Azithromycin Sandoz

Patient Information Leaflet

Azithromycin Sandoz 500 mg film-coated tablets

Generic medicine
Please read this leaflet carefully before taking this medicine because it contains important information for you.
Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Never give it to other people, even if they have the same symptoms as you, because it may be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist (See section 4).
Contents of this leaflet:

1. What Azithromycin Sandoz is and what it is used for
2. What you need to know before taking Azithromycin Sandoz
3. How to take Azithromycin Sandoz
4. Possible side effects
5. How to store Azithromycin Sandoz
6. Contents of the pack and other information

1. What Azithromycin Sandoz is and what it is used for

Azithromycin Sandoz contains the active substance azithromycin. Azithromycin is an antibiotic that belongs to a group of antibiotics called "macrolides", which block the growth of susceptible bacteria.
Azithromycin Sandoz is taken to treat the following infections:
Adults and adolescents weighing 45 kg or more:
Infections of the tonsils (tonsillitis) or throat (pharyngitis) caused by streptococcal bacteria
Bacterial infections of the paranasal sinuses (sinusitis)
Bacterial infections of the middle ear (otitis media)
Lung infection (community-acquired pneumonia, not contracted in hospital)
Bacterial skin and underlying tissue infections
Urethral and cervical infections caused by the bacterium Chlamydia trachomatis
Adults:

• Bacterial infections in patients with long-term bronchial inflammation (chronic bronchitis)

2. What you need to know before taking Azithromycin Sandoz

Do not take Azithromycin Sandoz
if you are allergic to azithromycin, erythromycin, or to other antibiotics known as "macrolides" or "ketolides", or
to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before taking Azithromycin Sandoz if you have or have had any of the
following conditions:
heart problems (e.g. problems with heart rhythm or heart failure) or low levels of
potassium or magnesium in the blood: these conditions may contribute to serious cardiac side effects caused by azithromycin;
liver problems: your doctor may need to monitor liver function or discontinue treatment;
severe diarrhoea after taking other antibiotics;
localized muscle weakness (myasthenia gravis), as symptoms of this disease may worsen during treatment;
or if you are taking ergot derivatives such as ergotamine (used to treat migraine), as these medicines must not be taken together with Azithromycin Sandoz.

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

• if you suspect you are having an allergic reaction (e.g. difficulty breathing, swelling of the face or throat, rash, blisters);
• if you notice any of the symptoms described in section 4 related to severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP), reported in association with azithromycin treatment;
• if you experience an abnormal heartbeat or palpitations, dizziness or fainting while taking Azithromycin Sandoz;
• 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 for diarrhoea without first consulting your doctor. If diarrhoea persists or recurs within the first few weeks of treatment, inform your doctor.

Superinfection
Your doctor may monitor symptoms of additional bacterial or fungal infections that cannot be treated with Azithromycin Sandoz (superinfection).

Sexually transmitted infections
Your doctor may perform a test to rule out a possible syphilis infection, a sexually transmitted disease that could otherwise progress undetected and be diagnosed late.
Furthermore, in any case of sexually transmitted bacterial infections, your doctor will perform follow-up laboratory tests to monitor the success of therapy.

Children and adolescents
If your body weight is less than 45 kg, there are other azithromycin-containing medicines that may be more convenient for you to take.

Other medicines and Azithromycin Sandoz
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Taking Azithromycin Sandoz together with other medicines may cause side effects. Therefore, it is particularly important that you inform your doctor if you are taking any of the following medicines:

Atorvastatin and other statins (to lower cholesterol in the blood and prevent heart disease, including heart attacks and strokes)
Cyclosporine (to prevent rejection of transplanted organs by the body)
Colchicine (for the treatment of gout and familial Mediterranean fever)
Dabigatran (to prevent and treat blood clot formation (anticoagulant))
Digoxin (for the treatment of heart conditions)
Warfarin or similar medicines used to thin the blood (anticoagulants)
medicines that may cause the heart muscle to take longer than usual to contract and relax (prolongation of the QT interval), such as the following:

• Quinidine, procainamide, dofetilide, amiodarone and sotalol (for the treatment of irregular heartbeat, including cases of heartbeat that is too fast or too slow – cardiac arrhythmia)
• Pimozide (for the treatment of mental illnesses)
• Citalopram (for the treatment of depression)
• Moxifloxacin and levofloxacin (antibiotics)
• Cisapride (for the treatment of gastrointestinal tract disorders)
• Hydroxychloroquine or chloroquine (for the treatment of autoimmune diseases, including rheumatoid arthritis, or for treating or preventing malaria)

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
Your doctor will decide whether you can take this medicine during pregnancy only after ensuring that the benefits outweigh the potential risks.

