AZITHROMYCIN KERN PHARMA 500 mg FILM-COATED TABLETS

2. What you need to know before taking Azitromicina Kern Pharma

Do not take Azitromicina Kern Pharma:

• If you are allergic to azitromicina, erythromycin, another macrolide antibiotic, or any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medication.

• During treatment with azitromicina, 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 interrupt treatment and initiate appropriate treatment.
• If you have liver problems or during treatment, your skin and/or the whites of your eyes turn yellow, discuss this with your doctor to confirm whether you should interrupt treatment or undergo liver function tests.
• If you are being treated with ergotamine derivatives (used to treat migraines), inform your doctor, as concomitant treatment with azitromicina may cause a potentially severe adverse reaction called ergotism.
• During treatment with this medication, there is a possibility of developing a superinfection with resistant germs, including fungi. In this case, inform your doctor.
• During or after treatment with azitromicina, symptoms suggesting antibiotic-associated colitis (diarrhea) may appear. If this occurs, treatment should be suspended, and your doctor will provide the most appropriate treatment.
• If you have any kidney function disorders, inform your doctor.
• If you have heart rhythm disorders (arrhythmias) or factors that predispose you to them (certain heart diseases, electrolyte level disorders in the blood, or certain medications), inform your doctor, as this medication may contribute to worsening or triggering these disorders.
• If you have a disease called myasthenia gravis or if muscle weakness and fatigue appear during treatment, inform your doctor, as azitromicina may trigger or worsen the symptoms of this disease.

Children and adolescents

Children and adolescents weighing less than 45 kg.

The tablets are not indicated for this patient group. Other pharmaceutical forms of azitromicina can be used. It should not be administered to children under 6 months.

Children and adolescents weighing over 45 kg.

This medication is not suitable for children who are unable to swallow the tablets whole. Other pharmaceutical forms of azitromicina can be used.

Other medications and Azitromicina Kern Pharma

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

Especially, you should 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 concomitant administration of both medications at the same time of day.
• Ergotamine derivatives (such as ergotamine, used to treat migraines), as concomitant administration with azitromicina may cause ergotism (a potentially severe adverse reaction with numbness or tingling in the extremities, muscle cramps, headaches, convulsions, or abdominal or chest pain).
• Digoxin (a medication used to treat heart arrhythmias): as azitromicina may increase digoxin levels in the blood, and these levels should be monitored.
• Colchicine (used for gout and familial Mediterranean fever)
• Cyclosporin (a medication used in transplant patients) as azitromicina may increase cyclosporin levels in the blood, and these levels should be monitored.
• Oral anticoagulants (medications used to prevent blood clots) as azitromicina may potentiate the effect of these anticoagulants. Your doctor should monitor coagulation parameters (prothrombin time).
• Nelfinavir, zidovudine (medications for the treatment of HIV infections), as they may increase azitromicina levels in the blood.
• Fluconazole (medications for the treatment of fungal infections), as they may increase azitromicina levels in the blood.
• Terfenadine (a medication used to treat allergies) as the combination of both may cause heart problems.
• Rifabutin (a medication for the treatment of pulmonary and non-pulmonary tuberculosis and mycobacterial infections) as it may cause a decrease in the number of white blood cells in the blood.
• Medications with active substances that prolong the QT interval, such as antiarrhythmics of class IA (quinidine and procainamide) and class III (dofetilide, amiodarone, and sotalol), cisapride, terfenadine, antipsychotic agents (such as pimozide), antidepressants (such as citalopram), and anti-infectives (fluoroquinolones such as moxifloxacin or levofloxacin and chloroquine), as they may cause severe heart rhythm disorders and even cardiac arrest.

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

Taking Azitromicina Kern Pharma with food and drinks

The tablets should be taken whole with water and can be taken with or without food. The score line is not intended to break the tablet.

Pregnancy, breastfeeding, and fertility

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

Your doctor will assess whether you should take this medication during pregnancy, if the benefit of treatment outweighs the potential risks. Azitromicina is excreted in breast milk. Due to potential adverse reactions in the infant, the use of azitromicina is not recommended during breastfeeding, although you may continue breastfeeding two days after completing treatment with azitromicina.

Driving and using machines

The influence of this medication on the ability to drive or use machines is negligible or non-existent.

Azitromicina Kern Pharma contains lactose and sodium

This medication contains lactose. If your doctor has told you 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; this is essentially "sodium-free".

3. How to take Azitromicina Kern Pharma

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

Your doctor will determine the most suitable dose and treatment duration for you, according to 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 weighing over 45 kg:

The recommended dose is 1500 mg divided into 3 or 5 days as follows:

• When taken for 3 days, 500 mg per day.
• When taken for 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 heart rhythm disorders, your doctor will closely monitor you.

Urethra or cervix infection (cervicitis)

The recommended dose is 1000 mg taken as a single dose, in one day.

