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Sindranol® (Tablets) Instructions for Use

ATC Code

N04BC04 (Ropinirole)

Active Substance

Ropinirole (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Antiparkinsonian drug – dopamine agonist

Pharmacotherapeutic Group

Antiparkinsonian agent, dopamine agonist

Pharmacological Action

Antiparkinsonian agent, a non-ergoline dopamine receptor agonist. It is structurally similar to dopamine and binds particularly actively to D2 and D3 receptor subtypes, acting, including on presynaptic autoreceptors.

In the early stage of Parkinson’s disease, Ropinirole is not inferior in efficacy to levodopa and is more effective than bromocriptine.

During a 3-year study, Ropinirole provided adequate correction of antiparkinsonian symptoms in 60% of patients.

In the late stage of Parkinson’s disease, Ropinirole in combination with levodopa reduced the duration of the “off” period by 12% and allowed a reduction in the levodopa dose by 31%.

Pharmacokinetics

After oral administration, it is rapidly absorbed from the gastrointestinal tract.

Cmax in blood plasma is reached within 1-2 hours.

Bioavailability is about 85%.

Plasma protein binding is about 40%.

It is metabolized in the liver to form inactive metabolites.

Vd is 7.5 L/kg.

Indications

Parkinson’s disease.

ICD codes

ICD-10 code Indication
G20 Parkinson's disease
ICD-11 code Indication
8A00.0Z Parkinson's disease, unspecified
8A0Y Other specified movement disorders
LD90.1 Early-onset parkinsonism-mental retardation

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Tablets

Take orally. During week 1 – 25 mcg 3 times/day, during week 2 – 500 mcg 3 times/day, during week 3 – 750 mcg 3 times/day, during week 4 – 1 mg 3 times/day.

Subsequently, the dose can be increased by 0.5-1 mg 3 times/day (1.5-3 mg/day).

The therapeutic effect is usually achieved at doses of 3-9 mg/day.

If the symptoms of the disease do not disappear, the dose can be increased to 24 mg/day.

Adverse Reactions

From the nervous system dizziness, drowsiness, nervousness, behavioral disorders, hypersexuality, psychotic reactions, sudden falling asleep, hallucinations, dyskinesia.

From the digestive system dyspeptic reactions (including nausea, heartburn), dry mouth, constipation, vomiting.

From the musculoskeletal system arthralgia, myalgia.

From the cardiovascular system: orthostatic hypotension, arterial hypertension.

From the respiratory system bronchitis, nasopharyngitis.

Other increased sweating, hypersensitivity reactions, chest pain.

Contraindications

Severe renal failure, severe hepatic failure, pregnancy, lactation (breastfeeding), hypersensitivity to ropinirole.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy and lactation (breastfeeding).

Use in Hepatic Impairment

Contraindicated in severe hepatic failure.

Use in Renal Impairment

Contraindicated in severe renal failure.

Pediatric Use

Not recommended for use in children and adolescents under 18 years of age.

Special Precautions

Ropinirole should be used with caution and only in cases where the expected benefit of therapy outweighs the potential risk in patients with mental disorders (including history), with neuroleptic-induced akathisia, in high doses, and in severe cardiovascular diseases.

Discontinuation of therapy should be gradual, by reducing the dose. When resuming treatment, dose titration should be performed.

Heart rate should be monitored during treatment.

Not recommended for use in children and adolescents under 18 years of age.

Effect on ability to drive vehicles and operate machinery

Caution should be exercised in patients who drive vehicles and engage in other potentially hazardous activities.

Drug Interactions

With simultaneous use with estrogens, ciprofloxacin, enoxacin and other fluoroquinolones, the plasma concentration of ropinirole increases.

Manifestations of drug interaction are possible with simultaneous use with neuroleptics, other centrally acting dopamine antagonists (including with sulpiride, metoclopramide).

With simultaneous use with drugs that are inhibitors or inducers of the CYP1A2 isoenzyme, a change in the clearance of ropinirole is possible (when prescribing or discontinuing therapy with these drugs, adjustment of the ropinirole dose is required).

With simultaneous use with levodopa, its Cmax at steady state may increase by 20%.

Ropinirole may potentiate the dopaminergic side effects of levodopa and may cause and/or worsen existing dyskinesia in patients with Parkinson’s disease receiving levodopa (a reduction in the levodopa dose is recommended).

With simultaneous use with estrogens in higher doses (during hormone replacement therapy), the clearance of ropinirole decreases by approximately 35% (when prescribing or discontinuing estrogen therapy, adjustment of the ropinirole dose may be required).

