Sumamed

Package leaflet: Information for the patient

Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
Sumamed (Azitromycine 500 mg Teva)
500 mg, film-coated tablets
Azithromycinum
Sumamed and Azitromycine 500 mg Teva are different brand names for the same medicinal product.
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

1. What Sumamed is and what it is 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 Sumamed is and what it is used for

Sumamed contains azithromycin as the active substance, which is an azalide antibiotic belonging to the macrolide group with broad-spectrum activity. It exerts a bactericidal effect against susceptible microorganisms.
Sumamed 500 mg film-coated tablets are indicated for the treatment of the following infections caused by microorganisms sensitive 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, cellulitis, and secondary bacterial skin infections; erythema migrans—the first sign of Lyme borreliosis; moderate acne vulgaris, in adults only.
• Sexually transmitted infections: uncomplicated infections caused by Chlamydia trachomatis.

2. Important information before using Sumamed

When not to use Sumamed

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

Warnings and precautions
Before starting treatment with Sumamed, discuss with your doctor or pharmacist if:

• the patient has conditions predisposing to cardiac arrhythmias (particularly important in women and elderly patients):
• congenital or previous history of cardiac arrhythmia (visible on ECG – electrocardiogram),
• severe heart failure,
• very slow heart rate (called bradycardia),
• electrolyte imbalances in the blood, especially low potassium or magnesium levels,
• taking other medicines that may cause QT interval prolongation on ECG (see section "Sumamed with 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 develops a new infection (this may indicate overgrowth of resistant microorganisms or fungal infection);
• the patient has neurological or psychiatric disorders;
• the patient has a sexually transmitted infection: the doctor should ensure that syphilis is not present;
• the patient is taking ergot derivatives (ergot alkaloids);
• the patient has infected burn wounds.

Also refer to the warnings contained in section 4.
If, despite treatment, symptoms of infection do not improve or new symptoms of infection occur,
e.g. fungal infection, the patient should consult a doctor again.
Streptococcal infections
For treatment of streptococcal pharyngitis and tonsillitis, penicillin is usually the drug of choice.
Pseudomembranous colitis
If diarrhoea occurs, it should be reported immediately to the doctor, as it may be a sign of pseudomembranous colitis – a complication that may sometimes occur during treatment with macrolide antibiotics.
Doctors should consider this diagnosis in patients who develop diarrhoea after starting azithromycin therapy. In cases of pseudomembranous colitis due to azithromycin use, discontinuation of Sumamed and initiation of appropriate treatment may be necessary. Antiperistaltic agents are contraindicated.
Long-term use
There is lack of data on the safety and efficacy of long-term use of azithromycin for the indications listed above. In cases of rapidly recurring infections, the doctor may consider treatment with another antibacterial agent.
Myasthenia
Worsening of myasthenia symptoms or development of a myasthenic syndrome has been observed during azithromycin treatment (see section "Possible side effects").

Children and adolescents
Sumamed tablets 500 mg are recommended for use in children only if body weight is at least 45 kg. For other children, Sumamed oral suspension or 125 mg coated tablets are recommended.

Sumamed with other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned for use.

It is especially important to inform your doctor or pharmacist if the patient is taking any of the following medicines:

• medicines affecting the QT interval, such as:
• quinidine, procainamide, dofetilide, amiodarone, sotalol (used to treat cardiac arrhythmias),
• hydroxychloroquine (used to treat rheumatological diseases or malaria),
• cisapride (used for gastric disorders),
• terfenadine (used to treat allergies),
• antipsychotics, e.g. pimozide,
• antidepressants, e.g. citalopram,
• fluoroquinolones (used for infections), e.g. moxifloxacin, levofloxacin;
• antacids (Sumamed should be taken at least 1 hour before or 2 hours after antacids);
• oral anticoagulants, e.g. warfarin;
• ergot alkaloids (used for migraine or vasoconstriction), e.g. ergotamine: co-administration with azithromycin may lead to ergotism (symptoms: peripheral vasoconstriction and ischemia);
• digoxin (used for heart disorders) and colchicine (used for gout and familial Mediterranean fever);
• cyclosporine (used for skin diseases, rheumatoid arthritis, or after organ transplantation);
• atorvastatin (used to lower cholesterol levels);
• rifabutin (used for HIV or tuberculosis treatment).

