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ATORVASTATIN 80MG FILM COATED TABLETS
Active substance(s): ATORVASTATIN CALCIUM / ATORVASTATIN CALCIUM TRIHYDRATE
Atorvastatin 30 mg film-coated tablets
Atorvastatin 60 mg film-coated tablets
Atorvastatin 80 mg film-coated tablets
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
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 cholesterol-lowering medicines (i.e. other ‘statin’ or
• had liver disease.
also take special care with Atorvastatin and 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 “Other medicines and Atorvastatin”).
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:
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.
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
3. HOW TO TAKE ATORVASTATIN
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if
you are not sure.
Before starting treatment, your doctor will advise a low-cholesterol diet: you should continue this diet whilst taking
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
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
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)
• 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
• 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
• 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 this medicine out of the sight and reach 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 this medicine 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.
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.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Atorvastatin contains
• The active substance is atorvastatin. Each Atorvastatin 30 mg, 60 mg, 80 mg film-coated tablet contains 30 mg,
60 mg, or 80 mg, respectively, of atorvastatin as atorvastatin calcium.
• The other ingredients are sodium hydroxide, hydroxypropylcellulose (E463), lactose monohydrate, microcrystalline
cellulose (E460), croscarmellose sodium, type A crospovidone, magnesium stearate (E572) and polysorbate 80 in
the tablet core and Opadry II White 85F28751 containing polyvinyl alcohol, titanium dioxide (E171) macrogol 3000
and talc (E553b) in the film-coating.
What Atorvastatin looks like and contents of the pack
30 mg film-coated tablets are white to almost white, round, slightly convex, film-coated tablets, bevel-edged, tablet
diameter 9 mm.
60 mg film-coated tablets are white to almost white, oval, biconvex, film-coated tablets, tablet dimensions 16 mm x
80 mg film-coated tablets are white to almost white, capsule shape, biconvex, film-coated tablets, tablet dimensions
18 mm x 9 mm.
Boxes of 4, 7, 10, 14, 20, 28, 30, 50, 56, 60, 84, 90, 98 and 100 film-coated tablets in blisters are available.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
1. KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
2. TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany
Distributed by: Consilient Health (UK) Ltd., No.1 Church Road, Richmond upon Thames, Surrey. TW9 2QE.
This leaflet was last revised in 08/2015
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.