Preservex 100mg tablets

Nazione: Regno Unito

Lingua: inglese

Fonte: MHRA (Medicines & Healthcare Products Regulatory Agency)

Principio attivo:

Aceclofenac

Commercializzato da:

Dowelhurst Ltd

Codice ATC:

M01AB16

INN (Nome Internazionale):

Aceclofenac

Dosaggio:

100mg

Forma farmaceutica:

Oral tablet

Via di somministrazione:

Oral

Classe:

No Controlled Drug Status

Tipo di ricetta:

Valid as a prescribable product

Dettagli prodotto:

BNF: 10010100

Foglio illustrativo

PRESERVEX
® 100MG TABLETS
ACECLOFENAC 100MG TABLETS
(aceclofenac)
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.
Your medicine is available using any one of the above names but will
be
referred to as Preservex throughout this following leaflet.
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 spo

Scheda tecnica

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.
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 NSAIDs caution should be exercised
(see also
Precautions).
HEPATIC INSUFFICIENCY
There is some evidence that the dose of Prese