Skip to Content

UK Edition. Click here for US version.

PREVENCOR 10MG TABLETS

Active substance(s): ATORVASTATIN / ATORVASTATIN CALCIUM TRIHYDRATE

View full screen / Print PDF » Download PDF ⇩
Transcript
Lipitor 10mg Tablets/
Prevencor 10mg Tablets/
Atorvastatin 10mg Tablets
(atorvastatin calcium)

Patient Information Leaflet
Your medicine is known by one of the above names but will be referred to
as Lipitor throughout this leaflet. Lipitor is available in other strengths.
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.
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 hypersensitive (allergic) to Lipitor or to any similar medicines
used to lower blood lipids or to any of the other ingredients of the
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.
The following are reasons why Lipitor 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.
Check with your doctor or pharmacist before taking Lipitor
• if you have severe respiratory failure.
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”).
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
Please tell your doctor or pharmacist if you are taking or have recently
taken any other medicines, including medicines obtained without a
prescription.
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.
Important information about some of the ingredients of Lipitor
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 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 daily for adults and 20 mg once daily for children.
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. 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 side effects (may affect up to 1 in 10 people) 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 (may affect up to 1 in 100 people) 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
Rare side effects (may affect up to 1 in 1,000 people) include:
• visual disturbance
• unexpected bleeding or bruising
• cholestasis (yellowing of the skin and whites of the eyes)
• tendon injury

Very rare side effects (may affect up to 1 in 10,000 people) 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).
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 via the Yellow Card Scheme at:
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 Lipitor
• Keep out of reach and sight of children.
• Do not use after the last day of the month shown in the expiry date on
the carton and blister.
• No special storage conditions are required for Lipitor Tablets.
• 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.
• 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 Lipitor contains
The active substance is atorvastatin (as atorvastatin calcium).
Each 10mg film-coated tablet contains atorvastatin calcium trihydrate
equivalent to 10mg of the active ingredient, atorvastatin.
Lipitor tablets also contain the inactive ingredients: Calcium carbonate,
microcrystalline cellulose, lactose monohydrate, croscarmellose sodium,
polysorbate 80, Hydroxypropyl cellulose, magnesium stearate,
hypromellose, polyethylene glycol 8000, titanium dioxide, talc,
simethicone, stearate emulsifiers and sorbic acid.
What Lipitor looks like and contents of the pack
Lipitor film coated tablets are white with a round shape. They are marked
with 10 on one side and “ATV” on the other side.
Lipitor tablets are supplied as calendar blister packs of 28 tablets
This product is manufactured by Industrias Farmaceuticas Almirall, S.L,
Ctra. Nacional II, Km. 593 08740 Sant Andreu de la Barca – Barcelona,
Spain and is procured from within the EU and repackaged by the Product
Licence holder: Primecrown Ltd, 4/5 Northolt Trading Estate, Belvue Road,
Northolt, Middlesex, UB5 5QS.
PL 10383/0901

Lipitor 10mg Tablets/
Prevencor 10mg Tablets/
Atorvastatin 10mg Tablets

POM

Leaflet date: 03.12.2015
Lipitor® is a registered trade mark of the Pfizer group of companies

Expand view ⇕

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.

Hide