Stalevo Filmtablet 100/25/200mg 30 pcs

What is Stalevo and when is it used?

On a doctor's prescription.

Stalevo is used to treat patients with Parkinson's disease suffer from certain symptoms (fluctuating motor symptoms, so-called end dose or «on-off» symptoms). Stalevo is used when the symptoms have not been adequately stabilized under previous therapy with one or two active ingredients.

Stalevo is a combination of three active substances in one film-coated tablet.

Each film-coated tablet Stalevo contains levodopa, an ingredient that works against Parkinson's disease. In addition, each film-coated tablet contains carbidopa and entacapone. These improve the effect of relieving the Parkinson's symptoms of levodopa.

When should Stalevo not be taken?

Do not take Stalevo if:

• You are hypersensitive to the active substances levodopa, carbidopa, entacapone or any of the other ingredients in Stalevo
• You have liver disease.
• You have increased pressure inside the eye due to narrow-angle glaucoma (glaucoma).
• You have pheochromocytoma (a tumor of Adrenal gland), as this can increase the risk of severe increases in blood pressure.
• You are taking certain antidepressants (selective MAO-A and MAO-B inhibitors in combination or non-selective MAO inhibitors) at the same time. You have developed neuroleptic malignant syndrome (NMS) and / or non-traumatic rhabdomyolysis (rare form of muscle disease).
• You have a melanoma or have a suspicious, previously undiagnosed skin lesion.
• You are under 18 years of age.

When should you be careful when taking Stalevo?

Take care when taking Stalevo:

• If you have had a heart attack or any other disease of the cardiovascular system or the lungs, bronchial asthma, a kidney or endocrine disorder, or suffer from a special form of involuntary movements (so-called extrapyramidal disorders), a stomach ulcer or Have had seizures or inflammatory bowel disease. In patients who have suffered from a gastric or intestinal ulcer, it is possible that the likelihood of gastrointestinal bleeding increases. Tell your doctor.
• If you feel depressed or have thoughts of suicide, or if you notice unusual changes in your behavior, you should see your doctor.
• If you have an elevated Have intraocular pressure due to chronic wide-angle glaucoma. The dose of Stalevo may need to be adjusted and your intraocular pressure monitored.
• If you are taking other medicines that can occasionally cause a drop in blood pressure (orthostatic hypotension), as Stalevo can worsen such reactions.
• If any involuntary movements occur or worsen after starting treatment with Stalevo, you should contact your doctor as the dose of your medicine may need to be adjusted.
• If you have severe muscle stiffness, violent muscle twitching If you notice severe muscle pain or weakness, tremors, restlessness, confusion, fever, rapid heartbeat or large fluctuations in blood pressure, you should contact your doctor immediately.
• If you have to stop Stalevo, this must only be done in consultation with Your doctor as Stalevo may be slowly withdrawn and the dose of your other Parkinson's disease medicines may have been adjusted must be adjusted to avoid worsening of your Parkinson's symptoms or side effects.
• If you have increased diarrhea, you should check your body weight regularly; If you notice any noticeable weight loss, your doctor should be informed.
• If you develop progressive loss of appetite, exhaustion (asthenia) and weight loss within a relatively short period of time. A full medical evaluation should be considered in this case.
• If you, family members, or caregivers notice that you are developing addiction-like symptoms that lead to cravings, tell your doctor or health care professional Doses of Stalevo and other medicines used to treat Parkinson's disease (known asDopamine Dysregulation Syndrome).
• If you, your family member, or caregiver notice that you are developing the urge or desire to behave in ways that are unusual for you, or you develop the urge, drive, or desire If you cannot resist taking certain actions that may be harmful to you or others, talk to your doctor. Such behaviors are known as impulse control disorders and can include gambling addiction, eating or shopping addiction, abnormally increased sexual desire, or overuse of sexual thoughts or feelings. Your doctor may need to review your treatment.

Stalevo may cause dizziness or mild headaches due to a drop in blood pressure. This can affect the ability to react, drive and use tools or machines.

In rare cases drowsiness and sudden sleep may occur during treatment. The latter can sometimes occur without warning or drowsiness. Therefore, if you suddenly fall asleep or are very drowsy during the day, you must not drive or engage in other activities (e.g. using tools or machines) while taking Stalevo that could cause you or others to be less alert. You should refrain from driving a vehicle, such as the activities mentioned above, until you have sufficient experience with the use of the drug and can rule out the possible occurrence of these impairments with sufficient certainty.

Taking other medicines:

Stalevo can affect the effects and side effects of many other medicines. Conversely, the effects and side effects of Stalevo can be influenced by other medicines.

It is particularly important that you tell your doctor which medicines (including those you have bought yourself or herbal ones) you are currently taking or are taking have recently taken.

Stalevo can enhance the effects and side effects of the following drugs with:

• Certain mood-enhancing drugs (antidepressants) from Type of tricyclic antidepressants, MAO-A inhibitors, noradrenaline reuptake inhibitors (active ingredients such as maprotiline and venlafaxine).
• Medicines with the following active ingredients: paroxetine, adrenaline, noradrenaline, dopamine, dobutamine, alpha-methyldopa and apomorphine .

