Dalacin C 150mg capsules

Pays: Royaume-Uni

Langue: anglais

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingrédients actifs:

Clindamycin hydrochloride

Disponible depuis:

Mawdsley-Brooks & Company 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

Notice patient

PACKAGE LEAFLET: INFORMATION FOR THE
USER
DALACIN® C 150MG 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
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.
The name of your medicine is Dalacin C 150mg Capsules, but
will be referred to as Dalacin throughout the remainder of the
leaflet.
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 r

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 ‘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 subsequent
rhe