Ibuprofen Zentiva 400 mg Filmdragerad tablett

Država: Švedska

Jezik: švedščina

Source: Läkemedelsverket (Medical Products Agency)

Aktivna sestavina:

ibuprofen

Dostopno od:

Zentiva k.s.

Koda artikla:

M01AE01

INN (mednarodno ime):

ibuprofen

Odmerek:

400 mg

Farmacevtska oblika:

Filmdragerad tablett

Sestava:

ibuprofen 400 mg Aktiv substans

Tip zastaranja:

Receptbelagt

Povzetek izdelek:

Förpacknings: Blister, 40 tabletter; Blister, 10 tabletter; Blister, 100 tabletter; Blister, 12 tabletter; Blister, 20 tabletter; Blister, 24 tabletter; Blister, 250 tabletter; Blister, 30 tabletter; Blister, 36 tabletter; Blister, 48 tabletter; Blister, 50 tabletter

Status dovoljenje:

Godkänd

Datum dovoljenje:

2021-05-04

Lastnosti izdelka

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Ibuprofen Zentiva 400 mg film-coated tablets
Ibuprofen Zentiva 600 mg film-coated tablets
Ibuprofen Zentiva 800 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 400 mg film-coated tablet contains ibuprofen 400
mg.
Each 600 mg film-coated tablet contains ibuprofen 600
mg.
Each 800 mg film-coated tablet contains ibuprofen 800
mg.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
400 mg film-coated tablet: white to off-white rounded
film-coated tablets with
diameter 12 mm.
600 mg film-coated tablet: white to off-white oblong
(17 x 10 mm) film-coated
tablets.
800 mg film-coated tablet: light yellow to beige oblong
(20 x 10 mm) film-coated
tablets.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
[ 400 mg, 600 mg and 800 mg film-coated tablets]
Rheumatic conditions such as arthritic diseases (e.g. rheumatoid
arthritis including juvenile
rheumatoid arthritis), non-articular rheumatic conditions, other
muscular and joint disorders, and soft
tissue injuries.
400 mg and 600 mg is recommended for adults and
adolescents from 40 kg
bodyweight (over 12 years).
800 mg is recommended for adults only (see section
4.2).
[400 mg film-coated tablets]
In addition, 400 mg is intended for short-term
symptomatic treatment of mild to
moderate pain, migraine, primary dysmenorrhea and/or fever.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The treatment should start with the lowest dose anticipated to be
effective, which can subsequently be
adjusted, depending on the therapeutic response and any undesirable
effects.
The maximum single dose should not exceed 800 mg of ibuprofen for
adults and 600 mg of ibuprofen
for adolescents.
Undesirable effects may be minimised by using the lowest effective
dose for the shortest duration
necessary to con