MIOFEN 200 Milligram Film Coated Tablet

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

IBUPROFEN

Available from:

Stasisport Pharma N.V.

ATC code:

M01AE01

INN (International Name):

IBUPROFEN

Dosage:

200 Milligram

Pharmaceutical form:

Film Coated Tablet

Administration route:

Oral use

Units in package:

Blister: 12, 16, 20, 24 and 30 film-coated tablets Bottle: 16, 100 film-coated tablets

Prescription type:

Product not subject to medical prescription

Manufactured by:

S.C. SANTA S.A, One Pharma Industrial Pharmaceutical Company S.A.

Therapeutic group:

Anti-inflammatory and antirheumatic products, nonsteroids; propionic acid derivatives.

Therapeutic area:

Propionic acid derivatives

Therapeutic indications:

For short-term symptomatic treatment of: - Pain of mild to moderate intensity. - Dysmenorrhoea with no organic cause. - Fever in adults and adolescents.

Authorization status:

Authorised

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), 
which 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, 
period pain, dental pain, and fever and pain in common cold. 

Children 6-12 years 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.�

Summary of Product characteristics

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.
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_
_C