Sumamed

Package leaflet: Information for the patient

SUMAMED, 100 mg/5 ml, powder for oral suspension
Azithromycinum
Please read carefully the entire leaflet before using this medicine, because it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please 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 the patient experiences any adverse reactions, including those 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 from the macrolide group with broad-spectrum activity. It acts bactericidally against susceptible microorganisms.
Sumamed in the form of powder for oral suspension is 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, impetigo, and secondary bacterial skin infections; erythema migrans – the first sign of Lyme disease.

2. Important Information Before Using Sumamed

When not to use Sumamed

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

Warnings and precautions
Before starting treatment with Sumamed, consult a doctor or pharmacist if:

• The patient has conditions predisposing to the development of cardiac arrhythmias (particularly relevant in women and elderly patients):
  • Congenital or previous history of cardiac arrhythmias (visible on ECG – electrocardiogram),
  • Severe heart failure,
• Very slow heart rate (called bradycardia),
• Electrolyte imbalances in the blood, especially low levels of potassium and magnesium,
• The patient is 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 a fungal infection);
  • The patient has neurological or psychiatric disorders;
  • The patient has a sexually transmitted disease: the doctor should confirm whether syphilis is also present;
  • The patient is taking ergot derivatives (ergot alkaloids);
  • The patient has infected burn wounds.

Please also refer to the warnings in section 4.
If symptoms of infection do not improve despite treatment, or if symptoms of a new infection (e.g., fungal) appear, consult the doctor again.
Streptococcal infections
For the treatment of streptococcal pharyngitis and tonsillitis, penicillin is usually the drug of choice.
Pseudomembranous colitis
If diarrhea occurs, it should be reported immediately to the doctor, as it may be a sign of pseudomembranous colitis—a complication that may occasionally occur during treatment with macrolide antibiotics. This diagnosis should be considered in patients who develop diarrhea after starting azithromycin therapy. In cases of pseudomembranous colitis due to azithromycin use, discontinuation of Sumamed and initiation of appropriate treatment may be necessary. Medications that inhibit peristalsis are contraindicated.
Long-term use
There is 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").
Treatment of Mycobacterium avium complex infections in children
The safety and efficacy of azithromycin for the treatment or prevention of infections caused by the Mycobacterium avium complex in children have not been established.
Children and adolescents
Dosage should be adjusted according to body weight (see section 3).
Sumamed with other medicines
Inform your doctor or pharmacist about all medicines currently used, recently taken, or planned for use.
It is particularly 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),
• antipsychotic medicines, 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 to reduce blood flow), e.g., ergotamine co-administered with azithromycin may cause 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 (a medicine used to lower cholesterol levels);
  • Rifabutin (used for HIV or tuberculosis treatment).

Sumamed with food and drink
Sumamed can be taken independently of meals.
Pregnancy, breastfeeding, and fertility
If the patient is pregnant or 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
The medicine may be used during pregnancy only if, in the opinion of the doctor, the benefit to the mother outweighs the risk to the fetus.
Breastfeeding
Azithromycin passes into human milk. Breastfeeding is not recommended during azithromycin treatment unless otherwise advised by a doctor.
Fertility
Fertility studies in rodents showed reduced pregnancy rates 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 convulsions.
Sumamed contains sucrose
5 ml of suspension contains 3.863 g of sucrose.
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult a doctor before taking this medicine.
The medicine contains 10.04 g of sucrose in the maximum daily dose (20 mg/kg body weight – 13 ml of suspension). This should be taken into account in patients with diabetes.
Sumamed contains sulphites in cherry, banana, and vanilla flavours
The medicine may rarely cause severe hypersensitivity reactions and bronchospasm.
Sumamed contains benzyl alcohol in cherry flavour
The medicine contains 0.65 micrograms of benzyl alcohol in 5 ml of suspension. Benzyl alcohol may cause allergic reactions.
Administration of benzyl alcohol to small children is associated with the risk of serious adverse reactions, including respiratory disturbances (so-called "gasping syndrome").
Do not administer to newborns (up to 4 weeks of age) without medical advice.
Do not administer to young children (under 3 years of age) for longer than one week without medical advice or pharmacist consultation.
Pregnant or breastfeeding women should consult a doctor before using the medicine, as high amounts of benzyl alcohol may accumulate in their bodies and cause adverse effects (so-called metabolic acidosis).
Patients with liver or kidney disease should consult a doctor before using the medicine, as high amounts of benzyl alcohol may accumulate in their bodies and cause adverse effects (so-called metabolic acidosis).
Sumamed contains sodium
The medicine contains 35.28 mg of sodium (main component of table salt) in 5 ml of suspension. This corresponds to 1.76% of the maximum recommended daily sodium intake in adults' diet.
The maximum daily dose of the medicine (20 mg/kg body weight – 13 ml of suspension) contains 91.73 mg of sodium. This corresponds to 4.59% of the maximum recommended daily sodium intake in adults' diet.

