ACECLOFENAC 100MG TABLETS

Active substance: ACECLOFENAC

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PACKAGE LEAFLET: INFORMATION FOR THE USER

PRESERVEX™ 100MG TABLETS
(aceclofenac)

Your medicine is available using the name Preservex 100mg
Tablets but will be referred to as Preservex throughout this leaflet.

Read all of this leaflet carefully before you
start taking this medicine.

Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or
pharmacist.
This medicine has been prescribed for you. Do not pass it on
to others. It may harm them, even if their symptoms are the
same as yours.
If any of the side effects gets serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor
or pharmacist.

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

What Preservex is and what it is used for
Before you take Preservex
How to take Preservex
Possible side effects
How to store Preservex
Further 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). These drugs have antiinflammatory and painkiller properties. The active ingredient of
Preservex is aceclofenac.
Preservex works by blocking the production of hormone-like
substances called prostaglandins. Prostaglandins are released at
the sites of injury, tissue damage and immune reactions.
Prostaglandins play an important role in both the inflammatory
response of the body and stimulating the re-absorption of bone in
diseases.
Preservex is used to relieve pain and inflammation in patients
suffering from:
arthritis of the joints (osteoarthritis). This commonly occurs
in patients over the age of 50 and causes the loss of the
cartilage and bone tissue next to the joint.
autoimmune disease that causes chronic inflammation of the
joints (rheumatoid arthritis).
arthritis of the spine which can lead to the fusion of the
vertebrae (ankylosing spondylitis).

2. Before you take Preservex
Do not take Preservex

if you are allergic (hypersensitive) to aceclofenac or any of
the other ingredients of Preservex.
if you are allergic (hypersensitive) 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
runny nose, itching and/or sneezing (irritation of the
nose)
raised red circular patchy rash on the skin which may
have been itchy, stung or had a burning sensation
severe allergic reaction (anaphylactic shock).
Symptoms include difficulty breathing, wheezing,
abnormal pain and vomiting
if you have a history of, suffer from, or suspect that you
have a stomach ulcer or intestinal bleeding.
if you have moderate to severe kidney disease.
if you have or have ever had a severe heart failure (heart
attack).
if you suffer from, or suspect that you have liver failure.
if you are pregnant (unless considered essential by your
doctor).
Preservex is not recommended for use in children.

Take special care with Preservex

Before you start taking Preservex, tell your doctor:
if you suffer from any other form of liver disease.
if you have any of the following gastro-intestinal disorders:
inflammatory bowel disease (ulcerative colitis)
chronic inflammatory bowel disease (Crohn’s disease)
bleeding
vomiting of blood
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 blood disorder known as porphyria.
if you have heart problems, previous stroke or think that
you might be at risk of these conditions (for example, if you
have high blood pressure, diabetes, high cholesterol or are a
smoker) you should discuss your treatment with your doctor
or pharmacist.
If you are elderly (your doctor will prescribe you the lowest
effective dose over the shortest duration).
Medicines such as Preservex may be associated with a small
increased risk of heart attack (”myocardial infarction”) or stroke.
Any risk is more likely with high doses and prolonged treatment.
Do not exceed the recommended dose or duration of treatment.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines obtained
without a prescription.
Please tell your doctor if you are taking:
medicines used to treat depression or manic depression
(lithium)
medicines used to treat heart failure and irregular heart
beats (cardiac glycosides)
medicines used to treat high blood pressure
(antihypertensives)
quinolone antibiotics
drugs used to increase the rate of urine excretion
(diuretics)
medicines that stop blood clotting (anticoagulants) such as
warfarin, heparin
Page 1 of 2

methotrexate which is used to treat cancer and
autoimmune disorders
mifepristone which is used as an emergency contraceptive
or to induce abortions
any steroids (oestrogens, androgens, or glucocorticoids)
medicines used to supress the immune system (cyclosporin
or tacrolimus)
medicines used to treat HIV (zidovudine)
medicines used to lower blood sugar levels (antidiabetics)
any other NSAID drugs (aspirin, ibuprofen, naproxen)

Taking Preservex with food and drink

Preservex must be taken preferably with or after food.

