Stalevo 100 Tablets

STALEVO 100/25/200 mg film-coated tablet is taken orally.

Active Ingredient

Each film-coated tablet contains 100 mg of levodopa, 25 mg of carbidopa and 200 mg of

entacapone.

• If you have other questions, please talk your doctor or pharmacist.

• This medicine has been prescribed for you personally, please do not give it to others.

• When using this medicine, tell your doctor that you are taking this medicine when you go to a doctor or hospital.

• Follow the instructions in this manual. Do not use high or low doses other than the recommended dose for the drug.

In these Instructions for Use:

1. What is STALEVO and what is it used for?

2. Things to consider before using STALEVO to use STALEVO

3. How

4. What are the possible side effects?

5. Storing

What is STALEVO and what is it used for?

STALEVO 100/25/200 mg film-coated tablets are brown or grayish-red, oval tablets with 'LCE 100' marking on one side.

A STALEVO film-coated tablet contains three active ingredients. Each film-coated tablet contains carbidopa and entacapone, which, as an active ingredient, increases the therapeutic effects of levodopa and levodopa in the treatment of Parkinson's disease.

STALEVO is a class of drugs called anti-Parkinson's dopaminergic drug. Your doctor has given you STALEVO to treat your Parkinson's disease.

Parkinson's disease is a disorder in the nervous system. This disease is caused by the deficiency of dopamine, a natural substance produced in the brain. Dopamine transmits messages in the part of the brain that controls the muscle movement. If dopamine is produced very little, problems arise with movements.

Levodopa acts by increasing the level of dopamine in the brain.

STALEVO helps to alleviate symptoms such as slowing of hands and feet, body stiffness and deceleration of movements, making it difficult to perform normal daily work in Parkinson's disease.

Other medications may also be given for the treatment of this condition.

3. How to use STALEVO?

Instructions for appropriate use and dose / frequency of application

Always use STALEVO following the instructions given by your doctor. If you are not sure, ask your doctor or pharmacist.

Your doctor will tell you exactly how many STALEVO tablets you will take each day. Your doctor may recommend a higher or lower dose depending on your response to treatment.

For Stalevo 50 / 12.5 / 200 mg, Stalevo 100/25/200 mg and Stalevo 150 / 37.5 / 200 mg film-coated tablet: Do not take more than 10 tablets per day.

For Stalevo 200/50/200 mg film-coated tablets: Do not take more than 7 tablets in one day.

Strictly follow the instructions of your doctor about how and when to use STALEVO, other levodopa drugs, and other Parkinson's medications. Consult your doctor or pharmacist if you are unsure about these instructions or if you are unsure about the type on the packaging.

Method and method

of administration Swallow the tablets with some water (eg 1 cup). Each STALEVO tablet contains a full dose of levodopa, carbidopa and entacapone. Take only one tablet at a time. Tablets should not be divided or divided into small pieces.

Different age groups

Use in children The use

of STALEVO in children and adolescents under the age of 18 is not recommended and therefore not recommended for use in these individuals.

Use in the elderly

If you are over 65 years of age, you may receive STALEVO without dose adjustment.

Specific use cases

STALEVO therapy should be administered with caution to patients with severe renal impairment, including those who undergo dialysis.

Care should be taken when applying STALEVO to patients with mild to moderate hepatic impairment. Dose reduction may be required.

Unless your doctor recommends otherwise follow these instructions.

Your doctor will tell you how long your treatment will take with STALEVO. Do not discontinue treatment early, because stopping STALEVO may cause your illness to deteriorate.

If you have an impression that the effect of STALEVO is too strong or too weak, talk to your doctor or pharmacist.

If you use from

use more STALEVO than you should use, talk to a doctor or pharmacist if you have used more than you should STALEVO.

If you have forgotten to use

STALEVO If you have more than one hour until your next dose: immediately take a dose and take your next dose in normal time.

If you have less than one hour until your next dose: immediately take a dose, wait an hour, then take another dose. Then return to your normal treatment regimen.

