Ibuprofen Bril 600 mg film-coated tablets

Krajina: Írsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktívna zložka:

Ibuprofen

Dostupné z:

Brillpharma (Ireland) Limited

ATC kód:

M01AE; M01AE01

INN (Medzinárodný Name):

Ibuprofen

Dávkovanie:

600 milligram(s)

Forma lieku:

Film-coated tablet

Terapeutické oblasti:

Propionic acid derivatives; ibuprofen

Stav Autorizácia:

Not marketed

Dátum Autorizácia:

2019-01-25

Príbalový leták

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

Súhrn charakteristických

Health Products Regulatory Authority
10 September 2021
CRN00C1FC
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 lowest effective dose
for the shortest duration necessary to control symptoms
(see section 4.4)
The tablet should be swallowed with a glass of water during or after
meal
The ibuprofen dose depends on the patient's age and body weight.
_Mild to moderate pain and fever _
Adults and adolescents older than 12 years (≥40 kg):
200-400 mg given as a single dose or 3 times a day with an interval of
4 to 6 hours.
The dosage in migraine headache should be: 400 mg given as a single
dose, if necessary 400 mg with intervals of 4 to 6 hours.
The maximum daily dose should not exceed 1200 mg.
If in adults this product is required for more than 3 days in the case
of fever or migraine headache, or for more than 4 days for
pain relief, or if symptoms worsen the patient is advised to consult a
doctor.
If in children and adolescents, this medicinal product is required for
more than 3 days, or if symptoms worsen a doctor should
be consulted.
CHILDREN 6-12 YEARS (>20 KG)
Children 6-9 years (20-29 kg):
200 mg 1-3 times a day with intervals of 4 to 6 hours as required. The
maximum daily dose should