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ACECLOFENAC 100 MG FILM-COATED TABLETS

Active substance(s): ACECLOFENAC / ACECLOFENAC

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Patient Information Leaflet

Preservex® 100 mg film-coated tablets
(aceclofenac)
Read all of this leaflet carefully before you start taking this medicine
because it contains important information for you.
 Keep this leaflet. You may need to read it again.
 If you have any further questions, ask your doctor, pharmacist or
nurse.
 This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if their signs of illness are the same as
yours.
 If you get any side effects talk to your doctor, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet.
See section 4.
 The name of your medicine is Preservex® 100 mg film-coated tablets
but will be referred to as Preservex throughout the remainder of this
leaflet.
What is in this leaflet:
1) What Preservex is and what it is used for
2) What you need to know before you take Preservex
3) How to take Preservex
4) Possible side effects
5) How to store Preservex
6) Contents of the pack and other information
1) WHAT PRESERVEX IS AND WHAT IT IS USED FOR
Preservex belongs to a group of medicines called non-steroidal
anti-inflammatory drugs (NSAIDs). They have anti-inflammatory and
painkiller properties causing a lowering of swelling, redness
(inflammation) and pain. The medicine/active ingredient of Preservex is
aceclofenac.
Preservex works by blocking the production of hormone-like substances
called prostaglandins. Prostaglandins have many functions in the body
including an important role in both the way the body responds to
inflammation and also the reabsorption of calcium in some diseases of
the bone.
Preservex is used to relieve pain and reduce redness and swelling
(inflammation) in patients suffering from:
 Osteoarthritis - inflammation of the joints. This is a common condition
in patients over the age of 50 and causes damage to the tissues and
bones in the joints.
 Rheumatoid arthritis - long term inflammation of the joints caused by
the body’s own immune system (autoimmune response).
 Ankylosing spondylitis - inflammation of the spine/backbone which can
lead to the joints fusing together.
2) WHAT YOU NEED TO KNOW BEFORE YOU TAKE PRESERVEX
Do not take Preservex
 if you are allergic to aceclofenac or any of the other ingredients of this
medicine (listed in section 6).
 if you are allergic to aspirin or any other NSAIDs (such as ibuprofen,
naproxen or diclofenac).
 if you have taken aspirin or any other NSAIDs and experienced one of
the following:
asthma attack causing tightness in the chest, wheezing and
difficulty breathing.
runny nose, itching and/or sneezing (irritation of the nose).
raised red circular patchy rash on the skin which may have felt
itchy or like a sting or burn.
a severe allergic reaction known as anaphylactic shock. The
symptoms may be life threatening and include difficulty breathing,
wheezing, abdominal pain and vomiting.
 if you have a history of, suffer from, or suspect that you have a
stomach ulcer or have vomited blood or passed blood in your faeces
(black tarry stools).
 if you have severe kidney disease.
 if you have established heart disease and /or cerebrovascular disease
e.g. if you have had a heart attack, stroke, mini-stroke (TIA) or
blockages to blood vessels to the heart or brain or an operation to
clear or bypass blockages.
 if you have or have had problems with your blood circulation
(peripheral arterial disease).
 if you suffer from, or suspect that you have severe liver failure.
 if you suffer from bleeding or any type of blood clotting disorders.
 if you are pregnant (unless your doctor considers it essential for you to
continue to take this medicine).
Preservex is not recommended for use in children.
Warnings and precautions
Before you start taking Preservex, tell your doctor:
 if you suffer from any other form of kidney or liver disease.
 if you have any of the following disorders, as they may worsen:
disorders of the stomach or gut/bowel
inflammatory bowel disease (ulcerative colitis)
chronic inflammatory bowel disease (Crohn’s disease)
ulceration, bleeding or perforation of the stomach or bowel
 if you have, or have ever had problems with the circulation of the blood
to your brain.
 if you suffer from asthma or any other breathing problems.
 if you suffer from a rare inherited disorder known as porphyria.
 if you smoke.
 if you have diabetes.
 if you have angina, blood clots, high blood pressure, raised cholesterol
or or other raised body fats such as triglycerides.
 if you suffer from an autoimmune condition known as systemic lupus
erythematosus or other connective tissue disorders.
 if you are infected with chicken pox, the use of this medicine should be
avoided because a rare serious infection of the skin may develop.
 if you are recovering from major surgery.
 if you are elderly (your doctor will prescribe you the lowest effective
dose over the shortest duration).

