Warnings and precautions Do not take Preservex if you are pregnant or think you are

PACKAGE LEAFLET: INFORMATION FOR THE USER Before you start taking Preservex, tell your doctor: pregnant. The safety of this medicine for use during
 if you suffer from any other form of kidney or liver pregnancy has not been established. It is not recommended
PRESERVEX™ 100MG TABLETS disease. for use in pregnancy unless considered essential by your
(aceclofenac)  if you have any of the following disorders, as they may doctor.
worsen:
Your medicine is available using the name Preservex 100mg  gastrointestinal disorders of the upper or lower Preservex should not be used if you are breast-feeding. It is
Tablets but will be referred to as Preservex throughout this tract not known if this medicine passes into breast milk. It is not
leaflet.  inflammatory bowel disease (ulcerative colitis) recommended for use during breastfeeding unless considered
 chronic inflammatory bowel disease (Crohn’s essential by your doctor.
disease)
Read all of this leaflet carefully before you  ulceration, bleeding or perforation Driving and using machines
start taking this medicine because it contains  blood disorders If you are taking Preservex and you experience dizziness,
important information for you.  if you have, or have ever had problems with the drowsiness, vertigo, tiredness or any visual disturbances, you
 Keep this leaflet. You may need to read it again. circulation of the blood to your brain. must not drive or use machinery.
 If you have any further questions, ask your doctor,  if you suffer from asthma or any other breathing
pharmacist or nurse. problems. 3. How to take Preservex
 This medicine has been prescribed for you only. Do not  if you suffer from porphyria.
pass it on to others. It may harm them, even if their  if you have heart problems, previous stroke or think that Always take this medicine exactly as your doctor or
signs of illness are the same as yours. you might be at risk of these conditions (for example, if pharmacist has told you. You will be prescribed the lowest
 If you get any side effects talk to your doctor, you have high blood pressure, diabetes, high cholesterol effective dose over the shortest duration to reduce side
pharmacist or nurse. This includes any possible side or are a smoker) you should discuss your treatment with effects. Check with your doctor or pharmacist if you are not
effects not listed in this leaflet. See also section 4. your doctor or pharmacist. sure.
 if chicken pox occurs, the use of this medicine should be
What is in this leaflet: avoided because of rare serious infections of the skin The recommended dose in adults is 200 mg (two Preservex
1. What Preservex is and what it is used for related to this use. tablets). One 100 mg tablet should be taken in the morning
2. What you need to know before you take Preservex  if you are recovering from major surgery. and one in the evening.
3. How to take Preservex  if you are elderly (your doctor will prescribe you the
4. Possible side effects lowest effective dose over the shortest duration). Tablets should be swallowed whole with plenty of water and
5. How to store Preservex should be taken with or after food.
6. Contents of the pack and other information Hypersensitivity reactions can occur and very rarely, very Do not crush or chew the tablets.
serious allergic reactions are appearing (see section 4.
1. What Preservex is and what it is used for Possible side effects). The risk is higher in the first month of Do not exceed the stated daily dose.
treatment.
Preservex belongs to a group of medicines called non- Preservex should be discontinued at the first onset of a skin Elderly
steroidal anti-inflammatory drugs (NSAIDs). These drugs rash, injuries of mucous membrane or any signs of If you are elderly, you are more likely to experience serious
have anti-inflammatory and painkiller properties. The active hypersensitivity. side-effects (listed in section 4 ‘Possible Side Effects’). If your
ingredient of Preservex is aceclofenac. doctor prescribes Preservex for you, you will be given the
Medicines such as Preservex may be associated with a small lowest effective dose over the shortest duration.
Preservex works by blocking the production of hormone-like increased risk of heart attack (”myocardial infarction”) or
substances called prostaglandins. Prostaglandins are released stroke. If you take more Preservex than you should
at the sites of injury, tissue damage and immune reactions. Any risk is more likely with high doses and prolonged If you accidentally take too many Preservex tablets, contact
Prostaglandins play an important role in both the treatment. your doctor immediately or go to your nearest hospital
inflammatory response of the body and stimulating the re- Do not exceed the recommended dose or duration of casualty department. Please take this leaflet or the box the
absorption of bone in diseases. treatment. Preservex tablets came in, with you to the hospital so that
they will know what you have taken.
Preservex is used to relieve pain and inflammation in patients Other medicines and Preservex
suffering from: Tell your doctor or pharmacist if you are taking, have recently If you forget to take Preservex
 arthritis of the joints (osteoarthritis). This commonly taken or might take any other medicines. If you miss a dose, do not worry, just take the next dose at
occurs in patients over the age of 50 and causes the loss the usual time. Do not take a double dose to make up for a
of the cartilage and bone tissue next to the joint. Please tell your doctor if you are taking: forgotten tablet dose.
 autoimmune disease that causes chronic inflammation of  medicines used to treat depression (selective
the joints (rheumatoid arthritis). serotonin-reuptake inhibitors) or manic depression If you stop taking Preservex
 arthritis of the spine which can lead to the fusion of the (lithium) Do not stop taking Preservex unless your doctor advises you.
vertebrae (ankylosing spondylitis).  medicines used to treat heart failure and irregular heart If you have any further questions on the use of this medicine,
beats (cardiac glycosides such as digoxin) ask your doctor, pharmacist or nurse.
 medicines used to treat high blood pressure
2. What you need to know before you take
(antihypertensives)
Preservex  quinolone antibiotics
4. Possible side effects
 drugs used to increase the rate of urine excretion
Do not take Preservex: (diuretics) Like all medicines, this medicine can cause side effects,
 if you are allergic to aceclofenac or any of the other  medicines that stop blood clotting (anticoagulants) such although not everybody gets them.
ingredients of this medicine (listed in section 6). as warfarin, heparin
 if you are allergic to aspirin or any other NSAIDs (such  methotrexate which is used to treat cancer and Stop taking the medicine and seek medical advice
as ibuprofen, naproxen or diclofenac). autoimmune disorders IMMEDIATELY, if you experience any of the following side
 if you have taken aspirin or any other NSAIDs and  mifepristone effects:
experienced one of the following:  any steroids (oestrogens, androgens, or  severe allergic reaction (anaphylactic shock).
 asthma attack glucocorticoids) Symptoms may develop quickly and can be life-
 runny nose, itching and/or sneezing (irritation of  medicines used to supress the immune system threatening if not immediately treated and include fever,
the nose) (cyclosporin or tacrolimus) difficulty breathing, wheezing, abdominal pain, vomiting,
 raised red circular patchy rash on the skin which  medicines used to treat HIV (zidovudine) swelling of the face and throat.
may have been itchy, stung or had a burning  medicines used to lower blood sugar levels  severe skin rashes such as Stevens-Johnnson
sensation (antidiabetics) Syndrome and Toxic Epidermal Necrolysis. These are
 severe allergic reaction (anaphylactic shock).  any other NSAID drugs (aspirin, ibuprofen, naproxen), potentially life-threatening and develop quickly forming
Symptoms include difficulty breathing, wheezing, including COX-2 inhibitors large blisters and the skin to peel away. The rash can
abnormal pain and vomiting also appear in the mouth, throat or eyes. Fever,
 if you have a history of, suffer from, or suspect that you headache and aching of the joints usually occur at the
Preservex with food and drink
have a stomach ulcer or intestinal bleeding. same time.
Preservex must be taken preferably with or after food.
 if you have severe kidney disease.  meningitis. The symptoms include high fever, headache,
 if you have or have ever had a severe heart failure vomiting, blotchy red rashes, neck stiffness, sensitivity
Pregnancy, breast-feeding and fertility
(heart attack). and intolerance to light.
If you are pregnant or breast-feeding, think you may be
 if you suffer from, or suspect that you have severe liver  passing blood in your faeces (stools/motions).
pregnant or are planning to have a baby, ask your doctor or
failure.  passing black tarry stools. Vomit any blood or dark
pharmacist for advice before taking this medicine.
 if you suffer from bleeding or bleeding disorders. particles that look like coffee grounds.
 if you are pregnant (unless considered essential by your  medicines such as Preservex may be associated with a
You should inform your doctor if you are planning to become
doctor). small increased risk of heart attack (“myocardial
pregnant or if you have problems becoming pregnant.
infarction”) or stroke.
NSAIDs may make it more difficult to become pregnant.
Preservex is not recommended for use in children.  kidney failure.

