Miofen 600mg Film-coated Tablet

Țară: Irlanda

Limbă: engleză

Sursă: HPRA (Health Products Regulatory Authority)

Ingredient activ:

Ibuprofen

Disponibil de la:

Alter Pharma

Codul ATC:

M01AE; M01AE01

INN (nume internaţional):

Ibuprofen

Dozare:

600 milligram(s)

Forma farmaceutică:

Film-coated tablet

Zonă Terapeutică:

Propionic acid derivatives; ibuprofen

Statutul autorizaţiei:

Not marketed

Data de autorizare:

2015-07-24

Prospect

PACKAGE LEAFLET: INFORMATION FOR THE USER
MIOFEN 600 MG FILM-COATED TABLETS
ibuprofen
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.
WHAT IS IN THIS LEAFLET
1. What Miofen is and what it is used for
2. What you need to know before you take Miofen
3. How to take Miofen
4.
Possible side effects
5.
How to store
Miofen
6.
Contents of the pack and other information
1.
WHAT MIOFEN
IS AND WHAT IT IS USED FOR
Miofen belongs to a group of medicines called NSAIDs (non-steroidal
anti-inflammatory drugs).
Miofen reduces fever, relieves pain and has an anti-inflammatory
effect.
Miofen is used for rheumatic conditions such as rheumatic arthritis,
and arthrosis in adults and
adolescents (12-18 years old, 40 kg and above).
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE MIOFEN
DO NOT TAKE MIOFEN:
-
if you are allergic to ibuprofen or any of the other ingredients of
this medicine (listed in
section 6)
-
if you are in the last three months of pregnancy
-
if you have an increased tendency to bleed
-
if you have severe liver and kidney disease
-
if you have severe heart failure
-
if you have a stomach ulcer, duodenal ulcer or bleeding, or if you
have had a stomach ulcer,
duodenal ulcer or bleeding previously when treated with Miofen or a
similar product.
-
if you have ever had bleeding or a tear in your stomach or gut when
taking NSAIDs
-
if you have experienced allergic reactions (e.g. breathing
difficulties, nasal obstruction, rash)
to acetylsalicylic acid or other anti-inflammatory drugs.
-
if you are a child or adolescent below 12 years of age
WARNING

Caracteristicilor produsului

Health Products Regulatory Authority
13 February 2024
CRN00F277
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Miofen 600mg Film-coated Tablet
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 600mg Ibuprofen
Excipients: lactose monohydrate 9.28mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
White coloured, capsule shaped, biconvex, 19 x 8.8mm, film coated
tablets, plain on both sides
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Rheumatoid arthritis, arthrosis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The treatment should start with the lowest dose anticipated to be
effective, which can subsequently be adjusted, depending on
the therapeutic response and any undesirable effects. In long-term
treatment a low maintenance dose should be the aim.
Undesirable effects may be minimised by using the lowest effective
dose for the shortest duration necessary to control
symptoms (see section 4.4).
_Adults and dolescents over 12 years of age (>40 kg):_
_Rheumatic diseases_
One 600 mg tablet three times daily. An interval of at least 4-6 hours
should be allowed between doses. For more rapid relief
of the morning stiffness, the first dose may be given on a fasting
stomach. The dose should be reduced in the event of renal
insufficiency.
The recommended dose of Miofen is 1200 – 1800 mg daily in divided
doses. Some patients can be maintained on
600-1200 mg daily.
In adolescents the recommended dose is 20 mg/kg to a maximum of 40
mg/kg body weight daily in 3 to 4 doses.
The maximum dose in a 24-hour period is 2,400 mg.
_Paediatric population_
There are other dosage forms which may be more suitable to attain the
required posology in this age and body weight group.
Miofen 600 mg film-coated tablets are contraindicated in children and
adolescents younger than 12 years of age (<40 kg) due
to lack of possibility of correct dosing.
_Elderly_
The elderly are at increased risk of serious consequences of adverse
reactions. If an