Azithromycin teva

Package leaflet: Information for the patient

Azithromycin Teva, 250 mg, tablets for oral suspension
Azithromycin Teva, 500 mg, tablets for oral suspension
Azithromycinum
Please read all of this leaflet carefully before 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 further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents

1. What Azithromycin Teva is and what it is used for
2. Important information 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 Azithromycin Teva is and what it is used for

Azithromycin Teva contains azithromycin as the active substance, which is an antibiotic belonging to the macrolide group. It is used to treat infections caused by microorganisms, such as bacteria sensitive to azithromycin. These infections include:

• Upper respiratory tract infections, e.g. of the sinuses, throat and tonsils (see also "Warnings and precautions" in section 2)
• Acute otitis media (middle ear infection)
• Chest infections (lower respiratory tract infections), 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, e.g. folliculitis (infection of hair follicles in the skin), cellulitis (infection of deeper skin layers and underlying tissues), and erysipelas (infection of the upper skin layer)
• Lyme disease – Erythema migrans (the first sign of Lyme disease) when antibiotics such as doxycycline, amoxicillin, or cefuroxime axetil cannot be used (see also section 2 "Warnings and precautions")
• Uncomplicated infections caused by the bacterium Chlamydia trachomatis, which may cause urethritis (infection of the urethra, the tube through which urine passes from the bladder) or cervicitis (infection of the cervix, where the uterus connects to the vagina)

2. Important information before using Azithromycin Teva

When NOT to use Azithromycin Teva:

• If the patient is allergic to azithromycin or to any of the other ingredients of this medicine (listed in section 6)
• If the patient is allergic to erythromycin or to any other macrolide or ketolide antibiotics.

Warnings and precautions
Before starting treatment with Azithromycin Teva, consult a doctor or pharmacist:

• if the patient develops symptoms of an allergic reaction, such as red or white patches on the skin, itching and skin irritation, swelling of the skin, larynx (throat) or tongue, and difficulty breathing, use of Azithromycin Teva must be discontinued
• if the patient has liver function disorders, as liver function monitoring by a physician or discontinuation of treatment may be necessary
• if the patient has kidney function disorders, as the doctor may need to adjust the dose
• if the patient is taking medicines known as ergot derivatives, such as ergotamine or dihydroergotamine (used to treat migraine), because azithromycin is not recommended in this combination (see also section "Azithromycin Teva with other medicines")
• if the patient develops symptoms of another infection
• if the patient develops diarrhoea or loose stools during or after treatment. In some cases, there is a risk of developing a severe intestinal inflammation known as Clostridioides difficile-associated diarrhoea. Do not take any anti-diarrhoeal medicine without first consulting a doctor.
• if the patient has conditions predisposing to cardiac arrhythmias (particularly important in women and elderly patients):
• if the patient has a prolonged QT interval (a heart condition)
• if the patient is taking medicines that prolong the QT interval (see section "Azithromycin Teva with other medicines")
• if the patient has low blood levels of potassium or magnesium
• if the patient has heart diseases such as slow or irregular heartbeat or reduced cardiac function
• if the patient has a certain type of muscle weakness known as myasthenia gravis. Azithromycin Teva may worsen or trigger symptoms of myasthenia.
• if the patient has neurological disorders or mental (psychiatric) conditions
• if the patient has a sexually transmitted disease caused by a specific pathogen (T. pallidum, including the pathogen causing syphilis).

Treatment of erythema migrans with azithromycin should be carefully monitored by a doctor, as it may fail.
If symptoms persist after completing azithromycin treatment, or if the patient notices any new and persistent symptoms, medical advice should be sought.

Azithromycin Teva with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
If the patient is taking or has recently taken any of the following medicines, inform the doctor:

