Sumamed

Leaflet attached to the packaging: patient information

Sumamed, 250 mg, tablets for oral suspension

Sumamed, 500 mg, tablets for oral suspension

Sumamed, 1000 mg, tablets for oral suspension

Azithromycin
Read the contents of 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 Sumamed and what is it used for
• 2. Important information before taking Sumamed
• 3. How to take Sumamed
• 4. Possible side effects
• 5. How to store Sumamed
• 6. Package contents and other information

1. What is Sumamed and what is it used for

Sumamed contains the active substance azithromycin, which is an antibiotic belonging to the group called macrolides. It is used to treat infections caused by microorganisms such as bacteria sensitive to azithromycin. These infections include:

• Infections of the upper respiratory tract, such as sinuses, throat, and tonsils (see also "Warnings and precautions" in section 2.)
• Acute middle ear infection
• Chest infections (lower respiratory tract infections), such as acute bronchitis, exacerbation of chronic bronchitis, and community-acquired pneumonia of mild to moderate severity, including interstitial pneumonia
• Mild to moderate skin and soft tissue infections, such as folliculitis (infection in the hair follicles of the skin), cellulitis (infection in the deeper layers of the skin and tissues beneath), and erysipelas (infection in the upper layer of the skin)
• Erythema migrans (the first symptom of Lyme disease) in cases where antibiotics such as doxycycline, amoxicillin, and cefuroxime axetil cannot be used (see also section 2 "Warnings and precautions")
• Uncomplicated infections caused by the bacterium Chlamydia trachomatis, which can cause urethritis (inflammation of the urethra) or cervicitis (inflammation of the cervix).

2. Important information before taking Sumamed

When not to take Sumamed:

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

Warnings and precautions

Before starting treatment with Sumamed, consult a doctor or pharmacist:

• if the patient experiences symptoms of an allergic reaction, such as red or white spots on the skin, itching, and skin irritation, swelling of the skin, throat (larynx), or tongue, and difficulty breathing, they should stop taking Sumamed
• if the patient has liver function disorders, as liver function may need to be monitored by a doctor or treatment may need to be discontinued
• if the patient has kidney function disorders, as the dose may need to be adjusted by a doctor
• if the patient is taking ergotamine or dihydroergotamine (used to treat migraines), as azithromycin is not recommended in this combination (see also section "Sumamed and other medicines")
• if the patient experiences symptoms of another infection
• if the patient experiences diarrhea or loose stools during or after treatment. In some cases, there is a risk of developing severe colitis known as Clostridioides difficile-associated diarrhea. Do not take any anti-diarrheal medication without consulting a doctor first.
• if the patient has conditions that predispose to cardiac arrhythmias (particularly important in women and elderly patients):
• if the patient has a prolonged QT interval (heart disease)
• if the patient is taking medications that prolong the QT interval (see section "Sumamed and other medicines")
• if the patient has low potassium or magnesium levels in the blood
• if the patient has heart diseases, such as slow or irregular heartbeat or decreased heart function
• if the patient has a certain type of muscle weakness known as myasthenia gravis. Sumamed may worsen or trigger myasthenia symptoms.
• if the patient has nervous system diseases or mental disorders
• if the patient has a sexually transmitted disease caused by a certain pathogen (T. pallidum, including the pathogen that causes syphilis).

Treatment of erythema migrans with azithromycin should be carefully monitored by a doctor, as it may fail. If symptoms persist after completion of azithromycin treatment or if the patient notices any new and persistent symptoms, they should consult a doctor.

Sumamed and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take. If you are taking or have recently taken any of the following medicines, tell your doctor:

