Ibuprofen (als lysine) Mylan 400 mg, filmomhulde tabletten

Država: Nizozemska

Jezik: nizozemski

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

Aktivni sastojci:

IBUPROFEN-(D,L)-LYSINE SAMENSTELLING overeenkomend met ; IBUPROFEN

Dostupno od:

Mylan B.V. Dieselweg 25 3752 LB BUNSCHOTEN

ATC koda:

M01AE01

INN (International ime):

IBUPROFEN-(D,L)-LYSINE COMPOSITION in accordance with ; IBUPROFEN

Farmaceutski oblik:

Filmomhulde tablet

Sastav:

AMMONIA (E 527) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSPOVIDON (E 1202) ; IJZEROXIDE ZWART (E 172) ; MACROGOL 3350 ; MAGNESIUMSTEARAAT (E 470b) ; POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203) ; POVIDON K 30 (E 1201) ; PROPYLEENGLYCOL (E 1520) ; SCHELLAK GLAZE, GEDEELTELIJK VERESTERD ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171) ; ZWARTE INKT,

Administracija rute:

Oraal gebruik

Područje terapije:

Ibuprofen

Proizvod sažetak:

Hulpstoffen: AMMONIA (E 527); CELLULOSE, MICROKRISTALLIJN (E 460); CROSPOVIDON (E 1202); IJZEROXIDE ZWART (E 172); MACROGOL 3350; MAGNESIUMSTEARAAT (E 470b); POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203); POVIDON K 30 (E 1201); PROPYLEENGLYCOL (E 1520); SCHELLAK GLAZE, GEDEELTELIJK VERESTERD; SILICIUMDIOXIDE (E 551); TALK (E 553 B); TITAANDIOXIDE (E 171); ZWARTE INKT;

Datum autorizacije:

2013-09-09

Uputa o lijeku

28
PACKAGE LEAFLET: INFORMATION FOR THE USER
IBUPROFEN (ALS LYSINE) MYLAN 200 MG, FILMOMHULDE TABLETTEN
IBUPROFEN (ALS LYSINE) MYLAN 400 MG, FILMOMHULDE TABLETTEN
Ibuprofen (as lysine)
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. See section 4.
- If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not
listed in this leaflet.
WHAT IS IN THIS LEAFLET:
1. What Ibuprofen (als lysine) Mylan is and what it is used for.
2. What you need to know before you take Ibuprofen (als lysine) Mylan.
3. How to take Ibuprofen (als lysine) Mylan.
4. Possible side effects.
5. How to store Ibuprofen (als lysine) Mylan.
6. Contents of the pack and other information.
1. WHAT IBUPROFEN (ALS LYSINE) MYLAN IS AND WHAT IT IS USED FOR
Ibuprofen (als lysine) Mylan 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 painand high temperature.
Ibuprofen (als lysine) Mylan tablets are used for the symptomatic
treatment of mild to moderate pain, such as
headache, acute migraine with or without aura, dental pain, period
pain and fever and pain as the result of a
cold.
Ibuprofen (als lysine) Mylan tablets are also 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 DO YOU NEED TO KNOW BEFORE YOU TAKE IBUPROFEN (ALS LYSINE)
MYLAN
DO NOT TAKE IBUPROFEN (ALS LYSINE) MYLAN :

if you are allergic to ibuprofen or any other ingredien

Svojstava lijeka

1
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Ibuprofen (als lysine) Mylan 200 mg, filmomhulde tabletten
Ibuprofen (als lysine) Mylan 400 mg, filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 200 mg of ibuprofen (as lysine)
Each tablet contains 400 mg of ibuprofen (as lysine)
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
White to off-white, film-coated, round, biconvex, bevelled edge tablet
imprinted with “M” over “IL1” in
black ink on one side of the tablet and blank on the other side.
Dimension: 10.5mm ± 0.3mm.
White to off-white, film-coated, oval, biconvex, bevelled edge tablet
imprinted with “M IL2” in black ink on
one side of the tablet and blank on the other side
Dimension: 17.9mm ± 0.3mm x 9.2mm ± 0.3mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
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.
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
Adults and adolescents ≥ 40 kg body weight (12 years of age and
above):
_ _
_[200 mg only] _
Initial dose: 200 mg or 400 mg. If necessary, an additional dose of 1
to 2 tablets (200 mg to 400 mg) may be
taken. The corresponding dosing interval should be chosen based on the
symptoms and the recommended
daily maximum dose. It should not be less than 6 hours for a 400 mg
dose, and not less than 4 hours for a
200 mg dose. Do not exceed 1200 mg dose in any 24 hour period.
_[400 mg only] _
Initial dose: 400 mg. If necessary, an additional dose of 400 mg may
be taken. The corresponding dosing
interval should be chosen based on the symptoms and the recommended
daily maximum dose. It should not
be less than