Mybufen 200 mg Film-coated Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Ibuprofen

Available from:

Bluefish Pharmaceuticals AB

ATC code:

M01AE01

INN (International Name):

Ibuprofen

Pharmaceutical form:

Film-coated tablet

Therapeutic area:

ibuprofen

Authorization status:

Marketed

Authorization date:

2022-09-23

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
MYBUFEN 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 have 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 in adolescents.
- after 3 days in the treatment of fever and after 4 days in the
treatment of pain in adults.
WHAT IS IN THIS LEAFLET:
1. What Mybufen is and what it is used for
2. What you need to know before you take Mybufen
3. How to take Mybufen
_ _
4. Possible side effects
5. How to store Mybufen
6. Contents of the pack and other information
1. WHAT MYBUFEN IS AND WHAT IT IS USED FOR
Ibuprofen belongs to the group of medicines called nonsteroidal
anti-inflammatory drugs (NSAID).
This medicinal product is used for the short-term symptomatic
treatment of mild to moderate pain such as
headaches, toothache, muscular pain, period pain and/ or fever of
duration up to 3 days.
Mybufen is indicated in adults and adolescents from 40 kg body weight
(12 years of age and above).
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MYBUFEN
DO NOT TAKE MYBUFEN:
-
If you are allergic to ibuprofen or any of the other ingredients of
this medicine (listed in section 6).
-If you have previously reacted with bronchospasm, asthma attacks,
swelling of the nasal mucosa,
angioedema or skin reactions following previous intake of
acetylsalicylic acid or other non-steroidal anti-
inflammatory drugs (NSAIDs).
-If you suffer from unclarified blood-formation disturbances.
-If you suffer from severe liver or severe kidney impairment.
-
If you have previously had a gastrointestinal bleedin

Summary of Product characteristics

Health Products Regulatory Authority
20 March 2024
CRN00F30S
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Mybufen 200 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 200 mg of ibuprofen.
Excipients with known effect:
Each film-coated tablet contains 15 mg of lactose monohydrate.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Film-coated tablet
Oblong, biconvex, white-coloured coated tablets with a score line on
one side and smooth on the opposite side. The
dimensions of the film-coated tablets are 6 mm of width, 12 mm of
length and 4.2 mm of thick.
The score line is not intended for breaking the tablet.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Mybufen is indicated for the short-term symptomatic treatment of mild
to moderate pain (e.g. headache, toothache, muscular
pain, dysmenorrhea) and/or fever of duration of less than 3 days.
Mybufen is indicated in adults and adolescents from 40 kg body weight
(12 years of age and above).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Undesirable effects may be minimised by using the lowest effective
dose for the shortest duration necessary to control
symptoms (see section 4.4).
The dosage is in line with the details in the following table.
BODY WEIGHT (AGE)
SINGLE DOSE
MAXIMUM DAILY DOSE
≥ 40 kg
(Adults and adolescents from 12 years)
200-400 mg
(1-2 tablets)
1200 mg ibuprofen
(6 tablets)
The respective dosing interval should be chosen in line with the
symptomatology and the maximum daily dose. The interval
between doses should not be below 4 hours. The recommended maximum
daily dose should not be exceeded.
Paediatric population
Mybufen is not intended for use in adolescents under 40 kg body weight
or children under 12 years of age.
Elderly patients
No special dosage adjustment is required. Due to possible
undesirable-effect profile (see section 4.4), it is recommended to
monitor the elderly particularly carefully.
Renal insufficiency (see section 5.2)