Azithromycin Tecnigen 500 mg powder for solution for infusion EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Azithromycin TecniGen 500 mg powder for solution for infusion EFG

Read the entire 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, ask your doctor, pharmacist or nurse.

• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Azithromycin TecniGen is and what it is used for
2. What you need to know before using Azithromycin TecniGen
3. How to use Azithromycin TecniGen
4. Possible side effects
5. How to store Azithromycin TecniGen
6. Contents of the pack and other information

1. What Azithromycin TecniGen is and what it is used for

Azithromycin belongs to the group of antibiotics known as macrolides. It is used to treat localized bacterial infections in different parts of the body.

What diseases are treated with azithromycin?

Azithromycin 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.

2. What you need to know before using Azithromycin TecniGen

Do not use Azithromycin TecniGen

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

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting azithromycin if:

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

Other important precautions:

• Fungal infections may occur while taking azithromycin.
• Severe allergic reactions may occur rarely.
• Medicines known as ergot derivatives, such as ergotamine or dihydroergotamine (medicines used for migraines or to reduce blood flow) must not be taken together with azithromycin.
• Precautions should also be taken if you have neurological or psychiatric disorders.
• This medicine will not be used to treat infected burn wounds.
• Worsening of symptoms has been observed in patients with myasthenia gravis receiving azithromycin.

Using Azithromycin TecniGen with other medicines

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

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

• ergot derivatives such as ergotamine (used to treat migraine)
• digoxin (used to treat heart failure)
• colchicine (used for gout and familial Mediterranean fever)
• warfarin or any other similar medicine used to prevent blood clots
• cyclosporine (used to suppress the immune system to prevent and treat rejection of a transplanted organ or bone marrow in transplant patients)
• 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 human immunodeficiency virus). Azithromycin may reduce zidovudine levels in the blood; therefore, it should be taken at least one or two hours before or after zidovudine
• atorvastatin or other statins (medicines to lower cholesterol)
• rifabutin (for human immunodeficiency virus or tuberculosis)
• quinidine (used to treat heart rhythm problems) and other medicines to treat irregular heartbeats (called antiarrhythmics)
• theophylline (for breathing problems)

You must not use azithromycin with antacids (used for indigestion).

Pregnancy, breastfeeding, and fertility

Consult your doctor or pharmacist before using any medicine.

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

Driving and using machines

Adverse effects may occur that could affect your ability to drive or operate machinery (see section 4). It is advised not to drive or operate machinery while taking azithromycin.

Azithromycin TecniGen contains sodium

This medicine contains 101.5 mg of sodium (a main component of table/cooking salt) per vial. This corresponds to 5.1% of the maximum daily recommended sodium intake for an adult. This should be taken into account in patients on low-sodium diets.

3. How to use Azithromycin TecniGen

Follow exactly the instructions for taking this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Your doctor will determine the most appropriate dose and duration of treatment 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

Azithromycin is intended for intravenous infusion.

This medicine must be reconstituted and diluted according to the instructions and administered as an intravenous infusion over no less than 60 minutes.

Average duration of treatment

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

Special patient groups

The use of azithromycin is not recommended in children and growing adolescents.

Patients with kidney or liver problems:

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

For elderly patients, the same dose as for adults applies.

If you use more Azithromycin TecniGen than you should

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

If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible adverse effects

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

The following adverse effects have been reported:

• Very common (may affect more than 1 in 10 patients)
• Common (may affect up to 1 in 10 patients)
• Uncommon (may affect up to 1 in 100 patients)
• Rare (may affect up to 1 in 1,000 patients)
• Very rare (may affect up to 1 in 10,000 patients)
• Frequency not known (cannot be estimated from available data)

Contact your doctor immediately if you experience any of the following adverse effects: you may require urgent medical treatment:

Uncommon:

• Allergic reactions, signs may include: itching or rash, swelling of the face, lips, tongue, body, or difficulty breathing. The frequency of severe acute allergic reactions (anaphylactic reactions) is unknown.

Rare:

• Especially caused by yellowing of the skin and whites of the eyes (cholestatic jaundice)
• Skin rash characterized by the rapid appearance of red skin areas dotted with small pustules (small blisters filled with white/yellow fluid)

Frequency not known:

• Inflammation of the large intestine (colon) with diarrhoea (sometimes bloody), abdominal pain, fever
• Severe liver disorders or liver failure may occur; signs may include: rapidly developing fatigue associated with yellowing of the skin or whites of the eyes (jaundice), dark urine, tendency to bleed
• Severe skin reaction called Stevens-Johnson syndrome. Signs may include: red or purple rash spreading 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)
• Kidney inflammation or kidney failure; signs may include: increased need to urinate at night, muscle twitching and cramps, loss of appetite, nausea or malaise, unpleasant taste in the mouth

Other adverse effects:

Very common:

• Diarrhoea

Common:

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

Uncommon:

• Fungal infection (candidiasis), vaginal infection, pneumonia, bacterial infection, throat infection, inflammation of the stomach and intestine, breathing problems, rhinitis, oral thrush (oral candidiasis)
• Reduction in the number of white blood cells (neutropenia and leucopenia), increase in a type of white blood cells (eosinophilia)
• Loss of appetite (anorexia)
• Nervousness, insomnia
• Dizziness, drowsiness, altered taste, abnormal skin sensations such as tingling and numbness in the limbs (paraesthesia)
• Visual disturbances
• Hearing disturbances, sensation of spinning or whirling (vertigo)
• Awareness of heartbeat or abnormal heart rate (palpitations)
• Redness of the face, neck or upper chest (flushing)
• Shortness of breath, nosebleeds
• Constipation, flatulence, indigestion (dyspepsia), inflammation of the stomach lining (gastritis), difficulty swallowing, bloating (abdominal distension), dry mouth, belching, mouth ulcers, increased saliva production
• Inflammation of the liver (hepatitis)
• Itching, rash, hives, skin inflammation, dry skin, excessive sweating
• Joint disease (osteoarthritis), muscle pain, back pain, neck pain
• Pain when urinating, kidney pain
• Irregular uterine bleeding, testicular disorder
• Fluid accumulation in tissues (oedema), facial swelling (facial oedema), or swelling of hands, feet and legs (peripheral oedema), feeling of weakness and fatigue (asthenia), general malaise, excessive drowsiness, chest pain, fever, pain
• Changes in liver enzymes (increased aspartate aminotransferase, increased alanine aminotransferase), changes in blood tests (increased blood bilirubin, increased blood urea, increased blood creatinine, blood potassium abnormalities, increased alkaline phosphatase in blood, increased chloride, increased glucose, increased platelets, decreased haematocrit, increased bicarbonate, sodium abnormalities)
• Complications following surgery

Rare:

• Agitation
• Impaired liver function
• Increased sensitivity to sunlight

Frequency not known:

• Changes in blood count, such as reduced platelet count (thrombocytopenia), which are essential for blood clotting, and abnormal breakdown of red blood cells (haemolytic anaemia), characterized by paleness, difficulty breathing, headache, dizziness
• Reactions of aggression, anxiety, delirium, hallucinations
• Loss of consciousness (syncope), seizures (fits), decreased sensitivity (hypoanaesthesia)
• Hyperactivity, loss of sense of smell or taste, altered sense of smell, muscle fatigue (myasthenia gravis)
• Hearing problems, including deafness and/or ringing in the ears (tinnitus)
• Heart rhythm disturbances, including increased heart rate (ventricular tachycardia); possible risk of changes in the electrocardiogram (prolongation of the QT interval and torsade de pointes), particularly in patients prone to such changes (see "Warnings and precautions")
• Decreased blood pressure
• Discoloration of the tongue, inflammation of the pancreas (pancreatitis)
• Joint pain

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

If you experience any adverse effect, consult your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Azithromycin TecniGen

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

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

Concentrated solution after reconstitution (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 below, or for 7 days if stored refrigerated (5 °C).

From a microbiological standpoint, the product should be used immediately. If not used immediately, the in-use storage times and conditions prior to use are the responsibility of the user and normally should not exceed 24 hours at 2°C to 8°C, unless the reconstitution/dilution was carried out under controlled and validated aseptic conditions.

Do not use this medicine if you notice any change in its appearance (e.g., if the solution is not free from visible particles).

Any unused medicine must be discarded.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of Azithromycin TecniGen

• The active substance 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.

Appearance of the product and contents of the container

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

The appearance of the product after reconstitution is a colorless and transparent solution, leaving no residue of undissolved material.

Azithromycin TecniGen is available in the following pack sizes:

Pack containing 1 vial

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Tecnimede España Industria Farmacéutica, S.A.

Avda. Bruselas, 13

28108 Alcobendas (Madrid)

Spain

Manufacturer:

Sofarimex – Indústria Química e Farmacêutica, S.A.

Av. das Indústrias, Alto do Colaride, Cacém

2735-213 Portugal

Local representative:

Pharmavic Ibérica, S.L.

• Compositor Lehmberg Ruiz, 6. Office 7

29007 Málaga. Spain.

Date of the most recent revision of this leaflet: March 2022

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

This information is intended for healthcare professionals only:

Azithromycin TecniGen must be reconstituted and diluted according to instructions and administered as an intravenous infusion over at least 60 minutes.

Do not administer as an intravenous bolus or by intramuscular injection.

Azithromycin powder for solution for infusion is supplied in single-use vials.

Step 1: Preparation of the reconstituted solution

This medicinal product must be prepared under aseptic conditions.

The initial reconstituted solution is prepared by adding 4.4 ml of sterile water for injection to the contents of the 15 ml vial using a standard 5 ml syringe (non-automated) and shaking the vial until the entire medication is dissolved. Each ml of reconstituted solution contains azithromycin dihydrate equivalent to 100 mg of azithromycin (100 mg/ml).

The reconstituted solution must be diluted before administration.

Step 2: Dilution of the reconstituted solution

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

Transfer 5 ml of the azithromycin solution prepared in step 1 (100 mg/ml) into 500 ml of one of the appropriate diluents listed below.

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

Transfer 5 ml of the azithromycin solution prepared in step 1 (100 mg/ml) into 250 ml of one of the appropriate diluents listed below.

The reconstituted solution may 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 (as per 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 refrigerated (5°C).

From a microbiological standpoint, the product should be used immediately. If not used immediately, the storage and handling times prior to use are the responsibility of the user and normally should not exceed 24 hours at 2°C to 8°C, unless reconstitution/dilution has been carried out under controlled and validated aseptic conditions.

Parenteral medicinal products should be visually inspected for particulate matter before administration. If particulate matter is evident in the reconstituted solution, it should be discarded.

Any unused medicinal product should be discarded.

Other intravenous substances, additives, or other medicinal products must not be added to Azithromycin TecniGen or co-administered simultaneously through the same intravenous line.