Mybufen Max 400 mg Film-coated Tablets

Valsts: Īrija

Valoda: angļu

Klimata pārmaiņas: HPRA (Health Products Regulatory Authority)

Aktīvā sastāvdaļa:

Ibuprofen

Pieejams no:

Bluefish Pharmaceuticals AB

ATĶ kods:

M01AE01

SNN (starptautisko nepatentēto nosaukumu):

Ibuprofen

Zāļu forma:

Film-coated tablet

Ārstniecības joma:

ibuprofen

Autorizācija statuss:

Marketed

Autorizācija datums:

2022-09-23

Lietošanas instrukcija

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
MYBUFEN MAX 400 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, pharmacist or nurse 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, pharmacist or nurse.
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 Max is and what it is used for
2. What you need to know before you take Mybufen Max
3. How to take Mybufen Max
_ _
4. Possible side effects
5. How to store Mybufen Max
6. Contents of the pack and other information
1. WHAT MYBUFEN MAX 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 in
adolescents from 40 kg bodyweight (12 years
of age and above) and adults.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MYBUFEN MAX
DO NOT TAKE MYBUFEN MAX:
- 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 bl

Produkta apraksts

Health Products Regulatory Authority
20 March 2024
CRN00F30S
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Mybufen Max 400 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 400 mg ibuprofen.
Excipients with known effect:
Each film-coated tablet contains 28.5 mg lactose (as monohydrate)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
400 mg: White, oblong, biconvex film-coated tablets scored on both
sides (length: 17 mm, width: 8 mm).
The score line is not intended for breaking the tablet.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Mybufen Max 400 mg film-coated tablets is indicated for:
- Short-term symptomatic treatment of mild to moderate pain (e.g.
headache, toothache, muscular pain, dysmenorrhea)
and/or fever of duration less than to 3 days.
Mybufen Max 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
The ibuprofen dose depends on patient's age or body weight.
Undesirable effects may be minimized by using the lowest effective
dose for the shortest duration necessary to control
symptoms (see section 4.4).
Mybufen Max 400 mg film-coated tablets:
Adults and adolescents from 12 years of age (≥ 40 kg body weight):
Initial dose 400 mg ibuprofen. If necessary, additional doses of 400
mg ibuprofen can be taken every 4-6 hours as necessary.. A
total dose of 1200 mg ibuprofen should not be exceeded in any 24-hour
period.
Special populations
Elderly:
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.
Renal insufficiency:
No dose adjustment is requir