Azimicin

Leaflet attached to the packaging: patient information

Azimycin, 100 mg/5 mL, powder for oral suspension
Azimycin, 200 mg/5 mL, powder 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 inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Azimycin and what is it used for
• 2. Important information before taking Azimycin
• 3. How to take Azimycin
• 4. Possible side effects
• 5. How to store Azimycin
• 6. Package contents and other information

1. What is Azimycin and what is it used for

Azimycin contains the active substance azithromycin, which is an azalide antibiotic from the macrolide group with a broad spectrum of activity. It has a bactericidal effect on susceptible microorganisms.
Azimycin in the form of powder 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 pyoderma; erythema migrans - the first symptom of Lyme disease.

2. Important information before taking Azimycin

When not to take Azimycin

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

Warnings and precautions

Before starting treatment with Azimycin, the patient should discuss with their doctor or pharmacist if:

• the patient has conditions that may lead to cardiac arrhythmias (especially in women and the elderly):
• congenital or existing cardiac arrhythmias (visible on an ECG - a test of heart electrical activity),
• severe heart failure,
• very slow heart rate (bradycardia),
• electrolyte disturbances in the blood, especially low potassium and magnesium levels,
• the patient is taking other medicines that may cause QT interval prolongation on an ECG (see "Azimycin and 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 has a new infection (this may indicate an overgrowth of resistant microorganisms or a fungal infection);
• the patient has neurological or mental disorders;
• the patient has a sexually transmitted disease: the doctor should ensure that the patient does not have a co-existing syphilis infection;
• the patient is taking ergotamine derivatives (for migraine or to reduce blood flow);
• the patient has infected burn wounds.

Also, read the warnings in section 4.
If, despite treatment, the symptoms of the infection do not subside or symptoms of a new infection appear, e.g., fungal infection, the patient should consult their doctor again.
Infections caused by streptococci
In the treatment of pharyngitis and tonsillitis caused by streptococci, the drug of choice is usually penicillin.
Pseudomembranous colitis
If diarrhea occurs, it should be reported to the doctor immediately, as it may be a symptom of pseudomembranous colitis - a complication that sometimes occurs during the use of macrolide antibiotics. Such a diagnosis should be considered in patients who develop diarrhea after starting treatment with azithromycin. In the case of pseudomembranous colitis caused by azithromycin, it may be necessary to discontinue Azimycin 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 for a long time in the above indications. In the 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 occurrence of a myasthenic syndrome (see "Possible side effects") has been observed.
Treatment of Mycobacterium avium complex infections in children
The safety and efficacy of azithromycin in the treatment of Mycobacterium avium complex infections or in the prevention of such infections in children have not been established.

Children and adolescents

The dose is modified depending on body weight (see section 3).

Azimycin 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),
• hydroxychloroquine (used to treat rheumatologic diseases or malaria),
• 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 (Azimycin should be administered at least 1 hour before or 2 hours after taking antacids);
• oral anticoagulants, e.g., warfarin;
• ergot alkaloids (used for migraine or to 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).

Azimycin with food and drink

Azimycin can be taken independently of meals.

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 considers that the benefit to the mother outweighs the risk to the fetus.
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 the fertility index was observed after administration of azithromycin. The significance of these study results for humans is unknown.

Driving and using machines

There is no data on the effect of Azimycin 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.

Azimycin contains sucrose

Caution should be exercised in patients with diabetes.
Azimycin, 100 mg/5 mL, powder for oral suspension: 5 mL of the prepared suspension contains 2134.2 mg of sucrose.
Azimycin, 200 mg/5 mL, powder for oral suspension: 5 mL of the prepared suspension contains 2029.4 mg of sucrose.
If the patient has previously been diagnosed with intolerance to some sugars, they should inform their doctor before starting treatment with the medicine.
Azimycin contains sodium benzoate (E 211)(25 mg/5 mL)
Benzoic acid salt may increase the risk of jaundice (yellowing of the skin and whites of the eyes) in newborns (up to 4 weeks of age).

3. How to take Azimycin

This medicine should always be taken as directed by the doctor. In case of doubts, consult a doctor or pharmacist.
The medicine is taken orally.
In infections of the upper and lower respiratory tract, otitis media, 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.
Treatment of pharyngitis and tonsillitis caused by Streptococcus pyogenes
In the treatment of pharyngitis caused by Streptococcus pyogenes bacteria in children with a body weight of up to 13 kg, azithromycin is administered either for 3 days, once a day at a dose of 20 mg/kg body weight, or for 5 days at a dose of 12 mg/kg body weight. Both in the 3-day and 5-day treatment, the total amount of azithromycin taken by the patient should be 60 mg/kg body weight.
Dosing of the 100 mg/5 mL suspension for children with a body weight of 5-13 kg is presented in the following table:

In the treatment of pharyngitis caused by Streptococcus pyogenes bacteria in patients with a body weight of up to 25 kg, azithromycin is administered either for 3 days at a dose of 20 mg/kg body weight once a day or for 5 days at a dose of 12 mg/kg body weight once a day. Both in the 3-day and 5-day treatment, the total amount of azithromycin taken by the patient should be 60 mg/kg body weight. The maximum daily dose of azithromycin is 500 mg.
In adults and children with a body weight over 25 kg, azithromycin is administered at a dose of 500 mg once a day for 3 days or for 5 days, with 500 mg on the first day and 250 mg from the 2nd to the 5th day.
Dosing of the 200 mg/5 mL suspension for children with a body weight of 10-25 kg is presented in the following table:

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 dysfunction

If the patient has kidney or liver dysfunction, 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
Azithromycin should be administered orally, once a day.
The prepared suspension can be taken independently of meals.
The prepared suspension should be administered orally, using the measuring spoon or dosing syringe provided with the packaging.
Before each use, the prepared oral suspension should be shaken vigorously.
After administering the medicine to a child, they should be given some tea or juice to drink to prevent the medicine from staying in the mouth.

Method of preparing the suspension

According to the attached instructions.

Using a higher dose of Azimycin than recommended

Side effects that occurred after taking the medicine in doses higher than recommended were similar to those reported after taking the correct 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 use symptomatic treatment, and if necessary, supportive treatment.

Missing a dose of Azimycin

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, this medicine can cause side effects, although not everybody gets them.

In case of the following side effects, the patient should stop taking Azimycin and immediately consult a doctor or go to the emergency department of the nearest hospital:

Azimycin and immediately consult a doctor or go to the emergency department of the nearest hospital:

• Allergic reactions: severe, rapidly progressing allergic reaction leading to shock (frequency not known) or sudden difficulty breathing and swallowing, swelling of the lips, tongue, face, and throat, itching rash, especially occurring all over the body (uncommon).
• Severe skin reactions: skin rash characterized by rapid onset of areas of redness on the skin, covered with small blisters (blisters filled with white or yellow fluid); severe skin rash causing redness and peeling; severe blistering and bleeding from the lips, eyes, mouth, nose, and genitals, associated with high fever and joint pain. This may be acute generalized exanthematous pustulosis (AGEP, rare), erythema multiforme, blistering erythema multiforme (Stevens-Johnson syndrome), or toxic epidermal necrolysis (all with unknown frequency).

Severe hypersensitivity reaction that may involve fever, skin rash, swollen lymph nodes, and inflammation of the liver, kidneys, and other organs (DRESS - Drug Reaction with Eosinophilia and Systemic Symptoms; unknown frequency).

• Severe or chronic diarrhea with blood or mucus. This symptom may occur during or after treatment and may indicate a serious intestinal infection (frequency not known).
• Weakness, lack of appetite, yellowing of the skin and whites of the eyes, dark urine, pale stools, abdominal pain, especially in the right upper quadrant. These may be symptoms of severe liver disease (liver failure, rare, sometimes leading to death, fulminant hepatitis, liver necrosis; frequency not known).
• Susceptibility to infections, especially of the mouth and throat, worsening despite treatment (symptoms of neutropenia, leukopenia; uncommon).
• Tendency to bruise or bleed - symptoms of thrombocytopenia (decreased platelet count).
• Fainting, weakness, and fatigue, pallor, shortness of breath, rapid heartbeat - symptoms of hemolytic anemia (increased breakdown of red blood cells; frequency not known).
• Rapid (ventricular tachycardia) or irregular heartbeat or changes in heart rhythm on an ECG (QT interval prolongation and torsades de pointes arrhythmia; frequency not known).
• Decreased urine output, weakness, swelling, shortness of breath, lack of appetite, nausea, and vomiting, itching, petechiae, back pain, hematuria (symptoms of acute renal failure and interstitial nephritis; frequency not known).

Other side effects

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

• diarrhea.

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

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

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

• fungal infections (candidiasis), vaginal infection, pneumonia, fungal infection, bacterial infection, pharyngitis, gastrointestinal upset, respiratory disorders, rhinitis, genital moniliasis;
• change in white blood cell count (eosinophilia);
• loss of appetite (anorexia);
• restlessness, insomnia; dizziness, drowsiness, taste disorders, abnormal skin sensations, e.g., tingling and numbness of limbs (paresthesia);
• vision disorders;
• hearing disorders, balance disorders;
• palpitations;
• hot flashes;
• shortness of breath, nosebleeds;
• constipation, bloating with gas, indigestion, gastritis, dysphagia, abdominal distension, dry mouth, belching, oral thrush, excessive salivation;
• skin rash, dry skin, excessive sweating;
• degenerative joint disease, muscle pain, back pain, neck pain;
• urinary disorders (dysuria), kidney pain;
• vaginal bleeding, testicular disorders;
• edema, weakness (asthenia), malaise (apathy), fatigue, facial edema, chest pain, fever, pain, peripheral edema;
• abnormal laboratory test results (e.g., blood, liver function, kidney function, glucose, electrolytes);
• post-procedure complications.

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

• agitation;
• liver function disorders;
• photosensitivity.

