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ATORVASTATIN 60 MG FILM-COATED TABLETS

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

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Atorvastatin 60 mg Film-Coated Tablets
(Atorvastatin calcium)
The name of your medicine is Atorvastatin 60 mg Film-Coated Tablets, but
will be referred to as Atorvastatin throughout 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 or pharmacist.
 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 or pharmacist. This
includes any possible side effects not listed in this leaflet. See section
4.
What is in this leaflet
1. What Atorvastatin is and what it is used for
2. What you need to know before you take Atorvastatin
3. How to take Atorvastatin
4. Possible side effects
5. How to store Atorvastatin
6. Contents of the pack and other information

1. WHAT ATORVASTATIN IS AND WHAT IT IS USED FOR
Atorvastatin belongs to a group of medicines known as statins. Statins
lower blood cholesterol (and triglycerides).
Atorvastatin is advised when a low-fat diet and lifestyle changes have not
been adequate to lower blood cholesterol as recommended.
If you are at an increased risk of heart disease, Atorvastatin may also be
used to reduce such risk even if your blood cholesterol is “normal”. You
should maintain a standard cholesterol-lowering diet during
treatment.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
ATORVASTATIN
Do not take Atorvastatin if you
 are allergic to atorvastatin or to any similar medicines used to lower
blood cholesterol or to any of the other ingredients of this medicine (listed
in section 6)
 have or have ever had a disease that affects the liver
 have had any unexplained abnormal blood tests for liver function
 are a woman able to have children and not using reliable contraception
 are pregnant or trying to become pregnant
 are breast-feeding.
Warnings and precautions
Talk to your doctor or pharmacist before taking Atorvastatin.
The following are reasons why Atorvastatin may not be suitable for you if
you have:
 had a previous stroke caused by bleeding
 kidney problems
 an under-active thyroid gland (hypothyroidism)
 (or have had) repeated or unexplained muscle aches or pains or a family
history of muscle problems. 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.
 had previous muscle problems during treatment with other cholesterollowering medicines (i.e. other ‘statin’ or ‘fibrate’ medicines)
 had liver disease.

Other medicines and Atorvastatin
There are some medicines that may change the effect of Atorvastatin or
their effect may be changed by Atorvastatin. 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 lower cholesterol e.g. gemfibrozil, other fibrates,
colestipol
 Medicines used for angina or high blood pressure known as “calcium
channel blockers” 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
 Other medicines known to interact with Atorvastatin include ezetimibe
(lowers cholesterol), warfarin (reduces blood clotting), oral
contraceptives, stiripentol (for epilepsy), cimetidine (for heartburn and
peptic ulcers), phenazone (a painkiller) and antacids (indigestion
products containing aluminium or magnesium)
 Medicines obtained without a prescription: St John’s Wort
Tell your doctor or pharmacist if you are taking, have recently taken or
might take any other medicines.
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.
Taking Atorvastatin with food, drink and alcohol
See Section 3 for instructions on how to take Atorvastatin. 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
Atorvastatin.
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 Atorvastatin if you are pregnant, or if you are trying to become
pregnant.
Do not take Atorvastatin if you are able to become pregnant unless you
use reliable contraceptive measures.
Do not take Atorvastatin if you are breast-feeding.
The safety of Atorvastatin during pregnancy and breast-feeding has not yet
been proven. Ask your doctor or pharmacist for advice before taking this
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.
Atorvastatin contains lactose
If you have been told by your doctor that you have an intolerance to some
sugars, contact your doctor before taking this medicine.

3. HOW TO TAKE ATORVASTATIN
also take special care with Atorvastatin and if you:
 regularly drink a large amount of alcohol
 are older than 70 years.

Always take this medicine exactly as your doctor or pharmacist has told
you. Check with your doctor or pharmacist if you are not sure.

Check with your doctor or pharmacist before taking Atorvastatin
 if you have severe respiratory failure.

Before starting treatment, your doctor will advise a low-cholesterol diet: you
should continue this diet whilst taking Atorvastatin.

The above are reasons why Atorvastatin may not be suitable for you: if any
of the above reasons apply to you, your doctor will need to carry out a
blood test before and possibly during your treatment with Atorvastatin
especially to predict your risk of muscle related side effects. The risk of
muscle related side effects is known to increase when certain medicines
are taken at the same time (see Section 2 “Other medicines and
Atorvastatin”).

