Sumamed

Leaflet accompanying 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
You should carefully read the contents of the leaflet before using the medicine,
as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should 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 side effects 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 a 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 in 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 case 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, the patient should 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. No anti-diarrheal medication should be taken without consulting a doctor first.
• if the patient has conditions that predispose to 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 heart rhythm or reduced 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 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 end in failure.
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

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 or has recently taken any of the following medicines, they should tell their 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), 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 levels), 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 it is absolutely necessary. The medicine should only be taken during pregnancy if, in the doctor's opinion, it is necessary.
Breastfeeding should not be done if the patient is 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, the patient should 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.
It should not be given to young children (under 3 years) for more than a week without the advice of a doctor or pharmacist.
Pregnant or breastfeeding women and patients with liver or kidney disease should consult a doctor before taking this medicine, as a large amount of benzyl alcohol may accumulate in their body and cause side effects (so-called 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 this 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 the doctor. If the patient has any doubts, they should 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 infection, 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 regimen
500 mg of azithromycin is taken in a single daily dose for 3 days.
5-day treatment regimen
During the 5-day treatment regimen, 500 mg of azithromycin is taken on the first day and 250 mg of azithromycin is taken 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 then 500 mg from the second to the fifth day, in single daily doses.

Elderly patients

In elderly patients, the recommended dose for other adults should be used.
It should be taken into account that they may be more prone to severe heart rhythm disorders (arrhythmia of the torsades 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 tell their doctor before taking Sumamed. The doctor will then decide whether it is necessary to adjust the dose.

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 of 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 of body weight on the first day and 5 mg/kg of 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 in a sufficient amount of liquid, such as water, apple juice or orange juice (at least 30 ml) to obtain a dispersed suspension. After swallowing the suspension, any remaining residue must be re-suspended 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 overdose of Sumamed, the patient should immediatelyconsult a doctor or go to the nearest hospital. The symptoms of overdose are similar to the 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, the patient should take this leaflet and the packaging with the remaining medicine, so that it is known what medicine the patient has taken.

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. A double dose should not be taken to make up for a missed dose.
The next dose should be taken at the scheduled time. If the patient has any doubts, they should consult a doctor or pharmacist.
Despite missing a dose, the patient should take all the prescribed tablets. This means that the therapy will be completed one day later.

Stopping Sumamed treatment

The patient should not stop taking Sumamed without first consulting a doctor, even if they feel better. If the prescribed treatment is not completed, the infection may recur.
If the patient has any further doubts about taking this medicine, they should 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, the patient should stop taking Sumamed and immediately consult a doctor or go to the emergency department of the nearest hospital:

Severe hypersensitivity reactions (such as anaphylactic reaction or angioedema), which may include:

• severe allergic reactions (such as anaphylactic reaction or angioedema), which may include sudden breathing or swallowing difficulties, swelling of the lips, tongue, face, and throat, itching rash, especially if it spreads over the whole 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 from 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 hypersensitivity 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 colitis.
• 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, tendency to bleed.
• 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 in the electrocardiogram (prolonged QT interval and torsades de pointes arrhythmia).

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
• shortness of breath, chest pain, wheezing and cough (respiratory disorders)
• runny nose/stuffy nose (rhinitis)
• 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 heartbeat, which may be fast or irregular
• hot flushes,
• shortness of breath,
• nasal bleeding,
• constipation, bloating with gas, indigestion, inflammation of the stomach lining, swallowing disorders (dysphagia), bloated abdomen, dry mouth, belching with reflux or gas, oral thrush, excessive salivation,
• rash, itching, urticaria, skin inflammation, dry skin, excessive sweating,
• joint pain, swelling and reduced mobility (arthralgia and arthritis), muscle pain (myalgia), back pain, neck pain,
• urinary pain or difficulty urinating (dysuria), kidney pain (renal colic),
• spotting (metrorrhagia), testicular disorders,
• weakness (asthenia), malaise, fatigue, facial swelling, arm and leg swelling, chest pain, fever, pain,
• changes in liver enzyme levels and blood test results, increased urea levels in the blood,
• post-procedural complications.

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

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

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 (hypoaesthesia), excessive psychomotor activity, changes in smell perception (anosmia, smell disorders), loss of taste, worsening or exacerbation of muscle fatigue (myasthenia)
• hearing loss or tinnitus
• low 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 perception,
• vision disorders,
• hearing loss,
• rash, itching,
• joint pain,
• fatigue.

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

• sensory disturbances (hypoaesthesia),
• hearing disorders or tinnitus,
• rapid heartbeat, which may be fast or irregular,
• liver inflammation,
• severe skin reaction (Stevens-Johnson syndrome), allergic reactions to light,
• malaise, weakness (asthenia).

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their 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 gathered on the safety of the medicine.

5. How to store Sumamed

The medicine should be stored out of sight and reach of children.

Do not use this medicine after the expiry date stated on the carton and blister after "EXP". The expiry date refers to the last day of the month stated.
There are no special precautions for storage.
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 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 is approximately 12.5 mm in diameter.
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 is approximately 17 mm in diameter.
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 is approximately 22 mm in diameter.
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