Package Leaflet: Information for the User

Azithromycin Sandoz 500 mg Film-Coated Tablets

Read this leaflet carefully before you start taking this medicine because it contains important information for you

• Keep this leaflet, as 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. Do not pass it on to others even if their symptoms are the same as yours. It may harm them.
• If you experience any side effects, talk to your doctor or pharmacist. See section 4.

1. What isAzithromycin Sandozand what it is used for

2. What you need to know before you start takingAzithromycin Sandoz

3. How to takeAzithromycin Sandoz

4. Possible side effects

5. Storage ofAzithromycin Sandoz

6. Contents of the pack and additional information

Azitromicina belongs to a group of antibiotics called macrolides. It eliminates bacteria that cause infections.

It is used for the treatment of bacterial infections in different parts of the body, in adults, and in children with a weight of 45 kg or more.

This medication is used for the treatment of the following bacterial infections: throat infections, tonsillitis, ear infections, or sinus infections,

• bronchitis and pneumonia (mild to moderate severity),
• skin and soft tissue infections (mild to moderate severity),
• urethritis or cervicitis, see section 3,

sexually transmitted infections (chancroid), see section 3.

Do not take Azitromicina Sandoz:

• if you are allergic to azithromycin, erythromycin, other macrolide or ketolide antibiotics, or any of the other ingredients in this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Azitromicina Sandoz.

• During treatment with azithromycin, allergic reactions (itching, redness, skin rash, swelling, or difficulty breathing, or an allergic reaction to the medication characterized by an increase in white blood cells in the blood and generalized symptoms) may occur, which could be severe. Inform your doctor, who may decide to discontinue treatment and initiate appropriate treatment.
• If you have liver problems or during treatment your skin and/or the white part of your eyes turns yellow, inform your doctor to confirm whether you should discontinue treatment or undergo liver function tests.
• If you are being treated with ergotamine derivatives (used for migraine treatment), inform your doctor as concurrent treatment with azithromycin may cause a condition called ergotism.
• During treatment with this medication, there is a possibility of overinfection by resistant germs, including fungi. In this case, inform your doctor.
• During or after treatment with azithromycin, symptoms may appear that suggest antibiotic-associated colitis (diarrhea). If this is the case, treatment should be discontinued and your doctor will prescribe the most suitable treatment.
• If you have severe kidney function impairment, inform your doctor.
• If you have arrhythmias or factors that predispose you to them (certain heart diseases, alterations in blood electrolyte levels, or certain medications), inform your doctor, as this medication may exacerbate or trigger these conditions.
• If you have myasthenia gravis or if muscle weakness and fatigue appear during treatment, inform your doctor, as azithromycin may trigger or worsen symptoms of this disease.

Children and adolescents

Children and adolescents weighing less than 45 kg.

Tablets are not indicated for this group of patients. Other pharmaceutical forms containing azithromycin may be used. Do not administer to children under 6 months.

Children and adolescents weighing more than 45 kg.

This medication is not suitable for children who are unable to swallow whole tablets. Other pharmaceutical forms containing azithromycin may be used.

Other medications and Azitromicina Sandoz

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

You must especially inform your doctor or pharmacist if you are being treated with any of the following medications:

• antacids (medications used for digestive problems). It is recommended to avoid simultaneous administration of both medications at the same time of day,
• ergotamine derivatives (such as ergotamine, for migraine treatment), as simultaneous administration with azithromycin may cause ergotism (a potentially severe adverse effect with numbness or tingling in the extremities, muscle cramps, headaches, convulsions, or abdominal or chest pain),
• digoxin (a medication used for heart arrhythmias) as azithromycin may elevate digoxin levels in the blood and levels should be monitored,
• colchicine (used for gout and familial Mediterranean fever),
• ciclosporin (a medication used in transplant patients) as azithromycin may elevate ciclosporin levels in the blood and levels should be monitored,
• dicumarol anticoagulants (medications used to prevent blood clotting) as azithromycin may potentiate the effect of these anticoagulants. Your doctor should control coagulation parameters (prothrombin time),
• nelfinavir, zidovudine (medications for HIV infection treatment), as azithromycin levels in the blood may be increased,
• fluconazole (medications for fungal infections), as azithromycin levels in the blood may be increased,
• terfenadine (a medication used for allergies) as the combination may cause heart problems,
• rifabutin (a medication for pulmonary and non-pulmonary tuberculosis and mycobacterial infections) as it may cause a decrease in white blood cells in the blood,
• medications with active substances that prolong the QT interval, such as antiarrhythmic class IA (quinidine and procainamide) and class III (dofetilide, amiodarone, and sotalol) medications, cisapride, antipsychotics (such as pimozide), antidepressants (such as citalopram), and antifungals (fluoroquinolones such as moxifloxacin or levofloxacin, or hydroxychloroquine or chloroquine), as it may cause severe heart rhythm alterations and even cardiac arrest.

