Ibuprofen Bril 400 mg film-coated tablet

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:

400 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 status:

Not marketed

Authorization date:

2019-01-25

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
IBUPROFEN BRIL 400 MG FILM-COATED TABLETS
Ibuprofen
The PL includes alternative texts for different legal status in
different countries as follows:
-Boxed texts are only applicable for OTC versions.
- [Grey shaded text in brackets ] are only applicable for prescription
versions. [For medicines
available only on prescription:]
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.]
[For medicines available without a prescription:]
<
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 after 3 days with a
fever and 5 days with pain.
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
belongs
to
a
group
of
medicines
called
NSAID
(non-steroidal
anti-
inflammatory drugs) which work by reducing pain, inflammation and

Summary of Product characteristics

Health Products Regulatory Authority
30 September 2019
CRN008LCN
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ibuprofen Bril 400 mg film-coated tablet
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 400 mg ibuprofen
Excipient with known effect: lactose monohydrate 16 mg
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablets
Ibuprofen Bril 400 mg film-coated tablets white, about 16.7 mm X 7.8
mm capsule shaped, film-coated tablets, with break line
on both sides.
The tablets can be divided in equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
_Symptomatic treatment of_
-For short term symptomatic treatment of mild to moderate pain such as
headache (including migraine), dysmenorrhoea
(period pain), dental pain, and fever and pain in the common cold.
-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.
Health Products Regulatory Authority
30 September 2019
CRN0