting), worsening of symptoms of Parkinson’s disease, dizziness, diarrhoea, abdominal pain, constipation, dry mouth, hallucinations (seeing/hearing/feeling/smelling things that are not really there), prolonged muscle contractions (dystonia), tiredness, increased sweating, sleeplessness, vivid dreams, fall and confusion.
Rare
Rashes and abnormal results in liver function test.
Very rare
Mental restlessness, decreased appetite, weight decrease, hives.
The exact frequencies of these side effects are not known but are based on reports received since the product has been on the market: colitis (inflammation of the colon), hepatitis and skin, hair, beard and nail discolorations.
The side effects are often caused by the increased effects of levodopa therapy and are most common at the start of treatment. Some, such as uncontrollable movements, nausea and abdominal pain, may also be more common with higher doses (1,400 to 2,000 mg per day). If you experience such effects at the start of treatment with Comtess you should contact your doctor, who may decide to adjust your dosage of levodopa.
Excessive daytime drowsiness has been reported in rare cases in patients receiving Comtess with levodopa and there have been isolated cases of sudden sleep onset episodes.
A few cases of neuroleptic malignant syndrome (NMS) and rhabdomyolysis have been reported. NMS is a rare severe reaction to medicines used to treat disorders of the central nervous system and characterised by stiffness, muscle twitching, shaking, mental changes, coma, high body temperature, increased heart rate, and unstable blood pressure. Rhabdomyolysis is a rare severe muscle disorder.
Behavioural changes such as urge to gamble (pathological gambling) or increased sexual desire and urges (increased libido and hypersexuality) have been reported in patients receiving dopaminergic medicines including Comtess with levodopa.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
How To Store Comtess
Keep out of the reach and sight of children.
Do not use Comtess after the expiry date which is stated on the carton and on the bottle label. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
Further Information
What Comtess contains
- The active substance is entacapone. Each tablet contains 200 mg of entacapone.
- The other ingredients in the tablet core are microcrystalline cellulose, croscarmellose sodium, povidone and magnesium stearate.
- The film-coating contains partly hydrolysed polyvinyl alcohol, talc, macrogol, soybean lecithin, yellow iron oxide (E 172), red iron oxide (E 172) and titanium dioxide (E 171).
What Comtess looks like and contents of the pack
Comtess 200 mg film-coated tablets are brownish-orange, oval tablets with "COMT" engraved on one side. They are packed in bottles.
There are four different pack sizes (bottles containing 30, 60, 100 or 175 tablets). Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer:
For further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
This leaflet was last approved on 05 August 2009
Detailed information on this medicine is available on the European Medicine’s Agency (EMEA) web site: http://www.emea.europa.eu
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