Sumamed

Package Leaflet: Information for the Patient

SUMAMED, 500 mg, Film-Coated Tablets

Azithromycin
You should carefully read the contents of this leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so you can read it again if you need to.
• If you have any further questions, 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 get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Pack

• 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 the active substance azithromycin, which is an azalide antibiotic belonging to the macrolide group with a broad spectrum of action. It works bactericidally 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 pneumonias caused by Legionella pneumophila.
• Skin and soft tissue infections: erythrasma, impetigo, secondary pyoderma; Lyme disease - erythema migrans, the first sign of Lyme disease; moderate acne in adults.
• Sexually transmitted diseases: uncomplicated chlamydial infections caused by Chlamydia trachomatis.

2. Important information before taking Sumamed

When not to take Sumamed

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

Warnings and precautions

Before taking Sumamed, you should discuss with your doctor or pharmacist if:

• you have conditions that may lead to heart rhythm disorders (especially in women and elderly patients):
• congenital or documented QT prolongation (visible on the ECG - a test of the heart's electrical activity),
• severe heart failure,
• very slow heart rate (bradycardia),
• electrolyte disturbances in the blood, especially low potassium and magnesium levels,
• taking other medicines that may cause QT prolongation (see "Sumamed and other medicines");
• you have severe kidney problems;
• you have severe liver problems: your doctor may monitor liver function or discontinue treatment;
• you have a new infection (this may indicate excessive growth of resistant microorganisms or a fungal infection);
• you have neurological or psychiatric disorders;
• you have a sexually transmitted disease: your doctor should ensure that you do not have a co-existing syphilis infection;
• you are taking ergotamine derivatives (for migraine or to reduce blood flow);
• you have infected burn wounds.

You should also read the warnings in section 4.
If, despite treatment, the symptoms of the infection do not disappear or if the symptoms of another infection appear, e.g., fungal infection, you should consult your doctor again.
Streptococcal infections
In the treatment of pharyngitis and tonsillitis caused by streptococci, penicillin is usually the drug of choice.
Pseudomembranous colitis
If you experience diarrhea, you should immediately inform your doctor, as this may be a sign of pseudomembranous colitis - a complication that sometimes occurs during the use of macrolide antibiotics. Your doctor should consider this diagnosis in patients who develop diarrhea after starting azithromycin treatment. 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 long-term use of azithromycin in the above indications. In the case of rapidly recurring infections, your doctor will consider treatment with another antibacterial agent.
Myasthenia gravis
During azithromycin treatment, exacerbation of myasthenia gravis 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 if their body weight is 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

You should tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or might take, including those you have bought without a prescription.
If you are taking any of the following medicines, it is especially important to inform your doctor or pharmacist:

• medicines that affect the QT interval, such as
• quinidine, procainamide, dofetilide, amiodarone, sotalol (used to treat heart rhythm disorders),
• hydroxychloroquine (used to treat rheumatological 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 taken 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 with or without food.

Pregnancy, breastfeeding, and fertility

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.
Pregnancy
The medicine should only be used during pregnancy if the doctor considers it necessary.
Breastfeeding
Azithromycin passes into breast milk. Breastfeeding should be avoided during treatment with azithromycin unless the doctor recommends otherwise.
Fertility
In fertility studies conducted in rodents, a decrease in fertility was observed after administration of azithromycin. The significance of these findings 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, you should take into account 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, which means it is essentially 'sodium-free'.

3. How to take Sumamed

This medicine should always be taken exactly as directed by your doctor. If you are unsure, consult your doctor or pharmacist.
The medicine is taken orally.
Dosage for adults, including the elderly, and children and adolescents with a body weight over 45 kg
Upper and lower respiratory tract infections, 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 as a single daily dose).
Alternatively, the same total dose (1500 mg) can 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, as a single daily dose.
Moderate acne - only 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 high dose of azithromycin used in the above dosing regimen for moderate acne, it is necessary to monitor liver enzyme activity before and during the treatment course with azithromycin.
The above cyclic treatment regimen for moderate acne (3 days + 9 weeks) can only be used once for a given patient, as there are no controlled clinical trials that have demonstrated the safety and efficacy of repeating this treatment regimen for moderate acne.
Uncomplicated chlamydial infections
1 g (2 film-coated tablets of 500 mg) as a single dose.

