What is it and how is it used?
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.
What do you have to consider before using it?
Do not take Stalevo if you
Take special care with Stalevo
Consult your doctor if you have or have ever had:
Consult your doctor if you are currently taking:
Consult your doctor if during the treatment with Stalevo you:
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:
The effects of Stalevo may be weakened by certain medicines. These include:
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 (1.6 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 is it used?
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:
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.
What are possible 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
Common
Uncommon
The following side effects have also been reported:
If you during the treatment with Stalevo experience the following symptoms, contact your doctor immediately:
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 should it be stored?
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.
