Azycyna

Package leaflet: Information for the patient

Azycyna, 500 mg, film-coated tablets
Azithromycinum
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Azycyna and what is it used for

Azycyna contains azithromycin as the active substance, which is an azalide antibiotic from the macrolide group with a broad spectrum of activity. It acts bactericidally against susceptible microorganisms.
Azycyna 500 mg film-coated tablets are indicated for the treatment of the following infections caused by microorganisms sensitive to azithromycin.

• Upper respiratory tract infections: bacterial pharyngitis, tonsillitis, sinusitis (see also section 2).
• Acute otitis media.
• Lower respiratory tract infections: acute bronchitis, exacerbation of chronic bronchitis, mild to moderate pneumonia, including interstitial pneumonia.
• Skin and soft tissue infections: erysipelas, impetigo, and secondary skin infections; erythema migrans (Erythema migrans) – the first sign of Lyme disease; moderate acne vulgaris, in adults only.
• Sexually transmitted diseases: uncomplicated infections caused by Chlamydia trachomatis.

2. Important information before using Azycyna

When not to use Azycyna

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

Warnings and precautions
Before starting treatment with Azycyna, discuss with your doctor or pharmacist if:

• the patient has conditions predisposing to development of cardiac arrhythmias (particularly relevant in women and elderly patients):
• congenital or previous history of cardiac arrhythmias (visible on ECG – test measuring electrical activity of the heart),
• severe heart failure,
• very slow heart rate (called bradycardia),
• electrolyte imbalances in blood, especially low levels of potassium and magnesium,
• taking other medicines that may cause QT interval prolongation on ECG (see section "Azycyna with other medicines");
  • the patient has severe kidney function impairment;
  • the patient has severe liver function impairment: the doctor may monitor liver function or discontinue treatment;
  • the patient has a new infection (this may indicate overgrowth of resistant microorganisms or fungal infection);
  • the patient has neurological or psychiatric disorders;
  • the patient has a sexually transmitted infection: the doctor should ensure that the patient does not have coexisting syphilis;
  • the patient has signs of superinfection (e.g. fungal infections);
  • the patient is taking ergot derivatives (ergot preparations);
  • the patient has infected burn wounds.

Streptococcal infections
For treatment of streptococcal pharyngitis and tonsillitis, penicillin is usually the drug of choice.
Pseudomembranous colitis
If diarrhea occurs, it should be reported immediately to the doctor, as it may be a symptom of pseudomembranous colitis—a complication that may sometimes occur during treatment with macrolide antibiotics. Physicians should consider this diagnosis in patients who develop diarrhea after starting azithromycin therapy. In case of pseudomembranous colitis due to azithromycin use, discontinuation of Azycyna and initiation of appropriate treatment may be necessary. Antiperistaltic agents are contraindicated.
Long-term use
There is lack of data on the safety and efficacy of long-term use of azithromycin for the indications listed above. In cases of rapidly recurring infections, the physician may consider treatment with another antibacterial agent.
Myasthenia
Worsening of myasthenia symptoms or development of a myasthenic syndrome has been observed during azithromycin treatment (see section "Possible side effects").
Treatment of Mycobacterium avium complex infections in children
The safety and efficacy of azithromycin for treatment or prevention of Mycobacterium avium complex infections in children have not been established.
Children and adolescents
Azycyna 500 mg film-coated tablets are recommended for use in children only if body weight is at least 45 kg. For other pediatric groups, use of Azycyna oral suspension or 125 mg film-coated tablets is recommended.
Azycyna with other medicines
Inform your doctor or pharmacist about all medicines currently used, recently taken, or planned for use.
If the patient is taking any of the following medicines, it is especially important to inform the doctor or pharmacist:

• medicines affecting the QT interval, such as
  • quinidine, procainamide, dofetilide, amiodarone, sotalol (used to treat cardiac arrhythmias),
  • cisapride (used for gastrointestinal disorders),
  • terfenadine (used to treat allergies),
  • antipsychotics, e.g. pimozide,
  • antidepressants, e.g. citalopram,
  • fluoroquinolones (used for infections), e.g. moxifloxacin, levofloxacin;
• antacids (Azycyna should therefore be taken at least 1 hour before or 2 hours after antacids);
• oral anticoagulants, e.g. warfarin;
• ergot alkaloids (used for migraine or vasoconstriction), e.g. ergotamine—concomitant use with azithromycin may lead to ergotism (symptoms: peripheral vasoconstriction and ischemia);
• digoxin (used for cardiac disorders);
• colchicine (used for gout and familial Mediterranean fever);
• cyclosporine (used for skin diseases, rheumatoid arthritis, or after organ transplantation);
• atorvastatin (used to lower cholesterol levels); rifabutin (used in treatment of HIV or tuberculosis).

Azycyna with food and drink
See section 3.
Pregnancy, breastfeeding, and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Pregnancy
This medicine may be used during pregnancy only if, in the opinion of the doctor, the benefit to the mother outweighs the risk to the fetus.
Breastfeeding
Azithromycin passes into human breast milk. Breastfeeding is not recommended during treatment with azithromycin unless otherwise advised by the doctor.
Fertility
In fertility studies conducted in rodents, a decreased pregnancy rate was observed after administration of azithromycin. The relevance of these findings to humans is unknown.
Driving and operating machinery
There are no data on the effect of Azycyna on the ability to drive or operate machinery. However, when performing such activities, consider the possibility of adverse effects such as dizziness and seizures.
Azycyna contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, i.e. the medicine is considered "sodium-free".

3. How to use Azycyna

This medicine should always be used as directed by the physician. In case of doubt, consult a doctor or pharmacist.

Dosage in adults and in children and adolescents with body weight above 45 kg
Upper and lower respiratory tract infections, otitis media, skin and soft tissue infections (except erythema migrans and acne vulgaris)
The total dose of azithromycin is 1.5 g over 3 days (500 mg as a single daily dose).
Alternatively, the same total dose (1500 mg) may also be administered over 5 days: 500 mg on the first day of treatment and 250 mg from the second to the fifth day of treatment.

Erythema migrans
The total dose is 3 g and should be taken according to the following regimen: 1 g on the first day (2 coated tablets of 500 mg each), followed by 500 mg (1 coated tablet) daily from the second to the fifth day.

Moderate acne vulgaris – in adults only
The total dose is 6 g and is recommended to be administered according to the following regimen: one 500 mg coated tablet once daily for 3 days, followed by one 500 mg coated tablet once weekly for the next 9 weeks. During the second week of treatment, the medicine should be taken 7 days after the first dose, and the subsequent eight doses should be taken at 7-day intervals.
Due to the administration of a high dose of azithromycin in the above regimen for patients with moderate acne vulgaris, monitoring of liver enzyme activity is necessary before starting and during the course of treatment with azithromycin.

The above cyclic regimen for the treatment of moderate acne vulgaris (3 days + 9 weeks) may be applied only once in a given patient, as there are no controlled clinical trials demonstrating the safety and efficacy of repeating this treatment regimen for acne vulgaris.

Uncomplicated infections caused by Chlamydia trachomatis
1 g (4 coated tablets of 250 mg each) as a single dose.

Elderly patients
The same dose as in other adult patients should be used in elderly patients. Caution is recommended in these patients due to the risk of cardiac diseases.

Patients with renal or hepatic impairment
If a patient has impaired renal or hepatic function, this should be reported to the physician, as dose reduction may be necessary. The medicine should not be used in patients with severe hepatic insufficiency.

Method of administration
Azycyna 500 mg coated tablets should be administered orally once daily, at least one hour before or two hours after a meal. Tablets should be swallowed whole.

Overdose of Azycyna
Adverse effects observed after administration of doses higher than recommended were similar to those reported after proper doses. Characteristic symptoms following overdose of macrolide antibiotics include transient hearing loss, severe nausea, vomiting, and diarrhea.
In case of ingestion of a dose higher than recommended, seek immediate medical advice from a doctor or pharmacist. In the event of overdose, activated charcoal is recommended, along with symptomatic treatment and, if necessary, supportive measures to maintain vital functions.

Missed dose of Azycyna
If a dose is missed, it should be taken as soon as possible, and subsequent doses should be taken according to the prescribed dosing schedule. Do not take a double dose to make up for a missed dose.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the following adverse reactions occur, discontinue the medicine immediately and
contact your doctor or the emergency department of the nearest hospital:

• allergic reactions: rash, urticaria, swelling of the hands, feet, ankles, face, lips, mouth or throat, difficulty breathing or swallowing;
• severe skin reactions, including erythema multiforme (circular red and swollen skin lesions), Stevens-Johnson syndrome (blisters and erosions on the skin, inside the mouth, eyes and genital organs, fever and joint pain), toxic epidermal necrolysis (Lyell's syndrome) (large subepidermal blisters, extensive skin erosions, shedding of large sheets of skin, and fever), acute generalized exanthematous pustulosis (skin eruption characterized by rapid appearance of red skin areas covered with small pustules [blisters filled with white or yellow fluid]);
• severe, persistent diarrhoea, especially if blood or mucus is present in the stool. (this may be a sign of an inflammatory bowel disease called pseudomembranous colitis)
• uterine bleeding. Frequencies of the above adverse reactions are given below.

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

• diarrhoea

Common (may occur in not more than 1 in 10 to 100 patients):

• headache;
• vomiting, abdominal pain, nausea;
• change in white blood cell count;
• decreased concentration of bicarbonate in blood.