No interactions have been observed between azithromycin and cetirizine (for allergic reactions); didanosine, efavirenz, indinavir (for HIV infection treatment); atorvastatin (for high cholesterol and heart problems); carbamazepine (for epilepsy treatment), cimetidine (for excess stomach acid); methylprednisolone (to suppress the immune system); theophylline (for respiratory problems); midazolam, triazolam (for sedation); sildenafil (for erectile dysfunction) and trimethoprim/sulfamethoxazole (for infections).

Use of Azitromicina Sandoz with food and beverages

Tablets should be swallowed whole with water and may be taken with or without food.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

There is not enough information about the safety of azithromycin during pregnancy. Therefore, azithromycin should not be used during pregnancy, or if you plan to become pregnant, unless it is strictly necessary according to medical criteria.

Azithromycin is excreted in breast milk. Due to potential adverse reactions in the infant, azithromycin should not be used during breastfeeding, although breastfeeding may be continued two days after completing azithromycin treatment.

Driving and operating machinery

The influence of this medication on the ability to drive or operate machinery is negligible or insignificant.

Azitromicina Sandoz contains lactose and sodium

If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

This medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially "sodium-free".

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor. In case of doubt, consult your doctor or pharmacist.

Your doctor will establish the most suitable dose and treatment duration for you, based on your condition and response to treatment. As a general rule, the recommended dose of medication and administration frequency is as follows:

Adults (including elderly patients) and children with a body weight of over 45 kg:

The usual dose is 1500 mg divided over 3 or 5 days as follows:

• When taken over 3 days, 500 mg per day.
• When taken over 5 days, 500 mg on the first day and 250 mg from the 2nd to the 5th day.

In elderly patients, the same dose as for adults can be administered. However, in the case of patients with cardiac rhythm disorders, your doctor will closely monitor you.

Urethral or cervical infection (cervicitis):

The usual dose is 1,000 mg taken as a single dose, on a single day.

If the infection is caused by N.gonorrhoea, your doctor will administer the same dose in combination with another antibiotic (ceftriaxone, 250 mg).

Chancroid:

The usual dose is 1,000 mg taken as a single dose, on a single day.

Sinusitis:

Treatment is indicated for adults and adolescents over 16 years old.

Children and adolescents weighing less than 45 kg:

The tablets are not recommended for these patients. Other pharmaceutical forms of azithromycin may be used.

Liver insufficiency

Inform your doctor if you have severe liver problems, as the normal dose may need to be adjusted.

Renal insufficiency

Inform your doctor if you have severe kidney problems, as the normal dose may need to be adjusted.

Administration form

Oral route.

This medication should be taken as a single daily dose. Tablets should be swallowed whole with water and can be taken with or without food.

If you take more Azitromicina Sandoz than you should

In case of overdose, you may experience reversible hearing loss, intense nausea, vomiting, and diarrhea.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service at 91 562 04 20, indicating the medication and the amount ingested. It is recommended to bring the packaging and the leaflet to the healthcare professional.

Information for the prescriber

In case of overdose, administration of activated charcoal is indicated, and general supportive measures and vital function support should be applied.

If you forget to take Azitromicina Sandoz

In case of forgotten dose, use the medication as soon as possible and continue treatment as prescribed. However, if the next dose is near, it is better not to take the missed dose and wait for the next one.

Do not take a double dose to compensate for the missed dose. Continue taking azithromycin as your doctor has recommended.

If you interrupt treatment with Azitromicina Sandoz

If you stop treatment with azithromycin before your doctor has recommended, symptoms may worsen or reappear.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

The side effects reported during clinical trials and after marketing, classified by frequency, are:

Side effectsvery frequent (may affect more than 1 in 10 people):

• diarrhea.

