Cefotaxime 1 g Powder for solution for injection vial

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, or pharmacist or nurse.
• 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. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor, or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

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

The name of your medicine is Cefotaxime 1g powder for injection or infusion, or Cefotaxime 2g powder for injection or infusion but will be referred to as Cefotaxime or as Cefotaxime Injection in this leaflet.

• you are allergic (hypersensitive) to Cefotaxime or to any cephalosporin antibiotics or any of the other ingredients of this medicine (listed in section 6).
• you have ever had a severe allergic reaction (hypersensitivity) to any other type of beta-lactam antibiotic (penicillins, monobactams and carbapenems).
• Cefotaxime is sometimes mixed with another medicine called lidocaine. In this case do not have this injection if:You are allergic to lidocaine or other local anaesthetics
• Your child is younger than 30 months
• You have heart disease, problems with your heartbeat of severe heart failure.
• You have ever developed a severe skin rash or skin peeling, blistering and/or mouth sores after taking cefotaxime or other cephalosporins.

Do not have this medicine if any of the above applies to you. If you are not sure, talk to your doctor or nurse before you are given Cefotaxime.

Talk to your doctor, pharmacist or nurse before you are given Cefotaxime:

• if you have allergic reactions. If you have had any allergic reaction to other antibiotics such as penicillin, you may also be allergic to Cefotaxime. If an allergic reaction occurs, tratment must be stopped.
• if you suffer from severe, persistent diarrhoea during or after treatment with Cefotaxime. In this case contact your doctor immediately. Do not take any anti-diarrhoea medicine without consulting your doctor.
• if you have a widespread rash with blisters and peeling skin. (These may be signs of Stevens-Johnson syndrome or toxic epidermal necrolysis).
• if you have kidney problems
• if you experince e.g. impairment of consciousness, abnormal movements and cramps after being given this medicine.
• if you are on a low salt diet. Then the sodium content of this product must be taken into account.
• Serious skin reactions including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalized exanthematous pustulosis (AGEP) have been reported in association with cefotaxime treatment. Stop using cefotaxime and seek medical attention immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.

If any of these apply to you, your doctor may want to change your treatment or give you special advice.

If you are given this medicine over a longer period, your doctor will take additional care and check your blood for possible changes. Also the overgrowth of bacteria that are unsusceptible to cefotaxime must be examined regularly in this case.

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This is extremely important, as using more than one medicine at the same time can strengthen or weaken the effect of the medicines.

Cefotaxime may interfere with:

• diuretics (used to increase the flow of urine)
• probenecid
• aminoglycoside antibiotics (such as gentamycin and streptomycin used to treat infections), other antibiotics (such as tetracycline, erythromycin and chloramphenicol)

In some cases your doctor will arrange further monitoring, but this is routine and nothing to worry about.

It is important to tell the doctor that you are taking this medicine if you require any blood, urine or diagnostic tests.

The effect of the contraceptive pill may be decreased during therapy with Cefotaxime. Additional non-hormonal contraceptive precautions should therefore be taken during therapy with Cefotaxime.

Before starting treatment, you must tell your doctor if you are pregnant or if you intend to become pregnant. Your doctor will then decide whether you should receive Cefotaxime

Mothers who wish to breast-feed should discuss this with their doctor who will then advise you on what to do.

Ask your doctor or pharmacist for advice before taking any medicine.

Cefotaxime should not affect your ability to drive or operate machinery.

You may start to move abnormally, suffer from sudden involuntary muscle contractions, dizziness or feel less alert.

If this happens, do not drive or use any tools or machines.

This medicinal product contains 2.09 mmol (or 48 mg) sodium per dose. To be taken into consideration by patients on a controlled sodium diet.

It is most unlikely that you will be given too much medicine by the nurse or doctor. Your doctor and nurse will be monitoring your progress, and checking the medicine that you are given. Always ask if you are not sure why you are getting a dose of medicine.

Your doctor or nurse have instructions 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 taken. You may start to feel better but it is important not to stop taking this medicine, until the doctor advises, otherwise your condition may get worse again.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Low dosage, irregular administration or stopping treatment too early can compromise the outcome of the treatment or lead to a relapse, whose treatment is more difficult. Please follow the instructions of your doctor.

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

• Increased tendency to bleed or bruise more easily caused by a fall in the number of blood platelets (thrombocytopenia), fever, sore throat or mouth ulcers due to infections caused by a low level of white blood cells (leucopenia) or high level of a specific type of white blood cells (eosinophilia)

Not known: frequency cannot be estimated from the available data

• Inflammation of the bowels, called colitis (or antibiotic-associated colitis), causing severe long-lasting watery or blood diarrhoea with stomach cramps and fever
• Serious blood problems, including changes in the numbers of some white blood cells (which may cause frequent infections, fever, severe chills, sore throat, or mouth ulcers)
• Damage to red blood cells (causing tiredness, being short of breath or looking pale)
• Severe allergic reactions with symptoms such as swelling of the lips, tongue, face and neck, sudden difficulty in breathing, speaking and swallowing
• Headache, dizziness, convulsions (fits) (these may be symptoms of a brain disorder called encephalopathy)
• Changes in heart beat (rhythm or rate), after a very quick injection into a vein
• Yellow skin and eyes, loss of appetite, light-coloured urine caused by inflammation of the liver
• Skin rash, which may blister, and looks like small targets (central dark spot surrounded by a paler area, with a dark ring around the edge)
• A widespread rash with blisters and peeling sking. (These may be signs of Stevens-Johnson syndrome or toxic epidermal necrolysis)
• Increased or reduced urinie output, or traces of blood in your urine, sometimes with swollen limbs and/ or flank pain caused by kidney problems
• For intramuscular injections: combination with lidocaine can cause systemic reactions.

Very common: may affect more than 1 in 10 people

• Intramuscular injection may be painful

Uncommon: may affect more than 1 in 100 people

• People being treated for injections with bacteria called spirochetes often show symptoms like fever and shivering which are described as ‘Herxheimer reaction’ and indicate the effectiveness of the therapy.
• Changes in the results of blood tests that check how the liver and kidneys are working
• Fever
• Allergic reactions such as skin rash (nettle rash), itchy skin
• Painfull swelling and inflammation where the injection is given into a vein
• Soft stools or diarrhoea
• Convulsions

Not known: frequency cannot be estimated from the available data

• Feeling sick (nausea) and being sick (vomiting)
• Pain in your stomach (abdomen)

Your doctor may want to perform tests during your treatment to measure any changes.

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 Cefotaxime Sodium.

Cefotaxime 1g powder for solution for injection or infusion contains Cefotaxime sodium equivalent to 1 g of Cefotaxime.

Cefotaxime 2g powder for solution for injection or infusion contains 2 g of Cefotaxime sodium Ph.

Eur., equivalent to 2 g of Cefotaxime base.

There are no other ingredients.

Cefotaxime is a white or slightly creamy powder which forms a straw-coloured solution on reconstitution.

Cefotaxime 1g powder for injection or infusion is available in packs of 10 or 50 vials.

Cefotaxime 2g powder for injection or infusion is available in packs of 10 vials.

Not all pack sizes may be marketed.

Marketing Authorisation Holder:

Manufacturer:

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.