Clindamycin 150mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Clindamycin hydrochloride

Available from:

Kent Pharma (UK) Ltd

ATC code:

J01FF01

INN (International Name):

Clindamycin hydrochloride

Dosage:

150mg

Pharmaceutical form:

Oral capsule

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 05010600

Patient Information leaflet

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 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
Dalacin contains clindamycin hydrochloride
which is an antibiotic used in the treatment of
serious bacterial infections.
2. What you need to know before you
take Dalacin
Do not take Dalacin
If you are allergic (hypersensitive) to clindamycin,
lincomycin or to any of the other ingredients in
this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before using
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 severe or prolonged
or bloody diarrhoea during or after using
Dalacin 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
hypersensitivity to Dalacin.
Dalacin does not get into the brain and is
therefore not suitable for treating serious
infections in and around the brain. Your doctor
may need to give you another antibiotic if y

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Dalacin C Capsules 150 mg or Clindamycin Hydrochloride Capsules150 mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains clindamycin hydrochloride equivalent to 150 mg
clindamycin.
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Capsule
Hard capsule (white/white) with markings of ‘CLIN 150 and Pfizer’
on cap and body.
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: _
Clindamycin hydrochloride capsules should only be used for children
who are able to swallow
capsules
Doses of 12-25 mg/kg/day every six hours depending on the severity of
the infection.
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 /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 Dalacin C should
continue for at least 10 days to diminish the likelihood of subsequen