Azithromycin 500 mg Tablets – patient leaflet, side effects, dosage

1. WHAT AZITHROMYCIN TABLETS ARE AND WHAT THEY ARE USED FOR

Azithromycin is an antibiotic. It belongs to a group of antibiotics called macrolides. It is used to treat infections caused by bacteria.

This medicine is usually prescribed to treat:

• chest infections such as chronic bronchitis, pneumonia
• infections of the tonsils, throat (pharyngitis) and sinuses
• ear infections (acute otitis media)
• skin and soft tissue infections, with exception of infected burn wounds
• urethra and cervix infections caused by chlamydia.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE AZITHROMYCIN TABLETS

Do not take this medicine if you are allergic (hypersensitive) to:

• azithromycin
• erythromycin
• any other macrolide or ketolide antibiotic
• any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before taking Azithromycin Tablets:

• Sometimes, allergic reactions (itching, rash) may occur as a result of using Azithromycin But if a serious allergic reaction occurs, you will notice it in the form of quickly developing swelling of the face and in the throat (angioedema), which causes a stuffy feeling, or by suddenly getting very sick (shock). High fever, skin rash, blisters on the skin, peeling of the skin, joint pain and/or inflammation of the eye (Stevens-Johnson syndrome, toxic epidermal necrolysis, DRESS syndrome or acute generalised exanthematous pustulosis) may also be signs of serious allergic.
• If you have a liver disease, inform your doctor before you start using Azithromycin. During the use of Azithromycin, cases of very severe inflammation of the liver have occurred, which can lead to lifethreatening decreases in the action of the liver. Tell your doctor immediately in case of signs such as: rapidly developing physical weakness (asthenia), combined with jaundice, dark urine, bleeding tendency, reduced level of consciousness (hepatic encephalopathy). Your doctor will examine your liver functions and probably have you stop taking Azithromycin.- Kidney problems: if you have severe kidney problems, the dose may have to be adjusted.
• Nervous (neurological) or mental (psychiatric) problems.
• A certain type of muscle weakness called myasthenia gravis
• If you had infections with azithromycin, erythromycin, lincomycin and/or clindamycin resistant pathogens or methicillin resistant staphylococci (possibility of cross-resistance)

Since azithromycin may increase the risk of abnormal heart rhythm please tell your doctor if you have any of the following problems before taking this medicine:

• Heart problems such as a weak heart (heart failure), very slow heart rate, irregular heart beat, or something called “long QT syndrome” (found by an electro-cardiogram)
• Low potassium or magnesium in your blood.

If you develop diarrhoea or loose stools during or after treatment, tell your doctor at once. Do not take any medicine to treat your diarrhoea without first checking with your doctor. If your diarrhoea continues, please inform your doctor.

Tell your doctor

• if you notice that your symptoms aggravate during or shortly after your treatment (possibility of superinfection/resistance)

Azithromycin is not suitable to treat severe infections, where high blood concentrations of antibiotic have to be rapidly achieved.

Children and adolescents up to age 18 years

If tablets are difficult to take, for example by small children, the use of Azithromycin suspension may be considered. The tablet form of Azithromycin is not suitable for children weighing less than 45 kg. If you give this medicine to a newborn baby (less than 6 weeks old) and he/she vomits or seems irritated during feeding, tell your doctor immediately.

Other medicines and Azithromycin Tablets

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes any medicines obtained without a prescription. It is especially important to mention before taking this medicine:

• Theophylline (used to treat asthma): the effect of theophylline may be increased.
• Warfarin or any similar medicine to prevent blood clots: concomitant use can increase the risk of bleeding.
• Ergotamine, dihydroergotamine (used to treat migraine): ergotism (ie. itching in the limbs, muscle cramps and gangrene of hands and feet due to poor blood circulation) may occur. Concomitant use is therefore not recommended.
• Cyclosporin (used to suppress the immune system to prevent and treat rejection of an organ or bone marrow transplant): if concomitant use is required, your doctor will check your blood levels regularly and may adapt the dose.
• Digoxin (for heart failure): digoxin levels may increase. Your doctor will check your blood levels.
• Colchicine (used for gout and familial Mediterranean fever): the amount of colchicine in the blood must be checked more often, and the colchicine dose changed if necessary
• Antacids (for indigestion): see section 3
• Cisapride (for stomach problems), terfenadine (used to treat hay fever), pimozide (used in some mental diseases), citalopram (used in depression), fluoroquinolones (antibiotics such as moxifloxacin and levofloxacin, used in bacterial infections): concomitant use with azithromycin may cause heart disorders, therefore is not recommended.
• Medicines for irregular heart beat (called anti-arrythmics).
• Zidovudine (used to treat HIV infections): concomitant use can increase the risk of side effects.
• Nelfinavir (used to treat HIV infections): concomitant use can increase the side effects of azithromycin.
• Alfentanil (used for narcosis) or astemizol (used to treat hay fever): concomitant use with azithromycin may increase the effect of these medicinal products.
• Rifabutin (used to treat tuberculosis): Your doctor may check your blood and blood levels of the medicines.
• Statins (such as atorvastatin, used to lower lipids in blood): concomitant use may cause muscle disorders.
• Certain medicines (such as hydroxychloroquine) known to cause abnormal heart rhythm i.e., prolonged QT interval found by an electrocardiogram: concomitant use may increase the risk of arrhythmia.
• Coumarin anticoagulants (blood thinners that prevent blood clotting); although the bloodthinning effect of the coumarin medicines does not seem to be affected by Azithromycin, it may be necessary for your blood clotting to be checked more often by the thrombosis service and the dose changed.

