Topicil

Country: Նոր Զելանդիա

language: անգլերեն

source: Medsafe (Medicines Safety Authority)

active_ingredient:

Clindamycin hydrochloride 162.87mg equivalent to clindamycin 150 mg;  

MAH:

Douglas Pharmaceuticals Limited

INN:

Clindamycin hydrochloride 162.87 mg (equivalent to clindamycin 150 mg)

dosage:

150 mg

pharmaceutical_form:

Capsule

composition:

Active: Clindamycin hydrochloride 162.87mg equivalent to clindamycin 150 mg   Excipient: Gelatin Lactose monohydrate Magnesium stearate Maize starch Opacode black S-1-277002 Purified talc Titanium dioxide

units_in_package:

Blister pack, PVC/Alu, 24 capsules

class:

Prescription

prescription_type:

Prescription

manufactured_by:

Chongqing Carelife Pharmaceutical Co Ltd

therapeutic_indication:

Clindamycin hydrochloride has been shown to be effective in the treatment of the following infections when caused by susceptible anaerobic bacteria or susceptible strains of gram positive bacteria such as streptococci, staphylococci and pneumococci: · Upper respiratory infections including tonsillitis, pharyngitis, sinusitis, otitis media and scarlet fever. · Lower respiratory infections including bronchitis, pneumonia, emphysema and lung abscess. · Skin and soft tissue infections including acne, furuncles, cellulitis, impetigo, abscesses, and wound infections. For specific skin and soft tissue infections like erysipelas and paronychia (panaritium), it would seem logical that these conditions would respond very well to clindamycin therapy. · Bone and joint infections including osteomyelitis and septic arthritis. · Pelvic infections including endometritis, cellulitis, vaginal cuff infection tubo-ovarian abscesses salpingitis and pelvic inflammatory disease when given in conjunction with an antibiotic of appropriate gram negative aerobic spectrum. In cases of cervicitis due to Chlamydia trachomatis, mono therapy with clindamycin has been shown to be effective in eradicating the organism. · Intra-abdominal infections including peritonitis and abdominal abscess when given in conjunction with an antibiotic of appropriate gram negative aerobic spectrum. · Septicemia and endocarditis - the effectiveness of clindamycin in the treatment of selected cases of endocarditis has been documented when clindamycin is determined to be bactericidal to the infecting organism by in vitro testing of appropriate achievable serum concentrations. · Dental infections such as periodontal abscess and periodontitis. · As an alternative therapy when used in combination with quinine or amodiaquine for the treatment of multi-drug resistant Plasmodium falciparum infection.

leaflet_short:

Package - Contents - Shelf Life: Blister pack, PVC/Alu - 16 capsules - 24 months from date of manufacture stored at or below 25°C protect from light - Blister pack, PVC/Alu - 24 capsules - 24 months from date of manufacture stored at or below 25°C protect from light - Blister pack, PVC/Alu - 100 capsules - 24 months from date of manufacture stored at or below 25°C protect from light

authorization_date:

2013-02-27

PIL

CONSUMER MEDICINE INFORMATION
TOPICIL
_Clindamycin hydrochloride _
150 mg Capsule
WHAT IS IN THIS LEAFLET
PLEASE READ THIS LEAFLET CAREFULLY BEFORE YOU START
TAKING TOPICIL.
This
leaflet
answers
some
common
questions
about Topicil. 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 Topicil 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 TOPICIL IS USED FOR
Topicil contains clindamycin, which belongs to a
group of medicines called antibiotics. Antibiotics
are used to treat infections. Topicil is used to treat
bacterial infections in different parts of the body.
It works by killing or stopping the growth of the
bacteria causing your infection.
Your
doctor
may
have
prescribed
Topicil
for
another reason. ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY TOPICIL HAS BEEN PRESCRIBED
FOR YOU.
BEFORE YOU TAKE TOPICIL
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE TOPICIL IF YOU HAVE AN ALLERGY TO:
•
any
medicine
containing
clindamycin
or
lincomycin.
•
any of the ingredients listed at the end of this
leaflet.
Some of the symptoms of an allergic reaction may
include:
•
difficulty in breathing or wheezing
•
shortness of breath.
•
swelling of the face, tongue, lips, or other
parts of the body.
•
hives on the skin, rash, or itching.
DO NOT TAKE TOPICIL IF:
DO NOT TAKE IT AFTER THE EXPIRY DATE (EXP) PRINTED
ON THE BACK. If you take it after the expiry date has
passed, it may not work as well.
DO NOT TAKE IT IF THE PACKAGING IS TORN OR SHOWS
SIGNS OF TAMPERING.
IF YOU ARE NOT SURE WHETHER YOU SHOULD START
TAKING TOPICIL, TALK TO YOUR DOCTOR.
_BEFORE YOU START TO TAKE IT _
_ _
TELL YOUR DOCTOR IF:
1.
YOU HAVE ALLERGIES TO:
•
any other medicines.
•
any
other
substances,
such
as
foods,
preservatives or dye

SPC

1 | P a g e
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
Topicil 150 mg Capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Topicil Capsule contains clindamycin hydrochloride 162.87 mg
(equivalent to clindamycin
150 mg).
EXCIPIENT(S) WITH KNOWN EFFECT
Topicil Capsules contain lactose. For the full list of excipients, see
section 6.1.
3.
PHARMACEUTICAL FORM
Topicil Capsules are white/white hard gelatin capsules with a marking
of ‘CLIN 150’ on the capsule
body.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Clindamycin hydrochloride has been shown to be effective in the
treatment of the following
infections when caused by susceptible anaerobic bacteria or
susceptible strains of gram-positive
bacteria such as streptococci, staphylococci and pneumococci:
•
Upper respiratory infections including tonsillitis, pharyngitis,
sinusitis, otitis media and
scarlet fever.
•
Lower respiratory infections including bronchitis, pneumonia,
emphysema and lung
abscess.
•
Skin and soft tissue infections including acne, furuncles, cellulitis,
impetigo, abscesses, and
wound infections. For specific skin and soft tissue infections like
erysipelas and paronychia
(panaritium), it would seem logical that these conditions would
respond very well to
clindamycin therapy.
•
Bone and joint infections including osteomyelitis and septic
arthritis.
•
Pelvic infections including endometritis, cellulitis, vaginal cuff
infection, tubo-ovarian
abscesses, salpingitis and pelvic inflammatory disease when given in
conjunction with an
antibiotic of appropriate gram-negative aerobic spectrum. In cases of
cervicitis due to
_Chlamydia trachomatis_, monotherapy with clindamycin has been shown
to be effective in
eradicating the organism.
•
Intra-abdominal infections including peritonitis and abdominal abscess
when given in
conjunction with an antibiotic of appropriate gram-negative aerobic
spectrum.
2 | P a g e
•
Septicaemia and endocarditis - the effectiveness of clindamycin in the
treatment of
selected cases of endocarditis has been do