Azithromycin Tevagen 500 mg dispersible tablets EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Azithromycin Tevagen 500 mg dispersible tablets EFG

Read the entire leaflet carefully before you start using this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents:

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

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

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

It is used to treat bacterial infections caused by microorganisms such as bacteria that are sensitive to azithromycin. These infections include:

• Infections of the upper respiratory tract, for example, sinuses, throat, and tonsils (see also “Warnings and precautions” in section 2).

• Acute otitis media.

• Infections of the chest (lower respiratory tract) such as acute bronchitis, exacerbation of chronic bronchitis, and mild to moderately severe community-acquired pneumonia, including interstitial pneumonia.

• Mild to moderate skin and soft tissue infections, for example, infection of the hair follicles (folliculitis), bacterial infection of the skin and underlying tissues (cellulitis), skin infection with swelling and bright red coloration (erysipelas).

• Erythema migrans (first stage of Lyme disease), if antibiotics such as doxycycline, amoxicillin, or cefuroxime axetil cannot be used (see section 2 “Warnings and precautions”).

• Uncomplicated infections caused by a bacterium called Chlamydia trachomatis, which may cause inflammation of the tube carrying urine from the bladder (urethra) or of the area where the uterus connects to the vagina (cervix).

2. What you need to know before taking Azithromycin Tevagen

Do NOT take Azithromycin Tevagen

• 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 erythromycin or any other macrolide or ketolide antibiotic.

Warnings and precautions

Talk to your doctor or pharmacist before taking Azithromycin Tevagen if:

• You experience an allergic reaction such as red or white spots on the skin, stinging and irritation of the skin, swelling of the skin, larynx (throat) or tongue, and difficulty breathing—in which case you must stop treatment with Azithromycin Tevagen.
• You have liver problems; your doctor may need to monitor your liver function or discontinue treatment.
• You have severe kidney problems; your doctor may adjust the dose.
• You are taking medications known as ergot alkaloids (such as ergotamine or dihydroergotamine), used to treat migraine: azithromycin is not recommended (see “Other medicines and Azithromycin Tevagen”).
• You develop signs of another infection.
• 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 Clostridioides difficile-associated diarrhea. Do not take any medication for your diarrhea without first consulting your doctor.
• You have conditions that favor the development of arrhythmias (especially important in women and elderly patients).
• You have prolonged QT interval (a heart condition).
• You are taking medicines known to prolong the QT interval (see section “Other medicines and Azithromycin Tevagen”).
• Your blood levels of potassium or magnesium are too low.
• You have heart problems such as slow or irregular pulse or reduced cardiac function.
• You have a type of muscle weakness known as myasthenia gravis. Azithromycin may worsen or trigger symptoms of myasthenia.
• You have mental or nervous system disorders.
• You have a sexually transmitted disease caused by a pathogen (T. pallidum, including the pathogen causing syphilis).

Treatment of erythema migrans with azithromycin should be carefully monitored by your doctor, as treatment failures may occur.

If symptoms persist after completing treatment with Azithromycin or if you notice any new and persistent symptoms, inform your doctor.

Other medicines and Azithromycin Tevagen

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

Consult your doctor if you are taking or have recently taken any of the following medicines:

