Preservex 100mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Aceclofenac

Available from:

Almirall 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: 5024091100604

Patient Information 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 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).
They have anti-inflammatory and painkiller
properties causing a lowering of swelling,
redness (inflammation) and pain. The medicine/
active ingredient of Preservex is aceclofenac.
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.
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.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
PRESERVEX
DO NOT TAKE PRESERVEX
• if you are allergic to aceclofenac or any of

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
PRESERVEX 100 mg film-coated tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 100 mg of aceclofenac.
Excipients with known effect:
Each tablet contains less than 1 mmol sodium (23mg).
For full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Preservex film-coated tablets 100 mg are presented as white round
film-coated
tablets, 8 mm in diameter.
4.1
THERAPEUTIC INDICATIONS
Preservex is indicated for the relief of pain and inflammation in
osteoarthritis,
rheumatoid arthritis and ankylosing spondylitis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Preservex film-coated tablets are supplied for oral administration.
Posology
When Preservex was administered to fasting and fed healthy volunteers
only the rate and not
the extent of aceclofenac absorption was affected.
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 200 mg daily, taken as two separate 100 mg
doses, one tablet in the
morning and one in the evening.
PAEDIATRIC POPULATION
There are no clinical data on the use of Preservex 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 Preservex are not altered in elderly patients,
therefore it is not
considered necessary to modify the dose or dose frequency.
RENAL INSUFFICIENCY
There is no evidence that the dosage of Preservex needs to be modified
in patients with mild
renal impairment, but as with other