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LIPITOR 5MG CHEWABLE TABLET

Active substance(s): ATORVASTATIN CALCIUM

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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

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Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking
Lipitor.
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
pockets of fluid in the brain from previous
strokes

• Some medicines used in the treatment of
hepatitis C e.g. telaprevir

Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.

• 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)

There are some medicines that may change the
effect of Lipitor or their effect may be changed by

• Medicines obtained without a prescription:
St John’s Wort

Other medicines and Lipitor

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

Pregnancy and breast-feeding
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.

Lipitor contains aspartame
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 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
````

14.09.15 13:20

Creator: EM

Smallest Font Size 9 pt

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Code Nr.: XXXX

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Betriebsstätte Freiburg

If you stop taking Lipitor

Reviewed by Pharma-Print-Design

• Medicines used in the treatment of HIV
e.g. ritonavir, lopinavir, atazanavir,
indinavir, darunavir, the combination of
tipranavir/ritonavir etc.

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.

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

Comments:

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”).
Also tell your doctor or pharmacist if you have a muscle
weakness that is constant. Additional tests and
medicines may be needed to diagnose and treat this.
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.

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.

Size: 420 x 180 mm

• if you have severe respiratory failure.

• 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

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.

Color: Black, Red (PMS 227 U), Blue (PMS 541 U)

What is in this leaflet:

• if you are allergic to atorvastatin or to any
similar medicines used to lower blood
lipids or to 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

Check with your doctor or pharmacist
before taking Lipitor

See section 3 for instructions on how to
take Lipitor chewable tablets. Please note
the following:

Techn. Kontrolle:

• 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.

Do not take Lipitor

• Other medicines to regulate lipid levels,
e.g. gemfibrozil, other fibrates, colestipol

Lipitor with food and drink

2. Draft
14.09.2015

Product: PP LIPITOR 5/10/20/40mg CT “GB/IE”

Read all of this leaflet carefully
before you start taking this medicine
because it contains important
information for you.

70

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

XXXXXX

2. What you need to know before
you take Lipitor

• Certain antibiotics or antifungal medicines,
e.g. erythromycin, clarithromycin,
telithromycin, ketoconazole, itraconazole,
voriconazole, fluconazole, posaconazole,
rifampin, fusidic acid

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3. How to take Lipitor

Documentation

5 mg, 10 mg, 20 mg and 40 mg
Chewable Tablets
Atorvastatin

• Medicines used to alter the way your
immune system works, e.g. ciclosporin

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

Ersetzt-Mat.-Nr.:

Lipitor

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:

Pfizer Manufacturing Deutschland GmbH

®

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.

• if you have kidney problems
• if you have an under-active thyroid gland
(hypothyroidism)
• 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
alcohol
• if you have a history of liver disease
• if you are older than 70 years

Druckreif:

IRELAND/UNITED KINGDOM

1. What Lipitor is and what it is
used for

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Package leaflet:
Information for the user

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United Kingdom: Yellow Card Scheme website:
www.mhra.gov.uk/yellowcard
Ireland: HPRA Pharmacovigilance, Earlsfort Terrace,
IRL – Dublin 2.
Tel: +353 1 6764971; Fax: +353 1 6762517
Website: www.hpra.ie ; e-mail: medsafety@hpra.ie
Malta: ADR Reporting
Website: www.medicinesauthority.gov.mt/adrportal

• The other ingredients of Lipitor chewable tablets
are: calcium carbonate, microcrystalline cellulose,
croscarmellose sodium, polysorbate 80,
hydroxypropyl cellulose, starch, pregelatinised
[maize], mannitol, aspartame, sucralose, grape
flavour (maltodextrin, grape juice concentrate,
acacia gum, pineapple juice concentrate, citric
acid, natural flavouring) and magnesium stearate.

Ref: LR 9_0

Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder:
Pfizer Ireland Pharmaceuticals, Operations Support
Group, Ringaskiddy, Co Cork, Ireland
Manufacturer:
Pfizer Manufacturing Deutschland GmbH
Betriebsstätte Freiburg
Mooswaldallee 1
79090
Freiburg,
Germany

14.09.15 13:20

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PPD

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Creator: EM
Reviewed by Pharma-Print-Design

This leaflet was last revised in MM/YYYY

Lipitor chewable tablets are available in blister packs
containing 30 chewable tablets.

Page 2

Betriebsstätte Freiburg

Tahor
Atorvastatin Pfizer
Xarator

Comments:

• 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).

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
side.

Zarator

Size: 420 x 180 mm

What Lipitor chewable tablets contains

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
side.

Lipitor

Color: Black, Red (PMS 227 U), Blue (PMS 541 U)

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.

6. Contents of the pack and
other information

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
side.

Sortis

Techn. Kontrolle:

Rare side effects (may affect up to 1 in 1,000 people)
include:
• visual disturbance
• unexpected bleeding or bruising
• cholestasis (yellowing of the skin and whites of
the eyes)
• tendon injury

Reporting of side effects

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 protect the environment.

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

2. Draft
14.09.2015

Product: PP LIPITOR 5/10/20/40mg CT “GB/IE”

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

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
medicine.

This medicine does not require any
special storage conditions.

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 side.

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XXXXXX

Other possible side effects with Lipitor:

Side effects of unknown frequency:
• Muscle weakness that is constant.

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.

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

Documentation

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.

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
memory
• 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
temperature
• urine tests that are positive for white blood cells

Keep this medicine out of the sight and
reach of children.

What Lipitor looks like and contents of
the pack

Ersetzt-Mat.-Nr.:

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
problems.

5. How to store Lipitor

Pfizer Manufacturing Deutschland GmbH

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.






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).

Druckreif:

Like all medicines, this medicine can cause side
effects, although not everybody gets them.

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

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4. Possible side effects

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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.

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