Leaflet: information for the user

Azithromycin pensa 500 mg powder for oral suspension 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, consult 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 Azithromycin pensa is and for what it is used

2. What you need to know before starting to take Azithromycin pensa

3. How to take Azithromycin pensa

4. Possible side effects

5. Storage of Azithromycin pensa

6. Contents of the pack and additional information

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 weighing more than 45 kg.

It is used for the treatment of the following infections:

• Mild to moderate bronchitis and pneumonia.

• Infections of the nasal sinuses, throat, tonsils, or ears.

• Skin and soft tissue infections.

• 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 of 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 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 whites of your eyes turn yellow, tell your doctor to confirm whether you should stop treatment or if you need to have 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 developing an overinfection by resistant germs, including fungi. In this case, inform your doctor.

• During or after treatment with Azitromicina pensa, symptoms may occur 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 appropriate.

• If you have severe kidney function impairment, inform your doctor.

• If you have severe heart rhythm disorders or factors that predispose you to them (certain heart diseases, alterations in the level of electrolytes in the blood, or certain medications), inform your doctor, as this medicine may contribute to worsening or triggering these disorders.

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

Children and adolescents

Children and adolescents with a weight of less than 45 kg:

This medicine is not recommended for children and adolescents weighing less than 45 kg. It should not be administered to children under 6 months.

Weight over 45 kg:

The same dose as adults, so it is recommended to use other pharmaceutical forms that are more suitable and available on the market.

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

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 drugs 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).

• Dicumarol anticoagulants (medicines used to prevent the formation of blood clots), as azithromycin may potentiate the effect of these anticoagulants. Your doctor should monitor coagulation parameters (prothrombin time).

• Digoxin (a medicine used to treat heart arrhythmias), as azithromycin may increase digoxin levels in the blood and these levels should be monitored.

• Colchicine (used to treat gout and familial Mediterranean fever).

• 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 pulmonary and non-pulmonary tuberculosis caused by mycobacteria), as it may cause a decrease in white blood cell count.

• Cyclosporine (a medicine used in transplant patients), as azithromycin may increase cyclosporine levels in the blood and these levels should be monitored.

• Terfenadine (a medicine used to treat allergies), as the combination of both may cause heart problems.

• Fluconazole (a medicine for the treatment of fungal infections), as azithromycin levels in the blood may be increased.

• Medicines with active substances that prolong the QT interval, such as antiarrhythmic class IA (quinidine and procainamide) and class III (dofetilide, amiodarone, and sotalol) drugs, 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 disorders and even cardiac arrest.

No interactions have been observed between azithromycin and cetirizine (an antihistamine); didanosine, efavirenz, indinavir (for HIV infection); atorvastatin (for high cholesterol and heart problems); carbamazepine (for epilepsy), cimetidine (for excessive stomach acid); methylprednisolone (to suppress the immune system); midazolam, triazolam (to induce sedation); sildenafil (for erectile dysfunction), theophylline (for respiratory problems), and trimethoprim/sulfamethoxazole (to treat infections).

Taking Azitromicina pensa with food and drinks

This medicine should be taken as a single daily dose. The contents of the sachet should be added to a glass with a little water and mixed well. Azitromicina pensa 500 mg granulated for oral suspension in sachet should be taken immediately with or without food.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, or are breastfeeding, 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 wish to become pregnant, unless it is strictly necessary according to medical criteria.

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

Driving and operating machinery

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

Azitromicina pensa contains saccharose, glucose, and sodium:

This medicine contains saccharose and glucose. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medicine.

This medicine contains 0.0044 mg of alcohol (ethanol) in each sachet, equivalent to 0.02% p/p. The amount in the dose of this medicine is equivalent to less than 1 ml of cherry or 1 ml of wine.

The small amount of alcohol contained in this medicine does not produce any perceptible effect.

And this medicine contains 23.958 mg of sodium (main component of table salt/for cooking) in each sachet. This is equivalent to 1.2% of the maximum daily sodium intake recommended for an adult.

Follow exactly the administration instructions of this medication as 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.

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:

This medicationis only suitable for children and adolescents over 45 kg of weight, for whom the same dose as for adults is recommended. For those weighing less, other presentations are recommended. Do not administer to children under 6 months.

Use in patients with liver or kidney insufficiency:

Inform your doctor if you have liver or kidney problems, as the normal dose may need to be modified.

Administration form

Oral route.

This medication should be taken as a single daily dose. The contents of the package should be added to a glass and mixed well with a little water. The resulting suspension is an opalescent, whitish solution.

Consume immediately after reconstitution with or without food.

If you take more Azitromicina than you should

In case of overdose, you may experience temporary 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 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 forgotten dose and wait for the next one. Do not take a double dose to compensate for the forgotten dose. Continue using Azitromicina as instructed 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 Azitromicina as instructed by your doctor, as the infection may recur if you stop treatment prematurely.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can 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, stomach 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)

• Respiratory alteration, nasal hemorrhage

• Allergic reaction, including a deep skin inflammatory process (angioedema)

• Alteration in eating behavior (anorexia)

• Nervousness, insomnia

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

• Vision alteration

• Hearing alteration, vertigo

• Palpitations

• Hot flashes

• Flatulence, constipation, 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

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

• Alteration in 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, yellowish discoloration of the skin

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

• Severe skin reactions: skin rash characterized by rapid appearance of red skin areas dotted 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

• Torsades de pointes, heart rhythm alterations, prolongation of the QTc interval in the electrocardiogram

• Decreased blood pressure

• Pancreatitis, change in tongue color

• Severe liver damage and liver 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 like 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 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 point at your 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 granulated for oral suspension

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

The other components (excipients) are:Sucrose, carboxymethylcellulose sodium type A (from potato), tribasic anhydrous sodium phosphate, sodium lauryl sulfate, xanthan gum (E415), sodium saccharin, cherry flavor (contains ethanol and glucose), vanilla flavor (contains ethanol and glucose), and banana flavor (contains glucose).

Appearance of the product and contents of the packaging

This medication is a white/off-white granulated oral suspension with a cherry odor.

It is presented in carton boxes containing 3 aluminum and paper surlyn sachets.

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

Date of the last review of this leaflet:August 2023

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