Ibuprofen Sandoz 200 mg, capsules, zacht

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

IBUPROFEN

Beschikbaar vanaf:

Sandoz B.V.

ATC-code:

M01AE01

INN (Algemene Internationale Benaming):

IBUPROFEN

farmaceutische vorm:

Capsule, zacht

Samenstelling:

AMMONIA (E 527) ; GELATINE (E 441) ; IJZEROXIDE ZWART (E 172) ; KALIUMHYDROXIDE (E 525) ; MACROGOL 400 ; PROPYLEENGLYCOL (E 1520) ; SCHELLAK GLAZE, GEDEELTELIJK VERESTERD ; SORBITANMONOOLEAAT (E 494) ; SORBITOL, VLOEIBAAR, NIET-KRISTALLISEERBAAR (E 420) ; TRIGLYCERIDEN MIDDELLANGE KETEN ; WATER, GEZUIVERD ; ZWARTE INKT,

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Ibuprofen

Product samenvatting:

Hulpstoffen: AMMONIA (E 527); GELATINE (E 441); IJZEROXIDE ZWART (E 172); KALIUMHYDROXIDE (E 525); MACROGOL 400; PROPYLEENGLYCOL (E 1520); SCHELLAK GLAZE, GEDEELTELIJK VERESTERD; SORBITANMONOOLEAAT (E 494); SORBITOL, VLOEIBAAR, NIET-KRISTALLISEERBAAR (E 420); TRIGLYCERIDEN MIDDELLANGE KETEN; WATER, GEZUIVERD; ZWARTE INKT;

Autorisatie datum:

2012-04-13

Bijsluiter

V6
PACKAGE LEAFLET: INFORMATION FOR THE USER
IBUPROFEN SANDOZ 200 MG CAPSULES, ZACHT
IBUPROFEN SANDOZ 400 MG, CAPSULES, ZACHT
Ibuprofen
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.

Ask your pharmacist if you need more information or advice.

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.

You must talk to a doctor if you do not feel better or if you feel
worse after 3 days, or in adults
treating pain after 4 days.
WHAT IS IN THIS LEAFLET
1.
What [Nationally completed name] is and what it is used for
2.
What you need to know before you take [Nationally completed name]
3.
How to take [Nationally completed name]
4.
Possible side effects
5.
How to store [Nationally completed name]
6.
Contents of the pack and other information
1.
WHAT [NATIONALLY COMPLETED NAME] IS AND WHAT IT IS USED FOR
[Nationally completed name] contains the active substance ibuprofen.
It belongs to a group of
medicines known as non-steroidal anti-inflammatory drugs (NSAIDs).
NSAIDs provide relief by
changing the body’s response to pain and high temperature.
[200mg only]
[Nationally completed name] is used for the short-term symptomatic
treatment of mild to moderate
pain, such as headache, dental pain, period pain and fever and pain in
the common cold.
[400 mg only]
[Nationally completed name] is used for the short-term symptomatic
treatment of mild to moderate
pain, such as headache, acute migraine headache with or without aura,
dental pain, period pain and
fever and pain in the common cold.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE [NATIONALLY COMPLETED NAME]
DO NOT TAKE [NATIONALLY COMPLETED NAME] IF YOU

are allergic to ibuprofen or any of the other ingredients of this
medicine (listed in secti

Productkenmerken

V5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Ibuprofen Sandoz 200 mg,capsules, zacht
Ibuprofen Sandoz 400 mg, capsules, zacht
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
{[Nationally completed name] 200 mg, capsules soft}
Each capsule contains 200 mg of ibuprofen.
Excipient with known effect: Each capsule contains 38.92 mg of
sorbitol (E420)
{[Nationally completed name] 400 mg, capsules, soft}
Each capsule contains 400 mg of ibuprofen.
Excipient with known effect: Each capsule contains 50 mg of sorbitol
(E420)
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Capsule, soft
{[Nationally completed name] 200 mg, capsules soft}
Clear oval shaped soft gelatin capsules containing colourless to pale
yellow coloured, transparent,
viscous liquid, printed ‘200’ in black colour on capsule shell.
Dimensions: 15 mm x 8 mm
{[Nationally completed name] 400 mg, capsules soft}
Clear oval shaped soft gelatin capsules containing colourless to pale
yellow coloured, transparent,
viscous liquid, printed ‘400’ in black colour on capsule shell.
Dimensions: 15 mm x 10 mm
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
[200 mg only]
For the short-term symptomatic treatment of mild to moderate pain,
such as headache, dental pain,
period pain and fever and pain in the common cold.
[400 mg only]
For the short-term symptomatic treatment of mild to moderate pain,
such as headache, acute migraine
headache with or without aura, dental pain, period pain and fever and
pain in the common cold.
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).
_ _
_Adults and adolescents ≥ 40 kg body weight (12 years of age and
above): _
V5
[200 mg only]
Initial dose: 200 mg or 400 mg. If necessary, an additional dose of 1
to 2 capsules (200 mg to 400 mg)
may be taken. The corresponding dosing interval should be chosen based
on the symptoms and the
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