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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.



5 mg, 10 mg, 20 mg and 40 mg
Chewable Tablets
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
• If you get any of the 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
3. How to take LIPITOR
4. Possible side effects
5. How to store LIPITOR
6. Contents of the pack and other

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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 hypersensitive (allergic) to
Lipitor or to any similar medicines used to
lower blood lipids or to any of the other
ingredients of the 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
• if you are breast-feeding.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking
The following are reasons why Lipitor may not be
suitable for you:
• if you have had a previous stroke with
bleeding into the brain, or have small

70 •

pockets of fluid in the brain from previous
if you have kidney problems
if you have an under-active thyroid gland
if you have had repeated or unexplained
muscle aches or pains, a personal history
or family history of muscle problems
if you have had previous muscular
problems during treatment with other
lipid-lowering medicines (e.g. other
‘-statin’ or ‘-fibrate’ medicines)
if you regularly drink a large amount of
if you have a history of liver disease
if you are older than 70 years.

Check with your doctor or pharmacist
before taking Lipitor
• if you have severe respiratory failure.
If any of these apply to you, your doctor will need to
carry out a blood test before and possibly during your
Lipitor treatment to predict your risk of muscle
related side effects. The risk of muscle related side
effects e.g rhabdomyolysis is known to increase
when certain medicines are taken at the same time
(see Section 2 “Other medicines and Lipitor”).
While you are on this medicine your doctor will
monitor you closely if you have diabetes or are at risk
of developing diabetes. You are likely to be at risk of
developing diabetes if you have high levels of sugars
and fats in your blood, are overweight and have high
blood pressure.

Other medicines and Lipitor
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
There are some medicines that may change the
effect of Lipitor or their effect may be changed by

Lipitor. This type of interaction could make one or
both of the medicines less effective. Alternatively it
could increase the risk or severity of side-effects,
including the important muscle wasting condition
known as rhabdomyolysis described in Section 4:
• Medicines used to alter the way
your immune system works, e.g.
• Certain antibiotics or antifungal medicines,
e.g. erythromycin, clarithromycin,
telithromycin, ketoconazole, itraconazole,
voriconazole, fluconazole, posaconazole,
rifampin, fusidic acid
• Other medicines to regulate lipid levels,
e.g. gemfibrozil, other fibrates, colestipol
• Some calcium channel blockers used for
angina or high blood pressure, e.g.
amlodipine, diltiazem,; medicines to
regulate your heart rhythm e.g. digoxin,
verapamil, amiodarone
• Medicines used in the treatment of HIV
e.g. ritonavir, lopinavir, atazanavir,
indinavir, darunavir, the combination of
tipranavir/ritonavir etc.
• Some medicines used in the treatment of
hepatitis C e.g. telaprevir
• Other medicines known to interact with
Lipitor include ezetimibe (which lowers
cholesterol), warfarin (which reduces
blood clotting), oral contraceptives,
stiripentol (an anti-convulsant for
epilepsy), cimetidine (used for heartburn
and peptic ulcers), phenazone (a
painkiller), colchicine (used to treat gout),
antacids (indigestion products containing
aluminium or magnesium) and boceprevir
(used to treat liver disease such as
hepatitis C)
• Medicines obtained without a prescription:
St John’s Wort

Please tell your doctor or pharmacist if you are taking
or have recently taken any other medicines, including
medicines obtained without a prescription.

3. How to take Lipitor
Before starting treatment, your doctor will place you
on a low-cholesterol diet, which you should maintain
also during therapy with Lipitor.

Lipitor with food and drink
See Section 3 for instructions on how to
take Lipitor chewable tablets. Please note
the following:
Grapefruit juice
Do not take more than one or two small glasses
of grapefruit juice per day because large quantities of
grapefruit juice can change the effects of Lipitor.

The usual starting dose of Lipitor is 10 mg once a
day in adults and children aged 10 years or older.
This may be increased if necessary by your doctor
until you are taking the amount you need. Your doctor
will adapt the dose at intervals of 4 weeks or more.
The maximum dose of Lipitor is 80 mg once daily for
adults and 20 mg once daily for children.

