Colomycin 1.5million unit tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Colistin sulfate

Available from:

Forest Laboratories UK Ltd

ATC code:

A07AA10

INN (International Name):

Colistin sulfate

Dosage:

1500000unit

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 05010700

Patient Information leaflet

COLOMYCIN TABLETS 1,500,000 UNITS
COLISTIN SULPHATE
PACKAGE LEAFLET: INFORMATION FOR THE USER
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor.

This medicine has been prescribed for you. Do not pass it on to
others. It may
harm them, even if their symptoms are the same as yours.

If you notice and side effects, please tell your doctor.
IN THIS LEAFLET:
1. WHAT COLOMYCIN TABLETS ARE AND WHAT THEY ARE USED FOR
2. BEFORE YOU TAKE COLOMYCIN TABLETS
3. HOW TO TAKE COLOMYCIN TABLETS
4. SIDE EFFECTS
5. HOW TO STORE COLOMYCIN TABLETS
6. FURTHER INFORMATION
1. WHAT COLOMYCIN TABLETS ARE AND WHAT THEY ARE USED FOR
Colomycin is an antibiotic. It belongs to a group of antibiotics
called polymyxins.
Colomycin kills bacteria that cause infections of the gut. It is also
used for bowel
preparation before surgical operations as it will kill some bacteria
that may cause
infections after surgery.
2. BEFORE YOU TAKE COLOMYCIN TABLETS
DO NOT TAKE COLOMYCIN TABLETS:

If you are allergic to Colomycin (also known as colistin, colistin
sulphate or
colistimethate sodium) or any of the other ingredients of Colomycin
Tablets
(see Section 6 for ingredients)

If you are allergic to another antibiotic called polymyxin B,

If you have myasthenia gravis (a disease causing weakened muscles and
excessive tiredness)
TAKE SPECIAL CARE AND SPEAK TO YOUR DOCTOR BEFORE USING COLOMYCIN
TABLETS:

If you have porphyria (a rare, often inherited disorder),

If you have kidney problems.
USE IN CHILDREN:

Colomycin tablets are not suitable for children under 15kg in weight,
because
a suitable dose cannot be given from a 1,500,000 unit tablet.
TAKING OR USING OTHER MEDICINES
Contact your doctor before taking this medicine:

If you are taking other antibiotics

If you are taking the oral contraceptive pill as some antibiotics
reduce the
effectiveness of this pill

If you are likely to require an o

Summary of Product characteristics

COLOMYCIN TABLETS
Summary of Product Characteristics Updated 26-Jan-2012 | Forest
Laboratories UK Limited (a subsidiary
of Actavis PLC)
1. Name of the medicinal product
COLOMYCIN TABLETS
2. Qualitative and quantitative composition
Colistin Sulphate BP 1.5MU per tablet.
3. Pharmaceutical form
Tablet.
4. Clinical particulars
4.1 Therapeutic indications
For the treatment of gastrointestinal infections caused by sensitive
Gram negative organisms. Also for
bowel preparation.
Colistin sulphate is not absorbed from the gastrointestinal tract and
must not, therefore, be used for
systemic infections.
4.2 Posology and method of administration
To be taken orally.
Adults (including the elderly) (over 30kg):
1,500,000 to 3,000,000 units every 8 hours.
Children (15-30kg):
750,000 to 1,500,000 units every 8 hours.
Children (under 15kg):
Colomycin tablets are not suitable for children under 15kg, because an
appropriate dose cannot be
delivered from a 1,500,000 unit tablet presentation.
A minimum of five days treatment is recommended. Dosage may be
increased when clinical or
bacteriological response is slow.
For bowel preparation, a 24 hour course at the normal dosage above is
given. Treatment should preferably
finish 12 hours before surgery.
4.3 Contraindications
Contra-indicated in patients with known sensitivity to colistin and
those with myasthenia gravis.
4.4 Special warnings and precautions for use
Colistin is subject to limited and unpredictable absorption from the
GI tract in infants under six months.
Studies in older children and in adults have demonstrated no systemic
absorption of colistin following
oral administration.
Nevertheless, caution should be employed in the use of the preparation
in patients with renal failure,
patients receiving curari-form muscle relaxants and patients with
porphyria.
4.5 Interaction with other medicinal products and other forms of
interaction
Neurotoxicity has been reported in association with the concomitant
use of either curariform agents or
antibiotics with similar neurotoxic effects.
T