Brupro Rx 600mg Film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Ibuprofen

Available from:

Rowa Pharmaceuticals Limited

ATC code:

M01AE; M01AE01

INN (International Name):

Ibuprofen

Dosage:

600 milligram(s)

Pharmaceutical form:

Film-coated tablet

Administration route:

Oral use

Units in package:

Pack size: 12, 24 and 60 film-coated tablets

Prescription type:

Product subject to prescription which may be renewed (B)

Manufactured by:

Temmler Werke Gmbh

Therapeutic group:

Propionic acid derivatives

Therapeutic area:

Propionic acid derivatives; ibuprofen

Therapeutic indications:

It is indicated in the symptomatic management of various arthroses such as rheumatoid arthritis (including juvenile rheumatoid arthritis or Still’s disease) and osteoarthritis, fibrositis, ankylosing spondylitis and other muscular syndromes, such as low back pain, soft tissue trauma and various inflammations of tendon, joint capsules and ligaments.

Authorization status:

Not marketed

Authorization date:

2015-03-13

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
BRUPRO RX 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 Brupro Rx is and what it is used for
2.
What you need to know before you take Brupro Rx
3.
How to take Brupro Rx
4.
Possible side effects
5.
How to store Brupro Rx
6.
Contents of the pack and other information.
1.
WHAT BRUPRO RX IS AND WHAT IT IS USED FOR
Brupro Rx 600 mg Film-coated tablets contain the active substance
ibuprofen. Ibuprofen belongs to a group
of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs)
that relieve pain and lower fever.
This medicine is used to manage pain and inflammation in conditions
such as osteoarthritis, rheumatoid
arthritis (including juvenile rheumatoid arthritis or Still’s
disease), fibrositis, arthritis of the spine
(ankylosing spondylitis) and other muscular conditions such as lower
back pain, soft tissue trauma,
inflammation of tendons, joints and ligaments. This medicine can also
be used to relieve mild to moderate
pain.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE BRUPRO RX
DO NOT TAKE BRUPRO RX:
- if you are allergic to ibuprofen or any of the other ingredients of
this medicine (listed in section 6)
- if you have a history of shortness of breath, asthma attacks or skin
reactions (swelling or hives) after taking
acetylsalicylic acid (aspirin) or other non-steroidal
anti-inflammatory drugs (NSAIDs)
- if you have an active or history of recurrent stomach/duodenal
ulcers (peptic ulcers) or bleeding (two or
more

Summary of Product characteristics

Health Products Regulatory Authority
15 March 2023
CRN00D8ZT
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Brupro Rx 600mg Film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 600 mg of ibuprofen.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
White, oblong, biconvex film-coated tablets with a score notch on both
sides (length approx. 17.1mm, width approx. 8.1mm)
The tablet can be divided into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Brupro Rx 600mg is indicated in the symptomatic management of various
arthroses such as rheumatoid arthritis (including
juvenile rheumatoid arthritis or Still’s disease) and
osteoarthritis, fibrositis, ankylosing spondylitis and other muscular
syndromes, such as low back pain, soft tissue trauma and various
inflammations of tendon, joint capsules and ligaments.
Brupro Rx 600mg is also used as an analgesic in the relief of mild to
moderate pain.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The lowest effective dose should be used for the shortest duration
necessary to control symptoms (see section 4.4).
Adults: The recommended dosage of ibuprofen is 1200-1800 mg daily in
divided doses. Some patients can be maintained on
600-1200 mg daily. The total daily dose should not exceed 2400 mg.
Children: The recommended dose of ibuprofen is 20-30 mg/kg bodyweight
daily in divided doses but in juvenile rheumatoid
arthritis, the daily dosage may be increased to 40 mg/kg bodyweight in
severe cases.
In children weighing less than 30 kg, the total daily dose of
ibuprofen should not exceed 500 mg (the liquid formulation should
be used).
Elderly: No specific dosage modifications are required for elderly
patients, unless renal or hepatic function is impaired, in which
case, dosage should be assessed individually.
NSAIDs should be used with particular caution in elderly patients who
are more prone to adverse events. The lowest dose
compatible with adequate safe clinical con