Azithromycin aurovitas

Package leaflet: Information for the user

Azithromycin Aurovitas, 250 mg, film-coated tablets
Azithromycin Aurovitas, 500 mg, film-coated tablets
Azithromycinum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• 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 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 effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Azithromycin Aurovitas is and what it is used for
2. What you need to know 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 Azithromycin Aurovitas is and what it is 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 caused by organisms sensitive to azithromycin, such as:

• chest infections, throat and nasal infections [such as bronchitis, pneumonia, tonsillitis, sore throat (pharyngitis), and sinusitis]
• ear infections
• skin and soft tissue infections (such as abscess or boil), except infected burn wounds
• sexually transmitted diseases caused by microorganisms called Chlamydia trachomatis and Neisseria gonorrhoeae

2. Important information before using Azithromycin Aurovitas

When not to use Azithromycin Aurovitas

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

Warnings and precautions
Before taking Azithromycin Aurovitas, consult a doctor or pharmacist if the patient:

• has ever had a severe allergic reaction causing swelling of the face and throat, possibly with breathing difficulties, rash, fever, swollen glands, or increased number of eosinophils (a type of white blood cells)
• has severe and persistent diarrhoea during or after treatment
• has severe liver or kidney function disorders
• has severe heart function disorders or heart rhythm disorders, such as long QT syndrome (seen on electrocardiogram or ECG monitor)
• has low levels of potassium or magnesium in the blood
• shows symptoms indicating an additional infection
• is taking any ergot alkaloids, such as ergotamine (used to treat migraine), because these medicines should not be used together with azithromycin (see "Azithromycin Aurovitas and other medicines")
• has a specific type of muscle weakness called myasthenia gravis
• has nerve function disorders (neurological disorders) or mental disorders (psychiatric disorders)
• is a newborn and shows vomiting and irritability during breastfeeding.

Azithromycin Aurovitas and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take:

• 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 for migraine); should not be taken at the same time, as serious adverse effects may occur (ergotism – e.g. limb itching, muscle cramps, and gangrene of hands and feet due to poor blood circulation)
• Cholesterol-lowering medicines (statins)
• Warfarin or similar medicines – used to reduce blood clotting; concomitant use may increase the risk of bleeding
• Hydroxychloroquine (used to treat rheumatic diseases or malaria); heart problems may occur
• Cisapride (used for stomach disorders) or terfenadine (used for hay fever) – should not be used together, as this may cause serious heart problems (seen on electrocardiogram or ECG monitor)
• Zidovudine or nelfinavir – used to treat HIV infections; concomitant use of nelfinavir with Azithromycin Aurovitas may increase the frequency of adverse effects listed in this leaflet
• Rifabutin – used to treat tuberculosis
• Quinidine – used for heart rhythm disorders, known as antiarrhythmic medicine
• Cyclosporine – used to suppress the immune system to prevent and treat organ or bone marrow transplant rejection; the doctor will regularly monitor cyclosporine blood levels and may adjust the dose.

Inform the doctor or pharmacist if the patient is taking any of the following medicines. Concomitant use of Azithromycin Aurovitas may enhance their effects. The doctor may recommend a dose adjustment:

• Alfentanil – a painkiller used, for example, during surgery
• Theophylline – used for breathing disorders such as asthma or chronic obstructive pulmonary disease
• Digoxin – used for heart disorders
• Colchicine (used for gout and familial Mediterranean fever)
• Astemizole – used to treat hay fever
• Pimozide – used for psychiatric 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, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.
There are insufficient data available on the use of azithromycin during pregnancy. Therefore, azithromycin should not be used during pregnancy unless clearly prescribed by the attending physician.
Azithromycin passes partially into human milk.
It is not known whether azithromycin may have an adverse effect on the breastfed infant.
Therefore, breastfeeding should be discontinued during treatment with Azithromycin Aurovitas. Discontinuation of breastfeeding is recommended during treatment and for 2 days after stopping treatment. Breastfeeding may then be resumed.
Driving and operating machinery
There are no available data on the effect of azithromycin on the ability to drive or operate machinery. However, azithromycin may cause dizziness and convulsions; therefore, patients should ensure they feel well before driving or operating machinery.
Azithromycin Aurovitas contains monohydrate lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
Sodium
Azithromycin Aurovitas contains less than 1 mmol (23 mg) of sodium per tablet; this medicine is therefore considered "sodium-free".