Hypersensitivity reactions can occur and very rarely, very serious allergic
reactions are appearing (see section 4. Possible side effects). The risk is
higher in the first month of treatment. Preservex should be stopped
immediately at the first onset of symptoms such as tightness of the chest,
breathing difficulties, fever, skin rashes, soreness of the skin lining the
mouth and other mucous membranes causing ulcers, or any signs of
hypersensitivity.
Medicines such as Preservex may be associated with a small increased
risk of heart attack (”myocardial infarction”). Any risk is more likely with
high doses and prolonged treatment. Do not exceed the recommended
dose or duration of treatment.
Other medicines and Preservex
Tell your doctor or pharmacist if you are taking, have recently taken or
might take any other medicines.
Please tell your doctor if you are taking:
 medicines used to treat mental health problems like depression
(selective serotonin-reuptake inhibitors (SSRIs) such as citalopram,
escitalopram, fluoxetine, fluvoxamine, paroxetine and sertraline) or
manic depression (lithium)
 medicines used to treat heart failure and irregular heart beats (cardiac
glycosides such as digoxin)
 medicines used to treat high blood pressure (antihypertensives:
ACE inhibitors such as enalopril, lisinopril; angiotensin II receptor
antagonists such as losartan, candesartan; also hydralazine,
methyldopa, clonidine, moxonidine, propranalol)
 medicines to treat infection (quinolone antibiotics such as
ciprofloxacin, ofloxacin, levofloxacin moxifloxacin)
 drugs used to increase the rate of urine excretion (diuretics such as
thiazides, furosemide amiloride hydrochloride)
 medicines that stop blood clotting (anticoagulants) such as
warfarin, heparin
 methotrexate which is used to treat cancer and autoimmune
disorders such as arthritis and skin conditions
 mifepristone
 any steroids for the treatment of swelling and inflammation
(glucocorticoids such as hydrocortisone, prednisolone)
 medicines used to suppress the immune system after organ
transplant (cyclosporin or tacrolimus)
 medicines used to treat HIV (zidovudine)
 medicines used to lower blood sugar levels in diabetes (antidiabetics
such as glibenclamide, glicazide, tolbutamide)
 any other painkiller NSAID drugs (aspirin, ibuprofen, naproxen, COX-2
inhibitors such as celecoxib and etoricoxib)
 antiplatelet drugs such as clopidogrel.
Preservex with food and drink
Preservex must be taken preferably with or after food.
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.
You should inform your doctor if you have problems becoming pregnant.
NSAIDs may make it more difficult to become pregnant.
Do not take Preservex if you are pregnant or think you are pregnant. The
safety of this medicine for use during pregnancy is not known. It is not
recommended for use in pregnancy unless considered essential by your
doctor.
Preservex should not be used if you are breast-feeding. It is not known if
this medicine passes into breast milk. It is not recommended for use
during breast-feeding unless considered essential by your doctor.
Driving and using machines
If you are taking Preservex and you experience dizziness, drowsiness,
vertigo, tiredness or any difficulty with your eyesight, you must not drive
or use machinery.
3) HOW TO TAKE PRESERVEX
Always take this medicine exactly as your doctor or pharmacist has told
you. You will be prescribed the lowest effective dose over the shortest
duration to reduce side effects. Check with your doctor or pharmacist if
you are not sure.
The recommended dose in adults is 200 mg (two Preservex tablets). One
100 mg tablet should be taken in the morning and one in the evening.
Tablets should be swallowed whole with plenty of water and should be
taken with or after food. Do not crush or chew the tablets.
Do not exceed the stated daily dose.
Elderly
If you are elderly, you are more likely to experience serious side-effects
(listed in section 4 ‘Possible Side Effects’). If your doctor prescribes
Preservex for you, you will be given the lowest effective dose over the
shortest duration of treatment.
If you take more Preservex than you should
If you accidentally take too many Preservex tablets, contact your doctor
immediately or go to your nearest hospital casualty department. Please
take this leaflet or the box the Preservex tablets came in, with you to the
hospital so that they will know what you have taken.
If you forget to take Preservex
If you miss a dose, do not worry, just take the next dose at the usual
time. Do not take a double dose to make up for a forgotten tablet dose.
If you stop taking Preservex
Do not stop taking Preservex unless your doctor advises you.
If you have any further questions on the use of this medicine, ask your
doctor, pharmacist or nurse.

4) POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not
everybody gets them.
Stop taking the medicine and seek medical advice IMMEDIATELY, if you
experience any of the following side effects:
 severe allergic reaction (anaphylactic shock). Symptoms may develop
quickly and can be life-threatening if not immediately treated and
include fever, difficulty breathing, wheezing, abdominal pain, vomiting,
swelling of the face and throat.
 severe skin rashes such as Stevens-Johnnson Syndrome and Toxic
Epidermal Necrolysis. These are potentially life-threatening and
develop quickly forming large blisters and the skin to peel away. The
rash can also appear in the mouth, throat or eyes. Fever, headache
and aching of the joints usually occur at the same time.
 meningitis. The symptoms include high fever, headache, vomiting,
blotchy red rashes, neck stiffness, sensitivity and intolerance to light.
 passing blood in your faeces (stools/motions).
 passing black tarry stools. Vomit any blood or dark particles that look
like coffee grounds.
 kidney failure.
STOP TAKING the medicine and seek medical advice if you experience:
 indigestion or heartburn.
 abdominal pain (pains in your stomach) or other abnormal stomach
symptoms.
 blood disorders such as reduced production of blood cells, abnormal
breakdown of red blood cells known as haemolytic anaemia, low
content of iron in the blood, low level of white blood cells, low number
of platelet cells, increased blood potassium levels which can irritate the
blood vessels causing inflammation known as vasculitis. These
disorders can cause you to feel extremely tired, breathless, aching of
the joints and be prone to repeated infections and bruising.
If any of the below side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or pharmacist.
Common (may affect up to 1 in 10 people):
 dizziness
 nausea (feeling sick)
 diarrhoea
 increased liver enzymes in the blood
Uncommon (may affect up to 1 in 100 people):
 wind
 inflammation or irritation of the lining of the stomach
 constipation
 vomiting
 mouth ulcers
 itching
 rash
 inflammation of the skin
 raised circular red itchy, stinging or burning patches on the skin (hives)
 increase in blood urea levels
 increase in blood creatinine levels
Rare (may affect up to 1 in 1,000 people):
 hypersensitivity (allergic reaction)
 problems with eyesight
 heart failure
 high blood pressure
 shortness of breath
 bleeding from the stomach or bowel
 stomach or bowel ulceration
Very Rare (may affect up to 1 in 10,000 people):
 depression
 strange dreams
 inability to sleep
 tingling, pricking or numbness of skin
 uncontrollable shaking
 drowsiness
 headaches
 abnormal taste in the mouth
 sensation of spinning when standing still
 ringing in the ears
 heart pounding or racing
 hot flushes
 difficulty breathing
 high pitched noise when breathing
 inflammation of the mouth
 perforation of either the stomach, large intestine or bowel wall
 worsening of colitis and Crohn’s disease
 inflammation of the pancreas
 injury of the liver (including hepatitis)
 yellowing of the skin
 spontaneous bleeding into the skin (appears as a rash)
 nephrotic syndrome: a condition which indicates kidney damage and
includes large amounts of protein in the urine, low blood albumin
levels, high blood cholesterol levels and swelling of the legs, feet or
ankles
 water retention and swelling
 tiredness
 leg cramps
 increased blood alkaline phosphatase levels
 weight gain
Other side effects that have been reported with this type of drug
(NSAIDs) are:
 hallucinations
 confusion
 blurred, partial or complete loss of vision
 painful movement of the eye
 worsening of asthma
 skin reaction to sunlight
 inflammation of the kidneys
 generally feeling unwell
Exceptionally, serious skin infections occur in association with
chickenpox.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card Scheme, 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 PRESERVEX
 Keep out of the sight and reach of children.
 Do not store above 30°C.
 Do not use this medicine after the expiry date which is stated on the
outer carton. The expiry date refers to the last day of that month. It is
recommended that you store Preservex in the original box.
 If your medicine becomes discoloured or shows any sign of
deterioration, return it to your pharmacist.
 Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines no longer
required. These measures will help to protect the environment.
6) CONTENTS OF THE PACK AND OTHER INFORMATION
What Preservex contains
Each film-coated tablet contains 100 mg aceclofenac.
The other ingredients are:
Microcrystalline cellulose, croscarmellose sodium, glyceryl
palmitostearate, povidone, hypromellose, polyoxyethylene 40 stearate
and titanium dioxide (E 171).
What Preservex looks like and contents of the pack
Preservex 100 mg film-coated tablets are white, round tablets.
Preservex tablets are available in boxes of 40 and 60 tablets.
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 by the Product Licence Holder:
MPT Pharma Ltd, Westgate Business Park, Unit 5-7 Tintagel Way,
Aldridge, Walsall, WS9 8ER.
Repackaged by MPT Pharma Ltd.
PL: 33532/0533

