Lipitor 10mg tablets

देश: यूनाइटेड किंगडम

भाषा: अंग्रेज़ी

स्रोत: MHRA (Medicines & Healthcare Products Regulatory Agency)

सक्रिय संघटक:

Atorvastatin calcium trihydrate

थमां उपलब्ध:

Necessity Supplies Ltd

ए.टी.सी कोड:

C10AA05

INN (इंटरनेशनल नाम):

Atorvastatin calcium trihydrate

डोज़:

10mg

फार्मास्यूटिकल फॉर्म:

Oral tablet

प्रशासन का मार्ग:

Oral

वर्ग:

No Controlled Drug Status

प्रिस्क्रिप्शन प्रकार:

Valid as a prescribable product

उत्पाद समीक्षा:

BNF: 02120000

सूचना पत्रक

mock up 6724
Package leaflet:
Information for the user
UNITED KINGDOM
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
•
if you use the combination of
glecaprevir/pibrentasvir in the
treatment of hepatitis C
Warnings and prec

उत्पाद विशेषताएं

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Lipitor
™
10mg chewable tablets.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each chewable tablet contains 10 mg atorvastatin (as atorvastatin
calcium
trihydrate).
Excipient(s) with known effect:
Each Lipitor 10 mg chewable tablet contains 1.25 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 "10"
on one side and “LCT” on the other measuring 7.1 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 should
be made at intervals
of 4 weeks or more. The maximum dose is 80 mg o