Azithromycin Teva 200 mg/5 ml powder for oral suspension EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Azithromycin Teva 200 mg/5 ml powder for oral suspension EFG

Azithromycin (as dihydrate)

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 or pharmacist.
• 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 could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Azitromicina Teva is and what it is used for

Azithromycin belongs to a group of antibiotics known as macrolide antibiotics.

Antibiotics are used to treat bacterial infections and are not effective against viral infections such as flu or the common cold.

It is important to follow your doctor's instructions regarding dosage, dosing interval, and duration of treatment.

Do not store or reuse this medicine. If you have any antibiotic left over after completing your treatment, return it to the pharmacy for proper disposal. Do not dispose of medicines via wastewater or household waste.

It is used to treat infections caused by certain microorganisms, namely bacteria. These infections include:

• Chest infections, such as acute bronchitis and pneumonia.
• Sinus, throat, tonsil, or ear infections.
• Mild to moderate skin and soft tissue infections, for example infection of the hair follicles (folliculitis), bacterial infection of the skin and underlying layers (cellulitis), or skin infection with swelling and bright red discoloration (erysipelas).
• Infections caused by a bacterium called Chlamydia trachomatis, which can cause inflammation of the tube carrying urine from the bladder (urethra) or of the area where the uterus meets the vagina (cervix).

2. What you need to know before taking Azithromycin Teva

Do not take Azithromycin Teva:

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

Warnings and precautions:

Consult your doctor or pharmacist before starting to take Azithromycin Teva if you:

• Have ever had a severe allergic reaction with swelling of the face and throat, possibly causing breathing difficulties.

• Have kidney problems; your doctor may need to adjust the dose.

• Have liver problems; your doctor may need to monitor your liver function or discontinue treatment.

• Know you have or have been diagnosed with prolonged QT interval (a heart condition): azithromycin is not recommended.

• Know you have a slow or irregular heartbeat or reduced cardiac function: azithromycin is not recommended.

• Know you have low levels of potassium or magnesium in your blood: azithromycin is not recommended.

• Are taking medicines known as antiarrhythmics (used to treat abnormal heart rhythm), hydroxychloroquine (used to treat rheumatic diseases or malaria), cisapride (used to treat stomach problems), or terfenadine (an antihistamine used to treat allergies), antipsychotics (e.g. pimozide), antidepressants (e.g. citalopram), or certain antibiotics (e.g. moxifloxacin, levofloxacin). Azithromycin should be used with caution.

• Are taking medicines known as ergot alkaloids (such as ergotamine), used to treat migraine: azithromycin is not recommended (see “Other medicines and Azithromycin Teva” below).

• Have been diagnosed with a neurological disease, or a disease affecting the brain or nervous system.

• Have mental, emotional, or behavioral disorders.

• Have a condition called myasthenia gravis, characterized by muscle weakness and fatigue, as azithromycin may worsen symptoms or trigger the condition.

If you experience any symptoms of liver dysfunction, such as anorexia (loss of appetite), yellowing of the skin or whites of the eyes, dark urine, itching, or abdominal pain, stop taking Azithromycin Teva and contact your doctor immediately.

If you have an allergic reaction (e.g. difficulty breathing, dizziness, swelling of the face or throat, skin rash, hives, blisters), stop taking Azithromycin Teva and contact a doctor immediately.

If you develop severe and persistent diarrhea, especially with blood or mucus, during or after treatment, consult your doctor immediately.

If symptoms persist after completing treatment with azithromycin, or if you notice any persistent or new symptoms, contact your doctor.

Azithromycin Teva is not indicated in children under 6 months of age.

Other medicines and Azithromycin Teva

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicine.

Tell your doctor if you are taking any of the following medicines:

• Antacids, for example aluminum hydroxide: take azithromycin at least 1 hour before or 2 hours after taking an antacid.

• Ergot derivatives, such as ergotamine (used to treat migraine): should not be administered at the same time, as ergotism (a potentially serious adverse effect with numbness or tingling in the limbs, muscle cramps, headaches, seizures, or abdominal or chest pain) may occur.

• Oral coumarin anticoagulants, for example warfarin (used to prevent blood clots): may increase the risk of bleeding.

• Digoxin (used to treat heart failure) or colchicine (used for gout and familial Mediterranean fever): may increase digoxin/colchicine blood levels.

