Azycyna

Package leaflet: Information for the patient

Azycyna, 200 mg/5 ml, granules for the preparation of oral suspension
Azithromycinum
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

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 broad-spectrum activity. It acts bactericidal against susceptible microorganisms.
Azycyna in the form of granules for the preparation of oral suspension is 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 – the first sign of Lyme borreliosis.

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 cardiac arrhythmias (particularly relevant in women and elderly patients):
• congenital or previous history of cardiac arrhythmia (visible on ECG – electrocardiogram),
• severe heart failure,
• very slow heart rate (known as bradycardia),
• electrolyte imbalances in the blood, especially low potassium or magnesium levels,
• use of other medicines that may prolong the QT interval on ECG (see section "Azycyna with other medicines");
• the patient has severe kidney dysfunction;
• the patient has severe liver dysfunction: the doctor may monitor liver function or discontinue treatment;
• the patient develops a new infection (which may indicate overgrowth of resistant microorganisms or fungal infection);
• the patient has neurological or psychiatric disorders;
• the patient has a sexually transmitted disease: the doctor should ensure that syphilis is not present;
• the patient has signs of superinfection (e.g. fungal infections);
• the patient is taking ergot derivatives (ergot alkaloids);
• the patient has infected burn wounds.

Streptococcal infections
For the treatment of streptococcal pharyngitis and tonsillitis, penicillin is usually the drug of choice.
Pseudomembranous colitis
If diarrhoea occurs, it must be reported immediately to the doctor, as it may be a sign 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 cases 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 no 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 Mycobacterium avium complex infections in children
The safety and efficacy of azithromycin for the treatment or prevention of infections caused by the Mycobacterium avium complex in children have not been established.
Children and adolescents
Dosage is adjusted according to body weight (see section 3).
Azycyna with other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines planned for future use.
It is particularly important to inform the doctor or pharmacist if the patient is taking any of the following medicines:

• 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: co-administration with azithromycin may lead to ergotism (symptoms include peripheral vasoconstriction and ischemia);
• digoxin (used for cardiac 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 to treat HIV or tuberculosis).

Azycyna with food and drink
Azycyna should be taken at least 1 hour before or 2 hours after a meal.
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 opinion of the doctor, the benefit to the mother outweighs the risk to the fetus.
Breastfeeding
Azithromycin passes into human milk. Breastfeeding is not recommended during azithromycin treatment unless otherwise advised by the doctor.
Fertility
Animal fertility studies showed reduced conception rates 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 sucrose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
The medicine contains 3.76 g of sucrose in 5 ml of reconstituted suspension. This should be taken into account in patients with diabetes.
Azycyna contains sodium
The medicine contains 35.2 mg of sodium (main component of table salt) in each 5 ml. This corresponds to 1.8% of the maximum recommended daily intake of sodium in the adult diet.
Azycyna contains benzyl alcohol – ingredient of cherry trusil flavour
The medicine contains 0.65 micrograms of benzyl alcohol in each 5 ml of suspension.
Benzyl alcohol may cause allergic reactions.
Administration of benzyl alcohol to young children is associated with a risk of severe adverse reactions, including respiratory disturbances (so-called "gasping syndrome").
Do not administer to neonates (up to 4 weeks of age) without medical advice.
Do not administer to young children (under 3 years of age) for longer than one week without medical advice or pharmacist's recommendation.
Pregnant or breastfeeding women should consult a doctor before using this medicine, as large amounts of benzyl alcohol may accumulate in their bodies and cause adverse effects (so-called metabolic acidosis).
Patients with liver or kidney disease should consult a doctor before using this medicine, as large amounts of benzyl alcohol may accumulate in their bodies and cause adverse effects (so-called metabolic acidosis).
Azycyna contains sulphur dioxide (E 220) – ingredient of cherry trusil flavour
The medicine may rarely cause severe hypersensitivity reactions and bronchospasm.
Azycyna contains corn maltodextrin (a source of glucose) – ingredient of vanilla flavour and ingredient of banana flavour
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

