Amikacin 250 mg/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.
• 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 are given Amikacin
3. How Amikacin will be given to you
4. Possible side effects
5. How to store Amikacin
6. Contents of the pack and other information

• are allergic to amikacin or any of the other ingredients of this medicine (listed in section 6);
• are allergic to other aminoglycoside antibiotics.
• you have bronchial asthma with a known allergy to sulfites.

Talk to your doctor or pharmacist before being given Amikacin:

• if you have kidney problems (impaired kidney function);
• if you have a muscular disorder (e.g. Parkinsons 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 allergic to sulfites;
• 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. This includes medicines obtained without a prescription.

Simultaneous administration of medicines which are potentially toxic to the inner ear or to the kidneys such as cephalosporins may lead to an exacerbation of renal toxicity.

Amikacin given with penicillin or cephalosporin via other routes of administration may reduce the effectiveness of the preparation. Indomethacin may increase plasma levels of amikacin in neonates.

If you are pregnant or breast-feeding, think you may be pregnant or plan to have a baby, ask your doctor for advice before being given 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.

This may 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.

Sodium content

This medicine contains less than 1 mmol sodium (23 mg) per 2 ml vial, that is to say essentially ‘sodium-free’.

If you think you have received too much Amikacin, contact your doctor. If you have any further questions on the use of this medicine, ask your doctor or nurse.

• 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)
• an increase in a white blood cell subset (eosinophilia)
• a reduction in blood platelets, which increases risk of bleeding or bruising (thrombocytopaenia)
• low levels of magnesium in the blood (hypomagnesaemia)
• 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)
• muscle weakness (hypotonia)
• inflammatory condition that causes blood clots to form in the veins (thrombophlebitis)
• 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 the 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 2 ml vial contains 500 mg of amikacin (as sulfate).
• The other ingredients are sodium metabisulfite (E223), sodium citrate dihydrate, sulfuric acid and water for injection.

Amikacin 250 mg/ml is available as a clear, colourless to light yellow coloured solution, packed in a 4 ml clear Type-I glass vial with a grey, bromobutyl rubber stopper and an aluminium cap with a plastic flip off seal.

2 ml (500 mg): 5 and 10 vials

Not all pack sizes may be marketed.