Gentamicin 10mg/ml Solution for Injection or Infusion

• Keep this leaflet. You may need to read it again
• If you have further questions, please 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 signs 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. See section 4.

1. What gentamicin is and what it is used for
2. What you need to know before you take gentamicin
3. How to take gentamicin
4. Possible side effects
5. How to store gentamicin solution for injection or infusion
6. Contents of the pack and other information

• You are allergic (hypersensitive) to gentamicin, any other antibiotics or to any of the other ingredients of this medicine (see section 6). Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat and tongue
• You have myasthenia gravis. This is a disease that causes muscle weakness.

Do not use this medicine if any of the above applies to you. If you are not sure, talk to your doctor or nurse before using gentamicin.

Talk to your doctor or pharmacist before taking Gentamicin if:

• You are pregnant, think you may be pregnant or are planning to have a baby
• You are breast-feeding or are planning to breast-feed
• You have any muscle weakness problems
• You are extremely overweight (obese)
• You have kidney problems
• You have cystic fibrosis
• You are elderly (over 65 years of age) or the patient is less than 1 year old
• You know (or think) you have a mitochondrial disease (mutations in the parts of your cells which help make energy). Certain mitochondrial diseases may increase your risk of hearing loss with this product
• If you have, or have a maternal history of mitochondrial mutation disease (a genetic condition) or loss of hearing due to antibiotic medicines, you are advised to inform your doctor or pharmacist before you take an aminoglycoside; certain mitochondrial mutations may increase your risk of hearing loss with this product. Your doctor may recommend genetic testing before administration of Gentamicin
• You experience severe diarrhoea
• You develop severe skin reactions such as Stevens-Johnson Syndrome (SJS) or toxic epidermal necrolysis (TEN) as described in section 4 ‘‘Possible side effects’’. If you have symptoms of a severe skin reaction, contact your doctor or nurse immediately.

Your doctor will need to monitor you before, during and shortly after your treatment. Your doctor may check your hearing, balance, how your kidneys are working and the amount of gentamicin in your blood.

This is to prevent damage to your ears and/or kidneys and is particularly important if you have kidney problems, are obese, suffer from cystic fibrosis or are over 65 years of age, or the patient is less than 1 year old.

If you are not sure if any of the above applies to you, talk to your doctor or nurse before using gentamicin.

Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines. This includes medicines you buy without a prescription, including herbal medicines. This is because gentamicin can affect the way some other medicines work. Also, some medicines can affect the way gentamicin works.

In particular tell your doctor if you are taking any of the following:

• Medicines used to thin the blood such as warfarin
• Water tablets or injections (diuretics) such as furosemide or etacrynic acid
• Amphotericin B - used to treat fungal infections
• Cephalosporin antibiotics such as cephaloridine – used to treat bacterial infections
• Ciclosporin - used in organ transplants or for severe skin problems
• Neostigmine or pyridostigmine – used to treat Myasthenia Gravis
• Muscle relaxants - sometimes used during operations which need an anaesthetic
• Indometacin - used to treat pain or swelling
• Bisphosphonates - used to treat osteoporosis
• Cisplatin (used to treat some cancers)
• Botulinum toxin – used to lower the activity of overactive muscles. This is also sometimes used in cosmetic procedures (botox).

These medicines may increase the chances of getting certain side effects. If you are unsure about any of the above, consult your doctor or nurse.

Gentamicin is not recommended during pregnancy or breast-feeding.

Ask your doctor or nurse for advice before having this medicine if:

• You are pregnant, think you may be pregnant or are planning to have a baby
• You are breast-feeding or are planning to breast-feed.

Your doctor will decide how much to give you, depending on your weight. The correct dose also depends on the type of infection and any other illnesses you may have, in particular diseases of the kidney.

Blood samples will be taken by your doctor or nurse to check the dose is right for you. You should not receive Gentamicin if these blood tests cannot be performed. You may also need tests to check your hearing and balance.

Elderly or obese people, newborns, people with impaired kidney function and those with cystic fibrosis should be particularly closely monitored when using this medicine.

Adults

• The usual daily dose in adults is 3-5mg for each kg of body weight
• This is given either as one single dose (preferred) or split into two or three daily doses
• This dose may be increased or decreased by your doctor depending on your illness and the results of your blood tests
• If you have kidney problems your doctor may give you a lower dose or may prolong the interval between doses.

