Zedbac 500mg powder for solution for infusion

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• If you get any side effects talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

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

Zedbac is indicated for treatment of serious infections or when oral treatment cannot be used. It is used for treatment of pneumonia (lung infection), and pelvic infections (infection of the reproductive organs) caused by susceptible organisms.

• if you are allergic to azithromycin or any of the ingredients of this medicine (listed in section 6).
• if you are allergic (hypersensitive) to any other macrolide antibiotic (such as erythromycin or clarithromycin) or ketolide (macrolide derivatives).
• if you are taking any ergot derivatives such as ergotamine (used to treat migraine) as these medicines should not be taken together with azithromycin.

Talk to your doctor, pharmacist or nurse before using Zedbac

• if you have an allergic reaction such as red or white spots on the skin, itching and skin irritation, swelling of the skin, larynx (throat) or tongue, and difficulty in breathing, in which case you should stop treatment with Zedbac.
• if you have or have had kidney problems.
• if you have or have had liver problems: your doctor may need to monitor your liver function or stop the treatment.
• if you have or have had an abnormal heart rhythm in particular problems such as long QT syndrome (shown on an electro-cardiogram or ECG machine).
• if you feel heart palpitations or have an abnormal heartbeat, or get dizzy or faint when taking Zedbac, in which case you should inform your doctor immediately.
• if you develop diarrhoea or loose stools during or after treatment. In some cases, there is the possibility of developing a serious intestinal inflammation known as pseudomembranous colitis. Do not take any medicine to treat your diarrhoea without first checking with your doctor.

Other important precautions:

• Fungal infections may occur while you take azithromycin.
• In rare cases severe allergic reactions may occur.
• Medicines known as ergot derivatives e.g. ergotamine or dihydroergotamine (medicines used for migraines or reducing blood flow) should not be taken together with Zedbac.
• Care must be also taken if you suffer from neurological or psychiatric diseases.
• This medicine shall not be used to treat infected burn wounds.
• Worsening of symptoms has been observed in patients with myasthenia gravis receiving azithromycin.

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

Medicines can interact with each other or with other substances causing unexpected drug reactions or in some cases may cause a decrease or increase of the expected effect. Therefore, you should inform your doctor about all the medicines you are taking or have taken, in particular:

• ergot derivatives such as ergotamine (used to treat migraine)
• digoxin (used to treat heart failure)
• colchicine (used for gout and familial Mediterranean fever)
• warfarin or any similar medicine to prevent blood clots
• ciclosporin (used to suppress the immune system to prevent and treat rejection of a transplanted organ or bone marrow)
• terfenadine (for hay fever or a skin allergy)
• nelfinavir (used for the treatment of HIV infection (AIDS))
• zidovudine (for HIV). Zedbac may reduce the blood levels of zidovudine and should therefore be taken at least 1-2 hours before or after zidovudine
• rifabutin (for HIV or tuberculosis)
• theophylline (for breathing problems)
• hydroxychloroquine or chloroquine (used to treat conditions including rheumatoid arthritis, or to treat or prevent malaria): Taking these medicines at the same time as azithromycin may increase the chance of you getting side effects that affect your heart.

You should not take Zedbac with antacids (used for indigestion).

Please contact your doctor or pharmacist before taking any medicine.

If you are pregnant or breast-feeding, think you may be pregnant or planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Side effects could occur which may influence your ability to drive or use machines (see section 4). You are advised not to drive or use machines whilst taking Zedbac.

This medicine contains 114mg (4.96mmol) sodium (main component of cooking/table salt) in each 500mg vial. This is equivalent to 5.7% of the recommended maximum daily dietary intake of sodium for an adult.

Zedbac is intended to be administered by intravenous infusion.

This medicine should be reconstituted and diluted according to the instructions, and should be administered as an intravenous infusion over at least 60 minutes.

The duration of your treatment will depend on the severity of your infection. Your doctor will inform you about it.

Zedbac is not recommended for use in children and growing adolescents.

