Ibuprofen FAIR-MED 200 mg filmomhulde tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

IBUPROFEN

Beschikbaar vanaf:

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

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:

2012-11-12

Bijsluiter

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
IBUPROFEN FAIR-MED 200 MG FILMOMHULDE TABLETTEN
IBUPROFEN FAIR-MED 400 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.
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, pharmacist or
nurse have 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 if you
have fever or migraine headache and after 4 days for the treatment of
pain.
- You must talk to a doctor if children (from 6 to 12 years) and
adolescents (from 12 to 18
years) do not feel better or feel worse after 3 days.
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
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 high temperature.
Ibuprofen FAIR-MED

Productkenmerken

1
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Ibuprofen FAIR-MED 200 mg filmomhulde tabletten
Ibuprofen FAIR-MED 400 mg filmomhulde tabletten
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 200 mg ibuprofen.
Each film-coated tablet contains 400 mg ibuprofen
Excipient(s) with known effect:
contains 14mg lactose.
contains 28mg lactose.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablet.
200mg
White coloured, film coated pillow shaped tablets debossed with
‘235’ on one side and plain
on the other.
400mg
White coloured, film coated pillow shaped tablets debossed with
‘236’ on one side and plain
on the other.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the symptomatic treatment of mild to moderate pain, such as
headache, acute migraine
headache with or without aura, period pain, dental 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)._ _
200 mg strength: Suitable for adult and children from 20kg (around 6
years old)
400 mg strength: Suitable for adults and adolescents from 40 kg (12
years and older)
If this product is required for more than 3 days in the case of fever
or migraine headache, or
for more than 4 days for pain relief, or if the symptoms worsen the
patient is advised to
consult a doctor.
_ADULTS AND ADOLESCENTS ≥40 KG: _
2
Initial dose, 200 mg or 400 mg ibuprofen. If necessary additional
doses of 200 mg or 400 mg
of ibuprofen can be taken. The respective dosing interval should be
chosen in line with the
observed symptoms and the maximum recommended daily dose. It should
not be below 6
hours for the 400 mg dose and not below 4 hours for the 200 mg dose. A
total dose of 1200
mg ibuprofen should not be exceeded in any 24-hour period.
BODY WEIGHT
SINGLE DOSE IN MG
MAXIMUM DAI