Stalevo Filmtablet 50/12.5/200mg 100 pcs

What is Stalevo and when is it used?

Prescriptened by your doctor.Stalevo is used to treat patients with Parkinson's disease who 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 substances.Stalevo is a combination of three active substances in one film-coated tablet.Each Stalevo film-coated tablet contains levodopa, an ingredient that works against Parkinson's disease. In addition, each film-coated tablet contains carbidopa and entacapone. These will improve the effect of levodopa in relieving Parkinson?s symptoms.

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 in the eye due to narrow-angle glaucoma (glaucoma).You have pheochromocytoma (a tumor of the adrenal gland) as this can increase the risk of severe blood pressure increases.You are taking certain antidepressants (selective MAO-A and MAO-B inhibitors in combination or non-selective MAOIs) at the same time.you have developed neuroleptic malignant syndrome (NOS) and / or non-traumatic rhabdomyolysis (a rare type of muscle disorder).You have a melanoma or have a suspicious, previously undiagnosed skin lesion.You are under 18 years of age.

In what circumstances should caution be required while taking Stalevo?

Caution should be taken when taking Stalevo:

• If you have had a heart attack or any other disease of the cardiovascular system or lungs, bronchial asthma, kidney or endocrine disorder, or have a special type of involuntary movement (so-called extrapyramidal disorders), a stomach ulcer or seizure or a had inflammatory bowel disease. In patients who have had a stomach or intestinal ulcer, the likelihood of gastrointestinal bleeding may increase.If you have gone through psychosis, you should tell your doctor or health care professional.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 increased 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 may occasionally cause a drop in blood pressure (orthostatic hypotension), as Stalevo can make such reactions worse.If any involuntary movements occur or worsen after starting treatment with Stalevo, you should contact your doctor as the dose of your medicines may need to be adjusted.If you notice severe muscle stiffness, severe muscle twitching, 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, you should only do so in consultation with your doctor, as Stalevo may need to be stopped slowly and the dose of your other Parkinson's disease medicines adjusted to prevent your Parkinson's symptoms or side effects from getting worse avoid.If you suffer from increased diarrhea, you should check your body weight regularly; your doctor should be informed of any noticeable weight loss.If you develop progressive loss of appetite, exhaustion (asthenia), and weight loss over a relatively short period of time. In this case, a full medical examination should be considered.Tell your doctor if you, family members, or caregivers notice that you develop addiction-like symptoms that lead to craving for high doses of Stalevo and other medicines used to treat Parkinson's disease (known to as dopamine dysregulation syndrome).If you, your loved ones, or caregivers notice that you are developing urges or cravings to behave in ways that are unusual for you, or you feel the urge, urge, or desire to perform certain actions that may be harmful to you or others are unable to resist, 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 sleepiness 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 above-mentioned activities until you have sufficient experience in taking the drug and can rule out the possible occurrence of these impairments with sufficient certainty.

Taking other drugs:

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 bought yourself or herbal ones) you are currently taking or have recently taken.Stalevo can enhance the effects and side effects of the following drugs with:

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

The following medicines can make Stalevo less effective:

• Certain drugs used to treat psychoses or schizophrenia [e.g. phenothiazines (e.g. active ingredients such as levomepromazine, thioridazine, fluphenazine) and butyrophenones (e.g. haloperidol)].Certain medicines used to treat nausea and vomiting (such as metoclopramide).As well as medicines to prevent seizures (epilepsy) with phenytoin and medicines with papavarin.

Therefore, you must tell your doctor or health care professional if you are taking these medicines and / or if you notice that Stalevo has lost its effectiveness.Stalevo can affect the absorption of iron through the gastrointestinal tract. Therefore, the intake of Stalevo and the intake of medicines containing iron should be at least 2-3 hours apart.Please only take Stalevo after consulting your doctor if you know that you are intolerant to sugar.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 dietary sodium intake for an adult.Tell your doctor or pharmacist if you:

• suffer from other diseases,have allergies ortake other medicines (including ones you have bought yourself!) or apply them externally.

Can Stalevo be used during pregnancy or while breastfeeding?

Stalevo should not be used during pregnancy. Women should not breast-feed during treatment with Stalevo.

How do you use Stalevo?

Each film-coated tablet of Stalevo contains one treatment dose. Take only one film-coated tablet of Stalevo at a time. You should not take 2 or more film-coated tablets of Stalevo at one time. Do not split the film-coated tablets.You should strictly follow your doctor's instructions when taking Stalevo, other medicines containing levodopa, and other medicines for Parkinson's disease. This includes following the instructions on when and how to take your medicine.Do not change the prescribed dosage on your own. If you think the medicine is too weak or too strong, talk to your doctor or pharmacist.You should not stop treatment with Stalevo without extensive advice from your doctor.Do not take Stalevo together or shortly before or after a very protein-rich meal (e.g. lots of meat, fish, cheese and eggs), as the absorption of an active ingredient in Stalevo can be impaired. Stalevo and iron supplements should be taken at least 2-3 hours apart.If you accidentally take too many tablets of Stalevo, you should talk to your doctor or pharmacist immediately.As soon as you realize you forgot to take Stalevo, it is time to do it. However, two film-coated tablets of Stalevo should not be taken within the same hour. You should also not take a double dose to make up for a forgotten single dose. You should then resume your usual dosing schedule.The use and safety of Stalevo in children and adolescents under 18 years of age has not been studied. No data is available. Stalevo should not be used by children and adolescents.

