LIPITOR 40 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

ATORVASTATIN AS CALCIUM

Available from:

PFIZER PFE PHARMACEUTICALS ISRAEL LTD

ATC code:

C10AA05

Pharmaceutical form:

TABLETS

Composition:

ATORVASTATIN AS CALCIUM 40 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

PFIZER MANUFACTURING DEUTSCHLAND GMBH, GERMANY

Therapeutic area:

ATORVASTATIN

Therapeutic indications:

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 rema

Authorization date:

2012-02-28

Patient Information leaflet

3. HOW SHOULD YOU USE THE MEDICINE?
Always use according to the doctor's instructions!
The dosage and treatment regimen will be determined by the
doctor only.
THIS MEDICINE IS NOT INTENDED FOR CHILDREN BELOW 10 YEARS
OF AGE.
Complete the treatment regimen recommended by the doctor.
Even if there is an improvement in your health, do not discontinue
treatment with the medicine without consulting a doctor.
Reduction of the dosage should generally be done gradually.
ATTENTION:
Wait at least two hours between taking this medicine and taking
antacids.
DO NOT EXCEED THE RECOMMENDED DOSE!
The tablet must not be crushed/halved/chewed, since it is
film-coated.
IF YOU TOOK AN OVERDOSE OR IF A CHILD HAS ACCIDENTALLY SWALLOWED
THE MEDICINE, immediately proceed to a hospital emergency room
and bring the package of the medicine with you.
IF YOU FORGET TO TAKE THE MEDICINE AT THE REQUIRED TIME, take a
dose as soon as you remember, but never take a double dose!
Adhere to the treatment regimen as recommended by the
doctor.
Do not take medicines in the dark! Check the label and the dose
each time you take medicine. Wear glasses if you need them.
If you have further questions regarding use of the medicine,
consult the doctor or pharmacist.
4. SIDE EFFECTS
As with any medicine, use of Lipitor
®
may cause side effects
in some users. Do not be alarmed when reading the list of side
effects. You may not suffer from any of them.
DISCONTINUE USE OF THE MEDICINE AND REFER TO A DOCTOR
IMMEDIATELY IF:
you develop a severe allergic reaction which causes swelling
of the face, tongue and throat and you suffer from breathing
difficulties (rare).
you develop a severe skin reaction, including peeling and swelling
of the skin, blisters on the skin, mouth, eyes, or genitals and
fever (rare).
you develop a rash with pink-red spots on the palms of the hands
and soles of the feet (rare).
you develop muscle weakness, muscle tenderness or pain, and if
you simultaneously feel bad and have a high fever. This may result
from muscle tissue breakdown which ca

Summary of Product characteristics

Lipitor Small Tablets, Israel, 29 Oct 2013
1
ע עבקנ הז ןולע טמרופ
"
רשואו קדבנ ונכותו תואירבה דרשמ י
1.
NAME OF THE MEDICINAL PRODUCT
LIPITOR 10, 20, 40, 80MG TABLETS
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains atorvastatin calcium equivalent to
10, 20, 40, or 80 mg atorvastatin.
EXCIPIENTS:
For a full list of excipients, see section 6.1 LIST OF EXCIPIENTS
3.
PHARMACEUTICAL FORM
Film coated tablets
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
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 addi