Azithromycin 500 mg powder for concentrate for solution for infusion – patient leaflet, side effects, dosage

1. What Azithromycin is and what it is used for

Azithromycin contains the active substance azithromycin. Azithromycin is an antibiotic that belongs to a group of antibiotics known as macrolides, which block the growth of susceptible bacteria.

Azithromycin is used for the treatment of the following infections in adults:

• Pneumonia (community-acquired pneumonia, not contracted in a hospital)
• Bacterial infection of the womb, fallopian tubes and ovaries (pelvic inflammatory disease) always in combination with another antibiotic(s) that is selected by your doctor or pharmacist.

2. What you need to know before Azithromycin is given

Do not use Azithromycin

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

Talk to your doctor or, pharmacist before using Azithromycin 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 Azithromycin. 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 Azithromycin.
• 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.

Superinfection

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

Sexually transmitted infections

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.

Children and adolescents

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.

Other medicines and Azithromycin

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

Using Azithromycin 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)

Pregnancy and breast-feeding

If you are pregnant or breastfeeding, 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

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

Driving and using machines

Azithromycin has a moderate influence on the ability to drive and use machines. Azithromycin 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.

Azithromycin contains sodium

This medicine contains 120 mg sodium (main component of cooking/table salt) in each vial. This is equivalent to 6% of the recommended maximum daily dietary intake of sodium for an adult.

3. How to use Azithromycin

This medicine is administered once daily. It will be administered by a healthcare professional as an infusion into a vein over 3 hours or 1 hour. If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

The recommended dosing regimens for adult patients are shown in the table below.

Package leaflet: Information for the patient Azithromycin 500 mg powder for concentrate for solution for infusion

Posology and method of administration

The recommended daily dose for treating community-acquired pneumonia requiring hospitalisation in adults amounts to 500 mg daily as a single intravenous dose for at least 2 days. The attending doctor should determine the timing of the changeover from intravenous to oral therapy with Azithromycin 500 mg depending on the clinical response.

The total duration of treatment should be determined by the attending doctor depending on the clinical response and should be 7–10 days.

Use in children and adolescents

The efficacy and tolerability of Azithromycin. in the treatment of infections in children and adolescents have not been studied.

Route of administration

Azithromycin is intended for intravenous use (infusion) after dissolution of the powder and dilution.

Azithromycin must not be given as an intravenous bolus or as an intramuscular injection.

Infusion should be carried out at a concentration of either 1 mg/ml over 3 hours or 2 mg/ml over 1 hour. Preparation of the infusion solution

Dissolution of the powder

To prepare the infusion solution, add 4.8 ml sterile water for injection to a 500 mg vial (using a standard

5 ml syringe so the volume of water of 4.8 ml can be measured accurately) and shake the vial until the powder is completely dissolved. Each ml of the solution prepared in this way contains 100 mg azithromycin.

If particles are found on visual inspection of the prepared solution, the solution should not be used. Before administration, the solution should be diluted as described below.

Dilution of the infusion solution

To obtain a concentration of 1.0 mg/ml, 5 ml of the 100 mg/ml solution should be diluted to 500 ml with one of the solvents listed below.

To obtain a concentration of 2.0 mg/ml, 5 ml of the 100 mg/ml solution should be diluted to 250 ml with one of the solvents listed below.

Solvents for dilution

• 0.9% Sodium Chloride Injection
• 0.45% Sodium Chloride
• 5% Dextrose in Water
• Lactated Ringer’s Injection
• 5% Dextrose in 0.45% Sodium Chloride Injection with 20 mEq Potassium Chloride
• 5% Dextrose in Lactated Ringer’s Injection
• 5% Dextrose in 0.3% Sodium Chloride Injection
• 5% Dextrose in 0.45% Sodium Chloride Injection The dose of 500 mg azithromycin prepared as described above should be administered over an infusion period of at least 60 minutes.