• medicines that prolong the QT interval, such as antiarrhythmics (used to treat heart rhythm disorders, e.g. quinidine, procainamide, dofetilide, amiodarone, sotalol), hydroxychloroquine (used to treat rheumatological diseases or malaria), cisapride (used for stomach disorders), terfenadine (used to treat allergies), pimozide, phenothiazines (used to treat certain psychiatric/mood disorders), citalopram (used to treat depression), and antibacterial agents such as moxifloxacin, levofloxacin (see also section "Warnings and precautions")
• antacids (used to treat heartburn and indigestion, e.g. aluminium hydroxide). Azithromycin Teva should be taken at least 1 hour before or 2 hours after taking antacids
• digoxin (used for heart failure), as digoxin blood levels may increase
• colchicine (used for gout and familial Mediterranean fever), as colchicine blood levels may increase
• zidovudine (used to treat HIV), as zidovudine levels may increase
• nelfinavir (used to treat HIV), as azithromycin levels may increase
• ergot alkaloids, e.g. ergotamine (used to treat migraine). Azithromycin should not be taken concurrently due to the risk of ergot poisoning (potentially serious adverse effects including numbness or tingling of limbs, muscle cramps, headache, seizures, abdominal or chest pain) (see also section "Warnings and precautions")
• astemizole (an antihistamine), as its effects may be enhanced
• alfentanil (a painkiller), as its effects may be enhanced
• atorvastatin (a medicine used to lower cholesterol levels), as cases of rhabdomyolysis (increased risk of muscle tissue damage) have been reported in patients taking azithromycin concurrently
• hydroxychloroquine (used to treat rheumatological diseases or malaria) which may increase the risk of heart problems
• cisapride (used to treat stomach disorders), as it may increase the risk of heart problems
• coumarin derivatives, e.g. warfarin (used to prevent blood clots), as the risk of bleeding may increase
• cyclosporine (used to prevent rejection of transplanted organs), as cyclosporine levels may be elevated and regular monitoring of blood cyclosporine levels may be required
• theophylline (used to treat breathing problems), as azithromycin may increase its levels.

Pregnancy, breast-feeding and fertility
If the patient is pregnant or breast-feeding, suspects she may be pregnant, or plans to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Azithromycin Teva should not be used during pregnancy unless absolutely necessary.
The medicine should be used during pregnancy only if considered essential by the physician.
Breast-feeding should not be continued if the patient is taking azithromycin, as it may cause adverse effects, including diarrhoea and infection in the infant. Breast-feeding may be resumed 2 days after stopping azithromycin treatment.

Driving and using machines
There are no data on the effect of azithromycin on the ability to drive or operate machinery. However, Azithromycin Teva may cause adverse effects such as dizziness and seizures, which may affect the patient's reaction time and ability to actively participate in road traffic or operate machinery. If such adverse effects occur, do not drive or operate machinery.

Azithromycin Teva contains aspartame
Azithromycin Teva 250 mg, oral suspension tablets:
This medicine contains 19.5 mg of aspartame per oral suspension tablet.
Aspartame is a source of phenylalanine. It may be harmful to patients with phenylketonuria. This is a rare genetic disorder in which phenylalanine accumulates in the body due to improper excretion.
Azithromycin Teva 500 mg, oral suspension tablets:
This medicine contains 39.0 mg of aspartame per oral suspension tablet.
Aspartame is a source of phenylalanine. It may be harmful to patients with phenylketonuria. This is a rare genetic disorder in which phenylalanine accumulates in the body due to improper excretion.

Azithromycin Teva contains benzyl alcohol
This medicine contains less than 1 mg of benzyl alcohol per oral suspension tablet. Benzyl alcohol may cause allergic reactions.
Do not administer to young children (under 3 years of age) for longer than one week without medical or pharmacist advice.
Pregnant or breast-feeding women and patients with liver or kidney disease should consult a doctor before using this medicine, as large amounts of benzyl alcohol may accumulate in their bodies and cause adverse effects (so-called metabolic acidosis).

Azithromycin Teva contains glucose (component of maltodextrin)
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

Azithromycin Teva contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to take Azithromycin Teva

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.

Dosage recommendations:

Dosage for adults, including elderly patients, and for children and adolescents with body weight of 45 kg or more:

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

The total dose of 1500 mg of azithromycin can be administered according to either a 3-day or a 5-day treatment regimen.

3-day treatment regimen
500 mg of azithromycin once daily for 3 days.

5-day treatment regimen
On the first day, take 500 mg of azithromycin, followed by 250 mg of azithromycin once daily from day 2 to day 5.

Treatment of uncomplicated genital infections caused by Chlamydia trachomatis:
The total dose is 1000 mg of azithromycin taken as a single dose.

Treatment of erythema migrans (the first manifestation of Lyme disease):
For treatment of erythema migrans, the total dose of azithromycin is 3000 mg, administered as follows: 1000 mg on day 1, followed by 500 mg once daily from day 2 to day 5.

Elderly patients
For elderly patients, the recommended dosage is the same as for other adult patients.
It should be noted that elderly patients may be more susceptible to severe cardiac arrhythmias (such as torsade de pointes) than younger patients (see also section 2. "Warnings and precautions").

Patients with renal or hepatic impairment:
If the patient has impaired kidney or liver function, inform the doctor before taking Azithromycin Teva. The doctor will decide whether dose adjustment is necessary.

