Fenofibrate, Fenorate 200mg Capsule

Product shot of Fenorate 200mg Capsule

THERAPEUTIC CATEGORY : Antihyperlipidemic Agent
STRENGTH : 200 mg capsule
SIZE : Box of 100s

FORMULATION
Each hard gelatin capsule contains Fenofibrate BP 200mg, Excipients – q.s.

INDICATION
Hypercholesterolaemia (type IIa) and endogenous hypertriglyceridaemia in adults, isolated (type IV) or Associated (Type IIb and III): - When an appropriate and assiduous diet has been followed but has not been sufficient, - Especially when the cholesterolaemia remains elevated after the diet, and/or When there are associated risk factors. It is always essential to continue the diet. Currently, there are no long-term controlled trials showing the efficacy of fenofibrate in the primary or secondary prevention of the omplications of atheorosclerosis.


DOSAGE AND ADMINISTRATION
The initial recommended dose is one capsule of fenofibrate 200mg taken daily food. However, in patients with severe dyslipidemia an increase dose of 200mg is recommended. Fenifibrate should be taken with food because it is less well absorbed from an empty stomach. Dietary measures instituted before therapy should be continued.

CONTRAINDICATION
This medical product should never be prescribed in the following situations:
hepatic insufficiency,
Renal Insufficiency,
In association with another fibrate.(
In Children
This medicine is usually not advised in association with inhibitors of HMG-Coa reductase.

PRECAUTION
If after period of administration of several months (3 to 6 months, a satisfactory eduction of serum lipids has not been obtained, a complementary or different therapeutic approach should be envisaged
If after period of administration of several months (3 to 6 months, a satisfactory eduction of serum lipids has not been obtained, a complementary or different therapeutic approach should be envisaged
Central Nervous System : Headache, dissiness
Gastrointestinal : Constipation, nausea, abdominal pain, diarrhea, dyspepsia, flatulence, vomiting. Serious clinically significant upper gastro-intestinal bleeding has been observed in patients receiving COXIV, although infrequently.
Respiratory System : Bronchitis, coughing, pharyngitis, rhinitis, sinusitis, upper respiratory tract infection.
Others: Arthralgia, back pain, insomia, myalgia, pain, peripheral pain, pruritus, tooth disorder, accidental injury allergy aggravated, flu-like symptoms, peripheral oedema, rash, urinary tract infection.

ADVERSE REACTION
- As with other fibrates, cases of muscle involvements (diffuse, myalgia, painful sensations, and weakness) ass well rare cases of rhabdomyyolysis, sometimes severe, have been reported. They are most often reversible when treatment is stopped. - Other, less frequent and of moderately intense adverse events have also been reported: gastric or intestinal digestive disorders, such as dyspepsia, elevated transaminases, skin allergic reactions. - To date there are no controlled studies to globally assess adverse events on the long term and more especially the risk of cholelithiasis.

AVAILABILITY
Fenofibrate (Fenorate) available in 10 blister strips containing 10 hard gelatin capsules packed in printed duplex carton. Box of 100s.

STORAGE
Store at temperatures not exceeding 30° C. Keep in a dry place. Protect from light.

Tricor alternative, Trilipix alternative