AZITHROMYCIN CINFA 500 mg POWDER FOR ORAL SUSPENSION

Introduction

Package Leaflet: Information for the User

azitromicina cinfa 500 mg powder for oral suspension EFG

azitromicina dihydrate

Read the package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication 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 or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

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

1. What is azitromicina cinfa and what is it used for

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

Azitromicina cinfa 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:

• Throat, tonsil, ear, or sinus infections.
• Bronchitis and pneumonia (mild to moderate severity).
• Skin and soft tissue infections (mild to moderate severity).
• Urethra (urethritis) or cervix (cervicitis) infections, see section 3.
• Sexually transmitted infections (chancroid), see section 3.

2. What you need to know before taking azitromicina cinfa

Do not take azitromicina cinfa:

• If you are allergic to azitromicina, erythromycin, or any other macrolide or ketolide antibiotic, or to any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take azitromicina cinfa:

? During treatment with azitromicina, 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 discontinue treatment and initiate appropriate treatment.

? If you have liver problems or if your skin and/or the whites of your eyes turn yellow during treatment, consult 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 azitromicina may cause a potentially serious adverse reaction called ergotism.

? During treatment with this medication, there is a possibility of developing a superinfection with resistant germs, including fungi. If this occurs, inform your doctor.

? During or after treatment with azitromicina, symptoms suggesting antibiotic-associated colitis (diarrhea) may appear. If this occurs, treatment should be discontinued, and your doctor will provide the necessary treatment.

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

? If you have heart rhythm disorders (arrhythmias) or factors that predispose you to them (certain heart diseases, electrolyte imbalances in the blood, or certain medications), inform your doctor, as this medication 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 azitromicina may trigger or worsen the symptoms of this disease.

Children and adolescents

Children and adolescents weighing less than 45 kg.

The sachets may not be suitable for this patient group. Other pharmaceutical forms of azitromicina may be used. It should not be administered to children under 6 months.

Weight over 45 kg

Same dose as adults, so it is recommended to use other more suitable pharmaceutical forms available on the market.

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

Taking azitromicina cinfa with other medications

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take 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 concomitant administration of both medications at the same time of day.
• Ergotamine derivatives (such as ergotamine, used to treat migraines), as concomitant administration with azitromicina may cause ergotism (a potentially serious adverse reaction 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 azitromicina may increase digoxin levels in the blood, and monitoring is required.
• Colchicine (used to treat gout and familial Mediterranean fever).
• Ciclosporin (a medication used in transplant patients), as azitromicina may increase ciclosporin levels in the blood, and monitoring is required.
• Anticoagulant dicumarolics (medications used to prevent blood clots), as azitromicina may enhance the effect of these anticoagulants. Your doctor should monitor coagulation parameters (prothrombin time).
• Nelfinavir, zidovudine (medications for the treatment of HIV infections), as they may increase azitromicina levels in the blood.
• Fluconazole (medications for the treatment of fungal infections), as it may increase azitromicina levels in the blood.
• Terfenadine (a medication used to treat allergies), as the combination of both may cause heart problems.
• Rifabutin (a medication for the treatment of pulmonary and non-pulmonary tuberculosis and mycobacterial infections), as it may decrease the number of white blood cells in the blood.
• Medications 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 chloroquine), as they may cause serious heart rhythm disorders and even cardiac arrest.

No interactions have been observed between azitromicina 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); theophylline (for respiratory problems); midazolam, triazolam (for sedation); sildenafil (for the treatment of impotence), and trimethoprim/sulfamethoxazole (for the treatment of infections).

Taking azitromicina cinfa 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. The suspension should be ingested immediately, with or without food.

Pregnancy and breastfeeding

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

There is not enough information regarding the safety of azitromicina during pregnancy. Consequently, the use of azitromicina is not recommended if you are pregnant or plan to become pregnant, unless it is strictly necessary according to medical judgment.

Azitromicina is excreted in breast milk. Due to potential adverse reactions in the infant, the use of azitromicina is not recommended during breastfeeding, although you may continue breastfeeding two days after completing treatment with azitromicina.

Driving and using machines

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

azitromicina cinfa contains sucrose

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

azitromicina cinfa contains sodium

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

3. How to take azitromicina cinfa

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If you have any doubts, 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 medication and administration frequency is as follows:

Adults (including elderly patients): 500 mg of azitromicina (1 sachet in a single dose) once a day for 3 consecutive days, with a total dose of 1500 mg of azitromicina (3 sachets).

Urethra or cervix infection (cervicitis):

The recommended dose is 1000 mg taken as a single dose, in one day.

If 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 1000 mg taken as a single dose, in one day.

Sinusitis:

Treatment is indicated in adults and adolescents over 16 years.

Use in children and adolescents

The dose of 500 mg of azitromicina in this presentation is only suitable for children and adolescents weighing over 45 kg, for whom the same dose as for adults is recommended. For those weighing less, other presentations are recommended.

Use in patients with hepatic impairment

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

Use in patients with renal impairment

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

Method of administration:

Oral route.

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 suspension should be ingested immediately, with or without food.

If you take more azitromicina cinfa 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 immediately or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take azitromicina cinfa

If you forget a dose, use the medication 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 doses. Continue using azitromicina as indicated by your doctor.

If you stop taking azitromicina cinfa

If you discontinue treatment with azitromicina before your doctor recommends it, your symptoms may worsen or reappear.

If you have any other doubts about 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 everyone will experience them.

The side effects reported during clinical trials and after marketing, classified by frequency, are:

The very common side effects (at least 1 in 10 people) are:

• Diarrhea.

The common side effects (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 uncommon side effects (at least 1 in 1,000 people) are:

• Candida infection 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.

? Somnolence, dizziness, 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.

? 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 the blood, alteration of sodium and potassium levels, decrease in hematocrit.

? Post-surgical complications

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

? 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).
• Skin rash characterized by the rapid appearance of red skin areas with small pus-filled bumps (small blisters filled with white/yellow liquid).

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

? 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.

? Torsade 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 tissue 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 renal 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 package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of azitromicina cinfa

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

This medication does not require special storage conditions.

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

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medications in the SIGRE collection point at the pharmacy. If you have any doubts, ask your pharmacist how to dispose of the packaging and any unused medications. This will help protect the environment.

6. Packaging Content and Additional Information

Azitromicina Cinfa Composition

• The active ingredient is azithromycin dihydrate.
• The other components are: sucrose, hydroxypropylcellulose (E-463), anhydrous trisodium phosphate (E-339iii), xanthan gum (E-415), cherry flavor, vanilla flavor, and banana flavor.

Product Appearance and Packaging Content

Azitromicina Cinfa is a dry powder for oral suspension, ivory in color, with a fruity odor, and a reconstituted suspension with a milky appearance.

The powder is packaged in sachets consisting of a complex formed by PET/ALU/LLDPE and is presented in packages with 3 and 100 (clinical package) single-dose sachets.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta.

31620 Huarte (Navarra) - Spain

Date of the Last Revision of this Prospectus:September 2020

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

You can access detailed and updated information about this medication by scanning the QR code included in the prospectus and packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/65601/P_65601.html

QR code at: https://cima.aemps.es/cima/dochtml/p/65601/P_65601.html