Label: information for the user

Azitromicina Altan 500 mg powder for solution for infusion EFG

Azitromicina

Read this label carefully before starting to use this medicine because it contains important information for you.

• Keep this label, as you may need to read it again.

If you have any questions, consult your doctor or pharmacist.

• This medicine has been prescribed only for you, 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 adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

1. What is Azitromicina Altan and how it is used

2. What you need to know beforestarting touse Azitromicina Altan

3. How to use Azitromicina Altan

4. Possible adverse effects

5. Storage of Azitromicina Altan

6.Contents of the package 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 in the lungs (pneumonia) or infections in the upper female genital tract (pelvic inflammatory disease).

No useAzitromicina Altan

If you are allergic to azithromycin, erythromycin, other macrolide or ketolide antibiotics, or any of the other components of this medication (listed in section 6), do not use Azitromicina Altan.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Azitromicina Altan.

• During treatment with Azitromicina 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 during treatment your skin and/or the white of your eyes turns yellow, inform 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 concurrent treatment with azithromycin may cause 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 Altan, symptoms may appear that suggest antibiotic-associated colitis (diarrhea). If this is the case, treatment should be suspended, and your doctor will prescribe the most suitable 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 myasthenia gravis or experience muscle weakness and fatigue during treatment, inform your doctor, as Azitromicina Altan may trigger or exacerbate symptoms of this disease.

Children and adolescents

Azitromicina Altan is not indicated for use in children.

Other medications and Azitromicina Altan

Inform your doctor or pharmacist if you are using, have used recently, or may need to use 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 azithromycin may cause ergotism (a potentially severe adverse effect characterized by numbness or tingling in the extremities, muscle cramps, headaches, convulsions, or abdominal or chest pain).
• Digoxin (a medication used to treat heart arrhythmias), as azithromycin 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 azithromycin may increase ciclosporin levels in the blood, and levels should be monitored.
• Anticoagulant dicumarins (medications used to prevent blood clotting), as azithromycin may potentiate the effect of these anticoagulants. Your doctor should control coagulation parameters (prothrombin time).
• Nelfinavir, zidovudine (medications used to treat HIV infections), as they may increase azithromycin levels in the blood.
• Fluconazole (medications used to treat fungal infections), as they may increase azithromycin levels in the blood.
• 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) medications, cisapride, antipsychotics (such as pimozide), antidepressants (such as citalopram), and antifungals (fluoroquinolones such as moxifloxacin or levofloxacin and chloroquine), as they may cause severe heart rhythm disturbances and even cardiac arrest.

No interactions have been observed between azithromycin 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).

Pregnancy, lactation, and fertility

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 azithromycin during pregnancy. Therefore, azithromycin is not recommended for use 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 potential adverse reactions in the infant, azithromycin is not recommended for use during lactation, although breastfeeding may be continued two days after completing treatment with Azitromicina Altan.

Driving and operating machinery

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

Important information about some of the components of Azitromicina Altan

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

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

The medication will be administered through intravenous infusion for at least 60 minutes.

As a general rule, the recommended dose of the medication and the frequency of administration is 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 oral dose for at least 5 consecutive days.

Pelvic inflammatory disease (female genital tract infection)

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 oral dose for at least 5 consecutive days.

Use in patients with liver insufficiency

Inform your doctor if you have severe liver problems, as the normal dose may need to be adjusted.

Use in patients with renal insufficiency

Inform your doctor if you have severe kidney problems, as the normal dose may need to be adjusted.

If you are given more Azitromicina Altan 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 supportive measures and vital function support should be applied.

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

If you forget to use Azitromicina Altan

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

If you interrupt treatment with Azitromicina Altan

If you discontinue treatment with Azitromicina Altan before the recommended duration, symptoms may worsen or recur.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

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

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

• Diarrea.

The side effectscommon(in 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 side effectsuncommon(in at least 1 in 1,000 people) are:

• Fungal infection of 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 inflammatory process of the skin (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 patches, dermatitis, dry skin, excessive sweating, erythema.
• Joint inflammation, muscle pain, back pain, neck pain.
• Difficulty urinating, kidney pain.
• Vaginal hemorrhage, alteration in testicles.
• Pain or swelling at the injection site, 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 side effectsrare(in at least 1 in 10,000 people) are:

• Agitation.
• Alteration of liver function, yellow discoloration of the skin.
• Sensitivity to sunlight (photosensitivity), allergic reaction to the medication with an increase in a type of white blood cell (eosinophilia) and generalized symptoms (multi-organ compromise) (DRESS syndrome).
• Rapidly appearing skin rash with small white/yellow-filled blisters (small pustules).

The side effectsfrequency not known(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, seizures, decreased 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 alterations of heart rhythm, prolongation of QTc interval in electrocardiogram.
• Decrease in blood pressure.
• Pancreatitis, change in color of the tongue.
• Severe liver damage and liver failure that rarely can be fatal, liver cell death, fulminant hepatitis.
• Appearance of red, elevated patches, 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, pharmacist, or nurse, 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 Pharmacovigilance of Medicines for Human Use:www.notificaram.es.

By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

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

From a microbiological standpoint, unless the opening/reconstitution/dilution method excludes the risk of microbial contamination, the product should be used immediately. If not used immediately, storage times in use and conditions prior to use are the responsibility of the user andshall not exceed the times indicated above for chemical and physical stability in use, the shorter of the two".

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 solution obtained contains 100 mg/ml of azithromycin base.

The other components are citric acid monohydrate and sodium hydroxide.

Appearance of the product and contents of the package

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

Holder of the marketing authorization and Responsible for manufacturing

Holder of the marketing authorization

Altan Pharmaceuticals, S.A.

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

28230 Las Rozas (Madrid)

Spain

Responsible for manufacturing

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

Last review date of this leaflet: May 2022

The detailed and updated information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS): http://www.aemps.gob.es/.

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INFORMATION FOR HEALTHCARE PERSONNEL:

Azitromicina Altan 500 mg powder for solution for infusion is presented in single-use vials. It is administered via 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 sterile water for injections to the 500 mg vial and shake the vial until all the powder is dissolved. It is recommended to use a standard 5 ml syringe (not automatic) to ensure that the exact amount of 4.8 ml of sterile water for injections 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 final 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

Lactated Ringer's solution

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

Dextrose 5% in Lactated Ringer's solution

Dextrose 5% in Sodium chloride 0.3%

Dextrose 5% in Sodium chloride 0.45%.

Unused diluted solution must be discarded. For single use only.

Concentrations above 2 mg/ml must not be used.

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