POM
th

Leaflet dated: 18 May 2017
Leaflet coded: XXXXXXXXXX
Preservex® is a registered trademark of Almirall S.A.

To request a copy of this leaflet in
Braille, large print or audio please
call 01922 745645 and ask for the
Regulatory Department

Patient Information Leaflet

Aceclofenac 100 mg film-coated tablets
Read all of this leaflet carefully before you start taking this medicine
because it contains important information for you.
 Keep this leaflet. You may need to read it again.
 If you have any further questions, ask your doctor, pharmacist or
nurse.
 This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if their signs of illness are the same as
yours.
 If you get any side effects talk to your doctor, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet.
See section 4.
 The name of your medicine is Aceclofenac 100 mg film-coated tablets
but will be referred to as Aceclofenac throughout the remainder of this
leaflet.
What is in this leaflet:
1) What Aceclofenac is and what it is used for
2) What you need to know before you take Aceclofenac
3) How to take Aceclofenac
4) Possible side effects
5) How to store Aceclofenac
6) Contents of the pack and other information
1) WHAT ACECLOFENAC IS AND WHAT IT IS USED FOR
Aceclofenac belongs to a group of medicines called non-steroidal
anti-inflammatory drugs (NSAIDs). They have anti-inflammatory and
painkiller properties causing a lowering of swelling, redness
(inflammation) and pain. The medicine/active ingredient of Aceclofenac is
aceclofenac.
Aceclofenac works by blocking the production of hormone-like
substances called prostaglandins. Prostaglandins have many functions in
the body including an important role in both the way the body responds
to inflammation and also the reabsorption of calcium in some diseases of
the bone.
Aceclofenac is used to relieve pain and reduce redness and swelling
(inflammation) in patients suffering from:
 Osteoarthritis - inflammation of the joints. This is a common condition
in patients over the age of 50 and causes damage to the tissues and
bones in the joints.
 Rheumatoid arthritis - long term inflammation of the joints caused by
the body’s own immune system (autoimmune response).
 Ankylosing spondylitis - inflammation of the spine/backbone which can
lead to the joints fusing together.
2) WHAT YOU NEED TO KNOW BEFORE YOU TAKE
ACECLOFENAC
Do not take Aceclofenac
 if you are allergic to aceclofenac or any of the other ingredients of this
medicine (listed in section 6).
 if you are allergic to aspirin or any other NSAIDs (such as ibuprofen,
naproxen or diclofenac).
 if you have taken aspirin or any other NSAIDs and experienced one of
the following:
asthma attack causing tightness in the chest, wheezing and
difficulty breathing.
runny nose, itching and/or sneezing (irritation of the nose).
raised red circular patchy rash on the skin which may have felt
itchy or like a sting or burn.
a severe allergic reaction known as anaphylactic shock. The
symptoms may be life threatening and include difficulty breathing,
wheezing, abdominal pain and vomiting.
 if you have a history of, suffer from, or suspect that you have a
stomach ulcer or have vomited blood or passed blood in your faeces
(black tarry stools).
 if you have severe kidney disease.
 if you have established heart disease and /or cerebrovascular disease
e.g. if you have had a heart attack, stroke, mini-stroke (TIA) or
blockages to blood vessels to the heart or brain or an operation to
clear or bypass blockages.
 if you have or have had problems with your blood circulation
(peripheral arterial disease).
 if you suffer from, or suspect that you have severe liver failure.
 if you suffer from bleeding or any type of blood clotting disorders.
 if you are pregnant (unless your doctor considers it essential for you to
continue to take this medicine).
Aceclofenac is not recommended for use in children.
Warnings and precautions
Before you start taking Aceclofenac, tell your doctor:
 if you suffer from any other form of kidney or liver disease.
 if you have any of the following disorders, as they may worsen:
disorders of the stomach or gut/bowel
inflammatory bowel disease (ulcerative colitis)
chronic inflammatory bowel disease (Crohn’s disease)
ulceration, bleeding or perforation of the stomach or bowel
 if you have, or have ever had problems with the circulation of the blood
to your brain.
 if you suffer from asthma or any other breathing problems.
 if you suffer from a rare inherited disorder known as porphyria.
 if you smoke.
 if you have diabetes.
 if you have angina, blood clots, high blood pressure, raised cholesterol
or or other raised body fats such as triglycerides.
 if you suffer from an autoimmune condition known as systemic lupus
erythematosus or other connective tissue disorders.
 if you are infected with chicken pox, the use of this medicine should be
avoided because a rare serious infection of the skin may develop.
 if you are recovering from major surgery.
 if you are elderly (your doctor will prescribe you the lowest effective
dose over the shortest duration).

