Doxat 100mg Film-coated Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

DOXYCYCLINE

Available from:

Delorbis Pharmaceuticals Limited 17 Athinon Str, Ergates Industrial Area, 2643 Ergates, PO Box 28629, 2081 Lefkosia, Cyprus

ATC code:

J01AA02

INN (International Name):

DOXYCYCLINE 100 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

DOXYCYCLINE 100 mg

Prescription type:

POM

Therapeutic area:

ANTIBACTERIALS FOR SYSTEMIC USE

Authorization status:

Authorised

Authorization date:

2006-11-28

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
DOXAT 100 MG FILM-COATED TABLETS
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 Doxat is and what it is used for
2.
What you need to know before you take Doxat
3.
How to take Doxat
4.
Possible side effects
5.
How to store Doxat
6.
Contents of the pack and other information
1. WHAT DOXAT IS AND WHAT IT IS USED FOR
Doxat contains the active substance doxycycline as doxycycline
hyclate. Doxat 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
•
Acne (a skin condition)
•
Eye infections
•
Sexually transmitted diseases e.g. gonorrhoea, syphilis, chlamydia
•
Fevers associated with louse or tick bites
•
Malaria, when chloroquine is not effective
Doxat 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 and leptospirosis (a
bacterial infection).
Your doctor may want you to take Doxat to treat another infection not
listed above. You may also be
prescribed an additional medicine to take with Doxat to treat your
infection. You must talk to your
doctor if you do not feel better or if you feel worse.
2
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DOXAT
DO NOT TA

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Doxat 100 mg Film-coated tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 100 mg of doxycycline as doxycycline
hyclate.
Excipient(s) with known effect: 174 mg of lactose per film-coated
tablet.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Yellow, oblong film-coated tablets scored on both sides.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Doxycycline 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 _
and other organisms.
_Mycoplasma pneumoniae_
. Treatment of chronic bronchitis, sinusitis.
_URINARY TRACT 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). Doxat is also indicated in chancroid, granuloma
inguinale and
lymphogranuloma venereum. Doxat is an alternative drug in the
treatment of gonorrhoea and
syphilis.
_SKIN INFECTIONS_
Acne vulgaris, when antibiotic therapy is considered necessary.
Since Doxat 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:
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_OPHTHALMIC INFECTIONS_
Due to susceptible strains of gonococci, staphylococci and
_ _
Haemophilus
influenzae. Trachoma, although the infectious agent, as judged by
immunofluorescence, is not
always eliminated. Inclusion conjunctivitis m