DALACIN C CAPSULES 300MG

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

CLINDAMYCIN HYDROCHLORIDE

Boleh didapati daripada:

PFIZER (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

CLINDAMYCIN HYDROCHLORIDE

Unit dalam pakej:

16 Tablet Tablets; 100 Tablet Tablets

Dikeluarkan oleh:

Fareva Amboise

Risalah maklumat

Pfizer confidential
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
DALACIN
®
C CAPSULES
Clindamycin hydrochloride (300 mg)
Pfizer confidential
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
DALACIN
®
C CAPSULES
Clindamycin hydrochloride (300 mg)
1
WHAT IS IN THIS LEAFLET
1. What Dalacin C is used for
2. How Dalacin C works
3. Before you use Dalacin C
4. How to use Dalacin C
5. While you are using it
6. Side effects
7. Storage and Disposal of Dalacin C
8. Product Description
9. Manufacturer and Product
Registration Holder
10. Date of Revision
11. Serial Number
WHAT DALACIN C IS USED FOR
Dalacin C contains clindamycin
hydrochloride, which is an antibiotic
used in the treatment of serious
bacterial infections. Its use should be
reserved for people who are allergic
to penicillin or for whom, in the
judgment of the physician, a
penicillin is inappropriate. It should
be used only when other less toxic
antibiotics are not effective.
HOW DALACIN C WORKS
Dalacin C works by killing or
stopping the growth of the bacteria
causing your infection.
BEFORE YOU USE DALACIN C

_When you must not use it_
Do not take Dalacin C if you are
allergic (hypersensitive) to
clindamycin, lincomycin or to any
of the other ingredients in this
medicine.
_Pregnancy and lactation_
If you are pregnant or think you
might be pregnant you should contact
your doctor before taking Dalacin C.
As clindamycin crosses the placenta,
Dalacin C capsules should be used in
pregnancy only if clearly needed
Tell your doctor if you will be breast-
feeding while taking Dalacin C.
Breast-feeding is not recommended
during administration of Dalacin C as
this medicine may be passed into
breast milk. Dalacin C has the
potential to cause serious side effects
to the nursing infant such as diarrhoea
or blood in the stool, or rash. If
Dalacin C is required, your doctor
may suggest you an alternate
medicine. Before taking the medicine,
discuss with your doctor regarding
the health benefits of nursing and the
potential side effects of Dalacin C on
the nursing child

Ciri produk

Pfizer Confidential
2
WARNING

Clindamycin therapy has been associated with severe colitis which may
end fatally.

It should be reserved for serious infections where less toxic
antimicrobial agents are
inappropriate.

It should not be used in patients with nonbacterial infections, such
as most upper respiratory
tract infections.

Its use in newborns is contraindicated.
1.
NAME OF THE MEDICINAL PRODUCT
DALACIN C
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Ingredient: clindamycin hydrochloride.
Clindamycin is a semisynthetic antibiotic produced by a
7(S)-chloro-substitution of the 7(R)-
hydroxyl group of the parent compound lincomycin.
Clindamycin hydrochloride is the hydrated hydrochloride salt of
clindamycin. Each capsule
contains clindamycin hydrochloride equivalent to 300 mg of
clindamycin.
3.
PHARMACEUTICAL FORM
Clindamycin HCl 300 mg capsule is a white hard gelatin capsule filled
with white powder marked
“Clin 300” and “Pfizer”.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Clindamycin is indicated in the treatment of serious infections caused
by susceptible anaerobic
bacteria.
Clindamycin is 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 judgment of the physician,
a penicillin is inappropriate.
Because of the risk of colitis, before selecting clindamycin the
physician should consider the
nature of the infection and the suitability of less toxic alternatives
(e.g., erythromycin).
ANAEROBES: Serious respiratory tract infections such as empyema,
anaerobic pneumonitis
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.
Pfizer Confidential