Hypersensitivity reactions can occur and very rarely, very serious allergic
reactions are appearing (see section 4. Possible side effects). The risk is
higher in the first month of treatment. Aceclofenac should be stopped
immediately at the first onset of symptoms such as tightness of the chest,
breathing difficulties, fever, skin rashes, soreness of the skin lining the
mouth and other mucous membranes causing ulcers, or any signs of
hypersensitivity.
Medicines such as Aceclofenac may be associated with a small
increased risk of heart attack (”myocardial infarction”). Any risk is more
likely with high doses and prolonged treatment. Do not exceed the
recommended dose or duration of treatment.
Other medicines and Aceclofenac
Tell your doctor or pharmacist if you are taking, have recently taken or
might take any other medicines.
Please tell your doctor if you are taking:
 medicines used to treat mental health problems like depression
(selective serotonin-reuptake inhibitors (SSRIs) such as citalopram,
escitalopram, fluoxetine, fluvoxamine, paroxetine and sertraline) or
manic depression (lithium)
 medicines used to treat heart failure and irregular heart beats (cardiac
glycosides such as digoxin)
 medicines used to treat high blood pressure (antihypertensives:
ACE inhibitors such as enalopril, lisinopril; angiotensin II receptor
antagonists such as losartan, candesartan; also hydralazine,
methyldopa, clonidine, moxonidine, propranalol)
 medicines to treat infection (quinolone antibiotics such as
ciprofloxacin, ofloxacin, levofloxacin moxifloxacin)
 drugs used to increase the rate of urine excretion (diuretics such as
thiazides, furosemide amiloride hydrochloride)
 medicines that stop blood clotting (anticoagulants) such as
warfarin, heparin
 methotrexate which is used to treat cancer and autoimmune
disorders such as arthritis and skin conditions
 mifepristone
 any steroids for the treatment of swelling and inflammation
(glucocorticoids such as hydrocortisone, prednisolone)
 medicines used to suppress the immune system after organ
transplant (cyclosporin or tacrolimus)
 medicines used to treat HIV (zidovudine)
 medicines used to lower blood sugar levels in diabetes (antidiabetics
such as glibenclamide, glicazide, tolbutamide)
 any other painkiller NSAID drugs (aspirin, ibuprofen, naproxen, COX-2
inhibitors such as celecoxib and etoricoxib)
 antiplatelet drugs such as clopidogrel.
Aceclofenac with food and drink
Aceclofenac must be taken preferably with or after food.
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.
You should inform your doctor if you have problems becoming pregnant.
NSAIDs may make it more difficult to become pregnant.
Do not take Aceclofenac if you are pregnant or think you are pregnant.
The safety of this medicine for use during pregnancy is not known. It is
not recommended for use in pregnancy unless considered essential by
your doctor.
Aceclofenac should not be used if you are breast-feeding. It is not known
if this medicine passes into breast milk. It is not recommended for use
during breast-feeding unless considered essential by your doctor.
Driving and using machines
If you are taking Aceclofenac and you experience dizziness, drowsiness,
vertigo, tiredness or any difficulty with your eyesight, you must not drive
or use machinery.
3) HOW TO TAKE ACECLOFENAC
Always take this medicine exactly as your doctor or pharmacist has told
you. You will be prescribed the lowest effective dose over the shortest
duration to reduce side effects. Check with your doctor or pharmacist if
you are not sure.
The recommended dose in adults is 200 mg (two Aceclofenac tablets).
One 100 mg tablet should be taken in the morning and one in the
evening.
Tablets should be swallowed whole with plenty of water and should be
taken with or after food. Do not crush or chew the tablets.
Do not exceed the stated daily dose.
Elderly
If you are elderly, you are more likely to experience serious side-effects
(listed in section 4 ‘Possible Side Effects’). If your doctor prescribes
Aceclofenac for you, you will be given the lowest effective dose over the
shortest duration of treatment.
If you take more Aceclofenac than you should
If you accidentally take too many Aceclofenac tablets, contact your
doctor immediately or go to your nearest hospital casualty department.
Please take this leaflet or the box the Aceclofenac tablets came in, with
you to the hospital so that they will know what you have taken.
If you forget to take Aceclofenac
If you miss a dose, do not worry, just take the next dose at the usual
time. Do not take a double dose to make up for a forgotten tablet dose.
If you stop taking Aceclofenac
Do not stop taking Aceclofenac unless your doctor advises you.
If you have any further questions on the use of this medicine, ask your
doctor, pharmacist or nurse.

4) POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not
everybody gets them.
Stop taking the medicine and seek medical advice IMMEDIATELY, if you
experience any of the following side effects:
 severe allergic reaction (anaphylactic shock). Symptoms may develop
quickly and can be life-threatening if not immediately treated and
include fever, difficulty breathing, wheezing, abdominal pain, vomiting,
swelling of the face and throat.
 severe skin rashes such as Stevens-Johnnson Syndrome and Toxic
Epidermal Necrolysis. These are potentially life-threatening and
develop quickly forming large blisters and the skin to peel away. The
rash can also appear in the mouth, throat or eyes. Fever, headache
and aching of the joints usually occur at the same time.
 meningitis. The symptoms include high fever, headache, vomiting,
blotchy red rashes, neck stiffness, sensitivity and intolerance to light.
 passing blood in your faeces (stools/motions).
 passing black tarry stools. Vomit any blood or dark particles that look
like coffee grounds.
 kidney failure.
STOP TAKING the medicine and seek medical advice if you experience:
 indigestion or heartburn.
 abdominal pain (pains in your stomach) or other abnormal stomach
symptoms.
 blood disorders such as reduced production of blood cells, abnormal
breakdown of red blood cells known as haemolytic anaemia, low
content of iron in the blood, low level of white blood cells, low number
of platelet cells, increased blood potassium levels which can irritate the
blood vessels causing inflammation known as vasculitis. These
disorders can cause you to feel extremely tired, breathless, aching of
the joints and be prone to repeated infections and bruising.
If any of the below side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or pharmacist.
Common (may affect up to 1 in 10 people):
 dizziness
 nausea (feeling sick)
 diarrhoea
 increased liver enzymes in the blood
Uncommon (may affect up to 1 in 100 people):
 wind
 inflammation or irritation of the lining of the stomach
 constipation
 vomiting
 mouth ulcers
 itching
 rash
 inflammation of the skin
 raised circular red itchy, stinging or burning patches on the skin (hives)
 increase in blood urea levels
 increase in blood creatinine levels
Rare (may affect up to 1 in 1,000 people):
 hypersensitivity (allergic reaction)
 problems with eyesight
 heart failure
 high blood pressure
 shortness of breath
 bleeding from the stomach or bowel
 stomach or bowel ulceration
Very Rare (may affect up to 1 in 10,000 people):
 depression
 strange dreams
 inability to sleep
 tingling, pricking or numbness of skin
 uncontrollable shaking
 drowsiness
 headaches
 abnormal taste in the mouth
 sensation of spinning when standing still
 ringing in the ears
 heart pounding or racing
 hot flushes
 difficulty breathing
