Tricor tablets film-coated

Land: Armenië

Taal: Engels

Bron: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Werkstoffen:

fenofibrate

Beschikbaar vanaf:

Recipharm Fontaine

ATC-code:

C10AB05

INN (Algemene Internationale Benaming):

fenofibrate

Dosering:

145mg

farmaceutische vorm:

tablets film-coated

Eenheden in pakket:

(30/3x10/) in blister

Prescription-type:

Prescription

Autorisatie-status:

Registered

Autorisatie datum:

2023-02-06

Productkenmerken

MASTER OF SUMMARY OF PRODUCT CHARACTERISTIC (SMPC)
FENOFIBRATE
This Information is Confidential
Page 1 of 11
1.
NAME OF THE MEDICINAL PRODUCT
Tricor® 145 mg, film-coated tablet
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Tricor® 145 mg:
Each tablet contains 145.0 mg fenofibrate (nanoparticles).
For a full list of excipients, see Section 6.1.
3.
PHARMACEUTICAL FORM
Film coated tablet.
Tricor® 145 mg: White, oblong, film-coated tablets engraved “145”
on one side and “Fournier logo” on the
other side.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Tricor® is indicated as an adjunct to diet and other
non-pharmacological treatment (e.g. exercise, weight
reduction) for the following:
-
Treatment of severe hypertriglyceridaemia with or without low HDL
cholesterol.
-
Mixed hyperlipidaemia when a statin is contraindicated or not
tolerated.
-
Mixed hyperlipidaemia in patients at high cardiovascular risk in
addition to a statin when triglycerides and
HDL cholesterol are not adequately controlled.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Response to therapy should be monitored by determination of serum
lipid values. If an adequate response
has not been achieved after several months (e.g. 3 months),
complementary or different therapeutic measures
should be considered.
Film-coated
tablet
may
be
given
at
any
time
of
the
day,
with
or
without
food
(see
section
5.2.
Pharmacokinetic properties). Tablet should be swallowed whole with a
glass of water.
The recommended dose is one tablet containing 145 mg fenofibrate taken
once daily. Patients currently
taking one 200 mg capsule (or one 160 mg tablet) can be changed to one
145 mg fenofibrate tablet without
further dose adjustment.
In case of missing the next dose, the next dose should be taken at the
usual time the next day. Do not take a
double dose to make up for a forgotten dose.
_Geriatric population _
In elderly patients, without renal impairment, the usual adult dose is
recommended.
_Pediatric population _
The safety and efficacy of fenofibrate in children an