Leaflet: information for the patient

Azitromicina Kern Pharma 500 mg film-coated tablets EFG

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, consult your doctor or pharmacist.

- This medicine has been prescribed for you only, and you must not give it to others, even if they have the same symptoms as you, as it may harm them.

- If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What isAzitromicina Kern Pharma tabletsand what it is used for

2. What you need to know before starting to takeAzitromicina Kern Pharma tablets

3. How to takeAzitromicina Kern Pharma tablets

4. Possible side effects

5. Storage ofAzitromicina Kern Pharma tablets

6. Contents of the pack and additional information

Azitromicina belongs to a group of antibiotics called macrolide antibiotics.

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

It is used for the treatment of the following infections:

• Throat, tonsil, ear, or sinus infections.
• Mild to moderate bronchitis and pneumonia.
• Mild to moderate skin and soft tissue infections.
• Urethritis or cervicitis, see section 3.
• Chancroid, see section 3.

Do not take Azitromicina Kern Pharma:

• If you are allergic to azithromycin, erythromycin, other macrolide or ketolide antibiotics, 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 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 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 to treat migraines), inform your doctor as the combined treatment with azithromycin may cause a condition called ergotism.
• During treatment with this medication, there is a possibility of developing an 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 any 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 occur 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 forms of azithromycin medication 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 the tablets whole. Other forms of azithromycin medication may be used.

Other medications and Azitromicina Kern Pharma

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

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, used to treat migraines), 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 to treat heart arrhythmias): as azithromycin may increase digoxin levels in the blood, and levels should be monitored.
• Colchicine (used to treat gout and familial Mediterranean fever)
• Ciclosporin (a medication used in transplant patients) as azithromycin may increase ciclosporin levels in the blood, and levels should be monitored.
• Anticoagulant dicumarins (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 used to treat HIV infections), as they may increase azithromycin levels in the blood.
• Fluconazole (medications used to treat fungal infections), as they may increase azithromycin levels in the blood.
• Terfenadine (a medication used to treat allergies) as the combination may cause heart problems.
• Rifabutin (a medication used to treat tuberculosis and non-pulmonary infections caused by mycobacteria) as it may cause a decrease in white blood cell count.
• 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 and chloroquine), as they may cause severe heart rhythm alterations and even cardiac arrest.

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

Taking Azitromicina Kern Pharma with food and drinks

Tablets should be swallowed whole with water and may be taken with or without food. The notch is not intended for breaking the tablet.

Pregnancy, breastfeeding, and fertility

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

Your doctor will assess whether you should take this medication during pregnancy, whether the benefits of treatment outweigh the potential risks. Azithromycin is excreted in breast milk. Due to potential adverse reactions in the infant, it is not recommended to use azithromycin 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 kern pharma contains lactose and sodium

This medication contains lactose. 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 administration instructions of this medication contained in this leaflet or those indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.Your doctor will establish 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 with a weight of over 45 kg:

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

In the case of an infection 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 under 45 kg in weight:

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

Use in patients with liver insufficiency:

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

Use in patients with kidney insufficiency:

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

Administration form

Oral route.

This medication should be taken as a single daily dose.

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

The groove is only for breaking the tablet if it is difficult to swallow whole.

If you take more Azitromicina Kern Pharma than you should

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

Information for the prescriber

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

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

If you forgot to take Azitromicina Kern Pharma

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 forgotten dose and wait for the next one. Do not take a double dose to compensate for the forgotten dose. Continue taking azithromycin as your doctor has recommended.

If you interrupt the treatment with Azitromicina Kern Pharma

If you abandon the treatment with azithromycin before your doctor has recommended, the 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 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 decreased bicarbonate.

Uncommon (may affect up to 1 in 100 people)

- Infection by the fungus Candida in the mouth or generalized, vaginal infection, pneumonia, infection by fungi or bacteria, pharyngitis, gastroenteritis, alteration of breathing, rhinitis.

- Decreased number of some types of white blood cells (leukocytes, neutrophils, and eosinophils).

- Allergic reaction, including a deep inflammatory process of the skin (angioedema).

- Alteration of eating behavior (anorexia).

- Nervousness, insomnia.

- Drowsiness, dizziness, alteration of taste, loss of tactile sensation.

- Alteration of vision

- Alteration of hearing, vertigo.

- Palpitations (abnormality in the rhythm or frequency of the heart and detection of the heartbeat)

- Hot flashes

- Alteration of breathing, nasal hemorrhage.

- Constipation, flatulence, indigestion, gastritis, difficulty swallowing, abdominal distension, dry mouth, belching, mouth ulcers, increased salivation.

- Eruption, pruritus, appearance of red, elevated patches, dermatitis, dry skin, excessive sweating, redness.

- Inflammation of the joints, muscle pain, back pain, neck pain

- Difficulty urinating, kidney pain.

- Vaginal hemorrhage, alteration in the testicles.

- Generalized swelling, weakness, discomfort, fatigue, facial edema, chest pain, fever, pain and swelling of the extremities.

- Alteration of 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 of sodium and potassium levels, decrease in hematocrit.

- Complications after surgical intervention.

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

- Agitation

- Alteration of liver function, yellow discoloration of the skin.

- Sensitivity to sunlight (photosensitivity), drug reaction with increase of a type of white blood cell (eosinophilia) and generalized symptoms (multi-organ compromise) (DRESS syndrome).

- Skin eruption characterized by rapid appearance of red skin patches with small white/yellow-filled blisters.

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

- Diarrhea caused by Clostridium difficile.

- Decrease in the number of platelets in blood, anemia.

- Severe allergic reaction.

- Aggressive behavior, 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 of hearing including deafness and tinnitus.

- Torsades de pointes alterations of heart rhythm, prolongation of QTc interval in electrocardiogram.

- Decrease in blood pressure.

- Inflammation of the pancreas, 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 patches, generalized eruption with blisters and peeling skin, 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 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 leaflet. You can also report them through the Spanish System of 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. Store in the original packaging.

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

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

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 cornstarch, crospovidone, dibasic calcium phosphate, sodium lauryl sulfate, and magnesium stearate.

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

See section 2Azitromicina Kern Pharma contains lactose and sodium.

Appearance of the product and contents of the packaging

Coated tablets with a white film coating and a capsule shape, with a transverse line on one of the faces.

The tablets are packaged in PVC-Aluminum blisters.

It is presented in packs of 3 and 150 tablets (clinical pack).

Holder of the marketing authorization and responsible for manufacturing

Kern Pharma, S.L.

Venus, 72 - Pol. Ind.Colón II

08228 Terrassa - Barcelona

Spain

Last review date of this leaflet:February 2025

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