Breastfeeding
Azithromycin Sandoz passes into breast milk. Therefore, your doctor will decide whether to discontinue breastfeeding or to avoid treatment with Azithromycin Sandoz, taking into account both the benefit of breastfeeding for the child and the benefit of therapy for you.

Driving and using machines
Azithromycin Sandoz has a moderate effect on the ability to drive and use machines. Dizziness, drowsiness, seizures, and vision and hearing problems have been reported in some people taking Azithromycin Sandoz. These possible side effects may impair the ability to drive or operate machinery.

Azithromycin Sandoz contains lactose and sodium.
If your doctor has told you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e. essentially "sodium-free".

3. How to take Azithromycin Sandoz

Take this medicine exactly as directed by your doctor or pharmacist. If you are
unsure, consult your doctor or pharmacist.
The amount of Azithromycin Sandoz you should take each day depends on the bacterial infection being
treated and the specific treatment course your doctor or pharmacist has advised you to follow.
Adults and adolescents with a body weight of 45 kg or more

Use in children and adolescents
If your weight is less than 45 kg or you are unable to swallow this medicine, consult your doctor or
pharmacist, as other azithromycin-containing medicines that may be more suitable for you are available.

Method of administration
For oral use.
Azitromicina Sandoz 500 mg film-coated tablets should be taken orally as a single daily dose. The tablets may be taken regardless of meals. Taking this medicine just before a meal may help improve gastrointestinal tolerability.
The tablets can be divided into two equal halves, which may be used to adjust the dose according to the instructions of the doctor or pharmacist.

If you take more Azitromicina Sandoz than you should
If you take more Azitromicina Sandoz than you should, you may feel unwell. Typical signs of overdose include vomiting, diarrhoea, abdominal pain and nausea. Inform your doctor immediately or contact the emergency department of the nearest hospital.

If you forget to take Azitromicina Sandoz
If you forget to take Azitromicina Sandoz, take it as soon as possible, provided that at least 12 hours remain before the next dose. If less than 12 hours remain before the next dose, do not take the missed dose; instead, take the next dose at the usual time. Do not take a double dose to make up for the missed dose.

If you stop treatment with Azitromicina Sandoz
If you stop treatment with Azitromicina Sandoz too early, the infection may recur. Take Azitromicina Sandoz for the entire duration of the treatment, even if you start to feel better.

If you have further questions about the use of this medicine, consult your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Serious side effects:
Stop taking Azithromycin Sandoz and contact your doctor immediately if you notice any of the
following symptoms:
sudden wheezing, difficulty breathing, swelling of the eyelids, face or lips, rash or itching mainly 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, signs of liver problems ( liver failure or hepatic necrosis , frequency not known)
severe diarrhoea with abdominal cramps, stools containing blood and/or fever may indicate an infection of the large intestine ( antibiotic-associated colitis , frequency not known). Do not take medicines for diarrhoea that inhibit intestinal movements ( antiperistaltics )
red, flat spots on the trunk, target-shaped or circular, often with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals and eyes. These serious skin reactions may be preceded by fever and flu-like symptoms ( Stevens-Johnson syndrome or toxic epidermal necrolysis , frequency not known)
widespread rash, high body temperature and swollen lymph nodes ( DRESS syndrome or drug hypersensitivity syndrome , rare (may affect up to 1 in 1,000 people))
widespread, red, scaly rash with subcutaneous bumps and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (generalized pustular eruption, rare (may affect up to 1 in 1,000 people)).
Other side effects
Very common (may affect more than 1 in 10 people)

• diarrhoea

Common (may affect up to 1 in 10 people)

• headache
• vomiting, stomach pain, feeling unwell ( nausea )
• changes in blood test results ( decreased lymphocyte count, increased eosinophil count, increased basophil count, increased monocyte count, increased neutrophil count, decreased blood bicarbonate )

Uncommon (may affect up to 1 in 100 people)

