AZITHROMYCIN NORMON 500 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Azitromicina Normon 500 mg film-coated tablets EFG

azitromicina

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What Azitromicina Normon is and what it is used for

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

Azitromicina is used to treat infections caused by bacteria in different parts of the body, in adults and children weighing over 45 kg.

It is used to treat the following infections:

• Throat, tonsil, ear, or sinus infections.
• Bronchitis and pneumonia (mild to moderate severity).
• Skin and soft tissue infections (mild to moderate severity).
• Urethra (urethritis) or cervix (cervicitis) infections, see section 3.
• Sexually transmitted infections (chancroid), see section 3.

2. What you need to know before you take Azitromicina Normon

Do not take Azitromicina Normon:

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medicine:

• During treatment with azitromicina, allergic reactions (itching, redness, skin rash, swelling, or difficulty breathing or an allergic reaction to the medicine 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 serious adverse reaction called ergotism.
• During treatment with this medicine, 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 so, treatment should be suspended, and your doctor will provide the most suitable treatment.
• If you have any kidney function disorders, inform your doctor.
• If you have heart rhythm disorders or factors that predispose you to them (certain heart diseases, electrolyte level alterations in the blood, or certain medications), inform your doctor, as this medicine 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 group of patients. Other pharmaceutical forms containing azitromicina can be used (e.g., suspensions). Do not administer to children under 6 months.

Children and adolescents weighing over 45 kg.

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

Other medicines and Azitromicina Normon

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Especially, you must inform your doctor or pharmacist if you are being treated with any of the following medicines:

• Antacids (medicines used for digestive problems). It is recommended to avoid simultaneous administration of both drugs 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 serious adverse reaction).
• Digoxin (a medicine 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).
• Ciclosporin (a medicine used in transplanted patients), as azitromicina may increase ciclosporin levels in the blood, and these levels should be monitored.
• Anticoagulant dicumarolics (medicines used to prevent blood clots), as azitromicina may enhance the effect of these anticoagulants. Your doctor should monitor coagulation parameters (prothrombin time).
• Nelfinavir, zidovudine (medicines for the treatment of infections caused by the human immunodeficiency virus), as they may increase azitromicina levels in the blood.
• Fluconazole (medicines for treating fungal infections), as they may increase azitromicina levels in the blood.
• Terfenadine (a medicine used to treat allergies), as the combination of both may cause heart problems.
• Rifabutin (a medicine for the treatment of pulmonary and non-pulmonary tuberculosis and infections caused by mycobacteria), as it may cause a decrease in the number of white blood cells in the blood.
• Medicines 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 antiinfectives (fluoroquinolones such as moxifloxacin or levofloxacino), as they may cause serious heart rhythm disorders and even cardiac arrest.

No interactions have been observed between azitromicina and cetirizine (for treating allergic reactions); didanosine, efavirenz, indinavir (for treating HIV infection); atorvastatin (for treating high 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 (for sedation); sildenafil (for treating impotence), and trimethoprim/sulfamethoxazole (for treating infections).

Using Azitromicina Normon with food and drinks

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Your doctor will assess whether you should take this medicine 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 medicine on the ability to drive or use machines is negligible or non-existent.

Azitromicina Normon contains lactose and sodium

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

This medicine contains less than 23 mg of sodium (1 mmol) per film-coated tablet; this is essentially "sodium-free".

3. How to take Azitromicina Normon

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

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 the medicine and the frequency of administration are as follows:

Adults (including elderly patients) and children weighing over 45 kg:

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

In case 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.

Use in children and adolescents under 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 hepatic impairment

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

Use in patients with renal impairment

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

Method of administration

Oral use.

This medicine 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 only to facilitate breaking the tablet if you find it difficult to swallow it whole.

If you take more Azitromicina Normon 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, immediately consult your doctor or pharmacist or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine 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 Normon

In case of forgetting a dose, use the medicine 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 using azitromicina as your doctor has indicated.

If you stop taking Azitromicina Normon

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

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

The side effects very common (at least 1 in 10 people):

• Diarrhea.

The side effects common (at least 1 in 100 people):

• Decrease in lymphocytes (a type of white blood cell), increased eosinophils (a type of white blood cell), and other alterations in the number of some types of white blood cells (basophils, monocytes, and neutrophils).
• Decrease in bicarbonate.
• Headache.
• Vomiting, abdominal pain, discomfort, nausea.

The side effects uncommon (at least 1 in 1,000 people):

• Infection by the Candida fungus in the mouth or generalized, vaginal infection, pneumonia, fungal or bacterial infection, pharyngitis, gastroenteritis, alteration of breathing, rhinitis.
• Decrease in the number of some types of white blood cells (leukocytes, neutrophils, and eosinophils).
• Allergic reaction, including an inflammatory process in the deep skin (angioedema).
• Alteration of eating behavior (anorexia).
• Nervousness, insomnia.
• Somnolence, dizziness, alteration of taste, loss of tactile sensation.
• Alteration of vision.
• Alteration of hearing, vertigo.
• Palpitations.
• Hot flashes.
• Alteration of 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 limbs.
• 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 the blood, alteration of sodium and potassium levels, decrease in hematocrit.
• Complications after surgery.

The side effects rare (at least 1 in 10,000 people):

• Agitation.
• Alteration of 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 compromise) (DRESS syndrome).
• Skin rash characterized by the rapid appearance of red skin areas with small pustules (small blisters filled with white/yellow liquid).

The side effects of unknown frequency (cannot be estimated from the available data) are:

• Diarrhea produced by Clostridium difficile.
• Decrease in the number of platelets in the blood and decrease in red blood cells, which can cause pale skin and weakness or shortness of breath.
• Severe allergic reaction.
• Aggressive reactions, anxiety, delirium, hallucinations.
• Loss of consciousness, convulsions, decreased sensitivity, hyperactivity, alteration and/or loss of smell, loss of taste, weakness, and muscle fatigue (myasthenia gravis).
• Deafness, hearing loss, ringing in the ears.
• Torsade de pointes, heart rhythm disorders, prolongation of the QTc interval in the electrocardiogram.
• Decrease in blood pressure.
• Pancreatitis (inflammation of the pancreas).
• Change in tongue color.
• Hepatic failure (rarely potentially fatal).
• 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.
• Kidney inflammation or renal failure.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Azitromicina Normon

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 that appears 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 pharmacy's SIGRE Point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medications. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Azitromicina Normon

• The active ingredient is azithromycin (as dihydrate). Each tablet contains 500 mg of azithromycin.
• The other components (excipients) are: Core: pregelatinized corn starch, crospovidone, calcium hydrogen phosphate, sodium lauryl sulfate, magnesium stearate. Coating: hypromellose, titanium dioxide (E171), lactose monohydrate, triacetin (E1518).

Appearance of the Product and Package Contents

Film-coated tablets, white in color and capsule-shaped.

The tablets are packaged in PVC-Aluminum blisters. They are available in packages of 3 and 150 tablets (clinical packaging).

Marketing Authorization Holder and Manufacturer

Laboratorios Normon, S.A. Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Date of the Last Revision of this Leaflet:May 2024

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