Ibuprofen (als lysine) HTP 400 mg, filmomhulde tabletten

Country: Նիդերլանդեր

language: հոլանդերեն

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

active_ingredient:

IBUPROFEN-(L)-LYSINE 684 mg/stuk SAMENSTELLING overeenkomend met ; IBUPROFEN 400 mg/stuk

INN:

IBUPROFEN-(L)-LYSINE 684 mg/stuk SAMENSTELLING overeenkomend met ; IBUPROFEN 400 mg/stuk

pharmaceutical_form:

Filmomhulde tablet

composition:

CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; COPOVIDON (E 1208) ; CROSPOVIDON (E 1202) ; MACROGOL 4000 ; MAGNESIUMSTEARAAT (E 470b) ; POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171), CELLULOSE, MICROKRISTALLIJN (E 460) ; COPOVIDON ; CROSPOVIDON (E 1202) ; MACROGOL 4000 ; MAGNESIUMSTEARAAT (E 470b) ; POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171)

administration_route:

Oraal gebruik

authorization_date:

1900-01-01

PIL

Healthypharm B.V., Breda, The Netherlands
MODULE 1
Administrative information
and prescribing information
_ _
_IBUPROFEN (ALS LYSINE) HTP 200 MG, filmomhulde tabletten _
_IBUPROFEN (ALS LYSINE) HTP 400 MG, filmomhulde tabletten_
_DE/H/6954/DC _
_RVG 127748 _
_RVG 127750_
ibuprofen lysine (342/ 684 mg)
1.3.1.3 PACKAGE LEAFLET
1.3.1.3 / 1 VAN 12
Department of
Regulatory Affairs
DATE: 2023-12
AUTHORISATION
CASE MANAGER:
LvR
REV. 3.0
APPROVED MEB
PACKAGE LEAFLET: INFORMATION FOR THE USER
IBUPROFEN (ALS LYSINE) HTP 200 MG, FILMOMHULDE TABLETTEN
IBUPROFEN (ALS LYSINE) HTP 400 MG, FILMOMHULDE TABLETTEN
Ibuprofen (as ibuprofen lysine)
For use in adults and adolescents from 40 kg (12 years and above).
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
contact a doctor if your
symptoms worsen or do not improve
-
after 3 days in adolescents.
-
after 3 days if you have fever and 4 days for the treatment of pain in
adults .
WHAT IS IN THIS LEAFLET
1.
What [Product name] is and what it is used for
2.
What you need to know before you take [Product name]
3.
How to take [Product name]
4.
Possible side effects
5.
How to store [Product name]
6.
Contents of the pack and other information
1. WHAT [PRODUCT NAME] IS AND WHAT IT IS USED FOR
[Product name] contains the active substance ibuprofen. Ibuprofen
belongs to a group of
medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs). These
medicines provide
relief by changing the body’s response to pain and high temperature.
[Product name] is indicated in short-term symptomatic treatment of
mild to moderate pain, such
as headache, to

SPC

Healthypharm B.V., Breda, The Netherlands
MODULE 1
Administrative information
and prescribing information
_ _
_IBUPROFEN (ALS LYSINE) HTP 200 MG, filmomhulde tabletten _
_IBUPROFEN (ALS LYSINE) HTP 400 MG, filmomhulde tabletten_
_DE/H/6954/DC _
_RVG 127748 _
_RVG 127750_
ibuprofen lysine (342/ 684 mg)
1.3.1.1 SUMMARY OF PRODUCT CHARACTERISTICS
1.3.1.1 / 1 VAN 14
Department of
Regulatory Affairs
DATE: 2023-12
AUTHORISATION
CASE MANAGER:
LvR
REV. 3.0
APPROVED MEB
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Ibuprofen (als lysine) HTP 200 mg, filmomhulde tabletten
Ibuprofen (als lysine) HTP 400 mg, filmomhulde tabletten
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
200 mg
Each film-coated tablet contains ibuprofen 200 mg (as 342 mg ibuprofen
lysine).
400 mg
Each film-coated tablet contains ibuprofen 400 mg (as 684 mg ibuprofen
lysine).
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablets
200 mg
Pale red, round, biconvex, film coated tablets, plain on both sides
with diameter of nucleus
11 mm.
400 mg
White to almost white, capsule shape, biconvex film-coated tablets,
plain on both sides, with
dimensions of nucleus 19x10 mm.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
is indicated in short-term symptomatic treatment of
mild to moderate pain
such as headache, dental pain and menstrual pain and/or fever.
is indicated in adults and adolescents from 40 kg body
weight (12 years of
age and above).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Undesirable effects may be minimised by using the lowest effective
dose for the shortest
duration necessary to control symptoms (see section 4.4).
Posology
200 mg
_Adults and adolescents from 40 kg body weight (12 years of age and
above)_
The initial dose is 200 to 400 mg, and then, if necessary, the dose
may be repeated every
6 hours.
The maximal daily dose of 1 200 mg (6 tablets) should not be exceeded
in any 24 hour