Aceclofenac 100mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Aceclofenac

Available from:

Accord-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: 5060149319802

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
ACECLOFENAC 100 MG FILM-COATED TABLETS
ACECLOFENAC
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 further questions, please 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 Aceclofenac Tablets is and what it is used for
2. What you need to know before you take Aceclofenac Tablets
3. How to take Aceclofenac Tablets
4. Possible side effects
5. How to store Aceclofenac Tablets
6. Content of the pack and other information
1. WHAT ACECLOFENAC TABLETS IS AND WHAT IT IS USED FOR
Aceclofenac Tablets belongs to a group of medicines called
non-steroidal anti-inflammatory drugs or
NSAIDs.
Aceclofenac Tablets 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 spondylitis).
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ACECLOFENAC TABLETS
DO NOT TAKE ACECLOFENAC TABLETS:

if you are allergic to aceclofenac or any of the other ingredients of
Aceclofenac Tablets

if you are pregnant (unless considered essential by your doctor).

if aspirin or other NSAIDs have caused asthma, rhinitis (running nose)
or urticaria (skin rash) or
other allergic reaction.

if you have a peptic ulcer (ulcer in your stomach or duodenum) or
bleeding in your stomach, or
have

Summary of Product characteristics

OBJECT 1
ACECLOFENAC 100 MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 03-Jul-2015 | Accord
Healthcare Limited
1. Name of the medicinal product
Aceclofenac 100 mg film-coated Tablets
2. Qualitative and quantitative composition
Each film-coated tablet contains 100 mg of Aceclofenac.
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
100 mg: Film-coated tablet
White to off-white, round shaped, biconvex, film-coated tablet
debossed with “100“ on one side and
plain on the other side.
4. Clinical particulars
4.1 Therapeutic indications
Aceclofenac film-coated tablets are indicated for the relief of pain
and inflammation in osteoarthritis,
rheumatoid arthritis and ankylosing spondylitis.
4.2 Posology and method of administration
Aceclofenac film-coated tablets are supplied for oral administration
and should be swallowed whole with
a sufficient quantity of liquid.
To be taken preferably with or after food. When Aceclofenac was
administered to fasting and fed healthy
volunteers only the rate and not the extent of aceclofenac absorption
was affected.
Undesirable effects may be minimized by using the lowest effective
dose for the shortest duration
necessary to control symptoms (see section 4.4).
_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 Aceclofenac in children and
therefore it is not recommended for
use in children under 18 years of age.
_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 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 are not altered in elderly
patients, theref