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LIPITOR 10 MG FILM COATED TABLETS/

Active substance(s): ATORVASTATIN CALCIUM

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France

Tahor




Germany

Atorvastatin Pfizer

Italy

Xarator



This leaflet was last revised in 06/2015



Ref: LR 27_0

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

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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.

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
• 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

70

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”).
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
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pressure.

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Smallest Font Size 8 pt

Creator: SBU
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Zarator

Talk to your doctor, pharmacist or nurse before taking Lipitor.

Comments:

Denmark, Iceland, Portugal,
Spain

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

Size: 170 x 210 mm

Lipitor

PPD

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

Page 1

Warnings and precautions

Belgium, Cyprus, Finland,
Greece, Ireland, Luxembourg,
Malta, Netherlands, Norway,
Sweden, United Kingdom

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.

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10 mg, 20 mg, 40 mg & 80 mg
film-coated tablets
Atorvastatin

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 squeezeand-turn child-resistant closure.

Not all pack sizes may be marketed.

Lipitor

Techn. Kontrolle:

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.
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.

Austria, Bulgaria, Czech Republic, Sortis
Estonia, Hungary, Latvia,
Lithuania, Poland, Romania,
Slovakia, Slovenia

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

Product: PP LIPITOR 10/20/40/80mg (Ro) SMT GB

What Lipitor looks like and contents of the pack

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

• if you are allergic to atorvastatin or to any similar

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02.09.2015

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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.

Manufacturer:
Pfizer Manufacturing Deutschland GmbH, Betriebsstätte
Freiburg, Mooswaldallee 1, D-79090 Freiburg, Germany.

Do not take Lipitor

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Pfizer Manufacturing Deutschland GmbH



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

UNITED KINGDOM

2. What you need to know before you
take Lipitor

Betriebsstätte Freiburg

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

What Lipitor contains


Package leaflet: Information for the user

Documentation

Marketing Authorisation Holder and
Manufacturer

Druckreif:

6. Contents of the pack and other
information

Page 1

Ersetzt-Mat.-Nr.:

Page 4

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

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.

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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.

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.
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Reporting of side effects

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 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

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.

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

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.
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Other possible side effects with Lipitor:



Comments:

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.

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.

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.

Size: 170 x 210 mm

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

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

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

3. How to take Lipitor

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).

Techn. Kontrolle:

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

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.

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02.09.2015
Betriebsstätte Freiburg

Lipitor contains lactose

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.

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Product: PP LIPITOR 10/20/40/80mg (Ro) SMT GB

Lipitor with food and drink

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.

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

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

XXXXXX

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

Driving and using machines

4. Possible side effects

Documentation

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

Do not take Lipitor if you are breast-feeding.
The safety of Lipitor during pregnancy and breastfeeding has not yet been proven. Ask your doctor or
pharmacist for advice before taking any medicine.

Ersetzt-Mat.-Nr.:

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

Pfizer Manufacturing Deutschland GmbH

Other medicines and Lipitor

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Druckreif:

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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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