AZITHROMYCIN ALTAN 500 mg POWDER FOR SOLUTION FOR INFUSION

2. What you need to know before you use Azithromycin Altan

Do not useAzithromycin Altan

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

Warnings and precautions

Consult your doctor or pharmacist before starting treatment with Azithromycin Altan

• During treatment with Azithromycin Altan, 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 interrupt 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, discuss this with your doctor to confirm whether you should interrupt 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 adverse reaction called ergotism.
• During treatment with this medication, 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 Altan, symptoms suggesting antibiotic-associated colitis (diarrhea) may appear. If so, treatment should be suspended, and your doctor will provide the most suitable treatment.
• If you have severe kidney problems, inform your doctor.
• If you have heart rhythm disturbances (arrhythmias) or factors that predispose you to them (certain heart diseases, electrolyte disturbances in the blood, or certain medications), inform your doctor, as this medication may contribute to worsening or triggering these disturbances.
• If you have a disease called myasthenia gravis or if muscle weakness and fatigue appear during treatment, inform your doctor, as Azithromycin Altan may trigger or worsen the symptoms of this disease.

Children and Adolescents

Azithromycin Altan is not indicated for use in children.

Other Medicines and Azithromycin Altan

Inform your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Especially, you must 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, seizures, or abdominal or chest pain).
• 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 for gout and familial Mediterranean fever).
• Cyclosporin (a medicine used in transplant patients), as azithromycin may increase cyclosporin levels in the blood, and these levels should be monitored.
• Oral anticoagulants (medicines used to prevent blood clots), as azithromycin may enhance the effect of these anticoagulants. Your doctor should monitor coagulation parameters (prothrombin time).
• Nelfinavir, zidovudine (medicines for the treatment of infections caused by the human immunodeficiency virus), as they may increase azithromycin levels in the blood.
• Fluconazole (medicines for treating fungal infections), as it may increase azithromycin levels in the blood.
• Terfenadine (a medicine used to treat allergies), as the combination of both may cause heart problems.
• Rifabutin (a medicine for the treatment of pulmonary tuberculosis and non-pulmonary infections caused by mycobacteria), as it may cause a decrease in the number of white blood cells in the blood.

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

Pregnancy, Breast-feeding, and Fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

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

Azithromycin is excreted in breast milk. Due to potential adverse reactions in the infant, the use of azithromycin is not recommended during breast-feeding, although you may continue breast-feeding two days after completing treatment with Azithromycin Altan.

Driving and Using Machines

The influence of this medicine on the ability to drive and use machines is negligible or non-existent.

Important Information about Some of the Ingredients of Azithromycin Altan

This medicine contains 101.5 mg of sodium (the main component of table/cooking salt) per vial. This is equivalent to 5.1% of the maximum recommended daily intake of sodium for an adult.

3. How to Use Azithromycin Altan

Your doctor will determine the most suitable dose and treatment duration for you, according to your condition and response to treatment.

It will be administered intravenously over at least 60 minutes.

As a general rule, the recommended dose of the medicine and the frequency of administration are as follows:

Adults (including elderly patients):

Pneumonia (lung infection)

Administer 500 mg per day in a single daily infusion for at least 1 or 2 consecutive days. Then, administer 500 mg per day in a single daily dose orally for at least 5 consecutive days.

Pelvic inflammatory disease (infection in the female genital tract)

Administer 500 mg per day in a single daily infusion for 1 or 2 consecutive days. Then, administer 250 mg per day in a single daily dose orally for at least 5 consecutive days.

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.

If You Are Given Too Much Azithromycin Altan

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

Information for the Prescriber

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

If You Miss a Dose of Azithromycin Altan

Given that you will receive this medicine under close medical supervision, it is unlikely that you will miss a dose. Nevertheless, inform your doctor or pharmacist if you think you have missed a dose.

If You Stop Using Azithromycin Altan

If you stop treatment with Azithromycin Altan before your doctor recommends, your symptoms may worsen or reappear.

If you have any further questions on 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.

Side effects reported during clinical trials and after marketing have been classified by frequency:

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

• Diarrhea.

Common side effects (at least 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.

Uncommon side effects (at least 1 in 1,000 people) are:

• 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).
• Allergic reaction, including a deep skin inflammatory process (angioedema).
• Alteration in eating behavior (anorexia).
• Nervousness, insomnia.
• Somnolence, dizziness, alteration in taste, loss of tactile sensation.
• Visual disturbances.
• Hearing disturbances, vertigo.
• Palpitations.
• Hot flashes.
• Respiratory disorders, 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.
• Pain or swelling at the injection site, generalized swelling, weakness, discomfort, fatigue, facial edema, chest pain, fever, pain, and swelling of the limbs.
• Alteration in 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 in sodium and potassium levels, decrease in hematocrit.
• Complications after surgery

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

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

Side effects of unknown frequency (cannot be estimated from the available data) are:

• Clostridium difficile-associated diarrhea.

• Decrease in platelet count in the blood, 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 disturbances, including deafness and ringing in the ears.
• Heart rhythm disturbances, including torsades de pointes and 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, pharmacist, or nurse. 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: www.notificaram.es.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Azithromycin Altan 500 mg

After reconstitutionwith sterile water for injectable preparations (100 mg/ml), chemical and physical stability has been demonstrated for 24 hours at 2-8°C.

After reconstitution with sterile water for injectable preparations and subsequent dilution (1 mg/ml; 2 mg/ml), chemical and physical stability has been demonstrated for 3 hours at 20°C for the 1 mg/ml dilution and 1 hour at 20°C for the 2 mg/ml dilution.

From a microbiological point of view, unless the method of opening/reconstitution/dilution excludes the risk of microbial contamination, the product should be used immediately. If not used immediately, the in-use storage times and conditions are the responsibility of the user and should not exceed the times indicated above for chemical and physical stability in use, whichever is shorter.

6. ADDITIONAL INFORMATION

Composition of Azitromicina Altan 500 mg

The active ingredient is azithromycin. Each vial contains 500 mg of azithromycin base (equivalent to 524 mg of azithromycin dihydrate). Once the powder is reconstituted with its diluent, the resulting solution contains 100 mg/ml of azithromycin base.

The other components are citric acid monohydrate and sodium hydroxide.

Appearance of the product and packaging content

Azitromicina Altan 500 mg powder for solution for infusion is presented as a lyophilized powder in a 10 ml capacity vial. Each package contains 1 vial.

Marketing authorization holder and manufacturer

Marketing authorization holder

Altan Pharmaceuticals, S.A.

C/ Cólquide 6, Portal 2, 1st floor. Edificio Prisma. Office F

28230 Las Rozas (Madrid)

Spain

Manufacturer

Altan Pharmaceuticals, S.A.

Pol. Industrial de Bernedo s/n

01118-Bernedo (Álava) Spain

or

Altan Pharmaceuticals, S.A.

Avda. Constitución n 198 - 199, Pol. Industrial Monte Boyal

45950 - Casarrubios del Monte (Toledo)

Spain

Date of the last revision of this prospectus: May 2022

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

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INFORMATION FOR HEALTHCARE PROFESSIONALS:

Azitromicina Altan 500 mg powder for solution for infusion is presented in single-use vials. It is administered by intravenous infusion for at least 60 minutes once reconstituted and diluted. To do this, the following instructions must be followed:

Reconstitution: prepare the initial solution of Azitromicina Altan 500 mg powder for solution for infusion by adding 4.8 ml of sterilized water for injectable preparations to the 500 mg vial and shake the vial until all the powder is dissolved. The use of a standard 5 ml syringe (not automatic) is recommended to ensure that the exact amount of 4.8 ml of sterilized water for injectable preparations is introduced. Each ml of reconstituted solution contains 100 mg of azithromycin.

Parenteral administration products must be visually inspected before administration for any foreign particles; if this occurs, being evident in the reconstituted fluid, the solution must be discarded.

Dilute the solution before administration as indicated below.

Dilution: to achieve a concentration of 1.0 or 2.0 mg/ml of azithromycin, transfer 5 ml of the 100 mg/ml azithromycin solution to the respective amounts of diluent indicated below:

Respect the recommended infusion time. The reconstituted solution can be diluted in:

Sodium chloride 0.9%

Sodium chloride 0.45%

Dextrose 5% in water

Ringer's lactate solution

Dextrose 5% in sodium chloride 0.45% with 20 mEq of KCl

Dextrose 5% in Ringer's lactate solution

Dextrose 5% in sodium chloride 0.3%

Dextrose 5% in sodium chloride 0.45%.

After dilution, the unused solution must be discarded. For single use only.

Concentrations higher than 2 mg/ml must not be used.

Azitromicina Altan 500 mg powder for solution for infusion must not be administered as a bolus or by intramuscular injection.