Ibuprofen Bril 200 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Ibuprofen

Available from:

Brillpharma (Ireland) Limited

ATC code:

M01AE; M01AE01

INN (International Name):

Ibuprofen

Dosage:

200 milligram(s)

Pharmaceutical form:

Film-coated tablet

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 200 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 they are 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 ARE AND WHAT ARE THEY USED FOR
Ibuprofen
Bril
belongs
to
a
group
of
medicines
called
NSAID
(non-steroidal
anti-
inflammatory drugs) which work by reducing pain and fever

Summary of Product characteristics

Health Products Regulatory Authority
10 September 2021
CRN00C1FC
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ibuprofen Bril 200 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 200 mg ibuprofen
Excipient with known effect: lactose monohydrate 8 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablets
Ibuprofen Bril 200 mg film-coated tablets are white, about 9.5 mm
circular, film coated tablets, plain on both the sides.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For short term symptomatic treatment of mild to moderate pain such as
headache (including migraine), dysmenorrhea (period
pain), dental pain, and fever and pain in common cold.
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 not exceed 600 mg.
Children 10-12 years (30-40 kg):
200 mg 1-4 times a day wi