Sunday, October 23, 2016

Colomycin Syrup and Tablets






COLOMYCIN SYRUP 250,000 units/5ml



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 Syrup and Tablets are and what they are used for
2. Before you take Colomycin Syrup or Tablets
3. How to take Colomycin Syrup or Tablets
4. Side Effects
5. How to store Colomycin Syrup and Tablets
6. Further information





What Colomycin Syrup And 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. Colomycin is available either as a syrup or in tablet form.




Before You Take Colomycin Syrup Or Tablets



Do not take Colomycin Syrup or Tablets:


  • If you are allergic to Colomycin (also known as colistin, colistin sulphate or colistimethate sodium) or any of the other ingredients of Colomycin Syrup or 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 Syrup:


  • If you have porphyria (a rare, often inherited disorder),

  • If you have kidney problems.



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 Syrup or Tablets if you are pregnant or breast-feeding. Ask your doctor for advice before taking any medicine.




Important information about some of the ingredients of Colomycin Syrup


Colomycin Syrup contains sodium methyl hydroxybenzoate (E219). This may cause allergic reactions (possibly delayed). If you notice anything unusual after taking Colomycin Syrup,consult your doctor.


Each 5ml spoonful of Colomycin Syrup contains 2.2g sucrose and this maybe important if you have diabetes mellitus or if you have been told by your doctor that you are intolerant to some sugars.


Each 5ml spoonful of Colomycin syrup also contains 0.2mmol (4mg) of sodium.


This should be taken into consideration by patients on a sodium controlled diet.


Colomycin tablets are sodium free.





How To Take Colomycin Syrup And Tablets


Colomycin Syrup is supplied as a powder. When dissolved in 58ml water, the powder will produce 80ml of syrup. Your pharmacist will dissolve the powder so that Colomycin Syrup is ready for you to use. Colomycin Syrup is taken by mouth using a 5ml medicine spoon supplied by the pharmacist. Shake the bottle well before each use.


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:



Children up to 15kg weight: One or two spoonfuls of syrup (5-10ml) every 8 hours.



Children between 15 and 30kg: half to 1 tablet or three to six spoonfuls of syrup (15ml-30ml) every 8 hours.



Adults, the elderly and children over 30kg: 1 or 2 tablets or six to twelve spoonfuls of syrup (30-60ml) every 8 hours.





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 Syrup or 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 use Colomycin Syrup or 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 Syrup or Tablets, ask your doctor.





Side Effects


Most people taking Colomycin Syrup or Tablets do not experience side effects.


It is possible that side effects may occur in young babies (below 6 months) but your doctor will be aware of this. If your baby is taking Colomycin Syrup monitor them carefully and if you notice anything unusual contact your doctor immediately. If you think that you are experiencing a side effect related to Colomycin Syrup or Tablets, contact your doctor or pharmacist.




How To Store Colomycin Syrup And Tablets


Keep out of the reach and sight of children.


Do not use Colomycin Syrup or Tablets after the expiry date printed on the container label.


Store in the original container to protect from light. Do not store above 25°C.


Discard any unused Colomycin Syrup 14 days after it has been dissolved in water. Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacy for safe disposal.




Further Information



What Colomycin Syrup and Tablets contain


The active substance is colistin sulphate. Colomycin Syrup contains 250,000 units colistin sulphate in every 5ml. Colomycin Tablets contain 1,500,000 units colistin sulphate per tablet.


The other ingredients of Colomycin Syrup are sucrose, benzoic acid (E210), sodium methyl hydroxybenzoate (E219) and sodium citrate.


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




What Colomycin Syrup and Tablets look like and contents of the pack


Colomycin Syrup is supplied as a powder in a bottle. When dissolved in 58ml water the powder produces 80ml of syrup.


Colomycin Tablets are supplied in containers of 50 tablets.




Marketing Authorisation holder and manufacturer



Forest Laboratories UK Limited

Riverbridge House

Anchor Boulevard

Crossways Business Park

Dartford

Kent
DA2 6SL



Manufacturer and site of batch release for Colomycin Tablets is



Penn Pharmaceutical Services

Tredegar

Gwent

NP22 3AA

UK



Manufacturer and site of batch release for Colomycin Syrup is:



Forest Laboratories UK Limited

Riverbridge House

Anchor Boulevard

Crossways Business Park

Dartford

Kent
DA2 6SL





This leaflet was last approved:



April 2010



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:



Product Name Reference Number


Colomycin Syrup 0108/5009R


Colomycin Tablets 0108/5008R



This is a service provided by the Royal National Institute for Blind People.






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