A reduction in the effect of Stalevo by the following drugs is possible with:

• Certain drugs that are used to treat psychoses or the S chizophrenia can be used [e.g. Phenothiazines (e.g. active ingredients such as levomepromazine, thioridazine, fluphenazine) and butyrophenones (e.g. haloperidol)].
• Certain drugs used to treat nausea and vomiting (such as metoclopramide).
• As well as drugs for Prevention of seizures (epilepsy) with phenytoin and medicines with papavarin.

Therefore, you must tell your doctor if you are taking these medicines and / or if you notice that Stalevo is not working properly .

Stalevo can affect the absorption of iron by the gastrointestinal tract. You should therefore take Stalevo and iron-containing medicines at least 2-3 hours apart.

Please only take Stalevo after consulting your doctor, if you know that you suffer from sugar intolerance.

This medicinal product contains up to 25.94 mg sodium (main component of table / table salt) when taking the maximum daily dose of Stalevo. This corresponds to 1.3% of the maximum recommended daily sodium intake with food for an adult.

Tell your doctor or pharmacist if you

• suffer from other illnesses,
• have allergies or
• take or apply other medicines (including those you have bought yourself!).

• What side effects can Stalevo have?

  The following side effects may occur when taking Stalevo:

  Stalevo is a combination of levodopa, carbidopa and entacapone in one preparation. Therefore, the side effects described for treatment with levodopa / carbidopa and the combination of entacapone together with levodopa / carbidopa can also occur with Stalevo.

  Very common (concerns more than one in 10 users)

  • involuntary movements mostly of the arms, legs or head (dyskinesia); Nausea;
  • diarrhea; harmless reddish-brown discoloration of the urine; muscle pain, pain in the musculoskeletal system.

  Common (affects 1 to 10 users in 100)

  • skin rash, increased sweating;
  • worsening of Parkinson's symptoms, tremors (tremor), changing mobility / Ability to move in Parkinson's disease with alternation between rigid motion ("off state") and mobility ("on state"), involuntary muscle tension (dystonia); psychological changes such as disorders of mental performance with e.g. memory / retentive disorders, dementia; drowsiness, drowsiness / dizziness, headache; complaints in connection with diseased coronary arteries (coronary artery disease) such as sudden feeling of tightness / pressure / pain in chest (angina pectoris), irregular heartbeat (irregular heartbeat), dizziness or fainting due to low blood pressure (blood pressure drop) all) when standing up; increased blood pressure; shortness of breath, shortness of breath; depression (possibly with suicidal ideation), delusions (hallucinations), confusion, abnormal dreams including nightmares, anxiety and insomnia; muscle cramps, joint pain; anemia; weight loss, loss of appetite, inflammation of the urinary tract (e.g. cystitis), dry mouth, vomiting, abdominal pain and discomfort in the upper abdomen, constipation , Heartburn; swollen legs, gait disorder, frequent falls, weakness, fatigue; blurred vision.

  occasionally (affects 1 up to 10 out of 1000 users)

  • myocardial infarction;
  • gastrointestinal bleeding; lack of blood platelets (thrombocytopenia) with impaired blood clotting (e.g. after Injuries, it takes longer than usual for the bleeding to stop, or bruises appear more quickly or without external influence); psychotic Sy mptome, restlessness; colon inflammation; difficulty swallowing; liver values ??outside the norm in blood tests; discoloration of the skin, nails, hair , sweat; Inability to urinate (urinary retention); general malaise.

  Other side effects are:

  Hypersensitivity reactions can occur. The signs may be: hives (hives), itching, skin rash, punctiform bleeding in the skin that comes on suddenlye and often rapid swelling of the face, lips, tongue or throat (this may make breathing or swallowing difficult). If you experience such hypersensitivity reactions, you must contact your doctor immediately.

  You may experience excessive sleepiness / sleepiness during the day and sudden uncontrolled attacks of sleep (see ?When to take Stalevo with care required? »).

  Inflammation of the liver with jaundice can occur.

  Very rarely a so-called neuroleptic malignant syndrome is caused, which manifests itself primarily as fever, impaired consciousness and muscle stiffness. Very rarely, you will experience severe muscle pain or weakness, which can be signs of severe muscle breakdown (rhabdomyolysis). In both cases, the attending physician must be contacted immediately.

  You may experience the following side effects:

  • The desire for high doses of Stalevo that exceed the doses needed to control motor symptoms, called dopamine dysregulation syndrome. Some patients experience severe uncontrolled movements (dyskinesia), mood changes, or other side effects after taking high doses of Stalevo.
  • Inability to resist the impulse to take an action that could be harmful; these include:
    • a strong impulse to gamble excessively despite significant or personal, family consequences,
    • changed or increased sexual interest and behavior that is worrying for you or others, for example an increased sex drive,
    • uncontrollable, excessive shopping and spending,
    • binge eating (eating large amounts in a short period) or compulsive eating (eating more than normal and more than is necessary to satisfy hunger).

  Notify your health care provider if you experience any of these behavior patterns; Your doctor will discuss ways to deal with or reduce these symptoms.

  If you get any side effects, talk to your doctor or pharmacist. This applies in particular to side effects that are not listed in this leaflet.