Skip to Content

SORTIS TABLETS 10MG

View full screen / Print PDF » Download PDF ⇩
Transcript
PATIENT INFORMATION LEAFLET
®

LIPITOR 10mg TABLETS
LIPITOR ® 20mg TABLETS
Atorvastatin calcium
The name of your medicine is either Lipitor 10mg Tablets or Lipitor 20mg
Tablets but will be referred to as Lipitor Tablets throughout this leaflet.
This medicine is available in other strengths.
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 gets serious, or if you notice any side
effects not listed in this leaflet please tell your doctor or pharmacist.
In this leaflet:
• What Lipitor Tablets are and what they are used for
• Before you take Lipitor Tablets
• How to take Lipitor Tablets
• Possible side effects
• How to store Lipitor Tablets
• Further information
1) WHAT LIPITOR TABLETS ARE AND WHAT THEY ARE USED
FOR
Lipitor Tablets belongs to a group of medicines known as statins, which
are lipid (fat) regulating medicines.
Lipitor Tablets 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
Tablets 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 TABLETS
Do not take Lipitor Tablets:
• If you are hypersensitive (allergic) to Lipitor Tablets 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 Tablets
The following are reasons why Lipitor Tablets 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 Tablets
• 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 Tablets treatment to predict your
risk of muscle related side effects. The risk of muscle related side effects
e.g. rhabdomyolyisis is known to increase when certain medicines are
taken at the same time (see Section 2 “Taking 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 other medicines
There are some medicines that may change the effect of Lipitor Tablets,
or their effect may be changed by Lipitor Tablets. 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, rifampicin, 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 Tablets 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
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 Tablets with food and drink
See Section 3 for instructions on how to take Lipitor Tablets. 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 Tablets
Alcohol
Avoid drinking too much alcohol while taking this medicine. See Section 2
“Take special care with Lipitor Tablets” for details.
Pregnancy and breast-feeding
Do not take Lipitor Tablets if you are pregnant, or if you are trying to
become pregnant.
Do not take Lipitor Tablets if you are able to become pregnant unless you
use reliable contraceptive measures.
Do not take Lipitor Tablets if you are breast-feeding.
The safety of Lipitor Tablets 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
Tablets
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 TABLETS
Before starting treatment, your doctor will place you on a low-cholesterol
diet, which you should maintain also during therapy with Lipitor Tablets.
The usual starting dose of Lipitor 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 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 Tablets 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 Tablets is determined by your
doctor.
Please ask your doctor if you think that the effect of Lipitor Tablets is too
strong or too weak.
If you take more Lipitor Tablets than you should:
If you accidentally 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 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.
If you stop taking Lipitor Tablets
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 Tablets 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.

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 gets serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.
5) HOW TO STORE LIPITOR TABLETS
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.
Store below 25ºC. Keep the tablets in the original packaging

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.

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.

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.

Lipitor Tablets also contain the inactive ingredients: calcium carbonate,
microcrystalline cellulose, lactose monohydrate, croscarmellose sodium,
polysorbate 80, hyprolose, and magnesium stearate.

Other possible side effects with Lipitor Tablets:
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 (yellow of the skin and whites of the eyes)
• tendon injury

6) FURTHER INFORMATION
Lipitor Tablets package and contents:
The active substance of Lipitor Tablets is atorvastatin. Each tablet
contains 10mg or 20mg of atorvastatin as atorvastatin calcium trihydrate.

The coating of Lipitor Tablets contains hypromellose, macrogol 8000,
titanium dioxide (E171), talc, simeticone, stearate emulsifiers, thickeners
(methylcellulose, xanthum gum), benzoic acid, sorbic acid and candelilla
wax.
Lipitor Tablets is supplied in blister packs of 28 and 30 tablets.
Manufacturer:
The manufacturer is Pfizer Manufacturing Deutschland GmbH, HeinrichMack-Strasse 35, 89257 Illertissen, Germany.
Procured within the EU by the licence holder BR Pharma International
Limited, Unit 3, Manor Point, Manor Way, Borehamwood, Herts, WD6
1EE.
Lipitor 10mg Tablets
Lipitor 20mg Tablets

