Miofen 200mg Film-coated Tablet

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Ibuprofen

Available from:

Alter Pharma

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:

2015-07-24

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
MIOFEN 200 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].
_ _
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 short term symptomatic treatment of mild to
moderate pain such as headache,
muscle and joint pain, back pain, menstrual pain, dental pain, and
fever and pain in common cold.
Children 6-12 years (over 20 kg) can be treated with Miofen 200 mg
tablets during acute painful
conditions and fever associated with common cold.
[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

Summary of Product characteristics

Health Products Regulatory Authority
13 February 2024
CRN00F277
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Miofen 200mg Film-coated Tablet
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 200 mg ibuprofen
Excipient(s) with known effect: lactose monohydrate 3.09 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
White coloured, capsule shaped, 13 x 6mm, biconvex, 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.
- Dysmenorrhoea with no organic cause.
- Fever in adults and adolescents.
Children 6–12 years (>20 kg): Acute pain and fever associated with
the common cold. The indications for children apply only to
the 200 mg tablets.
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 adolescents over 12 years (>40 kg)
One to two 200 mg tablets in a single dose or three to four times
daily, without exceeding a maximum daily dose of 6 tablets
(1200 mg). An interval of at least 4-6 hours should be allowed between
doses. For treatment of dysmenorrhoea, treatment is
started at the first sign of menstruation problems. 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.
Paediatric population
_ _
_Acute pain and fever in association with the common cold_
_ _
_CHILDREN 6–12 YEARS (>20 KG)_
One 200 mg tablet one to three times daily. An interval of at least 4
t