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 with levodopa / carbidopa can also occur with Stalevo.

Very common (affects more than 1 in 10 people)

• Involuntary movements mostly of the arms, legs or head (dyskinesia); Nausea;Diarrhea;Harmless reddish-brown discoloration of urine;Muscle pain, musculoskeletal pain.

Common (affects 1 to 10 users in 100)

• 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, for example, memory / retentiveness disorders, dementia;Drowsiness, drowsiness / dizziness, headache;Complaints related to coronary artery disease such as sudden tightness / pressure / pain in the chest (angina pectoris), irregular heartbeat (irregular heartbeat), dizziness or fainting due to low blood pressure (drop in blood pressure) 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 (anemia);Weight loss, loss of appetite, inflammation of the lower urinary tract (e.g. cystitis), dry mouth, vomiting, abdominal pain and discomfort in the upper abdomen, constipation, heartburn;Swollen legs, impaired gait, more frequent falls, weakness, fatigue;Blurred vision.

Uncommon (affects 1 to 10 users in 1,000)

• Heart attack;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 symptoms, restlessness;Colon inflammation;Difficulties 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 include hives (hives), itching, skin rash, punctiform bleeding in the skin, sudden and often rapid swelling of the face, lips, tongue or throat (this can make it difficult to breathe or swallow). If you experience such hypersensitivity reactions, you must contact your doctor immediately.It can lead to excessive tiredness / sleepiness during the day and sudden uncontrolled attacks of falling asleep (see ?When should you be careful when taking Stalevo??).Inflammation of the liver with jaundice can occur.Very rarely a so-called neuroleptic malignant syndrome is caused, which manifests itself primarily through 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 need for high doses of Stalevo in excess of the doses required 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 perform an act that could be harmful; this includes:
  • a strong impulse to gamble excessively despite significant or personal, family consequences,changed or increased sexual interest and behavior that is worrying to you or others, for example 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 doctor if you experience any of these behavior patterns; Your doctor will discuss ways to manage or reduce these symptoms with you.If you get any side effects, talk to your doctor or pharmacist. This also applies in particular to side effects that are not listed in this leaflet.

What should also be noted?

The drug may only be used up to the date marked ?EXP? on the container.

Storage advice

Store at room temperature (15-25 ° C).Keep out of reach of CHILDREN.

More information

Your doctor or pharmacist can provide you with further information. These people have the detailed information for specialists.

What's in Stalevo?

Active ingredients

The film-coated tablets contain the active substances levodopa, carbidopa and entacapone.Stalevo 50/12.5/200 mg: Levodopa 50 mg, Carbidopa 12.5 mg und Entacapon 200 mg.Stalevo 75/18.75/200 mg: Levodopa 75 mg, Carbidopa 18.75 mg und Entacapon 200 mg.Stalevo 100/25/200 mg: Levodopa 100 mg, Carbidopa 25 mg und Entacapon 200 mg.Stalevo 125/31.25/200 mg: Levodopa 125 mg, Carbidopa 31.25 mg und Entacapon 200 mg.Stalevo 150/37.5/200 mg: Levodopa 150 mg, Carbidopa 37.5 mg und Entacapon 200 mg.Stalevo 200/50/200 mg: Levodopa 200 mg, Carbidopa 50 mg und Entacapon 200 mg.

Auxiliary materials

Stalevo 50/12.5/200 mg, Stalevo 75/18.75/200 mg, Stalevo 100/25/200 mg; Stalevo 125/31.25/200 mg; Stalevo 150/37.5/200 mg, Stalevo 200/50/200 mg:Tablet core: corn starch, mannitol (E421), croscarmellose sodium, povidone, magnesium stearate.Film coating: hypromellose, sucrose, titanium dioxide (E171), red iron oxide (E172), magnesium stearate, polysorbate 80, glycerine 85% (E422).The film coating of Stalevo 50 / 12.5 / 200 mg, Stalevo 100/25/200 mg, Stalevo 150 / 37.5 / 200 mg also contains yellow iron oxide (E172).

Approval number

56676 (Swissmedic)

Where do you get Stalevo? Which packs are available?

In pharmacies, only with a prescription.Stalevo is available in two pack sizes, each 30 resp. 100 film-coated tablets contain.

• Stalevo 50 / 12.5 / 200 mg 100 film-coated tablets
  Stalevo 50 / 12.5 / 200 mg 30 film-coated tablets
  

Marketing authorization holder
Orion Pharma AG, 6300 Zug?????