Avoid drinking too much alcohol while taking this
medicine. See Section 2 “Warnings and precautions”
for details

Lipitor chewable tablets can be chewed or swallowed
whole with a drink of water, and can be taken at any
time of day, with or without food. However, try to take
your tablet at the same time every day.

Pregnancy and breast-feeding

Always take this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.

Do not take Lipitor if you are pregnant, or
if you are trying to become pregnant.
Do not take Lipitor if you are able to
become pregnant unless you use reliable
contraceptive measures.
Do not take Lipitor if you are breast-feeding.
The safety of Lipitor during pregnancy and
breast-feeding has not yet been proven.
Ask your doctor or pharmacist for advice
before taking any medicine.

The duration of treatment with Lipitor is
determined by your doctor.
Please ask your doctor if you think that the effect of
Lipitor is too strong or too weak.

If you take more Lipitor than you should
If you accidently take too many Lipitor chewable
tablets (more than your usual daily dose), contact
your doctor or nearest hospital for advice.

Driving and using machines

If you forget to take Lipitor

Normally this medicine does not affect
your ability to drive or operate machines.
However, do not drive if this medicine
affects your ability to drive. Do not use any
tools or machines if your ability to use
them is affected by this medicine.

Important information about some of the
ingredients of Lipitor
Contains a source of phenylalanine. May be harmful
for people with phenylketonuria.

If you forget to take a dose, just take your next
scheduled dose at the correct time. Do not take a
double dose to make up for a forgotten dose.

If you stop taking Lipitor
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Package leaflet:
Information for the user

If you have any further questions on the use of this
medicine or wish to stop your treatment, ask your
doctor or pharmacist.
You will find more about LIPITOR on the
back of this leaflet

15.04.14 10:00

Like all medicines, this medicine can cause side
effects, although not everybody gets them.
If you experience any of the following serious
side effects, stop taking your tablets and tell your
doctor immediately or go to the nearest hospital
accident and emergency department.
Rare: may affect up to 1 in 1,000 people
• Serious allergic reaction which causes swelling of
the face, tongue and throat that can cause great
difficulty in breathing.
• Serious illness with severe peeling and swelling of
the skin, blistering of the skin, mouth, eyes,
genitals and fever. Skin rash with pink-red
blotches especially on palms of hands or soles of
feet which may blister.
• Muscle weakness, tenderness or pain and
particularly, if at the same time, you feel unwell or
have a high temperature it may be caused by an
abnormal muscle breakdown. The abnormal
muscle breakdown does not always go away, even
after you have stopped taking atorvastatin, and it
can be life-threatening and lead to kidney
Very rare: may affect up to 1 in 10,000 people
• If you experience problems with unexpected or
unusual bleeding or bruising, this may be
suggestive of a liver complaint. You should consult
your doctor as soon as possible.

Other possible side effects with Lipitor:
Common side effects (may affect up to 1 in 10
people) include:
• inflammation of the nasal passages, pain in the
throat, nose bleed
• allergic reactions
• increases in blood sugar levels (if you have
diabetes continue careful monitoring of your

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blood sugar levels), increase in blood creatine
nausea, constipation, wind, indigestion, diarrhoea
joint pain, muscle pain and back pain
blood test results that show your liver function can
become abnormal

Uncommon side effects (may affect up to 1 in
100 people) include:
• anorexia (loss of appetite), weight gain, decreases
in blood sugar levels (if you have diabetes you
should continue careful monitoring of your blood
sugar levels)
• having nightmares, insomnia
• dizziness, numbness or tingling in the fingers
and toes, reductions of sensation to pain or
touch, change in sense of taste, loss of
• blurred vision
• ringing in the ears and/or head
• vomiting, belching, abdominal pain upper and
lower, pancreatitis (inflammation of the pancreas
leading to stomach pain)
• hepatitis (liver inflammation)
• rash, skin rash and itching, hives, hair loss
• neck pain, muscle fatigue
• fatigue, feeling unwell, weakness, chest pain,
swelling especially in the ankles (oedema), raised
• urine tests that are positive for white blood cells
Rare side effects (may affect up to 1 in 1,000 people)
• visual disturbance
• unexpected bleeding or bruising
• cholestasis (yellowing of the skin and whites of
the eyes)
• tendon injury

