Azicina

Leaflet attached to the packaging: patient information

Azycyna, 200 mg/5 ml, granules for oral suspension
Azithromycin

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

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their 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. Package contents and other information

1. What is Azycyna and what is it used for

Azycyna contains the active substance azithromycin, which is an azalide antibiotic from the macrolide group with a broad spectrum of action. It has a bactericidal effect on susceptible microorganisms.
Azycyna in the form of granules for oral suspension is indicated for the treatment of the following infections caused by microorganisms susceptible 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 bacterial infection of the skin; erythema migrans - the first symptom of Lyme disease.

2. Important information before taking Azycyna

When not to take 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, the patient should discuss with their doctor or pharmacist if:

• they have conditions that may lead to cardiac arrhythmias (especially in women and elderly patients):
• congenital or acquired arrhythmias (visible on the ECG - a test of the heart's electrical activity),
• severe heart failure,
• very slow heart rate (called bradycardia),
• electrolyte disturbances in the blood, especially low potassium and magnesium levels,
• they are taking other medicines that may cause prolongation of the QT interval on the ECG (see "Azycyna and other medicines");
• they have severe kidney problems;
• they have severe liver problems: the doctor may monitor liver function or discontinue treatment;
• they have a new infection (which may indicate an overgrowth of resistant microorganisms or a fungal infection);
• they have neurological or psychiatric disorders;
• they have a sexually transmitted disease: the doctor should ensure that the patient does not have a co-existing syphilis infection;
• they have signs of superinfection (e.g., fungal infections);
• they are taking ergotamine derivatives (ergot preparations);
• they have infected burn wounds.

Infections caused by streptococci
In the treatment of pharyngitis and tonsillitis caused by streptococci, the drug of choice is usually penicillin.
Pseudomembranous colitis
In case of diarrhea, the patient should immediately consult a doctor, as it may be a sign of pseudomembranous colitis - a complication that can occur during the use of macrolide antibiotics. Such a diagnosis should be considered in patients who develop diarrhea after starting treatment with azithromycin. In case of pseudomembranous colitis caused by azithromycin, it may be necessary to discontinue Azycyna and use appropriate treatment. It is contraindicated to administer anti-peristaltic agents.
Long-term use
There is no data on the safety and efficacy of azithromycin used long-term in the above indications. In case of rapidly recurring infections, the doctor will consider treatment with another antibacterial agent.
Myasthenia
During treatment with azithromycin, exacerbation of myasthenia symptoms or the development of a myasthenic syndrome (see "Possible side effects") has been observed.
Treatment of infections caused by Mycobacterium avium complex in children
The safety and efficacy of azithromycin in the treatment of infections caused by Mycobacterium avium complex or in the prevention of such infections in children have not been established.

Children and adolescents

The dose is modified according to body weight (see section 3).

Azycyna and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
If the patient is taking any of the following medicines, it is especially important to inform their doctor or pharmacist:

• medicines that affect the QT interval, such as
• quinidine, procainamide, dofetilide, amiodarone, sotalol (used to treat arrhythmias),
• cisapride (used to treat stomach disorders),
• terfenadine (used to treat allergies),
• antipsychotic medicines, e.g., pimozide,
• antidepressant medicines, e.g., citalopram,
• fluoroquinolones (used to treat infections), e.g., moxifloxacin, levofloxacin;
• antacids (Azycyna should be administered at least 1 hour before or 2 hours after taking antacids);
• oral anticoagulants, e.g., warfarin;
• ergot alkaloids (used to treat migraine or reduce blood flow), e.g., ergotamine, which can cause ergotism (symptoms - spasm of peripheral blood vessels and ischemia) when used with azithromycin;
• digoxin (used to treat heart rhythm disorders);
• colchicine (used to treat gout or familial Mediterranean fever);
• cyclosporin (used to treat 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 meals or 2 hours after a meal.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, or thinks they may be pregnant or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Pregnancy
The medicine may be used during pregnancy only if the doctor believes that the benefit to the mother outweighs the risk to the child.
Breastfeeding
Azithromycin passes into breast milk. It is recommended that breastfeeding be avoided during treatment with azithromycin, unless the doctor advises otherwise.
Fertility
In fertility studies conducted in rodents, a decrease in fertility was observed after administration of azithromycin. The significance of these findings for humans is unknown.

