Aceclofenac 100mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Aceclofenac

Available from:

Actavis UK Ltd

ATC code:

M01AB16

INN (International Name):

Aceclofenac

Dosage:

100mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 10010100; GTIN: 5012617018403

Patient Information leaflet

Page 1 of 2
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.
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
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 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 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 spondyl

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Aceclofenac 100mg Film-coated Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 100mg of aceclofenac
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet.
White, round, biconvex film-coated tablets, 8mm diameter.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Aceclofenac 100mg Film-coated Tablets is indicated for the relief of
pain and
inflammation in osteoarthritis, rheumatoid arthritis and ankylosing
spondylitis
in adults.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Undesirable effects may be minimised by using the lowest effective
dose for
the shortest duration necessary to control symptoms (see section 4.4
Special
warnings and precautions for use).
_Adults _
The recommended dose is 200mg daily, taken as two separate 100mg
doses,
one tablet in the morning and one in the evening.
_Paediatric population _
There are no clinical data on the use of Aceclofenac 100mg Tablets in
children
and therefore it is not recommended for use in children.
_Elderly _
The
elderly,
who
are
more
likely
to
be
suffering
from
impaired
renal,
cardiovascular or hepatic function and receiving concomitant
medication, are
at increased risk of the serious consequences of adverse reactions. If
an
NSAID is considered necessary, the lowest effective dose should be
used and
for the shortest possible duration. The patient should be monitored
regularly
for GI bleeding during NSAID therapy.
The pharmacokinetics of Aceclofenac 100mg Tablets are not altered in
elderly
patients, therefore it is not considered necessary to modify the dose
or dose
frequency.
_Patients with renal impairment _
There is no evidence that the dosage of Aceclofenac 100mg Tablets
needs to
be modified in patients with mild renal impairment, but as with other
NSAIDs
caution should be exercised (see section4.4).
_Patients with liver impairment _
There is some evidence that the dose of Aceclofenac 100mg Tablets
should be
reduced in p