Chloramphenicol 250mg capsules

Land: Storbritannien

Sprog: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv bestanddel:

Chloramphenicol

Tilgængelig fra:

Sussex Pharmaceutical Ltd

ATC-kode:

J01BA01

INN (International Name):

Chloramphenicol

Dosering:

250mg

Lægemiddelform:

Oral capsule

Indgivelsesvej:

Oral

Klasse:

No Controlled Drug Status

Recept type:

Valid as a prescribable product

Produkt oversigt:

BNF: 05010700

Indlægsseddel

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Package leaflet: Information for the patient
Chloramphenicol
Capsules BP 250 mg
WHAT IS IN THIS LEAFLET:
1. WHAT CHLORAMPHENICOL CAPSULES ARE
AND WHAT THEY ARE USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU
TAKE CHLORAMPHENICOL CAPSULES
3. HOW TO TAKE CHLORAMPHENICOL
CAPSULES
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE CHLORAMPHENICOL
CAPSULES
6. CONTENTS OF THE PACK AND OTHER
INFORMATION
1. WHAT CHLORAMPHENICOL CAPSULES
ARE AND WHAT THEY ARE USED FOR
Chloramphenicol capsules contain
chloramphenicol which is an antibiotic for
specific uses.
They are used for treatment of typhoid fever
and other dangerous infections where other
antibiotics are not effective.
2. WHAT YOU NEED TO KNOW BEFORE
YOU TAKE CHLORAMPHENICOL
CAPSULES
DO NOT TAKE CHLORAMPHENICOL CAPSULES:
• if you are allergic to chloramphenicol or
any of the other ingredients (listed in
section 6)
• if you have recently been vaccinated
• if you have porphyria (a metabolism
disorder which causes abdominal pains
and mental disorder)
• if you have a minor infection
• if you are taking medicines that may
suppress your bone marrow
• if you are pregnant or breast-feeding.
If any of the above apply to you, speak to
your doctor or pharmacist.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before
taking Chloramphenicol capsules
• if you have liver or kidney problems
• if you are elderly
• if you are taking any of the medicines
listed in the next section “Other medicines
and Chloramphenicol capsules”.
CHILDREN
Do not give this medicine to children
because it is unlikely to be safe.
OTHER MEDICINES AND CHLORAMPHENICOL
CAPSULES
Tell your doctor or pharmacist if you are
taking, have recently taken or might take
any other medicines.
Some medicines may be affected by
chloramphenicol or they may affect how
well chloramphenicol will work.
Tell your doctor or pharmacist if you are
taking:
• paracetamol
• medicines that thin the blood (e.g.
warfarin)
• antidiabetics (sulphonylureas such

Produktets egenskaber

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Chloramphenicol 250 mg Capsules
Cafcol
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 250 mg of Chloramphenicol BP
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Capsule
White, opaque gelatine capsules
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
To be reserved for the treatment of life-threatening infections,
particularly those
caused by Haemophilus influenza, and typhoid fever, where other
antibiotics will not
suffice.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology:
_Adults (including the elderly): _
The usual dose is 500 mg every 6 hours (50 mg/kg bodyweight daily in 4
divided
doses)
and
treatment
should
be
continued
for
2
or
3
days
after
the
patient's
temperature has returned to normal. For severe infections (meningitis,
septicaemia)
this dose may be doubled initially, but it must be reduced as soon as
clinically
practical.
_Children: _
Not recommended
Method of administration
: Oral
4.3
CONTRAINDICATIONS
Chloramphenicol is contra-indicated in:
•
individuals with a history of hypersensitivity or toxic reaction to
chloramphenicol
or to any of the excipients listed in section 6.1
•
prophylaxis or treatment of minor infections
•
active immunisation
•
porphyria patients
•
blood dyscrasias including aplastic anaemia
•
patients taking drugs liable to depress bone marrow function (see
section 4.5)
•
breast-feeding
mothers
and
during
pregnancy
or
labour,
due
to
a
risk
of
foetal/infant damage (Grey Baby syndrome)
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Dose reduction and plasma level monitoring may be required in patients
with hepatic
or
renal
impairment;
in
the
elderly;
and
in
patients
concurrently
treated
with
interacting drugs, see section 4.5
Determine
routine
blood
profile
before
therapy
and
repeat
blood
studies
at
appropriate intervals, especially during prolonged or repeated
therapy. The drug
should be withdrawn if evidence of a significant detrimental effect is
seen or
depr