Atorvastatin 10mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Atorvastatin calcium trihydrate

Available from:

Accord-UK Ltd

ATC code:

C10AA05

INN (International Name):

Atorvastatin calcium trihydrate

Dosage:

10mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02120000; GTIN: 5012617021939

Patient Information leaflet

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

Summary of Product characteristics

OBJECT 1
ATORVASTATIN 10MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 16-Apr-2018 | Accord-UK Ltd
1. Name of the medicinal product
Atorvastatin 10mg Film-coated Tablets
2. Qualitative and quantitative composition
Each film-coated tablet contains 10mg of atorvastatin as atorvastatin
calcium trihydrate.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet.
10mg: White, oval, biconvex, 4.9 x 9.1 mm film-coated tablets marked
with “10” on one side and “A” on
the other.
4. Clinical particulars
4.1 Therapeutic indications
Hypercholesterolaemia
Atorvastatin 10mg Film coated Tablets 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 10mg Film coated Tablets 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 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 10mg
Film coated Tablets and should continue on this diet during treatment
with Atorvastatin 10mg Film
coated Tablets.
The dose should be individualised according to baseline LDL-C levels,
the goal of therapy, and patient
response.
The usual starting dose is 10mg once a day. Adjustment of d