Azactam 2 g Powder for Solution for Injection or Infusion-vial

• Please keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor.

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.

1. What Azactam is and what it is used for
2. What you need to know before you are given your medicine
3. How you will be given your medicine
4. Possible side effects
5. How to store your medicine
6. Contents of the pack and other information

• You are allergic to Aztreonam or L-arginine
• You are pregnant or planning to become pregnant

Talk to your doctor before taking Azactam if

• You have ever had an allergic reaction to any antibiotics
• You have diarrhoea or usually get diarrhoea when you take antibiotics or have ever suffered from problems with your stomach or intestines. If you develop severe or prolonged or bloody diarrhoea during or after using Azactam tell your doctor as soon as possible since it may be necessary to interrupt the treatment.
• You have any Liver problems
• You have any Kidney problems
• You are taking a medicine against blood clots (anticoagulants)
• You have any blood disorders, e.g. severe reduction in blood cells which can cause weakness, bruising or make infections more likely (pancytopenia)
• You have skin disorders, including serious illness with blistering of the skin (toxic epidermal necrolysis)
• Positive results in a Coombs’ test (a test for some blood problems)
• You have fits (convulsions or seizures)
• You are taking an antibiotic or oral anticoagulants

You must tell your doctor if you experience encephalopathy (unexplained confusion, altered mental function, coma, seizure, or weakness).

Always tell your doctor or pharmacist about other medicines you are taking, have recently taken or may take including those obtained without a prescription. Some medicines can have an effect on each other’s actions.

If you are pregnant or may become pregnant or are breast feeding, you should speak to your doctor before being treated with Azactam.

This medicine could affect your ability to drive and use machinery should encephalopathy occur (see section 2 and 4).

Azactam contains Aztreonam.

The adult dose range is 1 to 8g daily. This dose can be split equally over the day meaning you may be given between one to four doses a day. Maximum recommended dose is 8 g per day.

The usual daily dose in children older than one week is 30mg per kg of body weight given every 6 to 8 hours, but in severe infections in patients two years of age or older this will be increased to 50mg per kg of body weight.

If you have kidney or liver problems, you may receive a lower dose than usual.

It is unlikely that you will receive more Azactam than you should as it will be administered by injection into a muscle or vein by a doctor, nurse or other suitably trained person. If this does happen you will be closely monitored.

You must tell your doctor if you experience unexplained confusion, altered mental function, coma, seizure, or weakness..

• swelling of the face, lips, tongue and/or throat with difficulty in swallowing or breathing. These may be signs of an allergic reaction.
• severe, persistent or bloody diarrhoea (which may be associated with stomach pain or fever). This is rare side effect which may occur after treatment with antibiotics and can be a sign of serious bowel inflammation.

Patients treated with Azactam have reported the following side effects:

Uncommon side effects (may affect up to 1 in 100 people)

• Increased levels of some chemicals in your blood (creatinine)

Rare side effects (may affect up to 1 in 1000 people)):

• Dizziness
• Ringing in the ears
• Double vision
• Bleeding of the stomach
• Painful or swollen colon
• Bad breath
• Chest pain
• High temperature
• Weakness
• Yellowing of the skin
• Thrush or other vaginal irritation
• Fits
• Headache
• Wheezing
• Breast tenderness
• Shortness of breath
• Sneezing
• Tingling/numbness
• Difficulty sleeping
• Blocked nose
• Change in heart beat
• Fall in blood pressure
• Confusion
• Bleeding
• Lengthening of the time it takes for a cut to stop bleeding
• Spontaneous bruising
• convulsion
• Muscle pain
• Painful or swollen liver
• Feeling of general discomfort
• Increase or decrease in the number of blood clotting cells
• Increase or decrease in the number of white blood cells
• Fall in the number of red blood cells
• A false positive test for antibodies (Coombs test)

Other side effects where the frequencies are unknown include:

• Abdominal cramps
• Mouth ulcers
• Feeling and/or being sick
• Looser and/or more frequent stools
• Altered taste
• Discomfort at the injection site
• Weakness
• Sweating
• General aches and pains
• Fever
• Changes in the levels of some chemicals in your blood serum (creatinine, transaminase, alkaline phosphatase)
• Skin irritation and flaking
• Itchy rash
• Flushing
• Small red spots
• Burning and blistering of the skin
• Hives
• Encephalopathy (confusion, altered mental function, coma, seizure, or weakness)
• Serious life threatening allergic reaction
• Difficulty breathing due to muscle spasms in the lung
• Swelling of the skin
• excessive bruising of the skin
• Rash
• swelling of the veins in the legs which may be related to a blood clot

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

By reporting side effects you can help provide more information on the safety of this medicine.

The active substance is aztreonam. The other ingredients are: L-arginine (780 mg per g of aztreonam or 1.54 g per 2 g of aztreonam).

Azactam comes in clear glass vials, closed with siliconed grey butyl rubber closure, sealed with aluminium seal with plastic flip off button, in packs of 1 x 15 mL.

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Date of last revision: January 2023