Minocycline Eurogenerics 50 mg filmomhulde tabletten

Држава: Холандија

Језик: Холандски

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

Активни састојак:

MINOCYCLINE HYDROCHLORIDE 2-WATER 57,93 mg/stuk SAMENSTELLING overeenkomend met ; MINOCYCLINE 50 mg/stuk

Доступно од:

Eurogenerics N.V. Heizel Esplanade b22 1020 BRUSSEL (BELGIË)

АТЦ код:

J01AA08

INN (Међународно име):

MINOCYCLINE HYDROCHLORIDE 2-WATER 57,93 mg/stuk SAMENSTELLING overeenkomend met ; MINOCYCLINE 50 mg/stuk

Фармацеутски облик:

Filmomhulde tablet

Састав:

CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE GEEL (E 172) ; LACTOSE 1-WATER ; MACROGOL 6000 ; MAGNESIUMSTEARAAT (E 470b) ; POVIDON K 25 (E 1201) ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171), CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE GEEL (E 172) ; LACTOSE 1-WATER ; MACROGOL 6000 ; MAGNESIUMSTEARAAT (E 470b) ; POVIDON K 25 (E 1201) ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171),

Пут администрације:

Oraal gebruik

Терапеутска област:

Minocycline

Резиме производа:

Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); CROSCARMELLOSE NATRIUM (E 468); HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464); IJZEROXIDE GEEL (E 172); LACTOSE 1-WATER; MACROGOL 6000; MAGNESIUMSTEARAAT (E 470b); POVIDON K 25 (E 1201); SILICIUMDIOXIDE (E 551); TITAANDIOXIDE (E 171);

Датум одобрења:

2012-11-01

Информативни летак

1/6
PACKAGE LEAFLET: INFORMATION FOR THE USER
MINOCYCLINE EUROGENERICS 50 MG FILMOMHULDE TABLETTEN
Minocycline
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.
WHAT IS IN THIS LEAFLET
1.
What Minocycline Eurogenerics is and what it is used for
2.
What you need to know before you take Minocycline Eurogenerics
3.
How to take Minocycline Eurogenerics
4.
Possible side effects
5.
How to store Minocycline Eurogenerics
6.
Contents of the pack and other information
1. WHAT MINOCYCLINE EUROGENERICS IS AND WHAT IT IS USED FOR
Minocycline is an antibiotic that is effective against a number of
bacteria types and belongs to the so-
called tetracyclines group.
Minocycline Eurogenerics 50 mg is used for the treatment of severe
acne with infections (a skin
condition).
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MINOCYCLINE EUROGENERICS
DO NOT TAKE MINOCYCLINE EUROGENERICS IF YOU:
•
are allergic to minocycline, to other tetracyclines or any of the
other ingredients of this medicine
(listed in section 6)
•
are pregnant or breast-feeding
•
suffer from severe liver function disorders
•
suffer from severe kidney disorders
Minocycline must not be administered to children under the age of 8
years.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Minocycline
Eurogenerics if you:
•
have reduced liver or kidney function
•
are sensitive to sunlight or artificial light (e.g. sunbeds)
•
suffer from a disease called Ménière.
During the treatment with Minocycline Eurogenerics, talk to your
doctor if any of the following
o

Карактеристике производа

Summary of Product Characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Minocycline Eurogenerics 50 mg filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains 57.93 mg minocycline hydrochloride dihydrate
equivalent to 50 mg minocycline base.
Excipient with known effect:
One tablet contains 10 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Minocycline Eurogenerics 50 mg film-coated tablets are light yellow,
round, biconvex tablets with a
smooth, mat surface with a diameter of approximately 7.1 mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Minocycline Eurogenerics 50 mg is used for severe inflammatory acne
vulgaris.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_ _
Posology
Initial and maintenance dosage: 50 mg every 12 hours. After reduction
of the inflammatory phase
maintenance dosage might be reduced to 50 mg once a day or 100 mg
every two days if justified by the
clinical effect. The acne treatment should last at least 4 to 6 weeks
and, preferably, it should not last
longer than 6 months (see section 4.4). Treatment should not be
continued if there is no sufficient response
during the first weeks.
Method of administration
Tablets should be swallowed with plenty of water to avoid oesophageal
irritation. Patients should not lie
down immediately after ingestion. Tablets may be taken during meals if
ingestion causes stomach
complaints. Absorption of minocycline is virtually not affected by
simultaneous consumption of milk (see
section 4.4).
4.3
CONTRAINDICATIONS
•
Hypersensitivity to the active substance, to tetracyclines or to any
of the excipients listed in section 6.1.
•
Severe liver impairment.
Summary of Product Characteristics
•
Pregnancy and lactation (see section 4.6).
•
Severe renal insufficiency.
As for all tetracyclines, minocycline should not be administered to
children under 8 years old (for children
aged between 8 and 12 years see section 4.4).
4.4
SPECIAL WA