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 Zedbac is given
3. How to use Zedbac
4. Possible side effects
5. How to store Zedbac
6. Contents of the pack and other information

• if you are allergic to azithromycin, erythromycin, any macrolide or ketolide antibiotic, or any of the ingredients of this medicine (listed in section 6).

Talk to your doctor, or pharmacist before using Zedbac if you have or have had any of the following conditions:

• heart problems (e.g. problems with your heart rhythm or cardiac insufficiency) or low levels of potassium or magnesium in your blood: these conditions may contribute to serious cardiac side effects of azithromycin
• liver problems: your doctor may need to monitor your liver function or stop the treatment
• severe diarrhoea after administration of any other antibiotics
• localised muscle weakness (myasthenia gravis), as the symptoms of this disease may worsen during treatment
• or if you are taking any ergot derivatives such as ergotamine (used to treat migraine) as these medicines should not be used together with Zedbac.

Stop using this medicine and contact your doctor immediately (see also “Serious side effects” in section 4):

• if you feel you are having an allergic reaction (e.g. difficulty in breathing, swelling of the face or throat, rash, blistering)
• if you notice any of the symptoms as described in section 4 related to serious skin reactions including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS) and acute generalised exanthematous pustulosis (AGEP), which have been reported in association with azithromycin treatment
• if you feel you have an abnormal heartbeat or palpitations, get dizzy or faint when receiving Zedbac
• if you develop signs of liver problems (e.g. dark urine, loss of appetite or yellowing of the skin or whites of the eyes)
• if you develop severe diarrhoea during or after treatment. Do not take any medicine to treat your diarrhoea without first checking with your doctor. If your diarrhoea continues or reappears within the first weeks after treatment, please also inform your doctor.

Your doctor may observe you for signs of additional bacterial or fungal infections that cannot be treated with Zedbac (superinfection).

Your doctor may test for and exclude a potential infection with syphilis, a sexually transmitted disease that may otherwise progress undetected and be diagnosed delayed. Furthermore, in any case of sexually transmitted bacterial infections your doctor will initiate laboratory follow-up tests to monitor the success of therapy.

If your child is under 12 years of age or if you are an adolescent (aged 12 to less than 18 years) do not use this medicinal product as its efficacy and safety have not been studied.

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

Using Zedbac at the same time as some other medicines may result in side effects. Therefore, it is particularly important that you tell your doctor if you are using any of the following medicines:

• Atorvastatin and other medicines from the statins group (to lower blood cholesterol and prevent heart disease, including heart attacks and strokes).
• Ciclosporin (to prevent rejection of organ transplants by the body).
• Colchicine (to treat gout and familial Mediterranean fever).
• Dabigatran (to prevent and treat blood clot formation (anticoagulant)).
• Digoxin (to treat heart diseases).
• Warfarin or similar medicines used to thin the blood (anticoagulants).
• Medicines that may cause the heart muscle to take longer to contract and relax than usual (QT prolongation), such as the following:
  • Quinidine, procainamide, dofetilide, amiodarone and sotalol (to treat an irregular heartbeat, including a too fast or too slow heartbeat - cardiac arrhythmia).
  • Pimozide (to treat mental illness).
  • Citalopram (to treat depression).
  • Moxifloxacin and levofloxacin (antibiotics).
  • Cisapride (to treat disorders in the gastrointestinal tract).
  • Hydroxychloroquine or chloroquine (to treat autoimmune diseases including rheumatoid arthritis, or to treat or prevent malaria).

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

Pregnancy

Your doctor will decide if you should take this medicine during pregnancy, only after making sure that the benefits outweigh the potential risks.

Breast-feeding

Zedbac passes into breast milk. Your doctor will decide therefore whether you should stop breast-feeding or should avoid treatment with Zedbac taking into account both the benefit of breast-feeding for your child and the benefit of therapy for you.

Zedbac has a moderate influence on the ability to drive and use machines. Zedbac has been reported to cause dizziness, drowsiness and seizures, as well as problems with seeing and hearing in some people. These possible side effects may have an influence on your ability to drive and use machines.

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.

Your doctor will decide how to treat you, including stopping the treatment and monitoring for signs of ill effects. The most common side effects of having been given more Zedbac than you should are vomiting, diarrhoea, stomach pain and nausea.