Dosage for children and adolescents with body weight below 45 kg:

• The doctor will determine the most appropriate dose for the child based on body weight.
• Due to the child's body weight, this medicine may not be suitable. In such cases, the doctor will prescribe azithromycin in another formulation, such as an oral suspension.
• The recommended dose is 10 mg/kg body weight, given as a single daily dose for 3 days. Alternatively, the same total dose may be administered over 5 days: 10 mg/kg body weight on day 1, followed by 5 mg/kg body weight once daily from day 2 to day 5.
• The maximum dose in these patients is 1500 mg.

Method of administration
The tablet should be dispersed by mixing it in a sufficient amount of liquid, such as water, apple juice, or orange juice (at least 30 ml), to form a fine suspension. After swallowing the suspension, any residue must be resuspended in a small amount of water and also swallowed.

The tablet for oral suspension may be taken with or without food.
The break line on the tablet is not intended for splitting the tablet.

If more Azithromycin Teva has been taken than recommended
If you have taken more than the recommended dose of Azithromycin Teva, you must immediately contact your doctor or go to the nearest hospital. Symptoms of overdose are similar to the adverse effects observed after taking the correct doses (see section 4). Typical symptoms of overdose include transient hearing loss, severe nausea, vomiting, and diarrhea.

When going to the hospital or seeing a doctor, bring this leaflet and the remaining medicine packaging so that it is clear which medicine has been taken.

If you forget to take Azithromycin Teva
Take the missed dose as soon as you remember, unless it is almost time for the next dose. Do not take a double dose to make up for the missed dose.

Take the next dose at the scheduled time. If in doubt, consult your doctor or pharmacist.

Even if a dose has been missed, all prescribed tablets should be taken. This means that the treatment will end one day later.

Stopping Azithromycin Teva treatment
Do not stop taking Azithromycin Teva without first consulting your doctor, even if you feel better. If the prescribed course of treatment is not completed, the infection may return.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If any of the following adverse effects occur, stop taking Azithromycin Teva immediately
and contact your doctor or go to the nearest hospital emergency department:

• Severe allergic reactions (such as anaphylactic reaction or angioedema), which may include sudden difficulty breathing or swallowing, swelling of the lips, tongue, face and neck, itchy rash, especially if widespread throughout the body.
• Severe skin reactions: skin eruption characterized by rapid appearance of red skin areas covered with small blisters (vesicles filled with white or yellow fluid); severe skin rash causing redness and peeling; severe blistering and bleeding from the lips, eyes, mouth, nose and genitals, associated with high fever and joint pain. These may be "acute generalized exanthematous pustulosis" (AGEP), "erythema multiforme", "Stevens-Johnson syndrome" or "toxic epidermal necrolysis".
• Severe hypersensitivity reaction possibly including fever, skin rash, organ swelling, increased number of a certain 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 or mucus present. This symptom may occur during or after treatment and may indicate a serious intestinal inflammation.
• Severe liver problems or liver failure (rarely life-threatening): symptoms 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: symptoms may include increased need to urinate at night, tremors and muscle cramps, loss of appetite, nausea or vomiting, unpleasant taste in the mouth.
• Unusual tendency to bruise or bleed: these may be symptoms of a blood disorder characterized by reduced platelet count (thrombocytopenia).
• Rapid (ventricular tachycardia) or irregular heartbeat, or changes in heart rhythm on electrocardiogram (prolonged QT interval and torsade de pointes-type arrhythmias).

The following other adverse effects have been reported:
Very common (may occur in more than 1 in 10 patients):

• Diarrhoea.

Common (may occur in up to 1 in 10 patients):

• Headache, vomiting, abdominal pain,
• Nausea,
• Changes in white blood cell count and blood bicarbonate levels.

Uncommon (may occur in up to 1 in 100 patients):

• Fungal and (or) bacterial infections:
  • Oral thrush, fungal infection caused by Candida
  • Vaginal infection
  • Pneumonia
  • Sore throat
  • Gastritis
• Shortness of breath, chest pain, wheezing and cough (respiratory disorders),
• Runny/stuffy nose (rhinitis)
  • Decreased white blood cell count,
  • Hypersensitivity,
  • Loss of appetite (anorexia),
  • Nervousness, difficulty sleeping (insomnia),
  • Dizziness, drowsiness, taste disturbances, sensation of tingling and numbness in limbs (paresthesia),
  • Visual disturbances,
  • Ear disorders, sensation of spinning,
  • Palpitations, which may be fast or irregular,
  • Hot flushes,
  • Shortness of breath (dyspnea), nosebleeds,
  • Constipation, bloating with passing of gas, indigestion, inflammation of the stomach lining, swallowing difficulties (dysphagia), abdominal distension, dry mouth, belching with regurgitation of stomach contents or gas, mouth ulcers, excessive salivation,
  • Rash, itching, urticaria, skin inflammation, dry skin, excessive sweating,
  • Joint pain, swelling and reduced mobility (arthralgia, arthritis), muscle pain (myalgia), back pain, neck pain,
  • Pain or difficulty urinating (dysuria), pain in the upper back (kidney pain),
  • Spotting (uterine bleeding), testicular disorders, weakness (asthenia), malaise, fatigue, swelling of the face, arms and legs, chest pain, fever, pain,
  • Changes in liver enzyme levels and blood laboratory test results, increased blood urea levels,
  • Post-procedural complications.

