Atorvastatin 40mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Atorvastatin calcium trihydrate

Available from:

MSN Laboratories Europe Ltd

ATC code:

C10AA05

INN (International Name):

Atorvastatin calcium trihydrate

Dosage:

40mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02120000; GTIN: 8904159674223

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
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 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 ATORVASTATIN IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ATORVASTATIN
3.
HOW TO TAKE ATORVASTATIN
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE ATORVASTATIN
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1. WHAT ATORVASTATIN IS AND WHAT IT IS USED FOR
ATORVASTATIN CONTAINS AN ACTIVE SUBSTANCE CALLED ATORVASTATIN AND
BELONGS TO A GROUP OF MEDICINES
KNOWN AS STATINS, WHICH ARE LIPID (FAT) REGULATING MEDICINES.
ATORVASTATIN IS 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 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
DO NOT TAKE ATORVASTATIN:
• IF YOU ARE ALLERGIC TO ATORVASTATIN OR ANY OF THE OTHER INGREDIENTS
OF THIS MEDICINE (LISTED IN SECTION
6)
• IF YOU HAVE OR HAVE EVER HAD A DISEASE WHICH AFFECTS THE LIVER
• IF YOU HAVE HAD ANY UNEXPLAINED ABNORMAL BLOOD TESTS FOR LIVER
FUNCTION
• IF YOU ARE A WOMAN ABLE TO HAVE CHILDREN AND NOT USING RELIABLE
CONTRACEPTION
• IF YOU ARE PREGNANT OR TRYI

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 with known effect
:
Lactose monohydrate:
40 mg film-coated
tablet
164.716 mg
Sodium:
40 mg film-coated
tablet
2.995 mg
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet
Atorvastatin 40 mg film-coated tablets are white coloured, oval
shaped, biconvex,
debossed with "MA" on one side and "3" 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 of