• Medicines known to prolong the QT interval, such as antiarrhythmics (used to treat abnormal heart rhythms, e.g., quinidine, procainamide, dofetilide, amiodarone, and sotalol), hydroxychloroquine (used to treat rheumatic diseases or malaria), cisapride (used to treat stomach problems), terfenadine (used to treat allergies), pimozide, phenothiazines (used to treat certain mental disorders), citalopram (used to treat depression), and antibacterial medicines such as moxifloxacin and levofloxacin (see also section “Warnings and precautions”).
• Antacids (used for acidity and indigestion, e.g., aluminum hydroxide). Azithromycin Tevagen should be taken at least 1 hour before or 2 hours after antacids.
• Digoxin (used to treat heart failure), as it may increase digoxin blood levels, which should be monitored.
• Colchicine (used for gout and familial Mediterranean fever), as digoxin/colchicine blood levels may increase.
• Zidovudine (used in the treatment of AIDS), as zidovudine levels may increase.
• Nelfinavir (used in the treatment of HIV), as azithromycin levels may increase.
• Ergotamine derivatives, e.g., ergotamine (used to treat migraine): Azithromycin should not be administered at the same time, as ergotism (a potentially serious adverse effect with numbness or tingling sensations in the limbs, muscle cramps, headaches, seizures, or abdominal or chest pain) may develop (see also section “Warnings and precautions”).
• Astemizole (an antihistamine), as its effects may be increased.
• Alfentanil (a painkiller), as its effects may be increased.
• Atorvastatin (a medicine to lower cholesterol), as cases of rhabdomyolysis (increased risk of muscle tissue breakdown) have been reported in patients taking this medicine and azithromycin.
• Hydroxychloroquine (used to treat rheumatic diseases or malaria): heart problems may occur.
• Cisapride (used to treat stomach problems), as heart problems may occur.
• Coumarin derivatives, e.g., warfarin (used to prevent blood clots): risk of bleeding may increase.
• Cyclosporine (an immunosuppressant used after organ transplant), as cyclosporine levels may rise and your doctor will need to monitor your blood levels of cyclosporine.
• Theophylline (used for respiratory problems), as azithromycin may increase its levels.

Pregnancy, breastfeeding, and fertility

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

Azithromycin Tevagen should not be used during pregnancy unless absolutely necessary. You should only take this medicine during pregnancy if your doctor considers it necessary.

Breastfeeding is not recommended while taking azithromycin, as it may cause side effects including diarrhea and infection in the infant. You may resume breastfeeding two days after completing azithromycin treatment.

Driving and using machines

There are no data on the effect of azithromycin on the ability to drive and use machines. However, azithromycin may cause certain adverse effects such as dizziness or seizures, which may alter your reaction time and affect your ability to participate in road traffic or use machines. If these effects occur, do not drive or operate machinery.

Azithromycin Tevagen contains aspartame

This medicine contains 19.5 mg of aspartame per tablet. Aspartame is a source of phenylalanine, which may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot eliminate it properly.

Azithromycin Tevagen contains benzyl alcohol

This medicine contains less than 1 mg of benzyl alcohol per dispersible tablet. Benzyl alcohol may cause allergic reactions.

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.

Consult your doctor or pharmacist if you are pregnant or breastfeeding, or if you have liver or kidney disease. This is because large amounts of benzyl alcohol may accumulate in your body and cause adverse effects (metabolic acidosis).

Azithromycin Tevagen contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet, which is essentially “sodium-free”.

Azithromycin Tevagen contains glucose (in maltodextrin derived from maize)

If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Azithromycin Tevagen

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

The recommended dose is:

Adults, including elderly patients, and children and adolescents weighing over 45 kg:

Treatment of upper and lower respiratory tract infections, otitis media, and skin and soft tissue infections

The total dose is 1,500 mg of azithromycin, which can be taken according to either a 3-day treatment regimen or a 5-day treatment regimen.

3-day treatment regimen

For 3 days, take 500 mg of azithromycin once daily.

5-day treatment regimen

For the 5-day treatment, take 500 mg of azithromycin on the first day and 250 mg of azithromycin once daily on days 2 to 5.

Treatment of uncomplicated genital infections caused by Chlamydia trachomatis

The total dose is 1,000 mg of azithromycin, taken as a single dose.

Treatment of erythema migrans (early stage of Lyme disease)

In the treatment of erythema migrans, the total dose of azithromycin is 3,000 mg, administered as follows: 1,000 mg on day 1 and 500 mg once daily from day 2 to day 5.

Elderly patients

Elderly patients should receive the recommended adult dose. It should be noted that they may be more susceptible to serious cardiac rhythm disorders (arrhythmia torsade de pointes) than younger patients (see also “Warnings and precautions” in section 2).

Patients with hepatic or renal impairment

Talk to your doctor before taking Azithromycin Tevagen if you have liver or kidney problems. Your doctor will then decide whether a dose adjustment is necessary.

