What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL13621/0059.


Tobramycin 40 mg/1 ml solution for injection

Package leaflet: Information for the user

Tobramycin Injection 40 mg/ml

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.
  • 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.

What is in this leaflet

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

1 What Tobramycin Injection is and what it is used for

Tobramycin Injection is a vial containing a solution for injection of the active ingredient tobramycin, which is an antibiotic.

Tobramycin Injection is used to treat the following infections caused by microorganisms that can be killed by tobramycin:

  • blood poisoning
  • infection of the lining of the brain and other infections of the nervous system
  • infection of the wall of the abdomen and other infections of the digestive system
  • infection of the kidneys, bladder, and other infections of the urinary tract which have been difficult to treat with other antibiotics
  • infection of lung tissue, the airways and other infections of the lower respiratory tract
  • skin, bone and soft tissue infections, including burns.

2 What you need to know before you are given Tobramycin Injection

You should not be given Tobramycin Injection if:

  • 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.

Warnings and precautions

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.

Other medicines and Tobramycin Injection

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.

Pregnancy, breast-feeding and fertility

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.

Driving and using machines

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.

Tobramycin Injection contains Sodium metabisulfite (E223)

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

Information about Sodium content

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

3 How you are given Tobramycin Injection

Dosage

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.

Use in children and adolescents

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.

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.

Very serious side effects

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.

The following side effects have also been reported:

  • 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.

Other side effects reported are:

  • 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).

Reporting of side effects

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.

5 How to store Tobramycin Injection

Your doctor or pharmacist knows how to store Tobramycin Injection.

Keep this medicine out of the sight and reach of children.

Store below 25°C.

Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use.These measures will help protect the environment.

6 Contents of the pack and other information

What Tobramycin Injection contains

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

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

What Tobramycin Injection looks like and contents of the pack

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

Marketing Authorisation Holder

Flynn Pharma Ltd
Marine House
Clanwilliam Place
Dublin 2
Ireland

Manufacturer

Vianex SA
12th km National Road
Athens-Lamia, 14451
Metamorphossis Attiki
Athens
Greece

This leaflet was last revised in July 2021.