LIPITOR 40 MG

Country: Իսրայել

language: անգլերեն

source: Ministry of Health

active_ingredient:

ATORVASTATIN AS CALCIUM

MAH:

PFIZER PFE PHARMACEUTICALS ISRAEL LTD

ATC_code:

C10AA05

pharmaceutical_form:

FILM COATED TABLETS

composition:

ATORVASTATIN AS CALCIUM 40 MG

administration_route:

PER OS

prescription_type:

Required

manufactured_by:

PFIZER INC, USA

therapeutic_group:

ATORVASTATIN

therapeutic_area:

ATORVASTATIN

therapeutic_indication:

Lipitor is indicated as an adjunct to diet for reduction of elevated total cholesterol LDL- cholesterol apolipoprotein B and triglycerides and to increase HDL Cholesterol in patients 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 patients with homozygous familial hypercholesterolemia as an adjunct to other lipid-lowering treatment (e.g. LDL apheresis) or if such treatments are unavailable. Pediatric patients (10-17 years of age) : Atorvastatin is indicated as an adjunct to diet to reduce total -C LDL-C and apo B levels in boys and postmenarchal girls 10 to 17 years of age with heterozygous familial hypercholesterolemia if after an adequate trial of diet therapy the following findings are present: 1. LDL-C remains >or = 190 mg/dl or 2. LDL-C remains > or = 160 mg/dl and: there is a positive family history of premature cardiovascular disease or two or more other CVD risk factors are present in the pediatric patient. Prevention of cardiovascular and/or cerebrovascular event sush as MI or stroke as an adjunct to correction of other risk factors such as hypertension in patients with three or more additional risk factors or diabetes with one additional risk factor. In patients with clinically evident coronary heart disease Lipitor is indicated to : Reduce the risk of non-fatal myocardial infarction. Reduce the risk of fatal and non fatal stroke. Reduce the risk for revascularization procedures. Reduce the risk of hospitalization for CHF. Reduce the risk of angina.

authorization_date:

2022-02-28

PIL

Lipitor PIL CC 100123
USPI
2022
-
12
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
This medicine is dispensed with a doctor’s prescription only
LIPITOR
®
10 MG
LIPITOR
®
20 MG
LIPITOR
®
40 MG
LIPITOR
®
80 MG
FILM-COATED TABLETS ATORVASTATIN (AS CALCIUM) 10 MG, 20 MG, 40 MG, 80 MG
For a list of inactive ingredients and allergens in this preparation:
see section 2 "Important information about
some of this medicine’s ingredients" and section 6 "Further
information".
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE. This
leaflet contains concise information
about this medicine. If you have any further questions, consult your
doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if it seems to
you that their medical condition is similar to yours.
1.
WHAT IS THIS MEDICINE INTENDED FOR?
•
To reduce blood lipid levels (cholesterol and triglycerides) and to
increase HDL.
•
To prevent cardiovascular diseases (such as myocardial infarction or
stroke) in patients at high risk
for a primary event.
•
In patients with a coronary heart disease, Lipitor
reduces the risk of myocardial infarction, stroke,
hospitalization due to heart failure, angina pectoris and/or need for
catheterization.
THERAPEUTIC GROUP:
Statins – HMG-CoA reductase enzyme inhibitors.
2.
BEFORE USING THIS MEDICINE
DO NOT USE THIS MEDICINE IF:
•
you have liver problems (acute liver failure or decompensated
cirrhosis)
•
you are sensitive (allergic) to the active ingredient or to any of the
other ingredients contain
the medicine (listed in section 6). Stop using the medicine and get
medical help right away
have signs of a serious allergic reaction including:
o
swelling of your face, lips, tongue or throat
o
difficulty breathing or swallowing
o
fainting or dizziness
o
very rapid heartbeat
o
severe skin rash or itching
•
o
flu-like symptoms including fever, sore throat, cough, tiredness, and
joint pain
SPECIAL WARNINGS REGARDING US

SPC

Lipitor LPD CC 100123
USPI 12-2022
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lipitor 10 mg
Lipitor 20 mg
Lipitor 40 mg
Lipitor 80 mg
2 THERAPEUTIC INDICATION
HYPERCHOLESTEROLAEMIA
LIPITOR is indicated as an adjunct to diet for reduction of elevated
total cholesterol, LDL-cholesterol, apolipoprotein B, and
triglycerides and
to increase HDL-cholesterol in patients 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 patients with
homozygous familial hypercholesterolaemia as an adjunct to other
lipid-lowering treatments (e.g. LDL apheresis) or if such treatments
are unavailable.
_ _
_ _
_Pediatric Patients (10-17 years of age) _
_ _
LIPITOR is indicated as an adjunct to diet to reduce total-C, LDL-C,
and apo B levels in boys and postmenarchal girls, 10 to 17 years of
age,
with heterozygous familial hypercholesterolemia if after an adequate
trial of diet therapy the following findings are present:
a. LDL-C remains
≥
190 mg/dL or
b. LDL-C remains
≥
160 mg/dL and:
• there is a positive family history of premature cardiovascular
disease or
• two or more other CVD risk factors are present in the pediatric
patient
PREVENTION OF CARDIOVASCULAR DISEASE
Prevention of cardiovascular and/or cerebrovascular events such as MI
or stroke: as an adjunct to correction of other risk factors such as
hypertension in patients with three or more additional risk factors or
diabetes with one additional risk factor.
In patients with clinically evident coronary heart disease, LIPITOR is
indicated to:
Reduce the risk of non-fatal myocardial infarction
Reduce the risk of fatal and non-fatal stroke
Reduce the risk for revascularization procedures
Reduce the risk of hospitalization for CHF
Reduce the risk of angina
3 DOSAGE AND ADMIN