3. How to use Azithromycin Aurovitas

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

Recommended dose

Adults and children weighing 45 kg or more

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 day 1 (two 250 mg tablets)
  • 250 mg (one 250 mg tablet) on days 2, 3, 4, and 5.

In urinary tract and cervical infections caused by Chlamydia trachomatis

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

Children and adolescents weighing less than 45 kg

Tablet use is not recommended. In children weighing less than 45 kg, another pharmaceutical form of this medicine should be used.

Patients with renal or hepatic impairment

If a patient has impaired kidney or liver function, inform the doctor, as the dose may need to be adjusted.

Dosing in elderly patients

Dosing in elderly patients is the same as in other adult patients. The tablet may be divided into equal doses.

Method of administration

Take the tablets with half a glass of water.

The tablets may be taken with or without food.

Taking more than the recommended dose of Azithromycin Aurovitas

If a patient takes more than the recommended dose, they should contact a doctor or pharmacist immediately or go directly to hospital.

Symptoms of overdose include transient hearing loss, nausea, vomiting, and diarrhoea. Hospitalization may be necessary in case of overdose.

Missing a dose of Azithromycin Aurovitas

If a patient forgets to take a dose of Azithromycin Aurovitas, they should take it as soon as they remember. However, if it is almost time for the next dose, the missed dose should be skipped and the next dose taken at the usual time. In case of doubt, consult a doctor or pharmacist. If a dose is missed, the patient should continue taking all prescribed tablets. This means the treatment will end one day later.

Do not take a double dose to make up for a missed dose.

Stopping treatment with Azithromycin Aurovitas

Never stop taking Azithromycin Aurovitas on your own—first discuss it with your doctor. If the prescribed treatment is not completed fully, the infection may return.

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

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the following symptoms of a severe allergic reaction occur, the medicine must be discontinued and medical advice must be sought immediately from a doctor or the nearest hospital emergency department.
The frequency of these reactions is unknown (frequency cannot be estimated from the available data):

• Sudden wheezing, difficulty breathing, speaking or swallowing
• Swelling of the eyelids, lips, tongue, face and neck
• Severe dizziness or collapse
• Severe or itchy skin rash, especially if accompanied by blisters and eye, mouth or genital pain
• Severe skin reactions:
  • Development of blisters on the skin, in the mouth, eyes and genital organs (Stevens-Johnson syndrome)
  • Development of blisters on the skin, severe skin reaction (toxic epidermal necrolysis)
  • Skin rash accompanied by other symptoms such as fever, swollen lymph nodes and increased eosinophil count (a type of white blood cell). The rash appears as small, itchy red lumps (drug reaction with eosinophilia and systemic symptoms (DRESS)).

If any of the following adverse symptoms occur, contact a doctor immediately:
Rare (may affect fewer than 1 in 1,000 people)

• Increased or decreased urine output or blood in the urine
• Skin eruption characterised by rapid appearance of red skin areas covered with small pustules (vesicles filled with white or yellow fluid) (acute generalised exanthematous pustulosis (AGEP)).

Frequency unknown (cannot be estimated from the available data)

• Severe diarrhoea, lasting a long time, or diarrhoea with blood, abdominal pain and fever; these may be symptoms of severe intestinal inflammation, which sometimes occurs after antibiotic use
• Yellowing of the skin or whites of the eyes (jaundice), caused by liver function disorders
• Pancreatitis, causing severe abdominal and back pain
• Increased or decreased urine output or blood in the urine
• Skin rash caused by photosensitivity
• Unusual bruising or bleeding
• Irregular heartbeat.

All of these adverse reactions are serious. The patient may require urgent medical attention.
Other adverse reactions:
Very common (may affect more than 1 in 10 people)

• Diarrhoea
• Abdominal pain
• Nausea
• Passing gas (bloating).

Common (may affect up to 1 in 10 people)

• Loss of appetite (anorexia)
• Headache
• Dizziness
• Pricking, tingling or numbness sensation (paraesthesia)
• Changes in taste perception
• Blurred vision
• 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 blood bicarbonate levels.

