Label: Information for the User

Azitromicina TecniGen 500 mg powder for solution for infusion EFG

Read this label carefully before starting to take 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, pharmacist, or nurse.

• This medicine has been prescribed only for you, 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 any side effects, consult your doctor, pharmacist, or nurse, even if they do not appear in this label. See section 4.

Azitromicina belongs to a group of antibiotics called macrolides. It is used to treat localized infections caused by bacteria in different parts of the body.

What diseases are treated with azitromicina?

Azitromicina is indicated for the treatment of severe infections or when oral treatment cannot be used. It is used for the treatment of pneumonia (lung infection) caused by susceptible organisms.

No useAzitromicina TecniGen

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).

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take azithromycin.

• If you have an allergic reaction such as red or white patches on the skin, itching, skin irritation, skin swelling, laryngeal (throat) or tongue swelling, and difficulty breathing, you must discontinue azithromycin treatment.
• If you have or have had kidney problems.
• If you have or have had liver problems: your doctor may need to monitor your liver function or discontinue treatment.
• If you have or have had an abnormal heart rhythm in specific conditions such as long QT syndrome (shown on an electrocardiogram or ECG machine).
• If you experience heart palpitations or have an abnormal heart rhythm, or feel dizzy or faint while taking azithromycin, you must immediately inform your doctor if you are also receiving treatment with:
• Medications used to treat irregular heart rhythms known as class IA and III antiarrhythmics (e.g., amiodarone, quinidine, sotalol, disopyramide, dofetilide, or procainamide).
• Cisapride (used to treat acid reflux and gastrointestinal disorders).
• Terfenadine (used to treat allergies).
• Medications used to treat mental health problems (e.g., pimozide).
• Medications used to treat depression (e.g., citalopram).
• Antibiotics from a group called fluoroquinolones (e.g., moxifloxacin and levofloxacin).
• If you develop diarrhea or loose stools during or after treatment. In some cases, there is a possibility of developing a severe intestinal inflammation known as pseudomembranous colitis. Do not take any medication to treat diarrhea without consulting your doctor first.

Other important precautions:

• May cause fungal infections while taking azithromycin.
• In rare cases, may cause severe allergic reactions.
• Medications known as ergot derivatives, such as ergotamine or dihydroergotamine (medications used to treat migraines or reduce blood flow), should not be taken with azithromycin.
• Also, take precautions if suffering from neurological or psychiatric diseases.
• This medication will not be used to treat infected burn wounds.
• A worsening of symptoms has been observed in patients with myasthenia gravis who receive azithromycin.

Use of azitromicina TecniGen with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Medications may interact with each other or with other substances causing unexpected medication reactions or, in some cases, may cause a decrease or increase in the expected effect. Therefore, you must inform your doctor about all the medications you are taking or have taken, particularly:

• Ergot derivatives such as ergotamine (used to treat migraines).
• Digoxin (used to treat heart failure).
• Colchicine (used to treat gout and familial Mediterranean fever).
• Warfarin or any other medication similar to prevent blood clots.
• Ciclosporin (used to suppress the immune system to prevent and treat organ transplant rejection or bone marrow transplant rejection in patients transplanted).
• Cisapride (used to treat stomach problems).
• Terfenadine (for hay fever or skin allergy).
• Nelfinavir (used to treat infections caused by the human immunodeficiency virus (HIV)).
• Zidovudine (for HIV). Azithromycin may reduce zidovudine levels in the blood and, therefore, should be taken at least one or two hours before or after zidovudine.
• Atorvastatin or other statins (medications to reduce cholesterol).
• Rifabutin (for HIV or tuberculosis).
• Quinidine (used to treat irregular heart rhythms) and other medications to treat irregular heartbeats (called antiarrhythmics).
• Theophylline (for respiratory problems).

Do not use azithromycin with antacids (used for indigestion).

Pregnancy, breastfeeding, and fertility

Consult your doctor or pharmacist before using any medication.

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

Driving and operating machines

May cause adverse effects that may affect your ability to drive or operate machines (see section 4). It is recommended not to drive or operate machines while taking azithromycin.

Azitromicina TecniGen contains sodium

This medication contains 101.5 mg of sodium (main component of table salt/for cooking) in each vial. This is equivalent to 5.1% of the maximum daily sodium intake recommended for an adult. You should be aware of this in patients with low-sodium diets.

Follow exactly the administration instructions for this medication as 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.

The following table describes the most commonly used doses in adults for the treatment of pneumonia (lung infection).

Form and route of administration

Azitromicina is intended to be administered via intravenous infusion.

This medication must be reconstituted and diluted according to the instructions and administered as an intravenous infusion for at least 60 minutes.

Mean duration of treatment

The duration of treatment will depend on the severity of the infection. Your doctor will inform you about this.

