Stalevo 50 mg/12.5 mg/200 mg film-coated tablets
Stalevo 75 mg/18.75 mg/200 mg film-coated tablets
Stalevo 100 mg/25 mg/200 mg film-coated tablets
Stalevo 125 mg/31.25 mg/200 mg film-coated tablets
Stalevo 150 mg/37.5 mg/200 mg film-coated tablets
Stalevo 175 mg/43.75 mg/200 mg film-coated tablets
Stalevo 200 mg/50 mg/200 mg film-coated tablets
What Stalevo is and what it is used for
Stalevo contains three active substances ( levodopa, carbidopa, and entacapone) in a film-coated tablet. Stalevo is used to treat Parkinson’s disease.
Parkinson’s disease is caused by low levels of the substance dopamine in the brain. Levodopa increases the amount of dopamine and therefore relieves the symptoms of Parkinson’s disease. Carbidopa and entacapone enhance the effect levodopa have on Parkinson’s disease.
What you need to know before you take Stalevo
Do not use Stalevo if you
- are allergic to levodopa, carbidopa or entacapone, or any of the other ingredients of this medicine (listed in section 6).
- have narrow-angle glaucoma (an eye disease)
- have a tumor in the adrenal gland
- are taking certain medicines for the treatment of depression (combinations of selective MAO-A and MAO-B inhibitors, or non-selective MAO inhibitors )
- previously had neuroleptic malignant syndrome (NMS – this is a rare reaction to medicines used to treat serious mental illness)
- previously had non-traumatic rhabdomyolysis (a rare muscle disease)
- have serious liver disease.
Warnings and precautions
Talk to your doctor or pharmacist before taking Stalevo if you have or have had:
- a heart attack or any other heart disease including arrhythmias, or blood vessel disease
- asthma or another lung disease
- liver problems, your dose may then need to be adjusted
- kidney disease or hormone-related disease
- stomach ulcers or seizures
- if you experience prolonged diarrhea, consult a doctor as this may be a sign of colon inflammation
- any form of serious mental illness, such as psychosis
- chronic wide-angle glaucoma. Your dose may then need to be adjusted and your eye pressure may need to be checked.
Consult your doctor if you are taking:
- antipsychotics (drugs to treat psychosis )
- medicines that can cause low blood pressure when you get up from a chair or bed. You should be aware that Stalevo may worsen this effect.
Consult your doctor during treatment with Stalevo:
- experience that your muscles become very stiff or jerk violently, or if you suffer from tremors, agitation, confusion, fever, rapid heart rate, or large fluctuations in blood pressure. If any of this happens, contact your doctor immediately.
- feel depressed, have suicidal thoughts, or notice a change in your behavior.
- suddenly fall asleep, or feel very sleepy. If this happens, do not drive or use machines (see also section Driving and using machines)
- have involuntary movements or if they have worsened after starting Stalevo treatment. If this happens, your doctor may need to change your dosage of medicines for Parkinson’s disease
- get diarrhea: your weight may need to be monitored to avoid possible severe weight loss
- experience loss of appetite that worsens over time, lack of energy (weakness, exhaustion), and weight loss within a short period. If this happens, a general medical examination including liver function tests should be considered
- feel that you want to stop using Stalevo, see the section “If you stop taking Stalevo”.
Tell your doctor if you or your family/caregiver notices that you develop addiction-like symptoms that lead to a craving for larger doses of Stalevo and other medicines used to treat Parkinson’s disease.
Tell your doctor if you or your family/carer find that you develop urges or urges to behave in ways that are unusual for you, or you cannot resist the impulse, drive, or temptation to engage in certain activities that could harm you or others. This behavior is called impulse control disorder and may include compulsive gambling, excessive food intake or spending, an abnormally high sex drive, or a preoccupation with an increase in sexual thoughts or feelings. Your doctor may need to review your treatment.
Your doctor may need to take regular tests on you during long-term treatment with Stalevo.
If you need surgery, tell your doctor that you are taking Stalevo.
Stalevo is not recommended for the treatment of extrapyramidal symptoms (such as involuntary movements, tremors, muscle stiffness, and muscle contractions) caused by other medicines.
Children and young people
Experience in treating patients under the age of 18 with Stalevo is limited. Stalevo is therefore not recommended for the treatment of children or adolescents.
Other medicines and Stalevo
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not take Stalevo if you are taking certain medicines for the treatment of depression (combinations of selective MAO-A and MAO-B inhibitors, or non-selective MAO inhibitors ).
