Azithromicin Aurovitas

Leaflet accompanying the packaging: information for the user

Azithromycin Aurovitas, 250 mg, film-coated tablets

Azithromycin Aurovitas, 500 mg, film-coated tablets

Azithromycin

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any further questions, you should ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Azithromycin Aurovitas and what is it used for
• 2. Important information before taking Azithromycin Aurovitas
• 3. How to take Azithromycin Aurovitas
• 4. Possible side effects
• 5. How to store Azithromycin Aurovitas
• 6. Contents of the packaging and other information

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

Azithromycin Aurovitas belongs to a group of antibiotics called macrolides. Antibiotics are used to treat infections caused by microorganisms, such as bacteria. Azithromycin Aurovitas is used to treat certain bacterial infections, such as:

• infections of the chest, throat and nose (such as bronchitis, pneumonia, tonsillitis, sore throat and sinusitis);
• ear infections;
• skin and soft tissue infections (such as abscesses or furuncles), except for infected burn wounds;
• sexually transmitted diseases caused by microorganisms called Chlamydia trachomatis and Neisseria gonorrhoeae. If there is no improvement or the patient feels worse, they should consult a doctor.

2. Important information before taking Azithromycin Aurovitas

When not to take Azithromycin Aurovitas

• if the patient is allergic to azithromycin or any other macrolide antibiotic, such as erythromycin or clarithromycin, or any of the other ingredients of this medicine (listed in section 6). An allergic reaction may cause a rash or wheezing.

Warnings and precautions

Before taking Azithromycin Aurovitas, the patient should tell their doctor or pharmacist if they:

• have ever had a severe allergic reaction that caused swelling of the face and throat, possibly with difficulty breathing, rash, fever, swelling of the lymph nodes or an increase in the number of eosinophils (a type of white blood cell);
• have severe and persistent diarrhea during or after treatment;
• have severe liver or kidney problems;
• have severe heart problems or heart rhythm disorders, such as a prolonged QT interval (visible on an electrocardiogram or ECG monitor);
• have low levels of potassium or magnesium in the blood;
• have symptoms of additional infections;
• are taking any ergot alkaloids, such as ergotamine (used to treat migraines), as these medicines should not be taken at the same time as azithromycin (see "Azithromycin Aurovitas and other medicines");
• have a particular type of muscle weakness called myasthenia;
• have nerve problems (neurological disorders) or mental problems (psychiatric disorders);
• have vomiting and irritability in newborns during breastfeeding.

The patient should immediately inform their doctor if they experience a faster than normal heartbeat (palpitations), or an irregular heartbeat, or dizziness, fainting or muscle weakness while taking azithromycin. If the patient experiences diarrhea or loose stools during or after treatment, they should immediately contact their doctor. The patient should not take any anti-diarrheal medicines without first consulting their doctor. If the diarrhea does not improve, the patient should inform their doctor.

Azithromycin Aurovitas and other medicines

The patient should tell their doctor or pharmacist about all the medicines they are currently taking or have recently taken, as well as any medicines they plan to take. The patient should inform their doctor or pharmacist if they are taking any of the following medicines:

• antacids - used to treat heartburn or indigestion; Azithromycin Aurovitas should be taken at least 1 hour before taking antacids or 2 hours after taking them;
• ergotamine - dihydroergotamine (used to treat migraines); it should not be taken at the same time, as serious side effects (ergotism - i.e., itching of the limbs, muscle cramps and gangrene of the hands and feet due to poor blood circulation) may develop;
• cholesterol-lowering medicines (statins);
• warfarin or similar medicines - used to reduce blood clotting; concurrent use may increase the risk of bleeding;
• hydroxychloroquine (used to treat rheumatic diseases or malaria): heart problems may occur;
• cisapride (used to treat stomach disorders) or terfenadine(used to treat hay fever)
• should not be taken at the same time, as they may cause serious heart problems (visible on an electrocardiogram or ECG monitor);
• zidovudine or nelfinavir - used to treat HIV infections; concurrent use of nelfinavir with Azithromycin Aurovitas may increase the severity of side effects listed in this leaflet;
• rifabutin - used to treat tuberculosis;
• quinidine - used to treat heart rhythm disorders, known as an antiarrhythmic medicine;
• cyclosporin - used to suppress the immune system to prevent and treat organ or bone marrow transplant rejection; the doctor will regularly monitor the cyclosporin level in the blood and may change the dose.