Stop using Zedbac and seek medical attention immediately if you notice any of the following symptoms:

• sudden wheeziness, difficulty in breathing, swelling of eyelids, face or lips, rash or itching especially affecting the whole body (anaphylactic reaction, frequency not known)
• rapid or irregular heartbeat (cardiac arrhythmia or torsades de pointes tachycardia, frequency not known)
• dark urine, loss of appetite or yellowing of the skin or whites of the eyes, which are signs of liver disorders (hepatic failure or hepatic necrosis (frequency not known), hepatitis (uncommon: may affect up to 1 in 100 people))
• severe diarrhoea with abdominal cramps, bloody stools and/or fever may mean that you have an infection of the large intestine (antibiotic-associated colitis, frequency not known). Do not take medicines against diarrhoea that inhibit the bowel movements (antiperistaltics)
• reddish non-elevated, target-like or circular patches on the trunk, often with central blisters, skin peeling, ulcers of mouth, throat, nose, genitals and eyes. These serious skin rashes can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome or toxic epidermal necrolysis, frequency not known)
• widespread rash, high body temperature and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome, rare (may affect up to 1 in 1,000 people))
• a red, scaly widespread rash with bumps under the skin and blisters accompanied by fever. The symptoms usually appear at the initiation of treatment (acute generalised exanthematous pustulosis, rare (may effect up to 1 in 1,000 people)).

Very common (may affect more than 1 in 10 people)

• diarrhoea
• abdominal discomfort.

Common (may affect up to 1 in 10 people)

• headache
• being sick (vomiting), stomach pain, feeling sick (nausea)
• changes in blood test results (lymphocyte count decreased, eosinophil count increased, basophil count increased, monocyte count increased, neutrophil count increased, blood bicarbonate decreased)
• pain at the injection site
• inflammation at the injection site.

Uncommon (may affect up to 1 in 100 people)

• thrush (candidiasis) - a fungal infection of the mouth and vagina, other fungal infections
• pneumonia, bacterial infection of the throat, inflammation of the gastrointestinal tract, respiratory disorder, inflammation of the mucous membrane inside the nose, vaginal infection
• changes in the number of white blood cells (leukopenia, neutropenia, eosinophilia)
• platelet count increased
• reduction in the proportion of all blood cells in the total blood volume (hematocrit decreased)
• allergic reactions, swelling of the hands, feet and face (angiooedema)
• lack of appetite
• nervousness, difficulty sleeping (insomnia)
• feeling dizzy, feeling drowsy (somnolence), change in your sense of taste (dysgeusia), sensation of pins and needles or numbness (paraesthesia)
• impaired vision
• ear disorder
• spinning sensation (vertigo)
• feeling your heartbeat (palpitations)
• hot flush
• sudden wheeziness, bleeding from the nose
• constipation, wind, impaired digestion (dyspepsia), inflammation of the lining of the stomach (gastritis), difficulty in swallowing (dysphagia), swollen belly, dry mouth, belching (eructation), mouth ulceration, increased salivation
• rash, itching, hives (urticaria), dermatitis, dry skin, abnormally increased sweating (hyperhidrosis)
• swelling and pain in the joints (osteoarthritis), muscle pain, back pain, neck pain
• painful urination (dysuria), kidney pain
• menstrual bleeding at irregular intervals (metrorrhagia), testicular disorder
• swelling due to fluid retention, especially of the face, ankles and feet (oedema, face oedema, peripheral oedema)
• weakness, tiredness, general feeling of being unwell, fever
• chest pain, pain
• abnormal laboratory test results (e.g. blood or liver tests)
• post procedural complication.

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

• feeling irritated
• liver problems, yellowing of the skin or eyes
• increased sensitivity to sunlight.

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

• reduced number of red blood cells due to increased cell breakdown which can cause tiredness and pale skin (haemolytic anaemia)
• reduction in number of blood platelets which can lead to bleeding and bruising (thrombocytopenia)
• feeling angry, aggressive, feeling of fear and concern (anxiety), acute confusional state (delirium)
• hallucination
• fainting (syncope)
• fits (seizures)
• reduced sensation to touch, pain and temperature (hypoaesthesia)
• feeling hyperactive
• change in your sense of smell (anosmia, parosmia)
• total loss of your sense of taste (ageusia)
• muscle weakness (myasthenia gravis)
• abnormal electrocardiogram (ECG) heart tracing (QT prolongation)
• deafness, reduced hearing or ringing in your ears (tinnitus)
• low blood pressure
• inflammation of the pancreas causing severe pain in the belly and back (pancreatitis)
• change in tongue colour
• joint pain (arthralgia)
• kidney inflammation (interstitial nephritis) and kidney failure.

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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