GENERIC NAME OF THE MEDICINAL PRODUCT:

Rosuvastatin Calcium+Fenofibrate Tablets IP 5mg+67mg
Rosuvastatin Calcium+Fenofibrate Tablets IP 10mg+67mg
Rosuvastatin Calcium+Fenofibrate Tablets IP 10mg+145mg
Rosuvastatin Calcium+Fenofibrate Tablets IP 5mg+145mg
Rosuvastatin Calcium+Fenofibrate Tablets IP 10mg+160mg
Rosuvastatin Calcium+Fenofibrate Tablets IP 20mg+160mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

a) Rosuvastatin Calcium+Fenofibrate Tablet IP 5mg+67mg
Each Film coated Tablet contains:
Rosuvastin Calcium IP
Eq. to Rosuvastin…………………5mg
Fenofibrate IP……………………67mg
Excipients…………………………. Q.s.
Colours: Ferric Oxide (red)

b) Rosuvastatin Calcium+Fenofibrate Tablet IP 10mg+67mg
Each Film coated Tablet contains:
Rosuvastin Calcium IP
Eq. to Rosuvastin…………………10mg
Fenofibrate IP……………………67mg
Excipients…………………………. Q.s.
Colours: Pigment yellow 3

c) Rosuvastatin Calcium+Fenofibrate Tablet IP 10mg+145mg
Each Film coated Tablet contains:
Rosuvastin Calcium IP
Eq. to Rosuvastin…………………10mg
Fenofibrate IP……………………145mg
Excipients…………………………. Q.s.
Colours: Red oxide of iron

d) Rosuvastatin Calcium+Fenofibrate Tablet IP 5mg+145mg
Each Film coated Tablet contains:
Rosuvastin Calcium IP
Eq. to Rosuvastin…………………5mg
Fenofibrate IP……………………145mg
Excipients…………………………. Q.s.
Colours: Indigo Carmine

e) Rosuvastatin Calcium+Fenofibrate Tablet IP 10mg+160mg
Each Film coated Tablet contains:
Rosuvastin Calcium IP
Eq. to Rosuvastin…………………10mg
Fenofibrate IP……………………160mg
Excipients…………………………. Q.s.
Colours: Quinoline Yellow

f) Rosuvastatin Calcium+Fenofibrate Tablet IP 20mg+160mg
Each Film coated Tablet contains:
Rosuvastin Calcium IP
Eq. to Rosuvastin…………………20mg
Fenofibrate IP……………………160mg
Excipients…………………………. Q.s.
Colours: Ferric Oxide (Yellow)

THERAPEUTIC INDICATIONS:

Rosuvastatin Calcium Fenofibrate is used together with a proper diet to reduce and treat high cholesterol and triglyceride (fat-like substances) levels in the blood. This may help prevent the development of pancreatitis (inflammation or swelling of the pancreas) caused by high levels of triglycerides in the blood.

CAUTION & SCHEDULE:

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.

Rosuvastatin Calcium + Fenofibrate Tablets IP (10mg+67mg) Technical Specification:

Product Name:        Rosuvastatin Calcium + Fenofibrate Tablets IP
Brand Name: Generics
Strength: (5mg+67mg), (10mg+67mg), (10mg+145mg), (5mg+145mg), (10mg+160mg), (20mg+160mg)
Dosage Form: Tablets (Film coated)
Route of Administration: Via oral Route
Packing: 30s, 90s, 100s
Pack Insert/Leaflet: PIL (Patient Information Leaflet)
Regulatory Documents: COA, MOA, Stability Studies, GMP
Therapeutic use: Antilipemic agents, Antihyperlipidemic, Lipid-Lowering Agents, Statins.
Indication: Fenofibrate is used together with a proper diet to reduce and treat high cholesterol and triglyceride (fat-like substances) levels in the blood. This may help prevent the development of pancreatitis (inflammation or swelling of the pancreas) caused by high levels of triglycerides 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:

  • Rosuvastatin Calcium+ Fenofibrate Tablets IP 10mg+67mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Rosuvastatin Calcium+ Fenofibrate Tablet IP (10mg+67mg)
    Each Film coated Tablet contains:
    Rosuvastin Calcium IP
    Eq. to Rosuvastin…………………10mg
    Fenofibrate IP……………………67mg
    Excipients…………………………. Q.s.
    Colours: Pigment yellow 3

THERAPEUTIC INDICATIONS:

Rosuvastatin Calcium Fenofibrate is used together with a proper diet to reduce and treat high cholesterol and triglyceride (fat-like substances) levels in the blood. This may help prevent the development of pancreatitis (inflammation or swelling of the pancreas) caused by high levels of triglycerides 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.