PL No. 16782/0005
PL No. 16782/0006

Lipitor is a registered trademark.
Date of preparation: 31st May 2012

POM

PATIENT INFORMATION LEAFLET

ATORVASTATIN 10mg TABLETS
ATORVASTATIN 20mg TABLETS
Atorvastatin calcium
The name of your medicine is either Atorvastatin 10mg Tablets or
Atorvastatin 20mg Tablets but will be referred to as Atorvastatin Tablets
throughout this leaflet. This medicine is available in other strengths.
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 gets serious, or if you notice any side
effects not listed in this leaflet please tell your doctor or pharmacist.
In this leaflet:
• What Atorvastatin Tablets are and what they are used for
• Before you take Atorvastatin Tablets
• How to take Atorvastatin Tablets
• Possible side effects
• How to store Atorvastatin Tablets
• Further information
1) WHAT ATORVASTATIN TABLETS ARE AND WHAT THEY ARE
USED FOR
Atorvastatin Tablets belongs to a group of medicines known as statins,
which are lipid (fat) regulating medicines.
Atorvastatin Tablets 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 Tablets 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 TABLETS
Do not take Atorvastatin Tablets:
• If you are hypersensitive (allergic) to Atorvastatin Tablets 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 Tablets
The following are reasons why Atorvastatin Tablets 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

Taking other medicines
There are some medicines that may change the effect of Atorvastatin
Tablets, or their effect may be changed by Atorvastatin Tablets. 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, rifampicin, 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 Tablets 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
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 Tablets with food and drink
See Section 3 for instructions on how to take Atorvastatin Tablets. 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 Tablets
Alcohol
Avoid drinking too much alcohol while taking this medicine. See Section 2
“Take special care with Atorvastatin Tablets” for details.
Pregnancy and breast-feeding
Do not take Atorvastatin Tablets if you are pregnant, or if you are trying to
become pregnant.
Do not take Atorvastatin Tablets if you are able to become pregnant
unless you use reliable contraceptive measures.
Do not take Atorvastatin Tablets if you are breast-feeding.
The safety of Atorvastatin Tablets 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
Tablets
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 TABLETS

Check with your doctor or pharmacist before taking Atorvastatin
Tablets
• If you have severe respiratory failure

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

If any of these apply to you, your doctor will need to carry out a blood test
before and possibly during your Atorvastatin Tablets treatment to predict
your risk of muscle related side effects. The risk of muscle related side
effects e.g. rhabdomyolyisis is known to increase when certain medicines
are taken at the same time (see Section 2 “Taking other medicines”).

The usual starting dose of 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 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.

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.

Always take Atorvastatin Tablets 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 Tablets is determined by
your doctor.
Please ask your doctor if you think that the effect of Atorvastatin Tablets is
too strong or too weak.
If you take more Atorvastatin Tablets 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 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.
If you stop taking Atorvastatin Tablets
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 Tablets 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.

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 gets serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.
5) HOW TO STORE ATORVASTATIN TABLETS
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.
Store below 25ºC. Keep the tablets in the original packaging

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.

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.

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.

Atorvastatin Tablets also contain the inactive ingredients: calcium
carbonate, microcrystalline cellulose, lactose monohydrate,
croscarmellose sodium, polysorbate 80, hyprolose, and magnesium
stearate.

Other possible side effects with Atorvastatin Tablets:

The coating of Atorvastatin Tablets contains hypromellose, macrogol
8000, titanium dioxide (E171), talc, simeticone, stearate emulsifiers,
thickeners (methylcellulose, xanthum gum), benzoic acid, sorbic acid and
candelilla wax.

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 (yellow of the skin and whites of the eyes)
• tendon injury

6) FURTHER INFORMATION
Atorvastatin Tablets package and contents:
The active substance of Atorvastatin Tablets is atorvastatin. Each tablet
contains 10mg or 20mg of atorvastatin as atorvastatin calcium trihydrate.

Atorvastatin Tablets is supplied in blister packs of 28 and 30 tablets.
Manufacturer:
The manufacturer is Pfizer Manufacturing Deutschland GmbH, HeinrichMack-Strasse 35, 89257 Illertissen, Germany.
Procured within the EU by the licence holder BR Pharma International
Limited, Unit 3, Manor Point, Manor Way, Borehamwood, Herts, WD6
1EE.
Atorvastatin 10mg Tablets PL No. 16782/0005
Atorvastatin 20mg Tablets PL No. 16782/0006
st