The usual starting dose of Atorvastatin 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
Atorvastatin is 80 mg once daily for adults and 20 mg once daily for
children.
Atorvastatin 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.

The duration of treatment with Atorvastatin is determined by your
doctor.
Please ask your doctor if you think that the effect of Atorvastatin is too
strong or too weak.
If you take more Atorvastatin than you should
If you accidently take too many Atorvastatin tablets (more than your usual
daily dose) then contact your doctor or nearest hospital for advice.
If you forget to take Atorvastatin
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.
Uncommon: may affect up to 1 in 100 people:
 Inflammation of the pancreas causing abdominal pain and vomiting
Rare: may affect up to 1 in 1,000 people:
 swelling of the face, tongue and windpipe that can cause great difficulty
in breathing
 severe, extensive, blistering skin rash
 severe muscle disease: symptoms include muscle weakness, tenderness
or pain and if you also feel unwell or have a high temperature then the
symptoms may be caused by abnormal muscle breakdown that can be
life-threatening and lead to kidney problems
Very rare: may affect up to 1 in 10,000 people:
 a sudden allergic reaction with shortness of breath, rash, wheezing and
drop of blood pressure
 unexpected or unusual bleeding or bruising
 severe liver problems
The following side-effects have also been reported:
Common: may affect up to 1 in 10 people:
 inflammation and pain in the upper airways, nose bleed
 allergic reactions
 change in blood sugar (if you have diabetes continue careful monitoring
of your blood sugar levels)
 headache
 nausea, constipation, wind, indigestion, diarrhoea
 joint pain, muscle pain and back pain
 changes in blood test results that report on your muscles and liver
Uncommon: may affect up to 1 in 100 people:
 loss of appetite, vomiting, belching, abdominal pain
 weight gain
 nightmares, insomnia
 dizziness, ringing in the ears (tinnitus)
 numbness or tingling in the fingers and toes, reductions of sensation to
pain or touch
 change in sense of taste
 loss of memory
 visual disturbance
 liver problems
 skin rash, itching, hives, hair loss
 neck pain, chest pain
 fatigue, feeling unwell, weakness
 fluid retention causing swelling of the extremities
 fever
 a urine test that gives a positive result for the presence of white blood
cells
Rare: may affect up to 1 in 1,000 people:
 jaundice (yellowing of skin)
 sore muscle tendons that may rupture
Very rare: may affect up to 1 in 10,000 people:
 hearing loss
 increase in breast tissue 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 or pharmacist. This includes
any possible side effects not listed in this leaflet. You can also report side
effects directly via: Yellow Card Scheme Website:
www.mhra.gov.uk/yellowcard. By reporting side effects you can help
provide more information on the safety of this medicine.

5. HOW TO STORE ATORVASTATIN
Keep out of the reach and sight of children.
Store in the original package in order to protect from moisture.
This medicinal product does not require any special temperature storage
conditions.
Do not use Atorvastatin after the expiry date which is stated on the carton
box and blister after EXP. The expiry date refers to the last day of that
month.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required.
These measures will help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Atorvastatin contains
 The active substance is Atorvastatin. Each film-coated tablet contains 60
mg of atorvastatin as atorvastatin calcium.
The other ingredients are sodium hydroxide, hyprolose, lactose
monohydrate, microcrystalline cellulose, croscarmellose sodium, type A
crospovidone, magnesium stearate and polysorbate 80 in the tablet core
and Opadry II White 85F28751 containing polyvinyl alcohol, titanium
dioxide (E171) macrogol 3000 and talc in the film-coating.
What Atorvastatin looks like and contents of the pack
Film-coated tablets are white to almost white, oval, biconvex.
Available in blister packs containing 30 or 100 tablets.
Not all pack sizes may be marketed.
Manufactured by Krka, tovarna zdravil, d.d., Novo mesto, Šmarješka cesta
6, 8501 Novo mesto, Slovenia and procured from within the EU and
repackaged in the UK by the Product Licence holder: CD Pharma Ltd, Unit
3, Manor Point, Manor Way, Borehamwood, Herts WD6 1EE.
Atorvastatin 60 mg Film-Coated Tablets
PL: 20492/0557
POM

Blind or partially sighted? Is this
leaflet hard to see or read?
Call 020 8236 3190 to obtain a leaflet
in a format suitable for you.
Date of preparation: 15th February 2017

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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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