MIOFEN 600 Milligram Film Coated Tablet
국가: 아일랜드
언어: 영어
출처: HPRA (Health Products Regulatory Authority)
환자 정보 전단 유효 성분:
IBUPROFEN
제공처:
Stasisport Pharma N.V.
ATC 코드:
M01AE01
INN (International Name):
IBUPROFEN
복용량:
600 Milligram
약제 형태:
Film Coated Tablet
관리 경로:
Oral use
패키지 단위:
Blister: 10, 20, 24 and 30 film-coated tablets Bottle: 24, 30, 100 and 250 film-coated tablets
처방전 유형:
Product subject to prescription which may be renewed (B)
Manufactured by:
S.C. SANTA S.A, One Pharma Industrial Pharmaceutical Company S.A.
치료 그룹:
anti-inflammatory and antirheumatic products, non-steroids, propionic acid derivative
치료 영역:
Propionic acid derivatives
치료 징후:
Rheumatoid arthritis, arthrosis.
승인 상태:
Authorised
승인 날짜:
2015-07-24
환자 정보 전단
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.
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 if you have had a
stomach ulcer or duodenal
ulcer previously when treated with Miofen or a
similar product.
-
if you have experienced allergic reac
전체 문서 읽기
제품 특성 요약
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_
_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 \..\ is 1200 – 1800 mg daily in divided doses. Some patients can
be maintained on 600-1200mg daily.
The maximum dose in a 24-hour period is 2,400 mg.
_Paediatric population_
Adolescents over 12 years of age (>40 kg):
The recommended dose is 20 mg/kg to a maximum of 40 mg/kg body weight daily in 3 to 4 doses.
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 is contraindicated in children and adolescents younger than 12 years of a
전체 문서 읽기
