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PRESERVEX TABLETS

Active substance(s): ACECLOFENAC / ACECLOFENAC / ACECLOFENAC

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Date and Signature
Frutiger LT Com Bold, Frutiger LT Com Light.

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.

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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.

Colour reference in
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Equate with CMYK

ITF code

Inline control code
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Do not exceed the stated daily dose.

Manufacturer’s Technical check:
Manufacturer confirms the printability and technical
compliance of this packaging material for correct use
during packaging process.

Tablets should be swallowed whole with plenty
of water and should be taken with or after food.
Do not crush or chew the tablets.

16.01.2017

The recommended dose in adults is 200mg (two
Preservex tablets). One 100mg tablet should be
taken in the morning and one in the evening.

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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.

Date:

Do not take Preservex
• if you are allergic to aceclofenac or any of the
other ingredients of this medicine (listed in
section 6).

3. How to take Preservex

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2. What you need to know before you take
Preservex

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.

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.

Material size: 160 X 250 mm

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.

Preservex is not recommended for use in children.

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.

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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.

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.

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.

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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.

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.

You should inform your doctor if you have
problems becoming pregnant. NSAIDs may make
it more difficult to become pregnant.

Regulatory text: uk-pl-preservex-proposed 16.01.17 (1/1)

ADHESIVE

1. What Preservex is and what it is used for

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.

Description: PIL Preservex tab GB Mock up

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

• 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)

Artwork Information Panel

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.

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.

4

Aceclofenac

Preservex with food and drink
Preservex must be taken preferably with or after
food.

Proof:

Preservex Film Coated Tablets 100 mg

• 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).

ADHESIVE

PACKAGE LEAFLET: INFORMATION FOR THE USER

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Date and Signature
Frutiger LT Com Bold, Frutiger LT Com Light.

Exceptionally, serious skin infections occur in
association with chickenpox.

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Not all pack sizes may be marketed.

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

Colour reference in
PMS Bridge
Equate with CMYK

ITF code

Inline control code

Preservex tablets are available in boxes of either
10 or 60 tablets.

Manufacturer’s Technical check:
Manufacturer confirms the printability and technical
compliance of this packaging material for correct use
during packaging process.

What Preservex looks like and contents of
the pack
Preservex 100 mg film-coated tablets are white,
round tablets.

16.01.2017

The other ingredients (excipients) are:
Tablet core - microcrystalline cellulose, sodium
croscarmellose, povidone and glyceryl
palmitostearate.
Coating Material - partially substituted
hydroxypropyl methylcellulose, microcrystalline
cellulose, polyoxyethylene 40 stearate and
titanium dioxide.

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What Preservex contains
The active substance is aceclofenac 100mg.

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6. Contents of the pack and other
information

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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.

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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.

Material size: 160 X 250 mm

Uncommon (may affect up to 1 in 100 people):
• wind
• inflammation or irritation of the lining of the
stomach

This leaflet was last approved in January 2017.

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Common (may affect up to 1 in 10 people):
• dizziness
• nausea (feeling sick)
• diarrhoea
• increased liver enzymes in the blood

Do not store above 30°C.

5. How to store Preservex

Regulatory text: uk-pl-preservex-proposed 16.01.17 (1/2)

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.

Keep this medicine out of the sight and reach of
children.

Manufacturer:
Industrias Farmacéuticas Almirall, S.A.
Ctra. Nacional II, km 593
08740 Sant Andreu de la Barca
Barcelona
Spain

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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.

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

Marketing Authorisation Holder:
Almirall S.A.
General Mitre 151
08022 Barcelona
Spain

Description: PIL Preservex tab GB Mock up

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.

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.

By reporting side-effects you can help provide
more information on the safety of this medicine

Marketing Authorisation Holder and
Manufacturer

Artwork Information Panel

ADHESIVE

Like all medicines, this medicine can cause side
effects, although not everybody gets them.

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.

4

4. Possible side effects

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

Proof:

If you have any further questions on the use of
this medicine, ask your doctor, pharmacist or
nurse.









ADHESIVE

If you stop taking Preservex
Do not stop taking Preservex unless your doctor
advises you.

Expand Transcript

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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