APO-DOXYCYCLINE (as monohydrate) 50mg tablet blister pack

Valsts: Austrālija

Valoda: angļu

Klimata pārmaiņas: Department of Health (Therapeutic Goods Administration)

Aktīvā sastāvdaļa:

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

Pieejams no:

Apotex Pty Ltd

Zāļu forma:

Tablet, uncoated

Kompozīcija:

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

Ievadīšanas:

Oral

Vienības iepakojumā:

25 tablets

Receptes veids:

(S4) Prescription Only Medicine

Ārstēšanas norādes:

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). 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

Produktu pārskats:

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

Autorizācija statuss:

Registered

Autorizācija datums:

2001-05-25

Lietošanas instrukcija

APO-DOXYCYCLINE
TABLETS
_Doxycycline monohydrate_
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about doxycycline. It does
not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have benefits and
risks. Your doctor has weighed the
risks of you using 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 want to read it again.
WHAT THIS MEDICINE IS
USED FOR
Doxycycline is used to:
•
treat certain types of infections
•
control acne
•
prevent some forms of malaria.
Doxycycline belongs to a group of
medicines called tetracycline
antibiotics.
_HOW IT WORKS_
Doxycycline works by killing or
stopping the growth of bacteria
which cause infections or make acne
worse. It also works against parasites
that cause malaria. It will not work
against infections caused by viruses
such as colds or the flu.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed this
medicine for another reason.
This medicine is available only with
a doctor's prescription.
This medicine is not addictive.
This medicine should not be given to
children 8 years of age or under for
infections, or to children 10 years of
age or under for preventing malaria.
Doxycycline, like other tetracyclines,
may cause enamel loss and staining
in developing teeth or increase the
pressure on your child's brain.
BEFORE YOU TAKE THIS
MEDICINE
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE THIS MEDICINE IF YOU
HAVE AN ALLERGY TO:
•
doxycycline
•
other tetracyclines
•
any of the ingredients listed at the
end of this leaflet.
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue,
throa

Produkta apraksts

1
AUSTRALIAN PRODUCT INFORMATION
APO-DOXYCYCLINE (DOXYCYCLINE MONOHYDRATE)
TABLETS
1
NAME OF THE MEDICINE
Doxycycline monohydrate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 50 mg or 100 mg of doxycycline (as monohydrate),
as the active
ingredient.
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
50 MG TABLETS
Dull yellow, round, biconvex tablets.
100 MG TABLETS
Dull yellow, round, biplane tablets with a single sided score notch.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Infections caused by the following microorganisms:
•
_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.)
•
_Calymmatobacterium _(Donovania)_ granulomatis_ (granuloma inguinale).
And the following Gram-negative micro-organisms:
•
_Vibrio species_ (cholera);
•
_Brucella _species_ _(brucellosis (in conjunction with streptomycin));
•
_Yersinia pestis_ (plague);
•
_Francisella tularensis_ (tularemia);
•
_Bartonella bacilliformis_ (bartonellosis);
•
_Bacteroides _species_ _
When penicillin is contraindicated, doxycycline is an alternative drug
in the treatment of infections
2
due to:
•
_Treponema pallidum_ (syphilis);
•
_Treponema pertenue_ (yaws);
•
_Neisseria gonorrhoea_ (see section 4.2 DOSE AND METHOD OF
ADMINISTRATION)
Note:
Doxycycline is not the drug of choice in the treatment of any type of
staphylococcal infection or
infections
caused
by
_Streptococcus _
_pneumoniae_,
_Haemophilus _
_influenzae_,
_Streptococcus _
_pyogenes_, _Streptococ