Pregnancy and breast-feeding

You should inform your doctor if you are planning to become
pregnant or 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
has not been estblished. 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.
Consult your doctor or pharmacist for advice before taking any
medicine.

Driving and using machines

If you are taking Preservex and you experience dizziness,
drowsiness, tiredness or any visual disturbances, you must not
drive or use machinery.

3. How to take Preservex
Always take Preservex exactly as your doctor has told you. You
will be prescribed the lowest effective dose over the shortest
duration to reduce side effects. You should check with your doctor
or pharmacist if you are not sure.
The recommended dose in adults is 200mg (two Preservex
tablets). One 100mg 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.

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 product, ask
your doctor or pharmacist.

4. Possible side effects
Like all medicines, Preservex can cause side effects, although not
everybody gets them.
If you experience any of the following side effects, tell your doctor
IMMEDIATELY:
medicines such as Preservex may be associated with a small
increased risk of heart attack, (”myocardial infarction”) or
stroke
severe allergic reaction (anaphylactic shock). Symptoms
may include difficulty breathing, wheezing, abnormal pain
and vomiting
swelling of the face
kidney failure
If you suffer from any of the following at any time during your
treatment STOP TAKING the medicine and seek immediate
medical help:
Pass blood in your faeces (stools/motions)
Pass black tarry stools
Vomit any blood or dark particles that look like coffee
grounds.
STOP TAKING the medicine and tell your doctor if you experience:
Indigestion or heartburn
Abdominal pain (pains in your stomach) or other abnormal
stomach symptoms.
If any of the below side effects get serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor or
pharmacist.

Common (occur in more than 1 in 100 patients but
in less than 1 in 10 patients):
dizziness
nausea (feeling sick)
diarrhoea
increased liver enzymes in the blood

Uncommon (occur in more than 1 in 1,000 patients
but in less than 1 in 100 patients):
wind (flatulence)
inflammation or irritation of the lining of the stomach
(gastritis)
constipation
vomiting
mouth ulcers
itching
rash

inflammation of the skin (dermatitis)
raised circular red itchy, stinging or burning patches on the
skin (hives)
increase in blood urea levels
increase in blood creatinine levels

Rare (occur in more than 1 in 10,000 patients but in
less than 1 in 1,000 patients):
low levels of iron in the blood
hypersensitivity (allergic reaction)
visual disturbance
shortness of breath

Very Rare (occur in less than 1 in 10,000 patients):
low white blood cells levels
low platelets levels in the blood
abnormal breakdown of red blood cells (anemia)
high potassium levels in the blood
depression
strange dreams
inability to sleep
tingling, pricking or numbness of skin
uncontrollable shaking (tremor)
drowsiness
headaches
abnormal taste in the mouth
sensation of spinning when standing still
heart pounding or racing (palpitations)
hot flushes
difficulty breathing
high pitched noise when breathing
inflammation of the mouth
stomach ulcer
inflammation of the pancreas (pancreatitis)
inflammation of the liver (hepatitis)
yellowing of the skin (jaundice)
spontaneous bleeding into the skin (appears as a rash)
blisters
water retention and swelling
tiredness
leg cramps
increased blood alkaline phosphatase levels
weight gain

If any of the below side effects get serious, please tell your
doctor or pharmacist.
Other side effects that have been reported with this type of drug
(NSAIDs) are:
bone marrow failure
hallucinations
confusion
blurred, partial or complete loss of vision
painful movement of the eye
ringing in the ears
aggravated asthma
ulcers
perforation of either the stomach, large intestine or bowel
wall
blistering and peeling of the top layer of skin
mild, itchy pink/redness of the skin
reddening or scaling of skin
skin irritation (eczema)
Page 2 of 2

skin reaction to sunlight
inflammation of the kidneys
generally feeling unwell
aseptic meningitis
exacerbation of colitis and Crohn’s disease
hypertension (high blood pressure)
cardiac failure
bone marrow depression

