Dalacin C 150mg capsules

Pays: Royaume-Uni

Langue: anglais

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingrédients actifs:

Clindamycin hydrochloride

Disponible depuis:

Pfizer Ltd

Code ATC:

J01FF01

DCI (Dénomination commune internationale):

Clindamycin hydrochloride

Dosage:

150mg

forme pharmaceutique:

Oral capsule

Mode d'administration:

Oral

classe:

No Controlled Drug Status

Type d'ordonnance:

Valid as a prescribable product

Descriptif du produit:

BNF: 05010600; GTIN: 5012882005818 5013457025514

Notice patient

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.
Acute kidney disorders may occur. Please inform
your doctor about any medication you currently
take and if you have any existing problems with
your kidneys. If you experience dec

Résumé des caractéristiques du produit

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
Clindamycin should be dosed based on total body weight regardless of
obesity.
Doses of 12-25 mg/kg/day six hourly 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
contin