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ATORVASTATIN 40MG TABLETS

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

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Lipitor® 10mg Tablets
Atorvastatin 10mg Tablets
Lipitor® 20mg Tablets
Atorvastatin 20mg Tablets
Lipitor® 40mg Tablets
Atorvastatin 40mg Tablets

1191/1192/1193
14.08.17[21]

(atorvastatin calcium)
PATIENT INFORMATION 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.
Your medicine is called Lipitor 10mg Tablets / Atorvastatin 10mg Tablets or
Lipitor 20mg Tablets / Atorvastatin 20mg Tablets or Lipitor 40mg Tablets /
Atorvastatin 40mg Tablets but will be referred to as Lipitor throughout the
patient information leaflet.
Lipitor Tablets are also available as the 80mg strength.
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
- 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.
- 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.
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.
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.
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.
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 the safety of this medicine.
United Kingdom
Yellow Card Scheme website: www.mhra.gov.uk/yellowcard
5. HOW TO STORE LIPITOR
Keep this medicine out of the sight and reach of children.
Do not take this medicine after the expiry date shown on the carton or blister
pack.
If your doctor tells you to stop taking this medicine, return any unused tablets
to your doctor for safe disposal. Only keep the tablets if your doctor tells you
to.
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.
If your tablets become discoloured or show any other signs of deterioration,
consult your doctor or pharmacist who will tell you what to do.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
Each tablet contains either 10mg, 20mg or 40mg of the active ingredient
atorvastatin (as the calcium trihydrate).
Your medicine also contains the inactive ingredients calcium carbonate,
microcrystalline cellulose, lactose monohydrate, croscarmellose sodium,
polysorbate 80, hyprolose, magnesium stearate, hypromellose, macrogol
8000, titanium dioxide (E 171), talc, simethicone, stearate emulsifiers,
thickeners, benzoic acid and sorbic acid.
Lipitor 10mg tablets are white, round film-coated tablets coded ‘ATV’ on one
side and ‘10’ on the reverse and available in blister packs of 28 tablets.
Lipitor 20mg tablets are white, round film-coated tablets coded ‘ATV’ on one
side and ‘20’ on the reverse and available in blister packs of 28 tablets.
Lipitor 40mg tablets are white, round film-coated tablets coded ‘ATV’ on one
side and ‘40’ on the reverse and available in blister packs of 28 tablets.
Manufacturer and Product Licence Holder:
Manufactured by Pfizer Manufacturing Deutschland GmbH, Mooswaldallee,
Freiburg, Germany. Procured from the EU by Product Licence holder:
Star Pharmaceuticals Ltd., 5 Sandridge Close, Harrow, Middlesex HA1 1XD.
Repackaged by Servipharm Ltd.

POM

Lipitor 10mg Tablets - PL 20636/1191
Lipitor 20mg Tablets - PL 20636/1192
Lipitor 40mg Tablets - PL 20636/1193

Leaflet revision and issue date (Ref) 14.08.17[21]
Lipitor is a registered trademark of Pfizer.

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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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