5. How to store Preservex
Keep out of the sight and reach of children.
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 carton.
The expiry date refers to the last day of that month.
It is recommended that you store Preservex in the original box.
Do not store above 30°C.
If your tablets appear to be discoloured or show any signs of
deterioration, please return them to your pharmacist who will
advise you.
If your doctor tells you to stop taking the tablets, please take
them back to the pharmacist. Only keep the tablets if your doctor
tells you to.
Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines no longer
required. These measures will help to protect the environment.

6. Further information
What Preservex contains

The active ingredient in Preservex is aceclofenac.
Each film-coated tablet contains 100mg of aceclofenac.
Preservex also contains the following inactive ingredients used to
bind and coat the tablets, these are: microcrystalline cellulose,
sodium croscarmellose polyvidone, glycerol palmitostearate,
and the film coat, containing partially substituted hydroxypropyl
methylcellulose, polyoxyethylene 40 stearate and
titanium dioxide.

What Preservex looks like and contents of the pack
Preservex are white round film-coated tablets, 8mm in diameter,

without any markings.

Preservex are available in blister strips of 20, 40 and 60 tablets.

Manufacturer

Preservex are manufactured by: Industrias Farmacéuticas Almirall
Prodesfarma, S.L., Ctra. Nacional II, Km. 593, 08740 Sant Andreu
de la Barca - Barcelona, Spain.
Procured from within the EU and repackaged by: Doncaster
Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.
Product Licence holder: Doncaster Pharmaceuticals Group Ltd.,
Kirk Sandall, Doncaster, DN3 1QR.
PL No: 04423/0339

POM

Leaflet revision date: 10.07.13
Preservex™ is a trademark of Almirall S.A.

PACKAGE LEAFLET: INFORMATION FOR THE USER

ACECLOFENAC 100MG TABLETS
Your medicine is available using the name Aceclofenac 100mg
Tablets but will be referred to as Aceclofenac throughout this
leaflet.

Read all of this leaflet carefully before you
start taking this medicine.

Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or
pharmacist.
This medicine has been prescribed for you. Do not pass it on
to others. It may harm them, even if their symptoms are the
same as yours.
If any of the side effects gets serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor
or pharmacist.

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

What Aceclofenac is and what it is used for
Before you take Aceclofenac
How to take Aceclofenac
Possible side effects
How to store Aceclofenac
Further 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). These drugs have antiinflammatory and painkiller properties. The active ingredient of
Aceclofenac is aceclofenac.
Aceclofenac works by blocking the production of hormone-like
substances called prostaglandins. Prostaglandins are released at
the sites of injury, tissue damage and immune reactions.
Prostaglandins play an important role in both the inflammatory
response of the body and stimulating the re-absorption of bone in
diseases.
Aceclofenac is used to relieve pain and inflammation in patients
suffering from:
arthritis of the joints (osteoarthritis). This commonly occurs
in patients over the age of 50 and causes the loss of the
cartilage and bone tissue next to the joint.
autoimmune disease that causes chronic inflammation of the
joints (rheumatoid arthritis).
arthritis of the spine which can lead to the fusion of the
vertebrae (ankylosing spondylitis).

2. Before you take Aceclofenac
Do not take Aceclofenac

if you are allergic (hypersensitive) to aceclofenac or any of
the other ingredients of Aceclofenac.
if you are allergic (hypersensitive) 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
runny nose, itching and/or sneezing (irritation of the
nose)
raised red circular patchy rash on the skin which may
have been itchy, stung or had a burning sensation
severe allergic reaction (anaphylactic shock).
Symptoms include difficulty breathing, wheezing,
abnormal pain and vomiting
if you have a history of, suffer from, or suspect that you
have a stomach ulcer or intestinal bleeding.
if you have moderate to severe kidney disease.
if you have or have ever had a severe heart failure (heart
attack).
if you suffer from, or suspect that you have liver failure.
if you are pregnant (unless considered essential by your
doctor).
Aceclofenac is not recommended for use in children.