Driving and using machines

There is no data on the effect of Azycyna on the ability to drive and use machines. However, when performing such activities, the possibility of side effects such as dizziness and seizures should be taken into account.

Azycyna contains sucrose

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.
The medicine contains 3.76 g of sucrose in 5 ml of the prepared suspension. This should be taken into account in patients with diabetes.

Azycyna contains sodium

The medicine contains 35.2 mg of sodium (the main component of common salt) in each 5 ml. This corresponds to 1.8% of the maximum recommended daily intake of sodium in the diet for adults.

Azycyna contains benzyl alcohol - a component of the cherry flavor trusil

The medicine contains 0.65 micrograms of benzyl alcohol in each 5 ml of the suspension.
Benzyl alcohol may cause allergic reactions.
Administration of benzyl alcohol to small children is associated with a risk of serious side effects, including respiratory distress (so-called "gasping syndrome").
Do not administer to newborns (up to 4 weeks of age) without a doctor's recommendation.
Do not administer to small children (under 3 years of age) for more than a week without a doctor's or pharmacist's recommendation.
Pregnant or breastfeeding women should consult their doctor before taking the medicine, as a large amount of benzyl alcohol may accumulate in their body and cause side effects (so-called metabolic acidosis).
Patients with liver or kidney disease should consult their doctor before taking the medicine, as a large amount of benzyl alcohol may accumulate in their body and cause side effects (so-called metabolic acidosis).

Azycyna contains sulfur dioxide (E 220) - a component of the cherry flavor trusil

The medicine may rarely cause severe hypersensitivity reactions and bronchospasm.

Azycyna contains maize maltodextrin (a source of glucose) - a component of the vanilla flavor and banana flavor

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

3. How to take Azycyna

This medicine should always be taken according to the doctor's instructions. In case of doubts, consult a doctor or pharmacist.
The medicine is taken orally.
In upper and lower respiratory tract infections, otitis media, and skin and soft tissue infections (except for erythema migrans), the total dose is 30 mg/kg body weight, i.e., 10 mg/kg body weight once a day for 3 days.

Dosing in children and adolescents

Dosing in children depends on body weight, as follows:

In 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, then 10 mg/kg body weight once a day from the 2nd to the 5th day of treatment.

Elderly patients

In elderly patients, the same dose is used as in other adult patients. Due to the risk of heart disease, caution is recommended when using the medicine in elderly patients.

Patients with kidney or liver function disorders

If the patient has kidney or liver function disorders, they should inform their doctor, as they may need to reduce the usual dose of the medicine. The medicine should not be used in patients with severe liver failure.

Method of administration

Azycyna should be administered once a day.
The prepared suspension should be taken at least 1 hour before meals or 2 hours after a meal.
The prepared suspension should be administered orally, using the measuring syringe provided with the packaging.
Shake well before each use!
After administering the medicine to a child, they should be given some tea or juice to drink, to prevent the medicine from remaining in the mouth.

Method of preparing the suspension

According to the instructions provided.

Using a higher dose of Azycyna than recommended

Side effects that occurred after taking the medicine in doses higher than recommended were similar to those reported after taking the recommended doses. Characteristic symptoms of overdose of macrolide antibiotics include: transient hearing loss, severe nausea, vomiting, and diarrhea.
In case of taking a higher dose of the medicine than recommended, the patient should immediately consult a doctor or pharmacist. In case of overdose, it is recommended to administer activated charcoal and provide symptomatic treatment, and if necessary, life-supporting treatment.

