Skip to Content

PRESERVEX TABLETS

Active substance: ACECLOFENAC

View full screen / Print PDF » Download PDF ⇩
Transcript
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.

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.

1

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.

01

4. Possible side effects

Version number:

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

00000000

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

PMS
PROCESS BLACK

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.

14/07/2014

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).

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.

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.

Date:

2. What you need to know before you take
Preservex

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.

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.

Name:

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).

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.

Do not exceed the stated daily dose.

Item Number:

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

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

DRAWING

Preservex belongs to a group of medicines called
non-steroidal anti-inflammatory drugs (NSAIDs).
These drugs have anti-inflammatory and painkiller
properties. The active ingredient of Preservex is
aceclofenac.

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 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).

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.

uk-packageleaflet-052014 (1/2)

1. What Preservex is and what it is used for

Preservex is not recommended for use in children.

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

Regulatory text number:

ADHESIVE

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 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)

P Preservex tab UK Mock up (Manuf Change)

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.

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.

PROOF:

Aceclofenac

3. How to take Preservex

Marked trade name:

Preservex Film Coated Tablets 100 mg

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.

ADHESIVE

Package leaflet: Information for the user

Not all pack sizes may be marketed.

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.
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 substance is aceclofenac 100 mg.

00000000

01

Do not store above 30°C.

Version number:

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

14/07/2014

5. How to store Preservex

Date:

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

00000000

This leaflet was last approved in 07/2014

Item Number:

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

PMS
PROCESS BLACK

1

PROOF:

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

Name:

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)

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.

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

DRAWING

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

Exceptionally, serious skin infections occur in
association with chickenpox

Preservex 100 mg film-coated tablets are white,
round tablets.

uk-packageleaflet-052014 (2/2)

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

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

What Preservex looks like and contents of
the pack

Regulatory text number:

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








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.

P Preservex tab UK Mock up (Manuf Change)

ADHESIVE

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.







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

Marked trade name:

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.








ADHESIVE

• 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.

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.

Hide