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

• aggressive behavior, anxiety, hallucinations, delirium;
• loss of consciousness (syncope), seizures, sensory disturbances (hypoesthesia), excessive psychomotor activity, anosmia, ageusia, taste disorders, olfactory disorders;
• hearing disorders, including deafness and/or tinnitus;
• hypotension;
• pancreatitis, tongue discoloration;
• arthralgia.

Side effects possibly or probably related to the use of azithromycin in the treatment of Mycobacterium avium complex infections or in the prevention of such infections, observed during clinical trials and after marketing authorization.

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

• diarrhea;
• abdominal pain;
• nausea;
• bloating;
• abdominal discomfort;
• loose stools.

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

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

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

• sensory disturbances (hypoesthesia);
• hearing disorders, tinnitus;
• palpitations;
• hepatitis;
• blistering erythema multiforme (Stevens-Johnson syndrome), photosensitivity;
• sudden weakness (asthenia), malaise.

Reporting side effects

If side effects occur, including any not listed in this leaflet, the patient should inform their doctor or pharmacist. 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: +48 22 49 21 301
Fax: +48 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 to gather more information on the safety of the medicine.

5. How to store Azimycin

The medicine should be stored out of sight and reach of children.
The powder should be stored in the original packaging at a temperature below 25°C.
The prepared oral suspension should be stored at a temperature below 25°C, for no longer than 5 days.
Do not use this medicine after the expiry date stated on the carton and label.
The expiry date (EXP) 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 no longer required. This will help protect the environment.

6. Package contents and other information

What Azimycin contains

The active substance of the medicine is azithromycin in the form of azithromycin dihydrate.
Azimycin, 100 mg/5 mL: 5 mL of the prepared suspension contains 100 mg of azithromycin.
Azimycin, 200 mg/5 mL: 5 mL of the prepared suspension contains 200 mg of azithromycin.
Other ingredients are: anhydrous sodium carbonate, sodium benzoate (E 211), sodium carmellose, glycine, titanium dioxide, anhydrous colloidal silica, sodium lauryl sulfate, raspberry flavor, strawberry flavor, orange flavor, sucrose.

What Azimycin looks like and contents of the pack

Powder, white to light yellow, after adding water forms a homogeneous suspension, white to light yellow.

Packaging

Azimycin, 100 mg/5 mL:1 bottle, in a cardboard box, containing 10 g of powder.
Azimycin, 200 mg/5 mL:1 bottle, in a cardboard box, containing 10 g or 15 g of powder.
A measuring spoon with a scale and a dosing syringe are attached to each package.
Azimycin is also available in the form of film-coated tablets with a strength of 125 mg, 250 mg, and 500 mg.

Marketing authorization holder and manufacturer

Tarchomińskie Zakłady Farmaceutyczne "Polfa" S.A.
ul. A. Fleminga 2
03-176 Warsaw
Phone number: 22-811-18-14
To obtain more detailed information about this medicine, the patient should contact the representative of the marketing authorization holder.

Date of last revision of the leaflet:

INSTRUCTIONS FOR PREPARING THE MEDICINE FOR USE

The measuring spoon with a scale allows for the administration of 1.25 mL, 2.5 mL, and 5 mL of the suspension.
The dosing syringe allows for the administration of up to 5 mL of the suspension with an accuracy of 0.1 mL.
Azimycin, 100 mg/5 mL
5 mL of the suspension contains 100 mg of azithromycin;
2.5 mL of the suspension contains 50 mg of azithromycin;
1.25 mL of the suspension contains 25 mg of azithromycin;
0.1 mL of the suspension contains 2 mg of azithromycin.
Azimycin, 200 mg/5 mL
5 mL of the suspension contains 200 mg of azithromycin;
2.5 mL of the suspension contains 100 mg of azithromycin;
1.25 mL of the suspension contains 50 mg of azithromycin;
0.1 mL of the suspension contains 4 mg of azithromycin.

Preparing the suspension for oral use

Azimycin, 100 mg/5 mL Bottle containing 10 g of powder (35 mL capacity)

To the bottle containing 10 g of powder, add, using the dosing syringe, 14 mL of boiled, cooled water - 20 mL of the suspension is obtained. Shake until a homogeneous suspension is obtained.

Azimycin, 200 mg/5 mL Bottle containing 10 g of powder (35 mL capacity)

To the bottle containing 10 g of powder, add, using the dosing syringe, 14 mL of boiled, cooled water - 20 mL of the suspension is obtained. Shake until a homogeneous suspension is obtained.
Bottle containing 15 g of powder (60 mL capacity)
To the bottle containing 15 g of powder, add, using the dosing syringe, 21 mL of boiled, cooled water - 30 mL of the suspension is obtained. Shake until a homogeneous suspension is obtained.
The prepared oral suspension should be stored at a temperature below 25°C, for no longer than 5 days.
Before each use, the prepared oral suspension should be shaken vigorously.
After administering the medicine to a child, they should be given some tea or juice to drink to prevent the medicine from staying in the mouth.