Sumamed with food and drink
Sumamed 500 mg coated tablets can be taken with or without food.

Pregnancy, breastfeeding and fertility

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult her doctor or pharmacist before using this medicine.

Pregnancy
This medicine may be used during pregnancy only if, in the opinion of the doctor, the benefit to the mother outweighs the risk to the foetus.

Breastfeeding
Azithromycin passes into human milk. Breastfeeding is not recommended during azithromycin treatment unless otherwise advised by a doctor.

Fertility
In fertility studies conducted in rodents, a decreased pregnancy rate was observed after administration of azithromycin. The relevance of these findings to humans is unknown.

Driving and operating machinery
There are no data on the effect of Sumamed on the ability to drive or operate machinery.
However, when performing such activities, consider the possibility of adverse effects such as dizziness and convulsions.

Sumamed contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. it is considered "sodium-free".

3. How to use Sumamed

This medicine should always be used as directed by the physician. In case of doubt, consult a
physician or pharmacist.
This medicine is taken orally.
Dosage in adults, including elderly patients, and in children and adolescents with body weight
above 45 kg
Upper and lower respiratory tract infections, otitis media, skin and soft tissue infections (except
erythema migrans and acne vulgaris)
The total dose of azithromycin is 1.5 g over 3 days (500 mg as a single daily dose).
Alternatively, the same total dose (1500 mg) may 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 according to the following regimen: 1 g on the first day
(2 film-coated tablets of 500 mg), followed by 500 mg (1 film-coated tablet) from the second to the
fifth day, as single daily doses.
Moderate acne vulgaris – in adults only
The total dose is 6 g and is recommended to be administered according to the following regimen:
1 film-coated tablet of 500 mg once daily for 3 days, followed by 1 film-coated tablet of 500 mg once
weekly for the next 9 weeks.
During the second week of treatment, the medicine should be taken 7 days after the first dose, and
the next eight doses should be taken with 7-day intervals between administrations.
Due to the administration of a high dose of azithromycin in the above regimen for moderate acne
vulgaris, monitoring of liver enzyme activity is required before starting and during the course of
treatment with azithromycin.
The above cyclic regimen for the treatment of moderate acne vulgaris (3 days + 9 weeks) may be
applied only once in a given patient, as there are no controlled clinical trials demonstrating the
safety and efficacy of repeating this treatment regimen for acne vulgaris.
Uncomplicated infections caused by Chlamydia trachomatis
1 g (2 film-coated tablets of 500 mg) as a single dose.
Patients with renal or hepatic impairment
If a patient has renal or hepatic impairment, inform the physician, as dose reduction may be
necessary. This medicine should not be used in patients with severe hepatic impairment.
Method of administration
Azithromycin should be taken orally, once daily.
Sumamed 500 mg film-coated tablets may be taken with or without food.
Tablets should be swallowed whole.
Taking more Sumamed than prescribed
Adverse reactions occurring after taking higher than recommended doses of the medicine were
similar to those reported following administration of correct doses. Characteristic symptoms after
overdose of macrolide antibiotics include: transient hearing loss, severe nausea, vomiting, and
diarrhea.
In case of taking more than the prescribed dose, seek immediate medical advice from a physician
or pharmacist.
In case of overdose, administration of activated charcoal is recommended, along with symptomatic
treatment and, if necessary, supportive measures to maintain vital functions.
If you forget to take Sumamed
If a dose is missed, take it as soon as possible, and then continue with the next doses according to
the prescribed dosing schedule. Do not take a double dose to make up for a missed dose.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the following adverse reactions occur, stop using the medicine
Sumamed and immediately contact a doctor or go to the emergency department of the
nearest hospital:

• Severe hypersensitivity reaction (sudden breathing and swallowing difficulties, swelling of lips, tongue, face and neck, itchy rash, especially if widespread over the body).
• Severe skin reactions: skin eruption characterized by rapid appearance of red skin areas covered with small blisters (vesicles filled with white or yellow fluid); severe skin rash causing redness and peeling; severe blistering and bleeding from lips, eyes, mouth, nose and genital organs, associated with high fever and joint pain. This may be "acute generalized exanthematous pustulosis" (AGEP), "erythema multiforme", "bullous erythema multiforme (Stevens-Johnson syndrome)" or "toxic epidermal necrolysis".
• Severe hypersensitivity reaction that may include fever, skin rash, organ swelling, increase in a certain type of white blood cells (eosinophilia), and inflammation of internal organs (drug reaction with eosinophilia and systemic symptoms (DRESS)).

