Leaflet: information for the user

azitromicina cinfa 500 mg powder for oral suspension EFG

azitromicina dihidrato

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 or pharmacist, even if they are not listed in this leaflet. See section 4.

Azitromicina belongs to a group of antibiotics called macrolides. It eliminates the 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 with a weight of 45 kg or more. It is used for the treatment of 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).

-Urethritis or cervicitis, see section 3.

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

Do not take azitromicina cinfa:

• If you are allergic to azitromicina, erythromycin, other macrolide or ketolide antibiotics, or 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:

?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 during treatment with azitromicina. 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 white of your eyes turns yellow, inform 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 condition called ergotism.

?During treatment with this medication, 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, symptoms may appear that suggest antibiotic-associated colitis (diarrhea). If this is the case, treatment should be discontinued and your doctor will prescribe the most appropriate treatment.

?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 medication may exacerbate or trigger these conditions.

?If you have a condition called myasthenia gravis or if you experience muscle weakness and fatigue during treatment, inform your doctor, as azitromicina may trigger or exacerbate symptoms of this condition.

Children and adolescents

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

The sachets may not be indicated for this group of patients. Other pharmaceutical forms of azitromicina may be used. Do not administer 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 for adults and adolescents over 16 years old.

Taking azitromicina cinfa with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, 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 simultaneous administration of both medications at the same time of day.
• Ergotamine derivatives (such as ergotamine, used to treat migraines), as simultaneous administration with azitromicina may cause ergotism (a potentially serious adverse effect 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 levels should be monitored.
• 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 levels should be monitored.
• Anticoagulant dicumarins (medications used to prevent blood clotting) as azitromicina may potentiate the effect of these anticoagulants. Your doctor should control coagulation parameters (prothrombin time).
• Nelfinavir, zidovudine (medications used to treat HIV infections), as levels of azitromicina in the blood may be increased.
• Fluconazole (medications used to treat fungal infections), as levels of azitromicina in the blood may be increased.
• Terfenadine (a medication used to treat allergies) as the combination may cause heart problems.
• Rifabutin (a medication used to treat pulmonary tuberculosis and non-pulmonary infections caused by mycobacteria) as it may cause a decrease in white blood cells in the blood.
• Medications with active substances that prolong the QT interval, such as antiarrhythmic class IA (quinidine and procainamide) and class III (dofetilide, amiodarone, and sotalol), cisapride, terfenadine, antipsychotics (such as pimozide), antidepressants (such as citalopram), and antifungals (fluoroquinolones such as moxifloxacino or levofloxacino and chloroquine), as they may cause severe heart rhythm alterations and even cardiac arrest.

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

Taking azitromicina cinfa with food and drinks

This medication should be taken 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 taken immediately with or without food.

Pregnancy and breastfeeding

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

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

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

Driving and operating machinery

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

Azitromicina cinfa contains saccharose

If your doctor has indicated 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; that is, 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):500 mg of azithromycin (1 tablet in a single dose) once a day for 3 consecutive days, with a total dose of 1500 mg of azithromycin (3 tablets).

Urethral or cervical infection (cervicitis):

The recommended 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.

Use in children and adolescents

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

Use in patients with liver insufficiency

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

Use in patients with renal insufficiency

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

Administration form:

Oral route.

This medication should be administered as a single daily dose. The content of the tablet 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 azithromycin cinfa 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 functions should be applied.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take azithromycin cinfa

In case of forgotten dose, use the medication as soon as possible, continuing the 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 doses. Continue using azithromycin as your doctor has indicated.

If you interrupt the treatment with azithromycin cinfa

If you abandon the treatment with azithromycin before your doctor recommends it, symptoms may worsen or reappear.

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:

The very common side effects (occurring in more than 1 in 10 people) are:

• Diarrhea.

The common side effects (occurring in more than 1 in 100 people) are:

?Headache.

?Vomiting, abdominal pain, nausea.

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

The uncommon side effects (occurring in more than 1 in 1,000 people) are:

• Candida fungal infection in the mouth or generalized, vaginal infection, pneumonia, fungal or bacterial infection, pharyngitis, gastroenteritis, respiratory alteration, rhinitis.
• Decrease in the 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.

?Drowsiness, dizziness, alteration of taste, loss of tactile sensation.

?Alteration of vision.

?Alteration of hearing, vertigo.

?Palpitations.

?Hot flashes.

?Alteration of breathing, nasal hemorrhage.

?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 hemorrhage, alteration in testicular function.

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

?Complications after surgical intervention

The rare side effects (occurring in more than 1 in 10,000 people) are:

?Agitation.

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

?Diarrhea caused by Clostridium difficile.

?Decrease in platelet count in blood, anemia.

?Severe allergic reaction

?Aggressive behavior, anxiety, delirium, hallucinations.

?Loss of consciousness, convulsions, decrease in sensitivity, hyperactivity, alteration and/or loss of smell, loss of taste, muscle weakness and fatigue (myasthenia gravis).

?Alteration of hearing including deafness and tinnitus.

?Torsades de pointes, cardiac rhythm alterations, prolongation of QTc interval in electrocardiogram.

?Decrease in blood pressure.

?Pancreatitis, change in tongue color.

?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.

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 to the Spanish System for 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.

This medication does not require special storage conditions.

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

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of azithromycin cinfa

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

Appearance of the product and contents of the packaging

Azithromycin cinfa is a dry powder for oral suspension, white in color, fruity in odor, and a reconstituted suspension with a milky appearance.

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

Only some sizes of containers may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Cinfa, S.A. Laboratories

Carretera Olaz-Chipi, 10. Areta Industrial Estate.

31620 Huarte (Navarra) - Spain

Date of the last review of this leaflet:September 2020

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

You can access detailed and updated information about this medication by scanning the QR code included in the leaflet and packaging with your 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 to:https://cima.aemps.es/cima/dochtml/p/65601/P_65601.html