Miofen 400mg Film-coated Tablet

Maa: Irlanti

Kieli: englanti

Lähde: HPRA (Health Products Regulatory Authority)

Aktiivinen ainesosa:

Ibuprofen

Saatavilla:

Alter Pharma

ATC-koodi:

M01AE; M01AE01

INN (Kansainvälinen yleisnimi):

Ibuprofen

Annos:

400 milligram(s)

Lääkemuoto:

Film-coated tablet

Terapeuttinen alue:

Propionic acid derivatives; ibuprofen

Valtuutuksen tilan:

Not marketed

Valtuutus päivämäärä:

2015-07-24

Pakkausseloste

PACKAGE LEAFLET: INFORMATION FOR THE USER
MIOFEN 400 MG FILM-COATED TABLETS
ibuprofen
[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.
- For adults: You must talk to a doctor if you do not feel better or
if you feel worse after 3 days
with a fever or migraine and 4 days with pain.
- For children and adolescents: a doctor should be consulted if in
children and in adolescents this
medicinal product is required for more than 3 days or if symptoms
worsen.
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),
reduces fever, relieves pain and has an anti-inflammatory effect
For medicines available without a prescription:
Miofen is used for short t

Valmisteyhteenveto

Health Products Regulatory Authority
13 February 2024
CRN00F277
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Miofen 400mg Film-coated Tablet
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 400mg ibuprofen
Excipients: lactose monohydrate 6.19 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
White coloured, capsule shaped, biconvex, 16.6 x 7.75mm, film coated
tablets, plain on both sides
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For short term symptomatic treatment of:
- Pain of mild to moderate intensity.
- Fever in adults and adolescents.
- Dysmenorrhoea with no organic cause.
For symptomatic treatment of 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.
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.
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 adolescents over 12 years (> 40 kg):_
_Rheumatic diseases_
One 400 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 dosage of Miofen is 1200-1800 mg daily in divided
doses. Some patients can be maintained on 600-1200
mg daily. In adolescent 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.
_ _
_Dysmenorrhoea_
On