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LIPITOR 20MG CHEWABLE TABLET

Active substance(s): ATORVASTATIN CALCIUM / ATORVASTATIN CALCIUM / ATORVASTATIN CALCIUM

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IRELAND/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

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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.
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

Warnings and precautions
Talk to your doctor, pharmacist or nurse
before taking Lipitor:
• if you have severe respiratory failure
• if you are taking or have taken in
the last 7 days a medicine called
fusidic acid, (a medicine for



70 ••

bacterial infection) orally or by
injection. The combination of
fusidic acid and Lipitor can lead
to serious muscle problems
(rhabdomyolysis).
if you have had a previous stroke
with bleeding into the brain, or
have small pockets of fluid in the
brain from previous strokes
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

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.

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.
ciclosporin
• 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.

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

• 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
• If you need to take oral fusidic
acid to treat a bacterial infection
you will need to temporarily stop
using this medicine. Your doctor
will tell you when it is safe to
restart Lipitor. Taking Lipitor with
fusidic acid may rarely lead to
muscle weakness, tenderness or
pain (rhabdomyolysis). See more
information regarding
rhabdomyolysis in section 4.

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.

Driving and using machines
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.

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.

3. How to take Lipitor
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Package leaflet:
Information for the user

Before starting treatment, your doctor will
place you on a low-cholesterol diet, which
you should maintain also during therapy
with Lipitor.
You will find more about LIPITOR on the
back of this leaflet
````

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.

If you forget to take Lipitor
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
If you have any further questions on the use
of this medicine or wish to stop your
treatment, ask your doctor or pharmacist.

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

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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 (rhabdomyolysis). 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.






monitoring of your 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

Other possible side effects with Lipitor:

Uncommon: may affect up to 1 in
100 people
• 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

Common: may affect up to 1 in 10 people
• inflammation of the nasal passages,
pain in the throat, nose bleed
• allergic reactions
• increases in blood sugar levels (if you
have diabetes continue careful

Rare: 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: 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.

Very rare: may affect up to 1 in 10,000 people
• 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).
Not known: frequency cannot be estimated
from the available data: Muscle weakness
that is constant.
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.

sucralose, grape flavour (maltodextrin,
grape juice concentrate, acacia gum,
pineapple juice concentrate, citric acid,
natural flavouring) and magnesium stearate.

Malta: ADR Reporting Website:
www.medicinesauthority.gov.mt/adrportal

5. How to store Lipitor
Keep this medicine out of the
sight and reach of children.

What Lipitor looks like and contents
of the pack

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.

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.
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.
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 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.

This medicine does not require
any special storage conditions.
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.

6. Contents of the pack and
other information

Reporting of side effects

What Lipitor chewable tablets contains

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: www.mhra.gov.uk/yellowcard

• 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).

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

• The other ingredients are: calcium
carbonate, microcrystalline cellulose,
croscarmellose sodium, polysorbate 80,
hydroxypropyl cellulose, starch,
pregelatinised [maize], mannitol, aspartame,

Lipitor chewable tablets are available in
blister packs containing 30 chewable tablets.
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
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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 a day.
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.
Always take this medicine exactly as your
doctor or pharmacist has told you. Check
with your doctor or pharmacist if you are
not sure.

This leaflet was last revised in
IE: MM/YYYY.
UK: 11/2016.
Ref: LR Chew 10_1

Expand Transcript

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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