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Marketing Authorization Holder

Egis Pharmaceuticals PLC (Hungary)

Manufactured By

Pharmathen International, S.A. (Greece)

Dosage Form

Bottle Rx Icon Sindranol® Prolonged-release film-coated tablets, 2 mg: 28, 56 or 84 pcs.

Dosage Form, Packaging, and Composition

Prolonged-release film-coated tablets pink, round, biconvex; the core is almost white in cross-section.

1 tab.
Ropinirole hydrochloride 2.28 mg,
   Equivalent to ropinirole content 2 mg

Excipients : copolymer of methyl methacrylate, trimethylammonioethyl methacrylate chloride and ethyl acrylate [2:0.1:1] – 5.28 mg, hypromellose – 89.955 mg, sodium lauryl sulfate – 6.75 mg, copovidone – 44.64 mg, magnesium stearate – 1.095 mg.

Shell composition: opadry II pink 32K14834 – 4.5 mg (lactose monohydrate 40% – 1.8 mg, hypromellose-2910 (hypromellose-15cP) 28% – 1.26 mg, titanium dioxide 23.46% – 1.0557 mg, triacetin 8% – 0.36 mg, iron oxide red dye 0.54% – 0.0243 mg).

14 pcs. – blisters (2) – cardboard packs.
14 pcs. – blisters (4) – cardboard packs.
14 pcs. – blisters (6) – cardboard packs.

Marketing Authorization Holder

Egis Pharmaceuticals PLC (Hungary)

Manufactured By

Pharmathen International, S.A. (Greece)

Dosage Form

Bottle Rx Icon Sindranol® Prolonged-release film-coated tablets, 4 mg: 28, 56 or 84 pcs.

Dosage Form, Packaging, and Composition

Prolonged-release film-coated tablets light brown, oblong, biconvex; the core is almost white in cross-section.

1 tab.
Ropinirole hydrochloride 4.56 mg,
   Equivalent to ropinirole content 4 mg

Excipients : copolymer of methyl methacrylate, trimethylammonioethyl methacrylate chloride and ethyl acrylate [2:0.1:1] – 10.56 mg, hypromellose – 179.91 mg, sodium lauryl sulfate – 13.5 mg, copovidone – 89.28 mg, magnesium stearate – 2.19 mg.

Shell composition: opadry yellowish-brown OY-27207 – 9 mg (hypromellose-2910 (hypromellose-6cP) 62.5% – 5.625 mg, titanium dioxide 21.25% – 1.9125 mg, sunset yellow FCF aluminum lake (FD&C yellow #6) (E110) 9% – 0.81 mg, macrogol-400 6.25% – 0.5625 mg, indigo carmine aluminum lake (FD&C blue #2) (E132) 1% – 0.09 mg).

14 pcs. – blisters (2) – cardboard packs.
14 pcs. – blisters (4) – cardboard packs.
14 pcs. – blisters (6) – cardboard packs.

Marketing Authorization Holder

Egis Pharmaceuticals PLC (Hungary)

Manufactured By

Pharmathen International, S.A. (Greece)

Dosage Form

Bottle Rx Icon Sindranol® Prolonged-release film-coated tablets, 8 mg: 28, 56 or 84 pcs.

Dosage Form, Packaging, and Composition

Prolonged-release film-coated tablets reddish-brown, oblong, biconvex; the core is almost white in cross-section.

1 tab.
Ropinirole hydrochloride 9.121 mg,
   Equivalent to ropinirole content 8 mg

Excipients : copolymer of methyl methacrylate, trimethylammonioethyl methacrylate chloride and ethyl acrylate [2:0.1:1] – 21.12 mg, hypromellose – 359.819 mg, sodium lauryl sulfate – 27 mg, copovidone – 178.56 mg, magnesium stearate – 4.38 mg.

Shell composition: opadry red 03B25227 – 18 mg (hypromellose-2910 (hypromellose-6cP) 62.5% – 11.25 mg, titanium dioxide 24.19% – 4.3542 mg, macrogol-400 6.25% – 1.125 mg, iron oxide red dye 6.14% – 1.105 mg, iron oxide black dye 0.89% – 0.1602 mg, iron oxide yellow dye 0.03% – 0.0054 mg).

14 pcs. – blisters (2) – cardboard packs.
14 pcs. – blisters (4) – cardboard packs.
14 pcs. – blisters (6) – cardboard packs.

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