DALACIN C CAPSULE 150MG

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:

24 Capsule Capsules; 100 Capsule Capsules; 16 Capsule Capsules

Dikeluarkan oleh:

Fareva Amboise

Risalah maklumat

Pfizer Confidential
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
DALACIN
®
C CAPSULE
Clindamycin hydrochloride (150 mg)
Pfizer Confidential
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
DALACIN
®
C CAPSULE
Clindamycin hydrochloride (150 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
to treat infections.
Dalacin C is also used in combination
with other antibiotics to prevent certain
types of abdominal infections.
HOW DALACIN C WORKS
Dalacin C works by killing or stopping
the growth of 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
and the nursing infant may get adverse
effects such as diarrhoea or blood in the
stool, or rash. Your doctor will decide if
you should take this medicine while
breastfeeding considering the benefits
and risks to you and your baby.
Ask your doctor or pharmacist for advice
before taking any medicine.

_Before you start to use it_
Tell your doctor if you have any of the
following conditions to help him or her
decide if Dalacin C is suitable for you:

you have diarrhoea or usually get
diarrhoea when you ta

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.

Clindamycin phosphate injectable formulation contains benzyl alcohol
as a preservative. Benzyl
alcohol has been associated with a fatal “Gasping Syndrome” in
premature infants. Its use should be
avoided in children under 2 years of age. Clindamycin is
contraindicated in newborns.
1.
NAME OF THE MEDICINAL PRODUCT
DALACIN C
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Ingredient: clindamycin hydrochloride or phosphate.
Clindamycin is a semisynthetic antibiotic produced by a
7(S)-chloro-substitution of the 7(R)-hydroxyl group
of the parent compound lincomycin.
_Capsules:_
Clindamycin hydrochloride is the hydrated hydrochloride salt of
clindamycin. Each capsule contains
clindamycin hydrochloride equivalent to 150 mg of clindamycin.
_Solution for injection:_
Clindamycin phosphate is a water-soluble ester of clindamycin and
phosphoric acid. Each mL contains the
equivalent of 150 mg clindamycin, 0.5 mg disodium edetate and 9.45 mg
benzyl alcohol added as preservative
in each mL.
3.
PHARMACEUTICAL FORM
_Capsules:_
Clindamycin HCl 150 mg capsule is a white capsule with “Clin 150”
and “Pfizer” marked on the capsule.
_Solution for injection:_
Clindamycin phosphate solution for injection is a clear colorless
sterile solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Clindamycin has been shown to be effective in the treatment of the
following infections when caused by
susceptible anaerobic bacteria; susceptible strains of gram positive
aerobic bacteria such as streptococci,
staphylococci and pneumococci; and susceptible strains of _Chlamydia
trachomatis_.
(a)
Upper respiratory infections including tonsillitis, pharyngitis,
sinusitis, otitis media and scarlet f