Missing a dose of Azycyna

A missed dose should be taken as soon as possible, and subsequent doses should be taken according to the recommended dosing schedule. A double dose should not be taken to make up for a missed dose.

4. Possible side effects

Like all medicines, Azycyna can cause side effects, although not everybody gets them.

In case of the following side effects, the medicine should be discontinued and the patient should immediately consult a 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 patches), Stevens-Johnson syndrome (blisters and ulcers on the skin, in the mouth, eyes, and genital areas, fever, and joint pain), toxic epidermal necrolysis (large blisters under the skin, widespread skin ulcers, and fever);

(large blisters under the skin, widespread skin ulcers, and fever), acute generalized exanthematous pustulosis (a skin rash characterized by rapid onset of areas of redness on the skin, covered with small pustules [blisters filled with white or yellow fluid]);

• severe and prolonged diarrhea, especially if there is blood or mucus in the stool. (this may be a sign of inflammatory bowel disease, called pseudomembranous colitis)
• menstrual bleeding Categorization of the frequency of side effects is as follows:

Very common(may occur in more than 1 in 10 patients) :

• diarrhea

Common(may occur in less than 1 in 10 patients):

• headache;
• vomiting, abdominal pain, nausea;
• change in white blood cell count;
• decrease in blood bicarbonate levels.

Uncommon(may occur in less than 1 in 100 patients):

• fungal infections (candidiasis), vaginal infection, pneumonia, fungal infection, bacterial infection, pharyngitis, gastrointestinal disorders, respiratory disorders, rhinitis, fungal infection of the mouth;
• change in white blood cell count (leukopenia, neutropenia, eosinophilia);
• angioedema (swelling in the face and throat, which can cause difficulty breathing), hypersensitivity;
• loss of appetite (anorexia);
• nervousness, insomnia, dizziness, somnolence, taste disorders, abnormal skin sensations, e.g., tingling and numbness of the limbs (paresthesia);
• vision disorders;
• hearing disorders, balance disorders;
• palpitations;
• hot flashes;
• dyspnea, epistaxis;
• constipation, flatulence, dyspepsia, gastritis, dysphagia, bloating, dry mouth, belching, oral ulcers, excessive salivation;
• rash, pruritus, urticaria, skin inflammation, dry skin, excessive sweating;
• degenerative joint disease, muscle pain, back pain, neck pain;
• urinary disorders (dysuria), kidney pain;
• menstrual bleeding, testicular disorders;
• edema, weakness (asthenia), malaise, facial edema, chest pain, fever, pain, peripheral edema;
• abnormal laboratory test results (e.g., blood, liver function, glucose, electrolytes);
• post-procedural complications.

Rare(may occur in less than 1 in 1000 patients):

• agitation;
• 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 (decreased platelet count), hemolytic anemia (decreased red blood cell count);
• anaphylactic reaction (a generalized allergic reaction that can rarely be fatal; may occur with symptoms such as: swelling of the lips, face, or throat, leading to severe breathing difficulties, rash, or urticaria);
• aggressive behavior, anxiety, hallucinations, delusions;
• loss of consciousness (syncope), 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;
• arrhythmias (including torsades de pointes and ventricular tachycardia), prolonged QT interval on the electrocardiogram;
• hypotension;
• pancreatitis, discoloration of the tongue;
• liver failure (rarely fatal), fulminant hepatitis, liver necrosis;
• severe skin reactions: Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme;
• arthralgia;
• acute renal failure, interstitial nephritis.

Side effects probably or possibly related to the use of azithromycin in the treatment of infections caused by Mycobacterium avium complex or in the prevention of such infections, observed during clinical trials and after the medicine was placed on the market.

Very common(may occur in more than 1 in 10 patients):

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

Common(may occur in less than 1 in 10 patients):

• loss of appetite;
• dizziness;
• headache;
• abnormal skin sensations, e.g., tingling and numbness of the limbs (paresthesia);
• taste disorders;
• vision disorders;
• deafness;
• pruritus;
• arthralgia;
• fatigue.

