Ibuprofen 600 mg Film-coated Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Ibuprofen

Available from:

Accord Healthcare Ireland Ltd.

ATC code:

M01AE; M01AE01

INN (International Name):

Ibuprofen

Dosage:

600 milligram(s)

Pharmaceutical form:

Film-coated tablet

Therapeutic area:

Propionic acid derivatives; ibuprofen

Authorization status:

Not marketed

Authorization date:

2016-10-07

Patient Information leaflet

IE/H/0755/001-003/IB/018, ver 03, Sep 2023
PACKAGE LEAFLET: INFORMATION FOR THE USER
IBUPROFEN 600 MG FILM-COATED TABLETS
ibuprofen
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 Ibuprofen tablets is and what it is used for
2.
What you need to know before you take Ibuprofen tablets
3.
How to take Ibuprofen tablets
4.
Possible side effects
5.
How to store
Ibuprofen tablets
6.
Contents of the pack and other information
1.
WHAT IBUPROFEN TABLETS IS AND WHAT IT IS USED FOR
Ibuprofen tablets belong to a group of medicines called NSAIDs
(non-steroidal anti-inflammatory
drugs). Ibuprofen tablets reduces fever, relieves pain and has an
anti-inflammatory effect.
They can be used in symptomatic treatment of pain and inflammation in
rheumatoid arthritis
(including systemic Juvenile Idiopathic Arthritis [sJIA]),
osteoarthritis, seronegative arthropathies and
in painful swelling and inflammation after soft tissue injuries.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE IBUPROFEN TABLETS
DO NOT TAKE IBUPROFEN TABLETS:
•
if you are allergic (hypersensitive) to ibuprofen or any of the other
ingredients of this medicine
(listed in section 6).
•
if you are in the last three months of pregnancy.
•
if you have an increased tendency to bleed
.
•
if you previously have had bleeding or perforation in your stomach or
intestine when treated
with Ibuprofen tablets or a similar product (other NSAIDs).
•
if you have severe liver and kidney disease.
•
if you have severe heart failure or coronary heart disease

Summary of Product characteristics

Health Products Regulatory Authority
27 October 2023
CRN00DSJD
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ibuprofen 600 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 600 mg ibuprofen
Excipient with known effect: each tablet contains 70 mg lactose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
Ibuprofen 600 mg film-coated tablets: pink coloured, oblong shape,
approximately 19 mm in length, 8 mm in width, biconvex,
film coated tablets debossed with ‘DL’ separated by break line on
one side and plain on other side. The score line is not
intended for breaking the tablet.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Symptomatic treatment of pain and inflammation in rheumatoid arthritis
(including systemic Juvenile Idiopathic Arthritis [sJIA]),
osteoarthritis, seronegative arthropathies and in painful swelling and
inflammation after soft tissue injuries.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The treatment should start with the lowest dose anticipated to be
effective, which can subsequently be adjusted, depending on
the therapeutic response and any undesirable effects. In long-term
treatment a low maintenance dose should be the aim.
The lowest effective dose should be used for the shortest duration
necessary to relieve symptoms (see section 4.4).
_Adults and adolescents (12 years and older, >40kg):_
_Rheumatic diseases_
One 600 mg tablet three times daily. An interval of at least 4-6 hours
should be allowed between doses. Some patients can be
maintained on 600-1200mg daily. In severe or acute conditions, it can
be advantageous to increase the dosage until the acute
phase is brought under control, provided that the total daily dose
does not exceed 2400mg in divided doses. This tablet cannot
be halved and in some instances a different strength or formulation of
ibuprofen must be used.
_Juvenile Rheumatoid Arthritis_
Adolescents over 12 years of age (>40 kg): The recom