Package Insert: Information for the User

Azitromicina Mabo 500 mg Film-Coated Tablets EFG

Read this package insert carefully before starting to take this medicine, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4

Azitromicina belongs to a group of antibiotics called macrolides. It eliminates bacteria causing 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 nasal sinus infections.
• Mild to moderate bronchitis and pneumonia.
• Mild to moderate skin and soft tissue infections.
• Urethritis or cervicitis, see section 3.

Sexually transmitted infections (chancroid), see section 3.

Do not take Azitromicina Mabo

• If you are allergic (hypersensitive) 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 this medication, 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 start 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 interrupt treatment or if you need to 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 this medication, symptoms may appear that suggest antibiotic-associated colitis (diarrhea). If so, treatment should be suspended and your doctor will prescribe the most suitable treatment.
• If you have severe 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 appear during treatment, inform your doctor, as this medication may trigger or worsen symptoms of this disease.

Children and adolescents

Children and adolescents weighing less than 45 kg.

This medication is 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 the entire tablets. Other forms of azithromycin may be used.

Other medications and Azitromicina Mabo

Inform your doctor or pharmacist if you are using, have used recently, or may need to use 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 pulmonary and non-pulmonary tuberculosis caused by mycobacteria) as it may cause a decrease in white blood cells in the blood.
• Medications with active substances that prolong the QT interval, such as antiarrhythmic class IA (quinidine and procainamide) and class III (dofetilide, amiodarone, and sotalol), cisapride, antipsychotics (such as pimozide), antidepressants (such as citalopram), and antifungals (fluoroquinolones such as moxifloxacin or levofloxacin, and hydroxychloroquine or 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 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).

Taking Azitromicina Mabo with food and drinks

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

Pregnancy and breastfeeding

Pregnancy

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

There is not enough information about the safety of azithromycin during pregnancy. Therefore, azithromycin should not be used during pregnancy, or if you plan to become pregnant, unless it is strictly necessary according to medical criteria.

Breastfeeding

Azithromycin is excreted in breast milk. Due to potential adverse reactions in the infant, azithromycin should not be used during breastfeeding, although breastfeeding may be continued two days after completing treatment with this medication.

Driving and operating machinery

The influence of this medication on the ability to drive or operate machinery is negligible or insignificant.

Azitromicina Mabo contains lactose

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

Azitromicina Mabo contains sodium

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

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

Your doctor will establish the most suitable dose and treatment duration for you, based on 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 1,500 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 usual dose is 1,000 mg taken as a single dose, on a single day.

In the case of an infection caused by N. gonorrohea, 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 of body weight:

The tablets are not recommended for these patients. Other pharmaceutical forms of azithromycin 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 severe 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 can be taken with or without food.

If you take more Azitromicina Mabo 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 immediately or call the Toxicological Information Service at 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Azitromicina Mabo

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 missed dose and wait for the next one. Do not take a double dose to compensate for the missed dose. Continue using this medication as your doctor has indicated.

If you interrupt treatment with Azitromicina Mabo

If you stop treatment with this medication 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:

The side effectsvery frequent (in at least 1 in 10 people)are:

• Diarrhea.

The side effectscommon (in at least 1 in 100 people)are:

• 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).

The side effectsinfrequent (in at least 1 in 1,000 people)are:

• Candida fungal infection in the mouth or generalized, vaginal infection, pneumonia, fungal or bacterial infection, pharyngitis, gastroenteritis, respiratory alteration, rhinitis.
• Decrease in the 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

The side effectsrare (in at least 1 in 10,000 people)are:

• Agitation.
• Liver function alteration, yellow discoloration of the skin.
• Sensitivity to sunlight (photosensitivity), allergic reaction with increase of 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 dotted with small white/yellow-filled blisters.

The side effects ofunknown frequency (cannot be estimated from available data)are:

• Diarrhea caused by Clostridium difficile.
• Decrease in 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).
• Auditory alteration including deafness and tinnitus.
• Torsade de pointes cardiac rhythm alterations, prolongation of the QTc interval on the electrocardiogram.
• Decrease in blood pressure.
• Pancreatitis, change in tongue color.
• Severe liver damage and hepatic failure that rarely can be fatal, liver tissue death, fulminant hepatitis.
• 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.
• Acute kidney failure and 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 directly through the Spanish System for the 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.

Do not use this medicationafter 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 the packaging and medicines you no longer need at the SIGRE point of your usual pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

Composition of Azitromicina Mabo

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

Appearance of the product and contents of the packaging

Coated tablets, white, capsule-shaped, with a transverse line marking on one face. Each package contains 3 or 150 (clinical package) tablets.

Only some package sizes may be commercially marketed.

Marketing Authorization Holder

MABO-FARMA S.A.

Vía de los Poblados, 3, Building 6

28033 Madrid,

Spain.

Responsible for Manufacturing

KERN PHARMA, S.L.

Polígono Ind. Colón II. Venus, 72

08228 Terrasa (Barcelona)

Spain

or

INDUSTRIA QUÍMICA Y FARMACÉUTICA VIR, S.A.

C/ Laguna 66-70. Polígono Industrial Urtinsa II.

28923 Alcorcón. Madrid

Spain

Last review date of this leaflet:May 2023

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