Leaflet: information for the user

Azitromicina Normon 500 mg film-coated tablets EFG

azitromicina

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, and you should 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 Normonand for what it is used

2.What you need to know before starting to takeAzitromicina Normon

3.How to take Azitromicina Normon

4.Possible side effects

5.Storage ofAzitromicina Normon

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 infections caused by bacteria 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 Normon:

- 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 this medication:

• During treatment with azithromycin, allergic reactions (itching, redness, skin rash, swelling, or difficulty breathing, or an allergic reaction characterized by increased 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 concurrent 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 kidney function impairment, inform your doctor.
• If you have arrhythmias or factors that predispose you to them (certain heart diseases, electrolyte imbalances in the blood, 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 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 forms of azithromycin may be used.

Other medications and Azitromicina Normon

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 characterized by 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 pulmonary and non-pulmonary tuberculosis 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 antibiotics (fluoroquinolones such as moxifloxacin or levofloxacin), as they may cause severe heart rhythm disturbances and even cardiac arrest.

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

Use of Azitromicina Normon 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.

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 Normon contains lactose and sodium

This medication contains lactose. If your doctor has indicated that you have a certain sugar intolerance, consult with them before taking this medication.

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

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

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 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 may 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.

In the case of an infection caused by N. gonorrhoeae, 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.

Use in children and adolescents weighing less than 45 kg

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

Use in patients with liver insufficiency

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

Use in patients with renal insufficiency

Inform your doctor if you have 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 may 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 Normon 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 functions should be applied.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately 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 that they know which tablets you have taken.

If you forgot to take Azitromicina Normon

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 using azithromycin as your doctor has recommended.

If you interrupt treatment with Azitromicina Normon

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 (in at least 1 in 10 people):

• Diarrhea.

Side effectscommon (in at least 1 in 100 people):

• Decreased 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).
• Decreased bicarbonate.
• Headache.
• Vomiting, abdominal pain, discomfort, nausea.

Side effectsinfrequent (in at least 1 in 1,000 people):

• Candida fungal infection in the mouth or generalized, vaginal infection, pneumonia, fungal or bacterial infection, pharyngitis, gastroenteritis, respiratory alteration, rhinitis.
• Decreased number of some types of white blood cells (leukocytes, neutrophils, and eosinophils).
• Allergic reaction, including a deep skin inflammatory process (angioedema).
• Alteration of eating behavior (anorexia).
• Nervousness, insomnia.
• Drowsiness, dizziness, alteration of taste, loss of tactile sensation.
• Visual alteration.
• Auditory alteration, vertigo.
• Palpitations.
• Hot flashes.
• Respiratory alteration, nasal hemorrhage.
• Constipation, flatulence, indigestion, gastritis, difficulty swallowing, abdominal distension, dry mouth, belching, mouth ulcers, increased salivation.
• Rash, 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 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.

Side effectsrare (in at least 1 in 10,000 people):

• Agitation.
• Liver function alteration, yellow discoloration of the skin.
• Sensitivity to sunlight (photosensitivity), allergic reaction with increased eosinophils and generalized symptoms (multi-organ compromise) (DRESS syndrome).
• Skin rash characterized by the rapid appearance of red skin areas dotted with small white/yellow-filled blisters.

Side effectsfrequency not known (cannot be estimated from available data) are:

• Diarrhea caused by Clostridium difficile.
• Decreased platelet count in blood and decreased red blood cells that can cause pale skin and cause weakness or shortness of breath.
• 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).
• Deafness, hearing loss, ringing in the ears.
• Torsade de pointes cardiac rhythm alterations, prolongation of the QTc interval in the electrocardiogram.
• Decreased blood pressure.
• Pancreatitis (inflammation of the pancreas).
• Change in tongue color
• Hepatic insufficiency (rarely potentially fatal).
• Appearance of red, elevated papules, generalized rash 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.
• Renal inflammation or renal insufficiency.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: 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.

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

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 cornstarch, crospovidone, calcium hydrogen phosphate, sodium lauryl sulfate, magnesium stearate. Coating: hydroxypropyl methylcellulose (hypromellose), titanium dioxide (E171), lactose monohydrate, triacetin (E1518).

Appearance of the product and contents of the packaging

Coated tablets with a white color and a capsule shape.

The tablets are packagedin PVC-Aluminum blisters. It is presented in packaging of 3 and 150 tablets (clinical packaging).

Holder of the marketing authorization and responsible for manufacturing

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

Date of the last review of this leaflet:May 2024

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