Patients with kidney or liver problems:

• You should tell your doctor if you have kidney or liver problems as your doctor may need to alter the normal dose.

No dose adjustment is needed for elderly patients.

• allergic reactions which may cause sudden wheeziness, difficulty in breathing, swelling of eyelids, face or lips, rash or itching (especially affecting the whole body)
• severe or prolonged diarrhoea, which may have blood or mucus in it, during or after treatment with Zedbac as this may be a sign of serious bowel inflammation
• severe skin rash causing redness and flaking
• rapid or irregular heartbeat
• low blood pressure
• serious skin reactions:
  • blistering of the skin, mouth, eyes and genitals (Stevens-Johnson Syndrome (SJS))
  • blistering of the skin, severe skin reaction (Toxic Epidermal Necrosis (TEN))
  • skin rash accompanied by other symptoms such as fever, swollen glands and an increase of eosinophils (a type of white blood cell). A rash appears as small, itchy red bumps (Drug reaction with Eosinophilia and Systemic symptoms (DRESS))
  • skin eruption that is characterised by the rapid appearance of areas of red skin studded with small pustules (small blisters filled with white/yellow fluid). (Acute Generalized Exanthematous Pustulosis (AGEP)).

Stop taking azithromycin if you develop these skin symptoms and contact your doctor or seek medical attention immediately.

Other side effects that may occur when taking Zedbac are listed below. These may go away during treatment as your body adjusts to the medicine. Tell your doctor if any of these side effects continue to bother you.

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

• stomach cramps, feeling sick, diarrhoea, wind

Common (may affect up to 1 in 10 people) side effects are:

• dizziness, headache
• numbness or pins and needles
• being sick, indigestion
• loss of appetite, taste disturbance
• visual disturbances, deafness
• joint pain
• low numbers of lymphocytes (a type of white blood cell), higher number of eosinophils (a type of white blood cell)
• low blood bicarbonate
• tiredness or weakness

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

• yeast infections of the mouth and vagina (thrush)
• low numbers of leukocytes (a type of white blood cell), low number of neutrophils (a type of white blood cell)
• skin more sensitive to sunlight than normal
• feeling nervous
• reduced sense of touch or sensation (hypoesthesia)
• sleepiness or sleeplessness (insomnia)
• poor hearing or ringing in the ears
• heart palpitations, chest pain
• constipation, stomach pain associated with diarrhoea and fever
• inflammation of the liver (hepatitis), changes in liver enzymes
• general loss of strength
• swelling
• general discomfort
• abnormal laboratory test values (e.g. blood or liver tests)

Rare (may affect up to 1 in 1,000 people) side effects are:

• agitation
• vertigo
• changes in liver function

Not known (frequency cannot be estimated from the available data) side effects are:

• fits or fainting
• aggression or anxiety
• feeling hyperactive
• localised muscle weakness
• loss of smell or altered sense of smell, loss of taste
• tongue discolouration
• inflammation of the pancreas (pancreatitis)
• inflammation of the kidney or kidney failure
• yellowing of the skin or eyes (jaundice) or liver failure (rarely life-threatening)
• bruising or prolonged bleeding after injury
• abnormal electrocardiogram (ECG)
• reduction in red blood cells which can make the skin pale and cause weakness or breathlessness

Local injection site reactions (inflammation/pain) have been reported with the intravenous administration of azithromycin.

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 (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 azithromycin (as dihydrate). Each vial contains 500mg of azithromycin (equivalent to 524.1mg azithromycin dihydrate).
• The other ingredients are: citric acid and sodium hydroxide 31% (for pH adjustment).

Zedbac is a free white powder, for solution for infusion. It comes in a 12ml glass single dose vial, colourless with rubber stopper and sealed with aluminium/plastic flip-off cap.

The appearance of the product after reconstitution is a colourless and clear solution and leaves no visible undissolved matter.

Zedbac is available in the following pack sizes:

Pack with 1 vial.

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