• medicines that prolong the QT interval, such as anti-arrhythmic medicines (used to treat heart rhythm disorders, e.g., quinidine, procainamide, dofetilide, amiodarone, sotalol), hydroxychloroquine (used to treat rheumatologic diseases or malaria), cisapride (used to treat stomach disorders), terfenadine (used to treat allergies), pimozide, phenothiazines (used to treat certain psychiatric disorders/mood disorders), citalopram (used to treat depression), and antibacterial medicines such as moxifloxacin, levofloxacin (see also section "Warnings and precautions")
• antacids (used to treat heartburn and indigestion, e.g., aluminum hydroxide). Sumamed should be taken at least 1 hour before or 2 hours after taking antacids
• digoxin (used to treat heart failure), as digoxin levels in the blood may increase
• colchicine (used to treat gout and familial Mediterranean fever), as colchicine levels in the blood may increase
• zidovudine (used to treat HIV), as zidovudine levels may increase
• nelfinavir (used to treat HIV), as azithromycin levels may increase
• ergot alkaloids, e.g., ergotamine (used to treat migraines). Azithromycin should not be taken at the same time due to the risk of ergotism (potentially severe side effects with symptoms of numbness or tingling in the limbs, muscle cramps, headaches, seizures, abdominal pain, or chest pain)
• astemizole (an antihistamine), as its effect may be enhanced
• alfentanil (a pain reliever), as its effect may be enhanced
• atorvastatin (a medicine used to lower cholesterol), as there have been reports of rhabdomyolysis (increased risk of muscle tissue damage) in patients taking azithromycin and atorvastatin at the same time
• hydroxychloroquine (used to treat rheumatologic diseases or malaria) may increase the risk of heart problems
• cisapride (used to treat stomach disorders), as it may increase the risk of heart problems
• warfarin (used to prevent blood clots), as the risk of bleeding may increase
• cyclosporin (used to prevent organ rejection), as cyclosporin levels may be elevated and regular monitoring of cyclosporin levels in the blood may be necessary
• theophylline (used to treat breathing problems), as azithromycin may increase its levels.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before taking this medicine. Sumamed should not be taken during pregnancy unless absolutely necessary. The medicine should only be taken during pregnancy if, in the doctor's opinion, it is necessary. Breastfeeding should not be done while taking azithromycin, as it may cause side effects, including diarrhea and infection in the baby. Breastfeeding can be resumed 2 days after stopping azithromycin treatment.

Driving and using machines

There is no data on the effect of azithromycin on the ability to drive and use machines. However, Sumamed may cause side effects such as dizziness and seizures, which may affect reaction time and impair the ability to actively participate in traffic or operate machinery. If such side effects occur, do not drive or operate machinery.

Sumamed contains aspartame

Sumamed, 250 mg, tablets for oral suspension: This medicine contains 19.5 mg of aspartame in each tablet for oral suspension. Aspartame is a source of phenylalanine. It may be harmful to patients with phenylketonuria. This is a rare genetic disorder in which phenylalanine accumulates in the body due to its improper excretion. Sumamed, 500 mg, tablets for oral suspension: This medicine contains 39.0 mg of aspartame in each tablet for oral suspension. Aspartame is a source of phenylalanine. It may be harmful to patients with phenylketonuria. This is a rare genetic disorder in which phenylalanine accumulates in the body due to its improper excretion. Sumamed, 1000 mg, tablets for oral suspension: This medicine contains 78.0 mg of aspartame in each tablet for oral suspension. Aspartame is a source of phenylalanine. It may be harmful to patients with phenylketonuria. This is a rare genetic disorder in which phenylalanine accumulates in the body due to its improper excretion.

Sumamed contains benzyl alcohol

This medicine contains less than 1 mg of benzyl alcohol in each tablet for oral suspension. Benzyl alcohol may cause allergic reactions. Do not give to young children (under 3 years) for more than a week without consulting a doctor or pharmacist. Pregnant or breastfeeding women and patients with liver or kidney diseases should consult a doctor before taking the medicine, as a large amount of benzyl alcohol may accumulate in their bodies and cause side effects (metabolic acidosis).

Sumamed contains glucose (maltodextrin component)

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

Sumamed contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to take Sumamed

This medicine should always be taken as directed by a doctor. In case of doubts, consult a doctor or pharmacist. Recommended dose:

Dosing in adults, including the elderly, and in children and adolescents with a body weight of 45 kg or more:

Treatment of upper and lower respiratory tract infections, middle ear infections, skin and soft tissue infections The total dose of 1500 mg of azithromycin can be taken according to a 3-day treatment regimen or a 5-day treatment regimen. 3-day treatment regimen500 mg of azithromycin is taken in a single daily dose for 3 days. 5-day treatment regimenDuring the 5-day treatment regimen, 500 mg of azithromycin is taken on the first day and 250 mg of azithromycin once daily from the second to the fifth day. Treatment of uncomplicated genital infections caused by Chlamydia trachomatis The total dose is 1000 mg of azithromycin, taken as a single dose. Treatment of erythema migrans (the first symptom of Lyme disease) In the treatment of erythema migrans, the total dose of azithromycin is 3000 mg and should be taken according to the following regimen: 1000 mg on the first day, and 500 mg from the second to the fifth day, in single daily doses.

Elderly patients

In elderly patients, the recommended dose for other adult patients is used. It should be taken into account that they may be more prone to severe heart rhythm disorders (arrhythmia of the torsade de pointes type) than younger patients (see also section 2 "Warnings and precautions").

