Atorvastatin 80mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Atorvastatin calcium trihydrate

Available from:

Viatris UK Healthcare Ltd

ATC code:

C10AA05

INN (International Name):

Atorvastatin calcium trihydrate

Dosage:

80mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02120000; GTIN: 5016695004730

Patient Information leaflet

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ATORVASTATIN CALCIUM 80 MG 28 (4X7) FILM-COATED TABLETS PIL - UK
Black
BBBA7760
RH
11-03-20
190x380
9.25pt
Teva Malta Zejtun
11-03-20
11-03-20
01
Version 7
12.02.2020
German GTIN 14
(incorporating PZN):
Cartons and label leaflets only
(labels only when specified)
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.
•
The full name of this medicine is Atorvastatin 80mg
Film-coated Tablets but within the leaflet it will be
referred to as Atorvastatin tablets.
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 belong 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

Summary of Product characteristics

OBJECT 1
ATORVASTATINE 80MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 25-Jun-2018 | Generics UK
T/A Mylan
1. Name of the medicinal product
Atorvastatin 80mg film-coated tablets
2. Qualitative and quantitative composition
Each film-coated tablet contains 80 mg atorvastatin (as atorvastatin
calcium trihydrate).
Excipient with known effect: Each tablet contains 340mg lactose.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet.
White, oval, biconvex, film coated tablet, approximately 18.2mm ×
8.7mm, with a score line on one side
and debossed '80' on the other side.
The score line is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
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 le