Very rare side effects (may affect up to 1 in
10,000 people) include:
• an allergic reaction – symptoms may include
sudden wheezing and chest pain or tightness,
swelling of the eyelids, face, lips, mouth, tongue or
throat, difficulty breathing, collapse
• hearing loss
• gynecomastia (breast enlargement in men and
Possible side effects reported with some statins
(medicines of the same type):
• Sexual difficulties
• Depression
• Breathing problems including persistent cough
and/or shortness of breath or fever
• Diabetes. This is more likely if you have high
levels of sugars and fats in your blood, are
overweight and have high blood pressure. Your
doctor will monitor you while you are taking this

Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist, or nurse. This includes any possible side
effects not listed in this leaflet. You can also report
side effects directly (see details below). By reporting
side effects you can help provide more information
on the safety of this medicine.
United Kingdom: Yellow Card Scheme website:
Ireland: IMB Pharmacovigilance, Earlsfort Terrace,
IRL - Dublin 2; Tel: +353 1 6764971; 
Fax: +353 1 6762517. Website:; e-mail:
Malta: ADR Reporting, The Medicines Authority,
Post-Licensing Directorate, 203 Level 3,
Rue D’Argens, GŻR-1368 Gżira.


5. How to store Lipitor
Keep this medicine out of the sight and
reach of children.
This medicine does not require any
special storage conditions.
Do not use this medicine after the expiry
date which is stated on the blister and
outer packaging after {EXP}. The expiry
date refers to the last day of that month.
Do not throw away any medicines
via wastewater or household waste. Ask
your pharmacist how to throw away
medicines you no longer use. These
measures will help to protect the

6. Contents of the pack and
other information
What Lipitor chewable tablets contains
• The active substance is atorvastatin.
Each tablet contains 5 mg atorvastatin
(as atorvastatin calcium trihydrate).
Each tablet contains 10 mg atorvastatin
(as atorvastatin calcium trihydrate).
Each tablet contains 20 mg atorvastatin
(as atorvastatin calcium trihydrate).
Each tablet contains 40 mg atorvastatin
(as atorvastatin calcium trihydrate).
• The other ingredients of Lipitor chewable tablets
are: calcium carbonate, microcrystalline cellulose,
croscarmellose sodium, polysorbate 80, hydroxypropyl cellulose, amylum pregelificatum, mannitol,
aspartame, sucralose, grape flavour and
magnesium stearate.

What Lipitor looks like and contents of
the pack

This medicinal product is authorised in the
Member States of the EEA under the following

Lipitor 5 mg chewable tablets are white to off-white
with pink to purple specks with a round shape. They
are marked with 5 on one side and LCT on the other

Austria, Bulgaria, Czech
Republic, Estonia, Germany,
Hungary, Latvia, Lithuania,
Poland, Romania, Slovakia,
Belgium, Cyprus, Finland,
Greece, Ireland, Italy,
Luxembourg, Malta,
Netherlands, Norway,
Sweden, UK
Denmark, Greece, Iceland,
Portugal, Spain

Lipitor 10 mg chewable tablets are white to off-white
with pink to purple specks with a round shape. They
are marked with 10 on one side and LCT on the other
Lipitor 20 mg chewable tablets are white to off-white
with pink to purple specks with a round shape. They
are marked with 20 on one side and LCT on the other
Lipitor 40 mg chewable tablets are white to off-white
with pink to purple specks with a round shape. They
are marked with 40 on one side and LCT on the other
Lipitor chewable tablets are available in blister packs
containing 30 chewable tablets.


Marketing Authorisation Holder and
Marketing Authorisation Holder:
Pfizer Ireland Pharmaceuticals, Operations Support
Group, Ringaskiddy, Co Cork, Ireland


Pfizer Manufacturing Deutschland GmbH
Betriebsstätte Freiburg
Mooswaldallee 1




Atorvastatin Pfizer,
Torvast, Totalip,

This leaflet was last revised in 01/2014
Ref: LR 7_0
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4. Possible side effects

15.04.14 10:00

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.