• candidiasis ( candidiasis ), a fungal infection of the mouth and vagina, other fungal infections
• lung infection, bacterial throat infection, inflammation of the gastrointestinal tract, respiratory disorder, inflammation of the mucous membrane inside the nose, vaginal infection
• changes in white blood cell count ( leucopenia, neutropenia, eosinophilia )
• increased platelet count
• reduced percentage of all blood cells in total blood volume ( reduced haematocrit )
• allergic reactions, swelling of the hands, feet and face ( angioedema )
• loss of appetite
• nervousness, difficulty sleeping ( insomnia )
• dizziness, drowsiness ( somnolence ), altered sense of taste ( dysgeusia ), tingling sensation ( paraesthesia )
• visual disturbances
• ear disorder
• sensation of dizziness ( vertigo )
• awareness of heartbeat ( palpitations )
• hot flushes
• sudden wheezing, nosebleed
• constipation, intestinal gas, impaired digestion ( dyspepsia ), inflammation of the stomach lining ( gastritis ), difficulty swallowing ( dysphagia ), bloated stomach, dry mouth, belching, mouth ulceration, increased salivation
• rash, itching, urticaria, dermatitis, dry skin, abnormally increased sweating ( hyperhidrosis )
• swelling and pain in joints ( osteoarthritis ), muscle pain, back pain, neck pain
• painful urination ( dysuria ), kidney pain
• irregular menstrual bleeding ( metrorrhagia ), testicular disorder
• swelling due to fluid retention, particularly of the face, ankles and feet ( oedema, facial oedema, peripheral oedema )
• weakness, fatigue, general malaise, 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)

• sensation of irritation
• 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 may cause fatigue and pale skin ( haemolytic anaemia )
• reduced number of platelets which may lead to bleeding and bruising ( thrombocytopenia )
• feeling angry, aggressive, frightened or worried ( anxiety ), acute confusional state ( delirium )
• hallucination
• fainting ( syncope )
• seizures ( convulsions )
• reduced sensitivity to touch, pain and temperature ( hypoesthesia )
• feeling overactive
• change in the sense of smell ( anosmia, parosmia )
• complete loss of taste ( ageusia )
• muscle weakness ( myasthenia gravis )
• abnormal electrocardiogram (ECG) ( prolonged QT interval ), deafness, reduced hearing or ringing in the ears ( tinnitus )
• low blood pressure
• inflammation of the pancreas causing severe abdominal and back pain ( pancreatitis ), change in tongue colour
• joint pain ( arthralgia )
• inflammation of the kidneys ( interstitial nephritis ) and impaired kidney function

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse.
You can also report side effects directly via the reporting system at the following website:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Azithromycin Sandoz

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Azitromicina Sandoz contains
The active substance is azithromycin.
Each film-coated tablet contains 250 mg of azithromycin (as dihydrate).
Each film-coated tablet contains 500 mg of azithromycin (as dihydrate).
The other components are:
Core: microcrystalline cellulose, pregelatinized starch, sodium starch glycolate type A, colloidal anhydrous silica, sodium lauryl sulfate, magnesium stearate;
Coating: hypromellose, titanium dioxide (E171), lactose monohydrate, macrogol 4000.

Description of the appearance of Azitromicina Sandoz and package contents
The 500 mg film-coated tablets of Azitromicina Sandoz are white or almost white, oblong, film-coated, with a deep score line on one side and a notch on the other side. The tablet can be divided into equal doses.
The 500 mg tablets are supplied in packages of:
cardboard box with blister pack containing: 2, 3, 6, 12, 24, 30, 50 and 100 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Sandoz S.p.A.
Viale Luigi Sturzo 43
20154 Milan
Italy

Manufacturer

• Sandoz GmbH, Biochemiestrasse 10, 6250 Kundl - Austria
• Lek d.d. Pharmaceuticals - Verovskova 57 - 1526 Ljubljana - Slovenia
• Novartis Pharmaceuticals S.R.L., Livezeni Street no 7A, Targu Mures - Romania

This medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
Austria Azithromycin Sandoz 500 mg – Filmtabletten
Finland Azithromycin Sandoz 500 mg tabletti, kalvopäällysteinen
Denmark Azithromycin Sandoz 500 mg
Germany Azithromycin Sandoz 500 mg Filmtabletten
Estonia Azithromycin Sandoz 500 mg õhukese polümeerkilega kaetud tabletid
Hungary Azi Sandoz 500 mg filmtabletta
Italy Azitromicina Sandoz 500 mg compresse rivestite con film
Latvia Azithromycin Sandoz 500 mg apvalkotās tabletes
Lithuania Azithromycin Sandoz 500 mg plėvelė dengtos tabletės
Luxembourg Azithromycine Sandoz 500 mg comprimés pelliculés
Netherlands Azitromycine Sandoz tablet 500, film-omhulde tablet
Poland AzitroLEK
Portugal AZITROMICINA SANDOZ 500 mg COMPRIMIDOS
United Kingdom Azithromycin 500 mg tablets
Czech Republic Azitromycin Sandoz
Slovakia Azithromycin Sandoz 500 mg filmom obalené tablety
Slovenia Azitromicin Sandoz 500 mg filmsko obložene tablete
Sweden Azithromycin Sandoz 500 mg filmdragerade tabletter