GENERIC NAME OF THE MEDICINAL PRODUCT:

Ezetimibe+Simvastatin Tablet 10mg+10mg
Ezetimibe+Simvastatin Tablet 10mg+20mg
Ezetimibe+Simvastatin Tablet 10mg+40mg
Ezetimibe+Simvastatin Tablet 10mg+80mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

a) Ezetimibe+Simvastatin Tablet 10mg+10mg
Each Film coated Tablet contains:
Simvastatin IP…………………10mg
Ezetimibe……………………10mg
Excipients…………………………. Q.s.
Colours: Ferric Oxide (RED)

b) Ezetimibe+Simvastatin Tablet 10mg+20mg
Each Film coated Tablet contains:
Simvastatin IP…………………20mg
Ezetimibe……………………10mg
Excipients…………………………. Q.s.
Colours: Pigment yellow 3

c) Ezetimibe+Simvastatin Tablet 10mg+40mg
Each Film coated Tablet contains:
Simvastatin IP…………………40mg
Ezetimibe……………………10mg
Excipients…………………………. Q.s.
Colours: Red oxide of iron

d) Ezetimibe+Simvastatin Tablet 10mg+80mg
Each Film coated Tablet contains:
Simvastatin IP…………………80mg
Ezetimibe……………………10mg
Excipients…………………………. Q.s.
Colours: Ponceau 4 R

THERAPEUTIC INDICATIONS:

Ezetimibe and simvastatin is a combination medicine that is used to lower blood levels of "bad" cholesterol (low-density lipoprotein, or LDL), to increase levels of "good" cholesterol (high-density lipoprotein, or HDL), and to lower triglycerides (a type of fat in the blood).

CAUTION & WARNING:

CAUTION:
Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
SCHEDULE “H” Prescription Drug -Warning: Not to be sold by retail without the prescription of a Registered Medical Prescriber.

STORAGE & DOSAGE:

Storage: Protect form moisture at a temperature not exceeding 30˚C.Do not freeze. Keep the container tightly closed in order to protect from moisture.
Dosage: As directed by the Physician.

Ezetimibe+Simvastatin Tablet  10mg+40mg Technical Specification:

Product Name:
 Ezetimibe+Simvastatin Tablet
Brand Name: Generics
Strength: (10mg+10mg), (10mg+20mg), (10mg+40mg), (10mg+80mg)
Dosage Form: Tablets (Film-coated)
Route of Administration: Via oral Route
Packing: 40s, 90s, 100s
Pack Insert/Leaflet: PIL (Patient Information Leaflet)
Regulatory Documents: COA, MOA, Stability Studies, GMP
Therapeutic use: Antihyperlipidemic, Cardiology
Indication: Ezetimibe and simvastatin is a combination medicine that is used to lower blood levels of “bad” cholesterol (low-density lipoprotein, or LDL), to increase levels of “good” cholesterol (high-density lipoprotein, or HDL), and to lower triglycerides (a type of fat in the blood).
Storage: Protect form moisture at a temperature not exceeding 30˚C.Do not freeze. Keep the container tightly closed in order to protect from moisture.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Ezetimibe+Simvastatin Tablet 10mg+10mg
  • Ezetimibe+Simvastatin Tablet 10mg+20mg
  • Ezetimibe+Simvastatin Tablet 10mg+40mg
  • Ezetimibe+Simvastatin Tablet 10mg+80mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • a) Ezetimibe+Simvastatin Tablet 10mg+10mg
    Each Film coated Tablet contains:
    Simvastatin IP…………………10mg
    Ezetimibe……………………10mg
    Excipients…………………………. Q.s.
    Colours: Ferric Oxide (RED)
  • b) Ezetimibe+Simvastatin Tablet 10mg+20mg
    Each Film coated Tablet contains:
    Simvastatin IP…………………20mg
    Ezetimibe……………………10mg
    Excipients…………………………. Q.s.
    Colours: Pigment yellow 3
  • c) Ezetimibe+Simvastatin Tablet 10mg+40mg
    Each Film coated Tablet contains:
    Simvastatin IP…………………40mg
    Ezetimibe……………………10mg
    Excipients…………………………. Q.s.
    Colours: Red oxide of iron
  • d) Ezetimibe+Simvastatin Tablet 10mg+80mg
    Each Film coated Tablet contains:
    Simvastatin IP…………………80mg
    Ezetimibe……………………10mg
    Excipients…………………………. Q.s.
    Colours: Ponceau 4 R

THERAPEUTIC INDICATIONS:

  • Ezetimibe and simvastatin is a combination medicine that is used to lower blood levels of “bad” cholesterol (low-density lipoprotein, or LDL), to increase levels of “good” cholesterol (high-density lipoprotein, or HDL), and to lower triglycerides (a type of fat in the blood).

CAUTION & WARNING:

  • CAUTION:
    Read enclosed leaflet before use.
    Keep medicine out of reach of children.
    SWALLOW WHOLE DO NOT CHEW OR CRUSH
  • SCHEDULE “H” Prescription Drug -Warning: Not to be sold by retail without the prescription of a Registered Medical Prescriber.

STORAGE & DOSAGE:

  • Storage:  Protect form moisture at a temperature not exceeding 30˚C.Do not freeze. Keep the container tightly closed in order to protect from moisture.
  • Dosage:  As directed by the Physician.