Rare (may occur in up to 1 in 1000 patients):

• Restlessness;
• Liver function disorders, yellowing of the skin or whites of the eyes (jaundice),
• Photosensitivity.

Frequency not known (frequency cannot be estimated from available data):

• Reduced number of red blood cells (hemolytic anemia),
• Aggressive behavior, anxiety, delirium, hallucinations,
• Loss of consciousness (fainting), seizures, sensory disturbances (hypoesthesia), excessive psychomotor activity, change in sense of smell (loss of smell, olfactory disturbances), loss of taste, worsening or increased muscle fatigue (myasthenia),
• Hearing loss or tinnitus,
• Low blood pressure,
• Pancreatitis, tongue discoloration,
• Hepatitis,
• Joint pain.

The following adverse effects have been reported in connection with prevention and treatment of infections caused by mycobacteria
belonging to the Mycobacterium avium complex:
Very common (may occur in more than 1 in 10 patients):

• Diarrhoea, abdominal pain, nausea, bloating with passing of gas, loose stools.

Common (may occur in up to 1 in 10 patients):

• Loss of appetite (anorexia),
• Dizziness, headache, sensation of tingling and numbness in limbs (paresthesia), altered taste sensation,
• Visual disturbances,
• Deafness,
• Rash, itching,
• Joint pain,
• Fatigue.

Uncommon (may occur in up to 1 in 100 patients):

• Sensory disturbances (hypoesthesia),
• Hearing disorders or tinnitus,
• Palpitations, which may be fast or irregular,
• Hepatitis,
• Severe skin reaction (Stevens-Johnson syndrome), photosensitivity,
• Malaise, weakness (asthenia).

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps provide more information on the safety of this medicine.

5. How to store Azithromycin Teva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the outer carton and
blister after “EXP”. The expiry date refers to the last day of the stated month.
No special storage conditions are required.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. These measures will help
protect the environment.

6. Contents of the pack and other information

What Azithromycin Teva contains

• The active substance is azithromycin (as azithromycin dihydrate). Each 250 mg oral suspension tablet contains 250 mg of azithromycin (as azithromycin dihydrate). Each 500 mg oral suspension tablet contains 500 mg of azithromycin (as azithromycin dihydrate).
• Other ingredients are: sodium saccharin, microcrystalline cellulose PH101, microcrystalline cellulose PH102, crospovidone type A, povidone K30, sodium lauryl sulfate, colloidal anhydrous silica, magnesium stearate, aspartame (E951), orange flavour (containing flavouring components, corn maltodextrin (containing glucose), benzyl alcohol and α-tocopherol) (see also section 2. "Azithromycin Teva contains aspartame, benzyl alcohol, glucose and sodium").

What Azithromycin Teva looks like and contents of the pack

Azithromycin Teva 250 mg oral suspension tablets are white to almost white, round, flat tablets with bevelled edges, having a score line on one side and an embossed mark ‘TEVA 250’ on the other side. Each tablet has a diameter of approximately 12.5 mm.

Azithromycin Teva 500 mg oral suspension tablets are white to almost white, round, flat tablets with bevelled edges, having a score line on one side and an embossed mark ‘TEVA 500’ on the other side. Each tablet has a diameter of approximately 17 mm.

Azithromycin Teva 250 mg and 500 mg is available in PVC/PE/PVDC/PE/PVC/Aluminium foil blisters containing 1, 2, 3, 6, 12 or 24 oral suspension tablets.

Marketing Authorisation Holder

Teva Pharmaceuticals Polska Sp. z o.o.
ul. Emilii Plater 53, 00-113 Warszawa
tel.: (22) 345 93 00

Manufacturer

Teva Operations Poland Sp. z o.o.
ul. Mogilska 80, 31-546 Kraków

Pliva Hrvatska d.o.o. (Pliva Croatia Ltd.)
Prilaz Baruna Filipoviča 25, 10000 Zagreb, Croatia

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

Spain: Azitromicina Tevagen dispersable tablets
Poland: Azithromycin Teva