Atorvastatin 80mg tablets

Maa: Yhdistynyt kuningaskunta

Kieli: englanti

Lähde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiivinen ainesosa:

Atorvastatin calcium trihydrate

Saatavilla:

Teva UK Ltd

ATC-koodi:

C10AA05

INN (Kansainvälinen yleisnimi):

Atorvastatin calcium trihydrate

Annos:

80mg

Lääkemuoto:

Oral tablet

Antoreitti:

Oral

luokka:

No Controlled Drug Status

Prescription tyyppi:

Valid as a prescribable product

Tuoteyhteenveto:

BNF: 02120000; GTIN: 5017007067719

Pakkausseloste

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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

Valmisteyhteenveto

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Atorvastatin 80mg Film-coated Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 80 mg of atorvastatin (as calcium).
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet.
Light yellow, dappled, glossy, round biconvex film-coated tablets,
debossed
with “HLA 80” on one side, measuring 19.3 mm in length.
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 once a day. Adjustment of dose should
be
made at intervals of 4 weeks or more. The maximum dose is 80 mg once a
day.
Primary hypercholesterolaemia and combined (mixed) hyperlipidaemia
The majority