Date of preparation: 31 May 2012

POM

PATIENT INFORMATION LEAFLET
®

SORTIS 10mg TABLETS
SORTIS ® 20mg TABLETS
Atorvastatin calcium
The name of your medicine is either Sortis 10mg Tablets or Sortis 20mg
Tablets but will be referred to as Sortis Tablets throughout this leaflet.
This medicine is available in other strengths.
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 gets serious, or if you notice any side
effects not listed in this leaflet please tell your doctor or pharmacist.
In this leaflet:
• What Sortis Tablets are and what they are used for
• Before you take Sortis Tablets
• How to take Sortis Tablets
• Possible side effects
• How to store Sortis Tablets
• Further information
1) WHAT SORTIS TABLETS ARE AND WHAT THEY ARE USED
FOR
Sortis Tablets belongs to a group of medicines known as statins, which
are lipid (fat) regulating medicines.
Sortis Tablets 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, Sortis
Tablets 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 SORTIS TABLETS
Do not take Sortis Tablets:
• If you are hypersensitive (allergic) to Sortis Tablets 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.

Taking other medicines
There are some medicines that may change the effect of Sortis Tablets,
or their effect may be changed by Sortis Tablets. 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, rifampicin, 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 Sortis Tablets 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
Please tell your doctor or pharmacist if you are taking or have recently
taken any other medicines, including medicines obtained without a
prescription.
Taking Sortis Tablets with food and drink
See Section 3 for instructions on how to take Sortis Tablets. 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
Sortis Tablets
Alcohol
Avoid drinking too much alcohol while taking this medicine. See Section 2
“Take special care with Sortis Tablets” for details.
Pregnancy and breast-feeding
Do not take Sortis Tablets if you are pregnant, or if you are trying to
become pregnant.
Do not take Sortis Tablets if you are able to become pregnant unless you
use reliable contraceptive measures.
Do not take Sortis Tablets if you are breast-feeding.
The safety of Sortis Tablets during pregnancy and breast-feeding has not
yet been proven. Ask your doctor or pharmacist for advice before taking
any medicine.

Take special care with Sortis Tablets

Driving and using machines

The following are reasons why Sortis Tablets 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

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.

Check with your doctor or pharmacist before taking Sortis Tablets
• If you have severe respiratory failure

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

If any of these apply to you, your doctor will need to carry out a blood test
before and possibly during your Sortis Tablets treatment to predict your
risk of muscle related side effects. The risk of muscle related side effects
e.g. rhabdomyolyisis is known to increase when certain medicines are
taken at the same time (see Section 2 “Taking other medicines”).

The usual starting dose of Sortis 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 Sortis is 80mg once daily for adults and
20mg once daily for children.
Sortis 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.

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.

Important information about some of the ingredients of Sortis
Tablets
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 SORTIS TABLETS

Always take Sortis Tablets 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 Sortis Tablets is determined by your
doctor.
Please ask your doctor if you think that the effect of Sortis Tablets is too
strong or too weak.
If you take more Sortis Tablets than you should:
If you accidentally take too many Sortis Tablets (more than your usual
daily dose), contact your doctor or nearest hospital for advice.
If you forget to take Sortis 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.
If you stop taking Sortis Tablets
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

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 gets serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.
5) HOW TO STORE SORTIS TABLETS

Like all medicines, Sortis Tablets 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 Sortis Tablets:
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 (yellow of the skin and whites of the eyes)
• tendon injury

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.
Store below 25ºC. Keep the tablets in the original packaging
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
Sortis Tablets package and contents:
The active substance of Sortis Tablets is atorvastatin. Each tablet
contains 10mg or 20mg of atorvastatin as atorvastatin calcium trihydrate.
Sortis Tablets also contain the inactive ingredients: calcium carbonate,
microcrystalline cellulose, lactose monohydrate, croscarmellose sodium,
polysorbate 80, hyprolose, and magnesium stearate.
The coating of Sortis Tablets contains hypromellose, macrogol 8000,
titanium dioxide (E171), talc, simeticone, stearate emulsifiers, thickeners
(methylcellulose, xanthum gum), benzoic acid, sorbic acid and candelilla
wax.
Sortis Tablets is supplied in blister packs of 28 and 30 tablets.
Manufacturer:
The manufacturer is Pfizer Manufacturing Deutschland GmbH, HeinrichMack-Strasse 35, 89257 Illertissen, Germany.
Procured within the EU by the licence holder BR Pharma International
Limited, Unit 3, Manor Point, Manor Way, Borehamwood, Herts, WD6
1EE.
Sortis 10mg Tablets
Sortis 20mg Tablets

PL No. 16782/0005
PL No. 16782/0006

Date of preparation: 31st May2012

POM

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