Sumamed

Patient Information Leaflet

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 medicine.
Please read the following information carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm others, even if their symptoms are the same.
• If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. 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 acts bactericidal 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 disease; 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 relevant in women and elderly patients):
• congenital or previous history of cardiac arrhythmias (visible on ECG - test measuring the heart's electrical activity),
• 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 prolong the QT interval on ECG (see section "Sumamed with other medicines");
• the patient has severe kidney function impairment;
• the patient has severe liver function impairment: 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.

Please also refer to the warnings contained in section 4.
If, despite treatment, symptoms of infection do not improve, or new symptoms of infection (e.g. fungal infection) appear, consult your 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 occur occasionally 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 are no 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
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
If the patient is taking any of the following medicines, it is especially important to inform the doctor or pharmacist:

• medicines affecting the QT interval, such as
• quinidine, procainamide, dofetilide, amiodarone, sotalol (used to treat cardiac arrhythmias),
• cisapride (used for stomach 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 reducing blood flow), e.g. ergotamine: co-administration with azithromycin may lead to ergotism (symptoms: peripheral vasoconstriction and ischemia);
• digoxin (used for heart disorders) and colchicine (used to treat gout and familial Mediterranean fever);
• cyclosporine (used for 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 500 mg coated tablets can be taken independently of meals.
Pregnancy, breastfeeding, and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning 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 doctor’s opinion, the benefit to the mother outweighs the potential risk to the fetus.
Breastfeeding
Azithromycin passes into human milk. Breastfeeding is not recommended during azithromycin treatment, unless otherwise advised by the 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 side effects such as dizziness and seizures.
Sumamed contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, meaning it is considered "sodium-free".

3. How to use Sumamed

This medicine should always be taken exactly as directed by your doctor. In case of doubt, consult your doctor or pharmacist.
This medicine is for oral use.
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 (excluding 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, to be taken according to the following regimen: 1 g (2 film-coated tablets of 500 mg each) on the first day, 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, 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 dose should be taken 7 days after the first dose, and the subsequent eight doses should be administered at 7-day intervals.
Due to the high dose of azithromycin used in the above regimen for moderate acne vulgaris, monitoring of liver enzyme activity is required before starting and during the course of azithromycin treatment.
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 each) as a single dose.
Patients with renal or hepatic impairment
If a patient has impaired kidney or liver function, this should be reported to the doctor, as the usual dose may need to be reduced. This medicine should not be used in patients with severe hepatic insufficiency.
Method of administration
Azithromycin should be taken orally, once daily.
Sumamed 500 mg film-coated tablets may be taken independently of meals.
Tablets should be swallowed whole.
Taking more Sumamed than recommended
Adverse effects observed after taking higher than recommended doses of the medicine were similar to those reported after administration of correct doses. Characteristic symptoms following overdose of macrolide antibiotics include transient hearing loss, severe nausea, vomiting, and diarrhoea.
If an overdose of this medicine is taken, seek immediate advice from a doctor 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.
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 adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody 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 difficulty breathing or swallowing, swelling of the lips, tongue, face and neck, itchy rash, especially if widespread over the body).
• Severe skin reactions: skin eruption characterized by rapidly appearing 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 the 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 which 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 a serious intestinal inflammation.
• 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 electrocardiogram (prolongation of QT interval and torsade de pointes-type arrhythmias).

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

• Diarrhoea.

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

• Headache;
• Vomiting, abdominal pain, nausea;
• Changes in white blood cell count;
• Decreased concentration of bicarbonate in blood.

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

• Fungal infections (candidiasis), vaginal infection, pneumonia, fungal infection, bacterial infection, sore throat, gastritis and enteritis, respiratory disorders, rhinitis, oral candidiasis;
• Changes in white blood cell count (leukopenia, neutropenia, eosinophilia);
• Angioedema (swelling of the face and throat, possibly causing breathing difficulties), hypersensitivity;
• Loss of appetite (anorexia);
• Nervousness, insomnia, dizziness, drowsiness, taste disturbances, unusual skin sensations such as tingling and numbness of limbs (paraesthesia);
• Visual disturbances;
• Ear disorders, balance disorders;
• Palpitations;
• Hot flushes;
• Shortness of breath, nosebleeds;
• Constipation, bloating with flatulence, dyspepsia, gastric mucosal inflammation, swallowing difficulties (dysphagia), abdominal distension, dry mouth, regurgitation with gastric content reflux, 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, 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 affect up to 1 in 1000 people):

• Restlessness;
• Liver function disorders, cholestatic jaundice (cholestatic jaundice);
• Photosensitivity, severe skin reactions: skin eruption characterized by rapidly appearing 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 (haemolytic anaemia);
• 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, smell disturbances, 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 or prevention of infections caused by Mycobacterium avium complex organisms, observed during clinical trials and post-marketing experience
Very common (may affect more than 1 in 10 people):

• Diarrhoea;
• Abdominal pain;
• Nausea;
• Bloating;
• Abdominal discomfort;
• Loose stools.

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

• Anorexia;
• Dizziness;
• Headache;
• Unusual skin sensations, such as tingling and numbness of limbs (paraesthesia);
• Taste disturbances;
• Visual disturbances;
• Deafness;
• Rash, itching;
• Joint pain;
• Fatigue.

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

• 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 effects occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the 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 this medicine.

5. How to store Sumamed

• Keep this medicine out of sight and reach of children.
• No special storage instructions are required.
• Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This helps protect the environment.

6. Contents of the pack and other information

What 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 medicinal product are: tablet core: calcium hydrogen phosphate, hypromellose, maize starch, pregelatinized starch, microcrystalline cellulose, sodium lauryl sulfate, magnesium stearate; coating: hypromellose, indigo carmine, lacquer (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 a score line on one side of the tablet,
imprinted with AI on one side of the score line and 500 on the other side.
The pack contains 3, 6 or 12 coated tablets in a cardboard box.
For further detailed information, please contact the Marketing Authorisation Holder or the Parallel Importer.
Marketing Authorisation Holder in the Netherlands, country of export:
Teva Nederland B.V.
Swensweg 5
2031 GA Haarlem
The Netherlands
Manufacturer:
Pliva Croatia Ltd.
Prilaz Baruna Filipoviča 25
10000 Zagreb, Croatia
Parallel Importer:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Marketing Authorisation number in the Netherlands, country of export: RVG 28934
Parallel Import Licence number: 123/22
Date of leaflet approval: 11.03.2022