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Stalevo 75/18,75/200 Mg 100 Tablets ingredients levodopa+ carbidopa+entacapone

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4.1. Therapeutic indications

4.2. Posology and route of administration

Posology:

Each STALEVO tablet should be taken orally, with or without nutrients. (See section 5.2 Pharmacokinetic properties). A tablet contains a treatment dose and the tablets should always be administered without dividing into a full tablet.

Frequency and duration of:

administrationUnless otherwise recommended by the doctor;

The optimal daily dose of STALEVO should be determined by careful titration in each patient. The daily dose of STALEVO is one of the preferred dosages of STALEVO tablets (50 / 12.5 / 200 mg, 75 / 18.75 / 200 mg, 100/25/200 mg, 125 / 31.25 / 200 mg, 150 / 37.5 / 200 mg or 200 / 50/200 mg levodopa / carbidopa / entacapone).

Patients should be told to take only one STALEVO tablet each time the tablet dose is administered. Experience with a total dose of 200 mg of carbidopa per day is limited, but nausea and vomiting are more likely to occur in patients who receive less than 70-100 mg carbidopa in one day. The recommended maximum daily dose of entacapone is 2000 mg, the maximum dose of STALEVO, STALEVO 50 / 12.5 / 200 mg, 75 / 18.75 / 200 mg, 100/25/200 mg, 125 / 31.25 / 200 mg and 150 / 37.5 / 200 mg film-coated tablets 10 tablets per day.

Ten (10) tablets of STALEVO 150 / 37.5 / 200 mg are equal to 375 mg of carbidopa per day. Accordingly, when the maximum recommended daily dose of carbidopa is 375 mg, the maximum daily dose of STALEVO 200/50/200 mg is 7 tablets per day.

The maximum daily dose of levodopa during STALEVO treatment should not exceed 1500 mg.

Starting with STALEVO Therapy

Levodopa / Dopa decarboxylase inhibitor (DDD) (carbidopa or benserazide) preparations and patients receiving Entacapon tablets are transferred to STALEVO application:

STALEVO is generally intended for use in patients treated with the corresponding standard release levodopa / DDK inhibitor and entacapone doses.

As in levodopa / carbidopa, non-selective monoamine oxidase (MAO) inhibitors are contraindicated for use with STALEVO. These inhibitors should be discontinued at least two weeks before starting STALEVO therapy. STALEVO may be administered simultaneously with the doses recommended by the manufacturers of MAO inhibitors (eg, selegiline HCl) which have selectivity for MAO type B.

a) Patients who are currently treated with entacapone and standard-release levodopa / carbidopa in equal doses to the dose of STALEVO may be transferred directly to the corresponding STALEVO tablet application.

b) 50 / 12.5 / 200 mg (or 75 / 18.75 / 200 mg, 100/25/200 mg, 125 / 31.25 / 200 mg, 150 / 37.5 / 200 mg or 200/50/200 mg) to the STALEVO tablet When starting STALEVO in patients treated with unequal doses of standard-release levodopa / carbidopa and entacapone, the dose of STALEVO should be carefully titrated to obtain an optimal clinical response. The dose of STALEVO should initially be adjusted so that it is as close as possible to the total daily dose of levodopa used up to that time.

c) In the patients who are currently treated with standard release levodopa / benserazide and entacapone, STALEVO administration is initiated, the dose of levodopa / benserazide is terminated the previous night and STALEVO application is started the following morning. The same amount or slightly higher (5-10%) should be initiated with a dose of STALEVO to provide levodopa.

Patients who are not currently treated with Entakapon are transferred to STALEVO administration: As with

levodopa / carbidopa, non-selective monoamine oxidase (MAO) inhibitors are contraindicated for use with STALEVO. These inhibitors should be discontinued at least two weeks before starting STALEVO therapy. STALEVOofwhich have selectivity for MAO type B.

may be administered simultaneously with the doses recommended by the manufacturersMAO inhibitors (eg, selegiline HCl)

In patients with Parkinson's disease and end-of-the-line motor fluctuations that cannot be stabilized with standard release levodopa / DDK inhibitor therapy, STALEVO can be initiated at doses corresponding to the current treatment. However, direct transitions from levodopa / DDK inhibitor therapy to STALEVO are not recommended in patients with dyskinesia or daily levodopa dose greater than 800 mg. In such patients, entacapone therapy (entacapone tablet) should be used as a separate medication and, if necessary, levodopa doses should be adjusted before STALEVO.

