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Package leaflet: Information for the patient

Nivemycin soomg Tablets

Neomycin Sulphate

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

-    Keep this leaflet. You may need to read it again.

-    If you have any further questions, ask your doctor or pharmacist.

-    This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their sign of illness are the same as yours.

-    If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet

What is in this leaflet:

1.    What Nivemycin Tablets are and what they are used for

2.    What you need to know before you take Nivemycin Tablets

3.    How to take Nivemycin Tablets

4.    Possible side effects

5.    How to store Nivemycin Tablets

6.    Contents of the pack and other information

1.    What Nivemycin Tablets are and what they are used for

Nivemycin Tablets belong to a group of medicines called antibiotics.

Nivemycin Tablets are used to treat the bowel before an operation. They can also be used to treat a type of liver disease.

2.    What you need to know before you take Nivemycin Tablets

Do not take Nivemycin Tablets

•    If you are allergic to any of the aminoglycosides group of medicines (this group includes gentamicin, tobramycin, amikacin, netilmicin, kanamycin, streptomycin, as well as neomycin) or to any of the other ingredients of this medicine (listed in section 6) (allergic reactions include mild symptoms such as itching and/or rash. More severe symptoms include swelling of the face, lips, tongue and/or throat with difficulty in swallowing or breathing).

•    If you suffer from a progressive muscle weakness called Myasthenia gravis.

•    If you suffer from intestinal obstruction (blockage of the bowel).

Nivemycin tablets should not be given to infants under one year of age.

Warning and precautions

Talk to your doctor or pharmacist before taking Nivemycin Tablets:

•    If you are pregnant or planning to become pregnant, or you are breast-feeding.

•    If you suffer from Parkinson's disease or any condition characterised by muscular weakness.

•    If you suffer from impaired hearing.

•    If you suffer from liver or kidney disease.

•    If you suffer from hypotension (low blood pressure).

•    If you suffer from an infection or from fever.

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•    If you have received or you are going to receive a general anaesthetic.

•    If you work in an environment where you are exposed to loud noises, as this may affect your hearing.

•    If you have become dehydrated (e.g. due to diarrhoea and/or vomiting).

Tell your doctor if any of the above applies to you.

Your doctor may wish to monitor you, especially if you are receiving Nivemycin Tablets in high doses or over a long period, have kidney problems, are overweight or have cystic fibrosis, or if the patient is very young or elderly

Children

Nivemycin Tablets are not recommended for children under six years of age.

Nivemycin tablets should not be given to infants under one year of age.

Other medicines and Nivemycin Tablets

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, specially the following:

•    penicillin or any other antibiotics (such as vancomycin, teicoplanin, cephalosporins, polymyxin and other aminoglycosides); amphotericin (antifungal drug); Capreomycin (used to treat tuberculosis);

•    opioid painkillers;

•    oral contraceptives (the “pill” or “mini-pill”);

•    anti-coagulant drugs (used to thin the blood) and digoxin (a treatment for heart disease);

•    any of the group of medicines known as neuromuscular blockers (sometimes called muscle relaxants);

•    vitamins (absorption of the vitamins may be impaired);

•    methotrexate (used for rheumatoid arthritis, psoriasis and certain types of cancer);

•    ciclosporin (used for rheumatoid arthritis, psoriasis and organ or bone marrow transplantation);

•    acarbose (a treatment for diabetes);

•    platinum compounds (drugs used in cancer treatment);

•    diuretic drugs also known as “water tablets” and used to treat fluid retention or high blood pressure;

•    botulinum toxin (used to treat facial spasms);

•    bisphosphonates (used to treat bone disorders such as osteoporosis);

•    neostigmine and pyridostigmine (used for treating myasthenia gravis);

•    oral typhoid vaccine.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

3. How to take Nivemycin Tablets

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

The number of tablets that you or your child will need to take will vary according to the condition being treated. Your doctor will decide on the best dose for you or your child and how long to take the tablets.

Nivemycin tablets are for oral use. As a guideline, the recommended doses of Nivemycin are as follows:

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To treat the bowel before an operation:

Adults including the elderly: Two tablets every hour for four hours, then two tablets every four hours for two or three days before the operation.

