DOXSIG doxycycline 100mg (as hydrochloride) tablet bottle

国: オーストラリア

言語: 英語

ソース: Department of Health (Therapeutic Goods Administration)

即購入

ダウンロード 製品の特徴 (SPC)
07-12-2018
ダウンロード 公開評価報告書 (PAR)
13-05-2019

有効成分:

doxycycline

から入手可能:

Arrow Pharma Pty Ltd

認証ステータス:

Registered

情報リーフレット

                                DOXSIG- Consumer Medicine Information
Page 1 of 5
DOXSIG
®
TABLETS
_doxycycline hydrochloride_
_ _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some of the
common questions about DOXSIG
Tablets. 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 DOXSIG Tablets against the
benefits the medicine is expected to
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 DOXSIG TABLETS ARE
USED FOR
The name of your medicine is
DOXSIG. It contains the active
ingredient doxycycline (as
hydrochloride).
DOXSIG Tablets are an antibiotic used
to:
•
treat bacterial infections
•
control acne
•
prevent malaria
DOXSIG Tablets belong to a class of
medicines called tetracyclines.
These medicines work by killing or
stopping the growth of bacteria which
cause infections or make acne worse.
They also work against parasites which
cause malaria.
Tetracyclines will not work against
viral infections such as colds or the flu.
Your doctor may have prescribed this
medicine for another purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY DOXSIG
TABLETS HAVE BEEN PRESCRIBED FOR
YOU.
This medicine is only available with a
doctor’s prescription.
There is no evidence that DOXSIG
Tablets are addictive.
BEFORE YOU TAKE IT
_WHEN YOU MUST NOT TAKE IT _
_ _
DO NOT TAKE DOXSIG TABLETS IF:
1.
YOU HAVE EVER HAD AN ALLERGIC
REACTION TO:
•
medicines containing
doxycycline,
or doxycycline
hydrochloride.
•
medicines containing other
tetracyclines
•
any of the ingredients listed at the
end of this leaflet
Some of the symptoms of an allergic
reaction to tetracyclines may include:
rash, itching, or hives on the skin,
swelling of the face, lips and tongue
or other parts of the body, shortness of
breath, wheezing or troubled
breathing.
2.
YO
                                
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製品の特徴

                                AUSTRALIAN PRODUCT INFORMATION – DOXSIG (DOXYCYCLINE
HYDROCHLORIDE) TABLETS
1
NAME OF THE MEDICINE
Doxycycline hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Doxycycline is a broad spectrum antibiotic synthetically derived from
oxytetracycline.
DOXSIG
®
tablets contain doxycycline hydrochloride equivalent to 100 mg of
doxycycline per tablet.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
DOXSIG doxycycline 100 mg tablets: White film-coated, biconvex
tablets, with a breakline on one face.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC 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 alone, or in combination with topical agents.)
Borreliae (relapsing fever); Calymmatobacterium (Donovania)
granulomatis (granuloma inguinale).
Infections caused by the following Gram-negative microorganisms:
Vibrio sp. (cholera); Brucella sp.
(Brucellosis;
in
conjunction
with
streptomycin);
Yersinia
pestis
(plague);
Francisella
tularensis
(tularaemia); Bartonella bacilliformis (Bartonellosis); Bacteroides
sp. When penicillin is contraindicated,
doxycycline is an alternative drug in the treatment of infections due
to: Treponema pallidum (syphilis);
Treponema perenue (yaws); Neisseria gonorrhoea (see 4.2 DOSE AND
METHOD OF ADMINISTRATION).
2
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,
Streptococcus faecalis or any type of
                                
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