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LIPITOR 80 MG FILM-COATED TABLETS

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

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United Kingdom
Yellow Card Scheme website:
www.mhra.gov.uk/yellowcard
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.
Do not use this medicine after the expiry date
which is stated on the container and outer
packaging after {EXP}. The expiry date refers to
the last day of that month.
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
What Lipitor contains
• The active substance is atorvastatin.
Each film-coated tablet contains 10 mg atorvastatin
(as atorvastatin calcium trihydrate).
Each film-coated tablet contains 20 mg atorvastatin
(as atorvastatin calcium trihydrate).
Each film-coated tablet contains 40 mg atorvastatin
(as atorvastatin calcium trihydrate).
Each film-coated tablet contains 80 mg atorvastatin
(as atorvastatin calcium trihydrate).

Lipitor 20 mg film-coated tablets are white 7.1 mm in
diameter with a round shape. They are marked with
20 on one side and “ATV” on the other side.
Lipitor 40 mg film-coated tablets are white 9.5 mm in
diameter with a round shape. They are marked with
40 on one side and “ATV” on the other side.
Lipitor 80 mg film-coated tablets are white 11.9 mm in
diameter with a round shape. They are marked with
80 on one side and “ATV” on the other side.
The blisters consist of a forming film made of
polyamide/aluminium foil/polyvinyl chloride and a
backing made of aluminium foil/vinyl heat-seal coating.
The bottle is made of HDPE, containing desiccant, with
squeeze-and-turn child-resistant closure.
Lipitor film-coated tablets are available in blister packs
containing 4, 7, 10, 14, 20, 28, 30, 50, 56, 84, 90,
98 and 100 film-coated tablets; hospital packs
containing 50, 84, 100, 200 (10 x 20) or 500 film-coated
tablets and bottles containing 90 film-coated tablets.
Not all pack sizes may be marketed.

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,
D-79090 Freiburg, Germany.
This leaflet was last revised in 11/2016.

LIPITOR®
10 mg, 20 mg, 40 mg & 80 mg
film-coated 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

1. What Lipitor is and what it is
used for

The coating of Lipitor contains hypromellose, macrogol
8000, titanium dioxide (E171), talc, simethicone
emulsion containing simethicone, stearate emulsifiers
(polyethylene glycol sorbitan tristearate, polyethoxylate
stearate, glycerides), thickeners (methylcellulose,
xanthan gum), benzoic acid, sorbic acid and sulfuric
acid.

Lipitor belongs to a group of medicines known as
statins, which are lipid (fat) regulating medicines.

What Lipitor looks like and contents of
the pack

Mock up 3771.indd 1

UNITED KINGDOM

Ref: LR 28_1

• The other ingredients are:
calcium carbonate, microcrystalline cellulose, lactose
monohydrate, croscarmellose sodium, polysorbate 80,
hydroxypropyl cellulose and magnesium stearate.

Lipitor 10 mg film-coated tablets are white 5.6 mm in
diameter with a round shape. They are marked with
10 on one side and “ATV” on the other side.

Package leaflet: Information for the user

Mock up 3771

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
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
Mock up 3771
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.
• 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.

Lipitor with food and drink
See section 3 for instructions on how to take Lipitor.
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.

Mock up 3771.indd 2

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

If you forget to take Lipitor

Pregnancy and breast-feeding

If you stop taking Lipitor

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 lactose
If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before
taking this medicinal product.

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.
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 tablets should be 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.
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 tablets (more
than your usual daily dose), contact your doctor or
nearest hospital for advice.
Mock up 3771

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.

4. Possible side effects
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 (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.
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: 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 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

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
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
• 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.

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
Mock up 3771
the safety of this medicine.

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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