Entacapone increases the effects of levodopa. Thus, in patients with dyskinesia, the dose of levodopa may need to be reduced by 10-30% over a period ranging from the first days after the start of STALEVO treatment to the first weeks. The daily dose of levodopa may be reduced by prolonging the dosage ranges according to the patient's clinical condition and / or by reducing the amount of levodopa per dose.

Adjustment of dosage during the course of treatment When

more levodopa is required, an increase in the frequency of doses and / or the use of an alternative STALEVO dosage should be considered within the scope of the dose recommendations mentioned in the Posology section.

If less levodopa is required, the total daily dose of STALEVO should be reduced by increasing the time between doses, by reducing the frequency of administration or by reducing the dosage of STALEVO in an administration.

If another levodopa product is used with STALEVO tablet application, the maximum dose recommendations should be followed.

Stopping STALEVO treatment

4.4. Special warnings and precautions for use

, rabdomioliza)

Application: For

oral use.

Additional information on specific populations:

Renal insufficiency: There is no reported specific study on the pharmacokinetics of levodopa and carbidopa in patients with renal insufficiency. Therefore, STALEVO therapy should be administered with caution to patients with severe renal failure, including those who undergo dialysis (see section

5.2 Pharmacokinetic Properties).

Hepatic impairment Patients with

mild to moderate hepatic impairment should be treated with caution when applying STALEVO. Dose reduction may be required. (See section 5.2. Pharmacokinetic properties). In case of severe liver failure is contraindicated.

The safety and efficacy of STALEVO in children under 18 years (children and adolescents) has not been demonstrated. No further data is available.

4.3. Contraindications

• A known hypersensitivity to levodopa, carbidopa or entacapone or any of the ingredients present in the formulation.

• Severe liver failure

• Narrow angle glaucoma

• Pheochromocytoma.

• The concomitant use of STALEVO with non-selective monoamine oxidase (MAO-A and MAO-B) inhibitors (eg phenelzine, tranylcypromine) is contraindicated.

• Concomitant use of a selective MAO-A inhibitor and a selective MAO-B inhibitor is also contraindicated for use with STALEVO. (See section 4.5 Interactions with other medicinal products and other forms of interaction, other antiparkinsonian drugs). These inhibitors should be discontinued at least two weeks before starting STALEVO therapy.

4.4. Special warnings and precautions for use

STALEVO is not recommended for the treatment of drug-induced extrapyramidal reactions.

STALEVO treatment should be applied to patients with ischemic heart disease, severe cardiovascular or pulmonary disease, patients with bronchial asthma, renal, hepatic or endocrine disease, or patients with a history of peptic ulcer disease or a history of convulsions.

Patients with a history of myocardial infarction and patients with residual atrial nodal or ventricular arrhythmias should be treated with levodopa. In such patients, cardiac function should be monitored with particular caution during the initial dosing period.

All patients treated with STALEVO should be carefully monitored for the possibility of developing mental changes (such as hallucinations and psychoses), depression associated with suicidal tendencies, and other serious antisocial behaviors. Patients with psychosis at present or in the past should be treated with caution.

Caution should be exercised when administering dopamine receptor-blocking antipsychotics, especially D2 receptor antagonists, simultaneously, and the patient should be carefully observed for the potential loss of STALEVO's anti-Parkinson effects or deterioration of Parkinson's symptoms.

Patients with chronic wide-angle glaucoma should be treated with STALEVO carefully and intraocular pressure should be controlled well and patients should be carefully monitored for pressure changes.

STALEVO may initiate orthostatic hypotension. Therefore, STALEVO should be administered with caution to patients using other drugs that may cause orthostatic hypotension.