Page 1 of 2
STOP TAKING the medicine and seek medical advice if you Reporting of side effects
experience: If you get any side effects, talk to your doctor, pharmacist or
 indigestion or heartburn. nurse. This includes any possible side effects not listed in this
 abdominal pain (pains in your stomach) or other leaflet. You can also report side effects directly via the Yellow
abnormal stomach symptoms. Card Scheme, Website: www.mhra.gov.uk/yellowcard.
 blood disorders such as reduced production of blood
cells, abnormal breakdown of red blood cells known as By reporting side-effects you can help provide more
haemolytic anaemia, low content of iron in the blood, low information on the safety of this medicine.
level of white blood cells, low number of platelet cells,
increased blood potassium levels which can irritate the 5. How to store Preservex
blood vessels causing inflammation known as vasculitis.
These disorders can cause you to feel extremely tired, Keep out of the sight and reach of children.
breathless, aching of the joints and be prone to repeated
infections and bruising. The box is marked by a “use by date”. Do not take the
tablets after this date. The expiry date is stated on the outer
If any of the below side effects gets serious, or if you notice carton.
any side effects not listed in this leaflet, please tell your The expiry date refers to the last day of that month.
doctor or pharmacist.
It is recommended that you store Preservex in the original
Common (may affect up to 1 in 10 people): box.
 dizziness
 nausea (feeling sick) Do not store above 30°C.
 diarrhoea
 increased liver enzymes in the blood If your tablets appear to be discoloured or show any signs of
deterioration, please return them to your pharmacist who will
Uncommon (may affect up to 1 in 100 people): advise you.
 wind (flatulence)
 inflammation or irritation of the lining of the stomach If your doctor tells you to stop taking the tablets, please take
(gastritis) them back to the pharmacist. Only keep the tablets if your
 constipation doctor tells you to.
 vomiting
 mouth ulcers Do not throw away any medicines via wastewater or
 itching household waste. Ask your pharmacist how to throw away
 rash medicines you no longer use. These measures will help
 inflammation of the skin (dermatitis) protect the environment.
 raised circular red itchy, stinging or burning patches on
the skin (hives) 6. Contents of the pack and other
 increase in blood urea levels
 increase in blood creatinine levels
information

