Atorvastatin Upjohn 10 mg film-coated tablets

Țară: Malta

Limbă: engleză

Sursă: Medicines Authority

Ingredient activ:

ATORVASTATIN

Disponibil de la:

Viatris Hellas Ltd 253-255, Mesogion Avenue, 154 51 Neo Psychiko, Athens,, Greece

Codul ATC:

C10AA05

INN (nume internaţional):

ATORVASTATIN 10 mg

Forma farmaceutică:

FILM-COATED TABLET

Compoziție:

ATORVASTATIN 10 mg

Tip de prescriptie medicala:

POM

Zonă Terapeutică:

LIPID MODIFYING AGENTS

Statutul autorizaţiei:

Authorised

Data de autorizare:

2012-08-03

Prospect

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

Caracteristicilor produsului

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Atorvastatin Upjohn 10 mg film-coated tablets
Atorvastatin Upjohn 20 mg film-coated tablets
Atorvastatin Upjohn 40 mg film-coated tablets
Atorvastatin Upjohn 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 Upjohn 10 mg film-coated tablet contains 27.25 mg
lactose monohydrate and
0.00004 mg benzoic acid.
Each Atorvastatin Upjohn 20 mg film-coated tablet contains 54.50 mg
lactose monohydrate and
0.00008 mg benzoic acid.
Each Atorvastatin Upjohn 40 mg film-coated tablet contains 109.00 mg
lactose monohydrate and
0.00016 mg benzoic acid.
Each Atorvastatin Upjohn 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 Upjohn 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)
hyperlip