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Tobramycin Injection BP 40mg in 1ml, 80mg in 2ml

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 or pharmacist.

•    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 any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

IN THIS LEAFLET:

1.    What Tobramycin is and what it is used for

2.    Before you receive Tobramycin

3.    How to receive Tobramycin

4.    Possible side effects

5.    How to store Tobramycin

6.    Further information

1. WHAT TOBRAMYCIN IS AND WHAT IT IS USED FOR

Tobramycin is an aminoglycoside antibiotic, effective against a number of different bacterium species. Aminoglycosides kill bacteria which cause infections in your body, by inhibiting the protein synthesis of the bacteria.

Tobramycin injection is used if you are suffering from an infectious disease such as:

•    infections of the lower respiratory tract (inflammation of the lungs, bronchitis, pneumonia);

•    infections of the skin, soft tissue, muscle and bone infections, including complications of burns;

•    urogenital infections (causing inflammation of the kidneys, bladder, and genitals);

•    infections of the stomach, the bowels and other abdominal organs, including peritonitis;

•    infections of the central nervous system (such as meningitis) and blood poisoning, including that in new-born infants;

•    infections of the heart valve (endocarditis)

2. BEFORE YOU RECEIVE TOBRAMYCIN

Do NOT receive Tobramycin if you:

•    are allergic (hypersensitive) to Tobramycin or any other aminoglycoside antibiotics, or ingredients in this medicine

•    are to have this injection into your spinal canal

Take special care with Tobramycin

Tell your doctor before you are given medicine, if you:

•    have any kidney problem

•    have any hearing problems

•    have any balance / gait problems

•    are pregnant or trying to get pregnant

•    are breast-feeding

Patients with kidney problems, or those who develop problems with their kidneys, hearing or balance during treatment will be regularly monitored and their dosage adjusted as necessary.

Taking other medicines

If you take any other drugs at the same time as Tobramycin, they may interfere with the effects of the other. Therefore, during your treatment with Tobramycin consult your doctor before taking any other drugs. Tobramycin should preferably not be given with the following drugs:

•    other antibiotics having possible toxic effects on the nervous system and the kidneys (e.g. amikacin, streptomycin, neomycin, kanamycin, gentamycin,

paromomycin, amphotericin B, cephaloridine, viomycin, polymyxin B, vancomycin)

•    diuretics (water tablets) (e.g. furosemide, etacrinic acid)

•    neuromuscular blockers (e.g. tubocurarine, succinylcholine), used to treat myasthenia gravis or Parkinson's disease.

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Pregnancy and breast-feeding The administration of tobramycin should be avoided in pregnant women unless the patient suffers from a life-threatening infection which cannot be treated with any other antibiotic. If a pregnant woman is treated with tobramycin, the drug may cause severe and permanent damage to the unborn baby. Tobramycin should not be administered to nursing mothers because it passes into the breast milk.

Driving and using machines

Tobramycin may cause dizziness, if affected do not drive or operate machinery.

Important information about some of the ingredients of Tobramycin

This medicine contains sodium metabisulphite, which may cause allergic reactions and breathing problems. Tell your doctor if you know that you are allergic to sodium metabisulphite, as you should not be given this medicine.

3. HOW TO RECEIVE TOBRAMYCIN

Tobramycin may be given on its own or with other medicines. You will receive it by intravenous or intramuscular injection, or in infusion. Before the treatment is started, your doctor may carry out some blood tests to find out what's causing your infection. In urgent cases, your doctor may start your treatment without this test.

The injection should always be given by a doctor or nurse.

How much Tobramycin will you receive, how often and how long?

This will depend on the severity of your disease, your age, weight and your general medical condition. Tobramycin will be given to you with care as it may affect your kidneys and the inner parts of your ears.

Your doctor may carry out blood tests while you are being treated with this medicine, to make sure you are getting the correct dose.

Adults:

Also refer to ‘recommendations for patients with impaired (less effective) kidney function’

•    The usual single dose for adults with normal kidney function is 1.0 - 1.5 mg/kg, which may be repeated depending on the severity of the disease.

•    In patients with cystic fibrosis, a dose up to 8 to 10 mg/kg/day in equally divided doses.

