Azithromicin Aurovitas

Package Leaflet: Information for the User

Azithromycin Aurovitas, 250 mg, Film-Coated Tablets

Azithromycin Aurovitas, 500 mg, Film-Coated Tablets

Azithromycin

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, 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, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Package 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 pack 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 bacteria.

Azithromycin Aurovitas is used to treat certain bacterial infections, such as:

• chest infections, throat and nose infections (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 bacteria 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

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, swollen glands or an increased 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 problems, such as QT prolongation (visible on an electrocardiogram or ECG monitor);
• have low levels of potassium or magnesium in the blood;
• have symptoms of additional infection;
• 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 certain type of muscle weakness called myasthenia;
• have nerve problems (neurological problems) or mental problems (psychiatric problems);
• have vomiting and irritability in newborns during breastfeeding.

The patient should immediately inform their doctor if they experience any of the following symptoms while taking azithromycin: a faster or irregular heartbeat, or dizziness, fainting or muscle weakness.

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 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 or 2 hours after taking antacids;
• ergotamine - dihydroergotamine (used to treat migraines); it should not be taken at the same time, as severe 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 severe 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 anti-arrhythmic 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 levels 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 e.g. during surgery;
• theophylline - used to treat breathing disorders, such as asthma or chronic obstructive pulmonary disease;
• digoxin - used to treat heart problems;
• 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 data on the use of azithromycin during pregnancy. Therefore, azithromycin should not be used during pregnancy unless strictly necessary.

Azithromycin passes into breast milk. It is not known whether azithromycin may harm the breastfed child. Therefore, breastfeeding should be stopped during treatment with Azithromycin Aurovitas. It is recommended to stop breastfeeding during treatment and up to 2 days after the end of treatment. Then, breastfeeding can be resumed.

Driving and using machines

There is no data available 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 are feeling well.

Azithromycin Aurovitas contains lactose monohydrate

If the patient has been diagnosed with an intolerance to some sugars, they should contact their doctor before taking the medicine.

Sodium

Azithromycin 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. If the patient is unsure, they should ask their doctor or pharmacist.

Recommended dose

Adults and children with a body weight of 45 kg and above

Azithromycin Aurovitas is taken for 3 or 5 days:

• 3-day treatment: 500 mg (two 250 mg tablets or one 500 mg tablet) once daily
• 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 the treatment of chlamydial urethritis and cervicitis

A single dose of 1000 mg (four 250 mg tablets or two 500 mg tablets) taken once.

Children and adolescents with a body weight below 45 kg

Tablet administration is not recommended. In children with a body weight below 45 kg, another pharmaceutical form of this medicine should be used.

Patients with renal or hepatic impairment

If the patient has kidney or liver problems, they should inform their doctor, as a dose adjustment may be necessary.

Dosing in elderly patients

In elderly patients, the dosing is the same as for 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.

Overdose of Azithromycin Aurovitas

If the patient has taken more than the recommended dose of the medicine, 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.

Missed 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 a 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 on 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 the patient experiences any of the following symptoms of a severe allergic reaction, they should stop taking the medicine and immediately contact their doctor or the emergency department of the nearest hospital:

• sudden wheezing, difficulty breathing, speaking or swallowing
• swelling of the eyelids, lips, tongue, face and throat
• severe dizziness or collapse
• severe skin rash, including blistering, or peeling of the skin, possibly with mouth sores, and fever, and possibly with blood problems (e.g. a low white blood cell count) (Stevens-Johnson syndrome, toxic epidermal necrolysis)
• severe skin reactions:
• blistering of the skin, mouth, eyes and genitals (Stevens-Johnson syndrome)
• blistering of the skin (toxic epidermal necrolysis)
• skin rash with fever, possibly with swollen lymph nodes and increased levels of eosinophils (a type of white blood cell) (DRESS syndrome)

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 urine output 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 a severe bowel inflammation, which can occur 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 urine output or blood in the urine
• skin rash caused by an allergic reaction to sunlight
• unusual bruising or bleeding
• abnormal heart rhythm

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
• gas (flatulence)

Common (may affect up to 1 in 10 people)

• loss of appetite
• headache
• dizziness
• tingling, numbness or hypersensitivity (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
• breathlessness, chest pain, wheezing and coughing (respiratory disorders)
• nasal inflammation
• gastroenteritis (stomach and intestinal inflammation)
• vaginitis
• pneumonia
• decreased white blood cell count
• angioedema
• hypersensitivity
• nervousness
• abnormal sensations (hypoesthesia)
• drowsiness (somnolence)
• sleep disturbances (insomnia)
• ear disorders
• dizziness
• balance disorders (vertigo)
• 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 increased sensitivity to sunlight, red, peeling and swollen skin
• severe form of erythema multiforme
• itching
• dermatitis
• dry skin
• increased sweating
• joint pain, swelling and reduced mobility (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-procedural complications
• sensitivity to sunlight
• abnormal laboratory test results (e.g. blood or liver tests)

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

• agitation, feeling unreal and detached from themselves and their 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 destruction (hemolytic anemia); decreased platelet count (thrombocytopenia)
• anaphylactic reactions
• feeling angry, aggressive
• restlessness
• disorientation
• hallucinations
• fainting (syncope)
• seizures (epileptic fits)
• reduced sensation (hypoesthesia)
• hyperactivity
• disorders of smell (complete loss of smell, perception of strange smells)
• taste disorders (loss of taste)
• worsening or exacerbation of muscle weakness (myasthenia)
• visual disturbances
• hearing disorders, including hearing loss or tinnitus
• fast (ventricular tachycardia) or irregular heartbeat, sometimes life-threatening, changes in heart rhythm detected on an electrocardiogram (QT prolongation and torsades 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 prevention of Mycobacterium avium complex (MAC) infections.

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

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

Common (may affect up to 1 in 10 people)

• loss of appetite
• dizziness
• headache
• tingling, numbness or hypersensitivity (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 sensation (hypoesthesia)
• hearing loss or tinnitus
• palpitations
• liver problems, such as hepatitis
• severe form of erythema multiforme
• allergic skin reactions, such as increased sensitivity to sunlight, red, peeling 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, the patient can help provide more information on the safety of this medicine.

5. How to store Azithromycin Aurovitas

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

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.

There are no special storage requirements.

Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer need. This will help protect the environment.

6. Contents of the pack and other information

What Azithromycin Aurovitas contains

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

Other ingredients are:

Tablet core: calcium hydrogen phosphate, maize starch, croscarmellose sodium, sodium lauryl sulfate, magnesium stearate.

Tablet 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 are 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 package leaflet: 05/2023