To avoid possible side effects, STALEVO tablets should always be taken at least one hour apart.

Consult your doctor if you are not sure what to do.

Do not take double doses to compensate for forgotten doses.

Effects that may occur when treatment is terminated with does

STALEVO Do not stop taking STALEVO if your doctor not tell you to quit. In such cases, your doctor may need to readjust the dose of your other Parkinson's medications (especially levodopa) to ensure adequate control of your symptoms. Immediate discontinuation of both STALEVO and other Parkinson's medications can lead to unwanted side effects (eg severe muscle stiffness, high fever, and consciousness changes).

4. What are the possible side effects?

As with all medicines, STALEVO may have side effects in people who are sensitive to the substances contained in its contents.

If you have any of the following, stop using STALEVO and IMMEDIATELY tell your doctor or contact the emergency department of your nearest hospital:

• Shortness of breath

• Dizziness or fainting due to low blood pressure

• Allergic reaction symptoms (hives), itching, rash, face, lips may include swelling in the tongue or throat. This may cause difficulty breathing or swallowing.

If you have one of these, you have a serious allergy to STALEVO.

• Psychological changes, including skepticism (paranoid) and psychotic symptoms, possibly associated with suicidal thoughts, mental depression (depression), and problems with memory or thought

• Chest pain

• Bowel bleeding (hemorrhage

)

• High blood pressure

• Inflammation in the veins of the leg veins

• High fever and consciousness changes

• Bleeding

• Heart or arterial diseases other than heart attack (eg chest pain)

• Heart attack (heart attack which may cause severe chest pain)

These are all very serious side effects . If you experience any of these side effects, talk to your doctor as soon as possible. Many of these side effects can be alleviated by dose adjustment.

You may need urgent medical attention or hospitalization. All of these very serious side effects are very rare.

If you notice any of the following, report it immediately to your doctor or contact the emergency department of your nearest hospital:

Very common (in at least 1 of 10 patients):

• Out of control movements

• Sudden deterioration of Parkinson's symptoms

Common (less than one of 10 patients, but from one of 100 patients:

• Dizziness

Overdose• Vomiting

• Diarrhea

• Feeling in spiritual turbulence

• Increased drop frequency

• Muscle cramps

Uncommon (less than 1 patient in 100 patients but more than 1 patient in 1000 patients):

• Irregular heartbeat

• Ulcers

• Fatigue (blood may be due to changes in cells, faintness, infections

• hallucinations and confusion (hallucinations and confusion)

Rare (less than 1 patient in 1000 patients but more than 1 patient in 10,000 patients):

• yellowing of the skin or eye cells

• strong muscular stiffness

• thick intestinal inflammation (diarrhea and weight loss can cause r) These are all serious side effects. Emergency medical intervention may be required. Tell your doctor if you notice any of the following:

Very common (in at least 1 of 10 patients):

• Nausea

• Urine color reddish brown

Common (less than one of 10 patients, but more than one in 100 patients):

• Drowsiness

• Tingling or numbness

• Abdominal pain

• Oral dryness

• Constipation

• Insomnia

• Hallucinations

• Confusion

• Nightmares

• Feeling restless, feeling uneasy

• Tiredness

• Increased sweating

• Itching and rashes

• Visually impaired

(100 patients more than 1 patient more than 1 patient in 1000 patients:

• Loss of appetite

• Weight loss or weight gain

Sparse (less than 1 in 1000 patients but more than 1 patient in 10,000 patients):

• Excessive sleepiness during the day

• Sudden sleep events

• The impulse to gamble (pathological gambling) or increase in sexual desire (libido increase and exceeds) behavioral changes such as sexuality.

Uncommon (less than one patient with unknown data):

•skin, hair, beard and nails

Discolorations of theThese are side effects of STALEVO that may develop mild to moderate, and usually resolve spontaneously within 1-2 days without treatment.