• Zidovudine, nelfinavir (used to treat HIV): levels of zidovudine or azithromycin may increase.

• Rifabutin (used to treat HIV and bacterial infections including tuberculosis): a decrease in white blood cell count may occur.

• Cyclosporine (an immunosuppressant used after organ transplant): cyclosporine levels may rise. Your doctor will need to monitor your blood levels of cyclosporine.

• Hydroxychloroquine (used to treat rheumatic diseases or malaria): cardiac problems may occur.

• Cisapride (used to treat stomach problems): heart problems may appear.

• Astemizole, terfenadine (antihistamines used to treat allergic reactions): their effects may be increased.

• Alfentanil (a medicine used to treat pain): the effect of alfentanil may increase.

• Fluconazole (for fungal infections): azithromycin levels may be reduced.

• Atorvastatin (a medicine to lower cholesterol): concomitant use of azithromycin and atorvastatin has been associated with an increased risk of muscle tissue breakdown (rhabdomyolysis), leading to muscle pain and dark urine.

No interactions have been observed between azithromycin and cetirizine (an antihistamine); didanosine, efavirenz, indinavir (for HIV infection); carbamazepine (for epilepsy); cimetidine (an antacid); methylprednisolone (to suppress the immune system); midazolam, triazolam (sedatives); sildenafil (for impotence); theophylline (for asthma); and trimethoprim/sulfamethoxazole (an antibiotic combination).

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Your doctor will assess whether you should take this medicine during pregnancy, weighing the benefits of treatment against possible risks.

Breast-feeding

It has been reported that azithromycin is excreted in breast milk. No serious adverse reactions to azithromycin have been observed in infants.

Driving and using machines

This medicine may cause adverse effects such as dizziness or seizures. This may affect your ability to drive or operate machinery.

Azithromycin Teva contains benzyl alcohol, sodium, sucrose, glucose, sulfur dioxide, sulfites, and wheat starch

This medicine contains 0.65 micrograms of benzyl alcohol in each 5 ml of suspension.

Benzyl alcohol may cause allergic reactions.

Benzyl alcohol has been associated with the risk of serious adverse effects, including breathing problems ("gasping syndrome") in children.

This medicine should not be used for more than one week in children under 3 years of age unless directed by your doctor or pharmacist.

This medicine contains 35.2 mg of sodium (main component of table/cooking salt) in each 5 ml of reconstituted suspension. This corresponds to 1.8% of the maximum daily sodium intake recommended for an adult.

This medicine contains sucrose. If your doctor has diagnosed you with an intolerance to certain sugars, consult with them before taking this medicine.

Patients with diabetes mellitus should be aware that this medicine contains 3.75 g of sucrose per 5 milliliters.

This medicine contains glucose (in maltodextrin derived from wheat and corn). If your doctor has diagnosed you with an intolerance to certain sugars, consult with them before taking this medicine.

This medicine contains sulfites. It may cause severe allergic reactions and bronchospasm.

This medicine contains sulfur dioxide. It may cause severe allergic reactions and bronchospasm.

This medicine contains wheat starch. It is suitable for patients with celiac disease. Patients with wheat allergy (other than celiac disease) should not take this medicine.

3. How to take Azithromycin Teva

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

Preparation of the suspension

By yourself: You can prepare the suspension yourself using the dosing syringe provided.

First, tap the bottle gently to loosen the powder properly.

For 15 ml bottles (600 mg): Add 9.5 ml of water.
For 22.5 ml bottles (900 mg): Add 12.0 ml of water.
For 30 ml bottles (1,200 mg): Add 16.5 ml of water.
For 37.5 ml bottles (1,500 mg): Add 20.0 ml of water.

Shake vigorously until a homogeneous suspension is obtained.

Dosage

Azithromycin suspension should be administered as a single daily dose, with or without food.

Shake the bottle vigorously before using the suspension.

The recommended dosage is as follows:

Use in children and adolescents weighing more than 45 kg, adults, and elderly patients

The total dose of azithromycin is 37.5 ml (1,500 mg), administered as a single daily dose for 3 consecutive days (12.5 ml (500 mg) once daily). Alternatively, the same total dose may be administered over 5 days (12.5 ml (500 mg) as a single dose on the first day, followed by 6.25 ml (250 mg) once daily).

