Patient leaflet - Azithromycin 250 mg tablets
1 What Azithromycin is and what it is 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
Do not take Azithromycin if you are allergic 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 if you have:
- Liver problems: your doctor may need to monitor your liver function or stop the treatment.
- Kidney problems: if you have severe kidney problems, the dose may have to be adjusted.
- Nervous (neurological) or mental (psychiatric) problems
- Heart problems such as a
- weak heart (heart failure),
- very slow heart rate,
- irregular heart beat, or
- a condition called “long QT syndrome” (found by an electrocardiogram) since azithromycin may increase the risk of abnormal heart rhythm.
- Low potassium or magnesium levels in your blood
- Myasthenia gravis, a certain type of muscle weakness
- If you had infections with azithromycin, erythromycin, lincomycin and/or clindamycin resistant pathogens or methicillin resistant staphylococci (possibility of cross-resistance)
Tell your doctor immediately:
- if you develop diarrhoea or loose stools during or after treatment Do not take any medicine to treat your diarrhoea without first checking with your doctor. If your diarrhoea continues, please inform your doctor.
- if you feel your heart beating in your chest or have an abnormal heartbeat, get dizzy or faint, or suffer from muscle weakness when taking Azithromycin.
- if you feel you are having an allergic reaction (e.g. difficulty in breathing, dizziness, swelling of the face or throat, rash, wheals, blistering). Stop taking this medicine and seek urgent medical advice.
- if you develop signs of liver problems (e.g. dark urine, profound loss of appetite or yellowing of the skin or whites of the eyes) Stop taking this medicine and seek urgent medical advice.
- if you are giving this medicine to an infant (less than 6 weeks of age) and they vomit or become irritable when fed
- if you notice that your symptoms aggravate during or shortly after your treatment (possibility of superinfection/resistance)
Other medicines and Azithromycin
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 that you take:
- Theophylline (used to treat asthma): the effect of theophylline may be increased
Blood-thinning medicines, such as warfarin, phenprocoumon:
concomitant use may increase the risk of bleeding. Your doctor may need to monitor more often the blood clotting parameters when Azithromycin is also being used.
Ergotamine, dihydroergotamine (used to treat migraine):
ergotism (i.e. 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 cyclosporine levels in your blood and may adapt the dose.
Digoxin (used for heart failure):
concomitant use may increase digoxin levels. Your doctor will check its levels in your blood.
- Colchicine (used for gout and familial Mediterranean fever)
- Antacids (used for indigestion): may make azithromycin less effective when used concomitantly see section 3. Azithromycin should be taken one hour before, or two hours after taking antacids.Fluconazole (for treating fungal infections)
Cisapride (used 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.
- Certain medicines for irregular heart beat (called anti-arrythmics, such as quinidine, amiodarone, sotalol). Concomitant use is not recommended.
- Zidovudine (used to treat HIV infections): concomitant use can increase the risk of side effects
- Nelfinavir (used to treat HIV infections): concomitant use may increase the risk of side effects.
- 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.
- 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.
Azithromycin with food and drink
The tablets may be taken with or without food.
Pregnancy, breast-feeding and fertility
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 or any other medicine.
You should not use this medicine during pregnancy and when you are breast-feeding unless your doctor has specifically recommended it.
Driving and using machines
Azithromycin is unlikely to impair the ability to drive and operate machinery. Visual impairment and blurred vision may have an effect on a patient’s ability to drive or operate machinery.
However, if side effects like dizziness, sleepiness or convulsions occur, be careful when driving or operating machinery.
Azithromycin contains lactose.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Azithromycin contains sodium.
This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.
3 How to take Azithromycin
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is:
Adults, adolescents and children weighing more than 45 kg:
Azithromycin is taken as a 3 day course.
Azithromycin 250 mg
- 3 day course: Take 2 tablets once each day
For urethra and cervix infections caused by Chlamydia, it is taken as a 1 day course:
- 1 single dose of 4 tablets (1,000 mg azithromycin).
Use in children
Children and adolescents weighing less than 45 kg should not take these tablets. Azithromycin in other pharmaceutical forms, e.g. oral suspensions, are preferred for these patients.