The dosage should be reduced as soon as your doctor determines it is safe to do so.

Children:

•    The recommended dose for children is 3 - 5 mg/kg/day, given in 3 equal doses every 8 hours.

Premature and full-term new-born babies:

•    The recommended dosage is 2 - 3 mg/kg/day, in 2 - 3 equal portions.

•    In new-born babies the dosage will be given with caution because their kidney function is not yet fully developed.

Overweight patients:

•    In obese patients the ideal body weight and 40% of excess weight should be taken into account when determining the correct dosage.

Elderly:

•    Same as adults, but see recommendations for patients with impaired (less effective) kidney function, below.

For patients with impaired (less effective) kidney function:

•    Patients with reduced kidney function are prone to the toxic effects of Tobramycin in the inner ear and the kidneys. To prevent these patients with kidney problems will be given either a reduced single dose or normal doses given at prolonged intervals.

•    If you suffer from kidney failure, the effective dose and the time between two consecutive doses will be based on your blood test (e.g. serum creatinine levels and creatinine clearance) and the levels of Tobramycin in the blood.

The recommended dose is 1 mg/kg/day, and the time between two consecutive doses is determined by your kidney function according to the following table:

If you receive more Tobramycin than you should or think you have missed a dose

• this medicine will be given to you in hospital. If you have any concerns about the amount of medicine you are given or how often you receive it, please tell your doctor or nurse.

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

4. POSSIBLE SIDE EFFECTS

Tobramycin can cause side effects. You should discuss them with your doctor, who will explain the risks and benefits of your treatment.

Like all medicines Tobramycin can have side effects.

Tell your doctor immediately if the following happens:

• an allergic reaction causing a sudden itchy rash (hives), swelling of the hands, feet, ankles, face, lips, mouth or throat (which may cause difficulty in swallowing or breathing).

This is a very rare but serious side effect. You may need urgent medical attention.

The risk of toxic effects on your kidneys and ears is low (less than 1 patient in 100) if you receive tobramycin in the correct dose and correct time period. The risks are low in patients with normal kidney functions who do not receive tobramycin in higher doses or for longer periods of time than recommended.

•    ringing in your ears

•    dizziness In rare cases:

•    there could be an increase in liver enzyme levels

•    a lower number of red blood cells (anaemia)

•    a lower number of white blood cells (leukopenia)

•    a lower number of platelets (thrombocytopenia)

•    a lowered calcium levels (hypocalcaemia)

•    a lowered sodium levels (hyponatraemia)

•    lowered potassium levels (hypokalaemia)

•    fever

•    rash

•    urticaria (hives)

•    vomiting

•    headache

•    lethargy

If you believe you are suffering from any of these effects then do report them to your doctor or nurse, who may confirm them by arranging for a blood test to be performed.

If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE TOBRAMYCIN

Keep out of the reach and sight of children. The ampoules should be kept below 25^oC protected from light.

Do not use Tobramycin after the expiry date that is stated on the outer packaging. The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. These measures will help to protect the environment.

6. FURTHER INFORMATION

What Tobramycin Injection contain(s):

•    The active ingredient is Tobramycin as sulphate salt

•    The other ingredients are disodium edentate, sodium metabisulphite and water for injection as excipients.

What Tobramycin Injection look(s) like and contents of the pack:

Tobramycin injections are available in two strengths:

•    Tobramycin injection BP 40 mg in 1 ml - each ampoule contains 40 mg tobramycin as sulphate salt.

•    Tobramycin injection BP 80 mg in 2 ml - each ampoule contains 80 mg tobramycin as sulphate salt.

•    Tobramycin injections are available in packs of 10 ampoules.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation holder:

Medimpex UK Limited, 127 Shirland Road, London, W9 2EP England.

Manufacturer:

Teva Pharmaceutical Works Private Limited Company Godollo, Tancsics Mihaly ut 82, Hungary

This leaflet was last revised: July 2011

Product Licence Nos. PL 05276/0008

Tobramycin may affect your hearing and sense of balance, you may experience:

• impaired hearing - this may occur if you are given high doses or over long periods of time.

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