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
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 further questions, you should ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your 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. Contents of the pack 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 mild to moderate community-acquired pneumonia, 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 you are allergic to azithromycin or any of the other ingredients of this medicine (listed in section 6)
• If you are allergic to erythromycin or other macrolide or ketolide antibiotics.

Warnings and precautions

Before taking Sumamed, you should consult your doctor or pharmacist:

• if you experience 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, you should stop taking Sumamed
• if you have liver function disorders, as there may be a need to monitor liver function by your doctor or to discontinue treatment
• if you have kidney function disorders, as there may be a need to adjust the dose by your doctor
• if you are taking ergotamine or dihydroergotamine (used to treat migraine), as azithromycin is not recommended in this combination (see also "Sumamed and other medicines")
• if you experience symptoms of another infection
• if you experience diarrhea or loose stools during or after treatment. In some cases, there is a risk of developing a severe intestinal infection known as Clostridioides difficile-associated diarrhea. You should not take any anti-diarrheal medication without consulting your doctor first.
• if you have conditions that predispose to cardiac arrhythmias (especially in women and elderly patients):
• if you have a prolonged QT interval (heart disease)
• if you are taking medications that prolong the QT interval (see "Sumamed and other medicines")
• if you have low potassium or magnesium levels in your blood
• if you have heart diseases, such as slow or irregular heartbeat or reduced heart function
• if you have a certain type of muscle weakness known as myasthenia gravis. Sumamed may worsen or trigger myasthenic symptoms.
• if you have nervous system diseases or mental disorders
• if you have 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 your doctor,
as it may fail.
If symptoms persist after completion of azithromycin treatment or if you notice any new and persistent symptoms, you should consult your doctor.

Sumamed and other medicines

You should tell your doctor or pharmacist about all the medicines you are taking, or have recently taken,
and about any medicines you plan to take.
If you are taking or have recently taken any of the following medicines, you should 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), citalopram (used to treat depression) and antibacterial medicines such as moxifloxacin, levofloxacin (see also "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 migraine). 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 of limbs, muscle cramps, headaches, seizures, abdominal pain or chest pain)
• astemizole (an antihistamine), as its effect may be increased
• alfentanil (a pain reliever), as its effect may be increased
• 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 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 increased 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 you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Sumamed should not be used during pregnancy, unless it is absolutely necessary. The medicine should only be used during pregnancy if your doctor considers it necessary.
You should not breastfeed if you are taking azithromycin, as it may cause side effects, including diarrhea and infection in the baby. You can resume breastfeeding after 2 days of 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 your reaction time and ability to participate actively 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 one week without consulting a doctor or pharmacist.
Pregnant or breastfeeding women and patients with liver or kidney disease should consult their 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 (a component of maltodextrin)

If you have been diagnosed with an intolerance to some sugars, you should consult your 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 your doctor. If you are unsure, you should ask your 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 administered according to a 3-day treatment regimen or a 5-day treatment regimen.
3-day treatment regimen
500 mg of azithromycin is taken as 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 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, as a single daily dose.

Elderly patients

In elderly patients, the recommended dose is the same as for other adult patients.
However, 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 you have kidney or liver function disorders, you should tell your doctor before taking Sumamed. Your doctor will then decide whether it is necessary to adjust the dose.

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

• Your doctor will determine the most suitable dose for your 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, your doctor will prescribe azithromycin in a different form, such as a suspension.
• The recommended dose is 10 mg/kg body weight, administered as a single dose once daily for 3 days. Alternatively, the same dose can be administered 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 in 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 re-suspended in a small amount of water and swallowed.
The tablet for oral suspension can be taken with or without food.
The break line on the tablet is not intended for breaking the tablet.

Overdose of Sumamed

In case of overdose, you should immediatelyconsult your 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, you should take this leaflet and the packaging with the remaining medicine, so that it is known what medicine you have taken.

Missing a dose of Sumamed

A missed tablet should be taken as soon as you remember, unless it is almost time for the next dose. You should not take a double dose to make up for a missed dose.
The next dose should be taken at the scheduled time. If you are unsure, you should consult your doctor or pharmacist.
Despite missing a dose, you should take all the prescribed tablets. This means that the therapy will be completed one day later.

Stopping Sumamed treatment

You should not stop taking Sumamed without first consulting your doctor, even if you feel better. If the prescribed treatment is not completed, the infection may recur.
If you have any further questions about taking this medicine, you should ask your 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, you should stop taking Sumamed and immediately consult your 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 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 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, swollen 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 a serious intestinal infection.
• severe liver disorders or liver failure (rarely life-threatening): symptoms may include fatigue associated with yellowing of the skin or whites of the eyes (jaundice), dark urine, tendency to bleed.
• kidney inflammation or kidney failure: symptoms may include increased need to urinate at night, trembling 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 reduced 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 blood bicarbonate levels.

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)
• reduced white blood cell count,
• allergic reactions,
• loss of appetite (anorexia),
• nervousness, difficulty sleeping (insomnia),
• dizziness, drowsiness, taste disorders, numbness or tingling of limbs (paresthesia),
• vision disorders,
• hearing disorders or ringing in the ears,
• rapid heartbeat, which may be fast or irregular
• hot flushes,
• shortness of breath,
• nasal bleeding,
• constipation, bloating with gas, indigestion, stomach inflammation, swallowing disorders (dysphagia), bloated stomach, dry mouth, belching, or regurgitation of stomach contents or gas, oral thrush, excessive salivation,
• rash, itching, urticaria, skin inflammation, dry skin, excessive sweating,
• joint pain, swelling, and reduced mobility (arthritis), muscle pain (myalgia), back pain, neck pain,
• urinary tract 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 blood urea levels,
• post-procedure complications.

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

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

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

• reduced 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 disturbances), 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, headache, numbness or tingling of 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 ringing in the ears,
• rapid heartbeat, which may be fast or irregular,
• liver inflammation,
• severe skin reaction (Stevens-Johnson syndrome), sensitivity to light,
• malaise, weakness (asthenia).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your 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, you can help provide more information on the safety of this medicine.

5. How to store Sumamed

The medicine should be stored out of the 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.
There are no special precautions for storage.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack 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).

• The other ingredients of the medicine are: sodium saccharin, microcrystalline cellulose PH101, microcrystalline cellulose PH102, crospovidone type A, povidone K30, sodium lauryl sulfate, anhydrous colloidal 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 break line on one side and embossed with "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 break line on one side and embossed with "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 break lines on one side and embossed with "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