SUVEZEN 20 mg10 mg FILM-COATED TABLETS

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Ezetimibe; Rosuvastatin Calcium eqv. Rosuvastatin

Available from:

SANOFI-AVENTIS SINGAPORE PTE. LTD.

ATC code:

C10BA06

Pharmaceutical form:

TABLET, FILM COATED

Composition:

Ezetimibe 10.0 mg; Rosuvastatin Calcium eqv. Rosuvastatin 20.0 mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

Sanofi Ilac Sanayi ve Ticaret Anonim Sirketi

Authorization status:

ACTIVE

Authorization date:

2023-01-05

Summary of Product characteristics

1.0 NAME OF THE MEDICINAL PRODUCT
Suvezen 10 mg/10 mg film-coated tablets
Suvezen 20 mg/10 mg film-coated tablets
2.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
SUVEZEN 10 MG/10 MG FILM-COATED TABLETS
Each film-coated tablet contains 10 mg rosuvastatin (as rosuvastatin
calcium) and 10 mg of
ezetimibe.
SUVEZEN 20 MG/10 MG FILM-COATED TABLETS
Each film-coated tablet contains 20 mg of rosuvastatin (as
rosuvastatin calcium) and 10 mg
ezetimibe.
Excipients with known effect:
Suvezen 10 mg/10 mg: Each film-coated tablet contains 210.9 mg of
lactose (as lactose
monohydrate).
Suvezen
20 mg/10 mg:
Each
film-coated
tablet
contains
268.9 mg
of
lactose
(as
lactose
monohydrate)
3.0 PHARMACEUTICAL FORM
Film-coated tablet
Suvezen 10 mg/10 mg: white to off-white, round, biconvex, film-coated
tablets with a diameter
about 9.1 mm.
Suvezen 20 mg/10 mg: yellow to light yellow, round, biconvex,
film-coated tablets with a
diameter about 9.9 mm
4.0 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Primary Hypercholesterolaemia/Homozygous Familial
Hypercholesterolaemia (HoFH)
Suvezen is indicated for substitution therapy in adult patients who
are adequately controlled with
rosuvastatin and ezetimibe given concurrently at the same dose level
as in the fixed combination,
but as separate products, as adjunct to diet for treatment of primary
hypercholesterolaemia
(heterozygous familial and non-familial) or homozygous familial
hypercholesterolaemia.
4.2 DOSAGE AND METHOD OF ADMINISTRATION
Dosage
The patient should be on an appropriate lipid-lowering diet and should
continue on this diet
during treatment with Suvezen.
Suvezen is not suitable for initial therapy. Treatment initiation or
dose adjustment if necessary
should only be done with the monocomponents and after setting the
appropriate doses the
switch to the fixed dose combination of the appropriate strength is
possible.
Patient should use the strength corresponding to their previous
treatment.
The recommended dose is one Suvezen tablet daily.
_Co-administration with bile acid sequestrants