Ibuprofen 20mg film-coated Tablets

국가: 몰타

언어: 영어

출처: Medicines Authority

유효 성분:

IBUPROFEN

제공처:

Accord Healthcare Ireland Ltd Euro House, Euro Business Park, Little Island Cork, T45 K857, Ireland

ATC 코드:

M01AE01

INN (International Name):

IBUPROFEN 200 mg

약제 형태:

FILM-COATED TABLET

구성:

IBUPROFEN 200 mg

처방전 유형:

POM

치료 영역:

ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS

승인 상태:

Withdrawn

승인 날짜:

2016-07-14

환자 정보 전단

PACKAGE LEAFLET: INFORMATION FOR THE USER
IBUPROFEN 200 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. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Ibuprofen tablets is and what it is used for
2.
What you need to know before you take Ibuprofen tablets
3.
How to take Ibuprofen tablets
4.
Possible side effects
5.
How to store
Ibuprofen tablets
6.
Contents of the pack and other information
1.
WHAT IBUPROFEN TABLETS IS AND WHAT IT IS USED FOR
Ibuprofen tablets belong to a group of medicines called NSAIDs
(non-steroidal anti-inflammatory
drugs).
In adults and children over 6 years (>20 kg): Short term treatment of
fever and pain of mild to
moderate intensity, including dysmenorrhea.
Long term symptomatic treatment of pain and inflammation in chronic
inflammatory rheumatic
diseases.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE IBUPROFEN TABLETS
DO NOT TAKE IBUPROFEN TABLETS:
•
if you are allergic (hypersensitive) 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 or coronary heart disease.
•
if you have a stomach ulcer, duodenal ulcer, or if you have had a
stomach ulcer or duodenal
ulcer previously when treated with ibuprofen or a similar product.
•
if you have experienced allergic reactions (e.g. breathing
difficulties, nasal obstruction, rash) to
acetylsalicylic acid or other anti-i

제품 특성 요약

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S
UMMARY OF
P
RODUCT
C
HARACTERISTICS
1.
N
AME OF THE
M
EDICINAL
P
RODUCT
Ibuprofen 200 mg film-coated tablets
2.
Q
UALITATIVE AND
Q
UANTITATIVE
C
OMPOSITION
Each film-coated tablet contains 200 mg ibuprofen
Excipient with known effect: each tablet contains 23 mg lactose.
For the full list of excipients, see section 6.1.
3.
P
HARMACEUTICAL
F
ORM
Film-coated tablet
Ibuprofen 200 mg film-coated tablets: pink coloured, round,
approximately 10 mm in diameter,
biconvex film coated tablets debossed with ‘DJ’ on one side and
plain on other side.
4.
C
LINICAL
P
ARTICULARS
4.1
THERAPEUTIC INDICATIONS
In adults and children over 6 years (>20 kg): Short term treatment of
fever and pain of mild to
moderate intensity, including dysmenorrhea.
Long term symptomatic treatment of pain and inflammation in chronic
inflammatory rheumatic
diseases.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
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.
The lowest effective dose should be used for the shortest duration
necessary to relieve symptoms (see
section 4.4).
_Rheumatic diseases_
- initial treatment of 4x200 mg tablets, three times daily, i.e. 2400
mg per day
- maintenance treatment : 2x200 mg tablets, three to four times daily,
i.e. 1200 to 1600 mg per day.
An interval of at least 4-6 hours should be allowed between doses. The
total daily dose must not
exceed 2400mg in divided doses. Some patients can be maintained on 600
– 1200mg daily. If a high
daily dose is required a different strength of ibuprofen tablet may be
more appropriate.
_Juvenile Rheumatoid Arthritis _
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For Juvenile Rheumatoid Arthritis, the recommended dose is
20mg-30mg/kg body weight daily in 3 to
4 divided doses up to a maximum of 40mg/kg body weight daily in severe
cases. In children weighing
less than 30 kg, use of a liquid formulation sho