What Preservex contains

Rare (may affect up to 1 in 1,000 people):
The active ingredient in Preservex is aceclofenac.
 hypersensitivity (allergic reaction)
Each film-coated tablet contains 100mg of aceclofenac.
 visual disturbance
 cardiac failure
Preservex also contains the following inactive ingredients
 hypertension
used to bind and coat the tablets, these are:
 shortness of breath
microcrystalline cellulose, sodium croscarmellose polyvidone,
 gastrointestinal haemorrhage
glycerol palmitostearate, and the film coat, containing
 gastrointestinal ulceration
partially substituted hydroxypropyl methylcellulose,
polyoxyethylene 40 stearate and titanium dioxide.
Very Rare (may affect up to 1 in 10,000 people):
 depression
What Preservex looks like and contents of the pack
 strange dreams
Preservex are white round film-coated tablets, 8mm in
 inability to sleep
diameter, without any markings.
 tingling, pricking or numbness of skin
 uncontrollable shaking (tremor)
Preservex are available in blister strips of 20, 40 and 60
 drowsiness
tablets.
 headaches
 abnormal taste in the mouth
 sensation of spinning when standing still Manufacturer
 ringing in the ears (tinnitus) Preservex are manufactured by:
 heart pounding or racing (palpitations) Industrias Farmacéuticas Almirall, S.A., Ctra. Nacional II, Km.
 hot flushes 593, 08740 Sant Andreu de la Barca - Barcelona, Spain.
 difficulty breathing
 high pitched noise when breathing Procured from within the EU and repackaged by:
 inflammation of the mouth Doncaster Pharmaceuticals Group Ltd., Kirk Sandall,
 perforation of either the stomach, large intestine or Doncaster, DN3 1QR.
bowel wall
 exacerbation of colitis and Crohn’s disease Product Licence holder:
 inflammation of the pancreas (pancreatitis) Doncaster Pharmaceuticals Group Ltd., Kirk Sandall,
 injury of the liver (including hepatitis) Doncaster, DN3 1QR.
 yellowing of the skin (jaundice)
PL No: 04423/0339 POM
 spontaneous bleeding into the skin (appears as a rash)
 nephrotic syndrome
 water retention and swelling Leaflet revision date: 09.06.16
 tiredness
 leg cramps Preservex™ is a trademark of Almirall S.A.
 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
 aggravated asthma
 skin reaction to sunlight
 inflammation of the kidneys
 generally feeling unwell

Exceptionally, serious skin infections occur in association with

chickenpox.