3. How to use Azycyna

This medicine should always be taken as prescribed by the doctor. In case of doubts, consult a doctor or pharmacist.
The medicine is taken orally.
For upper and lower respiratory tract infections, otitis media, skin and soft tissue infections (except erysipelas), the total dose is 30 mg/kg body weight, i.e. 10 mg/kg body weight once daily for 3 days.
Dosage in children and adolescents
Dosage in children depends on body weight, as follows:

For the treatment of erythema migrans, the total dose is 60 mg/kg body weight administered as follows: 20 mg/kg body weight on the first day, followed by 10 mg/kg body weight once daily from day 2 to day 5 of treatment.
Elderly patients
The same dosage should be used in elderly patients as in other adult patients. Due to the risk of heart diseases, caution is recommended when administering the medicinal product to elderly patients.
Patients with renal or hepatic impairment
If the patient has impaired renal or hepatic function, this should be reported to the physician, as the physician may reduce the usual dose of the medicinal product. The medicinal product should not be used in patients with severe hepatic impairment.
Method of administration
Azycyna should be administered once daily.
The prepared suspension should be taken at least 1 hour before or 2 hours after a meal.
The prepared suspension should be administered orally using the syringe provided in the package.
Shake well before each use!
After administering the medicinal product to a child, give the child some tea or juice to drink, to prevent the medicinal product from remaining in the mouth.
Preparation of the suspension
As described in the enclosed instructions.
Use of a higher than recommended dose of Azycyna
Adverse reactions observed after administration of doses higher than recommended were similar to those reported following administration of correct doses. Characteristic symptoms after 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 advice from a physician or pharmacist. In case 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 administered according to the recommended dosing schedule. A double dose should not be taken to make up for the 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
contact your doctor or go to the nearest hospital emergency department:

• 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 lesions), Stevens-Johnson syndrome (blisters and erosions on the skin, inside the mouth, eyes and genital organs, fever and joint pain), toxic epidermal necrolysis

(bursting large subepidermal blisters, extensive skin erosions, shedding of large sheets of skin, and fever), acute generalised exanthematous pustulosis (skin eruption characterised
by rapid appearance of red skin areas covered with small pustules [small 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 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 up to 1 in 10 patients):

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

Uncommon (may occur in up to 1 in 100 patients):

• 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, 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 (paraesthesiae);
• Visual disturbances;
• Ear disorders, disturbances of balance;
• Palpitations;
• Hot flushes;
• Dyspnoea, nosebleeds;
• Constipation, bloating with flatulence, indigestion, gastric mucositis, swallowing difficulties (dysphagia), abdominal distension, dry mouth, regurgitation with belching, 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, feeling of 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 (may occur in up to 1 in 1000 patients):

• Restlessness;
• Liver function disorders, cholestatic jaundice (cholestatic jaundice);
• Photosensitivity;
• Severe skin reactions: acute generalised exanthematous pustulosis.

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

• Pseudomembranous colitis;
• Thrombocytopenia (reduced platelet count), reduced number of red blood cells (haemolytic anaemia);
• Anaphylactic reaction (generalised 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, 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, 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 up to 1 in 10 patients):

• Anorexia;
• Dizziness;
• Headache;
• Unusual skin sensations such as tingling and numbness of limbs (paraesthesiae);
• Taste disturbances;
• Visual disturbances;
• Deafness;
• Rash, itching;
• Joint pain;
• Feeling of fatigue.

Uncommon (may occur in up to 1 in 100 patients):

• Sensory disturbances (hypoesthesia);
• Hearing disorders, tinnitus;
• Palpitations;
• Hepatitis;
• Stevens-Johnson syndrome (severe skin reaction), photosensitivity;
• Sudden weakness (asthenia), malaise.

Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist or nurse. 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.: 22 49-21-301
Fax: 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 provide more information on the safety of this medicine.

