Remycin Capsule 100mg

מדינה: מלטה

שפה: אנגלית

מקור: Medicines Authority

מרכיב פעיל:

DOXYCYCLINE

זמין מ:

Remedica Limited Limassol Industrial Estate, Aharnon Street, 3056 Limassol, Cyprus

קוד ATC:

J01AA02

INN (שם בינלאומי):

DOXYCYCLINE 100 mg

טופס פרצבטיות:

CAPSULE

הרכב:

DOXYCYCLINE 100 mg

סוג מרשם:

POM

איזור תרפויטי:

ANTIBACTERIALS FOR SYSTEMIC USE

מצב אישור:

Authorised

תאריך אישור:

2006-11-27

עלון מידע

Page 1 of 8
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
REMYCIN 100 MG HARD CAPSULES
Doxycycline
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 Remycin is and what it is used for
2.
What you need to know before you take Remycin
3.
How to take Remycin
4.
Possible side effects
5.
How to store Remycin
6.
Contents of the pack and other information
1.
WHAT REMYCIN IS AND WHAT IT IS USED FOR
This medicine contains doxycycline, which is an antibiotic belonging
to a group of
medicines called tetracyclines. It is used to treat many different
types of infections
including:
•
Chest, lung or nasal infections e.g. bronchitis, pneumonia, sinusitis.
•
Urinary tract infections (the passage through which urine passes) e.g.
cystitis,
urethritis.
•
Eye infections.
•
Sexually transmitted diseases e.g. gonorrhoea, syphilis, chlamydia.
•
Fevers associated with louse or tick bites.
•
Malaria, when chloroquine is not effective.
Remycin is also used to prevent certain infections developing, these
are scrub typhus
(a
disease
carried
by
small
insects),
Rocky
Mountain
spotted
fever,
travellers’
diarrhoea, malaria, cholera and leptospirosis (a bacterial infection
from contaminated
water).
Your doctor may want you to take Remycin to treat another infection
not listed above.
You may also be prescribed an additional medicine to take with Remycin
to treat your
infection. You must talk to your doctor if you do not feel better or
if you feel worse.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE REMYCIN
DO NOT TAKE REMYC

מאפייני מוצר

Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Remycin 100 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains doxycycline hyclate equivalent to 100 mg
doxycycline.
Excipient(s) with known effect
This product contains 102,3 mg lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsules.
Green / green capsules.
4.
CLINICAL PARTICULARS
_ _
4.1
THERAPEUTIC INDICATIONS
_ _
Remycin has been found clinically effective in the treatment of a
variety of infections
caused by susceptible strains of Gram-positive and Gram-negative
bacteria and certain
other micro- organisms.
_RESPIRATORY TRACT INFECTIONS:_
Pneumonia and other lower respiratory tract infections due to
susceptible strains of
_Streptococcus _
_pneumoniae, _
_Haemophilus _
_influenzae, _
_Klebsiella _
_pneumoniae, _
_Moraxella catarrhalis_
and other organisms.
_Mycoplasma pneumoniae_
. Treatment of
chronic bronchitis, sinusitis.
_ _
_URINARY TRACT INFECTIONS:_
Infections caused by susceptible strains of Klebsiella species,
Enterobacter species,
_Escherichia coli, Streptococcus faecalis_
and other organisms.
_ _
_SEXUALLY TRANSMITTED DISEASES:_
Infections
due
to
_Chlamydia_
_trachomatis_
including
uncomplicated
urethral,
endocervical or rectal infections. Non-gonococcal urethritis caused by
_Ureaplasma _
_urealyticum_
(T-mycoplasma).
Remycin
is
also
indicated
in
infections
due
to
_Calymmatobacterium granulomatis._
Remycin is an alternative drug in the treatment of
gonorrhoea and syphilis.
Page 2 of 12
Since Remycin is a member of the tetracycline series of antibiotics,
it may be expected
to be useful in the treatment of infections which respond to other
tetracyclines, such as:
_OPHTHALMIC INFECTIONS:_
Remycin is indicated in the treatment of trachoma, although the
infectious agent is not
always eliminated, as judged by immunofluorescence. Inclusion
conjunctivitis may be
treated with oral Remycin alone or in combination with topical agents.
_ _
_RICKETTSIAL IN