Stalevo can increase the effect and side effects of certain medicines. This includes:
- medicines to treat depression such as moclobemide, amitriptyline, desipramine, maprotiline, venlafaxine, and paroxetine
- rimiterol and isoprenaline, which are used to treat diseases of the respiratory tract
- adrenaline, which is used in severe allergic reactions
- norepinephrine, dopamine, and dobutamine, which are used to treat heart disease and low blood pressure
- alpha-methyldopa used to treat high blood pressure
- apomorphine used to treat Parkinson’s disease.
Some medicines can weaken the effect of Stalevo. These are:
- dopamine antagonists are used to treat mental illness, nausea, and vomiting.
- phenytoin is used to prevent seizures.
- papaverine is used for muscle relaxation.
Stalevo with food and drink
Stalevo can be taken with or without food. In some patients, Stalevo can be absorbed less well if it is taken at the same time as or shortly after eating protein-rich food (such as meat, fish, dairy products, seeds, and nuts). Contact your doctor if you think this applies to you.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
You should not breastfeed while being treated with Stalevo.
Driving ability and use of machinery
Stalevo can lower your blood pressure, which can cause you to feel lightheaded or dizzy. Therefore, be especially careful if you drive a car or use tools or machines.
If you feel very drowsy or sometimes fall asleep suddenly, wait until you feel fully awake before driving or doing anything else that requires you to be alert. Otherwise, you could expose yourself or others to injury or death.
Stalevo contains sucrose
Stalevo contains sucrose.
Stalevo 50 mg/12.5 mg/200 mg contains 1.2 mg per tablet.
Stalevo 75 mg/18.75 mg/200 mg contains 1.4 mg per tablet.
Stalevo 100 mg/25 mg/200 mg contains 1.6 mg per tablet.
Stalevo 125 mg/31.25 mg/200 mg contains 1.6 mg per tablet.
Stalevo 150 mg/37.5 mg/200 mg contains 1.9 mg per tablet.
Stalevo 175 mg/43.75 mg/200 mg contains 1.89 mg per tablet.
Stalevo 200 mg/50 mg/200 mg contains 2.3 mg per tablet.
How to take Stalevo
Always use this medicine as directed by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure.
For adults and the elderly:
- Your doctor will inform you exactly how many tablets to take each day.
- The tablets are not intended to be split or broken into small pieces.
- You should only take one tablet at a time.
- Depending on how you respond to the treatment, the doctor may suggest an increase or decrease in the 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.
If you feel that the effect of Stalevo is too strong or too weak or if you experience possible side effects, contact your doctor or pharmacist.
To open the jar for the first time: open the lid, then push the seal with your thumb until it breaks. See picture 1.
If you have taken too much Stalevo
If you have accidentally taken more Stalevo tablets than you should, contact your doctor or pharmacist immediately.
If you forget to take Stalevo
Do not take a double dose to make up for a missed tablet.
If it is more than 1 hour until the next dose:
Take one tablet as soon as you remember, and take the next tablet at the regular time.
If it is less than 1 hour until the next dose:
Take one tablet as soon as you remember, wait 1 hour and then take another tablet. After that, you can continue as usual.
Always make sure that there is at least an hour between the Stalevo doses, 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 change your other antiparkinsonian medication, especially levodopa, to maintain adequate symptom control. If you suddenly stop taking Stalevo and other antiparkinsonian drugs, it can lead to unwanted side effects.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Many side effects can be mitigated by adjusting the dose.
If you experience the following symptoms during treatment with Stalevo, contact your doctor immediately:
- Your muscles become rigid or jerk violently, you suffer from tremors, excitement, confusion, fever, rapid pulse, or large fluctuations in blood pressure. These may be symptoms of the neuroleptic malignant syndrome (NMS, a rare severe reaction to drugs used to treat diseases of the central nervous system ) or rhabdomyolysis (a rare severe muscle disease).
- Allergic reaction, symptoms may include hives, itching, rash, and swelling of the face, lips, tongue, or throat. This can cause difficulty breathing or swallowing.
