Simvastatin Tablets IP 10mg
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Simvastatin Tablets IP 10mg Technical specifications:

Product Name:Simvastatin Tablets IP 10mg
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)
Regulatory Documents:COA, MOA, Stability Studies, GMP
Therapeutic use:Antihyperlipidemic, Anti-hypertensive, 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:Store at a temperature not exceeding 30˚C. Protect from moisture.

GENERIC NAME OF THE MEDICINAL PRODUCT:

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Simvastatin Tablets IP 5mg
    Each film-coated tablet contains:
    Simvastatin IP………………05mg
    Excipients……………….………. q.s
    Colours: Ferric Oxide (Red) USF-NF and Titanium Dioxide IP
  • Simvastatin Tablets IP 10mg
    Each film-coated tablet contains:
    Simvastatin IP……………….10mg
    Excipients……………………………q.s
    Colours: Ferric Oxide (Yellow) USF-NF and Titanium Dioxide IP
  • Simvastatin Tablets IP 20mg
    Each film-coated tablet contains:
    Simvastatin IP……………….20mg
    Excipients: ………………………q.s
    Colours: Ferric Oxide (Red) USF-NF and Titanium Dioxide IP
  • Simvastatin Tablets IP 40mg
    Each film-coated tablet contains:
    Simvastatin IP …………………. 40mg
    Excipients……………………………q.s
    Colours: Ferric Oxide (Yellow) USF-NF and Titanium Dioxide IP
  • Simvastatin Tablets IP 80mg
    Each film-coated tablet contains:
    Simvastatin IP……………….80mg
    Excipients: ……………………… q.s
    Colours: Ferric Oxide (Red) USF-NF and Titanium Dioxide IP

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:

Read the enclosed leaflet before use.

Keep the medicine out of reach of children.

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

SCHEDULE “H” Prescription Drug -Warning:  Not to be sold by retail without the prescription of a Registered Medical Prescriber. 

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

STORAGE & DOSAGE:

Storage:  Store at a temperature not exceeding 30˚C. Protect from moisture.

Dosage: As directed by the Physician.

GENERIC NAME OF THE MEDICINAL PRODUCT:

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

QUALITATIVE AND QUANTITATIVE COMPOSITION:

a) Simvastatin Tablets IP 5mg
Each film-coated tablet contains:
Simvastatin IP………………05mg
Excipients……………….………. q.s
Colours: Ferric Oxide (Red) USF-NF and Titanium Dioxide IP

b) Simvastatin Tablets IP 10mg
Each film-coated tablet contains:
Simvastatin IP……………….10mg
Excipients………………………… q.s
Colours: Ferric Oxide (Yellow) USF-NF and Titanium Dioxide IP

c) Simvastatin Tablets IP 20mg
Each film-coated tablet contains:
Simvastatin IP……………….20mg
Excipients: …………………………. q.s
Colours: Ferric Oxide (Red) USF-NF and Titanium Dioxide IP

d) Simvastatin Tablets IP 40mg
Each film-coated tablet contains:
Simvastatin IP …………………. 40mg
Excipients……………………………. q.s
Colours: Ferric Oxide (Yellow) USF-NF and Titanium Dioxide IP

e) Simvastatin Tablets IP 80mg
Each film-coated tablet contains:
Simvastatin IP……………….80mg
Excipients: ………………………… q.s
Colours: Ferric Oxide (Red) USF-NF and Titanium Dioxide IP

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:
Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
USING THIS MEDICINE WHILE YOU ARE PREGNANT CAN HARM YOUR UNBORN BABY.

SCHEDULE “H” Prescription Drug -Warning: Not to be sold by retail without the prescription of a Registered Medical Prescriber.
Any unused product or waste material should be disposed of in accordance with local requirements.

STORAGE & DOSAGE:

Storage: Store at a temperature not exceeding 30˚C. Protect from moisture.

Dosage: As directed by the Physician.