DOXYCYCLINE SANDOZ doxycycline (as monohydrate) 50mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

doxycycline monohydrate, Quantity: 52.05 mg (Equivalent: doxycycline, Qty 50 mg)

Available from:

Sandoz Pty Ltd

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: colloidal anhydrous silica; sodium starch glycollate; magnesium stearate; microcrystalline cellulose; hydrogenated castor oil; povidone

Administration route:

Oral

Units in package:

25 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Infections caused by the following micro-organisms: Mycoplasma pneumoniae (primary atypical pneumonia); Rickettsiae (Queensland tick typhus, epidemic typhus fever, Q fever, murine endemic typhus fever, Australo-Pacific endemic scrub typhus); Chlamydia psittaci (psittacosis); Chlamydia trachomatis (lymphogranuloma venereum, trachoma, inclusion conjunctivitis). (Doxycycline is indicated in the treatment of trachoma, although the infectious agent is not always elminated, as judged by immunofluorescence. Inclusion conjunctivitis may be treated with oral doxycycline, or in combination with topical agents.) Borreliae (relapsing fever); Calymmatobacterium (Donovania) granulomatis (granuloma inguinale). DOXYCYCLINE SANDOZ is indicated for the treatment of Anthrax due to Bacillus anthracis, including inhalational anthrax (post-exposure) to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis (see Dosage and Administration). Infections caused by the following Gram-negative micro-organisms: Vibrio sp. (cholera); Brucella sp. (brucellosis; in conjunction with streptomycin); Yersinia pestis (plague); Francisella tularensis (tularaemia); Bartonella bacilliformis (bartonellosis); Bacteriodes sp. When penicillin is contraindicated, doxycycline is an alternative medicine in the treatment of infections due to: Treponema pallidum (syphilis); Treponema pertenue (yaws); Neisseria gonorrhoea (see Dosage and Administration). Note: DOXYCYCLINE SANDOZ is not the medicine of choice in the treatment of any type of staphylococcal infection or infections caused by Streptococcus pneumoniae, Haemophilus influenzae, Streptococcus pyogenes, Streptococcus faecalis or any type of enteric bacteria because many strains of these organisms have been shown to be resistant to doxycycline. DOXYCYCLINE SANDOZ should not be used in these infections unless the organism has been shown to be sensitive. For upper respiratory infections due to group A beta-haemolytic streptococci (including prophylaxis of rheumatic fever), penicillin is the usual medicine of choice. In acute intestinal amoebiasis DOXYCYCLINE SANDOZ may be a useful adjunct to amoebicides. In severe acne doxycycline may be a useful adjunctive therapy. Doxycycline is indicated, in adults and children older than 10 years, as chemoprophylaxis for malaria caused by Plasmodium falciparum and, in combination with other antimalarial agents, against malaria caused by Plasmodium vivax. Doxycycline is only able to suppress malaria caused by Plasmodium vivax. As there are relatively few locations where P. vivax does not coexist to some extent with P. falciparum, it is recommended that doxycycline should be used routinely with other agents, for example chloroquine.

Product summary:

Visual Identification: Dull yellow, round, biconvex tablets.; Container Type: Blister Pack; Container Material: PP/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

1999-05-19

Patient Information leaflet

DOXYCYCLINE SANDOZ
®
1
DOXYCYCLINE SANDOZ
®
_doxycycline monohydrate tablets _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some common
questions about Doxycycline Sandoz.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking this medicine
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT DOXYCYCLINE
SANDOZ IS USED
FOR
This medicine is used to:
•
treat certain infections
•
control acne
•
prevent a form of malaria
•
treat anthrax infection or for use
after exposure to anthrax.
It contains the active ingredient
doxycycline.
Doxycycline belongs to a group of
medicines called tetracyclines.
It works by killing or stopping the
growth of bacteria which cause
infections or make acne worse. They
also work against parasites that cause
malaria.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
This medicine is available only with
a doctor's prescription.
BEFORE YOU TAKE
DOXYCYCLINE
SANDOZ
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE THIS MEDICINE IF YOU
HAVE AN ALLERGY TO:
•
doxycycline, the active
ingredient, or to any of the other
ingredients listed at the end of
this leaflet under Product
Description
•
any other similar medicines such
as tetracyclines.
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue
or other parts of the body
•
rash, itching or hives on the skin.
DO NOT TAKE THIS MEDICINE IF YOU
ARE TAKING PREPARATIONS CONTAINING
ISOTRETINOIN, ETRETINATE OR VITAMIN
A. ASK YOUR DOCTOR OR PHARMACIST
IF YOU ARE NOT SURE IF YOU ARE TAKING
ONE OF THESE MEDICINES.
DO NOT

Summary of Product characteristics

190731-Doxycycline Sandoz-pi
Page 1 of 12
AUSTRALIAN PRODUCT INFORMATION
DOXYCYCLINE SANDOZ
® (DOXYCYCLINE MONOHYDRATE) TABLETS
1
NAME OF THE MEDICINE
Doxycycline monohydrate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Doxycycline Sandoz 50 mg tablets contains 50 mg doxycycline (as
monohydrate).
Each Doxycycline Sandoz 100 mg tablets contains 100 mg doxycycline (as
monohydrate).
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Doxycycline Sandoz 50 mg tablets – dull yellow, round, biconvex
tablets.
Doxycycline Sandoz 100 mg tablets – dull yellow, round, biplane
tablets with a single-sided
score notch.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Infections caused by the following micro-organisms:
_Mycoplasma pneumoniae_
(primary
atypical pneumonia); Rickettsiae (Queensland tick typhus, epidemic
typhus fever, Q fever,
murine endemic typhus fever, Australo-Pacific endemic scrub typhus);
_Chlamydia psittaci_
(psittacosis);
_Chlamydia _
_trachomatis_
(lymphogranuloma
venereum,
trachoma,
inclusion
conjunctivitis).
(Doxycycline 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 doxycycline, or in combination with topical agents.)
Borreliae
(relapsing
fever);
_Calymmatobacterium _
_(Donovania)_
_granulomatis_
(granuloma
inguinale).
Doxycycline Sandoz is indicated for
_ _
the treatment of Anthrax due to
_Bacillus anthracis_
,
including inhalational anthrax (post-exposure) to reduce the incidence
or progression of disease
following exposure to aerosolized
_Bacillus anthracis _
(see Section 4.2 Dose and method of
administration).
_ _
Infections caused by the following Gram-negative micro-organisms:
_Vibrio_
sp. (cholera);
_Brucella_
sp.
(brucellosis;
in
conjunction
with
streptomycin);
_Yersinia _
_pestis_
(plague);
_Francisella tularensis_
(tularaemia);
_Bartonella bacilliformis_
(bartonellosis);
_Bacteroides_
sp.
When penicillin is cont