Clindamycin 150 mg Capsule

Pajjiż: Irlanda

Lingwa: Ingliż

Sors: HPRA (Health Products Regulatory Authority)

Ingredjent attiv:

Clindamycin

Disponibbli minn:

Chanelle Medical Unlimited Company

Kodiċi ATC:

D10AF; D10AF01; G01AA; G01AA10; J01F

INN (Isem Internazzjonali):

Clindamycin

Dożaġġ:

150 milligram(s)

Għamla farmaċewtika:

Capsule, hard

Tip ta 'preskrizzjoni:

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

Żona terapewtika:

Antiinfectives for treatment of acne; clindamycin; Antibiotics; clindamycin; MACROLIDES, LINCOSAMIDES AND STREPTOGRAMINS

L-istatus ta 'awtorizzazzjoni:

Not marketed

Data ta 'l-awtorizzazzjoni:

2008-07-04

Fuljett ta 'informazzjoni

ID: PIL 11M (IE MRP-IE)
Version: 18
Effective Date: 13/10/2022
Page 1 of 5
PACKAGE LEAFLET: INFORMATION FOR THE USER
CLINDAMYCIN 150 MG CAPSULES
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 Clindamycin 150 mg Capsules are and what they are used for
2.
What you need to know before you take before you take Clindamycin 150
mg Capsules
3.
How to take Clindamycin 150 mg Capsules
4.
Possible side effects
5.
How to store Clindamycin 150 mg Capsules
6.
Contents of the pack and other information
1.
WHAT CLINDAMYCIN 150 MG CAPSULES ARE AND WHAT THEY ARE 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 CLINDAMYCIN 150 MG CAPSULES
DO NOT TAKE CLINDAMYCIN 150 MG CAPSULES:
•
if you are allergic (hypersensitive) to clindamycin, lincomycin or to
any of the other ingredients of
Clindamycin 150 mg Capsules (listed in section 6).
•
if you are experiencing diarrhoea or suffer from intestinal
inflammatory disease.
WARNINGS AND PRECAUTIONS
Talk to you doctor, pharmacist or nurse before taking Clindamycin 150
mg Capsules:
•
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 Clindamycin 150 mg
Capsules stop taking the capsules

Karatteristiċi tal-prodott

Health Products Regulatory Authority
03 January 2023
CRN00D89M
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Clindamycin 150 mg Capsule
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains clindamycin hydrochloride equivalent to 150 mg
clindamycin.
Excipient(s) with known effect:
Each capsule contains 230 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsule, hard.
A capsule with a lavender body and maroon cap imprinted with CL 150 in
white.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
In the treatment of serious infections due to gram-positive organisms,
including staphylococci (both penicillinase and
non-penicillinase producing), streptococci (except _Streptococcus
faecalis_) and pneumococci. It is also indicated in serious
infections caused by susceptible anaerobic pathogens.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults (including the elderly):_
Moderately severe infection: 150 - 300 mg every six hours
_Note: _In cases of beta-haemolytic streptococcal infection, treatment
with Clindamycin Capsules should continue for at least 10
days to diminish the likelihood of subsequent rheumatic fever or
glomerulonephritis.
_Dosage in elderly_
The dosage of clindamycin may require reduction in patients with renal
impairment due to prolongation of the serum half-life
of this drug. This is particularly important with parenteral dosage.
_Pediatric population:_
Clindamycin should be dosed based on total body weight regardless of
obesity. The total daily dose should not exceed the
maximum recommended daily dose for adults.
_ _
The usual daily dosage is 12 - 24 mg/kg in 4 divided doses.
Clindamycin Capsules are not suitable for children who are unable to
swallow them whole. The use of whole capsules may not
be suitable to provide the exact mg/kg doses required for the
treatment of children.
_Dosage in Renal Impairment: _
Clindamycin dosage modification is not necessary in patients with
renal insufficiency.
Method o