COLOMYCIN®

Colomycin Tablets 1,500,000 units COLISTIN SULPHATE

PACKAGE LEAFLET: INFORMATION FOR THE USER

Read all of this leaflet carefully before you start taking 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 any 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 operation where muscle relaxing (curariform) drugs may be used

•    If you are taking sucralfate, a treatment for stomach ulcers Pregnancy and breast-feeding

Your doctor will not normally prescribe Colomycin Tablets if you are pregnant or breast-feeding. Ask your doctor for advice before taking any medicine.

3.    How to take Colomycin Tablets

Colomycin Tablets should be swallowed with a small amount of water, or they can be crushed and dissolved in a small amount of liquid before swallowing.

Dose

Your doctor will choose the dose suitable for you. Always follow the doctor's instructions.

For guidance typical doses are as follows:

FRONT

Duration of treatment

Your doctor will decide on the length of your course of treatment. Usually, for gut infections, it will be at least five days. For bowel preparation, you will be given a 24 hour course of treatment which should finish twelve hours before your operation/procedure.

If you use more Colomycin Tablets than you should

It is important to keep to the dose on the label of your medicine. In the event that you take too much, or if someone else takes your medicine, it is unlikely that there will be any side effects but take the bottle to your doctor and ask for advice. Alternatively, contact the accident and emergency department of your nearest hospital.

If you forget to take Colomycin Tablets

If the forgotten dose is just a few hours late, take it straight away. If it is nearly time for your next dose miss out the forgotten one. Do not take a double dose to make up for the missed dose.

If you have any further questions on the use of Colomycin Tablets, ask your doctor.

4.    Side Effects

Most people taking Colomycin Tablets do not experience side effects.

If you think that you are experiencing a side effect related to Colomycin Tablets, contact your doctor or pharmacist.

5.    How to Store Colomycin Tablets

Keep out of the sight and reach of children.

Do not use Colomycin Tablets after the expiry date printed on the container label. The expiry date refers to the last day of that month.

Store in the original container to protect from light. Do not store above 25°C. Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacy for safe disposal.

6.    Further Information

What Colomycin Tablets contain

The active substance is colistin sulphate. Colomycin Tablets contain 1,500,000 units colistin sulphate per tablet.

The other ingredients are microcrystalline cellulose, maize starch, colloidal silicon dioxide and hydrogenated castor oil. Colomycin Tablets are sodium free.

What Colomycin Tablets look like and contents of the pack

Colomycin Tablets are supplied in containers of 50 tablets.

The Marketing Authorisation holder is

Forest Laboratories UK Ltd, Dartford, Kent DA2 6SL, UK

The Manufacturer and site of batch release for Colomycin Tablets is

Penn Pharmaceutical Services Ltd, Tredegar, Gwent NP22 3Aa, UK

This leaflet was last revised in January 2012

Forest Laboratories

Other formats:

To listen to or to request a copy of this leaflet in Braille, large print or audio please call, free of charge:

0800 198 5000 (UK only)

Please be ready to give the following information:

This is a service provided by the Royal National Institute of Blind People. Patients in the Republic of Ireland with visual impairment requiring this information in other formats should telephone Forest Laboratories UK Ltd. +44 (0) 1322 421 800

H Forest

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