Ibuprofen FAIR-MED 600 mg filmomhulde tabletten

Ország: Hollandia

Nyelv: holland

Forrás: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Aktív összetevők:

IBUPROFEN

Beszerezhető a:

Fair-Med Healthcare GmbH Planckstraße 13 22765 HAMBURG (DUITSLAND)

ATC-kód:

M01AE01

INN (nemzetközi neve):

IBUPROFEN

Gyógyszerészeti forma:

Filmomhulde tablet

Összetétel:

CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROMELLOSE (E 464) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; LACTOSE 1-WATER ; MACROGOL 400 ; MACROGOL 6000 ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171),

Az alkalmazás módja:

Oraal gebruik

Terápiás terület:

Ibuprofen

Termék összefoglaló:

Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); CROSCARMELLOSE NATRIUM (E 468); HYPROMELLOSE (E 464); HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464); LACTOSE 1-WATER; MACROGOL 400; MACROGOL 6000; MAGNESIUMSTEARAAT (E 470b); MAÏSZETMEEL; SILICIUMDIOXIDE (E 551); TITAANDIOXIDE (E 171);

Engedély dátuma:

2012-11-12

Betegtájékoztató

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
IBUPROFEN FAIR-MED 600 MG FILMOMHULDE TABLETTEN
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 FAIR-MED is and what it is used for
2. What you need to know before you take
3. How to take
4. Possible side effects
5. How to store
6. Contents of the pack and other information
1. WHAT IBUPROFEN FAIR-MED IS AND WHAT IT IS USED FOR
Ibuprofen
FAIR-MED
belongs
to
a
group
of
medicines
called
Non-Steroidal
Anti-
Inflammatory Drugs (NSAIDs). These medicines provide relief by
changing how the body
responds to pain and swelling.
Ibuprofen FAIR-MED is used for the symptomatic treatment of pain and
inflammation in
arthritic
diseases,
(e.g.
rheumatoid
arthritis),
degenerative
arthritic
conditions
(e.g.
osteoarthritis) and in painful swelling and inflammation after soft
tissue injuries.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
DO NOT TAKE
- if you are allergic to ibuprofen or any of the other ingredients of
this medicine (listed in
section 6)
- if you have ever suffered from shortness of breath, asthma, a runny
nose, swelling or hives
after using acetylsalicylic acid (known as aspirin) or other similar
painkillers (NSAIDs)
- if you have (or have had two or more episodes of ) a stomach ulcer
or bleeding of the
stomach
- if you have a history of gastro-intestinal bleeding or perforation
related to previous NSAID
therapy
- if you have severe liver, kidney, coronary heart diseas

Termékjellemzők

1
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Ibuprofen FAIR-MED 600 mg filmomhulde tabletten
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 600 mg ibuprofen
Excipient(s) with known effect:
contains 42mg lactose.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablet.
White coloured, film coated pillow shaped tablets de-bossed with
‘237’ on one side and plain
on the other.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Symptomatic
treatment of pain
and inflammation in arthritic
diseases
(e.g. rheumatoid
arthritis), degenerative arthritic conditions (e.g. osteoarthritis)
and in painful swelling and
inflammation after soft tissue injuries.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Undesirable effects may be minimised by using the lowest effective
dose for the shortest
duration necessary to control symptoms (see section 4.4).
The ibuprofen dose depends on the patient’s age and body weight. The
recommended dose
range for adults lies between 1200 mg and 2400 mg ibuprofen per day.
The maximum single
daily dose for adults should not exceed 800 mg of ibuprofen.
AGE
SINGLE DOSE IN MG
MAXIMUM DAILY DOSE
IN MG
Adults
600 mg ibuprofen
1200-2400
mg
ibuprofen
_RHEUMATIC DISEASES _
_Adults:_
The usual dose is 600 mg 3 times a day. Maintenance doses of 600
mg-1200 mg daily may be
effective in some patients. In acute and severe conditions the dose
may be increased to a
maximum of 2400 mg in divided doses.
2
In rheumatic diseases the use of can be required for a
longer period. The
treating physician decides on the duration of treatment.
_ _
SPECIAL PATIENT GROUPS
_Paediatric population _
is contraindicated in children and adolescents.
_Elderly _
NSAIDs should be used with particular caution in elderly patients who
are more prone to
adverse events and are at increased risk of potentially fatal
gastrointestinal haemorrhage,
ulceration or perforation (see section 4.4). If treatmen