Amikacin 250mg/ml Solution for Injection/Infusion

• 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 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 Amikacin is and what it is used for
2. What you need to know before you use Amikacin
3. How to use Amikacin
4. Possible side effects
5. How to store Amikacin
6. Contents of the pack and other information

• if you are allergic to amikacin or any of the other ingredients of this medicine (listed in section 6).
• if you are allergic to other aminoglycoside antibiotics.

Please talk to your doctor or pharmacist before being given Amikacin, especially:

• if you have previous kidney problems (impaired renal function).
• if you have a muscular disorder (e.g. Parkinson's disease).
• if you have hearing problems (inner ear injury).
• if you have balance disorders.
• if you are elderly.
• if you suffer from dehydration.
• if you are receiving concomitant anaesthetics (narcotics), neuromuscular blocking agents (such as suxamethonium, dexamethasone, atracurium, rocuronium or vecuronium) or a large blood transfusion (where citrate is added).
• if you are pregnant or breastfeeding.
• if the patient is a premature or newborn child, the excretion of this drug may be reduced due to the fact that kidney function is not fully developed.
• if you or your family members have a 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 Amikacin.

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

Simultaneous and/or sequential treatment with medicines which are potentially toxic to the nervous system or the kidneys, such as cisplatin, cephalosporins, polymyxins, amphotericin B, cyclosporin, tacrolimus, bacitracin, cephaloridine, paramomycin, viomycin, colistin, vancomycin, ethacrynic acid, furosemide, other aminoglycosides or cytostatics, may lead to an exacerbation of toxicity.

Toxicity risks are higher in the elderly and patients who have lost a large amount of body fluid.

It is especially important that you tell your doctor if you have recently received an anaesthetic or are taking any of the following:

• Diuretics (water tablets or injection) e.g. furosemide.
• Antibiotics including penicillin-type antibiotics or cephalosporins.
• Inhalation narcotics (e.g. ether, halothane).
• Muscle relaxants (e.g. d-tubocurarine, succinyl choline, decamethonium, atracurium, rocuronium, vecuronium) and volatile anaesthetics (increased risk of paralysis and respiratory paralysis [neuromuscular blockade]).
• Citrated blood transfusions (transfer of blood mixed with citrate to prevent its clotting).
• Amphotericin B, (used in the treatment of fungal infections).
• Bisphosphonates (used to treat osteoporosis or similar diseases) may lead to low blood calcium levels.
• Platinum compounds (used to treat cancer) which may increase the risk of kidney toxicity and possible hearing damage.
• Thiamine (vitamin B1), taken with amikacin, may lose its effectiveness.
• Any medicines which are bad for your kidneys or hearing.
• Indomethacin (an anti-inflammatory medicine) can increase the amount of amikacin which is absorbed by new born babies.

If you are pregnant or breast-feeding, think you may be pregnant or plan to have a baby, consult your doctor before using this medicine.

Pregnancy

The safety of the medicine in pregnant women has not been confirmed and therefore Amikacin should only be used during pregnancy when absolutely necessary.

Breast-feeding

It is not known whether amikacin passes into breast milk. Breastfeeding is not recommended during treatment. Therefore, talk to your doctor if breastfeeding or the treatment should be discontinued.

If you suffer from side effects such as dizziness, be especially careful when driving vehicles or operating machinery.

Amikacin contains sodium metabisulfite which may rarely cause severe allergic (hypersensitivity) reactions and difficulty in breathing or wheezing (bronchospasm).

Sulfite sensitivity is generally uncommon and more frequent in asthmatics than non-asthmatics.

This medicine contains 14.92 mg sodium (main component of cooking/table salt) in each 2 ml vial. This is equivalent to 0.75 % of the recommended maximum daily dietary intake of sodium for an adult.

If you think you have received too much Amikacin, contact your doctor.

• allergic reactions: swelling of the face, throat or tongue, difficulty breathing or dizziness (anaphylaxis).
• frequent wheezing, breathlessness, abdominal pain, diarrhoea, fever, cough and rashes due to an increase in certain white blood cells (eosinophilia).

Common (may affect up to 1 in 10 people)

• dizziness
• balance disorder associated with the inner ear (vestibular disorders) with nausea
• protein in the urine

Uncommon (may affect up to 1 in 100 people)

• super infections with resistant bacteria or yeasts
• feeling sick (nausea) or being sick (vomiting)
• elevation of liver enzymes (detected in blood test)
• rash

Rare (may affect up to 1 in 1,000 people)

• looking pale and feeling tired (anaemia)
• a deficiency in white blood cells (granulocytopenia, leukopenia)
• a reduction in blood platelets, which increases risk of bleeding or bruising (thrombocytopenia)
• low levels of magnesium in the blood (hypomagnesemia)
• tremors
• tingling or numbness (paraesthesia)
• headache
• balance disorders
• blindness
• blood flow to the retina is blocked causing blurry vision and possibly blindness (retinal infarction)
• ringing in the ears (tinnitus), hearing loss
• low blood pressure (hypotension)
• inflammatory condition that causes blood clots to form in the of veins (thrombophlebitis)
• muscle weakness (hypotonia)
• increased heart rate (tachycardia)
• inflammation of the heart muscle (myocarditis)
• severe itching (pruritus)
• skin rashes with the formation of wheals (urticaria)
• joint pain (arthralgia)
• muscle contractions
• decreased production of urine (oliguria)
• increase of creatinine in the blood (azotemia)
• kidney disorder causing too much albumin in the urine (albuminuria)
• fever

Not known (frequency cannot be estimated from the available data)

• rapid onset muscle weakness (acute muscular paralysis)
• deafness
• throat relaxes and collapse causing a total blockage of the airway (apnoea)
• breathing difficulties or wheezing (bronchospasm)
• sudden kidney failure, toxicity in kidneys
• cells in the urine
• pain at the injection site

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.

• The active substance is amikacin (as sulfate). Each ml contains 250 mg of amikacin (as sulfate).
• Each 2ml vial contains 500mg of amikacin (as sulfate).
• The other ingredients are sodium metabisulfite, sodium citrate, sulfuric acid and water for injections (see section 2, "Amikacin contains sodium metabisulfite” and "Amikacin contains sodium”).

Amikacin (250 mg/ml) is available as a colourless or pale yellow transparent solution, practically free from visible particles, packed in a 2 ml clear Type-I glass vial with bromobutyl rubber stoppers and an aluminum cap with plastic flip-off.

2 ml (500 mg): 1, 5 and 10 vials.

Not all pack sizes may be marketed.

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