The patient should inform their doctor or pharmacist if they are taking any of the following medicines. Concurrent use of Azithromycin Aurovitas may increase their effect. The doctor may recommend a dose change:

• alfentanil - a pain reliever used, for example, during surgery;
• theophylline - used to treat breathing disorders, such as asthma or chronic obstructive pulmonary disease;
• digoxin - used to treat heart disorders;
• colchicine (used to treat gout and familial Mediterranean fever);
• astemizole - used to treat hay fever;
• pimozide - used to treat mental disorders.

Azithromycin Aurovitas with food and drink

This medicine can be taken with or without food.

Pregnancy, breastfeeding and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant or are planning to have a baby, they should consult their doctor or pharmacist before taking this medicine. There is limited experience with the use of azithromycin during pregnancy. Therefore, azithromycin should not be used during pregnancy unless strictly necessary. Azithromycin partially passes into breast milk. It is not known whether azithromycin may have a harmful effect on the breastfed child. Therefore, breastfeeding should be discontinued during treatment with Azithromycin Aurovitas. It is recommended to stop breastfeeding during treatment and for 2 days after the end of treatment. Then, breastfeeding can be resumed.

Driving and using machines

There is no available data on the effect of azithromycin on the ability to drive and use machines. However, azithromycin may cause dizziness and seizures, so before driving or using machines, the patient should make sure they feel well.

Azithromycin Aurovitas contains lactose monohydrate

If the patient has been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine. SodiumAzithromycin Aurovitas contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially sodium-free.

3. How to take Azithromycin Aurovitas

This medicine should always be taken exactly as prescribed by the doctor. In case of doubt, the patient should consult their doctor or pharmacist. Recommended dose Adults and children with a body weight of 45 kg and moreAzithromycin Aurovitas is taken for 3 or 5 days:

• 3-day treatment: 500 mg (two 250 mg tablets or one 500 mg tablet) once a day
• 5-day treatment:
• 500 mg on the first day (two 250 mg tablets)
• 250 mg (one 250 mg tablet) on the second, third, fourth and fifth day.

In infections of the urethra and cervix caused by Chlamydia trachomatisOne dose of 1000 mg (four 250 mg tablets or two 500 mg tablets) taken once. Children and adolescents with a body weight of less than 45 kgThe use of tablets is not recommended. In children with a body weight of less than 45 kg, another pharmaceutical form of this medicine should be used. Patients with kidney or liver problemsIf the patient has kidney or liver problems, they should inform their doctor, as a dose adjustment may be necessary. Dosing in elderly patientsIn elderly patients, the dosing is the same as in other adult patients. The tablet can be divided into equal doses.

Method of administration

The tablets should be taken with a half glass of water. The tablets can be taken with or without food.

Taking a higher dose of Azithromycin Aurovitas than recommended

If the patient has taken a higher dose of the medicine than recommended, they should immediately contact their doctor or pharmacist or go to the hospital. Symptoms of overdose are temporary hearing loss, nausea or vomiting and diarrhea. In case of overdose, hospitalization may be necessary.

Missing a dose of Azithromycin Aurovitas

If the patient forgets to take a dose of Azithromycin Aurovitas, they should take it as soon as they remember. However, if it is soon time to take the next dose, they should skip the missed dose and take the next dose at the usual time. In case of doubt, the patient should consult their doctor or pharmacist. If the patient misses a dose, they should still take all the prescribed tablets. This means that the patient will finish the treatment one day later. The patient should not take a double dose to make up for the missed dose.

Stopping treatment with Azithromycin Aurovitas

The patient should never stop taking Azithromycin Aurovitas without first talking to their doctor. If the prescribed treatment is not completed, the infection may return. If the patient has any further questions about the use of this medicine, they should ask their doctor or pharmacist.

