Patient Product Information

Genticin® Injectable
Gentamicin

Roche

Please read this leaflet carefully. If you have any questions or you are not sure about anything, ask your doctor or pharmacist.

What is Genticin Injectable?

Genticin is a sterile, clear, colourless to pale yellow solution. Each ampoule contains a 2ml solution of an antibacterial called gentamicin sulphate (equivalent to 80mg gentamicin base) in water. Sulphuric acid is present as an excipient. The ampoules are available in packs of 10.

What is Genticin Injectable used for?

Genticin Injectable is used to treat bacterial infections such as severe chest infections, urinary-tract infections or septicaemia.

When must Genticin Injectable not be used?

• If you are allergic to Genticin Injectable, any of the ingredients it contains, or a similar medicine containing an aminoglycoside antibiotic.
• If you have myasthenia gravis (a disease causing muscle weakness).

When to be extra careful when using Genticin Injectable

In some patients, particularly in the elderly, blood or urine samples may be taken to assess kidney function and to ensure that the correct dose is given. Children will also be checked regularly.

Caution is required in patients:

• with kidney, liver or hearing problems, infection or fever
• with low blood pressure or low blood volume
• who are considered to be significantly overweight
• with Parkinson's disease or other diseases causing muscular weakness

Caution is also required when Genticin Injectable is given with any of the following medicines: penicillin, vancomycin, cephalosporins, ciclosporin, cisplatin, fludarabine, amphotericin, furosemide (frusemide), piretanide, etacrynic acid, ticarcillin, muscle relaxants (curare type), neostigmine, pyridostigmine, indometacin, other antibiotics or other medicines which are nephrotoxic or ototoxic (cause kidney or ear problems).

May Genticin Injectable be used during pregnancy or while breast feeding?

In serious cases, this product may be used during pregnancy. Your doctor will assess any risks and if treatment is started, will monitor it. There is a possibility of ear damage to unborn babies. Breast-feeding is unlikely to be harmful to the infant unless the mother has kidney problems. If so breast-feeding should be avoided.

How should Genticin Injectable be used?

• This product is usually injected by a doctor or nurse into a muscle or slowly into a vein. It should always be used as directed by a doctor.
• The normal adult dose is 80mg (2ml) every eight hours. The dose given to children, infants, the elderly, patients with kidney problems or patients who are considered to be significantly overweight, may differ from the normal adult dose.
• The treatment is normally continued for up to seven days but rarely can be for longer periods.
• In the unlikely event of overdose, contact your doctor, nurse, pharmacist or nearest hospital straight away. Symptoms include dizziness, vertigo and hearing loss.

What are the possible unwanted effects of Genticin Injectable?

The following unwanted effects have been reported in some people:

• hypersensitivity (allergy)
• hearing loss
• damage to ear function which can cause dizziness
• effect on kidney function
• infrequently: allergic rash, nausea and vomiting, electrolyte imbalance, blood disorders, sore mouth, liver dysfunction
• in rare cases, diarrhoea with blood and mucus.
• very rarely, anaphylactic reaction
• extremely rarely, central nervous system effects such as encephalopathy (brain disorder), convulsions, confusion, hallucinations, and mental depression.

If you are concerned about these or any other unwanted effects talk to your doctor or nurse.

How should Genticin Injectable be stored?

• Keep this medicine out of the reach and sight of children.
• Do not store above 25°C. Do not freeze.

This medicine must not be used after the date (EXP) printed on the pack.

• REMEMBER this medicine is for you. Only a doctor can prescribe it for you. It may not be suitable for others even if their symptoms are the same as yours.