Taking a higher dose of Sumamed than recommended

Side effects that occurred after taking the medicine in higher doses than recommended were similar to those described after taking the recommended doses. Characteristic symptoms after overdosing on macrolide antibiotics include: transient hearing loss, severe nausea, vomiting, and diarrhea.
In case of taking a higher dose of Sumamed than recommended, you should immediately consult a doctor or pharmacist. In case of overdose, activated charcoal and symptomatic treatment, as well as supportive therapy if necessary, are recommended.

Missing a dose of Sumamed

A missed dose should be taken as soon as possible, and the next doses should be taken according to the recommended dosing schedule. Do not take a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, Sumamed can cause side effects, although not everybody gets them.

If you experience any of the following side effects, stop taking Sumamed and contact your doctor or go to the emergency department of your nearest hospital immediately:

• Severe allergic reaction (sudden difficulty breathing and swallowing, swelling of the lips, tongue, face, and throat, itching rash, especially on the whole body).
• Severe skin reactions: a skin rash characterized by rapid onset of areas of redness on the skin 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 genitals, associated with high fever and joint pain. This may be "acute generalized exanthematous pustulosis" (AGEP), "Stevens-Johnson syndrome", "toxic epidermal necrolysis", or "drug reaction with eosinophilia and systemic symptoms" (DRESS).
• 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 (DRESS).

You should also stop taking Sumamed and contact your doctor if you notice:

• Severe or persistent 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 (QT prolongation and torsades de pointes).

The following 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;
• change in white blood cell count;
• decrease in blood bicarbonate levels.

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

• fungal infections (candidiasis), vaginal infection, pneumonia, fungal infection, bacterial infection, pharyngitis, gastrointestinal disorders, respiratory disorders, rhinitis, genital infections;
• change in white blood cell count (leukopenia, neutropenia, eosinophilia);
• angioedema (swelling of the face and throat, which may cause difficulty breathing), hypersensitivity;
• loss of appetite (anorexia);
• nervousness, insomnia, dizziness, somnolence, taste disorders, abnormal skin sensations, e.g., tingling and numbness of limbs (paresthesia);
• visual disturbances;
• hearing disorders, balance disorders;
• palpitations;
• flushing;
• dyspnea, epistaxis;
• constipation, flatulence, dyspepsia, gastritis, dysphagia, abdominal distension, dry mouth, eructation, oral mucosal disorders, excessive salivation;
• rash, pruritus, urticaria, skin inflammation, dry skin, excessive sweating;
• arthrosis, myalgia, back pain, neck pain;
• dysuria, renal pain;
• menorrhagia, genital disorders;
• edema, asthenia, malaise, fatigue, facial edema, chest pain, fever, pain, peripheral edema;
• abnormal laboratory test results (e.g., blood, liver function, glucose, electrolytes);
• post-procedural complications.

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

• agitation;
• liver disorders, jaundice with bile stasis (cholestatic jaundice);
• hypersensitivity to light, severe skin reactions: a skin rash characterized by rapid onset of areas of redness on the skin covered with small blisters (vesicles 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 (a generalized allergic reaction that 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, disturbances of smell, rapid fatigue of muscles (myasthenia);
• hearing disorders, including deafness and (or) tinnitus;
• heart rhythm disorders (including torsades de pointes and ventricular tachycardia), QT prolongation on the electrocardiogram;
• decreased blood pressure;
• pancreatitis, tongue discoloration;
• liver failure (rarely fatal), fulminant hepatitis, liver necrosis;
• severe skin reactions: Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, DRESS (Drug Reaction with Eosinophilia and Systemic Symptoms);
• arthralgia;
• acute renal failure, interstitial nephritis.

Side effects associated with the use of azithromycin in the treatment of infections caused by Mycobacterium avium complex or the prevention of such infections, observed during clinical trials and after the marketing authorization of the medicine

Very common(may affect more than 1 in 10 people):

• diarrhea;
• abdominal pain;
• nausea;
• flatulence;
• abdominal discomfort;
• loose stools.

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

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

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

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

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring 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. 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.
• There are no special storage instructions for this medicine.
• Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures 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 film-coated tablet contains 500 mg of azithromycin.
• The other ingredients of the medicine are: tablet core: calcium phosphate anhydrous, 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 contents of the pack

Sumamed is a light blue, oval, biconvex film-coated tablet. On one side of the tablet, 'PLIVA' is embossed, and on the other side, '500'.
The pack contains 2, 3, 6, or 12 film-coated tablets, in a cardboard box.

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

Date of last revision of the leaflet