AZITHROMYCIN NORMON 500 mg POWDER FOR ORAL SUSPENSION

Introduction

Package Leaflet: Information for the User

Azitromicina Normon 500 mg Powder for Oral Suspension in Sachet EFG

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 Package Leaflet

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

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

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

It is used to treat infections caused by bacteria in different parts of the body, in adults and children with a weight 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 azithromycin, 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 taking Azitromicina Normon:

• During treatment with Azitromicina Normon, 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 if your skin and/or the whites of your eyes turn yellow during treatment, consult 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 azithromycin 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. If this occurs, inform your doctor.
• During or after treatment with Azitromicina Normon, symptoms suggesting antibiotic-associated colitis (diarrhea) may appear. If this occurs, treatment should be suspended, and your doctor will provide the most suitable treatment.
• If you have severe kidney function impairment, inform your doctor.
• If you have heart rhythm disorders (arrhythmias) or factors that predispose you to them (certain heart diseases, electrolyte disturbances 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 Normon may trigger or worsen the symptoms of this disease.

Children and Adolescents

Children and adolescents with a weight below 45 kg

The sachets may not be indicated for this group of patients. Other pharmaceutical forms of azithromycin can be used.

Weight over 45 kg

Same dose as adults, so it is recommended to use other more suitable pharmaceutical forms available on the market.

Sinusitis: treatment is indicated in adults and adolescents over 16 years old.

Other Medicines and Azitromicina Normon

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

Especially, 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 concomitant administration of both drugs at the same time.
• Ergotamine derivatives (such as ergotamine, used to treat migraines), as concomitant treatment with azithromycin may cause ergotism (a potentially serious adverse reaction with numbness or tingling in the extremities, muscle cramps, headaches, convulsions, or abdominal or chest pain).

• Digoxin (a medicine used to treat heart arrhythmias), as azithromycin may increase digoxin levels in the blood, and monitoring is required.
• Colchicine (used to treat gout and familial Mediterranean fever).
• Cyclosporin (a medicine used in transplant patients), as azithromycin may increase cyclosporin levels in the blood, and monitoring is required.
• Oral anticoagulants (medicines used to prevent blood clots), as azithromycin may enhance the effect of these anticoagulants. Your doctor should monitor coagulation parameters (prothrombin time).
• Nelfinavir, zidovudine (medicines used to treat HIV infections), as they may increase azithromycin levels in the blood.
• Fluconazole (medicines used to treat fungal infections), as it may increase azithromycin levels in the blood.
• Terfenadine (a medicine used to treat allergies), as the combination of both may cause heart problems.
• Rifabutin (a medicine used to treat pulmonary and non-pulmonary tuberculosis and mycobacterial infections), as it may decrease the number of white blood cells in the blood.
• Medicines with active substances that prolong the QT interval, such as antiarrhythmic drugs 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 serious heart rhythm disorders and even cardiac arrest.

No interactions have been observed between azithromycin 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

This medicine should be administered as a single daily dose. The contents of the sachet should be added to a glass with a little water, mixing well. The suspension should be ingested immediately, with or without food.

Pregnancy, Breast-feeding, and Fertility

If you are pregnant or breast-feeding, 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.

Azithromycin is excreted in breast milk. Due to the potential adverse reactions in the infant, the use of azithromycin is not recommended during breast-feeding, although you may continue breast-feeding two days after completing treatment with Azitromicina Normon.

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 Saccharose, Sodium, and Benzyl Alcohol.

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

Patients with diabetes mellitus should note that this medicine contains 4.530 g of saccharose per sachet.

This medicine contains 22.7 mg of sodium (the main component of table salt) per sachet. This is equivalent to 1.14% of the maximum recommended daily sodium intake for an adult.

This medicine contains approximately 1.94 mg of benzyl alcohol per sachet.

Benzyl alcohol may cause allergic reactions.

Consult your doctor or pharmacist if you are pregnant or breast-feeding. This is because large amounts of benzyl alcohol can accumulate in your body and cause adverse effects (metabolic acidosis).