Patients with kidney or liver function disorders:

If the patient has kidney or liver function disorders, they should inform their doctor before taking Sumamed. The doctor will then decide whether dose adjustment is necessary.

Dosing in children and adolescents with a body weight below 45 kg:

• The doctor will determine the most suitable dose for the child based on their body weight.
• It is possible that, due to the child's body weight, this medicine is not suitable for them. In such a case, the doctor will prescribe azithromycin in a different form, such as a suspension.
• The recommended dose is 10 mg/kg body weight, taken as a single dose once daily for 3 days. Alternatively, the same dose can be taken for 5 days - 10 mg/kg body weight on the first day and 5 mg/kg body weight from the second to the fifth day.
• The maximum dose for these patients is 1500 mg.

Method of administration

The tablet should be dissolved by mixing it with a sufficient amount of liquid, such as water, apple juice, or orange juice (at least 30 ml), to obtain a granular suspension. After swallowing the suspension, any remaining residue must be resuspended in a small amount of water and swallowed. The tablet for oral suspension can be taken independently of meals. The dividing line on the tablet is not intended for breaking the tablet.

Overdose of Sumamed

In case of taking a higher dose of Sumamed than recommended, immediatelyconsult a doctor or go to the nearest hospital. Symptoms of overdose are similar to side effects observed after taking the recommended dose of the medicine (see section 4). Typical symptoms of overdose include transient hearing loss, severe nausea, vomiting, and diarrhea. When going to the hospital or doctor, take this leaflet and the packaging with the remaining medicine, so it is known what medicine the patient took.

Missed dose of Sumamed

A missed tablet should be taken as soon as the patient remembers, unless it is almost time for the next dose. Do not take a double dose to make up for a missed dose. The next dose should be taken at the scheduled time. In case of doubts, consult a doctor or pharmacist. Despite missing a dose, all prescribed tablets should be taken. This means that the therapy will be completed one day later.

Stopping Sumamed treatment

Do not stop taking Sumamed without first consulting a doctor, even if the patient feels better. If the prescribed treatment is not completed, the infection may recur. In case of further doubts about taking this medicine, consult a doctor or pharmacist.

4. Possible side effects

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

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

• Severe allergic reactions (such as anaphylactic reaction or angioedema), which may include sudden difficulty breathing and swallowing, swelling of the lips, tongue, face, and throat, itching, and rash, especially if it occurs all over the body.
• Severe skin reactions: a 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 of the lips, eyes, mouth, nose, and genitals, associated with high fever and joint pain. This may be "acute generalized exanthematous pustulosis" (AGEP), "erythema multiforme", "Stevens-Johnson syndrome", or "toxic epidermal necrolysis".
• Severe allergic reaction that may include fever, skin rash, swelling of organs, increased number of a certain type of white blood cell (eosinophilia), and inflammation of internal organs (drug rash with eosinophilia and systemic symptoms (DRESS)).
• Severe or persistent diarrhea with blood or mucus. This symptom may occur during or after treatment and may indicate severe intestinal inflammation.
• Severe liver disorders or liver failure (rarely life-threatening): symptoms may include fatigue associated with yellowing of the skin or whites of the eyes (cholestatic jaundice), dark urine, bleeding tendency.
• Kidney inflammation or kidney failure: symptoms may include increased need to urinate at night, tremors and muscle cramps, loss of appetite, nausea or vomiting, unpleasant taste in the mouth.
• Unusual tendency to bruise or bleed: these may be symptoms of a blood disorder characterized by a decreased number of platelets (thrombocytopenia).
• Rapid (ventricular tachycardia) or irregular heartbeat or changes in heart rhythm on an electrocardiogram (prolonged QT interval and torsade de pointes-type arrhythmias).

The following other side effects have been reported:

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,
• changes in white blood cell count and bicarbonate levels in the blood.

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

• fungal or bacterial infections:
• thrush, fungal infection caused by Candida
• vaginal infection
• pneumonia
• pharyngitis
• gastroenteritis
• respiratory disorders, such as shortness of breath, chest pain, wheezing, and cough (respiratory disorders)
• rhinitis (runny or stuffy nose)
• decreased white blood cell count,
• allergic reactions,
• loss of appetite (anorexia),
• nervousness, difficulty sleeping (insomnia),
• dizziness, drowsiness, taste disorders, numbness or tingling in the limbs (paresthesia),
• vision disorders,
• hearing disorders or tinnitus,
• rapid or irregular heartbeat, which may be accompanied by a feeling of palpitations
• hot flashes,
• shortness of breath,
• epistaxis (nosebleed),

Rare(may affect up to 1 in 1000 people):

• agitation
• liver disorders, yellowing of the skin or whites of the eyes (jaundice),
• allergic reactions to sunlight.