Azithromycin Tablets with food and drink

The tablets may be taken with or without food.

Pregnancy and breast-feeding

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 taking 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.

Breastfeeding:

Azithromycin has been reported to be excreted in human milk. No serious adverse reactions of azithromycin were observed in infants.

Driving and using machines

This medicine may cause side effects such as visual impairment, blurred vision, dizziness and sleepiness. This may have an effect on the ability to drive and operate machinery.

Azithromycin Tablets contain lactose and sodium

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.

3. HOW TO TAKE AZITHROMYCIN TABLETS

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. These doses are for adults and children weighing more than 45 kg. Children weighing less than this should not take these tablets. Suspension is available, which will allow for accurate doses in ml.

The recommended dose is:

Azithromycin Tablets is taken as a 3 or 5 day course

• 3 day course: Take 500 mg (two 250 mg or one 500 mg tablet) once each day

• 5 day course:

  • Take 500 mg on Day 1 (two 250 mg tablets)
  • Take 250 mg (one 250 mg tablet) on Days 2, 3, 4 and 5.

For urethra & cervix infections caused by chlamydia, it is taken as a 1 day course:

• 1 day course: 1,000 mg (four 250 mg tablets or two 500 mg tablets). Take the tablets together on one day only.

Elderly

For elderly patients, a doctor will prescribe the same dose as for adults.

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.

Swallow these tablets with a drink of water.

• You can take these tablets with or without food.
• Swallow 250 mg tablet as whole
• Divide 500 mg tablet in two equal halves if required

Taking Azithromycin Tablets with medicines for indigestion

If you need to take a medicine for indigestion, such as an antacid, take your tablets with an interval of two hours before or after antacid.

If you forget to take Azithromycin Tablets:

If you forgot to take a dose, take it as soon as possible. Then go on as before. Do not take more than one dose in a single day.

If you take more Azithromycin Tablets than you should:

If you take too many tablets you may feel unwell. You also may experience other side effects such

as temporary deafness, nausea, vomiting and diarrhoea. Tell your doctor or talk to your nearest hospital casualty department immediately. If possible, take your tablets or the box with you to show the doctor what you have taken.

If you stop taking Azithromycin Tablets:

Always keep taking the tablets until the course is finished, even if you feel better. If you stop taking the tablets too soon, the infection may come back.

Also, the bacteria may become resistant to the medicine and will then be more difficult to treat. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

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

Serious side effects:

If you have any of the following symptoms of a severe allergic reaction stop taking this medicine and tell your doctor immediately or go to the casualty department at your nearest hospital:

• sudden difficulty in breathing, speaking and swallowing
• swelling of the lips, tongue, face and neck
• extreme dizziness or collapse
• severe or itchy skin rash, especially if this shows blistering and there is soreness of the eyes, mouth or genital organs

If you experience any of the following side effects contact your doctor as soon as possible:

• diarrhoea that is serious, lasts a long time or has blood in it, with stomach pain or fever. This can be a sign of a serious bowel inflammation. This is something that can rarely happen after taking antibiotics.
• yellowing of the skin or whites of the eyes caused by liver problems
• inflammation of the pancreas, which causes severe pain in the abdomen and back.
• increased or reduced urine output, or traces of blood in your urine caused by kidney problems
• skin rash caused by sensitivity to sunlight
• unusual bruising or bleeding
• irregular or rapid heart beat

These are all serious side effects. You may need urgent medical attention. Serious side effects are uncommon (may affect up to 1 in 100 people), rare (may affect up to 1 in 1,000 people) or the frequency cannot be estimated from the available data.