Take special care with Aceclofenac

Before you start taking Aceclofenac, tell your doctor:
if you suffer from any other form of liver disease.
if you have any of the following gastro-intestinal disorders:
inflammatory bowel disease (ulcerative colitis)
chronic inflammatory bowel disease (Crohn’s disease)
bleeding
vomiting of blood
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 blood disorder known as porphyria.
if you have heart problems, previous stroke or think that
you might be at risk of these conditions (for example, if you
have high blood pressure, diabetes, high cholesterol or are a
smoker) you should discuss your treatment with your doctor
or pharmacist.
If you are elderly (your doctor will prescribe you the lowest
effective dose over the shortest duration).
Medicines such as Aceclofenac may be associated with a small
increased risk of heart attack (”myocardial infarction”) or stroke.
Any risk is more likely with high doses and prolonged treatment.
Do not exceed the recommended dose or duration of treatment.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines obtained
without a prescription.
Please tell your doctor if you are taking:
medicines used to treat depression or manic depression
(lithium)
medicines used to treat heart failure and irregular heart
beats (cardiac glycosides)
medicines used to treat high blood pressure
(antihypertensives)
quinolone antibiotics
drugs used to increase the rate of urine excretion
(diuretics)
medicines that stop blood clotting (anticoagulants) such as
warfarin, heparin
Page 1 of 2

methotrexate which is used to treat cancer and
autoimmune disorders
mifepristone which is used as an emergency contraceptive
or to induce abortions
any steroids (oestrogens, androgens, or glucocorticoids)
medicines used to supress the immune system (cyclosporin
or tacrolimus)
medicines used to treat HIV (zidovudine)
medicines used to lower blood sugar levels (antidiabetics)
any other NSAID drugs (aspirin, ibuprofen, naproxen)

Taking Aceclofenac with food and drink

Aceclofenac must be taken preferably with or after food.

Pregnancy and breast-feeding

You should inform your doctor if you are planning to become
pregnant or 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
has not been estblished. 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.
Consult your doctor or pharmacist for advice before taking any
medicine.

Driving and using machines

If you are taking Aceclofenac and you experience dizziness,
drowsiness, tiredness or any visual disturbances, you must not
drive or use machinery.

3. How to take Aceclofenac
Always take Aceclofenac exactly as your doctor has told you. You
will be prescribed the lowest effective dose over the shortest
duration to reduce side effects. You should check with your doctor
or pharmacist if you are not sure.
The recommended dose in adults is 200mg (two Aceclofenac
tablets). One 100mg 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.

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 product, ask
your doctor or pharmacist.

4. Possible side effects
Like all medicines, Aceclofenac can cause side effects, although
not everybody gets them.
If you experience any of the following side effects, tell your doctor
IMMEDIATELY:
medicines such as Aceclofenac may be associated with a
small increased risk of heart attack, (”myocardial infarction”)
or stroke
severe allergic reaction (anaphylactic shock). Symptoms
may include difficulty breathing, wheezing, abnormal pain
and vomiting
swelling of the face
kidney failure
If you suffer from any of the following at any time during your
treatment STOP TAKING the medicine and seek immediate
medical help:
Pass blood in your faeces (stools/motions)
Pass black tarry stools
Vomit any blood or dark particles that look like coffee
grounds.
STOP TAKING the medicine and tell your doctor if you experience:
Indigestion or heartburn
Abdominal pain (pains in your stomach) or other abnormal
stomach symptoms.
If any of the below side effects get serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor or
pharmacist.

