ATORVASTATIN 20 MG FILM COATED TABLETS

Active substance: ATORVASTATIN CALCIUM TRIHYDRATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Atorvastatin 10 mg film-coated tablets
Atorvastatin 20 mg film-coated tablets
Atorvastatin 40 mg film-coated tablets
Atorvastatin 80 mg film-coated tablets
Atorvastatin
Read all of this leaflet carefully before you start taking
this medicine.
• 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. Do not pass it on to
others. It may harm them, even if their symptoms are the same
as yours.
• If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor
or pharmacist.
In this leaflet:
1. What Atorvastatin is and what it is used for
2. Before you take Atorvastatin
3. How to take Atorvastatin
4. Possible side effects
5. How to store Atorvastatin
6. Further 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. Before you take Atorvastatin
Do not take Atorvastatin if you:
• are hypersensitive (allergic) to Atorvastatin or to any similar
medicines used to lower blood cholesterol or to any of the
other ingredients of the medicine - see Section 6 for details
• have or have ever had a disease which 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.
Take special care with Atorvastatin 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
• had previous muscular problems during treatment with other
cholesterol-lowering medicines (i.e. other ‘statin’ or ‘fibrate’
medicines)
• had liver disease.
Also take special care with Atorvastatin if you:
• regularly drink a large amount of alcohol
• are older than 70 years.
Check with your doctor or pharmacist before taking
Atorvastatin:
• if you have severe respiratory failure.
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 ‘Taking other medicines’).
Taking other medicines
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 including
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.
Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines
obtained without a prescription.
Taking Atorvastatin with food and drink
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 ‘Take special care with Atorvastatin’ 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
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.
Important information about some of the ingredients
of Atorvastatin
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
Before starting treatment, your doctor will advise a lowcholesterol diet; you should continue this diet whilst taking
Atorvastatin .
The usual starting dose of Atorvastatin is 10mg 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 80mg
once daily for adults and 20mg 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.
Always take Atorvastatin exactly as your doctor has told you. You
should check with your doctor or pharmacist if you are not sure.
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 accidentally 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 stop taking Atorvastatin
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, Atorvastatin 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: affects 1 to 10 users in 1,000:
• Inflammation of the pancreas causing abdominal pain
and vomiting.
Rare: affects 1 to 10 users in 10,000:
• 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: affect less than 1 user in 10,000:
• 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: affects 1 to 10 users in 100:
• 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: affects 1 to 10 users in 1,000:
• 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: affects 1 to 10 users in 10,000:
• jaundice (yellowing of skin)
• sore muscle tendons that may rupture.
Very rare: affects less than 1 user in 10,000:
• hearing loss
• increase in breast tissue in men
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
If any of the side effects gets serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor
or pharmacist.

5. How to store Atorvastatin
Keep out of reach and sight of children.
Store below 30°C.
Do not use Atorvastatin 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.
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. Further information
What Atorvastatin contains
The active substance is atorvastatin.
• Each 10mg film-coated tablets contains 10mg atorvastatin (as
atorvastatin calcium).
• Each 20mg film-coated tablets contains 20mg atorvastatin (as
atorvastatin calcium).
• Each 40mg film-coated tablets contains 40mg atorvastatin (as
atorvastatin calcium).
• Each 80mg film-coated tablets contains 80mg atorvastatin (as
atorvastatin calcium).
The other ingredients of Atorvastatin are:
• Tablet core: Activated attapulgite, lactose monohydrate,
cellulose microcrystalline, starch maize pregelatinised,
hydroxypropyl cellulose, magnesium stearate and silica
colloidal anhydrous.
• Film-coating: Titanium dioxide (E171), lactose monohydrate,
macrogol/PEG 4000, hypromellose 15 cP (E464), hypromellose
3cP (E464) and hypromellose 50cP (E464).
What Atorvastatin looks like and contents of the pack
10mg film-coated tablets:
White, oval, biconvex tablets, with dimensions 10.1±0.1mm
x 5.6±0.1mm and 3.7±0.2mm in thickness
20mg film-coated tablets:
White, oval, biconvex tablets, with a breakline on one side and
dimensions 12.7±0.1mm x 6.7±0.1mm and 4.6±0.2mm in
thickness
40mg film-coated tablets:
White, oblong, biconvex tablets with dimensions 19.4±0.1mm x
7.8±0.1mm and 4.7±0.2mm in thickness
80mg film-coated tablets:
White, oblong, biconvex tablets with a breakline on one side
and dimensions 22.8±0.1mm, 10.9±0.1mm and 5.7±0.2mm
in thickness
Atorvastatin is supplied in PA/ALL/PVC – Aluminium foil
blister packs.
The pack sizes are the following:
10, 14, 28, 30, 50, 60, 84, 90, 96, 98, 100
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Pharmathen SA, Dervenakion 6, 15351 Pallini, Attiki, Greece
Manufacturer:
Pharmathen SA, Dervenakion 6, 15351 Pallini, Attiki, Greece
or
Pharmathen International SA, Industrial Park Sapes, Rodopi
Prefecture, Block No 5, Rodopi 69300, Greece
Distributor:
Aspire Pharma Limited, Antrobus House Business Centre,
18 College Street, Petersfield, Hampshire, GU31 4AD,
United Kingdom
This leaflet was last approved in
05/2011
1010098-P3.1

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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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