Page 2 of 2
 Warnings and precautions Do not take Aceclofenac if you are pregnant or think you are
PACKAGE LEAFLET: INFORMATION FOR THE USER Before you start taking Aceclofenac, tell your doctor: pregnant. The safety of this medicine for use during
 if you suffer from any other form of kidney or liver pregnancy has not been established. It is not recommended
ACECLOFENAC 100MG TABLETS disease. for use in pregnancy unless considered essential by your
 if you have any of the following disorders, as they may doctor.
Your medicine is available using the name Aceclofenac 100mg worsen:
Tablets but will be referred to as Aceclofenac throughout this  gastrointestinal disorders of the upper or lower Aceclofenac should not be used if you are breast-feeding. It is
leaflet. tract not known if this medicine passes into breast milk. It is not
 inflammatory bowel disease (ulcerative colitis) recommended for use during breastfeeding unless considered
 chronic inflammatory bowel disease (Crohn’s essential by your doctor.
Read all of this leaflet carefully before you disease)
start taking this medicine because it contains  ulceration, bleeding or perforation Driving and using machines
important information for you.  blood disorders If you are taking Aceclofenac and you experience dizziness,
 Keep this leaflet. You may need to read it again.  if you have, or have ever had problems with the drowsiness, vertigo, tiredness or any visual disturbances, you
 If you have any further questions, ask your doctor, circulation of the blood to your brain. must not drive or use machinery.
pharmacist or nurse.  if you suffer from asthma or any other breathing
 This medicine has been prescribed for you only. Do not problems. 3. How to take Aceclofenac
pass it on to others. It may harm them, even if their  if you suffer from porphyria.
signs of illness are the same as yours.  if you have heart problems, previous stroke or think that Always take this medicine exactly as your doctor or
 If you get any side effects talk to your doctor, you might be at risk of these conditions (for example, if pharmacist has told you. You will be prescribed the lowest
pharmacist or nurse. This includes any possible side you have high blood pressure, diabetes, high cholesterol effective dose over the shortest duration to reduce side
effects not listed in this leaflet. See also section 4. or are a smoker) you should discuss your treatment with effects. Check with your doctor or pharmacist if you are not
your doctor or pharmacist. sure.
What is in this leaflet:  if chicken pox occurs, the use of this medicine should be
1. What Aceclofenac is and what it is used for avoided because of rare serious infections of the skin The recommended dose in adults is 200 mg (two Aceclofenac
2. What you need to know before you take Aceclofenac related to this use. tablets). One 100 mg tablet should be taken in the morning
3. How to take Aceclofenac  if you are recovering from major surgery. and one in the evening.
4. Possible side effects  if you are elderly (your doctor will prescribe you the
5. How to store Aceclofenac lowest effective dose over the shortest duration). Tablets should be swallowed whole with plenty of water and
6. Contents of the pack and other information should be taken with or after food.
Hypersensitivity reactions can occur and very rarely, very Do not crush or chew the tablets.
1. What Aceclofenac is and what it is used serious allergic reactions are appearing (see section 4.
Possible side effects). The risk is higher in the first month of Do not exceed the stated daily dose.
for treatment.
Aceclofenac should be discontinued at the first onset of a skin Elderly
Aceclofenac belongs to a group of medicines called non-
rash, injuries of mucous membrane or any signs of If you are elderly, you are more likely to experience serious
steroidal anti-inflammatory drugs (NSAIDs). These drugs
hypersensitivity. side-effects (listed in section 4 ‘Possible Side Effects’). If your
have anti-inflammatory and painkiller properties. The active
ingredient of Aceclofenac is aceclofenac. doctor prescribes Aceclofenac for you, you will be given the
Medicines such as Aceclofenac may be associated with a small lowest effective dose over the shortest duration.
increased risk of heart attack (”myocardial infarction”) or
Aceclofenac works by blocking the production of hormone-like
stroke. If you take more Aceclofenac than you should
substances called prostaglandins. Prostaglandins are released
Any risk is more likely with high doses and prolonged If you accidentally take too many Aceclofenac tablets, contact
at the sites of injury, tissue damage and immune reactions.
treatment. your doctor immediately or go to your nearest hospital
Prostaglandins play an important role in both the
Do not exceed the recommended dose or duration of casualty department. Please take this leaflet or the box the
inflammatory response of the body and stimulating the re-
treatment. Aceclofenac tablets came in, with you to the hospital so that
absorption of bone in diseases.
they will know what you have taken.
Other medicines and Aceclofenac
Aceclofenac is used to relieve pain and inflammation in
Tell your doctor or pharmacist if you are taking, have recently If you forget to take Aceclofenac
patients suffering from:
taken or might take any other medicines. If you miss a dose, do not worry, just take the next dose at
 arthritis of the joints (osteoarthritis). This commonly
occurs in patients over the age of 50 and causes the loss the usual time. Do not take a double dose to make up for a
Please tell your doctor if you are taking: forgotten tablet dose.
of the cartilage and bone tissue next to the joint.
 medicines used to treat depression (selective
 autoimmune disease that causes chronic inflammation of
serotonin-reuptake inhibitors) or manic depression If you stop taking Aceclofenac
the joints (rheumatoid arthritis).
(lithium) Do not stop taking Aceclofenac unless your doctor advises
 arthritis of the spine which can lead to the fusion of the
 medicines used to treat heart failure and irregular heart you.
vertebrae (ankylosing spondylitis).
beats (cardiac glycosides such as digoxin) If you have any further questions on the use of this medicine,
 medicines used to treat high blood pressure ask your doctor, pharmacist or nurse.
2. What you need to know before you take (antihypertensives)
Aceclofenac  quinolone antibiotics
 drugs used to increase the rate of urine excretion
4. Possible side effects
Do not take Aceclofenac: (diuretics)
 if you are allergic to aceclofenac or any of the other  medicines that stop blood clotting (anticoagulants) such Like all medicines, this medicine can cause side effects,
ingredients of this medicine (listed in section 6). as warfarin, heparin although not everybody gets them.
 if you are allergic to aspirin or any other NSAIDs (such  methotrexate which is used to treat cancer and
as ibuprofen, naproxen or diclofenac). autoimmune disorders Stop taking the medicine and seek medical advice
 if you have taken aspirin or any other NSAIDs and  mifepristone IMMEDIATELY, if you experience any of the following side
experienced one of the following:  any steroids (oestrogens, androgens, or effects:
 asthma attack glucocorticoids)  severe allergic reaction (anaphylactic shock).
 runny nose, itching and/or sneezing (irritation of  medicines used to supress the immune system Symptoms may develop quickly and can be life-
the nose) (cyclosporin or tacrolimus) threatening if not immediately treated and include fever,
 raised red circular patchy rash on the skin which  medicines used to treat HIV (zidovudine) difficulty breathing, wheezing, abdominal pain, vomiting,
may have been itchy, stung or had a burning  medicines used to lower blood sugar levels swelling of the face and throat.
sensation (antidiabetics)  severe skin rashes such as Stevens-Johnnson
 severe allergic reaction (anaphylactic shock).  any other NSAID drugs (aspirin, ibuprofen, naproxen), Syndrome and Toxic Epidermal Necrolysis. These are
Symptoms include difficulty breathing, wheezing, including COX-2 inhibitors potentially life-threatening and develop quickly forming
abnormal pain and vomiting large blisters and the skin to peel away. The rash can
if you have a history of, suffer from, or suspect that you also appear in the mouth, throat or eyes. Fever,
 Aceclofenac with food and drink
have a stomach ulcer or intestinal bleeding. headache and aching of the joints usually occur at the
Aceclofenac must be taken preferably with or after food.
 if you have severe kidney disease. same time.
 if you have or have ever had a severe heart failure  meningitis. The symptoms include high fever, headache,
Pregnancy, breast-feeding and fertility
(heart attack). vomiting, blotchy red rashes, neck stiffness, sensitivity
If you are pregnant or breast-feeding, think you may be
 if you suffer from, or suspect that you have severe liver and intolerance to light.
pregnant or are planning to have a baby, ask your doctor or
failure.  passing blood in your faeces (stools/motions).
pharmacist for advice before taking this medicine.
 if you suffer from bleeding or bleeding disorders.  passing black tarry stools. Vomit any blood or dark
 if you are pregnant (unless considered essential by your particles that look like coffee grounds.
You should inform your doctor if you are planning to become
doctor).  medicines such as Aceclofenac may be associated with a
pregnant or if you have problems becoming pregnant.
small increased risk of heart attack (“myocardial
NSAIDs may make it more difficult to become pregnant.
Aceclofenac is not recommended for use in children. infarction”) or stroke.
 kidney failure.