Uncommon (may occur in not more than 1 in 10 to 1,000 patients):

• fungal infections (candidiasis), vaginal infection, pneumonia, fungal infection, bacterial infection, pharyngitis, gastritis and enteritis, respiratory disorders, rhinitis, oral candidiasis;
• change in white blood cell count (leukopenia, neutropenia, eosinophilia);
• angioedema (swelling of the face and throat, possibly causing breathing difficulties), hypersensitivity;
• loss of appetite (anorexia);
• nervousness, insomnia; dizziness, drowsiness, taste disturbances, unusual skin sensations such as tingling and numbness of limbs (paresthesia);
• visual disturbances;
• ear disorders, balance disorders;
• palpitations;
• hot flushes;
• dyspnoea, epistaxis;
• constipation, bloating with flatulence, indigestion, gastritis, swallowing difficulties (dysphagia), abdominal distension, dry mouth, regurgitation with vomiting, oral ulcers, excessive salivation;
• rash, itching, urticaria, dermatitis, dry skin, excessive sweating;
• osteoarthritis, muscle pain, back pain, neck pain;
• urinary disorders (dysuria), kidney pain;
• uterine bleeding, testicular disorders;
• oedema, weakness (asthenia), malaise, fatigue, facial swelling, chest pain, fever, pain, peripheral oedema;
• abnormal laboratory test results (e.g. blood tests, liver function parameters, glucose, electrolytes);
• post-procedural complications.

Rare adverse reactions (may occur in not more than 1 in 10 to 10,000 patients):

• restlessness;
• liver function disorders, cholestatic jaundice (cholestatic jaundice);
• photosensitivity;
• severe skin reactions: acute generalized exanthematous pustulosis.

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

• pseudomembranous colitis;
• thrombocytopenia (reduced platelet count), reduced number of red blood cells (hemolytic anemia);
• anaphylactic reaction (generalized allergic reaction, rarely leading to death; may present with symptoms such as swelling of lips, face or neck leading to severe breathing difficulties, skin rash or urticaria);
• aggressive behaviour, anxiety, delirium, hallucinations;
• loss of consciousness (fainting), seizures, sensory disturbances (hypoesthesia), excessive psychomotor activity, loss of smell, loss of taste, olfactory disturbances, rapid muscle fatigue (myasthenia);
• hearing disorders including deafness and (or) tinnitus;
• cardiac arrhythmias (including torsade de pointes and ventricular tachycardia), QT interval prolongation on electrocardiogram;
• hypotension;
• pancreatitis, tongue discoloration;
• liver failure (rarely leading to death), fulminant hepatitis, hepatic necrosis;
• severe skin reactions: Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), erythema multiforme;
• joint pain;
• acute renal failure, interstitial nephritis.

Adverse reactions probably or possibly related to the use of azithromycin in the treatment of
infections caused by Mycobacterium avium complex or for prevention of such infections,
observed during clinical trials and after marketing.
Very common (may occur in more than 1 in 10 patients):

• diarrhoea;
• abdominal pain;
• nausea;
• bloating;
• discomfort in the abdominal cavity;
• loose stools.

Common (may occur in not more than 1 in 10 patients):

• anorexia;
• dizziness;
• headache;
• unusual skin sensations, such as tingling and numbness of limbs (paresthesia);
• taste disturbances;
• visual disturbances;
• deafness;
• rash, itching;
• joint pain;
• fatigue.

Uncommon (may occur in not more than 1 in 100 patients):

• sensory disturbances (hypoesthesia);
• hearing disorders, tinnitus;
• palpitations;
• hepatitis;
• Stevens-Johnson syndrome (severe skin reaction), photosensitivity;
• weakness (asthenia), malaise.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the 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 authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store the medicine Azycyna

Keep the medicine out of the sight and reach of children.
Store in the original packaging, at a temperature below 25 °C.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via the sewage system or in household waste. Ask your pharmacist how to dispose of medicines no longer required. Such practices will help protect the environment.

6. Contents of the packaging and other information

What Azycyna contains

• The active substance is azithromycin. Each coated tablet contains 500 mg of azithromycin in the form of azithromycin dihydrate.
• Other ingredients are: microcrystalline cellulose (101), microcrystalline cellulose (102), povidone (90), sodium croscarmellose, sodium lauryl sulfate, colloidal anhydrous silica, magnesium stearate. Film-coat composition: hypromellose (E 15), hypromellose (E 5), hydroxypropylcellulose, macrogol (8000), Opaspray K-1R-4210A, indigo carmine.

What Azycyna looks like and contents of the pack
Blue, round, biconvex coated tablets with a uniform surface.
The tablets are packed in PVC/Aluminum blisters with a leaflet, inside a cardboard box.
Packaging contains 2, 3, 6 or 12 coated tablets.
Marketing Authorization Holder
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
Manufacturer
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów