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PREVENCOR 10MG TABLETS

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

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Revision date: 03.03.2017
Ref.: PREV10 VER 4BEA/UT

PREVENCOR 10mg TABLETS / ATORVASTATIN 10mg TABLETS
(atorvastatin calcium)
This product is available in other strengths.
If any of these apply to you, your doctor will need to carry out a blood test
Your medicine is known as either Prevencor 10mg Tablets or Atorvastatin
before and possibly during your Prevencor / Atorvastatin Tablets
10mg Tablets, but will be referred to as Prevencor / Atorvastatin Tablets
treatment to predict your risk of muscle related side effects. The risk of
throughout this leaflet.
muscle related side effects e.g. rhabdomyolysis is known to increase
when certain medicines are taken at the same time (see section 2 “Other
Read all of this leaflet carefully before you start taking this medicine
medicines and Prevencor/Atorvastatin tablets”).
because it contains important information for you.
Also tell your doctor or pharmacist if you have a muscle weakness
that is constant. Additional tests and medicines may be needed to
 Keep this leaflet. You may need to read it again.
diagnose and treat this.
 If you have any further questions, ask your doctor, pharmacist or
While you are on this medicine your doctor will monitor you closely if you
nurse.
have diabetes or are at risk of developing diabetes. You are likely to be at
 This medicine has been prescribed for you only. Do not pass it on to
risk of developing diabetes if you have high levels of sugars and fats in
others. It may harm them, even if their signs of illness are the same
your blood, are overweight and have high blood pressure.
as yours.
 If you get any side effects, talk to your doctor, pharmacist or nurse.
Other medicines and Prevencor/Atorvastatin Tablets
This includes any possible side effects not listed in this leaflet. See
Tell your doctor or pharmacist if you are taking, have recently taken or
section 4.
might take any other medicines.
What is in this leaflet
There are some medicines that may change the effect of Prevencor /
Atorvastatin Tablets or their effect may be changed by Prevencor /
1. What Prevencor / Atorvastatin Tablets are and what they are used for
Atorvastatin Tablets. This type of interaction could make one or both of
2. What you need to know before you take Prevencor / Atorvastatin
the medicines less effective. Alternatively it could increase the risk or
Tablets
severity of side-effects, including the important muscle wasting condition
3. How to take Prevencor / Atorvastatin Tablets
known as rhabdomyolysis described in section 4:
4. Possible side effects
 Medicines used to alter the way your immune system works, e.g.
5. How to store Prevencor / Atorvastatin Tablets
ciclosporin
6. Contents of the pack and other information
 Certain antibiotics or antifungal medicines, e.g. erythromycin,
clarithromycin, telithromycin, ketoconazole, itraconazole,
1. WHAT PREVENCOR / ATORVASTATIN TABLETS ARE AND WHAT
voriconazole, fluconazole, posaconazole, rifampin, fusidic acid
THEY ARE USED FOR
 Other medicines to regulate lipid levels, e.g. gemfibrozil, other
fibrates, colestipol
Prevencor / Atorvastatin Tablets belong to a group of medicines known as
 Some calcium channel blockers used for angina or high blood
statins, which are lipid (fat) regulating medicines.
pressure, e.g. amlodipine, diltiazem; medicines to regulate your heart
Prevencor / Atorvastatin Tablets are used to lower lipids known as
rhythm e.g. digoxin, verapamil, amiodarone
cholesterol and triglycerides in the blood when a low fat diet and life style
 Medicines used in the treatment of HIV e.g. ritonavir, lopinavir,
changes on their own have failed. If you are at an increased risk of heart
atazanavir, indinavir, darunavir, the combination of tipranavir/ritonavir
disease, Prevencor / Atorvastatin Tablets can also be used to reduce
etc.
such risk even if your cholesterol levels are normal. You should maintain
 Some medicines used in the treatment of hepatitis C e.g. telaprevir
a standard cholesterol lowering diet during treatment.
 Other medicines known to interact with Prevencor / Atorvastatin
Tablets include ezetimibe (which lowers cholesterol), warfarin (which
reduces blood clotting), oral contraceptives, stiripentol (an anti2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PREVENCOR /
convulsant for epilepsy), cimetidine (used for heartburn and peptic
ATORVASTATIN TABLETS
ulcers), phenazone (a painkiller), colchicine (used to treat gout),
antacids (indigestion products containing aluminium or magnesium)
Do not take Prevencor / Atorvastatin Tablets:
and boceprevir (used to treat liver disease such as hepatitis C)
 if you are allergic to atorvastatin or any of the other ingredients of this
 Medicines obtained without a prescription: St John’s Wort
medicine (listed in section 6)
 If you need to take oral fusidic acid to treat a bacterial infection you
 if you have or have ever had a disease which affects the liver
will need to temporarily stop using this medicine. Your doctor will tell
 if you have had any unexplained abnormal blood tests for liver
you when it is safe to restart Lipitor. Taking Lipitor with fusidic acid
function
may rarely lead to muscle weakness, tenderness or pain
 if you are a woman able to have children and not using reliable
(rhabdomyolysis). See more information regarding rhabdomyolysis in
contraception
section 4.
 if you are pregnant or trying to become pregnant
Prevencor / Atorvastatin Tablets with food and drink
 if you are breast-feeding
Warnings and precautions

