GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Simvastatin Tablets USP 5mg
B. Simvastatin Tablets USP 10mg
C. Simvastatin Tablets USP 20mg
D. Simvastatin Tablets USP 40mg
E. Simvastatin Tablets USP 80mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

a) Simvastatin Tablets USP 5mg
Each film-coated tablets contains:
Simvastatin USP………………5mg
Excipients……………….………. Q.S.
Colours: Titanium Dioxide

b) Simvastatin Tablets USP 10mg
Each film-coated tablets contains:
Simvastatin USP……………….10mg
Excipients……………………………Q.S.
Colours: Iron Oxide Red

c) Simvastatin Tablets USP 20mg
Each film-coated tablets contains:
Simvastatin USP……………….20mg
Excipients: …………………………. Q.S.
Colours: Iron Oxide Yellow

d) Simvastatin Tablets USP 40mg
Each film-coated tablets contains:
Simvastatin USP …………………. 40mg
Excipients……………………………. Q.S.
Colours: Iron Oxide Black


e) Simvastatin Tablets USP 80mg
Each film-coated tablets contains:
Simvastatin USP……………….80mg
Excipients: …………………………. Q.S.
Colours: Quinoline Yellow

THERAPEUTIC INDICATIONS:

Simvastatin is used together with diet, weight-loss, and exercise to reduce the risk of heart attack and stroke and to decrease the chance that heart surgery will be needed in people who have heart disease or who are at risk of developing heart disease.

CAUTION & WARNING:

CAUTION: USING THIS MEDICINE WHILE YOU ARE PREGNANT CAN HARM YOUR UNBORN BABY.
Read enclosed leaflet before use.
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
Any unused product or waste material should be disposed of in accordance with local requirements.

STORAGE & DOSAGE:

Storage: Controlled room temperature medications must be stored between 68°F and 77°F (20°C and 25°C), with some allowances for temporary excursions.
Keep the container tightly closed in order to protect from moisture.
Dosage:
Usual dosage range: 5-40mg orally once/day
Initial: 10-20mg orally once/day in the evening
Patients at high CHD risk: start 40mg/day
Children under 10 years: Safety & efficacy not established.
Attach dispensing label as per end country.

Simvastatin Tablets USP 40mg Technical specifications:

Product Name:Simvastatin Tablets USP 40mg
Brand Name:Generics
Strength:5mg, 10mg, 20mg, 40mg, 80mg
Dosage Form:Tablets (Film-coated)
Route of Administration:Via oral route
Packing:30s, 90s, 500s
Pack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents:COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use:Antihyperlipidemic, Anti-hypertensive, Cardiology, Cardiovascular.
Indication: Simvastatin is used together with diet, weight-loss, and exercise to reduce the risk of heart attack and stroke and to decrease the chance that heart surgery will be needed in people who have heart disease or who are at risk of developing heart disease.
Storage:Controlled room temperature medications must be stored between 68°F and 77°F (20°C and 25°C), with some allowances for temporary excursions. Keep the container tightly closed in order to protect from moisture.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Simvastatin Tablets USP 40mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Simvastatin Tablets USP 40mg
    Each film-coated tablets contains:
    Simvastatin USP………………40mg
    Excipients……………….………. Q.S.
    Colours: Iron Oxide Black

THERAPEUTIC INDICATIONS:

Simvastatin is used together with diet, weight-loss, and exercise to reduce the risk of heart attack and stroke and to decrease the chance that heart surgery will be needed in people who have heart disease or who are at risk of developing heart disease.

CAUTION & WARNING:

CAUTION: Using this medicine while you are pregnant can harm your unborn baby.

Read enclosed leaflet before use.

Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.

Keep medicine out of reach of children.

Any unused product or waste material should be disposed of in accordance with local requirements.

STORAGE & DOSAGE:

Storage:  Controlled room temperature medications must be stored between 68°F and 77°F (20°C and 25°C), with some allowances for temporary excursions. Keep the container tightly closed in order to protect from moisture.

Dosage:
Usual dosage range: 5-40mg orally once/day
Initial: 10-20mg orally once/day in the evening
Patients at high CHD risk: start 40mg/day
Children under 10 years: Safety & efficacy not established.

Attach dispensing label as per end country.