3. How to use Sumamed

This medicine should always be used as directed by the physician. In case of doubt, consult
your doctor or pharmacist.
This medicine is for oral use.
For upper and lower respiratory tract infections, otitis media, and skin and soft tissue infections
(except erythema migrans), the total dose is 30 mg/kg body weight, i.e.
10 mg/kg body weight once daily for 3 days.
Dosage in children and adolescents
The dosage for children depends on body weight, as follows:

For the treatment of erythema migrans, the total dose is 60 mg/kg body weight administered as follows: 20 mg/kg body weight on the first day, followed by 10 mg/kg body weight once daily from day 2 to day 5 of treatment.
*Treatment of pharyngitis and tonsillitis caused by Streptococcus pyogenes
For the treatment of pharyngitis caused by Streptococcus pyogenes in children with body weight up to 13 kg, azithromycin can be administered either for 3 days at a dose of 20 mg/kg body weight once daily, or for 5 days at a dose of 12 mg/kg body weight once daily. In both the 3-day and 5-day regimens, the total amount of azithromycin received by the patient should amount to 60 mg/kg body weight.
The dosing of the 100 mg/5 mL suspension for children weighing 5–13 kg is shown in the table below:

Elderly patients
The same dose should be used in elderly patients as in other adult patients. Due to the risk of heart disease, caution is recommended when administering the medicinal product to elderly patients.

Patients with renal or hepatic impairment
If a patient has impaired renal or hepatic function, this should be reported to the physician, as the physician may reduce the usual dose of the medicinal product. The medicinal product should not be used in patients with severe hepatic insufficiency.

Method of administration
Azithromycin should be administered orally, once daily.
The reconstituted suspension may be taken with or without food.
The prepared suspension should be administered orally using the syringe supplied with the package.
Shake well before each use!
After administering the medicinal product to a child, give the child some tea or juice to drink, to ensure the medicinal product does not remain in the mouth.

Preparation of the suspension
As described in the enclosed instructions.

Use of a higher than recommended dose of Sumamed
Adverse reactions observed after administration of higher than recommended doses were similar to those reported following administration of correct doses. Characteristic symptoms following overdose of macrolide antibiotics include transient hearing loss, severe nausea, vomiting, and diarrhoea.
In case of ingestion of a higher than recommended dose, seek immediate medical advice from a physician or pharmacist. In the event of overdose, administration of activated charcoal is recommended, along with symptomatic treatment and, if necessary, supportive therapy to maintain vital functions.

Missed dose of Sumamed
If a dose is missed, it should be taken as soon as possible. Subsequent doses should be administered according to the recommended dosing schedule. Do not administer 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 everybody will experience them.
If any of the following adverse reactions occur, stop taking 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 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 possibly involving fever, skin rash, organ swelling, increased number of 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 taking 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;
• Changes 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, 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 (paresthesia);
• 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 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;
• Swelling, weakness (asthenia), malaise (apathy), feeling of fatigue, facial swelling, chest pain, fever, pain, peripheral edema;
• 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):

• Restlessness;
• 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 rhythm disorders (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 kidney failure, interstitial nephritis.

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

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

• Diarrhoea;
• Abdominal pain;
• Nausea;
• Bloating;
• Feeling of 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;
• Sudden weakness (asthenia), malaise.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions allows further information on the safety of the medicine to be collected.

5. How to store Sumamed

• Keep this medicine out of the sight and reach of children.
• Store below 25°C.
• The prepared suspension should be stored for no longer than 5 days at a temperature below 25°C.

Do not use this medicine after the expiry date stated on the container. 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 properly dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Sumamed contains

• The active substance is azithromycin in the form of azithromycin dihydrate. 5 ml of suspension contains 100 mg of azithromycin.
• Other ingredients are: sucrose, anhydrous trisodium phosphate, hydroxypropyl cellulose, xanthan gum, anhydrous colloidal silicon dioxide, cherry flavor, banana flavor, vanilla flavor.

What Sumamed looks like and contents of the pack
Sumamed is a white to yellowish-white powder.
HDPE bottles for the preparation of 20 ml of suspension.
Each bottle has a child-resistant closure.
Each bottle is packed in a cardboard box. An oral dosing syringe is included in the package.

Marketing Authorisation 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

INSTRUCTIONS FOR USE OF THE MEDICINAL PRODUCT
Preparation of oral suspension
The water needed to prepare the suspension should be measured preferably using the provided dosing syringe.

1. The bottle contains a powder which, after addition of water, forms an oral suspension.
2. Press the cap down and turn it counterclockwise to open.
3. Add 12 ml of boiled, cooled water. Measure 3 times 4 ml of water using the provided syringe and add to the bottle. The bottle will then contain 5 ml of excess suspension to ensure complete dosing.

4. Shake vigorously until a homogeneous suspension is formed.
5. The prepared suspension should be stored at a temperature below 25°C.

The ready-to-use suspension is stable for 5 days.

Instructions for using the dosing syringe
Before administering the medicine to the child, please read the following instructions carefully.

FILLING THE SYRINGE WITH MEDICINE

1. Shake the suspension well before use.
2. Press the cap down and turn it counterclockwise.
3. Immerse the tip of the syringe into the suspension and draw up the required amount by pulling the plunger upwards.

4. If air bubbles are observed in the syringe, inject the medicine back into the bottle and repeat step 3.

ADMINISTERING THE MEDICINE TO THE CHILD

5. Position the child as if for feeding.
6. Insert the tip of the syringe into the child's mouth.
7. Slowly push the plunger to allow the child to swallow the medicine gradually.

8. After the child has swallowed the medicine, give some tea or juice to drink to ensure the medicine does not remain in the mouth.

CLEANING AND STORAGE

9. After use, disassemble the syringe, wash it under running water, dry it, and store it in a clean place together with the medicine.

10. After administering the last dose to the child, dispose of the syringe together with the bottle.

Warning! Keep the medicine and syringe out of the reach of children.
The medicine should be used strictly according to the physician's instructions.
In case of any doubts, consult your doctor or pharmacist.