Sumamed

Package Leaflet: Information for the Patient

SUMAMED, 250 mg, hard capsules

Azithromycin

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your 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 pack and other information

1. What is Sumamed and what is it used for

Sumamed contains the active substance azithromycin, which is an azalide antibiotic belonging to the macrolide group with a broad spectrum of activity. It acts bactericidally on susceptible microorganisms. Sumamed, 250 mg, hard capsules, 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 pneumococcal pneumonia.
• Skin and soft tissue infections: erythema, impetigo, secondary infected animal bites; erythema migrans (first sign of Lyme disease).
• 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 or ketolide antibiotics, or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before taking Sumamed, 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 interval prolongation (visible in 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 interval 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, despite treatment, the symptoms of the infection do not disappear or if the 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 report it to your doctor immediately, as it 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 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 frequently recurring infections, the doctor will consider treatment with another antibacterial agent.

Miastenia

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 250 mg hard capsules is recommended for use in children only with a body weight of 45 kg or more. For the rest of the pediatric population, it is recommended to use Sumamed in the form of oral suspension or 125 mg film-coated tablets.

Sumamed and other medicines

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or plan to take.
If you are taking any of the following medicines, it is especially important to tell 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 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 can cause ergotism when used with azithromycin (symptoms - spasm of peripheral blood vessels and ischemia);
• digoxin (used to treat heart rhythm disorders) and colchicine (used to treat gout and 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 250 mg hard capsules should be taken at least 1 hour before meals or 2 hours after meals.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
The medicine may be used during pregnancy only if the doctor considers that 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 advises otherwise.
Fertility
In fertility studies conducted in rodents, a decrease in the fertility index 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

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 exactly as directed by your doctor. If you are unsure, consult your doctor or pharmacist.
The medicine is for oral use.
Dosage for adults 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)
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 (4 capsules of 250 mg) on the first day, and then 500 mg (2 capsules) from the second to the fifth day, in single daily doses.
Uncomplicated chlamydial infections
1 g (4 capsules of 250 mg) as a single dose.
Elderly patients
In elderly patients, the same dose is used as in other adult patients. Due to the risk of heart disease, caution is advised when using the medicine in these patients.
Patients with kidney or liver disorders
If you have kidney or liver disorders, tell 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 a day.
Sumamed in the form of 250 mg hard capsules should be taken whole, at least 1 hour before meals or 2 hours after meals. The capsules should be swallowed whole.

Overdose of Sumamed

Side effects that occurred after taking the medicine in doses higher than recommended were similar to those described after taking the correct doses. Characteristic symptoms after overdose of macrolide antibiotics include: transient hearing loss, severe nausea, vomiting, and diarrhea.
If you have taken more than the recommended dose of the medicine, consult your doctor or pharmacist immediately. In case of overdose, it is recommended to administer activated charcoal and provide 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. 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.

In case of the following side effects, stop taking Sumamed and contact your doctor or go to the emergency department of the nearest hospital immediately:

• Severe allergic reaction (anaphylactic reaction): sudden difficulty breathing and swallowing, swelling of the lips, tongue, face, and neck, itching rash, especially occurring all over the body.
• Severe skin reactions: a skin rash characterized by rapid onset of areas of redness on the skin, covered with small blisters (pustules 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 cells (eosinophilia), and inflammation of internal organs (DRESS).

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 intestinal infection.
• 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 interval 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 disorders, 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 can 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 mucosal ulceration, excessive salivation;
• rash, pruritus, urticaria, skin inflammation, dry skin, excessive sweating;
• degenerative joint disease, muscle pain, back pain, neck pain;
• urinary disorders (dysuria), kidney pain;
• menstrual bleeding, testicular disorders;
• edema, weakness (asthenia), malaise, 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 (pustules filled with white or yellow fluid).

Frequency not known(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 neck, leading to severe breathing difficulties, skin rash 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 muscle fatigue (myasthenia);
• hearing disorders, including deafness and (or) tinnitus;
• heart rhythm disorders (including torsade de pointesand ventricular tachycardia), QT interval prolongation in 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 (Lyell's syndrome), erythema multiforme, DRESS;
• arthralgia;
• acute kidney failure, interstitial nephritis.

Side effects possibly or probably 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 marketing authorization

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;
• weakness (asthenia), malaise.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell 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.
• Store in a temperature below 25°C.
• 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 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 hard capsule contains 250 mg of azithromycin.
• The other ingredients of the medicine are: microcrystalline cellulose, sodium lauryl sulfate, magnesium stearate. The capsule shell contains: gelatin, titanium dioxide (E 171), indigo carmine (E132).

What Sumamed looks like and contents of the pack

Hard capsules, blue cap and body, not transparent.
The pack contains 6 capsules, 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 Croatia Ltd. (Pliva Hrvatska d.o.o.)
Prilaz Baruna Filipovića 25, 10000 Zagreb
Croatia

Date of last revision of the leaflet: