Ibuprofen (als lysine) Mylan OTC 400 mg, filmomhulde tabletten

Krajina: Holandsko

Jazyk: holandčina

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

Aktívna zložka:

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

Dostupné z:

Mylan B.V. Dieselweg 25 3752 LB BUNSCHOTEN

ATC kód:

M01AE01

INN (Medzinárodný Name):

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

Forma lieku:

Filmomhulde tablet

Zloženie:

AMMONIA (E 527) ; CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; 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, 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,

Spôsob podávania:

Oraal gebruik

Terapeutické oblasti:

Ibuprofen

Prehľad produktov:

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;

Dátum Autorizácia:

2013-09-09

Príbalový leták

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PACKAGE LEAFLET
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PACKAGE LEAFLET: INFORMATION FOR THE USER
IBUPROFEN (ALS LYSINE) MYLAN OTC 200 MG
FILM-COATED TABLETS
IBUPROFEN (ALS LYSINE) MYLAN OTC 400 MG
FILM-COATED TABLETS
Ibuprofen (as lysine)
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 in the case of fever or
after 4 days for the treatment of pain.
WHAT IS IN THIS LEAFLET:
1. What Ibuprofen (als lysine) Mylan OTC is and what it is used for.
2. What you need to know before you take
Ibuprofen (als lysine) Mylan OTC.
3. How to take Ibuprofen (als lysine) Mylan OTC.
4. Possible side effects.
5. How to store Ibuprofen (als lysine) Mylan OTC.
6. Contents of the pack and other information.
1. WHAT IBUPROFEN (ALS LYSINE) MYLAN OTC IS AND WHAT IT IS USED FOR
Ibuprofen (als lysine) Mylan OTC 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.
_ _
Ibuprofen (als lysine) Mylan OTC tablets are used for the symptomatic
treatment of mild to moderate pain,
such as headache, dental pain, period pain and fever and pain as the
result of a cold.
2. WHAT DO YOU NEED TO KNOW BEFORE YOU TAKE IBUPROFEN (ALS LYSINE)
MYLAN OTC
DO NOT TAKE IBUPROFEN (ALS LYSINE) MYLAN OTC :
•
if you are allergic to ibuprofen or any other ingredients of this
medicine (listed in section 6)
•
if you have had an allergic reaction such as asthma, difficulty in
breathing, swelling of the face,
tongue or

Súhrn charakteristických

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SUMMARY OF PRODUCT CHARACTERISTICS
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1.
NAME OF THE MEDICINAL PRODUCT
Ibuprofen (als lysine) Mylan OTC 200 mg, filmomhulde tabletten
Ibuprofen (als lysine) Mylan OTC 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
_ _
For the symptomatic treatment of mild to moderate pain, such as
headache, dental pain, period pain and fever
and pain in the common cold
.
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 6 hours for a 400 mg dose. Do not exceed 1200 mg dose in
any 24 hour period.
_Paediatric population _
_[200 mg only] _
Children over 6 years (20 kg – 40 kg body weight):
Ibuprofen should only be used in children with a body weight of at
least 20 kg.
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