Clindamycin 300 mg Capsules

Страна: Ирландия

Език: английски

Източник: HPRA (Health Products Regulatory Authority)

Активна съставка:

Clindamycin hydrochloride

Предлага се от:

Chanelle Medical

АТС код:

D10AF; D10AF01; G01AA; G01AA10; J01F

INN (Международно Name):

Clindamycin hydrochloride

дозиране:

300 milligram(s)

Лекарствена форма:

Capsule, hard

Вид предписание :

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

Терапевтична област:

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

Статус Оторизация:

Marketed

Дата Оторизация:

2009-05-15

Листовка

Page 1 of 5
PACKAGE LEAFLET: INFORMATION FOR THE USER
CLINDAMYCIN 300 MG CAPSULES
Clindamycin (as 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 pharmacist.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even
if their symptoms are the same as yours.
•
If you get any of the side effects, talk to your doctor or pharmacist.
This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Clindamycin 300 mg Capsules are and what they are used for
2.
What you need to know before you take Clindamycin 300 mg Capsules
3.
How to take Clindamycin 300 mg Capsules
4.
Possible side effects
5.
How to store Clindamycin 300 mg Capsules
6.
Contents of the pack and other information
1.
WHAT CLINDAMYCIN 300 MG CAPSULES ARE AND WHAT THEY ARE USED FOR
This medicine contains Clindamycin hydrochloride which is an
antibiotic used to fight certain pathogens. It
belongs to the group of lincosamides. Clindamycin 300 mg Capsules are
used in cases of serious bacterial
infections of the nose, throat, ears, airways, skin, skeleton, joints,
sexual organs and digestive system.
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 300 MG CAPSULES
DO NOT TAKE CLINDAMYCIN 300 MG CAPSULES:
•
if you are allergic to clindamycin or lincomycin which is a very
similar antibiotic
•
if you are allergic to any of the other ingredients of Clindamycin 300
mg Capsules (listed in
section 6).
WARNING AND PRECAUTIONS
TAKE SPECIAL CARE WITH CLINDAMYCIN 300 MG
CAPSULES AND CONSULT YOUR DOCTOR:
Tell your doctor if you have any of the following conditions, to help
him or her decide if Clindamycin 300
mg Capsules are suitable for you:
Talk to your doctor or pharmacist before taking Clindam

Данни за продукта

Health Products Regulatory Authority
27 October 2021
CRN00CKV3
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Clindamycin 300 mg Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains clindamycin hydrochloride equivalent to 300 mg
clindamycin.
Excipient(s) with known effect:
Each capsule contains lactose monohydrate 228.57mg (approximately).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsule, hard.
Powder blue capsule.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Clindamycin is indicated for the treatment of patients with serious
infections caused by susceptible micro-organisms,
particularly in recurrent infections, and not responding to first line
antibiotics, and as an alternative treatment in the case of
penicillin-allergic patients with infections caused by Gram-positive
aerobic bacteria. It is also indicated in serious infections
caused by susceptible anaerobic pathogens (see section 5.1).
- Pneumonia
- Chronic sinusitis due to anaerobic bacteria
- Tonsillitis
- Skin and soft tissue infections
- Bone and joint infections e.g. osteomyelitis and septic arthritis
- Female pelvic and genital infections such as endometritis, pelvic
cellulitis, paravaginal infections, tubo ovarian abscesses and
salpingitis. Should be treated in combination with an antibiotic
effective against Gram-negative aerobic bacteria
- Intra-abdominal infections including peritonitis and abdominal
abscess. Should be treated in combination with an antibiotic
effective against Gram-negative aerobic bacteria.
As for all antibiotics, in vitro sensitivity tests must be performed
in serious infections.
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults, adolescents over 12 years of age and the elderly:_
The usual dose is 150 – 450 mg every six hours depending on the
severity of the infection. For dosing below 300 mg other
presentations of clindamycin are