Common (occur in more than 1 in 100 patients but
in less than 1 in 10 patients):
dizziness
nausea (feeling sick)
diarrhoea
increased liver enzymes in the blood

Uncommon (occur in more than 1 in 1,000 patients
but in less than 1 in 100 patients):
wind (flatulence)
inflammation or irritation of the lining of the stomach
(gastritis)
constipation
vomiting
mouth ulcers
itching
rash

inflammation of the skin (dermatitis)
raised circular red itchy, stinging or burning patches on the
skin (hives)
increase in blood urea levels
increase in blood creatinine levels

Rare (occur in more than 1 in 10,000 patients but in
less than 1 in 1,000 patients):
low levels of iron in the blood
hypersensitivity (allergic reaction)
visual disturbance
shortness of breath

Very Rare (occur in less than 1 in 10,000 patients):
low white blood cells levels
low platelets levels in the blood
abnormal breakdown of red blood cells (anemia)
high potassium levels in the blood
depression
strange dreams
inability to sleep
tingling, pricking or numbness of skin
uncontrollable shaking (tremor)
drowsiness
headaches
abnormal taste in the mouth
sensation of spinning when standing still
heart pounding or racing (palpitations)
hot flushes
difficulty breathing
high pitched noise when breathing
inflammation of the mouth
stomach ulcer
inflammation of the pancreas (pancreatitis)
inflammation of the liver (hepatitis)
yellowing of the skin (jaundice)
spontaneous bleeding into the skin (appears as a rash)
blisters
water retention and swelling
tiredness
leg cramps
increased blood alkaline phosphatase levels
weight gain

If any of the below side effects get serious, please tell your
doctor or pharmacist.
Other side effects that have been reported with this type of drug
(NSAIDs) are:
bone marrow failure
hallucinations
confusion
blurred, partial or complete loss of vision
painful movement of the eye
ringing in the ears
aggravated asthma
ulcers
perforation of either the stomach, large intestine or bowel
wall
blistering and peeling of the top layer of skin
mild, itchy pink/redness of the skin
reddening or scaling of skin
skin irritation (eczema)
Page 2 of 2

skin reaction to sunlight
inflammation of the kidneys
generally feeling unwell
aseptic meningitis
exacerbation of colitis and Crohn’s disease
hypertension (high blood pressure)
cardiac failure
bone marrow depression

5. How to store Aceclofenac
Keep out of the sight and reach of children.
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 carton.
The expiry date refers to the last day of that month.
It is recommended that you store Aceclofenac in the original box.
Do not store above 30°C.
If your tablets appear to be discoloured or show any signs of
deterioration, please return them to your pharmacist who will
advise you.
If your doctor tells you to stop taking the tablets, please take
them back to the pharmacist. Only keep the tablets if your doctor
tells you to.
Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines no longer
required. These measures will help to protect the environment.

6. Further information
What Aceclofenac contains

The active ingredient in Aceclofenac is aceclofenac.
Each film-coated tablet contains 100mg of aceclofenac.
Aceclofenac also contains the following inactive ingredients used
to bind and coat the tablets, these are: microcrystalline cellulose,
sodium croscarmellose polyvidone, glycerol palmitostearate,
and the film coat, containing partially substituted hydroxypropyl
methylcellulose, polyoxyethylene 40 stearate and
titanium dioxide.

What Aceclofenac looks like and contents of the
pack
Aceclofenac are white round film-coated tablets, 8mm in
diameter, without any markings.

Aceclofenac are available in blister strips of 20, 40 and 60 tablets.

Manufacturer

Aceclofenac are manufactured by: Industrias Farmacéuticas
Almirall Prodesfarma, S.L., Ctra. Nacional II, Km. 593, 08740
Sant Andreu de la Barca - Barcelona, Spain.
Procured from within the EU and repackaged by: Doncaster
Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.
Product Licence holder: Doncaster Pharmaceuticals Group Ltd.,
Kirk Sandall, Doncaster, DN3 1QR.
PL No: 04423/0339

POM

Leaflet revision date: 10.07.13

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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