Minocycline Eurogenerics 100 mg filmomhulde tabletten

Χώρα: Ολλανδία

Γλώσσα: Ολλανδικά

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

Δραστική ουσία:

MINOCYCLINE HYDROCHLORIDE 2-WATER 115,85 mg/stuk SAMENSTELLING overeenkomend met ; MINOCYCLINE 100 mg/stuk

Διαθέσιμο από:

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

Φαρμακολογική κατηγορία (ATC):

J01AA08

INN (Διεθνής Όνομα):

MINOCYCLINE HYDROCHLORIDE 2-WATER 115,85 mg/stuk SAMENSTELLING overeenkomend met ; MINOCYCLINE 100 mg/stuk

Φαρμακοτεχνική μορφή:

Filmomhulde tablet

Σύνθεση:

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),

Οδός χορήγησης:

Oraal gebruik

Θεραπευτική περιοχή:

Minocycline

Περίληψη προϊόντος:

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);

Ημερομηνία της άδειας:

2012-11-01

Φύλλο οδηγιών χρήσης

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PACKAGE LEAFLET: INFORMATION FOR THE USER
MINOCYCLINE EUROGENERICS 100 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 100 mg is used to treat
-
certain types of bacterial infections of the airways and
gastro-intestinal tract
-
certain types of bacterial infections of the urinary tracts and
genitals
-
trachoma (a certain type of eye infection)
-
syphilis (a certain type of venereal disease), certain types of
chronic infection (actinomycosis)
and anthrax in patients who are hypersensitive to penicillin
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

Αρχείο Π.Χ.Π.

Summary of Product Characteristics
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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Minocycline Eurogenerics 100 mg filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains 115.85 mg minocycline hydrochloride dihydrate
equivalent to 100 mg minocycline
base.
Excipient with known effect:
One tablet contains 20 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Minocycline Eurogenerics 100 mg film-coated tablets are light yellow,
oblong-formed, biconvex tablets
with a smooth, mat surface (approximately 11.25 mm by 5.25 mm).
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Minocycline Eurogenerics 100 mg is used for treatment of
-
uncomplicated non-gonococcal urethritis
-
acute tracheobronchitis caused by Mycoplasma pneumonia
-
trachoma (ocular infection caused by
_Chlamydia trachomatis_
)
-
syphilis, actinomycosis or anthrax in patients allergic to penicillin.
See section 5.1 concerning micro-organisms that are susceptible to
minocycline.
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Usual dosages for most infections: _
Adults: a dose of 200 mg on the first day, followed by a daily dose of
100 mg. For severe infections the
dosage can be increased to 200 mg initially, followed by 100 mg every
12 hours.
_Paediatric population _
For children between 9 to 12 years old the usual initial dose is 4
mg/kg/day, followed by a dose of
2 mg/kg every 24 hours. Minocycline should not be prescribed to
children under 8 years old.
Summary of Product Characteristics
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Elderly: Clinical studies on minocycline hydrochloride contain an
insufficient number of patients of 65
and older to assess whether this age group’s reactions to treatment
differs from that of younger patients.
Caution is required when administering minocycline to elderly
patients. Treatment should be initiated at
the lowest possible dosage (