Ibuprofen Bril 600 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Ibuprofen

Available from:

Bristol Laboratories Limited

ATC code:

M01AE; M01AE01

INN (International Name):

Ibuprofen

Dosage:

600 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Propionic acid derivatives; ibuprofen

Authorization date:

2019-01-25

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
IBUPROFEN BRIL 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. It
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1. What Ibuprofen Bril is and what is it used for
2. What you need to know before you take Ibuprofen Bril
3. How to take Ibuprofen Bril
4. Possible side effects
5. How to store Ibuprofen Bril
6. Contents of the pack and other information
1. WHAT IBUPROFEN BRIL IS AND WHAT IS IT USED FOR
Ibuprofen
Bril
belong
to
a
group
of
medicines
called
NSAID
(non-steroidal
anti-
inflammatory drugs) which work by reducing pain, inflammation and
fever.
Ibuprofen Bril is used to relieve pain and inflammation in conditions
such as osteoarthritis,
rheumatoid arthritis, arthritis of the spine (ankylosing spondylitis),
swollen joints, frozen
shoulder, bursitis, tendinitis, tenosynovitis, lower back pain,
sprains and strains.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE IBUPROFEN BRIL
DO NOT TAKE IBUPROFEN BRIL
•
if you are allergic to ibuprofen or any of the other ingredients of
this medicine listed in
section 6.
•
if you have had allergic reactions such as asthma, runny nose, itchy
skin rash or swelling
of
the
lips,
face,
tongue,
or
throat
after
you
have
taken
medicines
containing
acetylsalicylic acid (such as aspirin) or other drugs for pain and
inflammation (NSAIDs).
•
if
you have suffered from an ulcer or bleeding in the stomach or
small intestine
(duodenum)related to previous use of drugs for pain and inflammation
(NSAIDs)
•
if
you
are
suffering
from
an
ulcer
or
bleeding
in

Summary of Product characteristics

Health Products Regulatory Authority
30 September 2019
CRN008LCN
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ibuprofen Bril 600 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 600 mg ibuprofen
Excipient with known effect: lactose monohydrate 24 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablets
Ibuprofen 600 mg film-coated tablets are white, about 19 mm X 8 mm
capsule shaped, film-coated tablets, plain on both sides.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
_Symptomatic treatment of_
Symptomatic treatment of pain and inflammation in arthritic diseases
(e.g. rheumatoid arthritis), degenerative arthritic
conditions (e.g. osteoarthritis), and in painful swelling and
inflammation after soft tissue injuries.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For oral use.
Undesirable effects may be minimised by using the lowest effective
dose for the shortest duration necessary to control
symptoms (see section 4.4)
The tablet should be swallowed with a whole glass of water during or
after a meal.
The ibuprofen dose depends on the patient’s age and body weight.
_Rheumatic diseases_
Adults:
The usualdose is400-600mgthree times daily.In somepatients,maintenance
dosesof 600mg-1200 mg per dayare effective. In
acute andseverediseasemaybe increased toa maximum of2400 mgin 3
or4doses.
Adolescents older than12 years(> 40kg):`
The recommendeddose is20mg/kgup to 40 mg/kg bodyweight perday in
3-4doses.
Special populations:
Paediatric population:
Ibuprofen 600 mg film-coated Tablets is contraindicated in children
and adolescents younger than 12 years of age due to lack
of possibility of correct dosing.
Older people
NSAIDs should be used with particular caution in elderly patients who
are more prone to adverse events and are at increased
risk of potentially fatal gastrointestinal haemorrhage, ulceration or
perforation (see section 4.4). If treatment is considered
necessary, the lowest dose for the sh