 high pitched noise when breathing
 inflammation of the mouth
 perforation of either the stomach, large intestine or bowel wall
 worsening of colitis and Crohn’s disease
 inflammation of the pancreas
 injury of the liver (including hepatitis)
 yellowing of the skin
 spontaneous bleeding into the skin (appears as a rash)
 nephrotic syndrome: a condition which indicates kidney damage and
includes large amounts of protein in the urine, low blood albumin
levels, high blood cholesterol levels and swelling of the legs, feet or
ankles
 water retention and swelling
 tiredness
 leg cramps
 increased blood alkaline phosphatase levels
 weight gain
Other side effects that have been reported with this type of drug
(NSAIDs) are:
 hallucinations
 confusion
 blurred, partial or complete loss of vision
 painful movement of the eye
 worsening of asthma
 skin reaction to sunlight
 inflammation of the kidneys
 generally feeling unwell
Exceptionally, serious skin infections occur in association with
chickenpox.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. You can also
report side effects directly via the Yellow Card Scheme, 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 ACECLOFENAC
 Keep out of the sight and reach of children.
 Do not store above 30°C.
 Do not use this medicine after the expiry date which is stated on the
outer carton. The expiry date refers to the last day of that month. It is
recommended that you store Aceclofenac in the original box.
 If your medicine becomes discoloured or shows any sign of
deterioration, return it to your pharmacist.
 Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines no longer
required. These measures will help to protect the environment.
6) CONTENTS OF THE PACK AND OTHER INFORMATION
What Aceclofenac contains
Each film-coated tablet contains 100 mg aceclofenac.
The other ingredients are:
Microcrystalline cellulose, croscarmellose sodium, glyceryl
palmitostearate, povidone, hypromellose, polyoxyethylene 40 stearate
and titanium dioxide (E 171).
What Aceclofenac looks like and contents of the pack
Aceclofenac 100 mg film-coated tablets are white, round tablets.
Aceclofenac tablets are available in boxes of 40 and 60 tablets.
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 by the Product Licence Holder:
MPT Pharma Ltd, Westgate Business Park, Unit 5-7 Tintagel Way,
Aldridge, Walsall, WS9 8ER.
Repackaged by MPT Pharma Ltd.
PL: 33532/0533

POM
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Leaflet dated: 18 May 2017
Leaflet coded: XXXXXXXXXX

To request a copy of this leaflet in
Braille, large print or audio please
call 01922 745645 and ask for the
Regulatory Department

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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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