Uncommon (may affect up to 1 in 100 people)

• Fungal infections (candidiasis)
• Bacterial infections
• Sore throat
• Shortness of breath, chest pain, wheezing and cough (respiratory disorders)
• Nasal mucosal inflammation
• Stomach flu (gastroenteritis)
• Vaginal inflammation
• Pneumonia
• Decreased white blood cell count
• Angioedema
• Hypersensitivity
• Nervousness
• Sensory disturbances (hypoesthesia)
• Drowsiness (somnolence)
• Difficulty sleeping (insomnia)
• Ear disorders
• Dizziness
• Sensation of spinning (vertigo)
• Palpitations
• Hot flushes
• Shortness of breath
• Nosebleeds
• Inflammation of the stomach lining (gastritis)
• Constipation, abdominal pain with diarrhoea and fever
• Difficulty swallowing
• Abdominal swelling
• Dry mouth
• Belching
• Mouth ulcers
• Increased salivation
• Liver function disorders, such as hepatitis
• Allergic skin reactions, such as photosensitivity, red, peeling and swollen skin
• Severe form of erythema multiforme
• Itching
• Dermatitis
• Dry skin
• Excessive sweating
• Pain, swelling and reduced mobility in joints (arthropathy)
• Muscle pain
• Back pain
• Neck pain
• Increased blood urea levels
• Painful or difficult urination
• Lower back pain (kidney pain)
• Spotting
• Testicular pain
• Urticaria
• Chest pain
• Facial swelling
• Fever
• Pain
• Swelling of limbs (peripheral oedema)
• Oedema
• General feeling of malaise
• Weakness (asthenia)
• Changes in liver enzyme activity and other blood test parameters
• Post-procedural complications
• Photosensitivity
• Abnormal laboratory test results (e.g. blood or liver tests).

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

• Restlessness, feeling of unreality regarding oneself and one's emotions
• Dizziness
• Abnormal liver function
• Allergic skin reactions
• Swelling of hands, feet, lips, genital organs or throat (angioedema)
• Kidney problems.

Frequency unknown (cannot be estimated from the available data)

• Intestinal infection (pseudomembranous colitis)
• Decreased number of red blood cells due to haemolysis (haemolytic anaemia); decreased platelet count (thrombocytopenia)
• Anaphylactic reactions
• Irritability, aggression
• Anxiety
• Disorientation
• Hallucinations
• Weakness (fainting)
• Seizures (epileptic fits)
• Reduced sense of touch (hypoesthesia)
• Hyperexcitability
• Smell disturbances (complete loss of smell, perception of strange odours)
• Taste disturbances (loss of taste)
• Worsening or increased muscle weakness (myasthenia)
• Vision disorders
• Hearing disorders, including hearing loss or tinnitus
• Rapid (ventricular tachycardia) or irregular heartbeat, sometimes life-threatening, changes in heart rhythm detected on electrocardiogram (QT interval prolongation and torsade de pointes)
• Low blood pressure
• Pancreatitis
• Tongue discolouration
• Liver failure
• Allergic skin reactions
• Kidney inflammation.

The following adverse reactions have been observed during prophylactic use against Mycobacterium avium complex (MAC) infection.
Very common (may affect more than 1 in 10 people)

• Diarrhoea
• Abdominal pain
• Nausea
• Passing gas (bloating)
• Abdominal discomfort
• Loose stools.

Common (may affect up to 1 in 10 people)

• Loss of appetite (anorexia)
• Dizziness
• Headache
• Pricking, tingling or numbness sensation (paraesthesia)
• Taste disturbances
• Vision disorders
• Deafness
• Vomiting, stomach pain or cramps, loss of appetite, digestive problems
• Skin rash and itching
• Joint pain (arthralgia)
• Fatigue.

Uncommon (may affect up to 1 in 100 people)

• Reduced sense of touch (hypoesthesia)
• Hearing loss or tinnitus
• Palpitations
• Liver function disorders, such as hepatitis
• Severe form of erythema multiforme
• Allergic skin reactions, such as photosensitivity, red, peeling and swollen skin
• General malaise
• Weakness (asthenia).

**Reporting of adverse reactions
**If any adverse reactions occur, including any not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions 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 reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps to provide more information on the safety of the 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 stated on the carton 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. Such measures help protect the environment.

6. Package contents and other information

What Azithromycin Aurovitas contains

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

The other ingredients are:
Tablet core: calcium hydrogen phosphate, pregelatinized maize starch, sodium croscarmellose, 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, elongated, biconvex film-coated tablets, embossed with "66" on one side 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, embossed with "6" and "7" on either side of the break line on one side 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/Aluminium blisters.
Pack sizes: 2, 3, 4, 6, 12 and 24 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Aurovitas Pharma Polska Sp. z o.o.
Sokratesa 13D, lokal 27
01-909 Warszawa
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 authorised in the European Economic Area countries 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