Stalevo

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.

How to take Stalevo

Always take this medicine exactly as your doctor or pharmacist has told you. 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. To open the bottle for the first time: open the closure, and then press with your thumb on the seal until it breaks. See picture 1. Picture 1 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. In case of an overdose you may feel confused or agitated, your heart rate may be slower or faster than normal or the colour of your skin, tongue, eyes or urine may change. 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 medicine, ask your doctor or pharmacist.

Possible 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 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.

Very common (may affect more than 1 in 10 people)
•uncontrolled movements (dyskinesias)
•feeling sick (nausea)
•harmless reddish-brown discolouration of urine
•muscle pain
•diarrhoea

Common (may affect up to 1 in 10 people)
•light-headedness 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
•headache, joint pain
•urinary tract infection

Uncommon (may affect up to 1 in 100 people)
•heart attack
•bleeding in the gut
•changes in the 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

The following side effects have also been reported:
•hepatitis (inflammation of the liver)
•itching You may experience the following side effects:
•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 to you or to others 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 your hunger). Tell your doctor if you experience any of these behaviours; they will discuss ways of managing or reducing the symptoms.

Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

How to Store Stalevo

Keep this medicine out of the sight and reach of children. Do not use this medicine 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. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.