Dalacin C 150 mg Hard Capsules

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Clindamycin

Available from:

PCO Manufacturing Ltd.

ATC code:

D10AF; D10AF01

INN (International Name):

Clindamycin

Dosage:

150 milligram(s)

Pharmaceutical form:

Capsule, hard

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Antiinfectives for treatment of acne; clindamycin

Authorization status:

Authorised

Authorization date:

2007-10-05

Patient Information leaflet

_ _
_ _
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DALACIN C
® 150 MG HARD CAPSULES
clindamycin (as clindamycin hydrochloride)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU.
–
Keep this leaflet. You may need to read it again.
–
If you have any further questions, ask your doctor or your
pharmacist.
–
This medicine has been prescribed for you only. Do not
pass it on to others.
–
It may harm them, even if their signs of illness are the same
as yours.
–
If you get any side effects, talk to your doctor, pharmacist or
nurse. This includes any possible side effects not listed in
this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Dalacin is and what it is used for
2.
What you need to know before you take Dalacin
3.
How to take Dalacin
4.
Possible side effects
5.
How to store Dalacin
6.
Contents of the pack and other information
1.
WHAT DALACIN IS AND WHAT IT IS USED FOR
This medicine contains clindamycin hydrochloride which is an
antibiotic used in the treatment of serious bacterial infections.
You must talk to a doctor if you do not feel better or if you feel
worse.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE DALACIN
DO NOT TAKE DALACIN:

if you are allergic (hypersensitive) to clindamycin,
lincomycin, soya, peanuts or to any of the other ingredients
of this medicine (listed in section 6).

if you are experiencing diarrhoea or suffer from intestinal
inflammatory disease.
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before taking Dalacin:

if you have diarrhoea or usually get diarrhoea when you
take antibiotics or have ever suffered from problems with
your stomach or intestines.

if you develop diarrhoea during or after using Dalacin stop
taking the capsules and TELL YOUR DOCTOR IMMEDIATELY. This
may be a sign of bowel inflammation (_pseudomembranous _
_colitis_) which can occur even after 2 to 3 weeks following
treatment with antibiotics.

if you suffer from problems with your kidneys or

Summary of Product characteristics

Health Products Regulatory Authority
29 July 2020
CRN009VYG
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dalacin C 150 mg Hard Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains clindamycin hydrochloride equivalent to 150 mg
of clindamycin base.
Excipient(s)with known effect:
Lactose monohydrate
Medicinal product contains soya oil.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Hard capsule
_ _
_Product imported from Hungary, Poland, Czech Republic and Spain:_
Hard gelatin capsules with an opaque white body and an opaque white
cap, containing a white to off-white powder. The
capsule is imprinted with 'CLIN 150' and 'Pfizer'.
4 CLINICAL PARTICULARS
As per PA0822/120/001
5 PHARMACOLOGICAL PROPERTIES
As per PA0822/120/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
_Product imported from Hungary_
Lactose Monohydrate
Maize starch
Talc
Magnesium stearate
Capsules:
Gelatin
Black iron oxide (E172)
Titanium dioxide (E171)
_Product imported from Poland and the Czech Republic_
Lactose Monohydrate
Maize starch
Talc
Magnesium stearte
Capsules:
Gelatin
Titanium dioxide (E171)
_Product imported from Spain _
Lactose monohydrate
Health Products Regulatory Authority
29 July 2020
CRN009VYG
Page 2 of 2
Maize starch
Talc
Magnesium stearate
Capsules:
Gelatin
Erythrosine (E127)
Indigo carmine (E132)
Titanium dioxide (E171)
6.2 INCOMPATIBILITIES
Not applicable
6.3 SHELF LIFE
The shelf-life expiry date of this product shall be the date shown on
the container and outer package of the product on the
market in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Store below 25 °C. Store in the original package in order to protect
from moisture.
6.5 NATURE AND CONTENTS OF CONTAINER
Dalacin C 150 mg Hard Capsules are available in blister packs of 16 or
24 capsules
Not all pack sizes may be marketed.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
PCO Manufacturing Ltd.
Unit 1