Use in children and adolescents

Children (aged 1 year and above)

• The usual daily dose is 3-6mg for each kg of body weight
• This is given either as one single dose (preferred) or split into two separate doses.

Babies (aged 4 weeks to 1 year)

• The usual daily dose is 4.5 to 7.5mg for each kg of body weight
• This is given either as one single dose (preferred) or split into two separate doses.

Premature babies or new born babies (up to 4 weeks):

• The usual daily dose is 4 to 7mg for each kg of body weight
• This is given in one single dose.

It is most unlikely that you will be given too much medicine by the doctor or nurse.

Your doctor or nurse will be checking your progress and checking the medicine that you are given. Ask if you are not sure why you are getting a dose of medicine.

Your doctor or nurse have instructions about when to give you your medicine. It is most unlikely that you will not be given the medicine as it has been prescribed. If you think that you may have missed a dose then talk to your nurse or doctor.

It is important that the course of treatment your doctor has prescribed is finished.

You may start to feel better but it is important to continue your treatment until the doctor advises. If you stop, your infection may get worse again.

Not known (frequency cannot be estimated from available data)

Allergic reactions (including serious allergic reactions such as anaphylaxis), which may include:

• An itchy, lumpy rash (hives) or nettle rash (urticaria)
• Swelling of the hands, feet, ankles, face, lips or throat which may cause difficulty in swallowing or breathing
• Fainting, dizziness, feeling lightheaded (low blood pressure).

Severe allergic reaction of the skin and mucous membranes accompanied by blistering, peeling, bleeding and reddening of any part of the skin (including the lips, eyes, mouth, nose, genitals, hands or feet) with or without a rash. You may also have flu-like symptoms such as fever, chills or aching muscles. In very severe cases this might affect inner organs and might be life-threatening (Stevens-Johnson syndrome, toxic epidermal necrolysis).

Very rare side effects (may affect less than 1 in 10,000 people)

• Acute kidney failure, which may cause you to pass less urine than is normal for you, fluid retention, breathlessness or fatigue/tiredness.

Not known (frequency cannot be estimated from available data)

• Temporary or irreversible hearing loss or deafness
• Unusual difficulty in moving which has not happened before
• Numbness, weakness and pain in the arms and legs (peripheral neuropathy)
• Blood in the urine
• Diarrhoea, with or without blood and/or stomach cramps
• Infection with other gentamicin-resistant germs.

Very common side effects (may affect more than 1 in 10 people)

• Feeling sick (vomiting).

Not known (frequency cannot be estimated from available data)

• Feeling sick (nausea)
• Mouth ulcers
• Rash, itching or a purplish or reddish-brown skin colouring
• Depression
• Seeing or hearing things that are not real (hallucinations)
• Feeling confused, tired or weak
• Fits.

Very rare side effects (may affect less than 1 in 10,000 people)

• High levels of phosphate and amino acids (so-called Fanconi-like syndrome, associated with high doses given over a long time)

Not known (frequency cannot be estimated from available data)

• Changes in the number of blood cells (including anaemia) – shown up in the results of blood tests
• Changes in the amount of liver enzymes – shown up in the results of blood tests
• A decrease in the level of magnesium in the blood, associated with prolonged therapy.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: 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

• The active substance is gentamicin as gentamicin sulfate
• The other ingredients are sulfuric acid or sodium hydroxide (for pH adjustment), sodium metabisulfite (E223) and water for injections.

Each 2ml ampoule of Gentamicin 10mg/ml Solution for Injection or Infusion contains the equivalent of 20mg of gentamicin.

Each 2ml ampoule of Gentamicin 40mg/ml Solution for Injection or Infusion contains the equivalent of 80mg of gentamicin.

The medicine is a clear, colourless solution for injection or infusion in 2ml ampoules.

Gentamicin 10mg/ml is available in packs containing 5 ampoules.

Gentamicin 40mg/ml is available in packs containing 5 or 10 ampoules.

Not all pack sizes may be marketed.

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Product name Reference Number

Gentamicin 10mg/ml Solution for Injection or Infusion PL 29831/0659

Gentamicin 40mg/ml Solution for Injection or Infusion PL 29831/0660

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