Atorvastatin 40 mg Film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Atorvastatin

Available from:

Accord Healthcare Limited

ATC code:

C10AA; C10AA05

INN (International Name):

Atorvastatin

Dosage:

40 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

HMG CoA reductase inhibitors; atorvastatin

Authorization status:

Authorised

Authorization date:

2017-07-28

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Atorvastatin 10 mg
film-coated tablets
Atorvastatin 20 mg
film-coated tablets
Atorvastatin 40 mg
film-coated tablets
Atorvastatin 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 .
• 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 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 belongs 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 changes on their own
have failed. If you are at an increased risk of heart
disease, 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 ATORVASTATIN TABLETS
DO NOT TAKE ATORVASTATIN TABLETS IF YOU:
• are allergic to atorvastatin or any of the other
ingredients of this medicine (listed in section 6)
• have or have ever had a disease which affects
the liver
• have had any unexplained abnormal blood tests
for liver function
• are a woman able to have children and not
using reliable cont

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Atorvastatin 40 mg Film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 40 mg atorvastatin (as atorvastatin
calcium trihydrate).
Excipient(s) with known effect
Each Atorvastatin 40 mg film-coated tablet contains 93.52 mg lactose
monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
White to off-white, round shaped, biconvex, film coated tablets with
approx. 9.6 mm diameter, debossed with “FU3”
on one side and plain on other side.
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