Medication Guide App

ATORVASTATIN 10MG TABLETS

Active substance: ATORVASTATIN CALCIUM TRIHYDRATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

LIPITOR® 10MG TABLETS
(atorvastatin calcium)

Your medicine is available using the name Lipitor 10mg Tablets
but will be referred to as Lipitor throughout this leaflet.

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 get serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor
or pharmacist.

In this leaflet:
1.
2.
3.
4.
5.
6.

What Lipitor is and what it is used for
Before you take Lipitor
How to take Lipitor
Possible side effects
How to store Lipitor
Further 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 lifestyle 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. 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 – 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.

Take special care with 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.
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.

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
“Taking other medicines”).

Taking 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, etc.
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) and antacids
(indigestion products containing aluminium or magnesium)
Medicines obtained without a prescription: St John’s Wort.

Page 1 of 2

Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines obtained
without a prescription.

Taking 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 “Take special care with Lipitor” 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 lowcholesterol diet, which you should maintain also during therapy
with Lipitor.
The usual starting dose of Lipitor is 10mg 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 80mg once daily for adults
and 20mg 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 Lipitor exactly as your doctor has told you. You
should 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, Lipitor 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: affects 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 Lipitor:
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).

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.
If any of the side effects get serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist.

5. How to store Lipitor
Remember as with all medicines, keep Lipitor out of the
reach and sight of children.
Do not store Lipitor after the last day of the month shown in
the expiry date. This will be printed on the outside of the
pack. The expiry date refers to the last day of the month.
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 any other signs of
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. Further information
What Lipitor contains

Each tablet contains 10mg of the active ingredient atorvastatin as
calcium trihydrate.
Lipitor also contains the inactive ingredients: Calcium carbonate,
Microcrystalline cellulose, Lactose monohydrate, Croscarmellose
sodium, Polysorbate 80, Hydroxypropyl cellulose and Magnesium
stearate.
The coating of Lipitor contains Hypromellose, Macrogol 8000,
Titanium dioxide (E171), Talc, Simethicone, Stearate emulsifiers
and Sorbic acid.

What Lipitor looks like and contents of the pack

Lipitor are white, round, film coated tablets marked with 10 on
one side and ATV on the other side.
Your tablets are available in calendar blister packs of 28. The
translations of days of the week are as follows:
LU
MON

MA
TUE

MI
WED

JU
THUR

VI
FRI

SA
SAT

DO
SUN

Manufacturer

Lipitor is manufactured by: Industrias Farmacéuticas Almirall, S.L.
Ctra, Nacional II, Km. 593 08740 Sant Andreu de la Barca,
Barcelona, Spain.
Procured from within the EU and repackaged by: Doncaster
Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.
Product Licence holder: BR Lewis Pharmaceuticals Ltd.,
Kirk Sandall, Doncaster, DN3 1QR.
PL No: 08929/0094

POM

Lipitor is also known as Totalip, Cardyl, Sortis, Tahor, Torvast and
Zarator.
Leaflet revision and issue date (ref): 28.02.12
LIPITOR® is a registered trademark of Pfizer Ireland
Pharmaceuticals.

Page 2 of 2

PACKAGE LEAFLET: INFORMATION FOR THE USER

ATORVASTATIN 10MG TABLETS
(atorvastatin calcium)

Your medicine is available using the name Atorvastatin 10mg
Tablets but will be referred to as Atorvastatin throughout this
leaflet.

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 get serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor
or pharmacist.

In this leaflet:
1.
2.
3.
4.
5.
6.

What Atorvastatin is and what it is used for
Before you take Atorvastatin
How to take Atorvastatin
Possible side effects
How to store Atorvastatin
Further 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 lifestyle 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. 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.

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.
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.

Check with your doctor or pharmacist before taking
Atorvastatin
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 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.
Page 1 of 2

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 lowcholesterol diet, which you should maintain also during therapy
with Atorvastatin.
The usual starting dose of Atorvastatin is 10mg 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 80mg once daily for
adults and 20mg 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.
Always take Atorvastatin exactly as your doctor has told you. You
should check with your doctor or pharmacist if you are not sure.
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 accidentally take too many Atorvastatin tablets (more than
your usual daily dose), 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 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.

4. Possible side effects
Like all medicines, Atorvastatin 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: affects 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).

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

5. How to store Atorvastatin
Remember as with all medicines, keep Atorvastatin out of
the reach and sight of children.
Do not store Atorvastatin after the last day of the month
shown in the expiry date. This will be printed on the outside
of the pack. The expiry date refers to the last day of the
month.
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 any other signs of
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. Further information
What Atorvastatin contains

Each tablet contains 10mg of the active ingredient atorvastatin as
calcium trihydrate.
Atorvastatin also contains the inactive ingredients: Calcium
carbonate, Micro-crystalline cellulose, Lactose monohydrate,
Croscarmellose sodium, Polysorbate 80, Hydroxypropyl cellulose
and Magnesium stearate.
The coating of Atorvastatin contains Hypromellose, Macrogol
8000, Titanium dioxide (E171), Talc, Simethicone, Stearate
emulsifiers and Sorbic acid.

What Atorvastatin looks like and contents of the
pack

Atorvastatin are white, round, film coated tablets marked with 10
on one side and ATV on the other side.
Your tablets are available in calendar blister packs of 28. The
translations of days of the week are as follows:
LU
MON

MA
TUE

MI
WED

JU
THUR

VI
FRI

SA
SAT

DO
SUN

Manufacturer

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.

Atorvastatin is manufactured by: Industrias Farmacéuticas
Almirall, S.L. Ctra, Nacional II, Km. 593 08740 Sant Andreu de la
Barca, Barcelona, Spain.

If any of the side effects get serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist.

Procured from within the EU and repackaged by: Doncaster
Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.
Product Licence holder: BR Lewis Pharmaceuticals Ltd.,
Kirk Sandall, Doncaster, DN3 1QR.
PL No: 08929/0094

POM

Leaflet revision and issue date (ref): 28.02.12

Page 2 of 2

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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