Brupro 200mg 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:

200 milligram(s)

Pharmaceutical form:

Film-coated tablet

Administration route:

Oral use

Units in package:

Pack size: 12, 24 and 50 film-coated tablets

Prescription type:

Product not subject to medical prescription

Manufactured by:

Rowa Pharmaceuticals Limited

Therapeutic group:

Propionic acid derivatives

Therapeutic area:

Propionic acid derivatives; ibuprofen

Therapeutic indications:

For the short-term management of mild to moderate pain such as headache, dental pain, period pain, muscular strain and backache and for the management of feverishness and the symptoms of colds and influenza

Authorization status:

Marketed

Authorization date:

2015-03-13

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
BRUPRO 200 MG FILM-COATED TABLETS
IBUPROFEN
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
Always take this medicine exactly as described in this leaflet or as
your doctor or pharmacist has told you.
-
Keep this leaflet. You may need to read it again.
-
Ask your pharmacist if you need more information or advice.
-
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.
-
You must talk to a doctor if you do not feel better or if you feel
worse.
WHAT IS IN THIS LEAFLET
1.
What Brupro is and what it is used for
2.
What you need to know before you take Brupro
3.
How to take Brupro
4.
Possible side effects
5.
How to store Brupro
6.
Contents of the pack and other information.
1.
WHAT BRUPRO IS AND WHAT IT IS USED FOR
Brupro 200 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 lowers fever.
This medicine is used for the management of mild to moderate pain such
as headache, dental pain, period
pain, muscular strain and backache and to treat fever and colds and
flu symptoms.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE BRUPRO
DO NOT TAKE BRUPRO:
- 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 distinct episodes of proven ulceration or bleeding)
- if you have a history of gastro-intestinal bleeding or perforation,
related to previous NSAIDs therapy
- if you have severe heart failure, liver failure or kidney failure
- if you h

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 200mg Film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 200 mg of ibuprofen.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film–coated tablet.
White, round, biconvex film-coated tablets (diameter approx. 9mm)
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the short-term management of mild to moderate pain such as
headache, dental pain, period pain, muscular strain and
backache and for the management of feverishness and the symptoms of
colds and influenza.
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 and children over the age of 12 years only: Initial dose is
400mg and subsequently if necessary 200mg – 400mg every
four hours with a maximum dose of 1200 mg in a 24 hour period.
Children under the age of 12 years: Not recommended.
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 (Nonsteroidal anti-inflammatories) should be used with
particular caution in elderly patients who are more prone to
adverse events. The lowest dose compatible with adequate safe clinical
control should be employed. (_See section 4.4, special _
_warnings and special precautions for use_). Treatment should be
reviewed at regular intervals and discontinued if no benefit is
seen or intolerance occurs.
Take ibuprofen tablets with a glass of water. Ibuprofen tablets should
be swallowed whole and not chewed, broken, crushed or
sucked on to avoid oral discomfort and throat irritation.
For oral administration. To be taken preferably with or after food.
4.3 CONTRAINDICATIONS
Ibuprofen is contraindicated in patients with known hypersensitivity
to the active substance or to any of the e