See section 3 for instructions on how to take Prevencor / Atorvastatin
Tablets. Please note the following:

Talk to your doctor, pharmacist or nurse before taking Prevencor /
Atorvastatin Tablets.
 if you have severe respiratory failure
 if you are taking or have taken in the last 7 days a medicine called
fusidic acid, (a medicine for bacterial infection) orally or by injection.
The combination of fusidic acid and Lipitor can lead to serious muscle
problems (rhabdomyolysis).
 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

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
Prevencor / Atorvastatin Tablets.
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 Prevencor / Atorvastatin Tablets if you are pregnant, or if you
are trying to become pregnant.
Do not take Prevencor / Atorvastatin Tablets if you are able to become
pregnant unless you use reliable contraceptive measures.
Do not take Prevencor / Atorvastatin Tablets if you are breast-feeding.
The safety of Prevencor / Atorvastatin Tablets during pregnancy and
breast-feeding has not yet been proven. Ask your doctor or pharmacist for
advice before taking any medicine.

1

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.






Prevencor / Atorvastatin Tablets contains lactose

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: may affect up to 1 in 100 people

If you have been told by your doctor that you have an intolerance to some
sugars, contact your doctor before taking this medicinal product.



3. HOW TO TAKE PREVENCOR / ATORVASTATIN TABLETS



Before starting treatment, your doctor will place you on a low-cholesterol
diet, which you should maintain also during therapy with Prevencor /
Atorvastatin Tablets.





The usual starting dose of Prevencor / Atorvastatin Tablets 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 Prevencor / Atorvastatin Tablets is 80 mg once a day.






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



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: may affect up to 1 in 1,000 people

The duration of treatment with Prevencor / Atorvastatin Tablets is
determined by your doctor.

visual disturbance
unexpected bleeding or bruising
cholestasis (yellowing of the skin and whites of the eyes)
tendon injury

Please ask your doctor if you think that the effect of Prevencor /
Atorvastatin Tablets is too strong or too weak.






If you take more Prevencor / Atorvastatin Tablets than you should

Very rare: may affect up to 1 in 10,000 people


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

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).

If you forget to take Prevencor / Atorvastatin Tablets




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.

Not known: frequency cannot be estimated from the available data:
Muscle weakness that is constant.

If you stop taking Prevencor / Atorvastatin Tablets

Possible side effects reported with some statins (medicines of the same
type):

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.





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 (rhabdomyolysis). 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.

What Prevencor / Atorvastatin Tablets looks like and contents of the
pack
Prevencor / Atorvastatin Tablets are white, film-coated and round, with
the markings “10” on one side and “ATV” on the reverse side.
Prevencor / Atorvastatin Tablets are available in blister packs of 28
tablets.
Who manufactured your medicine
Prevencor / Atorvastatin Tablets are manufactured by Industrias
Farmaceuticas Almirall Prodesfarma S.L., Ctra. Nacional ll, Km 593,
08740 Sant Andreu de la Barca, Barcelona, Spain and are procured from
within the EU and repackaged by Product Licence holder: Beachcourse
Limited, 20 Alliance Court, Alliance Road, London W3 0RB.
PL 16378/0062

POM

Revision date: 03.03.2017
Leaflet reference: PREV10 VER 4BEA/UT

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Beachcourse,
Tel: 020 8896 9054 for help.

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.

5. HOW TO STORE PREVENCOR / ATORVASTATIN TABLETS
Keep out of the sight and reach of children.
Do not store above 25C. Store in the original packaging.
Do not take this medicine after the expiry date which is printed on the
carton label. The expiry date refers to the last date of that month.
If your doctor stops your treatment, return any unused medicine to your
pharmacist for safe disposal. Only keep this medicine, if your doctor tells
you to.
Remember this medicine is for you. It can only be prescribed by a doctor.
Never give it to other people. It may harm them, even if their symptoms
are the same as yours.

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.

If your tablets show signs of deterioration or discolouration, you should
ask your pharmacist what to do.

Other possible side effects with Prevencor / Atorvastatin Tablets

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.

Common: may affect up to 1 in 10 people



Each tablet contains 10mg of the active ingredient atorvastatin (as the
calcium trihydrate salt). Each tablet also contains calcium carbonate,
microcrystalline cellulose, lactose monohydrate, croscarmellose sodium,
polysorbate 80, hydroxypropyl cellulose, magnesium stearate,
hypromellose, macrogol, titanium dioxide (E171), talc, simethicone, sorbic
acid and stearate emulsifiers.

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.

Very rare: may affect up to 1 in 10,000 people


What Prevencor / Atorvastatin Tablets contain

Reporting of side effects

Rare: may affect up to 1 in 1,000 people


6. CONTENTS OF THE PACK AND OTHER INFORMATION

inflammation of the nasal passages, pain in the throat, nose bleed
allergic reactions

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Expand Transcript

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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