Uncommon(may occur in less than 1 in 100 patients):

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

Reporting side effects

If side effects occur, including any not listed in this leaflet, the patient should inform their doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw,
Phone: 22 49-21-301
Fax: 22 49-21-309
Website: https://smz.ezdrowie.gov.pl .
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Azycyna

• The medicine should be stored out of sight and reach of children.
• Store in a temperature below 25°C.
• The prepared suspension of 200 mg/5 ml can be stored for:
• 5 days (packaging for the preparation of 20 ml suspension),
• 10 days (packaging for the preparation of 30 ml and 37.5 ml suspension).

Do not use this medicine after the expiry date stated on the carton and on the label after "EXP:". The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Azycyna contains

• The active substance of the medicine is azithromycin in the form of azithromycin dihydrate. 5 ml of the prepared suspension contains 200 mg of azithromycin.
• Other ingredients are: sucrose, anhydrous disodium phosphate, hydroxypropyl cellulose, xanthan gum, cherry flavor trusil, banana flavor, vanilla flavor, colloidal silica.

What Azycyna looks like and what the package contains

Azycyna is a white or yellowish-white granule.

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

Each bottle has a child-resistant closure.
Each bottle is packaged in a cardboard box. A measuring syringe is provided with the packaging.

Marketing authorization holder and manufacturer

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
Teva Operations Poland Sp. z o.o.
ul. Mogilska 80, 31-546 Kraków
Date of last revision of the leaflet:07.2023

INSTRUCTIONS FOR USE OF THE MEDICINE

Preparing the oral suspension

Water for preparing the suspension is best measured with the provided measuring syringe.

• 1. The bottle contains granules, from which an oral suspension is prepared after adding water.
• 2. Press the bottle cap and turn it counterclockwise.
• To prepare 20 mlof oral suspension, add 12 ml of boiled and cooled water. Measure 4 times 3 ml of water with the provided syringe and add to the bottle with the medicine.
• To prepare 30 mlof oral suspension, add 16.5 ml of boiled and cooled water. Measure 3 times 5 ml and 1 time 1.5 ml of water with the provided syringe and add to the bottle with the medicine.
• To prepare 37.5 mlof oral suspension, add 20 ml of boiled and cooled water. Measure 5 times 4 ml of water with the provided syringe and add to the bottle with the medicine. Each bottle then contains 5 ml of excess suspension to ensure complete dosing.

• 4. Shake the bottle well until a uniform suspension is formed.
• 5. The prepared suspension should be stored in a temperature below 25°C.

Packaging with granules for the preparation of 20 ml suspension - the suspension can be stored for 5 days.
Packaging with granules for the preparation of 30 ml and 37.5 ml suspension - the suspension can be stored for 10 days.

Instructions for using the measuring syringe

Before administering the medicine to a child, read the following instructions carefully.
FILLING THE SYRINGE WITH MEDICINE:

• 1. The suspension should be shaken before use
• 2. Press the syringe cap and turn it counterclockwise.
• 3. Insert the syringe tip into the suspension and, pulling the plunger up, draw the appropriate amount of suspension.

• 4. If a air bubble is visible in the syringe, the medicine should be injected back into the bottle and the steps from point 3 repeated.

ADMINISTERING THE MEDICINE TO A CHILD:

• 5. Place the child in a feeding position.
• 6. Insert the syringe tip into the child's mouth.
• 7. Slowly push the plunger so that the child can swallow the medicine gradually.

• 8. After the child has swallowed the medicine, give them some tea or juice to drink, to prevent the medicine from remaining in the mouth.

CLEANING AND STORAGE:

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

• 10. After administering the last dose to a child, discard the syringe together with the bottle.

Warning!
The medicine and syringe should be stored in a place inaccessible to children.
The medicine should be used strictly according to the doctor's instructions.
In case of any doubts, consult a doctor or pharmacist.