Atorvastatin 10mg tablets

Երկիր: Միացյալ Թագավորություն

Լեզու: անգլերեն

Աղբյուրը: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ակտիվ բաղադրիչ:

Atorvastatin calcium trihydrate

Հասանելի է:

Zentiva Pharma UK Ltd

ATC կոդը:

C10AA05

INN (Միջազգային անվանումը):

Atorvastatin calcium trihydrate

Դոզան:

10mg

Դեղագործական ձեւ:

Oral tablet

Կառավարման երթուղին:

Oral

Դաս:

No Controlled Drug Status

Ռեկվիզորի տեսակը:

Valid as a prescribable product

Ապրանքի ամփոփագիր:

BNF: 02120000; GTIN: 5000283657620

Տեղեկատվական թերթիկ

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
PREVENCOR 10MG TABLETS / ATORVASTATIN 10MG TABLETS
(atorvastatin calcium)
THIS PRODUCT IS AVAILABLE IN OTHER STRENGTHS.
Your medicine is known as either Prevencor 10mg Tablets or
Atorvastatin
10mg Tablets, but will be referred to as Prevencor / Atorvastatin
Tablets
throughout this 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, 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 Prevencor / Atorvastatin Tablets are and what they are used for
2.
What you need to know before you take Prevencor / Atorvastatin
Tablets
3.
How to take Prevencor / Atorvastatin Tablets
4.
Possible side effects
5.
How to store Prevencor / Atorvastatin Tablets
6.
Contents of the pack and other information
1. WHAT PREVENCOR / ATORVASTATIN TABLETS ARE AND WHAT
THEY ARE USED FOR
Prevencor / Atorvastatin Tablets belong to a group of medicines known
as
statins, which are lipid (fat) regulating medicines.
Prevencor / 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, Prevencor / 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 PREVENCOR /
ATORVASTATIN TABLETS
DO NOT TAKE PREVENCOR / ATORVASTATIN TABLETS:

if you are allergic to atorvastatin or any of the other ingredients o

Ապրանքի հատկությունները

OBJECT 1
ATORVASTATIN CRYSTALLINE 10MG FILM-COATED
TABLETS
Summary of Product Characteristics Updated 15-Aug-2017 | Zentiva
1. Name of the medicinal product
Atorvastatin 10 mg film-coated tablets
2. Qualitative and quantitative composition
Each film-coated tablet contains 10 mg atorvastatin (as atorvastatin
calcium trihydrate).
Excipients with known effect:
Each film-coated tablet contains 11.990 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet
Atorvastatin 10 mg film-coated tablets: White to off white,
film-coated, round, biconvex tablet. Diameter
of the tablet is approx. 6 mm.
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 triglycerides in adults,
adolescents and children aged 10 years
or older with primary hypercholesterolaemia including familial
hypercholesterolaemia (heterozygous
variant) or combined (mixed) hyperlipidaemia (corresponding to Types
IIa and IIb of the Fredrickson
classification) when response to diet and other nonpharmacological
measures is inadequate.
Atorvastatin is also indicated to reduce total-C and LDL-C in adults
with homozygous familial
hypercholesterolaemia as an adjunct to other lipid-lowering treatments
(e.g. LDL apheresis) or if such
treatments are unavailable.
Prevention of cardiovascular disease
Prevention of cardiovascular events in adult patients estimated to
have a high risk for a first
cardiovascular event (see section 5.1), as an adjunct to correction of
other risk factors.
4.2 Posology and method of administration
Posology
The patient should be placed on a standard cholesterol-lowering diet
before receiving Atorvastatin and
should continue on this diet during treatment with Atorvastatin.
The dose should be individualised according to baseline LDL-C levels,
the goal of therapy, and patient
response.
The usual starting dose is 10 mg on