AZITHROMYCIN PENSA 500 mg ORAL SUSPENSION GRANULES

Introduction

Package Leaflet: Information for the User

Azithromycin Pensa 500 mg Granules for Oral Suspension EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Azithromycin Pensa and what is it used for
2. What you need to know before you take Azithromycin Pensa
3. How to take Azithromycin Pensa
4. Possible side effects
5. Storage of Azithromycin Pensa
6. Contents of the pack and other information

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

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

Azithromycin Pensa is used to treat 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.
• Infections of the urethra (urethritis) or cervix (cervicitis), see section 3.
• Sexually transmitted infections (chancroid), see section 3.

Children and Adolescents

Children and adolescents weighing less than 45 kg:

This medication 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 is recommended, and it is suggested 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.

Other Medications and Azithromycin Pensa

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medications.

Especially, inform your doctor or pharmacist if you are taking any of the following medications:

• Antacids (medications 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 concurrent administration with azithromycin may cause ergotism (a potentially serious side effect with numbness or tingling in the extremities, muscle cramps, headaches, seizures, or abdominal or chest pain).
• Anticoagulants (medications used to prevent blood clots), as azithromycin may enhance the effect of these anticoagulants. Your doctor should monitor coagulation parameters (prothrombin time).
• Digoxin (a medication used to treat heart arrhythmias), as azithromycin may increase digoxin levels in the blood, and these levels should be monitored.
• Colchicine (used for gout and familial Mediterranean fever).
• Zidovudine, nelfinavir (medications for the treatment of HIV infections), as they may increase azithromycin levels in the blood.
• Rifabutin (a medication for the treatment of pulmonary and non-pulmonary tuberculosis), as it may decrease the number of white blood cells in the blood.
• Cyclosporin (a medication used in transplant patients), as azithromycin may increase cyclosporin levels in the blood, and these levels should be monitored.
• Terfenadine (a medication used to treat allergies), as the combination of both may cause heart problems.
• Fluconazole (a medication used to treat fungal infections), as it may increase azithromycin levels in the blood.
• Medications with active substances that prolong the QT interval, such as antiarrhythmic agents (quinidine and procainamide) and class III (dofetilide, amiodarone, and sotalol), cisapride, terfenadine, antipsychotic agents (such as pimozide), antidepressants (such as citalopram), and anti-infective agents (fluoroquinolones such as moxifloxacin or levofloxacin and hydroxychloroquine or chloroquine), as they may cause serious heart rhythm disturbances 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 excess stomach acid); methylprednisolone (to suppress the immune system); midazolam, triazolam (for sedation); sildenafil (for impotence), theophylline (for respiratory problems), and trimethoprim/sulfamethoxazole (to treat infections).

Taking Azithromycin Pensa with Food and Drinks

This medication should be administered as a single daily dose. The contents of the sachet should be added to a glass with a little water, mixing well. Azithromycin Pensa 500 mg granules 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 are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

There is not enough information on the safety of azithromycin during pregnancy. Therefore, azithromycin is not recommended during pregnancy, unless it is strictly necessary according to medical criteria.

Azithromycin is excreted in breast milk. Due to potential adverse reactions in the infant, 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 medication on the ability to drive or use machines is negligible.

Azithromycin Pensa Contains Sucrose, Glucose, and Sodium:

This medication contains sucrose and glucose. If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medication.

This medication contains 0.0044 mg of alcohol (ethanol) per sachet, which is equivalent to 0.02% w/w. The amount in a dose of this medication is equivalent to less than 1 ml of cherry or 1 ml of wine.

The small amount of alcohol in this medication does not produce any noticeable effect.

This medication also contains 23.958 mg of sodium (the main component of table salt) per sachet, which is equivalent to 1.2% of the maximum recommended daily intake of sodium for an adult.

3. How to Take Azithromycin Pensa

Always take this medication exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

Your doctor will determine the most suitable dose and duration of treatment for you, according to your condition and response to treatment. As a general rule, the recommended dose of medication and frequency of administration is 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.

Urethral or cervical infection (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:

This medication is only suitable for children and adolescents weighing over 45 kg, for whom the same dose as adults is recommended. For those weighing less, it is recommended to use other presentations. It should not be administered to children under 6 months.

Use in Patients with Hepatic or Renal Impairment:

Tell your doctor if you have liver or kidney problems, as it may be necessary to modify the usual dose.

Method of administration

Oral use.

This medication should be administered as a single daily dose. The contents of the sachet should be added to a glass with a little water, mixing well. The resulting suspension is an opaque, whitish solution.

Take immediately after reconstitution with or without food.

If You Take More Azithromycin Pensa Than You Should

In case of overdose, you may experience temporary hearing loss, severe nausea, vomiting, and diarrhea.

Information for the prescriber:

In case of overdose, 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 Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If You Forget to Take Azithromycin Pensa

If you miss a dose, use the medication as soon as possible and continue 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 doses. Continue using Azithromycin Pensa as your doctor has indicated.

If You Stop Taking Azithromycin Pensa

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

If you have any further questions on the use of this medication, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medications, this medication 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, stomach pain, nausea

Uncommon (may affect up to 1 in 100 people)

• Candida fungal infection in the mouth or generalized, vaginal infection, pneumonia, fungal or bacterial infection, pharyngitis, gastroenteritis, respiratory disorders, rhinitis
• Decrease in the number of some types of white blood cells (leukocytes, neutrophils, and eosinophils)
• Respiratory disorders, nosebleeds
• Allergic reaction, including a deep skin inflammatory process (angioedema)
• Alteration of eating habits (anorexia)
• Nervousness, insomnia
• Dizziness, drowsiness, taste disorders, loss of tactile sensation
• Visual disturbances
• Hearing disorders, vertigo
• Palpitations
• Hot flashes
• Flatulence, constipation, 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, testicular disorders
• Chest pain, generalized swelling, discomfort, weakness, fatigue, facial edema, fever, chest pain, 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
• Liver function disorders, 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: a 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)

• Clostridium difficile-associated diarrhea
• Decrease in platelet count, anemia
• Severe allergic reaction
• Aggressive reactions, 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)
• Hearing disorders, including deafness and tinnitus
• Torsades de pointes, heart rhythm disorders, prolongation of the QTc interval in the electrocardiogram
• Decrease in blood pressure
• Pancreatitis, change in tongue color
• 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, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Azitromicina 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 CAD. The expiration date is the last day of the month indicated.

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

6. Package contents and additional information

Composition of Azitromicina pensa 500 mg granules for oral suspension

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

The other components (excipients) are: sucrose, sodium carboxymethyl starch type A (derived from potato), anhydrous sodium phosphate tribasic, 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 package contents

This medicine is a white/ivory-colored granule for oral suspension with a cherry odor.

It is presented in cardboard boxes containing 3 thermosealed aluminum and surlyn sachets.

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

Date of the last revision of this prospectus:August 2023

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