Atorvastatin

Maa: Malta

Kieli: englanti

Lähde: Medicines Authority

Aktiivinen ainesosa:

ATORVASTATIN CALCIUM TRIHYDRATE

Saatavilla:

Accord Healthcare Limited

ATC-koodi:

C10AA05

INN (Kansainvälinen yleisnimi):

ATORVASTATIN CALCIUM TRIHYDRATE

Lääkemuoto:

FILM-COATED TABLET

Koostumus:

ATORVASTATIN CALCIUM TRIHYDRATE 80 mg

Prescription tyyppi:

POM

Terapeuttinen alue:

LIPID MODIFYING AGENTS

Valtuutuksen tilan:

Authorised

Pakkausseloste

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ATORVASTATIN 10 MG FILM-COATED TABLETS
ATORVASTATIN 20 MG FILM-COATED TABLETS
ATORVASTATIN 40 MG FILM-COATED TABLETS
ATORVASTATIN 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 , 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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Atorvastatin tablets are and what they are used for
2.
What you need to know before you take Atorvastatin tablets
3.
How to take Atorvastatin tablets
4.
Possible side effects
5.
How to store Atorvastatin tablets
6.
Contents of the pack and other information
1.
WHAT ATORVASTATIN TABLETS ARE AND WHAT THEY ARE USED FOR
Atorvastatin tablets belongs to a group of medicines known as statins,
which are lipid (fat) regulating
medicines.
Atorvastatin tablets are used to lower lipids known as cholesterol and
triglycerides in the blood when a
low fat diet and life style changes on their own have failed. If you
are at an increased risk of heart
disease, Atorvastatin tablets 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 ATORVASTATIN TABLETS
DO NOT TAKE ATORVASTATIN TABLETS IF YOU:

are allergic to atorvastatin or any of the other ingredients of this
medicine (listed in section 6)

have or have ever had a disease which affects the liver

have had any unexplained abnormal blood tests for liver function

are a woman able to have children and not using reliable cont

Valmisteyhteenveto

1.
NAME OF THE MEDICINAL PRODUCT
Atorvastatin 10 mg film-coated tablets
Atorvastatin 20 mg film-coated tablets
Atorvastatin 40 mg film-coated tablets
Atorvastatin 80 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 10 mg atorvastatin (as atorvastatin
calcium trihydrate).
Each film-coated tablet contains 20 mg atorvastatin (as atorvastatin
calcium trihydrate).
Each film-coated tablet contains 40 mg atorvastatin (as atorvastatin
calcium trihydrate).
Each film-coated tablet contains 80 mg atorvastatin (as atorvastatin
calcium trihydrate).
Excipient(s) with known effect
Each Atorvastatin 10 mg film-coated tablet contains 23.38 mg lactose
monohydrate.
Each Atorvastatin 20 mg film-coated tablet contains 46.76 mg lactose
monohydrate.
Each Atorvastatin 40 mg film-coated tablet contains 93.52 mg lactose
monohydrate.
Each Atorvastatin 80 mg film-coated tablet contains 187.04 mg lactose
monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Atorvastatin 10 mg film-coated tablet:
White to off-white, round shaped, biconvex, film coated tablets with
approx. 5.6 mm
diameter, debossed with “FUI” on one side and plain on other side.
Atorvastatin 20 mg film-coated tablet:
White to off-white, round shaped, biconvex, film coated tablets with
approx. 7.1 mm
diameter, debossed with “FU2” on one side and plain on other side.
Atorvastatin 40 mg film-coated tablet:
White to off-white, round shaped, biconvex, film coated tablets with
approx. 9.6 mm
diameter, debossed with “FU3” on one side and plain on other side.
Atorvastatin 80 mg film-coated tablet:
White to off-white, round shaped, biconvex, film coated tablets with
approx. 12.1 mm
diameter, debossed with “FU4” on one side and plain on other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Hypercholesterolaemia
Atorvastatin is indicated as an adjunct to diet for reduction of
elevated total cholesterol
(total-C), LDL-cholesterol (LDL-C), apolipoprotein B, and
tr