DALACIN C CAPSULES 150 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

CLINDAMYCIN HYDROCHLORIDE

Available from:

PFIZER PFE PHARMACEUTICALS ISRAEL LTD

ATC code:

J01FF01

Pharmaceutical form:

CAPSULES

Composition:

CLINDAMYCIN HYDROCHLORIDE 150 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

FAREVA AMBOISE, FRANCE

Therapeutic group:

CLINDAMYCIN

Therapeutic area:

CLINDAMYCIN

Therapeutic indications:

Treatment of infections caused by susceptible strains of anaerobic microorganisms.

Authorization date:

2021-05-31

Patient Information leaflet

Dalacin C capsules PIL CC 121023
2023-0088338
1
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
This medicine is dispensed with a doctor’s prescription only
DALACIN
® C CAPSULES 150 MG
DALACIN
® C CAPSULES 300 MG
CAPSULES
EACH CAPSULE CONTAINS:
Clindamycin hydrochloride 150 mg, 300 mg
Inactive ingredients and allergens: See section 2 under "Important
information about some of this medicine’s
ingredients" and section 6 “Further information”.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE. This
leaflet contains concise
information about this medicine. If you have any further questions,
consult your doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if it
seems to you that their medical condition is similar to yours.
1. WHAT IS THIS MEDICINE INTENDED FOR?
To treat infections caused by bacteria susceptible to clindamycin.
THERAPEUTIC GROUP:
Antibiotics from the lincosamide group.
2.
BEFORE USING THIS MEDICINE
DO NOT USE THIS MEDICINE IF:
you are sensitive (allergic) to clindamycin, lincomycin or any of the
other ingredients contained
in the medicine (see section 6).
SPECIAL WARNINGS REGARDING USE OF THE MEDICINE
BEFORE TREATMENT WITH DALACIN C CAPSULES, TELL YOUR DOCTOR IF:

you are suffering from diarrhea or generally suffer from diarrhea when
you take antibiotics, or if you
have ever suffered from gastric or intestinal problems.

you are suffering, or have suffered in the past, from impaired
function of the liver or kidneys.

you are suffering from atopy (eczema, allergic rhinitis, asthma).
ADDITIONAL WARNINGS REGARDING USE OF THE MEDICINE:

The use of the medicine, similarly to other antibiotics, may cause
diarrhea due to Clostridium
difficile infection (CDAD). Tell the doctor immediately if you develop
severe or prolonged diarrhea
during or after use of this medicine.

Prolonged use may also increase the risk of developing other
infections not responding to
treatment with

Summary of Product characteristics

Dalacin C Capsules LPD CC 121023
2023-0088338
1
DALACIN
® C CAPSULES 150 MG
DALACIN
® C CAPSULES 300MG
NAME OF THE MEDICINAL PRODUCT
Dalacin® C Capsules 150 mg
Dalacin® C Capsules 300 mg
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains clindamycin hydrochloride equivalent to 150mg or
300mg of
clindamycin.
Each capsule contains lactose.
For the full list of excipients, see section Description (8) in this
leaflet.
PHARMACEUTICAL FORM
Capsules.To reduce the development of drug-resistant bacteria and
maintain the
effectiveness of Dalacin C Capsules and other antibacterial drugs,
Dalacin C Capsules
should be used only to treat or prevent infections that are proven or
strongly suspected to
be caused by bacteria.
WARNING
_Clostridioides difficile_ associated diarrhea (CDAD) has been
reported with use of nearly
all antibacterial agents, including Dalacin C Capsules and may range
in severity from
mild diarrhea to fatal colitis. Treatment with antibacterial agents
alters the normal flora of
the colon, leading to overgrowth of _C. difficle._
Because Dalacin C Capsules 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, as described in the INDICATIONS AND USAGE
section. It
should not be used in patients with nonbacterial infections such as
most upper respiratory
tract infections.
_C. difficile_ produces toxins A and B, which contribute to the
development of CDAD.
Hypertoxin producing strains of _C. difficile_ cause increased
morbidity and mortality, as
these infections can be refractory to antimicrobial therapy and may
require colectomy.
CDAD must be considered in all patients who present with diarrhea
following antibiotic
use. Careful medical history is necessary since CDAD has been reported
to occur over
two months after the administration of antibacterial agents.
If CDAD is suspected or confirmed, ongoing antibiotic use not directed
against _C_.
_difficile_ may need to be discontinued.