The following information is intended for healthcare professionals only: Method of administration

The recommended route of administration is by intravenous infusion only after reconstitution and dilution. This medicine should be reconstituted and diluted according to the instructions. Do not administer as an intravenous bolus or an intramuscular injection. The solution concentration and rate of infusion should be either 1 mg/ml over 3 hours or 2 mg/ml over 1 hour. A dose of 500 mg azithromycin should be infused for a minimum duration of 1 hour.

If you are given more Azithromycin than you should

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 Azithromycin than you should are vomiting, diarrhoea, stomach pain and nausea.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects

Stop using Azithromycin 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)).

Other side effects

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

Reporting of side effects

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.

5. How to store Azithromycin

No special storage conditions are required for storing the powder for preparing an infusion solution.

After reconstitution, the preparation has been demonstrated to have a chemical and physical shelf life of 24 hours at 30°C. On dilution in accordance with the instructions, the diluted solution can be stored for 24 hours at a temperature of 30°C and for 7 days if stored is a refrigerator between 2°C and 8°C). From a microbiological standpoint, however, the preparation should be used immediately. If the solution is not used immediately, responsibility for the storage time and storage conditions lies with the user, but storage should not exceed 24 hours at 2 to 8°C, unless reconstitution was carried out under controlled and validated aseptic conditions.

Do not use this medicine if you notice that the visual appearance has changed (e.g. the solution is not free from visible particles).

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is shown on the label and outer carton. The expiry date refers to the last day of the stated month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Azithromycin contains

• The active substance is azithromycin dihydrate. One vial contains 500 mg azithromycin (as dihydrate) for producing a 100 mg/ml solution.
• The other ingredients are citric acid and sodium hydroxide.

What Azithromycin looks like and contents of the pack

10ml glass vial containing white to off-white powder with a rubber stopper and aluminium cap.

Hospital packs containing 1 vial

Marketing Authorisation Holder

Kensington Pharma Limited,

Unit A Newlands House, 60 Chain House Lane, Whitestake, Preston, Lancashire, PR4 4LG, United Kingdom.

Manufacturer

Northumbria Pharma Ltd., NETPark, Discovery 1, William Armstrong Way, Sedgefield, Stockton-on-Tees, TS21 3FH, United Kingdom.

This leaflet was last revised in October 2025

Specific dosage instructions

Use in patients with renal impairment

No dose adjustment is required in patients with mild to moderate renal impairment (GFR 10–80 ml/min). Caution should be exercised in patients with severe renal impairment (GFR < 10 ml/min).

Use in patients with hepatic impairment The same dose may be used with caution in patients with mild to moderate hepatic impairment as in patients with normal hepatic function.

Since azithromycin is excreted primarily via the liver, its use in patients with severe hepatic impairment is not recommended.

Use in patients with renal and hepatic impairment Use of Azithromycin is not recommended in patients with renal and hepatic impairment since no corresponding data is available.

Use in dialysis patients

Use of Azithromycin is not recommended in dialysis patients since no corresponding data is available. Use in elderly patients

No dose adjustment is required in elderly patients. Since elderly patients may possibly suffer from proarrhythmic disorders, particular caution should be taken due to the risk of the development of cardiac arrhythmias and torsade de pointes (see section 4.4).

Incompatibilities

After dissolution of the powder, Azithromycin can be diluted in accordance with the instructions in the above section “Preparation of the infusion solution” using the listed solvents. Other intravenously administered substances, additives or medicines should neither be added to the infusion solution nor administered simultaneously with it via the same infusion line.

Shelf life

Powder for preparing an infusion solution: 24 months. After reconstitution, the preparation has been demonstrated to have a chemical and physical shelf life of 24 hours at 30°C. On dilution in accordance with the instructions, the diluted solution can be stored for 24 hours at a temperature of 30°C and for 7 days if stored is a refrigerator between 2°C and 8°C). From a microbiological standpoint, however, the preparation should be used immediately. If the solution is not used immediately, responsibility for the storage time and storage conditions lies with the user, but storage should not exceed 24 hours at 2 to 8°C, unless reconstitution was carried out under controlled and validated aseptic conditions.