Atorvastatin Viatris 10 mg film-coated tablets

Country: Malta

Language: English

Source: Medicines Authority

Available from:

Viatris Limited Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland

ATC code:

C10AA05

INN (International Name):

ATORVASTATIN 10 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

ATORVASTATIN 10 mg

Prescription type:

POM

Therapeutic area:

LIPID MODIFYING AGENTS

Authorization status:

Authorised

Authorization date:

2012-08-03

Patient Information leaflet

1
PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE USER
ATORVASTATIN VIATRIS 10 MG FILM-COATED TABLETS
ATORVASTATIN VIATRIS 20 MG FILM-COATED TABLETS
ATORVASTATIN VIATRIS 40 MG FILM-COATED TABLETS
ATORVASTATIN VIATRIS 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 or
nurse.
−
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 Viatris is and what it is used for
2.
What you need to know before you take Atorvastatin Viatris
3.
How to take Atorvastatin Viatris
4.
Possible side effects
5.
How to store Atorvastatin Viatris
6.
Contents of the pack and other information
1.
WHAT ATORVASTATIN VIATRIS IS AND WHAT IT IS USED FOR
Atorvastatin Viatris belongs to a group of medicines known as statins,
which are lipid (fat) regulating
medicines.
Atorvastatin Viatris is 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 Viatris 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 VIATRIS
DO NOT TAKE ATORVASTATIN VIATRIS
−
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
−
if you have had any unexplained abnormal blood tests for liver
function
−
if you are a woman

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Atorvastatin Viatris 10 mg film-coated tablets
Atorvastatin Viatris 20 mg film-coated tablets
Atorvastatin Viatris 40 mg film-coated tablets
Atorvastatin Viatris 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 Viatris 10 mg film-coated tablet contains 27.25 mg
lactose monohydrate and
0.00004 mg benzoic acid.
Each Atorvastatin Viatris 20 mg film-coated tablet contains 54.50 mg
lactose monohydrate and
0.00008 mg benzoic acid.
Each Atorvastatin Viatris 40 mg film-coated tablet contains 109.00 mg
lactose monohydrate and
0.00016 mg benzoic acid.
Each Atorvastatin Viatris 80 mg film-coated tablet contains 218.00 mg
lactose monohydrate and
0.00032 mg benzoic acid.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
White round, 5.6 mm, film-coated tablets debossed "10" on one side and
"ATV" on the other.
White round, 7.1 mm, film-coated tablets debossed "20" on one side and
"ATV" on the other.
White round, 9.5 mm, film-coated tablets debossed "40" on one side and
"ATV" on the other.
White round, 11.9 mm, film-coated tablets debossed "80" on one side
and "ATV" on the other.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Hypercholesterolaemia
Atorvastatin Viatris is indicated as an adjunct to diet for reduction
of elevated total cholesterol
(total-C), LDL-cholesterol (LDL-C), apolipoprotein B, and
triglycerides in adults, adolescents and
children aged 10 years or older with primary hypercholesterolaemia
including familial
hypercholesterolaemia (heterozygous variant) or combined (mixed)