Special patient groups

Azitromicina is not recommended for use in children and adolescents in growth.

Patients with kidney or liver problems:

• You must inform your doctor if you have kidney or liver problems, as you may need to adjust the normal dose.

The same dose as for adults applies to elderly patients.

If you use more Azitromicina TecniGen than you should

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

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

The following side effects have been reported:

Seek medical attention immediately if you experience any of the following side effects: you may need urgent medical treatment:

Uncommon:

• Allergic reactions, symptoms may include: itching or hives, swelling of the face, lips, tongue, body, or difficulty breathing. The frequency of severe allergic reactions (anaphylaxis) is unknown.

Rare

• Especially caused by yellowing of the skin and white of the eyes (cholestasis)
• Skin rash characterized by the rapid appearance of red skin areas dotted with small white or yellow blisters (small fluid-filled bumps)

Unknown frequency

• Colitis with diarrhea (sometimes with blood), pain, and fever
• May cause severe liver damage or liver insufficiency, symptoms may include: rapid fatigue associated with yellowing of the skin or white of the eyes (jaundice), dark urine, tendency to bleed
• Severe skin reaction called Stevens-Johnson syndrome. Symptoms may include: a red or purple skin rash that spreads within hours or days, blisters on the skin and mucous membranes, especially in the mouth, nose, and eyes, skin peeling
• Severe skin reactions with swelling of the skin and mucous membranes and peeling of the skin in large areas of the body (erythema multiforme and toxic epidermal necrolysis)
• Renal inflammation or insufficiency, symptoms may include: increased need to urinate at night, muscle twitching and cramps, loss of appetite, nausea or discomfort, unpleasant taste in the mouth

Other side effects:

Very common:

• Diarrhea

Common:

• Headache
• Vomiting, abdominal pain, feeling of discomfort (nausea)
• Changes in blood count (decreased lymphocyte count, increased eosinophil count, increased basophil count, increased monocyte count, increased neutrophil count), decreased bicarbonate in blood

Uncommon:

• Fungal infection (candidiasis), vaginal infection, pneumonia, bacterial infection, throat infection, stomach and intestine inflammation, respiratory problems, rhinitis, oral candidiasis
• Decreased white blood cell count (neutropenia and leucopenia), increased white blood cell count (eosinophilia)
• Loss of appetite (anorexia)
• Nervousness, insomnia
• Dizziness, somnolence, altered taste, abnormal skin sensations, for example, tingling and numbness in the extremities (paresthesia)
• Visual disturbances
• Auditory disturbances, sensation of spinning or whirling (vertigo)
• Heartbeat detection or abnormal frequency (palpitations)
• Face, neck, or upper chest redness (flushing)
• Shortness of breath, nasal bleeding
• Constipation, flatulence, indigestion (dyspepsia), stomach lining inflammation (gastritis), difficulty swallowing, bloating (abdominal distension), dry mouth, belching, mouth ulcers, increased saliva production
• Liver inflammation (hepatitis)
• Itching, skin rash, urticaria, skin inflammation, dry skin, excessive sweating
• Joint disease (osteoarthritis), muscle pain, back pain, neck pain
• Urination pain, kidney pain
• Irregular uterine bleeding, testicular changes
• Fluid accumulation in tissue (edema), facial swelling (facial edema) or peripheral edema, feeling of weakness and fatigue (asthenia), general discomfort, excessive somnolence, chest pain, fever, pain
• Changes in liver enzymes (increased aspartate aminotransferase, increased alanine aminotransferase), changes in blood tests (increased bilirubin in blood, increased urea in blood, increased creatinine in blood, potassium abnormalities in blood, increased alkaline phosphatase in blood, increased chloride, increased glucose, increased platelets, decreased hematocrit, increased bicarbonate, sodium abnormalities)
• Post-procedure complications

Rare:

• Agitation
• Liver function alteration
• Increased sensitivity to sunlight

Unknown frequency:

• Changes in blood count, such as reduced platelet count (thrombocytopenia), which are essential for blood clotting, and abnormal breakdown of red blood cells (hemolytic anemia), characterized by pallor, difficulty breathing, headache, dizziness
• Aggressive reactions, anxiety, delirium, hallucinations
• Loss of consciousness (syncope), seizures (convulsions), decreased sensitivity (hypoaesthesia)
• Hypervigilance, loss of sense of smell or taste, altered sense of smell, muscle fatigue (myasthenia gravis)
• Auditory disturbances, including hearing loss and/or tinnitus
• Cardiac rhythm disturbances, including increased heart rate (tachycardia); possible risk of changes in the electrocardiogram (prolongation of the QT interval and torsades de pointes), particularly in patients prone to these changes (see "Warnings and precautions").
• Decreased blood pressure
• Lingual discoloration, pancreatitis
• Joint pain

Local reactions at the injection site (inflammation/pain) have been reported with intravenous administration of azithromycin.

