GENERIC NAME OF THE MEDICINAL PRODUCT:

Rosuvastatin+Ezetimibe Tablet 5mg+10mg
Rosuvastatin+Ezetimibe Tablet 10mg+10mg
Rosuvastatin+Ezetimibe Tablet 20mg+10mg
Rosuvastatin+Ezetimibe Tablet 40mg+10mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

a) Rosuvastatin+Ezetimibe Tablet 5mg+10mg
Each Film coated Tablet contains:
Rosuvastin Calcium
Eq. to Rosuvastin…………………5mg
Ezetimibe……………………10mg
Excipients…………………………. Q.s.
Colours: Ferric Oxide (RED)

b) Rosuvastatin+Ezetimibe Tablet 10mg+10mg
Each Film coated Tablet contains:
Rosuvastin Calcium
Eq. to Rosuvastin…………………10mg
Ezetimibe……………………10mg
Excipients…………………………. Q.s.
Colours: Pigment yellow 3

c) Rosuvastatin+Ezetimibe Tablet 20mg+10mg
Each Film coated Tablet contains:
Rosuvastin Calcium
Eq. to Rosuvastin…………………20mg
Ezetimibe……………………10mg
Excipients…………………………. Q.s.
Colours: Red oxide of iron

d) Rosuvastatin+Ezetimibe Tablet 40mg+10mg
Each Film coated Tablet contains:
Rosuvastin Calcium
Eq. to Rosuvastin…………………40mg
Ezetimibe……………………10mg
Excipients…………………………. Q.s.
Colours: Ponceau 4 R

THERAPEUTIC INDICATIONS:

Rosuvastatin and ezetimibe combination is used together with a proper diet to lower bad cholesterol (LDL) in the blood. It is also used alone or together with other medicines to treat homozygous familial hypercholesterolemia (HoFH).

CAUTION & WARNING:

CAUTION:
Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.

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: As directed by the Physician.
Attach dispensing label as per end county.

Rosuvastatin+Ezetimibe Tablet 5mg+10mg Technical Specification:

Product Name:                              Rosuvastatin+Ezetimibe Tablet
Brand Name: Generics
Strength: (5mg+10mg), (10mg+10mg), (20mg+10mg), (40mg+10mg)
Dosage Form: Tablets (Film-coated)
Route of Administration: Via oral Route
Packing: 40s, 90s, 100s
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, Cardiology
Indication: Rosuvastatin and ezetimibe combination is used together with a proper diet to lower bad cholesterol (LDL) in the blood. It is also used alone or together with other medicines to treat homozygous familial hypercholesterolemia (HoFH).
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:

  • Rosuvastatin+Ezetimibe Tablet 5mg+10mg
  • Rosuvastatin+Ezetimibe Tablet 10mg+10mg
  • Rosuvastatin+Ezetimibe Tablet 20mg+10mg
  • Rosuvastatin+Ezetimibe Tablet 40mg+10mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • a) Rosuvastatin+Ezetimibe Tablet 5mg+10mg
    Each Film coated Tablet contains:
    Rosuvastin Calcium
    Eq. to Rosuvastin…………………5mg
    Ezetimibe……………………10mg
    Excipients…………………………. Q.s.
    Colours: Ferric Oxide (RED)
  • b) Rosuvastatin+Ezetimibe Tablet 10mg+10mg
    Each Film coated Tablet contains:
    Rosuvastin Calcium
    Eq. to Rosuvastin…………………10mg
    Ezetimibe……………………10mg
    Excipients…………………………. Q.s.
    Colours: Pigment yellow 3
  • c) Rosuvastatin+Ezetimibe Tablet 20mg+10mg
    Each Film coated Tablet contains:
    Rosuvastin Calcium
    Eq. to Rosuvastin…………………20mg
    Ezetimibe……………………10mg
    Excipients…………………………. Q.s.
    Colours: Red oxide of iron
  • d) Rosuvastatin+Ezetimibe Tablet 40mg+10mg
    Each Film coated Tablet contains:
    Rosuvastin Calcium
    Eq. to Rosuvastin…………………40mg
    Ezetimibe……………………10mg
    Excipients…………………………. Q.s.
    Colours: Ponceau 4 R

THERAPEUTIC INDICATIONS:

  • Rosuvastatin and ezetimibe combination is used together with a proper diet to lower bad cholesterol (LDL) in the blood. It is also used alone or together with other medicines to treat homozygous familial hypercholesterolemia (HoFH).

CAUTION & WARNING:

  • CAUTION:
    Read enclosed leaflet before use.
    Keep medicine out of reach of children.
    SWALLOW WHOLE DO NOT CHEW OR CRUSH
  • Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.

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:  As directed by the Physician.
Attach dispensing label as per end county.