Ibuprofen Sandoz 600 mg, filmomhulde tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

IBUPROFEN

Beschikbaar vanaf:

Sandoz B.V. Veluwezoom 22 1327 AH ALMERE

ATC-code:

M01AE01

INN (Algemene Internationale Benaming):

IBUPROFEN

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

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),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Ibuprofen

Product samenvatting:

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);

Autorisatie datum:

2015-09-15

Bijsluiter

Sandoz B.V.
Page 1/10
Ibuprofen Sandoz 600 mg, filmomhulde tabletten
RVG 117346
1313-v3
1.3.1.3 Bijsluiter
november 2019
PACKAGE LEAFLET: INFORMATION FOR THE USER
IBUPROFEN SANDOZSANDOZ 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 Sandoz 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 SANDOZ IS AND WHAT IT IS USED FOR
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 Sandoz 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 bl

Productkenmerken

Sandoz B.V.
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Ibuprofen Sandoz 600 mg, filmomhulde tabletten
RVG 117346
1311-v3
1.3.1.1 Samenvatting van de Productkenmerken
November 2019
1. NAME OF THE MEDICINAL PRODUCT
Ibuprofen Sandoz 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:_
Sandoz B.V.
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Ibuprofen Sandoz 600 mg, filmomhulde tabletten
RVG 117346
1311-v3
1.3.1.1 Samenvatting van de Productkenmerken
November 2019
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.
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 adoles