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 prospectus.

Reporting 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 prospectus. You can also report them directly through the Spanish System for the Vigilance 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.

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

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.

Store the vial in the outer packaging to protect it from light.

Reconstituted solution (according to instructions): azithromycin powder for solution for infusion is chemically and physically stable for 24 hours, when stored below 25 °C.

Diluted solutions, prepared according to instructions, are chemically and physically stable for 24 hours at 25 °C or less, or for 7 days if stored in refrigeration (5 °C).

From a microbiological standpoint, the product must be used immediately. If not used immediately, storage times in use and pre-use conditions are the responsibility of the user and are normally not greater than 24 hours at 2°C to 8°C, unless reconstitution/dilution has taken place in controlled and validated aseptic conditions.

Do not use this medication if you observe that the visual appearance has changed (for example, the solution is not free of visible particles).

All unused medication must be discarded.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of unused packaging and medication. This will help protect the environment.

Azitromicina TecniGen Composition

• The active ingredient is azithromycin (as dihydrate). Each vial contains 500 mg of azithromycin (equivalent to 524.0 mg of azithromycin dihydrate).
• The other components are: citric acid monohydrate and sodium hydroxide.

Product Appearance and Packaging Contents

Azitromicina TecniGen is a white powder with small aggregates, for intravenous infusion solution. It is presented in a transparent 15 ml glass vial, single-dose, with a rubber stopper and closed with an aluminum cap with a flip-off device.

The product appearance after reconstitution is a colorless and transparent solution, and it does not leave any residue of undissolved material.

Azitromicina TecniGen is available in the following packaging sizes:

Package with 1 vial

Marketing Authorization Holder and Responsible Manufacturer

Marketing Authorization Holder:

Tecnimede España Industria Farmacéutica, S.A.

Avda. Bruselas, 13

28108 Alcobendas (Madrid)

Spain

Responsible Manufacturer:

Sofarimex – Indústria Química e Farmacêutica, S.A.

Av. das Indústrias, Alto do Colaride, Cacém

2735-213 Portugal

Local Representative:

Pharmavic Ibérica, S.L.

C. Compositor Lehmberg Ruiz, 6. Office 7

29007 Málaga. Spain.

Last Review Date of this Leaflet:March 2022

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

This information is intended solely for healthcare professionals:

Azitromicina TecniGen must be reconstituted and diluted according to the instructions and must be administered as an intravenous infusion for at least 60 minutes.

Do not administer as a bolus intravenously or as an intramuscular injection.

Azitromicina powder for intravenous infusion solution is presented in single-use vials.

Phase 1: Preparation of the reconstituted solution

This medicine must be prepared in aseptic conditions.

The initial reconstituted solution is prepared by adding 4.4 ml of sterile water for injections to the initial content of the 15 ml vial with a standard 5 ml syringe (non-automated) and agitating the vial until the medicine is completely dissolved. Each ml of the reconstituted solution contains azithromycin dihydrate equivalent to 100 mg of azithromycin (100 mg/ml).

The reconstituted solution must be diluted before administration.

Phase 2: Dilution of the reconstituted solution

To achieve azithromycin at a concentration of 1.0 mg/ml:

Transfer 5 ml of the azithromycin solution prepared in Phase 1 (100 mg/ml) to 500 ml of the appropriate diluents described below.

To achieve azithromycin at a concentration of 2.0 mg/ml:

Transfer 5 ml of the azithromycin solution prepared in Phase 1 (100 mg/ml) to 250 ml of the appropriate diluents described below.

The reconstituted solution can be diluted with:

Sodium chloride 0.9%

Sodium chloride 0.45%

Dextrose 5%, in water

Lactated Ringer's solution

Dextrose 5% in Sodium chloride 0.3%

Dextrose 5% in Sodium chloride 0.45%

The concentrated solution after reconstitution (according to the instructions): azithromycin powder for intravenous infusion solution is chemically and physically stable for 24 hours, when stored below 25 °C.

The diluted solutions, prepared according to the instructions, are chemically and physically stable for 24 hours at 25 °C or less, or for 7 days if stored in refrigeration (5 °C).

From a microbiological point of view, the product must be used immediately. If not used immediately, the storage times in use and the conditions prior to use are the responsibility of the user and are normally not greater than 24 hours at 2°C to 8°C, unless the reconstitution/dilution has taken place in controlled and validated aseptic conditions.

Parenteral medications must be visually inspected to detect particles in suspension before administration. If particles in suspension are evident in the reconstituted solution, they must be discarded.

Any unused medication must be discarded.

Other intravenous substances, additives, or other medications must not be added to Azitromicina TecniGen or infused simultaneously through the same intravenous line.