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Stalevo 50/12,5/200 Mg 100 Tablets ingredients levodopa+ carbidopa+entacapone

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Stalevo 50/12,5/200 Mg 100 Tablets ingredients levodopa+ carbidopa+entacapone

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4.3. Contraindications

4.4. Special warnings and precautions for use

Interactions with other drugs:

Dopamine receptor antagonists (eg some antipsychotics and antiemetics) may reduce the therapeutic effect of phenytoin and papaverine levodopa. Patients using these drugs with STALEVO should be carefully monitored for therapeutic response loss.

STALEVO, due to the in vitro affinity of entacapone to the cytochrome P450 2C9 enzyme (see Section

5.2. Pharmacokinetic properties), its metabolism such as S-warfarin may potentially interact with drugs dependent on this isoenzyme. However, in an interaction study with healthy volunteers, the R-warfarin sub-curve area (AUC) increased by an average of 18% [CI90% 11-26] with the effect of entacapone, whereas the S-warfarin plasma levels did not change. INR values ​​increased by 13% [CI90 6-19%]. Therefore, INR control is recommended when considering the initiation of STALEVO in patients using warfarin.

Other forms of interaction: As

Levodopa competes with certain amino acids, STALEVO absorption may be impaired in some patients who are on a high-protein diet.

8.4. Undesirable effects

STALEVO can be applied to patients with Parkinson's disease who use vitamin preparations containing pyridoxine hydrochloride (vitamin B6).

In vitro data:

Entagapone binds to the human albumin II binding site to which various drugs, including diazem and ibuprofen, are bound. According to the in vitro studies, a significant displacement of these drugs is not expected at therapeutic concentrations. To this end, no sign of such an interaction has ever been found.

Additional information onfor

specific populations No clinical interaction studies have been conductedspecific populations.

4.6. Pregnancy and lactation

General advice

Pregnancy category: C.

Women with childbearing potential / Contraception The

women with childbearing potential should apply appropriate contraception.

Pregnancy

The studies on animals are insufficient in terms of the effects on pregnancy and / or embryonal / fetal development and / or birth and / or postnatal development. The potential risk for humans is unknown. It should not be used unless necessary.

There is not enough data on the use of levodopa / carbidopa / entacapone combination in pregnant women. Animal studies have shown that individual compoundsreproductive toxicity

lead to(see section 5.3. Pre-clinical safety data). The potential risk for humans is unknown. STALEVO should not be used during pregnancy.

lactation period

Levodopa inpasses into human milk. There is evidence that lactation is suppressed during levodopa treatment. In animal studies, carbidopa and entacapone have been found to pass into breast milk, but it is not known whether they have been excreted in human milk. Whether levodopa, carbidopa or entacapone are safe for the baby is unknown. Women should not breast-feed during their STALEVO treatment.

Fertility / Fertility

4.7. Effects on

ability to drive and use machines STALEVO has significant implications for vehicle and machine use. Levodopa, carbidopa and entacapone may lead to dizziness and symptomatic orthostatism. Therefore, care should be taken when driving or driving a machine.

8.4. Undesirable effects The

most commonly reported adverse events with STALEVO are dyskinesia in 19% of patients; gastrointestinal symptoms including nausea and diarrhea, occurring in approximately 15% and 12% of patients, respectively; Muscle, musculoskeletal and connective tissue pain occurring in approximately 12% of patients and harmless, reddish brown color change in urine in approximately 10% of patients. In clinical studies with STALEVO or entacapone in combination with levodopa / DDK inhibitor, severe gastrointestinal bleeding (uncommon) and angiocyte (sparse) cases were detected. Although no data were found in the clinical trial data; severe hepatitis, rhabdomyolysis and neuroleptic malignant syndrome with cholestatic properties may occur.

Undesirable effects listed below are a pair of eleven blinds in which 3230 patients were included (1810 patients were treated with placebo with levodopa / DDK inhibitor in combination with levodopa / DDK inhibitor, placebo in combination with levodopa / DDK inhibitor, or in combination with levodopa / DDK inhibitor, or in combination with levodopa / DDK inhibitor). data from clinical trials and post-marketing studies since entacapone was introduced to be used in combination with levodopa / DDK inhibitor.

8.4. Undesirable effects

are ranked by using the appropriate association of the following values ​​to be placed in the first order: Very common (> 1/10); commonly (1 to 100 to <1/10); non-widespread (> 1 / 1,000 to <1/100); infrequently (> 1 / 10,000 to <1 / 1,000) and very rare (<1 / 10,000); unknown (unpredictable); Isolated notifications are included. In each frequency group, undesirable effects were listed in order of decreasing importance.