Side effectscommon (may affect up to 1 in 10 people):

• headache,
• vomiting, abdominal pain, nausea,
• alteration in the number of some types of white blood cells (lymphocytes, eosinophils, basophils, monocytes, and neutrophils),
• decrease in blood bicarbonate.

Side effectsinfrequent (may affect up to 1 in 100 people):

• oral or generalized Candida infection, vaginal infection, pneumonia, fungal or bacterial infection, pharyngitis, gastroenteritis, respiratory alteration, rhinitis,
• decrease in the number of some types of white blood cells (leukocytes, neutrophils, and eosinophils),
• allergic reaction, including a deep skin inflammatory process (angioedema),
• alteration in eating behavior (anorexia),
• nervousness, insomnia,
• drowsiness, dizziness, alteration in taste, loss of tactile sensation,
• vision alteration,
• hearing alteration, vertigo,
• palpitations,
• angina,
• breathing alteration, nasal hemorrhage,
• constipation, flatulence, indigestion, gastritis, difficulty swallowing, abdominal distension, dry mouth, belching, mouth ulcers, increased salivation,
• eruption, pruritus, appearance of red, elevated papules, dermatitis, dry skin, excessive sweating, erythema,
• joint inflammation, muscle pain, back pain, neck pain,
• difficulty urinating, kidney pain,
• vaginal hemorrhage, alteration in testicles,
• generalized swelling, weakness, discomfort, fatigue, facial edema, chest pain, fever, pain and swelling of the extremities,
• alteration in liver function tests (increase in liver enzymes GOT, GPT, and alkaline phosphatase) and increase in bilirubin, urea, creatinine, chloride, glucose, bicarbonate, and platelets in blood, alteration in sodium and potassium levels, decrease in hematocrit,
• complications after surgical intervention.

Side effectsrare (may affect up to 1 in 1,000 people):

• agitation,
• liver function alteration, yellow discoloration of the skin,
• sensitivity to sunlight (photosensitivity), drug reaction with increase in a type of white blood cell (eosinophilia) and generalized symptoms (multi-organ compromise) (DRESS syndrome),
• skin eruption characterized by rapid appearance of red skin areas dotted with small white/yellow-filled blisters.

Side effectsof unknown frequency(cannot be estimated from available data):

• diarrhea caused by Clostridium difficile,
• decrease in platelets in blood, anemia,
• severe allergic reaction,
• aggressive behavior, anxiety, delirium, hallucinations,
• loss of consciousness, seizures, decreased sensitivity, hyperactivity, alteration and/or loss of smell, loss of taste, muscle weakness and fatigue (myasthenia gravis),
• hearing alteration including deafness and tinnitus,
• torsade de pointes alterations of heart rhythm, prolongation of QTc interval in electrocardiogram,
• decrease in blood pressure,
• pancreatitis, change in color of the tongue,
• severe liver damage and hepatic failure that rarely can be fatal, liver tissue death, fulminant hepatitis,
• appearance of red, elevated papules, generalized eruption with blisters and peeling skin, occurring especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), severe skin reactions such as erythema multiforme, toxic epidermal necrolysis.
• joint pain,
• acute kidney failure and inflammation of the tissue between renal tubules (interstitial nephritis).

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

No special storage conditions are required.

Do not use this medication after the expiration date that appears on the packaging, after CAD/EXP. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition of Azitromicina Sandoz

• The active ingredient is azithromycin. Each tablet contains 500 mg of azithromycin (as dihydrate).
• The other components (excipients) are:

Core: pregelatinized cornstarch, crospovidone, anhydrous calcium hydrogen phosphate, sodium lauryl sulfate, magnesium stearate.

Coating: hydroxypropylmethylcellulose (hypromellose) (E-464), titanium dioxide (E-171), lactose monohydrate and triacetin (E-1518).

Appearance of the product and contents of the packaging

The tablets are packaged in PVC/Aluminum blisters.

Azitromicina Sandoz 500 mg film-coated tablets are white, capsule-shaped tablets with a transverse line on one side.

They are presented in packs of 3 and 150 tablets (clinical pack).

Only some pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Sandoz Farmacéutica, S.A.
Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer:

Kern Pharma, S.L.

Polígono Ind. Colón II Venus, 72

08228 Terrassa (Barcelona)

Spain

Last review date of this leaflet:May 2022

Further information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es