ATORVASTATIN 40MG TABLETS

Active substance: ATORVASTATIN CALCIUM TRIHYDRATE

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1. What Atorvastatin is and what it is used for
Atorvastatin belongs to a group of medicines known as statins, which are lipid (fat) regulating medicines.
Atorvastatin 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, Atorvastatin 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.

Take special care with Atorvastatin
The following are reasons why Atorvastatin 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.

DATE:

CUSTOMER
APPROVED:

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
lipids or to any of the other ingredients of the medicine – see Section 6 for details
• 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.

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

UK PIL DATED JULY 201
AND SAFETY WARNING

27/3/12
DATE OF PROOF:
6464/0864 0865B

ks

CODE:

04-1957

Atorvastatin 10mg 40mg tabs

ARTWORKER:

DATE:

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.

PRODUCT:

CUSTOMER: Waymade

PRE-PRESS NO.:

Q.A.
APPROVED:

If any of these apply to you, your doctor will need to carry out a blood test before and possibly during your
Atorvastatin 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 “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 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, etc.
• Other medicines known to interact with Atorvastatin 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) 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 place you on a low-cholesterol diet, which you should maintain also
during therapy with 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.

WARNING!

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD
FONT SIZE 8
BRIDGED TO
CRESTOR 6464/2069 2070

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

PROOF HISTORY:
v.1 - waymade - 21/02/12
v.2 - waymade - 27/3/12

Leaflet Flat Size = 148 x 432

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.

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

This product is available in the above names and strengths, but will be referred to throughout this leaflet as
Atorvastatin. Other strengths (20mg and 80mg), are also available.

WARNING!

27mm

ATORVASTATIN 10mg TABLETS
AND
ATORVASTATIN 40mg TABLETS
(atorvastatin)
Patient Information Leaflet

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

000-0000B

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.

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD
FONT SIZE 8
BRIDGED TO
CRESTOR 6464/2069 2070

4. Possible side effects
Like all medicines, Atorvastatin can cause side effects, although not everybody gets them.
Leaflet Flat Size = 148 x 432

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.

Very rare: affect less than 1 user in 10,000:
• 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 Atorvastatin:
Common side effects (affects 1 to 10 users in 100) 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.
Uncommon side effects (affects 1 to 10 users in 1000) 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.

DATE:
27/3/12
DATE OF PROOF:

Rare side effects (affects 1 to 10 users in 10,000) include:
• visual disturbance
• unexpected bleeding or bruising
• cholestasis (yellowing of the skin and whites of the eyes)
• tendon injury.
Very rare side effects (affects less than 1 user in 10,000) 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 and women).

UK PIL DATED JULY 201
AND SAFETY WARNING

6464/0864 0865B

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.

CODE:

ks

DATE:

Q.A.
APPROVED:
04-1957

ARTWORKER:
Atorvastatin 10mg 40mg tabs
PRODUCT:

CUSTOMER: Waymade

PRE-PRESS NO.:

CUSTOMER
APPROVED:

PROOF HISTORY:
v.1 - waymade - 21/02/12
v.2 - waymade - 27/3/12

Rare: affects 1 to 10 users in 10,000:
• 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 which can be life-threatening
and lead to kidney problems.

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 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
Store below 25°C. Keep in the original package.
KEEP ALL MEDICINES OUT OF THE REACH AND SIGHT OF CHILDREN.
If your doctor tells you to stop taking the tablets, please take them back to the pharmacist for safe
disposal.
Only keep the tablets if your doctor tells you to.
If the tablets become discoloured or show signs of any deterioration, you should seek the advice of
your pharmacist who will advise you what to do.
Do not use after the last day of the month shown in the expiry date on the carton and blister.
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.

Atorvastatin package and contents:
Your medicine is called Atorvastatin 10mg and 40mg tablets. Each tablet contains the active ingredient,
atorvastatin (as the calcium trihydrate) in two strengths 10mg and 40mg.
The 10mg tablets are white, oval and marked 'PD 155' on one side and '10' on the other side.
The 40mg tablets are white, oval and marked 'PD 157' on one side and '40' on the other side.
Atorvastatin 10mg and 40mg tablets also contain the following:
Lactose monohydrate, magnesium stearate, microcrystalline cellulose, croscarmellose sodium,
hydroxypropylcellulose, calcium carbonate, polysorbate 80, hydroxypropylmethylcellulose, polyethylene
glycol, talc, simethicone, sorbic acid, candelilla wax, stearate emulsifiers and titanium dioxide (E171).
Atorvastatin 10mg and 40mg tablets, each strength, are available as calendar blister packs of 28 tablets and
packs of 30 and 90 tablets.

POM

6. Further information
PL No: 6464/0864 Atorvastatin 10mg tablets
PL No: 6464/0865 Atorvastatin 40mg tablets

These products are manufactured by Godecke A.G., Mooswaldallee 1-9, D-79090 Freiburg, Germany and are
procured from within the EU and repackaged by the Product Licence holder:
Waymade plc, Miles Gray Road, Basildon, Essex, SS14 3FR
Leaflet revision and issue date (Ref.) 27.3.2012

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

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.

WARNING!

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

WARNING!

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.

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

Always take Atorvastatin exactly as your doctor has told you. You should check with your doctor or
pharmacist if you are not sure.

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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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