STALEVO DO NOT use STALEVO hypersensitivity to

if:You

•levodopa, carbidopa, or entacapone or other substances in STALEVO.

• If you have severe hepatic impairment.

• If you have a narrow angle glaucoma (an eye disease with increased pressure in the eye).

• If you have an adrenal tumor (known as pheochromocytoma, it can increase the risk of severe high blood pressure).

• You are using certain drugs for the treatment of mental depression (selective MAO-A and MAO-B enzyme inhibiting or non-selective MAO enzyme inhibiting drugs).

• If you have previously had a neuroleptic malignant syndrome (NHS), a rare reaction to drugs used to treat severe mental disorders.

• If you have had a disease (rhabdomyolysis with a muscle disease) that has previously been damaged by muscle cells.

CAREFULLY USE STALEVO

if:

• You have previously had a heart attack, shortness of breath (asthma) or any other heart, vascular, or lung disease.

• If you have liver failure.

• If you have severe renal failure.

• You have had a disease with kidneys, liver, or hormones.

• You have had inflammatory bowel disease before.

• If you have had stomach ulcers before.

• If you have previously had a convulsion.

• If you have experienced any kind of severe mental disorder before.

• If you feel mentally depressed, have suicidal thoughts or have noticed unusual changes in your emotions and behaviors.

• You have chronic (chronic) wide angle glaucoma. You may need to adjust your dose and monitor the pressure in your eyes.

• If you are using other medications that may decrease blood pressure. You must be aware that STALEVO may increase this effect.

• If some actions outside your control start or deteriorate after you start to receive STALEVO. In this case, your doctor may need to change the dose of your Parkinson's disease medication.

• If you have been told by your doctor that some of your sugars cannot lift. In this case, consult your doctor before taking this medicine.

Use of and machines

tools• If your muscles become too hard or show severe contractions, or if you have tremors, restlessness, confusion, fever, increased heart rate or large fluctuations in your blood pressure.

• If you have diarrhea. In this case, your doctor may want to monitor weight to prevent the possibility of excessive weight loss.

• If you experience progressive anorexia (loss of appetite), asthenia (weakness, fatigue) and weight loss in a short time, report it to your doctor. Your doctor may want to make a general health assessment, including liver function.

• If you are going to be operated with general anesthesia. In this case, report to the doctor that you have received STALEVO.

• If you feel you should stop using STALEVO, consult your doctor first. To prevent side effects and deterioration of your Parkinson's symptoms, a gradual reduction in the dose of STALEVO and other changes in your Parkinson's medication may be required.

Please consult doctor these warnings are valid for you, even at any time of the past

yourif.

Using STALEVO with food and drink You can

purchase STALEVO with or without food.

In some patients, STALEVO may not be absorbed well if it is taken together with foods containing plenty of protein (eg meat, fish, dairy products, seeds and nuts) or shortly after them. Consult your doctor if you think this is the case.

Do not take STALEVO and iron-containing preparations at the same time. After swallowing one, wait at least 2 or 3 hours before taking the other.

Pregnancy

Consult your doctor or pharmacist before using the medicine.

If you are pregnant or think you may be pregnant, do not use STALEVO without consulting your doctor. STALEVO should not be used during pregnancy unless absolutely necessary. Your doctor will share with you the possible risks of using STALEVO during pregnancy.

If you discover that you are pregnant during your treatment, consult your doctor or pharmacist immediately.

Breastfeeding

Consult your doctor or pharmacist before using the medicine.

Tell your doctor if you are breastfeeding your baby. You should not breastfeed your baby while you are on STALEVO treatment.

Using the machine and the machine

STALEVO can lower your blood pressure, causing dizziness or dizziness. Therefore, you should be especially careful when using the car or any tool or machine.

If you feel very dazed or sometimes suddenly asleep, you should not drive or do anything else that requires you to be careful (you must not drive or drive). Ask your doctor for advice. Otherwise, you can put yourself and others at risk of serious injury or death.

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