Tintaros 40mg film-coated Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

ROSUVASTATIN

Available from:

Actavis Group PTC ehf

ATC code:

C10AA07

INN (International Name):

ROSUVASTATIN

Pharmaceutical form:

FILM-COATED TABLET

Composition:

ROSUVASTATIN 40 mg

Prescription type:

POM

Therapeutic area:

LIPID MODIFYING AGENTS

Authorization status:

Authorised

Authorization date:

2012-04-09

Patient Information leaflet

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.
-
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 Tintaros is and what it is used for
2. What you need to know before you take Tintaros
3. How to take Tintaros
4. Possible side effects
5. How to store Tintaros
6. Contents of the pack and other information
1. WHAT TINTAROS IS AND WHAT IT IS USED FOR
Tintaros belongs to a group of medicines called statins. You have been
prescribed Tintaros because:
-
You have a high cholesterol level. This means you are at risk from
a heart attack or stroke. Tintaros is used in adults, adolescents and
children 6 years or older to treat high cholesterol. You have been
advised to take a statin, because changing your diet and taking
more exercise were not enough to correct your cholesterol levels.
You should continue with your cholestrol-lowering diet and exercise
while you are taking Tintaros.
Or
-
You have other factors that increase your risk of having a heart
attack, stroke or related health problems. Heart attack, stroke and
other problems can be caused by a disease called atherosclerosis.
Atherosclerosis is due to a build up of fatty deposits in your
arteris.
WHY IT IS IMPORTANT TO KEEP TAKING TINTAROS
Tintaros is used to correct the levels of fatty substances in the
blood
called lipids, the most common of which is cholesterol.
There are different types of cholesterol found in the blood –
“bad”
cholesterol (LDL-C) and “good” cholesterol (HDL-C).
-
Tintaros can reduce the “bad” cholesterol and increase the
“good”
cholesterol.
-
It works by helpi

Summary of Product characteristics

Page 1 of 21
_ _
SUMMARY OF PRODUCT CHARACTERISTICS
Page 2 of 21
1.
NAME OF THE MEDICINAL PRODUCT_ _
Tintaros 5 mg film-coated tablets.
Tintaros 10 mg film-coated tablets.
Tintaros 20 mg film-coated tablets.
Tintaros 40 mg film-coated tablets.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg rosuvastatin (as rosuvastatin calcium).
Each tablet contains 10 mg rosuvastatin (as rosuvastatin calcium).
Each tablet contains 20 mg rosuvastatin (as rosuvastatin calcium).
Each tablet contains 40 mg rosuvastatin (as rosuvastatin calcium).
Excipients with known effect:
Each 5 mg tablet contains 32,15 mg lactose monohydrate.
Each 10 mg tablet contains 64,30 mg lactose monohydrate.
Each 20 mg tablet contains 128,60 mg lactose monohydrate.
Each 40 mg tablet contains 257,21 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
5mg tablets:
White, round, 5.5mm, biconvex, film-coated tablets with “ST 1”
engraved on one side.
10mg tablets:
Pink, round, 7mm, biconvex, film-coated tablets with “ST 2”
engraved on one side.
20mg tablets:
Pink, round, 9mm, biconvex, film-coated tablets with “ST 3”
engraved on one side.
40mg tablets:
Pink, oval, 16mm x 8mm, biconvex, film-coated tablets with “ST 4”
engraved on one side.
Page 3 of 21
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
TREATMENT OF HYPERCHOLESTEROLAEMIA
Tintaros is indicated in adults, adolescents and children aged 6 years
or older with primary
hypercholesterolaemia (type IIa including heterozygous familial
hypercholesterolaemia) or mixed
dyslipidaemia (type IIb) as an adjunct to diet when response to diet
and other non-pharmacological
treatments (e.g. exercise, weight reduction) is inadequate.
Tintaros is indicated in homozygous familial hypercholesterolaemia as
an adjunct to diet and other lipid
lowering treatments (e.g. LDL apheresis) or if such treatments are not
appropriate.
PREVENTION OF CARDIOVASCULAR EVENTS
Tintaros is indicated in prevention of major cardiovascular