Aceclofenac 100mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Aceclofenac

Available from:

A A H Pharmaceuticals 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: 5025903006701

Patient Information leaflet

PRESERVEX
® 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 the 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 spondylit

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Aceclofenac 100 mg Film-coated Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 100 mg aceclofenac.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Round white or off-white in colour bi-convex film-coated tablets
marked “G” on one
side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Aceclofenac is indicated for the relief of pain and inflammation in
osteoarthritis,
rheumatoid arthritis and ankylosing spondylitis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults: The maximum recommended dose is 200 mg daily, taken as two
separate
doses of 100 mg, one tablet in the morning and one tablet in the
evening.
Children: There are no clinical data supporting the use of aceclofenac
in children
therefore its use is not recommended.
Elderly: Caution should be exercised in the treatment of elderly
patients, who are
generally more prone to adverse reactions, and who are more likely to
be suffering
from impaired renal, cardiovascular or hepatic function and receiving
concomitant
medication. If an NSAID is considered necessary, the lowest effective
dose should be
used and for the shortest possible duration. The elderly should be
monitored for GI
bleeding regularly during NSAID therapy. The pharmacokinetics of
aceclofenac 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 to suggest that the dosage
needs to be
altered for patients with mild renal impairment, however caution
should be exercised
(see section 4.4).
Hepatic insufficiency: There is some evidence that the dose of
aceclofenac should be
reduced in patients with hepatic impairment. It is suggested that an
initial daily dose
of 100 mg is used.
Undesirable effects may be minimised by using the lowest effective
dose for the
shortest duration necessary to control symptoms (see section 4.4).
Method of administration:
For