Rovastat Duo tablets

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

rosuvastatin (rosuvastatin calcium), ezetimibe

Available from:

Adamed Pharma S.A.

ATC code:

C10BA06

INN (International Name):

rosuvastatin (rosuvastatin calcium), ezetimibe

Dosage:

10mg+ 10mg

Pharmaceutical form:

tablets

Units in package:

(30/3x10/) in blister

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2022-03-01

Patient Information leaflet

1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ROVASTAT DUO 20 MG/10 MG, TABLET
ROVASTAT DUO 10 MG/10 MG, TABLET
rosuvastatin and ezetimibe
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
−
Keep this leaflet. You may need to read it again.
−
If you have any further questions, ask your doctor or pharmacist.
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This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even
if their signs of illness are the same as yours.
−
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What ROVASTAT DUO tablets is and what it is used for
2.
What you need to know before you take Rovastat Duo tablets
3.
How to take Rovastat Duo tablets
4.
Possible side effects
5.
How to store Rovastat Duo tablets
6.
Contents of the pack and other information
1.
WHAT ROVASTAT DUO TABLETS IS AND WHAT IT IS USED FOR
Rovastat Duo tablets contains two different active substances in one
tablet. One of the active substances is
rosuvastatin, belonging to the group of so called statins, the other
active substance is ezetimibe.
Rovastat Duo tablets is a medicine used to lower levels of total
cholesterol, “bad” cholesterol (LDL
cholesterol) and fatty substances called triglycerides in your blood.
In addition, it also raises levels of
“good” cholesterol (HDL cholesterol). This medicine works to
reduce your cholesterol in two ways: it
reduces the cholesterol absorbed in your digestive tract, as well as
the cholesterol your body makes by
itself.
_ _
For most people, high cholesterol does not affect the way they feel
because it does not produce any
symptoms. However, if it is left untreated, fatty deposits can build
up in the walls of your blood vessels
causing them to narrow.
Sometimes, these narrowed blood vessels can get blocked which can cut
off the blood supply to the heart
or brain leading to a heart attack

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Rovastat Duo 20 mg/10 mg, tablet
Rovastat Duo 10 mg/10 mg, tablet
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Rovastat Duo 20 mg/10 mg tablet
Each tablet contains 20 mg rosuvastatin (as calcium salt) and 10 mg of
ezetimibe.
Excipients of known activity: lactose monohydrate 228.29 mg
Rovastat Duo 10 mg/10 mg tablet
Each tablet contains 10 mg rosuvastatin (as calcium salt) and 10 mg of
ezetimibe.
Excipients of known activity: lactose monohydrate 238.39 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablets,.
Rovastat Duo 20 mg/10 mg tablet: white to off-white, round, biconvex,
uncoated tablet. The diameter of
the tablet is 11 mm.
Rovastat Duo 10 mg/10 mg tablet: white to off-white, oval, biconvex,
uncoated tablet, engraved E1 on one side
and 1 on the other side. The dimensions of the tablet are 15 mm x 7 mm
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Primary Hypercholesterolaemia
Rovastat Duo is indicated as adjunct to diet for treatment of primary
hypercholesterolemia as substitution
therapy in adult patients adequately controlled with the individual
substances given concurrently at the same
dose level as in the fixed dose combination, but as separate products.
_ _
Prevention of Cardiovascular Events
Rovastat Duo is indicated to reduce the risk of cardiovascular events
(see section 5.1)
as substitution therapy
in patients with coronary heart disease (CHD) and a history of acute
coronary syndrome (ACS), who are
adequately controlled with the individual substances given
concurrently at the same dose level as in the fixed
dose combination, but as separate products.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Rovastat Duo is indicated in adult patients whose hypercholesterolemia
is adequately controlled with
1
separately administered monocomponent preparations of the same doses
as the recommended combination.
The patient should be on an appropriate lipid-lowering diet and should
continue on this diet during