Very common (may affect more than 1 in 10 people):
- involuntary movements ( dyskinesias )
- reddish-brown discoloration of the urine (harmless)
- muscle pain
Common (may affect up to 1 in 10 people):
- the feeling of emptiness or fainting due to low blood pressure, high blood pressure
- worsening symptoms of Parkinson’s disease, dizziness, drowsiness
- vomiting, abdominal pain and discomfort, heartburn, dry mouth, constipation
- difficulty sleeping, hallucinations, confusion, abnormal dreams (including nightmares), tiredness
- mental changes – including memory disturbances, anxiety, and depression (possibly with suicidal thoughts)
- heart or artery disease (eg chest pain), irregular heart rate or rhythm
- increased tendency to fall
- shortness of breath
- increased sweating, rash
- muscle cramps, swelling of the legs
- blurred vision
- decreased appetite, weight loss
- headache, joint pain
- urinary tract infection
Uncommon (may affect up to 1 in 100 people):
- heart attack
- intestinal bleeding
- change in the cell picture of the blood which can lead to bleeding, abnormal liver function values
- feelings of outrage
- psychotic symptoms
- colitis ( inflammation of the colon)
- discoloration of other than urine (e.g. skin, nails, hair, sweat)
- difficulty swallowing
- inability to urinate
Has been reported (occurring in an unknown number of people):
Ask for a higher dose of Stalevo than is needed to control motor symptoms known as dopaminergic dysregulation syndrome. Some patients experience severe abnormal involuntary movements ( dyskinesias ), mood swings, or other side effects after taking larger doses of Stalevo.
The following side effects have also been reported:
- hepatitis ( inflammation of the liver)
You may experience the following side effects:
- Inability to resist the impulse to perform an action that may be harmful, which may include:
- strong impulse to gamble excessively despite serious personal or family consequences;
- changed or increased sexual interest and behavior that affects you or others significantly, example, an increased sex drive;
- uncontrolled excessive shopping or spending;
- binge eating (eating large amounts of food in a short 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 symptoms; we will discuss how to manage or reduce these symptoms.
How Stalevo should be stored
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the label and carton. after the Expiration date. The expiration date is the last day of the specified month.
No special storage instructions.
The medicine must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
- The active substances in Stalevo are levodopa , carbidopa and entacapone.
- Each 50 mg/12.5 mg/200 mg tablet contains 50 mg levodopa , 12.5 mg carbidopa and 200 mg entacapone.
- Each 75 mg/18.75 mg/200 mg tablet contains 75 mg levodopa , 18.75 mg carbidopa and 200 mg entacapone.
- Each 100 mg/25 mg/200 mg tablet contains 100 mg levodopa , 25 mg carbidopa and 200 mg entacapone.
- Each 125 mg/31.25 mg/200 mg tablet contains 125 mg levodopa , 31.25 mg carbidopa and 200 mg entacapone.
- Each 150 mg/37.5 mg/200 mg tablet contains 150 mg levodopa , 37.5 mg carbidopa and 200 mg entacapone.
- Each Stalevo 175 mg/43.75 mg/200 mg tablet contains 175 mg levodopa , 43.75 mg carbidopa and 200 mg entacapone.
- Each 200 mg/50 mg/200 mg tablet contains 200 mg levodopa , 50 mg carbidopa and 200 mg entacapone.
- Other ingredients in the tablet core are croscarmellose sodium, magnesium stearate, corn starch, mannitol (E421), and povidone (E1201).
- The film coating contains glycerol (85 percent) (E422), hypromellose, magnesium stearate, polysorbate 80, red iron oxide (E172), sucrose, and titanium dioxide (E171), and yellow iron oxide (E172).
Appearance and package sizes of the medicine
Stalevo 50 mg/12.5 mg/200 mg: brown or grey-red round convex (ie top and bottom are rounded) unscored film-coated tablets marked with “LCE 50” on one side.
Stalevo 75 mg/18.75 mg/200 mg: light reddish-brown oval film-coated tablets marked with “LCE 75” on one side.
Stalevo 100 mg/25 mg/200 mg: brownish or greyish-red oval film-coated tablets without score marked with “LCE 100” on one side.
Stalevo 125 mg/31.25 mg/200 mg: light reddish-brown oval film-coated tablets marked with “LCE 125” on one side.
Stalevo 150 mg/37.5 mg/200 mg: brownish or grey-red elongated elliptical film-coated tablets without score marked with “LCE 150” on one side.
Stalevo 175 mg/43.75 mg/200 mg: light reddish-brown oval film-coated tablets marked with “LCE 175” on one side.
Stalevo 200 mg/50 mg/200 mg: dark red-brown, oval, unscored film-coated tablets marked with “LCE 200” on one side.
Stalevo is available in six different pack sizes (10, 30, 100, 130, 175, and 250 tablets). 250 tablets are not available in the strengths Stalevo 75 mg/18.75 mg/200 mg or Stalevo 125 mg/31.25 mg/200 mg or Stalevo 175 mg/43.75 mg/200 mg or Stalevo 200 mg/50 mg/200 mg.