Tobramycin 40mg/ml Injection

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Tobramycin Injection is and what it is used for
2. What you need to know before you are given Tobramycin Injection
3. How you are given Tobramycin Injection
4. Possible side effects
5. How to store Tobramycin Injection
6. Contents of the pack and other information

• you are allergic to tobramycin, any aminoglycoside (similar antibiotic) or any of the other ingredients of this medicine (listed in section 6). An allergic reaction may include rash, itching, difficulty breathing or swelling of the face, lips, throat or tongue.

Tobramycin Injection must only be injected into a muscle or vein.

Tell your doctor if you:

• have ever had an allergic reaction to a sulfate or bisulfite (preservatives)
• have a kidney disorder or need dialysis (you may need a reduced dose, especially if you are elderly)
• have a muscle disorder, such as myasthenia gravis, or Parkinson’s disease
• are elderly or dehydrated (needing fluids).
• or your family members have a mitochondrial mutation disease (condition caused by variants in the genome of mitochondria, the parts of your cells which help make energy) or loss of hearing due to antibiotic medicines; certain mitochondrial mutations may increase your risk of hearing loss with this product.

Tobramycin Injection should be used with caution in premature and neonatal infants, and also in patients with extensive burns.

Tell your doctor if any of the above applies to you before this medicine is given to you.

Tell your doctor if you are taking, have recently taken or might take any other medicines.

In particular, the following medicines may interact with this medicine:

• other aminoglycosides (similar antibiotics such as amikacin, streptomycin, neomycin, kanamycin, gentamicin or paromomcyin)
• other antibiotics such as amphotericin B, cephaloridine, viomycin, polymyxin B, colistin, vancomycin, and cephalosporin antibiotics (such as cephalothin)
• cisplatin (a drug used for chemotherapy)
• diuretics (water tablets)
• medicines used as muscle relaxants during general anaesthesia.
• ciclosporin (used to reduce the activity of the immune system)
• neostigmine and pyridostigmine (for the treatment of muscle weakness)
• warfarin and phenindione (used to thin the blood).

It may still be alright for you to be given Tobramycin Injection and your doctor will be able to decide what is suitable for you.

You should not have Tobramycin Injection if you are pregnant unless your doctor tells you to. Tobramycin may harm the unborn baby.

You should not have Tobramycin Injection if you are breast-feeding.

Ask your doctor or pharmacist for advice before taking any medicine.

Following rapid injection, Tobramycin Injection may cause muscle weakness or certain muscles not to work, and so may affect your ability to drive or use machines. If you are affected, you should not drive or operate heavy machinery until you feel it is safe to do so.

May rarely cause severe hypersensitivity reactions and bronchospasm (difficulty in breathing).

This medicine contains less than 1 mmol sodium (23 mg) per ml, that is to say essentially ‘sodium free’.

A doctor or nurse will give you Tobramycin Injection.

The recommended dose is:

Adults: 3mg per kg of body weight every 24 hours, given as 3 doses of 1mg per kg of body weight every 8 hours. If you have a serious bacterial infection, your doctor may use larger doses.

Children: 6 to 7.5mg per kg of body weight every 24 hours, given as 3 or 4 equal doses.

Premature or new-born babies: Up to 4mg per kg of body weight every 24 hours, given as 2 equal doses every 12 hours.

Kidney disorder: If you have a kidney disorder, your doctor will reduce your dose. This may happen during your treatment.

The usual length of treatment is 7 to 10 days. If you are treated for longer than this, your doctor will need to test your kidneys and ears because they may be damaged by the treatment.

All medicines can cause allergic reactions, although serious allergic reactions are very rare. Tell your doctor straight away if you get any sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching (especially affecting your whole body), or any of the following:

• severe peeling skin (exfoliative dermatitis)
• ringing or roaring in one or both ears (tinnitus)
• hearing loss in one or both ears
• dizziness
• sensation of spinning (vertigo)
• muscle twitching
• numbness or pins and needles
• fits
• changes in the number of different types of blood cells. You may notice unexplained bleeding or bruising (caused by low platelets) or are unable to fight off infections (reduced levels of white blood cells), feel tired all the time (reduced blood cells, anaemia) or have sudden fever or sore throat.*

These are serious side effects, and you may only notice them after you stop treatment. You should see your doctor immediately.

• effects on the kidneys causing an increase in waste products in the blood which are normally eliminated by them or the kidneys not to work properly
• reduced or no urine production
• cloudy urine (caused by protein or granules).

If you notice changes in your urine or the number of times you need to urinate, tell your doctor straight away.

• headache
• tiredness
• confusion and disorientation
• fever
• rash (with no other symptoms)
• itching
• feeling sick
• being sick
• diarrhoea
• pain at the injection site
• raised liver enzymes*
• the amount of calcium, magnesium, sodium and potassium in your blood may decrease (symptoms are muscle weakness, muscle cramps, feeling thirsty all the time, drinking all the time, urinating frequently, vomiting and, possibly, having a fit)*

*(these conditions would be detected in a blood test carried out by a doctor).

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

Each 1ml solution contains 40mg of the active substance tobramycin.

The other ingredients are: phenol, sodium metabisulfite, disodium edetate, water for injection, sulfuric acid.

Tobramycin Injection is a clear, colourless solution provided in rubber stoppered glass vials in individual cartons.