4. Possible side effects

Like all medicines, Azithromycin Aurovitas can cause side effects, although not everybody gets them. If any of the following serious allergic reactions occur, the patient should stop taking the medicine and immediately contact their doctor or the emergency department of the nearest hospital: Frequency not known (cannot be estimated from the available data)

• sudden wheezing, difficulty breathing, speaking or swallowing
• swelling of the eyelids, lips, tongue, face and throat
• severe dizziness or fainting
• severe or itchy skin rash, especially with blisters and if there is sensitivity to light, mouth, genital and eye problems
• severe skin reactions:
• blistering of the skin, mouth, eyes and genitals (Stevens-Johnson syndrome)
• blistering of the skin, severe skin reaction (toxic epidermal necrolysis)
• skin rash with other symptoms such as fever, swollen lymph nodes and increased eosinophils (a type of white blood cell). The rash appears as small, itchy red bumps (drug reaction with eosinophilia and systemic symptoms (DRESS)).

If the patient experiences any of the following side effects, they should immediately contact their doctor:

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

• increased or decreased urination or blood in the urine
• skin rash characterized by rapid onset of areas of redness on the skin, covered with small blisters (acute generalized exanthematous pustulosis (AGEP)).

Frequency not known (cannot be estimated from the available data)

• severe and persistent diarrhea, which may be bloody, with abdominal pain and fever; these may be symptoms of severe colitis, which sometimes occurs after taking antibiotics
• yellowing of the skin or whites of the eyes (jaundice), caused by liver problems
• pancreatitis, causing severe abdominal and back pain
• increased or decreased urination or blood in the urine
• skin rash caused by hypersensitivity to sunlight
• unusual bruising or bleeding
• abnormal heart rhythm.

All these side effects are serious. The patient may need urgent medical attention. Other side effects: Very common(may affect more than 1 in 10 people)

• diarrhea
• abdominal pain
• nausea
• passing gas (flatulence)

Common(may affect up to 1 in 10 people)

• loss of appetite
• headache
• dizziness
• tingling, numbness or prickling sensation (paresthesia)
• taste disturbances
• visual disturbances
• hearing loss
• vomiting, stomach pain or cramps, loss of appetite, digestive problems
• skin rash and itching
• joint pain (arthralgia)
• fatigue
• changes in white blood cell count and bicarbonate levels in the blood.

Uncommon(may affect up to 1 in 100 people)

• thrush (candidiasis) - fungal infections
• bacterial infections
• pharyngitis
• shortness of breath, chest pain, wheezing and cough (respiratory disorders)
• nasal inflammation
• gastroenteritis (stomach and intestinal inflammation)
• vaginitis
• pneumonia
• decreased white blood cell count
• angioedema
• hypersensitivity
• nervousness
• sensory disturbances (hypoesthesia)
• feeling of tiredness (somnolence)
• difficulty sleeping (insomnia)
• ear disorders
• dizziness
• feeling of spinning (balance disorders)
• palpitations
• hot flushes
• shortness of breath
• nosebleeds
• gastritis (stomach inflammation)
• constipation, abdominal pain with diarrhea and fever
• difficulty swallowing
• abdominal distension
• dry mouth
• belching
• mouth ulcers
• increased salivation
• liver problems, such as hepatitis
• allergic skin reactions, such as hypersensitivity to sunlight, red, flaky and swollen skin
• severe form of erythema multiforme
• itching
• dermatitis
• dry skin
• increased sweating
• pain, swelling and reduced mobility of the joints (arthritis)
• muscle pain
• back pain
• neck pain
• increased urea levels in the blood
• painful or difficult urination
• back pain (kidney pain)
• spotting
• testicular pain
• hives
• chest pain
• facial swelling
• fever
• pain
• peripheral edema (peripheral edema)
• edema
• general feeling of illness
• weakness (asthenia)
• changes in liver enzyme activity and other blood test parameters
• post-procedure complications
• hypersensitivity to sunlight
• abnormal laboratory test results (e.g., blood or liver tests).

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

• agitation, feeling of unreality towards oneself and one's feelings
• dizziness
• abnormal liver function
• allergic skin reactions
• swelling of the hands, feet, lips, genitals or throat (angioedema)
• kidney problems.