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.
Dosage for elderly
For elderly the same dosage as for adults applies.
Method of administration
Swallow these tablets once daily with a drink of water. The tablets can be divided in to equal halves if required.You can take the tablets with or without food.
Taking Azithromycin with medicines for indigestion
If you need to take a medicine for indigestion, such as an antacid, take Azithromycin at least one hour before or two hours after the antacid.
If you take more Azithromycin than you should
If you take too many tablets you may feel unwell or be sick. 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 forget to take Azithromycin
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 stop taking Azithromycin
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 eyelids, 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
- 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)
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, 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
- Skin rash caused by sensitivity to sunlight
- Unusual bruising or bleeding
- Irregular 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
Common side-effects (may affect up to 1 in 10 people):
- Headache
- Nausea, vomiting, abdominal pain
- Changes in number of white blood cells (low numbers of lymphocytes, higher number of eosinophils, higher number of basophils, monocytes and neutrophils
- Decreased blood bicarbonate (what indicates too much acidic substances in blood)
Uncommon side-effects (may affect up to 1 in 100 people):
- Yeast and bacterial infections especially of the mouth, throat, nose, lung, stomach, bowel and vagina
- Changes in number of white blood cells (low numbers of leukocytes, low number of neutrophils, higher number of eosinophils)
- Swelling, allergic reactions of various severity
- Loss of apetite (anorexia)
- Nervousness, insomnia, drowsiness, sleeplessness, dizziness, taste disturbance, tingling or numbness of the hands and/or feet
- Visual disturbances
- Impaired hearing, spinning sensation (vertigo)
- Pounding heart beat
- Feeling of intense heat with sweating and rapid heartbeat (hot flush)
- Difficulty breathing, nose bleeds
- Constipation, wind, indigestion, inflammation of the stomach, difficulty in swallowing, bloating, dry mouth, eructation, mouth sores, increased formation of saliva
- inflammation of the liver (hepatitis)
- Skin rash, itching, hives, skin inflammation, dry skin, sweating
- Bones and joint inflammation, muscle, back and neck pains
- Difficulty and pain when passing urine, kidney pain
- Uterine bleeding, testis disorder
- Skin swelling, weakness, generally feeling unwell, tiredness, swelling of the face, chest pain, fever, pain, swelling of extremities
- Abnormal laboratory test values (e.g. blood, liver and kidney function test results)
- post procedural complications
Rare side-effects (may affect up to 1 in 1,000 people):
- Agitation
- Abnormal liver function
- Sensitivity to sunlight
- 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 cannot be estimated from the available data):
- Low level of red blood cells which can make the skin pale yellow and cause weakness or breathlessness
- Reduction in blood platelets, which increases risk of bleeding or bruising
- Severe allergic reaction
- Aggression, anxiety, severe confusion, hallucination
- Fainting, fits, decreased skin sensitivity, feeling hyperactive, disturbed sense of smell, loss of sense of smell or taste, muscle weakness (myasthenia)
- Poor hearing, deafness or ringing in the ears
- Arrhythmia, abnormal electrocardiogram (ECG)
- Low blood pressure
- Tongue discoloration
- Inflammation of the pancreas
- Hepatic failure, serious liver inflammation
- Joint pain
- Renal failure, renal inflammation
- Problems with your eye sight (blurred vision)
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
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 and the blister pack after ‘EXP’. The expiry date refers to the last day of that month.
Do not store above 25 °C.
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.
Each film-coated tablet contains 250 mg azithromycin (as azithromycin monohydrate).
- The other ingredients are: microcrystalline cellulose, maize starch, sodium starch glycolate, silicium dioxide, magnesium stearate, sodium laurylsulphate, lactose monohydrate, hypromellose, macrogol 4000, titanium dioxide
What Azithromycin looks like and contents of the pack
White to off-white, oval film-coated tablets with a breaking notch on both sides and embossed “A 250” on one side.
Packs with 2, 3, 4, 6, 9, 12 and 24 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:
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1, 39179 Barleben
Germany