AZITHROMYCIN PENSA 500 mg FILM-COATED TABLETS

Introduction

Leaflet: information for the user

Azithromycin Pensa 500 mg film-coated tablets EFG

Read the entire leaflet carefully before starting to take this medicine, as 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 to 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 side effects, consult your doctor, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Azithromycin Pensa is and what it is used for
2. What you need to know before taking Azithromycin Pensa
3. How to take Azithromycin Pensa
4. Possible side effects
5. Storage of Azithromycin Pensa
6. Package contents and additional information

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

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

Azithromycin Pensa is used to treat bacterial 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:

• Bronchitis and pneumonia (mild to moderate severity).
• Infections of the paranasal sinuses, throat, tonsils, or ears.
• Infections of the skin and soft tissues (mild to moderate severity).
• Infections of the urethra (urethritis) or cervix (cervicitis), see section 3.
• Sexually transmitted infections (chancroid), see section 3.

2. What you need to know before taking Azithromycin Pensa

Do not take Azithromycin Pensa

• if you are allergic to azithromycin, erythromycin, another macrolide antibiotic, or ketolide, or any of the other components of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Azithromycin Pensa.

• During treatment with Azithromycin 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 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 whites of your eyes turn yellow, discuss this with 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 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. In this case, inform your doctor.

• During or after treatment with Azithromycin Pensa, symptoms suggesting antibiotic-associated colitis (diarrhea) may appear. If so, treatment should be discontinued, 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 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 azithromycin may trigger or worsen the symptoms of this disease.

Children and adolescents

Children and adolescents weighing less than 45 kg:

The tablets are not recommended for children and adolescents weighing less than 45 kg. They should not be administered 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 pharmaceutical forms of azithromycin can be used.

Other medicines and Azithromycin Pensa

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

Especially, you should 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 azithromycin may cause ergotism (a potentially serious adverse effect with numbness or tingling in the limbs, 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 their levels should be monitored.
• Colchicine (used for gout and familial Mediterranean fever).
• Anticoagulant dicumarolics (medicines used to prevent blood clots), as azithromycin may potentiate the effect of these anticoagulants. Your doctor should monitor coagulation parameters (prothrombin time).
• Zidovudine, nelfinavir (medicines for the treatment of HIV infections), as they may increase azithromycin levels in the blood.
• Rifabutin (a medicine for the treatment of tuberculosis and non-pulmonary infections caused by mycobacteria), as it may decrease the number of white blood cells in the blood.
• Cyclosporin (a medicine used in transplant patients), as azithromycin may increase cyclosporin levels in the blood, and their levels should be monitored.

• Terfenadine (a medicine used to treat allergies), as the combination of both may cause heart problems.
• Fluconazole (medicines for the treatment of fungal infections), as they may increase azithromycin levels 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 anti-infectives (fluoroquinolones such as moxifloxacin or levofloxacin and hydroxychloroquine or chloroquine), as they may cause serious heart rhythm disorders and even cardiac arrest.

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

Taking Azithromycin Pensa 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 plan to become pregnant or are breastfeeding, consult your doctor or pharmacist before using this medicine.

There is not enough information regarding the safety of azithromycin during pregnancy. Therefore, the use of azithromycin is not recommended if you are pregnant or plan 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 breastfed infant, the use of azithromycin is not recommended during breastfeeding, although you may continue breastfeeding two days after completing treatment with Azithromycin Pensa.

Driving and using machines

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

Azithromycin Pensa contains sodium:

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

3. How to take Azithromycin Pensa

Follow the administration instructions of this medicine indicated by your doctor or pharmacist. In case of 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 weighing over 45 kg:

The usual dose is 1,500 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 in adults can be administered. However, if they have heart rhythm disorders, your doctor will closely monitor them.

Urethritis or cervicitis

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

Sinusitis:

Treatment is indicated in adults and adolescents over 16 years.

Children and adolescents weighing less than 45 kg:

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

Use in patients with hepatic or renal impairment

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

Method of administration:

Oral route.

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.

If you take more Azithromycin Pensa 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 or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Azithromycin Pensa

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 Azithromycin Pensa as your doctor has indicated.

If you stop taking Azithromycin Pensa

Do not stop taking your medicine without consulting your doctor first, even if you feel better. It is very important to continue taking this medicine for the time indicated by your doctor, or the infection may recur.

If you have any other questions about 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:

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

• Diarrhea

Common (may affect up to 1 in 10 people)

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

Uncommon (may affect up to 1 in 100 people)

• Infection with the fungus Candida 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 a deep skin inflammation (angioedema)
• Alteration of eating behavior (anorexia)
• Nervousness, insomnia
• Dizziness, somnolence, 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
• Chest pain, generalized swelling, discomfort, weakness, 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

Rare (may affect up to 1 in 1,000 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 cells (eosinophilia) and generalized symptoms (multi-organ involvement) (DRESS syndrome)
• Severe skin reactions: skin rash characterized by the rapid appearance of red areas with small pus-filled bumps (small blisters filled with white/yellow liquid)

Not known (frequency cannot be estimated from the available data)

• Diarrhea caused by Clostridium difficile
• Decrease in the number of platelets in the 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 of hearing, including deafness and ringing
• Torsades de pointes, alteration of heart rhythm, prolongation of the QTc interval in the electrocardiogram
• Decrease in blood pressure
• Change in tongue color, pancreatitis
• Severe liver damage and liver failure, which can be fatal, liver cell death, fulminant hepatitis
• 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
• Acute kidney failure and inflammation of the tissue between the kidney tubules (interstitial nephritis)

Reporting of side effects:

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Azithromycin Pensa

Keep this medicine out of the sight and reach of children.

Do not store above 30°C. Store in the original packaging.

Do not use this medicine after the expiration date stated on the packaging, after EXP. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Packaging Contents and Additional Information

Composition of Azithromycin 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 starch (derived from corn), corn starch, sodium croscarmellose, sodium lauryl sulfate, magnesium stearate, anhydrous calcium hydrogen phosphate, hypromellose, titanium dioxide (E-171), triacetin.

Appearance of the Product and Packaging Contents

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

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

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Manufacturer

Laboratorios Alter, S.A.

Mateo Inurria, 30

28036 Madrid

Spain

Date of the Last Revision of this Leaflet:August 2023

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