Leaflet: information for the user

Azithromycin pensa 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, ask 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, even if they are not listed in this leaflet. See section 4.

1. What is Azithromycin pensa and what it is used for

2. What you need to know before you start taking Azithromycin pensa

3. How to take Azithromycin pensa

4. Possible side effects

5. Storage of Azithromycin pensa

6. Contents of the pack and additional informationadditional information

Azithromycin belongs to a group of antibiotics called macrolides. It eliminates bacteria causing infections.

It is used for the treatment of bacterial infections caused by bacteria in different parts of the body, in adults and children with a weight of 45 kg or more.

It is used for the treatment of the following infections:

•Bronchitis and pneumonia (mild to moderate severity).

•Upper respiratory tract infections, throat, tonsils, or ear infections.

•Skin and soft tissue infections (mild to moderate severity).

•Urethritis or cervicitis, see section 3.

•Sexually transmitted infections (chancroid), see section 3.

Do not take Azitromicina pensa if

- you are allergic to azithromycin, erythromycin, other macrolide or ketolide antibiotics, or any of the other ingredients in this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Azitromicina pensa.

• During treatment with Azitromicina pensa, 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 general symptoms) may occur, which could be severe. Inform your doctor, who may decide to stop treatment and start the appropriate treatment.

• If you have liver problems or during treatment your skin and/or the white part of your eyes turns yellow, inform your doctor to confirm whether you should stop 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 medicine, there is a possibility of overinfection by resistant germs, including fungi. In this case, inform your doctor.

• During or after treatment with Azitromicina pensa, symptoms may appear that suggest antibiotic-associated colitis (diarrhea). If this is the case, treatment should be suspended and your doctor will prescribe the treatment they consider most suitable.

• 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 medicine may contribute to worsening or triggering these conditions.

• If you have myasthenia gravis or if muscle weakness and fatigue appear during treatment, inform your doctor, as azithromycin may trigger or worsen the symptoms of this disease.

Children and adolescents

Children and adolescents weighing less than 45 kg:

Tablets are not recommended for children and adolescents weighing less than 45 kg. Do not administer to children under 6 months.

Weight over 45 kg

This medicine is not suitable for children who are unable to swallow the tablets whole. Other forms of azithromycin may be used.

Other medicines and Azitromicina pensa

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

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 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 medicine 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).
• Anticoagulant dicumarins (medicines used to prevent the formation of blood clots) as azithromycin may potentiate the effect of these anticoagulants. Your doctor should control coagulation parameters (prothrombin time).
• Zidovudine, nelfinavir (medicines used to treat HIV infections), as they may increase azithromycin levels in the blood.
• Rifabutin (a medicine used to treat tuberculosis and non-pulmonary infections caused by mycobacteria), as it may cause a decrease in white blood cell count.
• Ciclosporin (a medicine used in transplant patients), as azithromycin may increase ciclosporin levels in the blood and levels should be monitored.

• Terfenadine (a medicine used to treat allergies), as the combination may cause heart problems.
• Fluconazole (medicines used to treat fungal infections), as they may increase azithromycin levels in the blood.
• Medicines 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 antibiotics (fluoroquinolones such as moxifloxacin or levofloxacin, or 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); midazolam, triazolam (for inducing sedation); sildenafil (for treating impotence), theophylline (for respiratory problems), and trimethoprim/sulfamethoxazole (for treating infections).

Taking Azitromicina pensa with food and drinks

The tablets should be swallowed 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 become pregnant, consult your doctor or pharmacist before using this medicine.

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

Azithromycin is excreted in breast milk. Due to potential adverse reactions in the infant, azithromycin should not be used during breastfeeding, although breastfeeding can continue two days after completing treatment with Azitromicina pensa.

Driving and operating machines

The influence of this medicine on the ability to drive or operate machines is negligible or insignificant.

Azitromicina pensa contains sodium:

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

Follow exactly the administration instructions of this medication 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 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 may be administered. However, in the case of patients with cardiac rhythm disorders, your doctor will closely monitor you.

Urethral or cervical inflammation (cervicitis)

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

In the case of an infection caused byN. 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:

The tablets are not recommended for these patients. Other pharmaceutical forms are available for this group of patients.

Use in patients with liver or kidney insufficiency

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

Administration form:

Oral.

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 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.

If you forget to take Azitromicina

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 Azitromicina as directed by your doctor.

If you interrupt treatment withAzitromicina

Do not stop taking your medication without consulting your doctor, even if you feel better. It is very important that you continue taking this medication for the time your doctor has indicated, as the infection may recur if you stop.

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:

Very common (may affect more than 1 in 10 people):

• Diarrhea

Common (may affect at least 1 in 10 people)

• Alteration in the number of some types of white blood cells (lymphocytes, eosinophils, basophils, monocytes, and neutrophils), decreased bicarbonate

• Headache

• Vomiting, abdominal pain, nausea

Uncommon (may affect at least 1 in 100 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

• Dizziness, somnolence, taste alterations, loss of tactile sensation

• Vision alteration

• Hearing alteration, vertigo

• Palpitations

• Hot flashes

• Respiratory alteration, nasal bleeding

• 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 bleeding, testicular alteration

• Chest pain, generalized swelling, discomfort, weakness, fatigue, facial edema, chest pain, fever, pain and swelling of the extremities

• Alteration of liver function tests (increased liver enzymes GOT, GPT, and alkaline phosphatase) and increased bilirubin, urea, creatinine, chloride, glucose, bicarbonate, and platelets in blood, alteration of sodium and potassium levels, decreased hematocrit

• Post-surgical complications

Rare (may affect at least 1 in 1,000 people)

• Agitation

• Liver function alteration, yellow discoloration of the skin

• Sensitivity to sunlight (photosensitivity) drug reaction with increased eosinophils and generalized symptoms (multi-organ compromise) (DRESS syndrome)

• Severe skin reactions: skin rash characterized by the rapid appearance of red skin patches with small white/yellow-filled blisters

Not known (frequency cannot be estimated from available data)

• Diarrhea caused by Clostridium difficile

• Decreased platelet count in blood, anemia

• Severe allergic reaction

• Aggressive behavior, anxiety, delirium, hallucinations

• Loss of consciousness, seizures, decreased sensitivity, hyperactivity, alteration and/or loss of smell, loss of taste, muscle weakness and fatigue (myasthenia gravis)

• Alteration in hearing including deafness and tinnitus

• Torsade de pointes, cardiac rhythm alteration, prolonged QTc interval on electrocardiogram

• Decreased blood pressure

• Change in tongue color, pancreatitis inflammation

• Severe liver damage and liver failure that can rarely 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 inflammation

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 store at a temperature above 86°F (30°C). Store in the original packaging.

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

Unused medications should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection pointat 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 pensa 500 mg film-coated tablets

• The active ingredient is azithromycin. Each tablet contains 500 mg of azithromycin (as dihydrate).
• The other components (excipients) are: pregelatinized maize starch, maize starch, sodium croscarmellose, sodium lauryl sulfate, magnesium stearate, anhydrous calcium hydrogen phosphate, hypromellose, titanium dioxide (E-171), triacetin.

Appearance of the product and content of the packaging

Azitromicina pensa are film-coated tablets, white in color, scored, and capsule-shaped.

Each carton box contains a PVC/AL blister pack with 3 tablets and 500 tablets (clinical packaging).

Only some packaging sizes may be commercially available.

Holder of the marketing authorization

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Responsible for manufacturing

Laboratorios Alter, S.A.

Mateo Inurria, 30

28036 Madrid

Spain

Last review date of this leaflet:August 2023

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