Stalevo 50 mg/12.5 mg/200 mg film-coated tablets
Levodopa/carbidopa/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 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 Stalevo is and what it is used for
2. Before you take Stalevo
3. How to take Stalevo
4. Possible side effects
5 How to store Stalevo
6. Further information
What Stalevo Is And What It Is Used For
Stalevo contains three active substances (levodopa, carbidopa and entacapone) in one film-coated tablet. Stalevo is used for the treatment of Parkinson’s disease.
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.
Before You Take Stalevo
Do not take Stalevo if you
- are allergic (hypersensitive) to levodopa, carbidopa or entacapone, or any of the other ingredients of Stalevo
- have narrow-angle glaucoma (an eye disorder)
- have a tumour of the adrenal gland
- are taking certain medicines for treating depression (combinations of selective MAO-A and MAO-B inhibitors, or non-selective MAO-inhibitors)
- have ever had neuroleptic malignant syndrome (NMS – this is a rare reaction to medicines used to treat severe mental disorders)
- have ever had non-traumatic rhabdomyolysis (a rare muscle disorder)
- have a severe liver disease.
Take special care with Stalevo
Consult your doctor if you have or have ever had:
- a heart attack or any other diseases of the heart including cardiac arrythmias, or of the blood vessels
- asthma or any other disease of the lungs
- a liver problem, because your dose may need to be adjusted
- kidney or hormone-related diseases
- tomach ulcers or convulsions
- if you experience prolonged diarrhoea consult your doctor as it may be a sign of inflammation of the colon
- any form of severe mental disorder like psychosis
- chronic wide-angle glaucoma, because your dose may need to be adjusted and the pressure in your eyes may need to be monitored.
Consult your doctor if you are currently taking:
- antipsychotics (medicines used to treat psychosis)
- a medicine which may cause low blood pressure when rising from a chair or bed. You should be aware that Stalevo may make these reactions worse.
Consult your doctor if during the treatment with Stalevo 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
- feel depressed, have suicidal thoughts, or notice unusual changes in your behaviour
- find yourself suddenly falling asleep, or if you feel very drowsy. If this happens, you should not drive or use any tools or machines (see also section 'Driving and using machines')
- notice that uncontrolled movements begin or get worse after you started to take Stalevo. If this happens, your doctor may need to change the dose of your antiparkinson medicine
- experience diarrhoea: monitoring of your weight is recommended in order to avoid potentially excessive weight loss
- experience 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
- experience excessive gambling or excessive sexual activity
- feel the need to stop using Stalevo, see section 'If you stop taking Stalevo'.
Your doctor may take some regular laboratory tests during a long term treatment with Stalevo.
If you must undergo surgery, please tell your doctor that you are using Stalevo.
Stalevo 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.
Children
Experience with Stalevo in patients under 18 years is limited. Therefore, the use of Stalevo in children is not recommended.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription and herbal medicines.
Do not take Stalevo if you are taking certain medicines for treating depression (combinations of selective MAO-A and MAO-B inhibitors, or non-selective MAO inhibitors).
Stalevo may increase the effects and side effects of certain medicines. These include:
- medicines used to treat depression such as moclobemide, amitryptiline, desipramine, maprotiline, venlafaxine and paroxetine
- rimiterole 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, which is used to treat Parkinson’s disease.
The effects of Stalevo 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.
Stalevo may make it harder for you to digest iron. Therefore, do not take Stalevo and iron supplements at the same time. After taking one of them, wait at least 2 to 3 hours before taking the other.
Taking Stalevo with food and drink
Stalevo may be taken with or without food. For some patients, Stalevo 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). Consult your doctor if you think this applies to you.
Pregnancy and breast-feeding
If you are pregnant or think you may be pregnant, consult your doctor before taking Stalevo.
You should not breast-feed during treatment with Stalevo.
Driving and using machines
Stalevo may lower your blood pressure, which may make you feel light-headed or dizzy. Therefore, be particularly careful when you drive or when you use any tools or machines.
If you feel very drowsy, or if you sometimes find yourself suddenly falling asleep, wait until you feel fully awake again before driving or doing anything else that requires you to be alert. Otherwise, you may put yourself and others at risk of serious injury or death.
Important information about some of the ingredients of Stalevo
Stalevo contains sucrose (1.2 mg/tablet). If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicinal product.
How To Take Stalevo
Always take Stalevo exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
For adults and elderly:
- Your doctor will tell you exactly how many tablets of Stalevo to take each day.
- The tablets are not intended to be split or broken into smaller pieces.
- You should take only one tablet each time.
- Depending on how you respond to treatment, your doctor may suggest a higher or lower dose.