For inflammation of the urethra or cervix caused by Chlamydia trachomatis, the dose is 25 ml (1,000 mg) as a single dose.

Treatment of sinusitis is indicated only in adults and adolescents over 16 years of age.

Use in children and adolescents weighing less than 45 kg

Treatment with azithromycin suspension must be carefully measured using the provided dosing syringe and administered according to the following table:

Weight	3-day treatment	5-day treatment
10-15 kg	0.25 ml/kg (10 mg/kg) once daily, days 1 to 3	0.25 ml/kg (10 mg/kg) as a single dose on day 1, followed by 0.125 ml/kg (5 mg/kg) once daily, days 2 to 5
16-25 kg	5 ml (200 mg) once daily, days 1 to 3	5 ml (200 mg) as a single dose on day 1, followed by 2.5 ml (100 mg) once daily, days 2 to 5
26-35 kg	7.5 ml (300 mg) once daily, days 1 to 3	7.5 ml (300 mg) as a single dose on day 1, followed by 3.75 ml (150 mg) once daily, days 2 to 5
36-45 kg	10 ml (400 mg) once daily, days 1 to 3	10 ml (400 mg) as a single dose on day 1, followed by 5 ml (200 mg) once daily, days 2 to 5
>45 kg	Same dose as for adults

For the treatment of tonsillitis/pharyngitis in children aged 2 years and older: the recommended dose of azithromycin is 10 mg/kg or 20 mg/kg for 3 days, with no daily dose exceeding a maximum of 500 mg.

Sinusitis

For the treatment of sinusitis, available data in children under 16 years of age are limited.

Patients with liver or kidney problems:

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

Instructions for using the syringe

Filling the syringe with the medication

1. Shake the bottle well before use and remove the child-resistant safety cap.
2. Place the bottle on a stable, flat surface and hold it firmly with one hand, while inserting the tip of the syringe into the adapter with the other hand.
3. Slowly pull back the plunger of the syringe until the graduation line indicated on the plunger aligns with the top edge of the barrel.
4. If large air bubbles are visible, slowly press the plunger to return the medication back into the bottle. Repeat step 3 again.
5. Remove the syringe from the bottle.

Administration of the medication using the syringe

1. Ensure the child is in an upright position before administering the medication.

2. Carefully insert the tip of the syringe into the child's mouth, directing it toward the inside of the cheek.

3. Slowly press the plunger of the syringe: Do not expel the medication rapidly. The medication will be delivered into the child's mouth.

4. Allow the child to swallow the medication.

5. Replace the cap on the bottle. Wash the syringe following the instructions below.

6. When daily doses of less than 5 ml have been administered for three days, some suspension will remain in the bottle. The remaining suspension must be discarded.

Cleaning and storage of the syringe

Remove the plunger from the syringe and wash both parts with warm running water or by immersing them in a sterilizing solution used for baby bottles, etc.

Dry both parts thoroughly. Reinsert the plunger into the syringe and store it in a clean and safe place with the medication. After administering the last dose of medication to the child, wrap the syringe in paper and dispose of it.

WARNING: ADMINISTER THE MEDICATION TO THE CHILD SLOWLY AND ENSURE THE CHILD IS SITTING OR HELD IN AN UPRIGHT POSITION. THIS WILL HELP PREVENT THE RISK OF CHOKING.

If you take more Azithromycin Teva than you should

If you or someone takes more azithromycin than recommended, inform your doctor or pharmacist immediately. An overdose may cause temporary hearing loss, severe nausea (feeling unwell), vomiting, and diarrhea.

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or the Toxicology Information Service immediately at telephone number: 91 562 04 20. Bring this leaflet, any remaining medication, and the container with you to the hospital or doctor so they know which medication has been taken.

If you forget to take Azitromycin Teva

If you have forgotten to take a dose, take it as soon as possible, unless it is almost time for the next dose. Do not take a double dose to make up for a missed dose.

If you stop taking Azitromycin Teva

Do not stop taking your medication without first consulting your doctor, even if you feel better. It is very important that you continue taking Azithromycin for the full duration prescribed by your doctor; otherwise, the infection may return.