5. How to store Azycyna

• Keep this medicine out of sight and reach of children.
• Store below 25°C.
• The reconstituted 200 mg/5 ml suspension, after reconstitution with water, should be stored below 25°C:
  • 5 days (pack for preparation of 20 ml suspension),
  • 10 days (pack for preparation of 30 ml and 37.5 ml suspension).

Do not use this medicine after the expiry date stated on the carton and label after "Expiry date (EXP):". 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. These measures will help protect the environment.

6. Contents of the pack and other information

What Azycyna contains

• The active substance is azithromycin in the form of azithromycin dihydrate. 5 ml of reconstituted suspension contains 200 mg of azithromycin.
• The other ingredients are: sucrose, trisodium phosphate anhydrous, hydroxypropylcellulose, xanthan gum, Trusil cherry flavour, banana flavour, vanilla flavour, colloidal silicon dioxide.

What Azycyna looks like and contents of the pack
Azycyna is a white or yellowish-white granulate.

• A bottle containing granulate with 800 mg azithromycin, for the preparation of 20 ml of suspension.
• A bottle containing granulate with 1.2 g azithromycin, for the preparation of 30 ml of suspension.
• A bottle containing granulate with 1.5 g azithromycin, for the preparation of 37.5 ml of suspension.

Each bottle has a child-resistant closure.
Each bottle is packaged in a cardboard box. An oral dosing syringe is included in the pack.

Marketing Authorisation Holder and Manufacturer
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
Teva Operations Poland Sp. z o.o.
ul. Mogilska 80, 31-546 Kraków

DIRECTIONS FOR USE OF THE MEDICINAL PRODUCT
Preparation of oral suspension

The water needed for preparing the suspension should be measured preferably using the provided dosing syringe.

1. The bottle contains granulate which, after addition of water, forms an oral suspension.
2. Press the cap down and turn it counterclockwise.
   • To prepare 20 ml of oral suspension, add 12 ml of boiled, cooled water. Using the provided syringe, measure 4 times 3 ml of water and add it to the bottle with the medicine.
   • To prepare 30 ml of oral suspension, add 16.5 ml of boiled, cooled water. Using the provided syringe, measure 3 times 5 ml and once 1.5 ml of water and add it to the bottle with the medicine.
   • To prepare 37.5 ml of oral suspension, add 20 ml of boiled, cooled water. Using the provided syringe, measure 5 times 4 ml of water and add it to the bottle with the medicine. Each bottle will then contain 5 ml of excess suspension to ensure complete dosing.

4. Shake vigorously until a homogeneous suspension is formed.
5. The prepared suspension should be stored at a temperature below 25°C.

For packs of granulate for preparing 20 ml of suspension at a concentration of 200 mg/5 ml – the suspension may be stored for 5 days.
For packs of granulate for preparing 30 ml and 37.5 ml of suspension at a concentration of 200 mg/5 ml – the suspension may be stored for 10 days.

Instructions for using the dosing syringe
Before administering the medicine to a child, please read the instructions below carefully.

FILLING THE SYRINGE WITH MEDICINE:

1. Shake the suspension well before use.
2. Press the cap down and turn it counterclockwise.
3. Immerse the tip of the syringe into the suspension and draw up the required amount by pulling the plunger upwards.

4. If an air bubble is observed in the syringe, inject the medicine back into the bottle and repeat step 3.

ADMINISTERING THE MEDICINE TO THE CHILD:

5. Position the child as for feeding.
6. Insert the tip of the syringe into the child's mouth.
7. Slowly push the plunger to allow the child to swallow the medicine gradually.

8. After the child has swallowed the medicine, give a small amount of tea or juice to drink, to ensure the medicine does not remain in the mouth.

CLEANING AND STORAGE:

9. After use, disassemble the syringe, wash it under running water, dry it, and store it in a clean place together with the medicine.

10. After administering the last dose to the child, dispose of the syringe together with the bottle.

Warning! Keep the medicine and syringe out of the reach of children.
The medicine should be used strictly according to the doctor's instructions.
In case of any doubts, consult your doctor or pharmacist.