Sumamed

Leaflet attached to the packaging: patient information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Sumamed(Azithromycin 500 mg Teva)
500 mg, film-coated tablets
Azithromycin
Sumamed and Azithromycin 500 mg Teva are different trade names for the same medicine.
You should carefully read the contents of the leaflet before taking 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.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness 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. Contents of the packaging and other information

1. What is Sumamed and what is it used for

Sumamed contains the active substance azithromycin, which is a macrolide antibiotic with a broad spectrum of activity. It has a bactericidal effect on susceptible microorganisms.
Sumamed, 500 mg, film-coated tablets, 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 community-acquired pneumonia, including interstitial pneumonia.
• Skin and soft tissue infections: erythrasma, impetigo, and secondary infected dermatitis; erythema migrans - the first sign of Lyme disease; moderate acne, exclusively in adults.
• Sexually transmitted diseases: uncomplicated infections caused by Chlamydia trachomatis.

2. Important information before taking Sumamed

When not to take Sumamed

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

Warnings and precautions

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

• the patient has conditions that may lead to the development of arrhythmias (especially in women and elderly patients):
• congenital or previously occurring arrhythmias (visible in the ECG - a test of heart electrical activity),
• severe heart failure,
• very slow heart rate (called bradycardia),
• electrolyte disturbances in the blood, especially low potassium and magnesium levels,
• the patient is taking other medicines that may cause prolongation of the QT interval in the ECG (see "Sumamed and other medicines”);
• the patient has severe kidney problems;
• the patient has severe liver problems: the doctor may monitor liver function or discontinue treatment;
• the patient has a new infection (this may indicate excessive growth of resistant microorganisms or a fungal infection);
• the patient has neurological (neurological) or mental (psychiatric) 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 (ergot preparations);
• the patient has infected burn wounds.

You should also read the warnings in section 4.
If, despite treatment, the symptoms of the infection do not disappear or new symptoms of another infection appear, e.g. fungal,
you should consult your doctor again.
Infections caused by streptococci
In the treatment of pharyngitis and tonsillitis caused by streptococci, penicillin is usually the drug of choice.
Pseudomembranous colitis
If diarrhea occurs, you should immediately report it to your doctor, as it may be a sign of
pseudomembranous colitis - a complication that sometimes occurs during the use of macrolide antibiotics.
Such a diagnosis should be considered by the doctor 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 Sumamed 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 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 myasthenic syndrome (see "Possible side effects”) has been observed.

Children and adolescents

Sumamed in the form of 500 mg film-coated tablets is recommended for use in children only with a body weight of not less than 45 kg. For the remaining group of children, it is recommended to use Sumamed in the form of an oral suspension or 125 mg film-coated tablets.

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 any of the following medicines, it is especially important to tell their doctor or pharmacist:

• medicines that affect the QT interval, such as
• quinidine, procainamide, dofetilide, amiodarone, sotalol (used to treat arrhythmias),
• hydroxychloroquine (used to treat rheumatologic diseases or malaria),
• 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 (Sumamed 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, when used with azithromycin, may cause ergotism (symptoms - spasm of peripheral blood vessels and ischemia);
• digoxin (used to treat heart rhythm disorders) and 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).

Sumamed with food and drink

Sumamed in the form of 500 mg film-coated tablets can be taken regardless of meals.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, 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, in the doctor's opinion, 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 recommends otherwise.
Fertility
In fertility studies conducted in rodents, a decrease in the conception rate 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 Sumamed on the ability to drive and use machines.
However, when performing such activities, one should take into account the possibility of side effects such as dizziness and seizures.

Sumamed contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per dose, which means that the medicine is considered "sodium-free”.

3. How to take Sumamed

This medicine should always be taken as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.
The medicine is taken orally.
Dosing in adults, including the elderly, and in children and adolescents with a body weight over 45 kg

Infections of the upper and lower respiratory tract, otitis media, skin and soft tissue infections (except for erythema migrans and moderate acne)
The total dose of azithromycin is 1.5 g over 3 days (500 mg in a single daily dose).
Alternatively, the same total dose (1500 mg) can also be administered over 5 days: 500 mg on the first day of treatment and 250 mg from the second to the fifth day of treatment.
Erythema migrans
The total dose is 3 g and should be taken in the following regimen: 1 g (2 film-coated tablets of 500 mg) on the first day, and then 500 mg (1 film-coated tablet) from the second to the fifth day, in single daily doses.
Moderate acne - exclusively in adults
The total dose is 6 g and is recommended to be administered in the following regimen: 1 film-coated tablet of 500 mg once a day for 3 days, and then 1 film-coated tablet of 500 mg once a week for the next 9 weeks.
In the second week of treatment, the medicine should be taken 7 days after the first dose, and the next eight doses should be taken at 7-day intervals.
Due to the use of a high dose of azithromycin in the above dosing regimen for moderate acne, it is necessary to monitor liver enzyme activity before and during the course of treatment with azithromycin.
The above regimen of cyclic treatment of moderate acne (3 days + 9 weeks) can only be used once in a given patient, as there are no controlled clinical trials that have demonstrated the safety and efficacy of repeating this regimen for moderate acne.
Uncomplicated infections caused by Chlamydia trachomatis
1 g (2 film-coated tablets of 500 mg) in a single dose.
Patients with kidney or liver problems
If the patient has kidney or liver problems, they should tell their doctor, as it may be necessary 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 taken orally, once a day.
Sumamed in the form of 500 mg film-coated tablets can be taken regardless of meals.
The tablets should be swallowed whole.

Overdose of Sumamed

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 after 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, life-supporting treatment.