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

4. Possible adverse effects

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

If you experience any of the following adverse effects, stop using Azithromycin Teva and tell your doctor immediately or go to the nearest hospital emergency department:

Uncommon: may affect up to 1 in 100 people

• Angioedema: allergic reaction with swelling of the lips, face or neck, causing severe breathing difficulty; skin rash or eruption.

Rare: may affect up to 1 in 10,000 people

• Skin rash characterized by the rapid appearance of red skin areas dotted with small pustules (small blisters filled with white/yellow liquid)

Very rare: (may affect up to 1 in 10,000 people)

• Hypersensitivity reaction with skin rash, fever, lymph node swelling and possible organ damage (DRESS)

Frequency not known: frequency cannot be estimated from available data

• Anaphylactic reaction: severe allergic reaction causing difficulty breathing or dizziness

• Severe liver disorders or liver failure (rarely life-threatening): signs may include fatigue associated with yellowing of the skin or whites of the eyes (jaundice), dark urine, tendency to bleed

• Blisters/bleeding of lips, eyes, nose, mouth and genitals, which may be caused by Stevens-Johnson syndrome, erythema multiforme or toxic epidermal necrolysis, all of which are serious conditions.

• Changes in heart rate, changes in heart rhythm on electrocardiogram (prolongation of QT interval, ventricular tachycardia and torsades de pointes)

• prolonged diarrhoea with blood and mucus (pseudomembranous colitis)

These are very serious adverse effects. You may require urgent medical attention or hospitalization.

Other adverse effects

Very common (may affect more than 1 in 10 people)

• Diarrhoea

Common (may affect up to 1 in 10 people)

• Headache
• Vomiting, abdominal pain, nausea
• Changes in the number of certain types of white blood cells and blood bicarbonate levels

Uncommon (may affect up to 1 in 100 people)

• Fungal infections, for example in the mouth (thrush), vaginal infection, pneumonia, bacterial infection
• Sore throat, inflammation of the lining of the stomach and intestine
• Shortness of breath, chest pain, wheezing and cough (respiratory disorders), nasal congestion
• Blood disorders characterized by fever or chills, sore throat, mouth or throat ulcers
• Allergic reactions
• Loss of appetite
• Nervousness, difficulty sleeping
• Dizziness, drowsiness, altered taste, tingling or numbness
• Vision disorders
• Ear disorders
• Vertigo (spinning sensation)
• Irregularity in heart rhythm or rate and awareness of heartbeat (palpitations)
• Hot flushes
• Difficulty breathing
• Nosebleed
• Stomach inflammation, constipation, gas, indigestion, difficulty swallowing
• Feeling bloated, dry mouth
• Burping, mouth ulcers, increased salivation, soft stools
• Hepatitis (inflammation of the liver)
• Rash, itching, urticaria (itchy rash)
• Skin inflammation, dry skin, increased sweating
• Inflammation of bones and joints, muscle pain, back pain, neck pain
• Pain and difficulty urinating, loin pain (kidney pain)
• Vaginal inflammation, irregular menstrual bleeding, testicular disorders
• Chest pain, generalized swelling, malaise, weakness, fatigue
• Facial, hand, leg and foot swelling, fever, pain
• Changes in liver enzymes and blood test values

Rare (may affect up to 1 in 1,000 people)

• Restlessness
• Feeling of unreality
• Discoloration of teeth
• Abnormal liver function, jaundice (yellowish pigmentation of the skin)
• Photosensitivity (redness and blistering of the skin upon exposure to sunlight)

Frequency not known: frequency cannot be estimated from available data

• Blood disorders characterized by unusual bleeding or unexplained bruising, decreased red blood cell count causing weakness or unusual fatigue
• Aggression, anxiety, confusion, seeing or hearing things that are not real
• Fainting, seizures, decreased sensation, hyperactivity, disturbance or loss of smell, loss of taste, myasthenia gravis (muscle weakness and fatigue, see section 2 “Warnings and precautions”)
• Hearing disturbances including deafness and/or tinnitus
• Decreased blood pressure (which may be associated with weakness, fainting and collapse)
• Tongue discoloration, pancreatitis causing nausea, vomiting, abdominal pain, back pain
• Rash with spots and blisters
• Joint pain
• Kidney problems

The following adverse effects have been reported during prophylactic treatment against Mycobacterium Avium Complex (MAC):

Very common (may affect more than 1 in 10 people):

• Diarrhoea
• Abdominal pain
• Nausea
• Gas (flatulence)
• Abdominal discomfort
• Soft stools

Common (may affect up to 1 in 10 people)

• Loss of appetite (anorexia)
• Dizziness
• Headache
• Tingling or numbness sensation (paraesthesia)
• Changes in taste sensation (dysgeusia)
• Visual disturbance
• Deafness
• Skin rash
• Itching (pruritus)
• Joint pain (arthralgia)
• Fatigue

Uncommon (may affect up to 1 in 100 people)

• Reduced sensation (hypoesthesia)
• Hearing loss or ringing in the ears
• Irregularity in heart rhythm or rate and awareness of heartbeat (palpitations)
• Liver problems such as hepatitis
• Blisters/bleeding of lips, eyes, nose, mouth and genitals, which may be caused by Stevens-Johnson syndrome
• Skin allergic reactions such as sensitivity to sunlight, red, scaly and inflamed skin
• Weakness (asthenia)
• Feeling of general malaise

Reporting of adverse effects

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

5. Storage of Azithromycin Teva

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

Do not use azithromycin after the expiry date stated on the carton and the bottle after EXP.

Powder for suspension: Store below 25°C.

After reconstitution: Store below 25°C and use within 5 days (azithromycin suspension 15 ml and 22.5 ml) or within 10 days (azithromycin suspension 30 ml and 37.5 ml).

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point in your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Pack contents and other information

Composition of Azithromycin Teva

• The active substance is azithromycin.

Each ml contains 40 mg of azithromycin (as dihydrate) after reconstitution with water (equivalent to 200 mg of azithromycin per 5 ml of suspension).

• The other components are: anhydrous colloidal silica, sucrose, xanthan gum (E415), anhydrous trisodium phosphate, hydroxypropylcellulose, cherry flavour (containing maltodextrin from wheat, gum arabic, benzyl alcohol and sulphur dioxide E220), vanilla flavour (containing sulphites, maltodextrin from wheat and maize, and gum arabic), banana flavour (containing sulphites, maltodextrin from wheat) (see section 2).

Nature of the product and pack contents

• The powder for the preparation of suspension is a white to off-white powder. After reconstitution with water, it forms an off-white suspension.
• The oral suspension powder is packed in bottles containing 600, 900, 1,200 or 1,500 mg of azithromycin, which after reconstitution with water provide 600 mg/15 ml, 900 mg/22.5 ml, 1,200 mg/30 ml and 1,500 mg/37.5 ml of azithromycin suspension, respectively.

Pack sizes:

Azithromycin 600 mg/15 ml: 12.555 g of powder for the preparation of 15 ml of suspension.

Azithromycin 900 mg/22.5 ml: 18.8325 g of powder for the preparation of 22.5 ml of suspension.

Azithromycin 1,200 mg/30 ml: 25.110 g of powder for the preparation of 30 ml of suspension.

Azithromycin 1,500 mg/37.5 ml: 31.3875 g of powder for the preparation of 37.5 ml of suspension.

A dosing syringe is included with the bottles.

Only some pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Teva Pharma, S.L.U.

C/ Anabel Segura, Edificio Albatros B, 1st floor

28108 Alcobendas, Madrid

Spain

Manufacturer:

Teva Operations Poland Sp. Z.o.o.

ul. Mogilska 80

31-546 Kraków

Poland

or

Merckle GmbH

Ludwig Merckle Straße 3

89143 Blaubeuren

Germany

or

PLIVA CROATIA LIMITED (PLIVA KRVATSKA D.O.O.)

Prilaz Baruna Filipovica, 25

10000 Zagreb, Croatia

This medicinal product is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Germany	Azi-TEVA® 200mg/5ml Powder for Oral Suspension
Italy	AZITHROMYCIN TEVA ITALIA 200mg/5ml powder for oral suspension
Netherlands	Azithromycin 200mg/5ml Teva powder for oral suspension
United Kingdom (Northern Ireland)	Azithromycin 200mg/5ml Powder for Suspension
Spain	Azithromycin Teva 200 mg/5ml powder for oral suspension EFG

Date of the last review of this leaflet: November 2024

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

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/69516/P_69516.html

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