Aceclofenac 100mg film-coated Tablets tablets fim-coated

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

aceclofenac

Available from:

Accord Healthcare Limited

ATC code:

M01AB16

INN (International Name):

aceclofenac

Dosage:

100mg

Pharmaceutical form:

tablets fim-coated

Units in package:

(60/6x10/), in blister

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2015-09-15

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
•
Keep this leaflet. You may need to read it
again.
•
If you have further questions, please 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 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. BEFORE YOU TAKE
ACECLOFENAC TABLETS
DO NOT TAKE ACECLOFENAC TABLETS IF;
•
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 had two or more episodes
of
peptic
ulcers,
stomach
bleeding
or
perforation.
•
If you have severe kidney disease
•
If you have severe heart di

Summary of Product characteristics

ACECLOFENAC PSUR – 20 MARCH 2011 TO 19 MARCH 2014
The data and conclusions included in this report are confidential and
proprietary information of Accord Healthcare
Ltd.
52
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Aceclofenac 100 mg film-coated Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 100 mg Aceclofenac.
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
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
is
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).
ACECLOFENAC PSUR – 20 MARCH 2011 TO 19 MARCH 2014
The data and conclusions included in this report are confidential and
proprietary information of Accord Healthcare
Ltd.
53
_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 lowe