Children over 12 years: Two tablets every four hours for two or three days before the operation.

Children from 6-12 years: Half to one tablet every four hours for two or three days before the operation.

To treat liver disease:

Adults including the elderly: If your doctor has recommended short-term treatment, the usual dose is eight to 24 tablets spread throughout the day, for up to seven days. If your doctor has recommended long-term treatment, you may need to take up to eight tablets each day.

Children: The dose depends on the weight of the child.

It is important that you finish the course of tablets that your doctor has prescribed for you. The usual duration of treatment is five to seven days.

Do not exceed the prescribed dose.

If you take more Nivemycin Tablets than you should

Contact your doctor or nearest hospital emergency department immediately. Remember to take this leaflet and the bottle with you to show the doctor what you have taken, whether or not there are any tablets left.

If you forget to take Nivemycin Tablets

Take the next dose as soon as you remember then carry on as before. However, if you are more than two hours late taking a dose, miss it out altogether then take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If any of the following happen, stop taking Nivemycin Tablets and tell your doctor immediately or go to your nearest hospital emergency department:

•    hypersensitivity (allergic) reactions such as inflammation and itching of the skin, fever, breathlessness, angioedema (swelling) or dizziness;

•    abnormal changes in the blood such as: anaemia, which may result in tiredness, breathlessness on exertion and/or pallor; low blood cell counts causing symptoms such as chills and, occasionally, bruising;

•    confusion or disorientation;

•    an infection arising during the course of another infection (superinfection).

These side effects are rare but serious. You may need medical attention.

Nivemycin can occasionally cause damage to the ear, especially if your kidneys do not work very well. Tell your doctor immediately if you experience any problems which can be caused by damage to the ear, such as difficulty keeping your balance, dizziness or poor hearing. Nivemycin may also occasionally cause kidney problems. Tell your doctor if you notice anything unusual when you pass water, for example, if you see a sign of blood in your urine or if you find you are passing less water than usual. Nivemycin may also cause disturbances in the levels of various salts in your body (electrolyte disturbances).

Nivemycin may also cause other side effects such as:

•    stomach upsets such as nausea, vomiting or diarrhoea (as neomycin removes many natural bacteria from the bowel);

•    increased production of saliva;

•    changes in liver function;

•    tingling, burning, itching and tickling sensations of the skin ;

•    twitching of the eyes;

•    inflammation/soreness of the mouth (stomatitis);

•    reduced fat absorption leading to fatty stools (steatorrhoea).

Tell your doctor if these symptoms become troublesome or last for more than a few days.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

5.    How to store Nivemycin Tablets

Keep this medicine out of the sight and reach of children. Store your tablets in a dry place at room temperature (below 30°C), protected from light.

Do not use Nivemycin Tablets after the expiry date shown on the bottle and carton after EXR The expiry date refers to the last day of that month.

If your doctor decides to stop the treatment, return any left over medicine to your pharmacist. Only keep the tablets if your doctor tells you to.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6.    Contents of the pack and other information

What Nivemycin Tablets contain

The active substance is neomycin sulphate.

The other ingredients are plasdone K29-32, isopropyl alcohol and calcium stearate.

What Nivemycin Tablets look like and the contents of the pack

Nivemycin Tablets are pale cream, round plain biconvex tablets.

Nivemycin Tablets are available in bottles of 100 tablets.

The Marketing Authorisation Holder is:

Amdipharm UK Limited, Capital House, 85 King William Street, London EC4N 7BL, UK

Manufacturer Responsible for Release:

Waymade Plc, Sovereign House, Miles Gray Road, Basildon, Essex, SS14 3AF.

Dales Pharmaceuticals Ltd

Snaygill Industrial Estate

Keighley Road, Skipton, North Yorkshire,

BD23 2RW United Kingdom

This leaflet was last revised in December 2013.

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Confirmation that this artwork has been approved by the appropriate market authority (if applicable, e.g. MHRA, IMB, etc and that Amdipharm have license approval to distribute this component for sale in the relevent market.

Accept Artwork ................................................................

Reject Artwork .................................................................

Signature ..........................................................................

Name ................................................................................

Date ...................................................................................

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