Clindamycin 150mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Clindamycin hydrochloride

Available from:

Somex Pharma

ATC code:

J01FF01

INN (International Name):

Clindamycin hydrochloride

Dosage:

150mg

Pharmaceutical form:

Capsule

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 05010600; GTIN: 15060089611179 15060089611186

Patient Information leaflet

Package leaflet: Information for the patient
Clindamycin 75 mg Capsules, hard
Clindamycin 150 mg Capsules, hard
Clindamycin 300 mg Capsules, hard
Clindamycin
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 signs of illness are the same as yours.
-
If you get any 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 is and what it is used for
2.
What you need to know before you take Clindamycin
3.
How to take Clindamycin Capsules
4.
Possible side effects
5.
How to store Clindamycin Capsules
6.
Contents of the pack and other information
1. What Clindamycin is and what it is used for
Clindamycin Capsules contain clindamycin which is an antibiotic used in the treatment of
serious bacterial infections.
2. What you need to know before you take Clindamycin
Do not take Clindamycin Capsules:
•
if you are allergic to clindamycin, lincomycin or any of the other ingredients of this
medicine listed in section 6.
Warnings and precautions
Talk to your doctor or pharmacist before taking Clindamycin 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 severe or
prolonged or bloody diarrhoea during or after using Clindamycin Capsules
tell your
doctor immediately since it may be necessary to interrupt the treatment. This may be
a sign of bowel inflammation (pseudomembranous colitis) which can occur following
treatment with antibiotics.
•
you suffer from problems with your kidneys or liver.
•
you suffer from asthma, eczema or hayfever.
•
you develop any severe skin reactions or hypersens

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Clindamycin 150mg Capsules, hard
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Clindamycin 150mg Capsules, hard
Each capsule contains clindamycin hydrochloride equivalent to 150 mg clindamycin.
Excipient with known effect
Each capsule contains 114.65 mg lactose monohydrate equivalent to 108.92 mg of
lactose (see section 4.4).
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Capsule, hard.
Clindamycin 150mg Capsules, hard
Size ‘1’ hard gelatin white capsules with marking ‘I 62’ on cap.
4
CLINICAL PARTICULARS
4.1
Therapeutic indications
Antibacterial. Serious infections caused by susceptible Gram-positive organisms,
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.
Clindamycin does not penetrate the blood/brain barrier in therapeutically effective
quantities.
4.2
Posology and method of administration
Posology
Adults: Moderately severe infection, 150 - 300 mg every six hours; severe infection,
300 - 450 mg every six hours.
Elderly patients: The half-life, volume of distribution and clearance, and extent of
absorption after administration of clindamycin hydrochloride are not altered by
increased age. Analysis of data from clinical studies has not revealed any age-related
increase in toxicity. Dosage requirements in elderly patients, therefore, should not be
influenced by age alone.
Paediatric population: 3 - 6 mg/kg every six hours depending on the severity of the
infection.
Dosage in Renal/Hepatic Impairment: Clindamycin dosage modification is not
necessary in patients with renal or hepatic insufficiency.
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.
Method of administration
Oral. Clindamycin Ca