Page 1 of 2
STOP TAKING the medicine and seek medical advice if you Reporting of side effects
experience: If you get any side effects, talk to your doctor, pharmacist or
 indigestion or heartburn. nurse. This includes any possible side effects not listed in this
 abdominal pain (pains in your stomach) or other leaflet. You can also report side effects directly via the Yellow
abnormal stomach symptoms. Card Scheme, Website: www.mhra.gov.uk/yellowcard.
 blood disorders such as reduced production of blood
cells, abnormal breakdown of red blood cells known as By reporting side-effects you can help provide more
haemolytic anaemia, low content of iron in the blood, low information on the safety of this medicine.
level of white blood cells, low number of platelet cells,
increased blood potassium levels which can irritate the 5. How to store Aceclofenac
blood vessels causing inflammation known as vasculitis.
These disorders can cause you to feel extremely tired, Keep out of the sight and reach of children.
breathless, aching of the joints and be prone to repeated
infections and bruising. The box is marked by a “use by date”. Do not take the
tablets after this date. The expiry date is stated on the outer
If any of the below side effects gets serious, or if you notice carton.
any side effects not listed in this leaflet, please tell your The expiry date refers to the last day of that month.
doctor or pharmacist.
It is recommended that you store Aceclofenac in the original
Common (may affect up to 1 in 10 people): box.
 dizziness
 nausea (feeling sick) Do not store above 30°C.
 diarrhoea
 increased liver enzymes in the blood If your tablets appear to be discoloured or show any signs of
deterioration, please return them to your pharmacist who will
Uncommon (may affect up to 1 in 100 people): advise you.
 wind (flatulence)
 inflammation or irritation of the lining of the stomach If your doctor tells you to stop taking the tablets, please take
(gastritis) them back to the pharmacist. Only keep the tablets if your
 constipation doctor tells you to.
 vomiting
 mouth ulcers Do not throw away any medicines via wastewater or
 itching household waste. Ask your pharmacist how to throw away
 rash medicines you no longer use. These measures will help
 inflammation of the skin (dermatitis) protect the environment.
 raised circular red itchy, stinging or burning patches on
the skin (hives) 6. Contents of the pack and other
 increase in blood urea levels
 increase in blood creatinine levels
information

What Aceclofenac contains

Rare (may affect up to 1 in 1,000 people):
The active ingredient in Aceclofenac is aceclofenac.
 hypersensitivity (allergic reaction)
Each film-coated tablet contains 100mg of aceclofenac.
 visual disturbance
 cardiac failure
Aceclofenac also contains the following inactive ingredients
 hypertension
used to bind and coat the tablets, these are:
 shortness of breath
microcrystalline cellulose, sodium croscarmellose polyvidone,
 gastrointestinal haemorrhage
glycerol palmitostearate, and the film coat, containing
 gastrointestinal ulceration
partially substituted hydroxypropyl methylcellulose,
polyoxyethylene 40 stearate and titanium dioxide.
Very Rare (may affect up to 1 in 10,000 people):
 depression
What Aceclofenac looks like and contents of the
 strange dreams
 inability to sleep pack
 tingling, pricking or numbness of skin Aceclofenac are white round film-coated tablets, 8mm in
 uncontrollable shaking (tremor) diameter, without any markings.
 drowsiness
 headaches Aceclofenac are available in blister strips of 20, 40 and 60
 abnormal taste in the mouth tablets.
 sensation of spinning when standing still
 ringing in the ears (tinnitus) Manufacturer
 heart pounding or racing (palpitations) Aceclofenac are manufactured by:
 hot flushes Industrias Farmacéuticas Almirall, S.A., Ctra. Nacional II, Km.
 difficulty breathing 593, 08740 Sant Andreu de la Barca - Barcelona, Spain.
 high pitched noise when breathing
 inflammation of the mouth Procured from within the EU and repackaged by:
 perforation of either the stomach, large intestine or Doncaster Pharmaceuticals Group Ltd., Kirk Sandall,
bowel wall Doncaster, DN3 1QR.
 exacerbation of colitis and Crohn’s disease
 inflammation of the pancreas (pancreatitis) Product Licence holder:
 injury of the liver (including hepatitis) Doncaster Pharmaceuticals Group Ltd., Kirk Sandall,
 yellowing of the skin (jaundice) Doncaster, DN3 1QR.
 spontaneous bleeding into the skin (appears as a rash)
 nephrotic syndrome PL No: 04423/0339 POM
 water retention and swelling
 tiredness Leaflet revision date: 09.06.16
 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
 aggravated asthma
 skin reaction to sunlight
 inflammation of the kidneys
 generally feeling unwell

Exceptionally, serious skin infections occur in association with

chickenpox.

Page 2 of 2