Missed dose of Sumamed

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, 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 their doctor or go to the emergency department of the nearest hospital:

• Severe allergic reaction (sudden difficulty breathing and swallowing, swelling of the lips, tongue, face, and throat, itching rash, especially occurring all over the body).
• Severe skin reactions: a 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), "Stevens-Johnson syndrome", "toxic epidermal necrolysis".
• Severe allergic reaction that may include fever, skin rash, organ swelling, increased number of a certain type of white blood cell (eosinophilia), and inflammation of internal organs (drug rash with eosinophilia and systemic symptoms (DRESS)).

The patient should also stop taking Sumamed and immediately consult their doctor if they notice:

• Severe or chronic diarrhea with blood or mucus. This symptom may occur during or after treatment and may indicate serious colitis.
• Weakness, yellowing of the skin or whites of the eyes, and dark urine.
• Unusual tendency to bruise or bleed.
• Rapid (ventricular tachycardia) or irregular heartbeat or changes in heart rhythm on the electrocardiogram (prolongation of the QT interval and torsade de pointes).

The following side effects have been reported:
Very common(may occur in more than 1 in 10 patients):

• diarrhea.

Common(may occur in up to 1 in 10 patients):

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

Uncommon(may occur in up to 1 in 100 patients):

• fungal infections (candidiasis), vaginal infection, pneumonia, fungal infection, bacterial infection, pharyngitis, gastrointestinal upset, respiratory disorders, rhinitis, oral thrush;
• 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, drowsiness, taste disorders, abnormal skin sensations, e.g. tingling and numbness of limbs (paresthesia);
• visual disturbances;
• hearing disorders, balance disorders;
• palpitations;
• flushing;
• shortness of breath, nosebleeds;
• constipation, bloating with gas, indigestion, gastritis, swallowing disorders (dysphagia), bloated stomach, dry mouth, belching, oral ulcers, excessive salivation;
• rash, itching, urticaria, skin inflammation, 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 swelling, chest pain, fever, pain, peripheral edema;
• abnormal laboratory test results (e.g. blood, liver function, glucose, electrolytes);
• post-procedural complications.

Rare(may occur in up to 1 in 1000 patients):

• agitation;
• liver function disorders, jaundice with bile stasis (cholestatic jaundice);
• hypersensitivity to light, severe skin reactions: a rash characterized by rapid onset of areas of redness on the skin covered with small blisters (blisters filled with white or yellow fluid).

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

• pseudomembranous colitis;
• thrombocytopenia (decreased platelet count), decreased red blood cell count (hemolytic anemia);
• anaphylactic reaction (generalized allergic reaction, which can rarely be fatal; may occur with symptoms such as: swelling of the lips, face, or throat, leading to severe breathing difficulties, rash on the skin or urticaria);
• aggressive behavior, anxiety, hallucinations, delusions;
• loss of consciousness (syncope), seizures, sensory disturbances (hypoesthesia), excessive psychomotor activity, loss of smell, loss of taste, smell disorders, hearing disturbances, including deafness and (or) tinnitus;
• heart rhythm disorders (including torsade de pointesand ventricular tachycardia), prolongation of the QT interval in the electrocardiogram;
• decrease in blood pressure;
• pancreatitis, tongue discoloration;
• liver failure (rarely leading to death), fulminant hepatitis, liver necrosis;
• severe skin reactions: Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, drug rash with eosinophilia and systemic symptoms (DRESS);
• joint pain;
• acute kidney failure, interstitial nephritis.

Side effects probably or possibly related to the use of azithromycin in the treatment of infections caused by mycobacteria of the Mycobacterium aviumcomplex or prevention of them, 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 up to 1 in 10 patients):

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

Uncommon(may occur in up to 1 in 100 patients):

• sensory disturbances (hypoesthesia);
• hearing disturbances, tinnitus;
• palpitations;
• hepatitis;
• Stevens-Johnson syndrome (severe skin reaction), hypersensitivity to light;
• weakness (asthenia), malaise.

Reporting side effects

If side effects occur, including any side effects not listed in this leaflet, the patient should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Pharmacovigilance 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.
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Sumamed

• The medicine should be stored out of sight and reach of children.
• There are no special recommendations for storage.
• The medicine should not be used after the expiry date stated on the packaging. The expiry date refers to the last day of the specified 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. Contents of the packaging and other information

What Sumamed contains

• The active substance of the medicine is azithromycin in the form of azithromycin dihydrate. Each film-coated tablet contains 500 mg of azithromycin.
• The other ingredients of the medicine are: tablet core: calcium hydrogen phosphate, hypromellose, maize starch, pregelatinized starch, microcrystalline cellulose, sodium lauryl sulfate, magnesium stearate; coating: hypromellose, indigo carmine, lake (E 132), titanium dioxide (E 171), polysorbate 80, talc.

What Sumamed looks like and what the pack contains

Sumamed is a light blue, elongated, biconvex film-coated tablet with the inscription "Al 500" and a dividing line on one side. The tablet can be divided into two equal doses.
The packaging contains 3, 6, or 12 film-coated tablets, in a cardboard box.
For more detailed information, the patient should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in the Netherlands, the country of export:

Teva Nederland B.V.
Swensweg 5
2031 GA Haarlem, Netherlands

Manufacturer:

Pliva Croatia Ltd.
Prilaz baruna Filipovića 25
10000 Zagreb, Croatia
Teva Operations Poland Sp. z o.o.
ul. Mogilska 80
31-546 Krakow, Poland
Merckle GmbH
Ludwig Merckle Straße 3
89143 Blaubeuren, Germany

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Netherlands marketing authorization number:RVG 28934

Netherlands parallel import authorization number: 332/22 Date of leaflet approval: 07.09.2022

[Information about the trademark]