- If you are taking Stalevo 50 mg/12.5 mg/200 mg, 75 mg/18.75 mg/200 mg, 100 mg/25 mg/200 mg, 125 mg/31.25 mg/200 mg or 150 mg/37.5 mg/200 mg tablets, do not take more than 10 tablets per day.
Talk to your doctor or pharmacist if you think the effect of Stalevo is too strong or too weak, or if you experience possible side effects
If you take more Stalevo than you should
If you have accidentally taken more Stalevo tablets than you should, talk to your doctor or pharmacist immediately.
If you forget to take Stalevo
Do not take a double dose to make up for a forgotten tablet.
If it is more than 1 hour until your next dose:
Take one tablet as soon as you remember, and the next tablet at the normal time.
If it is less than 1 hour until your next dose:
Take a tablet as soon as you remember, wait 1 hour, then take another tablet. After that carry on as normal.
Always leave at least an hour between Stalevo tablets, to avoid possible side effects.
If you stop taking Stalevo
Do not stop taking Stalevo unless your doctor tells you to. In such a case your doctor may need to adjust your other antiparkinson medicines, especially levodopa, to give sufficient control of your symptoms. If you suddenly stop taking Stalevo and other antiparkinsonian medicines it may result in unwanted side effects.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Stalevo 50/12.5/200mg Side Effects
Like all medicines, Stalevo can cause side effects, although not everybody gets them. If you experience any of these side effects, talk to your doctor as soon as possible. Many of the side effects can be relieved by adjusting the dose.
The frequencies are defined as:
Very common (affects more than 1 user in 10)
Common (affects 1 to 10 users in 100)
Uncommon (affects 1 to 10 users in 1,000)
Rare (affects 1 to 10 users in 10,000)
Very rare (affects less than 1 user in 10,000)
Not known (frequency cannot be estimated from the available data).
Very common
- uncontrolled movements (dyskinesias), worsening of Parkinson’s symptoms
- feeling sick (nausea)
- harmless reddish-brown discoloration of urine
Common
- light-headedness or fainting due to low blood pressure
- dizziness, drowsiness, tingling or numbness
- vomiting, abdominal pain, dry mouth, constipation, diarrhoea
- inability to sleep, hallucinations, confusion, nightmares, feeling agitated, tiredness
- mental changes – including paranoid and psychotic symptoms, depression (possibly with thoughts of suicide) and problems with memory or thinking
- heart or artery disease events (e.g. chest pain), irregular heart rate or rhythm
- more frequent falling
- shortness of breath
- increased sweating, itching and rashes
- muscle cramps
- vision disturbances
Uncommon
- heart attack
- loss of appetite, weight loss or gain, bleeding in the gut, duodenal ulcers
- high blood pressure
- changes in the blood cell count (which may result in symptoms such as tiredness, fainting, infections, bleeding)
- inflammation of the veins in the legs
- convulsions
The following side effects have also been reported:
- colitis (inflammation of the colon)
- hepatitis (inflammation of the liver)
- skin, hair, beard and nail discolorations
If you during the treatment with Stalevo experience the following symptoms, contact your doctor immediately:
- Your muscles get very rigid or jerk violently, you get tremors, agitation, confusion, fever, rapid pulse, or wide fluctuations in your blood pressure. 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 your face, lips, tongue or throat. This may cause difficulties in breathing or swallowing.
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 dopamine replacement therapy including Stalevo.
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.
How To Store Stalevo
Keep out of the reach and sight of children.
Do not use after the expiry date which is stated on the bottle and the carton after EXP. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Further Information
What Stalevo contains
- The active substances of Stalevo are levodopa, carbidopa and entacapone.
- Each Stalevo 50 mg/12.5 mg/200 mg tablet contains 50 mg of levodopa, 12.5 mg of carbidopa and 200 mg of entacapone.
- The other ingredients in the tablet core are croscarmellose sodium, magnesium stearate, maize starch, mannitol (E421) and povidone (E1201)
- The ingredients in the film-coating are glycerol (85 per cent) (E422), hypromellose, magnesium stearate, polysorbate 80, red iron oxide (E172), sucrose, titanium dioxide (E171), and yellow iron oxide (E172).
What Stalevo looks like and contents of the pack
Stalevo 50 mg/12.5 mg/200 mg: brownish or greyish red, round, convex unscored film-coated tablets marked with ‘LCE 50’ on one side.
Stalevo comes in six different pack sizes (10, 30, 100, 130, 175 or 250 tablets). Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
This leaflet was last approved on 2 June 2010
Detailed information on this medicine is available on the European Medicine’s Agency (EMA) web site: http://www.ema.europa.eu
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