Aceclofenac 100mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Aceclofenac

Available from:

Viatris UK Healthcare 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: 5016695001913

Patient Information leaflet

1
PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
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 any further questions, ask your doctor or pharmacist.
-
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 or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Aceclofenac is and what it is used for
2.
What you need to know before you take Aceclofenac
3.
How to take Aceclofenac
4.
Possible side effects
5.
How to store Aceclofenac
6.
Contents of the pack and other information
1.
WHAT ACECLOFENAC IS AND WHAT IT IS USED FOR
Aceclofenac belongs to a group of medicines called non-steroidal
anti-inflammatory drugs, or
NSAIDs.
Aceclofenac is used to relieve pain and inflammation that occur with:
-
osteoarthritis
-
rheumatoid arthritis
-
ankylosing spondylitis.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ACECLOFENAC
DO NOT TAKE ACECLOFENAC:

if you are allergic to aceclofenac or any of the other ingredients of
this medicine (listed in
section 6)

if you are allergic to aspirin (acetylsalicylic acid) or any other
non-steroidal anti-inflammatory
drugs (NSAIDs) such as ibuprofen, naproxen or diclofenac

if you have taken aspirin (acetylsalicylic acid) or any other NSAIDs
and experienced one of
the following:
o
asthma attack (wheezing, chest tightness, breathlessness)
o
runny nose, itching and/or sneezing (irritation of the nose)
o
swelling of the face, lips, tongue or throat (angioedema) leading to
difficulty breathing
o
raised red circular patchy rash on the skin which may have been itchy,
stung or had a
burning sensation, known as hives

if you have a history of, suffer from, or suspect that

Summary of Product characteristics

OBJECT 1
ACECLOFENAC 100 MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 28-Jun-2017 | Generics UK
T/A Mylan
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 shor