Children and adolescents weighing less than 45 kg:

• Your doctor will determine the most appropriate dose for your child based on body weight.
• It may be possible that, based on their weight, this medicine is not suitable for your child. In this case, your doctor will prescribe a different formulation of azithromycin, such as a suspension.
• The recommended dose is 10 mg per kg of body weight, given as a single daily dose for 3 days. Alternatively, the same total dose may be administered over 5 days with 10 mg/kg on day 1 followed by 5 mg/kg once daily for the following 4 days.
• The maximum total dose in these patients is 1,500 mg.

Method of administration

The tablet should be dispersed by stirring in a sufficient amount of liquid such as water, apple juice, or orange juice (at least 30 ml) until a fine suspension is obtained. After swallowing the suspension, any residue should be resuspended in a small volume of water and swallowed. The dispersible tablet may be taken with or without food.

The score line should not be used to divide the tablet.

If you take more Azithromycin Tevagen than you should

If you ingest too many Azithromycin Tevagen tablets, contact your doctor or pharmacist or go to the nearest hospital immediately. Symptoms of overdose are similar to the adverse effects observed at normal doses (see section 4). Typical signs of overdose include temporary hearing loss, severe nausea, vomiting, and diarrhea.

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount ingested. Bring this leaflet, any remaining tablets, and the packaging with you to the hospital or doctor so they know which tablets you have taken.

If you forget to take Azithromycin Tevagen

If you forget to take a tablet, take it as soon as you remember, unless it is almost time for your next dose. Do not take a double dose to make up for forgotten doses.

Instead, take the next dose at your usual time. If you have any doubts, contact your doctor or pharmacist.

If you have missed a dose, still take all the tablets. This means you will finish your treatment one day later.

If you stop taking Azithromycin Tevagen

Do not stop taking Azithromycin Tevagen without first consulting your doctor, even if you feel better. If the prescribed treatment is not completed, the infection may recur.

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, stop taking Azithromycin Tevagen and contact your doctor immediately or go to the nearest hospital emergency department:

• Severe allergic reaction (such as anaphylactic reaction or angioedema), which may include sudden difficulty breathing or swallowing, swelling of the lips, tongue, face and neck, itchy rash affecting the whole body
• Severe skin rash: A rash characterized by the rapid appearance of red skin areas dotted with small pustules (small blisters filled with white/yellow fluid); severe rash causing redness and peeling, blisters and severe bleeding in the lips, eyes, mouth, nose and genitals, associated with high fever and joint pain. This could be “Acute Generalized Exanthematous Pustulosis (AGEP)”, “Erythema multiforme”, “Stevens-Johnson Syndrome” or “Toxic Epidermal Necrolysis”.
• Severe allergic reaction that may include fever, rash, swollen glands, increase in a type of white blood cells (eosinophilia), and inflammation of internal organs (Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)).
• Severe or prolonged diarrhoea with blood and mucus. This may occur during or after treatment and could be a sign of serious intestinal inflammation.
• Severe liver disorders or liver failure (rarely fatal): signs may include fatigue associated with yellowing of the skin or whites of the eyes (cholestatic jaundice), dark urine, tendency to bleed.
• Kidney inflammation or kidney failure: signs may include increased need to urinate at night, muscle spasms and cramps, loss of appetite, nausea or vomiting, unpleasant taste in the mouth.
• Unusual tendency to bruise or bleed, which may be signs of a blood formation disorder characterized by a reduced number of platelets (thrombocytopenia).
• Rapid (ventricular tachycardia) or irregular heartbeat, or changes in heart rhythm on electrocardiogram (prolongation of QT interval and torsades de pointes).

The following other adverse effects have been reported:

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 or bacterial infection
• Candidiasis, a fungal infection caused by Candida
• Vaginal infection
• Pneumonia
• Throat inflammation (pharyngitis)
• Stomach upset (gastroenteritis)
• Shortness of breath, chest pain, wheezing and cough (respiratory disorders)
• Nasal congestion (rhinitis)
• Reduction in the number of white blood cells
• Hypersensitivity
• Loss of appetite (anorexia)
• Nervousness, difficulty sleeping (insomnia)
• Dizziness, drowsiness, changes in taste sensation (dysgeusia), tingling or numbness sensation (paraesthesia)
• Visual disturbances
• Hearing problems, vertigo
• Strong heartbeat that may be rapid or irregular
• Palpitations
• Hot flushes
• Difficulty breathing (dyspnoea), nosebleeds (epistaxis)
• Constipation, gas, indigestion, inflammation of the stomach lining (gastritis), difficulty swallowing (dysphagia), stomach inflammation, dry mouth, burping, mouth ulcers, increased salivation
• Allergic reactions such as rash, pruritus and urticaria, skin inflammation (dermatitis), dry skin, increased sweating
• Pain, swelling and reduced movement in joints (osteoarthritis), muscle pain (myalgia), back and neck pain
• Pain or difficulty urinating, upper back pain (renal pain)
• Irregular menstrual bleeding (metrorrhagia), testicular disorder
• Weakness (asthenia), general malaise, fatigue, swelling of face, arms and legs, chest pain, fever (pyrexia), pain
• Changes in liver enzymes and blood test values, increased blood urea levels
• Post-procedural complications

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

• Feeling of restlessness
• Abnormal liver function, yellowish pigmentation of the skin or whites of the eyes (jaundice)
• Light sensitivity

Not known (frequency cannot be estimated from available data)

• Inflammation of the intestine (pseudomembranous colitis)
• Decreased number of platelets (thrombocytopenia), decreased number of red blood cells (haemolytic anaemia)
• Anaphylactic reaction
• Aggression, anxiety, confusion (delirium), hallucinations
• Fainting (syncope), seizures, reduced sense of touch (hypoesthesia), hyperactivity, changes in sense of smell (anosmia, parosmia), loss of taste (ageusia), worsening or exacerbation of muscle weakness (myasthenia gravis)
• Hearing loss or ringing in the ears (tinnitus)
• Rapid (ventricular tachycardia) or irregular heartbeat, sometimes fatal, changes in heart rhythm detected on electrocardiogram (prolongation of QT interval and torsades de pointes)
• Decreased blood pressure (hypotension)
• Inflammation of the pancreas (pancreatitis), discoloration of the tongue, hepatitis
• Joint pain (arthralgia)

The following adverse effects have been reported in patients receiving prevention and treatment of infections due to Mycobacterium Avium Complex (MAC):

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

• Diarrhoea, abdominal pain, nausea, gas (flatulence), 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 (dysgeusia)
• Visual impairment
• Deafness
• Skin rash and itching
• Joint pain (arthralgia)
• Fatigue

Uncommon (may affect up to 1 in 100 people)

• Reduced sensitivity (hypoesthesia)
• Hearing loss or ringing in the ears (tinnitus)
• Strong heartbeat that may be rapid or irregular
• Hepatitis
• Severe skin reaction (Stevens-Johnson syndrome), light sensitivity
• General malaise, weakness (asthenia)

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via 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 Tevagen

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.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Return unused or expired containers and medicines to the SIGRE point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of any containers and medicines you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Azithromycin Tevagen

• The active substance is: azithromycin (as dihydrate)

Each dispersible tablet contains 500 mg of azithromycin (as dihydrate).

• The other components are sodium saccharin dihydrate, microcrystalline cellulose, crospovidone type A, povidone, sodium lauryl sulfate, colloidal anhydrous silica, magnesium stearate, aspartame (E951) and orange flavour (which contains flavouring agents, maltodextrin derived from maize (contains glucose), benzyl alcohol and alpha-tocopherol) (see also section 2 “Azithromycin Tevagen contains aspartame, benzyl alcohol, glucose and sodium”).

Appearance of the product and contents of the pack

Azithromycin Tevagen 500 mg dispersible tablets are white to almost white, round, smooth tablets with bevelled edges, with a score line on one side and marked “TEVA 500” on the other. Each tablet has an approximate diameter of 17 mm.

The 500 mg tablets are available in aluminium PVC/PE/PVDC/PE/PVC blisters containing 1, 2, 3, 6, 12 or 24 dispersible tablets.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Teva Pharma, S.L.U
C/ Anabel Segura 11, 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

Pliva Croatia Ltd. (PLIVA HRVATSKA D.O.O.)
Prilaz Baruna Filipovica 25
10000 Zagreb, Croatia

This medicinal product is authorised in the European Economic Area member states under the following names:

Date of the most recent review of this leaflet: June 2023

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (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 on the packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/82366/P_82366.html

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