Consult your doctor or pharmacist if you have liver or kidney disease. This is because large amounts of benzyl alcohol can accumulate in your body and cause adverse effects (metabolic acidosis).

Benzyl alcohol has been associated with the risk of serious adverse effects, including respiratory problems ("gasping syndrome") in children.

Do not give this medicine to your newborn (up to 4 weeks old) unless your doctor has recommended it.

This medicine should not be used for more than one week in children under 3 years old unless your doctor or pharmacist has indicated it.

3. How to Take Azitromicina Normon

Follow exactly the administration instructions of this medicine contained in this leaflet or as indicated by your doctor or pharmacist. If in 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 the medicine and the frequency of administration are as follows:

Adults (including elderly patients) and children with a weight 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.

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 old.

Use in Children and Adolescents under 45 kg

The sachets may not be indicated for this group of patients. Other pharmaceutical forms of azithromycin can be used.

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

This medicine is administered orally, as a single daily dose. The contents of the sachet should be added to a glass with a little water, mixing well. The suspension, which has a milky appearance, should be ingested immediately, with or without food.

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, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken. Bring this leaflet and the packaging to the hospital or your doctor so they know what you have taken.

If you Forget to Take Azitromicina Normon

In case of a missed 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 this medicine as your doctor has indicated.

If you Interrupt Treatment with Azitromicina Normon

If you stop treatment with azithromycin 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 Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

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

Very common adverse effects (at least 1 in 10 people):

• Diarrhea.

Common adverse effects (at least 1 in 100 people)

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

Uncommon adverse effects (at least 1 in 1,000 people)

• Candida fungus infection 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 layer of the 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, belching, mouth ulcers, increased salivation.
• Rash, itching, appearance of reddish raised patches, dermatitis, dry skin, excessive sweating, redness.
• Inflammation of the joints, muscle pain, back pain, neck pain.
• Difficulty urinating, pain in the kidneys.
• 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 blood, alteration of sodium and potassium levels, decrease in hematocrit.
• Complications after surgical intervention.

Rare adverse effects (at least 1 in 10,000 people)

• Agitation.
• Alteration of liver function, yellowing of the skin.
• Sensitivity to sun exposure (photosensitivity), drug reaction with increased white blood cell count (eosinophilia) and generalized symptoms (multi-organ involvement) (DRESS syndrome).
• Skin rash characterized by the rapid appearance of red skin areas sprinkled with small pus-filled blisters (small white/yellow-filled pimples).

Adverse effects of unknown frequency (cannot be estimated from available data)

• Diarrhea caused by Clostridium difficile.
• Decrease in platelet count in 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.
• Torsades de pointes, cardiac 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 rarely be fatal, liver tissue death, fulminant hepatitis.
• Appearance of reddish raised 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 renal tubules (interstitial nephritis).

Reporting of Adverse Effects

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

5. Conservation of Azitromicina Normon

Keep this medicine out of sight and reach of children.

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

Before reconstitution: no special storage conditions are required. Store in the original packaging.

After reconstitution: take the suspension immediately. Discard the remaining solution.

Medicines should not be thrown away through the sewers or in the trash. Deposit the packaging and medicines you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Azitromicina Normon

The active ingredient is azithromycin (as dihydrate). Each sachet contains 500 mg of azithromycin.

The other components (excipients) are: sucrose, hydroxypropylcellulose (E463), trisodium phosphate, xanthan gum (E415), cherry flavor (contains benzyl alcohol), vanilla flavor, and banana flavor. See section 2 Azitromicina Normon contains sucrose and sodium.

Aspect of the Product and Package Contents

Azitromicina Normon 500 mg is a dry, ivory-colored powder with a fruity odor for oral suspension in a sachet. Packaging of 3 sachets. Packaging of 100 sachets (clinical packaging).

Only some package sizes may be marketed.

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 Prospectus:July 2025

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