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

• decreased red blood cell count (hemolytic anemia),
• aggressive behavior, anxiety, hallucinations,
• loss of consciousness (syncope), seizures, sensory disturbances (paresthesia), excessive psychomotor activity, changes in smell (loss of smell, smell disorders), loss of taste, worsening or exacerbation of muscle fatigue (myasthenia)
• hearing loss or tinnitus
• decreased blood pressure,
• pancreatitis, tongue discoloration,
• liver inflammation,
• joint pain.

The following side effects have been reported in connection with the prevention and treatment of Mycobacterium avium complex infections:

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

• diarrhea, abdominal pain, nausea, bloating with gas, loose stools.

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

• loss of appetite (anorexia),
• dizziness, headaches, numbness or tingling in the limbs (paresthesia), changes in taste,
• vision disorders,
• deafness,
• rash, itching,
• joint pain,
• fatigue.

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

• sensory disturbances (paresthesia),
• hearing disorders or tinnitus,
• rapid or irregular heartbeat, which may be accompanied by a feeling of palpitations
• liver inflammation,
• severe skin reaction (Stevens-Johnson syndrome), allergic reactions to sunlight,
• general malaise, weakness (asthenia).

Reporting side effects

If side effects occur, including any not listed in this leaflet, tell a doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Sumamed

Keep the medicine out of the sight and reach of children.

Do not take this medicine after the expiration date stated on the carton and blister after "EXP". The expiration date refers to the last day of the month. There are no special storage instructions for the medicine. Medicines should not be disposed of via wastewater or household waste. Ask a pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Sumamed contains

• The active substance of Sumamed is azithromycin (in the form of azithromycin dihydrate). Each 250 mg tablet for oral suspension contains 250 mg of azithromycin (in the form of azithromycin dihydrate).

Each 500 mg tablet for oral suspension contains 500 mg of azithromycin (in the form of azithromycin dihydrate). Each 1000 mg tablet for oral suspension contains 1000 mg of azithromycin (in the form of azithromycin dihydrate).

• Other ingredients of the medicine are: sodium saccharin, microcrystalline cellulose PH101, microcrystalline cellulose PH102, crospovidone type A, povidone K30, sodium lauryl sulfate, colloidal anhydrous silica, magnesium stearate, aspartame (E 951), orange flavor (contains flavoring ingredients, corn maltodextrin (contains glucose), benzyl alcohol, and α-tocopherol) (see also section 2 "Sumamed contains aspartame, benzyl alcohol, glucose sodium").

What Sumamed looks like and contents of the pack

Sumamed, 250 mg, tablets for oral suspension are white to almost white, round, flat tablets with beveled edges and a dividing line on one side and the inscription "TEVA 250" on the other side. Each tablet has a diameter of approximately 12.5 mm. Sumamed, 500 mg, tablets for oral suspension are white to almost white, round, flat tablets with beveled edges and a dividing line on one side and the inscription "TEVA 500" on the other side. Each tablet has a diameter of approximately 17 mm. Sumamed, 1000 mg, tablets for oral suspension are white to almost white, round, flat tablets with beveled edges and perpendicular dividing lines on one side and the inscription "TEVA 1000" on the other side. Each tablet has a diameter of approximately 22 mm. Sumamed, 250 mg, 500 mg is available in PVC/PE/PVDC/PE/PVC/Aluminum blisters containing 3, 6, 12, or 24 tablets for oral suspension. Sumamed 1000 mg is available in PVC/PE/PVDC/PE/PVC/Aluminum blisters containing 1, 2, 3, or 6 tablets for oral suspension.

Marketing authorization holder

Teva Pharmaceuticals Polska Sp. z o.o. ul. Emilii Plater 53, 00-113 Warsaw tel.: (22) 345 93 00

Manufacturer

Teva Operations Poland Sp. z o.o. ul. Mogilska 80, 31-546 Kraków Pliva Hrvatska d.o.o. (Pliva Croatia Ltd.) Prilaz Baruna Filipoviča 25, 10000 Zagreb, Croatia

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Spain Azitromicina Teva Lithuania Azithromycin Teva Poland Sumamed Portugal Sumamed Date of last revision of the leaflet:June 2023