Chloramphenicol 250mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Chloramphenicol

Available from:

Essential Generics Ltd

ATC code:

J01BA01

INN (International Name):

Chloramphenicol

Dosage:

250mg

Pharmaceutical form:

Oral capsule

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 05010700; GTIN: 5050204100223

Patient Information leaflet

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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

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Chloramphenicol Capsules BP 250mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 250 mg of chloramphenicol
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Hard capsules
Off-white, hard gelatin capsules
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Typhoid fever and life-threatening infections, particularly those
caused by Haemophilus
influenzae where other antibiotics will not suffice.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults and elderly
The normal dose is 50 mg/kg body weight daily in 4 divided doses. For
severe
infections (meningitis, septicaemia) this dose may be doubled
initially, but it must be
reduced as soon as clinically practical.
Paediatric population
The safety and efficacy of Chloramphenicol 250 mg Capsules BP have not
yet been
established in children.
Method of administration
For oral administration.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section
6.1.
Chloramphenicol is contra-indicated in prophylaxis or treatment of
minor infections;
during active immunisation; and in porphyria patients.
Chloramphenicol is contra-indicated in patients taking drugs liable to
depress bone
marrow function (see section 4.5).
Chloramphenicol must not be used in breast-feeding mothers and during
pregnancy or
labour, due to a risk of foetal/ infant damage (Gray Baby syndrome).
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Chloramphenicol should only be used if other treatments are
ineffective and its use
should always be carefully monitored.
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)._ _
Periodic blood testing should be conducted during prolonged or
repeated treatment.
Chloramphenicol should be discontinued if a significant detrimental
effect is seen.
This medicine contains le