Common: Anemia

Uncommon: Thrombocytopenia

Metabolism and nutritional disorders Common: Weight reduction *, loss of appetite *

Psychiatric disorders

Common: Depression, hallucinations, confusion status *, abnormal dreams *,

anxiety, insomnia.

Uncommon: Psychosis, agitation *

Unknown: Suicidal behavior

Nervous system disorders

Very common: Dyskinesia *: Exacerbation of

CommonParkinsonism (eg bradykinesia) *, tremors, open-

closed phenomenon, dystonia, mental disorder (eg memory disorders, dementia), drowsiness, dizziness *, headache

Unknown: Neuroleptic malignant syndrome *

Eye disorders

Common: Blurred vision

Cardiac disorders

Common: Ischemic heart disease events other than myocardial infarction (

angina pectoris) **, irregular heart rhythm

Uncommon: Myocardial infarction * *

Vascular disorders

common:orthostatic hypotension, hypertension

Uncommon: Gastrointestinal haemorrhage

Respiratory system disorders:

common: Dyspnea

Very common: diarrhea *, nausea *

common: Constipation *, vomiting *, dyspepsia, abdominal pain and discomfort *, dry

mouth*

Uncommon : Colitis *, dysphagia

Hepato-biliary disorders

Uncommon: Abnormal liver function tests *

B non-invasive: Hepatitis, which is mostly cholestatic. Chapter 4.4)

Skin and subcutaneous tissue disorders

Common: Skin rash *, hyperhidrosis

Uncommon: Color changes other than urine (eg skin, nails, hair, sweat) *

Ingestion: Angiedema

Unknown: Urticaria *

Musculoskeletal and connective tissue disorders

Very common: Muscle, musculoskeletal and connective tissue pain *

Common: Muscle spasms, arthralgia

Unknown: Rhabdomyolysis *

Kidney and urinary tract disorders Very common: Chromatics *

Common: Urinary tract infections

Uncommon: Urinary retention

General and application-area disorders

Common: Pain in the chest, peripheral edema, falls, gait disturbances, asthenia,

fatigue

Uncommon: Fatiguecommonly associated with

* Undesirable effectsentacapone or more frequently with entacapone compared to levodopa / DDK inhibitor (with a frequency difference of at least 1% in clinical study data) .

** The incidence rates of myocardial infarction and other ischemic heart disease (0.43% and 1.54%) were obtained from the analysis of 13 double-blind subjects in which 2082 patients with motor fluctuations at the end of dosing were included.

Undesirable effects, which are usually associated with entacapone or are more common with entacapone compared to levodopa / DDK inhibitor alone, are indicated by asterisks. Some of these undesirable effects are associated with increased dopaminergic activity (eg dyskinesia, nausea and vomiting), and most often occur at the beginning of treatment, reducing the dose of levodopa, which reduces the severity and frequency of dopaminergic reactions. Very few undesirable effects, including diarrhea and reddish brown discoloration in urine, are known to be directly related to the active substance entacapone. In some cases, entacapone may cause discoloration of the skin, nail and sweat. Other adverse effects indicated above by asterisks are based on individual case safety reports, which are more common in the clinical trial data compared to levodopa / DDK alone (compared to at least 1% frequency difference) or after entacapone is released.

Convulsions with levodopa / carbidopa were rare; however, a causal relationship with levodopa / carbidopa treatment has not been demonstrated.

4.9. Overdosage and treatment The

post-marketing data also included isolated overdose cases and the highest reported daily levodopa and entacapone doses were at least 10,000 mg and 40,000 mg, respectively. The acute symptoms and symptoms of these overdose cases included agitation, confusional state, coma, bradycardia, ventricular tachycardia, Cheyne-Stokes respiration, color change of the skin, tongue and conjunctiva, and chromaticity. What should be done in acute overdose with STALEVO treatment is similar to what should be done in acute overdose by levodopa. Hospitalization is recommended; Supportive general measures should be taken with immediate gastric lavage and occasional repeated doses of coal. These accelerate the elimination of entacapone, particularly by reducing absorption and reabsorption in the gastrointestinal tract. Respiratory, circulatory systems and the adequacy of the renal system should be carefully monitored and appropriate supportive measures should be taken. ECG monitoring should be initiated and the patient should be carefully monitored for the possibility of arrhythmia. If necessary, an appropriate anti-arrhythmic treatment should be performed. The possibility of taking other active substances other than STALEVO should be considered. The role of dialysis in the treatment of overdose is unknown.

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