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ACECLOFENAC 100MG TABLETS

Active substance(s): 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 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 also section 4.

What is in this leaflet:

1.
2.
3.
4.
5.
6.

What Preservex is and what it is used for
What you need to know before you take Preservex
How to take Preservex
Possible side effects
How to store Preservex
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 nonsteroidal anti-inflammatory drugs (NSAIDs). These drugs
have anti-inflammatory 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 reabsorption 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. 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

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 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 severe liver
failure.
if you suffer from bleeding or bleeding disorders.
if you are pregnant (unless considered essential by your
doctor).

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:

gastrointestinal disorders of the upper or lower
tract

inflammatory bowel disease (ulcerative colitis)

chronic inflammatory bowel disease (Crohn’s
disease)

ulceration, bleeding or perforation

blood disorders

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 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 chicken pox occurs, the use of this medicine should be
avoided because of rare serious infections of the skin
related to this use.

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 discontinued at the first onset of a skin
rash, injuries of mucous membrane or any signs of
hypersensitivity.
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.

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 depression (selective
serotonin-reuptake inhibitors) 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)

quinolone antibiotics

drugs used to increase the rate of urine excretion
(diuretics)

medicines that stop blood clotting (anticoagulants) such
as warfarin, heparin

methotrexate which is used to treat cancer and
autoimmune disorders

mifepristone

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),
including COX-2 inhibitors

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 are planning to become
pregnant or if you have problems becoming pregnant.
NSAIDs may make it more difficult to become pregnant.

Page 1 of 2

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 established. 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 breastfeeding unless considered
essential by your doctor.

Driving and using machines

If you are taking Preservex and you experience dizziness,
drowsiness, vertigo, tiredness or any visual disturbances, 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.

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 lifethreatening 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.

medicines such as Preservex may be associated with a
small increased risk of heart attack (“myocardial
infarction”) or stroke.

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 (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 (may affect up to 1 in 1,000 people):









hypersensitivity (allergic reaction)
visual disturbance
cardiac failure
hypertension
shortness of breath
gastrointestinal haemorrhage
gastrointestinal 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 (tremor)
drowsiness
headaches
abnormal taste in the mouth
sensation of spinning when standing still
ringing in the ears (tinnitus)
heart pounding or racing (palpitations)
hot flushes
difficulty breathing
high pitched noise when breathing
inflammation of the mouth
perforation of either the stomach, large intestine or
bowel wall
exacerbation of colitis and Crohn’s disease
inflammation of the pancreas (pancreatitis)
injury of the liver (including hepatitis)
yellowing of the skin (jaundice)
spontaneous bleeding into the skin (appears as a rash)
nephrotic syndrome
water retention and swelling
tiredness
leg cramps
increased blood alkaline phosphatase levels
weight gain

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.
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.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw away
medicines you no longer use. These measures will help
protect the environment.

6. Contents of the pack and other
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.
POM

PL No: 04423/0339
Leaflet revision date: 26.01.16

Preservex™ is a trademark of Almirall S.A.

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.
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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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