Atorvastatina Zentiva Italia Tablet, film coated 40mg

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

ATORVASTATIN

Available from:

Zentiva k.s. U kabelovny 130, Dolní Mecholupy, 102 37 Praha 10, Czech Republic

ATC code:

C10AA05

INN (International Name):

ATORVASTATIN 40 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

ATORVASTATIN 40 mg

Prescription type:

POM

Therapeutic area:

LIPID MODIFYING AGENTS

Authorization status:

Withdrawn

Authorization date:

2015-04-01

Patient Information leaflet

PAGE 1 OF 8
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ATORVASTATINA ZENTIVA ITALIA 10 MG FILM-COATED TABLETS
ATORVASTATINA ZENTIVA ITALIA 20 MG FILM-COATED TABLETS
ATORVASTATINA ZENTIVA ITALIA 40 MG FILM-COATED TABLETS
ATORVASTATINA ZENTIVA ITALIA 80 MG FILM-COATED TABLETS
Atorvastatin
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 Atorvastatina Zentiva Italia is and what it is used for
2. What you need to know before you take Atorvastatina Zentiva Italia
3. How to take Atorvastatina Zentiva Italia
4. Possible side effects
5. How to store Atorvastatina Zentiva Italia
6. Contents of the pack and other information
1.
WHAT ATORVASTATINA ZENTIVA ITALIA IS AND WHAT IT IS USED FOR
Atorvastatina Zentiva Italia belongs to a group of medicines known as
statins, which are lipid
(fat) regulating medicines.
Atorvastatina Zentiva Italia is used to lower lipids known as
cholesterol and triglycerides in
the blood when a low fat diet and lifestyle changes on their own have
failed. If you are at an
increased risk of heart disease, Atorvastatina Zentiva Italia can also
be used to reduce such
risk even if your cholesterol levels are normal. You should maintain a
standard cholesterol
lowering diet during treatment.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ATORVASTATINA ZENTIVA ITALIA
DO NOT TAKE ATORVASTATINA ZENTIVA ITALIA
−
if you are allergic to atorvastatin or any of the other ingredients of
this medicine (listed
in section 6).
−
if you have or have ever had a disease which affects the liver.
�

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS,
LABELLING AND PACKAGE LEAFLET
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Atorvastatina Zentiva Italia 10 mg film-coated tablets
Atorvastatina Zentiva Italia 20 mg film-coated tablets
Atorvastatina Zentiva Italia 40 mg film-coated tablets
Atorvastatina Zentiva Italia 80 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 10 mg atorvastatin (as atorvastatin
calcium trihydrate).
Excipient with known effect:
Each film-coated tablet contains 11.990 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
Each film-coated tablet contains 20 mg atorvastatin (as atorvastatin
calcium trihydrate).
Excipient with known effect:
Each film-coated tablet contains 23.980 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
Each film-coated tablet contains 40 mg atorvastatin (as atorvastatin
calcium trihydrate).
Excipient with known effect:
Each film-coated tablet contains 47.960 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
Each film-coated tablet contains 80 mg atorvastatin (as atorvastatin
calcium trihydrate).
Excipient with known effect:
Each film-coated tablet contains 95.920 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Atorvastatina Zentiva Italia 10 mg film-coated tablets: White to off
white, film-coated, round,
biconvex tablet. Diameter of the tablet is approx. 6 mm.
Atorvastatina Zentiva Italia 20 mg film-coated tablets: Yellowish,
film-coated, round,
biconvex tablet. Diameter of the tablet is approx. 8 mm.
Atorvastatina Zentiva Italia 40 mg film-coated tablets: Orange-yellow
to yellow-orange, film-
coated, round, biconvex tablet. Diameter of the tablet is approx. 10
mm.
Atorvastatina Zentiva Italia 80 mg film-coated tablets: Yellow-orange
film-coated round,
biconvex tablet. Diameter of the tablet is approx. 12 mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Hypercholeste