Aceclofenac 100mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Aceclofenac

Available from:

Sigma Pharmaceuticals Plc

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

Patient Information leaflet

1
ACTAVIS LOGO
PACKAGE LEAFLET: INFORMATION FOR THE USER
ACECLOFENAC 100MG FILM-COATED TABLETS
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
-
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. Do not pass it on to
others. It may harm them, even if their
symptoms are the same as yours.
-
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please
tell your doctor, pharmacist or nurse.
-
The full name of this medicine is Aceclofenac 100mg Film-coated
Tablets but within the leaflet it will
be referred to as Aceclofenac Tablets.
IN THIS LEAFLET
1.
What Aceclofenac Tablets are and what they are used for
2.
Before you take Aceclofenac Tablets
3.
How to take Aceclofenac Tablets
4.
Possible side effects
5.
How to store Aceclofenac Tablets
6.
Further information
1.
WHAT ACECLOFENAC TABLETS ARE AND WHAT THEY ARE USED FOR
Aceclofenac Tablets contain a medicine called aceclofenac. This
belongs to a group of medicines called
non-steroidal anti-inflammatory drugs (NSAIDs).
Aceclofenac Tablets are used to relieve pain and inflammation in adult
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).
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ACECLOFENAC TABLETS
DO NOT TAKE ACECLOFENAC TABLETS:
•
if you are allergic (hypersensitive) to aceclofenac or any of the
other ingredients of Aceclofenac
Tablets
•
if you are allergic (hypersensitive) to aspirin or any other NSAIDs
(such as ibuprofen, naproxen or
diclofenac)
•
if you have taken aspirin or any other NSAIDs and experienced one of
the following:
-
asthma

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