Azycyna

Package leaflet: Information for the patient

Azycyna, 250 mg, film-coated tablets
Azithromycinum
Please read the entire 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 another person, 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 Azycyna is and what it is 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 package and other information

1. What Azycyna is and what it is 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 bactericidal against susceptible microorganisms.
Azycyna 250 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, cellulitis, and secondary bacterial skin infections; erythema migrans – the first sign of Lyme disease.
• Sexually transmitted infections: 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 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 that may predispose to development of heart rhythm disorders (particularly relevant in women and elderly patients):
  • congenital or previously occurring heart rhythm disorders (visible on ECG – a test measuring the heart's electrical activity),
  • severe heart failure,
  • very slow heart rate (called bradycardia),
  • electrolyte imbalances in the 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 develops a new infection (this may indicate overgrowth of resistant microorganisms or a fungal infection);
• the patient has neurological or psychiatric disorders;
• the patient has a sexually transmitted disease: the doctor should ensure that syphilis is not co-existing;
• the patient has symptoms 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 diarrhoea occurs, it should be reported immediately to the doctor, as it may be a symptom of pseudomembranous colitis – a complication that may occasionally occur during treatment with macrolide antibiotics. The doctor should consider this diagnosis in patients who develop diarrhoea 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 a 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 doctor 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 infections caused by Mycobacterium avium complex in children
The safety and efficacy of azithromycin for treatment or prevention of infections caused by the Mycobacterium avium complex in children have not been established.
Children and adolescents
Azycyna 250 mg film-coated tablets are recommended for use in children only if body weight is at least 45 kg. For other children, use of Azycyna oral suspension or 125 mg film-coated tablets is recommended.
Azycyna with other medicines
Tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
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 heart rhythm disorders),
  • cisapride (used for stomach disorders),
  • terfenadine (used to treat allergies),
  • antipsychotic medicines, 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 to reduce blood flow), e.g. ergotamine, which when used with azithromycin may cause ergotism (symptoms: peripheral vasoconstriction and ischemia);
• digoxin (used for heart function disorders);
• colchicine (used to treat gout and familial Mediterranean fever);
• cyclosporine (used for skin diseases, rheumatoid arthritis, or after organ transplantation);
• atorvastatin (a medicine used to lower cholesterol levels);
• rifabutin (used in the treatment of HIV or tuberculosis).

Azycyna with food and drink
See section 3.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or 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 doctor’s opinion, the benefit to the mother outweighs the risk to the fetus.
Breastfeeding
Azithromycin passes into 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 convulsions.
Azycyna contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, meaning the medicine is considered "sodium-free".

3. How to use Azycyna

This medicine should always be used according to the doctor's instructions. If in doubt, consult your doctor or pharmacist.
The medicine is taken orally.
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)
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 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, to be taken according to the following regimen: 1 g (4 coated tablets of 250 mg each) on the first day, followed by 500 mg (2 coated tablets) from the second to the fifth day, as single daily doses.
Uncomplicated infections caused by Chlamydia trachomatis
1 g (4 coated tablets of 250 mg each) as a single dose.
Elderly patients
In elderly patients, the same dosage as in other adult patients should be used. Due to the risk of cardiac diseases, caution is recommended when using this medicine in these patients.
Patients with renal or hepatic impairment
If the patient has impaired renal or liver function, this should be reported to the doctor, as dose reduction may be necessary. This medicine should not be used in patients with severe hepatic impairment.
Method of administration
Azycyna 250 mg coated tablets should be administered orally once daily, at least one hour before or two hours after meals. Tablets should be swallowed whole.
Use of a higher than recommended dose of Azycyna
Adverse effects observed after administration of doses higher than recommended were similar to those reported with correct doses. Characteristic symptoms following overdose of macrolide antibiotics include: transient hearing loss, severe nausea, vomiting and diarrhoea.
In case of ingestion of a higher than recommended dose, seek immediate medical advice from a doctor or pharmacist. In the event of overdose, administration of 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 recommended 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 experiences them.
If any of the following adverse reactions occur, discontinue the medicine immediately and seek medical advice or go to the emergency department of your nearest hospital:

• Allergic reactions: rash, urticaria, swelling of hands, feet, ankles, face, lips, mouth or throat, difficulty breathing or swallowing;
• Severe skin reactions, including erythema multiforme (circular red and swollen 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 areas of skin 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

The frequency of the above adverse reactions is given below. The following adverse reactions have been reported:

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

• Diarrhoea

Common (may affect up to 1 in 100 people):

• Headache;
• Vomiting, abdominal pain, nausea;
• Changes in white blood cell count;
• Decreased concentration of bicarbonate in blood.

Uncommon (may affect up to 1 in 1,000 people):

• Fungal infections (candidiasis), vaginal infection, pneumonia, fungal infection, bacterial infection, pharyngitis, gastritis and enteritis, respiratory disorders, rhinitis, oral candidiasis;
• Changes in white blood cell count (leukopenia, neutropenia, eosinophilia);
• Angioedema (swelling of the face and throat, which may cause 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, disturbances of balance;
• Palpitations;
• Hot flushes;
• Dyspnea, epistaxis;
• Constipation, bloating with flatulence, dyspepsia, gastric mucosal inflammation, swallowing difficulties (dysphagia), abdominal distension, dry mouth, regurgitation with vomiting, oral ulcers, excessive salivation;
• Rash, pruritus, urticaria, dermatitis, dry skin, excessive sweating;
• Osteoarthritis, muscle pain, back pain, neck pain;
• Urinary disorders (dysuria), kidney pain;
• Uterine bleeding, testicular disorders;
• Edema, weakness (asthenia), malaise, fatigue, facial swelling, chest pain, fever, pain, peripheral edema;
• Abnormal laboratory test results (e.g. blood tests, liver function parameters, glucose, electrolytes);
• Post-procedural complications.

Rare adverse reactions (may affect up to 1 in 10,000 people):

• Restlessness;
• Liver function disorders, cholestatic jaundice;
• Photosensitivity.

Severe skin reactions: acute generalized exanthematous pustulosis

Frequency not known (frequency cannot be estimated from the 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 behavior, anxiety, delirium, hallucinations;
• Loss of consciousness (fainting), seizures, sensory disturbances (hypoesthesia), excessive psychomotor activity, loss of smell, loss of taste, disturbances of smell, 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 thereof, observed during clinical trials and after marketing.

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

• Diarrhoea;
• Abdominal pain;
• Nausea;
• Bloating;
• Abdominal discomfort;
• Loose stools.

Common (may affect up to 1 in 10 people):

• Anorexia;
• Dizziness;
• Headache;
• Paresthesia (e.g. tingling and numbness of limbs);
• Taste disturbances;
• Visual disturbances;
• Deafness;
• Rash, pruritus;
• Joint pain;
• Fatigue.

Uncommon (may affect up to 1 in 100 people):

• 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 of 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 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 wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Azycyna contains

• The active substance is azithromycin. Each coated tablet contains 250 mg of azithromycin in the form of azithromycin dihydrate.
• Other ingredients: 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/Aluminium blisters and placed in a cardboard box with a leaflet.
The pack contains 3 or 6 coated tablets.
Marketing Authorisation 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