Lipitor 20mg chewable tablets
Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Patient Information leaflet
(PIL)
19-06-2018
Summary of Product characteristics
(SPC)
19-06-2018
Public Assessment Report
(PAR)
20-04-2020
Active ingredient:
Atorvastatin calcium trihydrate
Available from:
Viatris UK Healthcare Ltd
ATC code:
C10AA05
INN (International Name):
Atorvastatin calcium trihydrate
Dosage:
20mg
Pharmaceutical form:
Chewable tablet
Administration route:
Oral
Class:
No Controlled Drug Status
Prescription type:
Valid as a prescribable product
Product summary:
BNF: 02120000; GTIN: 5013457010015
Patient Information leaflet
Page 1 of 7
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PACKAGE LEAFLET: INFORMATION FOR THE USER
LIPITOR
5MG, 10 MG, 20 MG AND 40 MG CHEWABLE 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 LIPITOR is and what it is used for
2.
What you need to know before you take LIPITOR
3.
How to take LIPITOR
4.
Possible side effects
5.
How to store LIPITOR
6.
Contents of the pack and other information
1.
WHAT LIPITOR IS AND WHAT IT IS USED FOR
Lipitor belongs to a group of medicines known as statins, which are
lipid (fat) regulating
medicines.
Lipitor 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, Lipitor 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 LIPITOR
DO NOT TAKE LIPITOR:
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 trying to become pregnant
if you are breast-feeding
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before taking Lipitor:
if you have severe respira
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Summary of Product characteristics
OBJECT 1
LIPITOR 20MG CHEWABLE TABLETS.
Summary of Product Characteristics Updated 10-May-2018 | Pfizer
Limited
1. Name of the medicinal product
Lipitor 20 mg chewable tablets.
2. Qualitative and quantitative composition
Each chewable tablet contains 20 mg atorvastatin (as atorvastatin
calcium trihydrate).
Excipient(s) with known effect
Each Lipitor 20 mg chewable tablet contains 2.5 mg aspartame.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Chewable tablet
White to off-white, round chewable tablets with pink to purple specks
debossed "20" on one side and
"LCT" on the other measuring 8.7 mm in diameter.
4. Clinical particulars
4.1 Therapeutic indications
Hypercholesterolaemia
Lipitor 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.
Lipitor 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 Lipitor and should
continue on this diet during treatment with Lipitor.
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 shoul
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