Other possible side effects:

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

• diarrhoea, abdominal pain, nausea, gassiness (flatulence)

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

• headache
• vomiting, stomach upset, stomach cramps, feeling sick
• low numbers of lymphocytes (type of white blood cells), higher number of eosinophils (type of white blood cells), low blood bicarbonate, higher number of basophils, monocytes and neutrophils (types of white blood cells),
• taste disturbance (dysgeusia)
• dizziness
• drowsiness
• sensation of pins and needles, itching or tingling without a reason for this (paraesthesia)
• visual disturbances
• deafness
• skin rash, itching (pruritus)
• belching and burning stomach acid (dyspepsia)
• joint pain (arthalgie)
• fatigue

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

• yeast and bacterial infections especially of the mouth, throat, nose, lung, bowel and vagina
• low numbers of leukocytes (type of white blood cells), low number of neutrophils (type of white blood cells), higher number of eosinophils (type of white blood cells)
• swelling, allergic reactions of various severity (angiooedema)
• loss of appetite (anorexia)
• nervousness, sleeplessness, tingling or numbness of the hands or feet
• spinning sensation (vertigo)
• pounding heart beat
• sweating (hot flush)
• difficulty breathing, nose bleeds
• constipation, wind, indigestion, inflammation of the stomach, difficulty in swallowing, bloating, dry mouth, eructation, mouth sores, increased salivary flow
• inflammation of the liver, abnormal liver function
• inflammation of the skin, dry skin, sweating
• Stevens-Johnson syndrome
• joint inflammation, muscle, back and neck pains
• difficulty and pain when passing urine, kidney pain
• uterine bleeding, testis disorder
• skin swelling, weakness, swelling of the face, chest pain, fever, pain
• abnormal laboratory test values (e.g. blood, liver and kidney function test results)
• problems after treatment
• inflammation of the throat (pharyngitis)
• hearing problems, ringing in the ears (tinnitus)
• hypersensitivity to light or sunlight, possibly with development of skin abnormalities (photosensitivity reaction)
• reduced sensory sensitivity (hypoesthesia)

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

• irritability
• jaundice
• agitation
• skin eruptions that is characterised by the rapid appearance of areas of red skin studded with small pustules (small blisters filled with white/yellow fluid)
• A delayed allergic reaction (up to several weeks after exposure) with rash and other possible symptoms such as swelling of the face, swollen glands and abnormal test results (e.g. liver tests and raised levels of some white blood cells) (Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS))

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

• reduction in blood platelets, which increases risk of bleeding or bruising
• reduction in red blood cells which can make the skin pale yellow and cause weakness or breathlessness
• feelings of aggression, anxiety, severe confusion, hallucination
• fits, fainting, feeling hyperactive, disturbed sense of smell, loss of sense of smell or taste, muscle weakness (myasthenia gravis)
• abnormal electrocardiogram (ECG, arrhythmia)
• low blood pressure
• staining of the tongue, discolouration of the teeth
• hepatic failure, serious liver inflammation
• renal failure, renal inflammation
• toxic epidermal necrolysis
• Erythema multiforme
• Severe allergic reaction

The following side effects have been reported in prophylaxis and treatment against Mycobacterium Avium Complex (MAC):

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

• Diarrhoea
• Abdominal pain
• Feeling sick (nausea)
• Loose wind (flatulence)
• Abdominal discomfort
• Loose stools

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

• Lack of appetite (anorexia)
• Feeling dizzy (dizziness)
• Headache
• Sensations of pins and needles or numbness (paraesthesia)
• Changes in your sense of taste (dysgeusia)
• Visual impairment
• Deafness
• Skin rashes
• Itching (pruritus)
• Joint pain (arthralgia)
• Fatigue

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

• Reduced sense of touch (hypoesthesia)
• Hearing impairment or ringing in your ears (tinnitus)
• Abnormality of the rhythm or rate and awareness of the heart beat (palpitations)
• Liver problems such as hepatitis
• Blisters/bleeding of the lips, eyes, nose, mouth and genitals, which may be caused by Stevens- Johnson syndrome
• Allergic skin reactions such as being sensitive to sunlight, red, flaking and swollen skin
• Weakness (asthenia)
• General feeling of being unwell (malaise)

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme (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 TABLETS

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

Do not use this medicine after the expiry date which is stated on the carton after ‘EXP’. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

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 Tablets contains

The active substance is azithromycin.

• Each film-coated tablet contains 500 mg of azithromycin (as dihydrate).

• The other ingredients are:

  Core: cellulose, microcrystalline, starch, pregelatinised, sodium starch glycolate Type A, silica, colloidal anhydrous, sodium laurilsulfate, magnesium stearate

  Coating: hypromellose, titanium dioxide (E 171), lactose monohydrate, macrogol 4000.

What Azithromycin Tablets looks like and contents of the pack

Azithromycin 500 mg Tablets are white to off-white, oblong, film-coated, deep break line on one side and scoreline on other side. The tablet can be divided into equal doses.

The 500 mg tablets are packed in the following pack sizes:

Carton box with blister(s) containing: 2, 3, 6, 12, 24, 30, 50, or 100 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing authorisation holder:

Sandoz Limited, Park View, Riverside Way, Watchmoor Park, Camberley, Surrey , GU15 3YL, United Kingdom

Manufacturer: Sandoz GmbH, Biochemiestraße 10, 6250 Kundl, Austria or Lek d.d. Pharmaceuticals, Verovškova 57, 1526 Ljubljana, Slovenia

or Novartis Pharmaceuticals S.R.L., Livenzeni Street no 7A, Targu Mures, RO – 540472, Romania.

This leaflet was last revised in 01/2025.