TERRYWHITE CHEMISTS Clindamycin 150 mg Clindamycin (as hydrochloride) 150 mg capsules blister pack
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
24-08-2020
Summary of Product characteristics
(SPC)
24-08-2020
Public Assessment Report
(PAR)
26-11-2017
Active ingredient:
clindamycin hydrochloride
Available from:
Apotex Pty Ltd
INN (International Name):
clindamycin hydrochloride
Authorization status:
Registered
Patient Information leaflet
TERRY WHITE CHEMISTS
CLINDAMYCIN CAPSULES
_Contains the active ingredient Clindamycin hydrochloride_
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 this medicine. 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 THIS MEDICINE IS
USED FOR
Clindamycin is an antibiotic. It is
used to treat infections in different
parts of the body caused by bacteria.
It works by killing or stopping the
growth of the bacteria causing your
infection.
Clindamycin will not work against
viral infections such as colds or flu.
Clindamycin is recommended for
patients who are allergic to penicillin
or patients for whom penicillin is not
suitable.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY CLINDAMYCIN
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed
Clindamycin for another reason.
This medicine is available only with
a doctor's prescription.
Clindamycin capsules are not
recommended in children for
formulation reasons.
Clindamycin is not addictive.
BEFORE YOU TAKE THIS
MEDICINE
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE THIS MEDICINE IF YOU
HAVE AN ALLERGY TO:
•
any medicine containing
clindamycin or lincomycin
•
lactose or 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
or other parts of the body
•
rash, itching or hives on the skin
DO NOT TAKE THIS MEDICINE AFTER THE
EXPIRY DATE PRINTED ON THE PACK OR
IF THE PACKAGING IS TORN OR SHOWS
SIGNS OF TAMPERING.
If it has expi
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Summary of Product characteristics
1
AUSTRALIAN PRODUCT INFORMATION –TERRY WHITE
CHEMISTS CLINDAMYCIN CAPSULES (CLINDAMYCIN
HYDROCHLORIDE)
1
NAME OF THE MEDICINE
Clindamycin hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Clindamycin hydrochloride is white or almost white, crystalline
powder, very soluble in water,
slightly soluble in ethanol (96 per cent). It is a semi- synthetic
antibiotic produced by a 7(S)-
chloro-substitution of the 7(R)-hydroxyl group of the parent compound
lincomycin. The pKa
value is 7.6.
EXCIPIENTS WITH KNOWN EFFECT
Lactose monohydrate
For the full list of excipients, see Section 6.1 List of excipients
3
PHARMACEUTICAL FORM
The capsules consist of a white cap and white body imprinted with
‘Clin 150’. Each capsule
contains 150 mg of clindamycin hydrochloride as active ingredient.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Clindamycin hydrochloride capsules are indicated in the treatment of
serious infections caused
by susceptible anaerobic bacteria.
Clindamycin capsules are also indicated in the treatment of serious
infections due to
susceptible strains of streptococci, pneumococci and staphylococci.
Its use should be reserved for penicillin-allergic patients or other
patients for whom, in the
judgement of the physician, a penicillin is inappropriate.
ANAEROBES
Serious respiratory tract infections such as empyema, anaerobic
pneumonitis and lung
abscess; serious skin and skin structure infections; septicaemia;
intra-abdominal infections
such as peritonitis and intra-abdominal abscess (typically resulting
from anaerobic organisms
resident in the normal gastrointestinal tract); infections of the
female pelvis and genital tract
such as endometritis, non-gonococcal tubo-ovarian abscess, pelvic
cellulitis and post-surgical
vaginal cuff infection.
STREPTOCOCCI
Serious respiratory tract infections; serious skin and skin structure
infections, septicaemia.
STAPHYLOCOCCI
Serious respiratory tract infections; serious skin and skin structure
infections; septicaemia;
acute haematogenous osteomyelitis.
PNEUMOCOCCI
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