The active substance is azithromycin.
Each film-coated tablet contains 250 mg or 500 mg azithromycin (as azithromycin monohydrate).
Excipients/Inactive Ingredients: The other ingredients are: microcrystalline cellulose, maize starch, sodium starch glycolate, silicium dioxide, magnesium stearate, sodium laurylsulphate, lactose monohydrate, hypromellose, macrogol 4000, titanium dioxide
Azithromycin Sandoz 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.
Always take this medicine exactly as the doctor or pharmacist has prescribed. Check with the doctor or pharmacist if the patient is not sure.
The recommended dose is: Adults, adolescents and children weighing more than 45 kg: Azithromycin Sandoz is taken as a 3 day course.
Azithromycin Sandoz 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: The patient should tell the doctor if they have kidney or liver problems as the 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 into equal halves if required. The patient can take the tablets with or without food.
Taking Azithromycin Sandoz with medicines for indigestion: If the patient needs to take a medicine for indigestion, such as an antacid, take Azithromycin Sandoz at least one hour before or two hours after the antacid.
If the patient takes more Azithromycin Sandoz than they should: If the patient takes too many tablets the patient may feel unwell or be sick. The patient also may experience other side effects such as temporary deafness, nausea, vomiting and diarrhoea. Tell the doctor or talk to the nearest hospital casualty department immediately. If possible, take the tablets or the box with the patient to show the doctor what they have taken.
If the patient forgets to take Azithromycin Sandoz: If the patient 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 the patient stops taking Azithromycin Sandoz: Always keep taking the tablets until the course is finished, even if the patient feels better. If the patient stops 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 the patient has any further questions on the use of this medicine, ask the doctor or pharmacist.
Do not take Azithromycin Sandoz if the patient is allergic to: azithromycin, erythromycin, any other macrolide or ketolide antibiotic, any of the other ingredients of this medicine (listed in Description).
Talk to the doctor or pharmacist before taking Azithromycin Sandoz if the patient has: Liver problems: the doctor may need to monitor the liver function or stop the treatment.
Kidney problems: if the patient has 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 the blood.
Myasthenia gravis, a certain type of muscle weakness
If the patient had infections with azithromycin, erythromycin, lincomycin and/or clindamycin resistant pathogens or methicillin resistant staphylococci (possibility of cross-resistance).
Tell the doctor immediately: if the patient develops diarrhoea or loose stools during or after treatment. Do not take any medicine to treat the diarrhoea without first checking with the doctor. If the diarrhoea continues, inform the doctor.
If the patient feels their heart beating in the chest or has an abnormal heartbeat, gets dizzy or faint, or suffers from muscle weakness when taking Azithromycin Sandoz.
If the patient feels they 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 the patient develops 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 the patient is giving this medicine to an infant (less than 6 weeks of age) and they vomit or become irritable when fed.
If the patient notices that the symptoms aggravate during or shortly after the treatment (possibility of superinfection/resistance).
Azithromycin Sandoz contains lactose: If the patient has been told by the doctor that they have an intolerance to some sugars, contact the doctor before taking this medicinal product.
Azithromycin Sandoz contains sodium: This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially 'sodium-free'.
Driving and using machines: Azithromycin Sandoz 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.
If the patient is pregnant or breast-feeding, thinks she may be pregnant or is planning to have a baby, ask the doctor or pharmacist for advice before taking this or any other medicine.
The patient should not use this medicine during pregnancy and when she is breast-feeding unless the doctor has specifically recommended it.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects: If the patient has any of the following symptoms of a severe allergic reaction, stop taking this medicine and tell the doctor immediately or go to the casualty department at the 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 the patient experiences any of the following side effects, contact the 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 the urine.
Skin rash caused by sensitivity to sunlight.
Unusual bruising or bleeding.
Irregular heart beat.
These are all serious side effects. The patient 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 appetite (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 the eye sight (blurred vision).
Reporting of side effects: If the patient gets any side effects, talk to the doctor or pharmacist. This includes any possible side effects not listed in this monograph. The patient can also report side effects directly via the national reporting system listed in Appendix V*. By reporting side effects the patient can help provide more information on the safety of this medicine.
Tell the doctor or pharmacist if the patient is taking, has recently taken or might take any other medicines. This includes any medicines obtained without a prescription.
It is especially important to mention that the patient takes: 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. The doctor may need to monitor more often the blood clotting parameters when Azithromycin Sandoz 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, the doctor will check cyclosporine levels in the blood and may adapt the dose.
Digoxin (used for heart failure): concomitant use may increase digoxin levels. The doctor will check its levels in the blood.
Colchicine (used for gout and familial Mediterranean fever).
Antacids (used for indigestion): may make azithromycin less effective when used concomitantly, see Dosage & Administration. Azithromycin Sandoz 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-arrhythmics, 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 astemizole (used to treat hay fever): concomitant use with azithromycin may increase the effect of these medicinal products.
Rifabutin (used to treat tuberculosis): The doctor may check the blood and blood levels of the medicines.
Statins (such as atorvastatin, used to lower lipids in blood): concomitant use may cause muscle disorders.
Azithromycin Sandoz with food and drink: The tablets may be taken with or without food.
Do not store above 25°C.
Do not throw away any medicines via wastewater or household waste. Ask the pharmacist how to throw away medicines no longer used. These measures will help protect the environment.
J01FA10 - azithromycin ; Belongs to the class of macrolides. Used in the systemic treatment of infections.
FC tab 250 mg (white to off-white, oval, with a breaking notch on both sides and embossed "A 250" on one side) x 6's. 500 mg x 3's.
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