Frequency not known(cannot be estimated from the available data)

• intestinal infection (pseudomembranous colitis)
• decreased red blood cell count due to breakdown (hemolytic anemia); decreased platelet count (thrombocytopenia)
• anaphylactic reactions
• feeling of anger, aggression
• restlessness
• disorientation
• hallucinations
• weakness (syncope)
• seizures (epileptic fits)
• reduced sense of touch (hypoesthesia)
• hyperactivity
• disturbances of smell (complete loss of smell, perception of strange smells)
• disturbances of taste (loss of taste)
• worsening or exacerbation of muscle weakness (myasthenia)
• visual disturbances
• hearing disturbances, including hearing loss or tinnitus
• rapid (ventricular tachycardia) or irregular heartbeat, sometimes life-threatening, changes in heart rhythm detected on an electrocardiogram (prolonged QT interval and torsade de pointes)
• low blood pressure
• pancreatitis
• discoloration of the tongue
• liver failure
• allergic skin reactions
• kidney inflammation.

The following side effects have been observed during the use of Azithromycin Aurovitas to prevent Mycobacterium aviumcomplex (MAC) infections. Very common(may affect more than 1 in 10 people)

• diarrhea
• abdominal pain
• nausea
• passing gas (flatulence)
• abdominal discomfort
• loose stools.

Common(may affect up to 1 in 10 people)

• loss of appetite (anorexia)
• feeling of dizziness
• headache
• tingling, numbness or prickling sensation (paresthesia)
• taste disturbances
• visual disturbances
• hearing loss
• vomiting, stomach pain or cramps, loss of appetite, digestive problems
• skin rash and itching
• joint pain (arthritis)
• fatigue.

Uncommon(may affect up to 1 in 100 people)

• reduced sense of touch (hypoesthesia)
• hearing loss or tinnitus
• palpitations
• liver problems, such as hepatitis
• severe form of erythema multiforme
• allergic skin reactions, such as hypersensitivity to sunlight, red, flaky and swollen skin
• general feeling of illness
• weakness (asthenia).

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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 Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Azithromycin Aurovitas

The medicine should be stored out of sight and reach of children. Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date refers to the last day of the month stated. There are no special precautions for storage. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Azithromycin Aurovitas contains

• The active substance of the medicine is azithromycin dihydrate. Each film-coated tablet contains 250 mg of azithromycin (in the form of azithromycin dihydrate). Each film-coated tablet contains 500 mg of azithromycin (in the form of azithromycin dihydrate).

Other ingredients are: Core: calcium hydrogen phosphate, maize starch, croscarmellose sodium, sodium lauryl sulfate, magnesium stearate. Coating: lactose monohydrate, hypromellose, titanium dioxide (E 171), triacetin.

What Azithromycin Aurovitas looks like and contents of the pack

Film-coated tablets. Azithromycin Aurovitas, 250 mg, film-coated tablets:White or almost white, oblong, biconvex film-coated tablets, with "66" embossed on one side of the tablet and "D" on the other side. Tablet dimensions: 13.5 mm x 6.6 mm. Azithromycin Aurovitas, 500 mg, film-coated tablets:White or almost white, oval, biconvex film-coated tablets, with "6" and "7" embossed on either side of the break line on one side of the tablet and "D" on the other side. Tablet dimensions: 17.1 mm x 8.5 mm. Azithromycin Aurovitas, film-coated tablets, is available in transparent PVC/Aluminum blisters. Pack sizes: 2, 3, 4, 6 or 12 film-coated tablets. Not all pack sizes may be marketed.

Marketing authorization holder:

Aurovitas Pharma Polska Sp. z o.o. ul. Sokratesa 13D lokal 27 01-909 Warsaw e-mail: [email protected]

Manufacturer/Importer:

APL Swift Services (Malta) Limited HF26, Hal Far Industrial Estate, Hal Far Birzebbugia, BBG 3000 Malta

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Belgium: Azithromycin AB 250 mg/ 500 mg filmomhulde tabletten Czech Republic: Azithromycin Aurovitas Netherlands: Azitromycine Aurobindo 250 mg/ 500 mg, filmomhulde tabletten Portugal: Azitromicina Ritisca Poland: Azithromycin Aurovitas Spain: AZITROMICINA AUROVITAS 500 mg comprimidos recubiertos con película EFG

Date of last revision of the leaflet: 05/2023