Chloramphenicol 250mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Chloramphenicol

Available from:

Special Order

ATC code:

J01BA01

INN (International Name):

Chloramphenicol

Dosage:

250mg

Pharmaceutical form:

Oral capsule

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 05010700

Patient Information leaflet

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1. Tell your doctor, pharmacist or nearest
hospital casualty department immediately.
2. Take the container and any remaining
capsules with you so that people can see
what you have taken.
3. Do this even if you feel well.
If you forget to take
If you forget to take a dose take it as soon as
you remember, but if it is almost time for your
next dose, skip the missed dose and continue
as usual.
Do not take a double dose to make up for a
missed dose.
Tell the doctor if you miss a dose.
If you stop taking
Do not stop just because you feel better. If you
stop too soon, the infection may come back.
Keep taking your capsules until the prescribed
course is finished.
If you have any further questions on the use of
this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Chloramphenicol Capsules
can cause side effects, although not everybody
gets them. Do not be alarmed by this list of
possible side effects. You may not experience
any of them.
STOP taking the capsules and seek medical
help immediately if you have any of the
following allergic reactions:

difficulty breathing or swallowing, swelling
of the face, lips, tongue or throat

severe itching of the skin, with a red rash
or raised lumps

blistering of the mouth, eyes, or genital
region, patchy areas of rash, peeling skin.
Seek immediate medical attention if you have
any of the following symptoms:

drowsiness, feeling faint, sudden loss of
consciousness, shortness of breath,
nausea, vomiting

unusual or increased bleeding or bruising

fever, sore throat, mouth ulcers, repeated
infections or infections that will not go away

feeling tired, breathless, and looking pale

sudden loss or blurring of vision, loss of
colour vision, eye pain which worsens with
eye movement

ringing in the ears or temporary hearing
loss, head-spins (vertigo), dizziness.
Tell your doctor if you get any of the
following side effects:

inflamed, sore and swollen tongue, sore
mouth,

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