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

Chancroid

The usual dose is 1000 mg taken as a single dose, in one day.

Sinusitis:

Treatment is indicated in adults and adolescents over 16 years.

Children and adolescents weighing less than 45 kg:

The tablets are not recommended for these patients. Other pharmaceutical forms containing azitromicina can be used (e.g., suspensions).

Use in patients with liver impairment:

Inform your doctor if you have liver problems, as it may be necessary to modify the normal dose.

Use in patients with kidney impairment:

Inform your doctor if you have kidney problems, as it may be necessary to modify the normal dose.

Method of administration

Oral route.

This medication should be administered as a single daily dose.

The tablets should be taken whole with water and can be taken with or without food.

The score line is intended to break the tablet if you find it difficult to swallow it whole.

If you take more Azitromicina Kern Pharma than you should

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

Information for the prescriber

In case of overdose, activated charcoal administration is indicated, and general symptomatic and supportive measures for vital functions should be applied.

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested. Bring this leaflet, any remaining tablets, and the packaging to the hospital or your doctor so they know what tablets you have taken.

If you forget to take Azitromicina Kern Pharma

In case of a missed dose, use the medication as soon as possible, continuing with the 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 make up for the missed dose. Continue taking azitromicina as your doctor has indicated.

If you interrupt treatment with Azitromicina Kern Pharma

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

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

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

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

• Diarrhea

Common (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) and decrease in bicarbonate.

Uncommon (may affect up to 1 in 100 people)

• Candida infection in the mouth or generalized, vaginal infection, pneumonia, fungal or bacterial infection, pharyngitis, gastroenteritis, alteration in breathing, rhinitis.
• Decrease in the number of some types of white blood cells (leukocytes, neutrophils, and eosinophils).
• Allergic reaction, including a deep skin inflammation (angioedema).
• Alteration in eating behavior (anorexia).
• Nervousness, insomnia.
• Somnolence, dizziness, alteration in taste, loss of tactile sensation.
• Alteration in vision
• Alteration in hearing, vertigo.
• Palpitations (abnormality in heart rhythm or frequency and detection of heartbeat)
• Hot flashes
• Alteration in breathing, nosebleeds.
• Constipation, flatulence, indigestion, gastritis, difficulty swallowing, abdominal distension, dry mouth, eructation, mouth ulcers, increased salivation.
• Rash, itching, appearance of red elevated patches, dermatitis, dry skin, excessive sweating, redness.
• Joint inflammation, muscle pain, back pain, neck pain
• Difficulty urinating, kidney pain.
• Vaginal bleeding, alteration in the 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 the blood, alteration in sodium and potassium levels, decrease in hematocrit.
• Complications after surgery.

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

• Agitation
• Alteration in liver function, yellowing of the skin.
• Sensitivity to sun exposure (photosensitivity), drug reaction with an increase in a type of white blood cell (eosinophilia) and generalized symptoms (multi-organ involvement) (DRESS syndrome).
• Skin rash characterized by the rapid appearance of red skin areas with small pustules (small blisters filled with white/yellow liquid).

Frequency not known (cannot be estimated from available data):

• Diarrhea caused by Clostridium difficile.
• Decrease in platelet count in the blood, anemia.
• Severe allergic reaction.
• Aggressive reactions, anxiety, delirium, hallucinations.
• Loss of consciousness, convulsions, decreased sensitivity, hyperactivity, alteration and/or loss of smell, loss of taste, muscle weakness and fatigue (myasthenia gravis).
• Alteration in hearing, including deafness and ringing.
• Torsade de pointes, heart rhythm disorders, prolongation of the QTc interval in the electrocardiogram.
• Decrease in blood pressure.
• Pancreatitis, change in tongue color.
• Severe liver damage and liver failure, which can be fatal, liver tissue death, fulminant hepatitis.
• Appearance of red elevated patches, generalized rash with blisters and peeling skin, which occurs 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 the kidney tubules (interstitial nephritis).

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them through the Spanish Pharmacovigilance System for Human Use Medicines. https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Azitromicina Kern Pharma

Keep this medication out of sight and reach of children.

No special storage conditions are required. Store in the original packaging.

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

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medications at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medications. This will help protect the environment.

6. Packaging contents and additional information

Composition of Azitromicina Kern Pharma

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

Tablet core: pregelatinized corn starch, crospovidone, calcium phosphate dibasic, sodium lauryl sulfate, and magnesium stearate.

Tablet coating: hypromellose (hydroxypropyl methylcellulose), titanium dioxide (E171), lactose, and triacetin.

See section 2 Azitromicina Kern Pharma contains lactose and sodium.

Product appearance and packaging contents

White, capsule-shaped film-coated tablets with a transverse line on one face.

The tablets are packaged in PVC-Aluminum blisters.

Available in packs of 3 and 150 tablets (clinical packaging).

Marketing authorization holder and manufacturer

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Date of the last revision of this leaflet:February 2025

Detailed information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es