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ATORVASTATIN 80 MG FILM COATED TABLETS

Active substance(s): ATORVASTATIN CALCIUM TRIHYDRATE

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CONFORME
LABORATORIO:

Anverso:
150 mm

Atorvastatin
10/20/40/80 mg
film-coated tablets
Atorvastatin

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 use 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, 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.

2. WHAT YOU NEED TO
KNOW BEFORE YOU TAKE
ATORVASTATIN
Do not use Atorvastatin:
- if you are allergic to atorvastatin, or to any
similar medicines used to lower blood
lipids or any of the other ingredients of this
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 or pharmacist before
taking 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.
Check with your doctor or pharmacist
before taking Atorvastatin
- if you have severe respiratory failure.
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.
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. 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”).

Other medicines and Atorvastatin
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 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
Atorvastatin with food, drink and alcohol
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, breast-feeding and fertility
If you are pregnant or breast-feeding, think
you may be pregnant or are planning to
have a baby, ask your doctor or pharmacist
for advice before taking this medicine.
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.

420 mm

PACKAGE LEAFLET: INFORMATION
FOR THE USER

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 and sucrose
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 USE 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
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.
The score line is only there to help you
break the tablet if you have difficulty
swallowing it whole.
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.

I/C01-01.Rev.1

CONFORME
LABORATORIO:

Anverso:
150 mm

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, 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: 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.
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
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).

pressure. Your doctor will monitor you
while you are taking this medicine.
Side effects of unknown frequency:
• Muscle weakness that is constant.
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
the 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.
This medicinal product does not require any
special temperature storage conditions.
Store in the original blister packaging.
Do not use this medicine after the expiry
date which is stated on the carton or blister
foil 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 no
longer use. These measures will help to
protect the environment.

6. CONTENTS OF THE PACK
AND OTHER INFORMATION
What Atorvastatin contains
- The active substance is atorvastatin.
Each film-coated tablet contains 10 mg of
atorvastatin (as atorvastatin calcium).
Each film-coated tablet contains 20 mg of
atorvastatin (as atorvastatin calcium).
Each film-coated tablet contains 40 mg of
atorvastatin (as atorvastatin calcium).
Each film-coated tablet contains 80 mg of
atorvastatin (as atorvastatin calcium).
- The other ingredientes are:
Lactose monohydrate, magnesium stearate
(E572), sodium laurilsulfate, microcrystalline
cellulose, anhydrous colloidal silica,
butylhydroxyanisole (E320), crospovidone
(E1202), sodium hydrogen carbonate
(E500) and sinespum (which consist of
sucrose, sorbitan tristearate, polyethylene
glycol stearate (E-171), dimeticone, silicon
dioxide, 2-Bromo-2-nitropropane-1,3-diol).
The coating of Atorvastatin contains Opadry
OYL-28900 white (which consists of lactose
monohydrate, hypromellose, titanium
dioxide (E171) and macrogol 4000).

420 mm

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.

What Atorvastatin looks like and
contents of the pack
The tablets in all strengths 10/20/40 mg are
white, round, biconvex, scored and coded
with AT1/AT2/AT4 on one side.
The tablets in strength 80 mg are white,
oblong, biconvex, scored and coded with
AT8 on one side.
Contents:
This medicine is available as 10 mg, 20 mg,
40 mg and 80 mg film-coated tablets.
All strengths are available in blister packs
containing 14 (only for 10mg), 28, 30, 56,
100 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Galenicum Health S.L
Avda Diagonal 123-11ª Planta
08005 Barcelona
Spain
Manufacturer
SAG Manufactruing, S.L.U.
Crta. N-I, Km 36
28750 San Agustin de Guadalix, Madrid
Spain
Distributed by:
Accord Healthcare Limited,
Sage House, 319 Pinner Road,
North Harrow, Middlesex, HA1 4HF
United Kingdom
PL 32854-0023 Atorvastatin 10mg Film-coated Tablets
PL 32854-0024 Atorvastatin 20mg Film-coated Tablets
PL 32854-0025 Atorvastatin 40mg Film-coated Tablets
PL 32854-0026 Atorvastatin 80mg Film-coated Tablets
This leaflet was last revised in July 2016.

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

I/C01-01.Rev.1

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.

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