Aceclofenac 100mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Aceclofenac

Available from:

Rivopharm (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: 5060388650391

Patient Information leaflet

Aceclofenac 100 mg Film-coated Tablets
Ver0116
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
ACECLOFENAC 100 MG FILM-COATED TABLETS
aceclofenac
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 or pharmacist.

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 or pharmacist.
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
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 attack
- runny nose, itching and/or sneezing (irritation of the nose)
- raised red circular patchy rash on

Summary of Product characteristics

OBJECT 1
ACECLOFENAC 100 MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 07-Feb-2017 | Rivopharm UK
Ltd
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 the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet.
White, round, biconvex film-coated tablets, 8 mm diameter.
4. Clinical particulars
4.1 Therapeutic indications
Aceclofenac 100 mg Film-coated Tablets is indicated for the relief of
pain and inflammation in
osteoarthritis, rheumatoid arthritis and ankylosing spondylitis in
adults.
4.2 Posology and method of administration
Posology
Undesirable effects may be minimised 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.
_Children_
There are no clinical data on the use of Aceclofenac 100 mg Tablets 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 Aceclofenac 100 mg Tablets are not altered in
elderly patients, therefore it is not
considered necessary to modify the dose or dose frequency.
_Patients with renal impairment_
There is no evidence that the dosage of Aceclofenac 100 mg Tablets
needs to be modified in patients with
mild renal impairment, but as with other NSAIDs caution should be
exercised (see section4.4).
_Patients with liver impairment_
There is some evidence that the dose of Aceclof