4.7. Effects on tool and machine use

Clinical trials have shown undesirable dopaminergic effects, such as dyskinesia, in patients receiving entacapone and dopamine agonists (bromocriptine), selegiline, or amantadine, as compared to patients receiving placebo. When a patient who is not currently treated with entacapone is to be treated for STALEVO, an adjustment of the doses of other anti-Parkinson drugs may be necessary.

Rhabdomyolysis due to neuroleptic malignant syndrome (NMS) or dyskinesia has rarely been observed in patients with Parkinson's disease. Isolated cases of rhabdomyolysis have been reported with Entakapon treatment. NMS, including rhabdomyolysis and hyperthermia, is characterized by motor symptoms (rigidity, myoclonus, tremor), mental state changes (agitation, confusion, coma), hyperthermia, autonomic dysfunction (tachycardia, labile blood pressure) and elevated serum creatine phosphokinase level. . Only a fraction of these symptoms and / or findings may have occurred in each case. Early diagnosis is important for proper treatment of NMS. With the abrupt discontinuation of anti-Parkinson drugs, a syndrome similar to NMS has been reported which gives signs and symptoms, such as muscle rigidity, body temperature increase, mental changes, and elevated serum creatinine phosphokinase level. Isolated NMS cases have been reported, especially after sudden reduction or discontinuation of the entacapone.

If necessary, STALEVO or other dopaminergic therapies should be discontinued slowly, and if symptoms and / or symptoms occur after STALEVO is slowly discontinued, it may be necessary to increase the levodopa dose.

Physicians should be careful when deciding whether patients should switch from STALEVO to an entacapone-free levodopa / DDK inhibitor treatment. If necessary, STALEVO or other dopaminergic therapies should be discontinued slowly, and if signs and / or symptoms occur after STALEVO is slowly discontinued, it may be necessary to increase the dose of levodopa.

If general anesthesia is required, STALEVO treatment can be continued as long as oral fluid and drug intake is allowed. If the treatment should be stopped temporarily, STALEVO treatment may be resumed with the same daily dose as from the first moment of oral administration.

It is recommended that hepatic, hematopoietic, cardiovascular and renal functions should be evaluated periodically during long-term STALEVO treatment.

In patients with diarrhea, weight tracking is recommended in order to prevent possible excess body weight loss. Prolonged or stubborn diarrhea suspected to be associated with Stalevo may be a sign of colitis. In the case of prolonged or persistent diarrhea, medication should be discontinued and appropriate medical treatment and investigations should be performed.

Patients with progressive anorexia, asthenia and weight loss in a short period should be considered to undergo a general medical evaluation including liver function.

Pathological gambling, increased libido, and hypersexuality have been reported in Parkinson's patients treated with dopamine agonists and other dopaminergic drugs, including STALEVO.

If the dipstick is used to test the urinary ketone, Levodopa / carbidopa may cause a false positive result, and this reaction does not change by boiling the urine sample. The use of glucose oxidase methods may cause false negative results in terms of glycosuria.

4.5. Interactions with other medicinal products and other forms of interaction Interactions with

other anti-Parkinson drugs:

To date, there have been no signs of interactions that would interfere with the use of standard anti-Parkinson drugs with STALEVO treatment.

High doses of entacapone may affect carbidopa absorption. However, no interaction was observed with carbidopa in the recommended treatment program (200 mg entacapone 10 times a day). No interaction was observed between entacapone and selegiline in repeated dose studies with patients treated with Levodopa / DDK inhibitor Parkinson's patients. When used with STALEVO, the daily dose of selegiline should not exceed 10 mg.

Since STALEVO contains entacapone, it should not be used concurrently with Comtan (entacapone).

Care should be taken when applying the following active ingredients simultaneously with levodopa therapy.

Interactions with antihypertensive drugs:

Symptomatic postural hypotension may occur when levodopa is added to the treatment of patients currently being treated with antihypertensive drugs. Doses of antihypertensive agents may need to be adjusted.

Interactions with antidepressants:

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