You should also stop using Sumamed and immediately contact a doctor if you notice:

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

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

• diarrhoea.

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

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

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

• fungal infections (candidiasis), vaginal infection, pneumonia, fungal infection, bacterial infection, sore throat, gastritis and enteritis, respiratory disorders, rhinitis, oral candidiasis;
• change in white blood cell count (leukopenia, neutropenia, eosinophilia);
• angioedema (swelling of face and throat, which may cause breathing difficulties), hypersensitivity;
• loss of appetite (anorexia);
• nervousness, insomnia, dizziness, drowsiness, taste disturbances, unusual skin sensations such as tingling and numbness of limbs (paresthesia);
• visual disturbances;
• ear disorders, balance disorders;
• palpitations;
• hot flushes;
• dyspnoea, nosebleeds;
• constipation, bloating with flatulence, dyspepsia, gastric mucosal inflammation, swallowing difficulties (dysphagia), abdominal distension, dry mouth, regurgitation with vomiting, oral ulcers, excessive salivation;
• rash, itching, urticaria, dermatitis, dry skin, excessive sweating;
• arthropathy, muscle pain, back pain, neck pain;
• urinary disorders (dysuria), kidney pain;
• uterine bleeding, testicular disorders;
• oedema, weakness (asthenia), malaise, feeling of fatigue, facial swelling, chest pain, fever, pain, peripheral oedema;
• abnormal laboratory test results (e.g. blood tests, liver function parameters, glucose, electrolytes);
• post-procedural complications.

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

• agitation;
• liver function disorders, cholestatic jaundice (cholestatic jaundice);
• photosensitivity, severe skin reactions: skin eruption characterized by rapid appearance of red skin areas covered with small blisters (vesicles filled with white or yellow fluid).

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

• pseudomembranous colitis;
• thrombocytopenia (reduced platelet count), reduced number of red blood cells (hemolytic anemia);
• anaphylactic reaction (generalized allergic reaction rarely leading to death; may present with symptoms such as swelling of lips, face or neck leading to severe breathing difficulties, skin rash or urticaria);
• aggressive behaviour, anxiety, delirium, hallucinations;
• loss of consciousness (fainting), seizures, sensory disturbances (hypoesthesia), excessive psychomotor activity, loss of smell, loss of taste, disturbances of smell, rapid muscle fatigue (myasthenia);
• hearing disorders including deafness and (or) tinnitus;
• cardiac arrhythmias (including torsade de pointes and ventricular tachycardia), QT interval prolongation on electrocardiogram;
• hypotension;
• pancreatitis, tongue discoloration;
• liver failure (rarely leading to death), fulminant hepatitis, liver necrosis;
• severe skin reactions: bullous erythema multiforme (Stevens-Johnson syndrome), toxic epidermal necrolysis, erythema multiforme, drug reaction with eosinophilia and systemic symptoms (DRESS);
• joint pain;
• acute renal failure, interstitial nephritis.

Adverse reactions probably or possibly related to the use of azithromycin in the treatment of infections caused by
Mycobacterium avium complex or for prevention thereof, observed during clinical trials and after marketing authorization

Very common (may occur in more than 1 in 10 patients):

• diarrhoea;
• abdominal pain;
• nausea;
• bloating;
• discomfort in the abdominal cavity;
• loose stools.

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

• anorexia;
• dizziness;
• headache;
• unusual skin sensations such as tingling and numbness of limbs (paresthesia);
• taste disturbances;
• visual disturbances;
• deafness;
• rash, itching;
• joint pain;
• feeling of fatigue.

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

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

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Sumamed

• Keep this medicine out of sight and reach of children.
• No special storage conditions required.
• Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month indicated. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What the medicine Sumamed contains

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

What Sumamed looks like and contents of the pack
Sumamed is a light blue, elongated, biconvex coated tablet with the imprint ‘Al 500’ and a division line on one side. The tablet can be divided into two equal doses. The pack contains 3, 6 or 12 coated tablets in a cardboard box. For more detailed information, please 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, the Netherlands

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

Parallel Importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw, Poland

Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw, Poland

Marketing Authorization Number in the Netherlands, the country of export: RVG 28934
Parallel Import License Number: 332/22