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LIPITOR 20MG TABLETS

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

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689 LEAFLET Lipitor 20170426

PACKAGE LEAFLET: INFORMATION FOR THE USER

LIPITOR 20mg TABLETS
ATORVASTATIN 20mg TABLETS
(atorvastatin calcium)
Your medicine is known with either of the above names but will be
referred to as Lipitor throughout the following leaflet.
Information for other strengths of Lipitor (10mg, 40mg and 80mg)
also may be present in this leaflet.
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.

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.



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.

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.
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

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.
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.
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.



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

3. HOW TO TAKE LIPITOR



if you are older than 70 years

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

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”).

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.

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

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

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.

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.

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

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.
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.

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:
www.mhra.gov.uk/yellowcard
5. HOW TO STORE LIPITOR


KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Do not store above 25°C.



Do not use Lipitor after the expiry date which is stated on the
carton and blister strip. The expiry date refers to the last day of
that month.



Tablets should not be thrown in your bin or put down the drain.
If they are out of date, or no longer suitable for you, return them
to your pharmacist.



If the medicine becomes discoloured or shows any other signs
of deterioration, you should seek the advice of your pharmacist
who will tell you what to do.

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.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

Other possible side effects with Lipitor

What Lipitor contains

Common: may affect up to 1 in 10 people



Each tablet contains 20mg of atorvastatin (as atorvastatin
calcium trihydrate) as the active ingredient.



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



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

The coating of tablets contains hypromellose, macrogol 8000,
titanium dioxide (E171), talc, simeticone, stearate emulsifiers,
thickeners, benzoic acid and sorbic acid.



headache



nausea, constipation, wind, indigestion, diarrhoea



joint pain, muscle pain and back pain

What Lipitor looks like and contents of the pack



blood test results that show your liver function can become
abnormal



Lipitor 20mg tablets are round, white tablets marked ‘ATV’ on
one side and ‘20’ on the other.



Lipitor is available in calendar blister packs contain 28 tablets.

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)

Product Licence holder
Procured from within the EU and repackaged by the Product
Licence holder: Chemilines Ltd, Chemilines House, Alperton Lane,
Wembley, HA0 1DX.



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)

Leaflet revision date: 26 April 2017



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

Blind or partially sighted? Is
this leaflet hard to see or read?
Call 02087997607 to obtain the
leaflet in large print, tape, CD
or Braille.

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

Manufacturer
This product is manufactured by Pfizer Manufacturing Deutschland
GmbH, Mooswaldallee, Freiburg, Germany.
POM

PL: 08747/0689

Lipitor is a registered trade mark of Pfizer Ireland Pharmaceuticals,
Ireland.
689 LEAFLET Lipitor 20170426

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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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