Sumamed

Package Leaflet: Information for the Patient

SUMAMED, 125 mg, Film-Coated Tablets

Azithromycin

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• 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 experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Contents of the Package Leaflet

• 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 a macrolide antibiotic with a broad spectrum of action. It works bactericidal on susceptible microorganisms. Sumamed, 125 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 lobar pneumonia.
• Skin and soft tissue infections: erythema, impetigo, secondary infected animal bites; erythema migrans - the first sign of Lyme disease.

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, tell 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,
• you are 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 stop treatment;
• you have a new infection (this may indicate an overgrowth 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 (ergot preparations);
• you have infected burn wounds.

Also, read the warnings in section 4.
If symptoms of infection do not improve or if symptoms of a new 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 inform your doctor immediately, as this may be a sign of pseudomembranous colitis - a complication that can occur during the use of macrolide antibiotics. Such a diagnosis should be considered in patients who develop diarrhea after starting azithromycin treatment. In case of pseudomembranous colitis, it may be necessary to discontinue Sumamed and use appropriate treatment. It is contraindicated to administer anti-peristaltic agents.
Long-term use
There are no data on the safety and efficacy of azithromycin used long-term in the above indications. In case of frequently recurring infections, the doctor will consider treatment with another antibacterial agent.
Myasthenia
During azithromycin treatment, exacerbation of myasthenia symptoms or the occurrence of a myasthenic syndrome (see "Possible side effects") has been observed.

Children and adolescents

Sumamed in the form of 125 mg film-coated tablets is recommended for use in children with a suitable body weight who can swallow the tablet. For the rest of the pediatric population, Sumamed oral suspension is recommended. For children weighing over 45 kg, 250 mg hard capsules or 500 mg film-coated tablets are recommended.

Sumamed and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take.
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 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 used with azithromycin may cause ergotism (symptoms - spasm of peripheral blood vessels and ischemia);
• digoxin (used to treat heart 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 125 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 benefit to the mother outweighs the risk to the fetus.
Breastfeeding
Azithromycin passes into breast milk. Breastfeeding should be avoided during azithromycin treatment, 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 are no data on the effect of Sumamed on the ability to drive and use machines. However, you should be aware of the possibility of side effects such as dizziness and seizures when performing such activities.

Sumamed contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per dose, which means it is essentially 'sodium-free'.

3. How to take Sumamed

Always take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.
The medicine should be taken orally.
Upper and lower respiratory tract infections, otitis media, skin and soft tissue infections (except for erythema migrans)
Dosing in children and adolescents with a body weight below 45 kg
The total dose is 30 mg/kg, i.e., 10 mg/kg once daily for 3 days.
Dosing in children and adolescents with a body weight above 45 kg
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 60 mg/kg and should be administered as follows: 20 mg/kg on the first day, and 10 mg/kg once daily from the second to the fifth day, in single daily doses.
Elderly patients
In elderly patients, the same dose is used as in other adult patients. Due to the risk of heart disease, caution is recommended when using the medicine in these patients.
Patients with renal or hepatic impairment
If you have kidney or liver problems, you should inform your 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 daily.
Sumamed in the form of 125 mg film-coated tablets can be taken with or without food.
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 administration of the recommended doses. Characteristic symptoms after overdose of macrolide antibiotics include transient hearing loss, severe nausea, vomiting, and diarrhea.
In case of overdose, 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.

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. 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:

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 if it occurs all over the body).
• Severe skin reactions: a 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, swollen organs, increased number of a certain type of white blood cell (eosinophilia), and inflammation of internal organs (drug reaction with eosinophilia and systemic symptoms - DRESS).

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

• Severe or persistent diarrhea with blood or mucus. This symptom may occur during or after treatment and may indicate a serious bowel 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 an electrocardiogram (QT prolongation and torsade 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 inflammation, respiratory disorders, rhinitis, fungal infection of the mouth;
• change in white blood cell count (leukopenia, neutropenia, eosinophilia);
• angioedema (swelling in 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, bloating with gas, indigestion, gastritis, dysphagia, flatulence, abdominal distension, dry mouth, eructation, oral thrush, excessive salivation;
• rash, pruritus, urticaria, skin inflammation, dry skin, excessive sweating;
• arthrosis, muscle pain, back pain, neck pain;
• urinary disorders (dysuria), kidney 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 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 (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 (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, disorders of smell, rapid muscle fatigue (myasthenia);
• hearing disorders, including deafness and (or) tinnitus;
• heart rhythm disorders (including torsade de pointesand ventricular tachycardia), QT prolongation on the electrocardiogram;
• decreased blood pressure;
• pancreatitis, tongue discoloration;
• liver failure (rarely leading to death), fulminant hepatitis, liver necrosis;
• severe skin reactions: Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS);
• arthralgia;
• 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 for 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;
• bloating;
• 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 (severe skin reaction), hypersensitivity to light;
• asthenia, malaise.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please 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
Phone: +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

• Keep this medicine 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.

Medicines should not be disposed of via wastewater or household waste. 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 the medicine is azithromycin in the form of azithromycin dihydrate.

Each film-coated tablet contains 125 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, colorant - indigo carmine (E132), titanium dioxide (E171), polysorbate 80, talc.

What Sumamed looks like and contents of the pack

Film-coated tablets are light blue, round, and biconvex.
On one side of the tablet, there is the inscription 'PLIVA', and on the other - '125'.
The pack contains 6 film-coated tablets in a cardboard box.

Marketing authorization holder

Teva Pharmaceuticals Polska Sp. z o.o.
ul. Emilii Plater 53, 00-113 Warsaw
phone: (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 the last revision of the leaflet: