Sumamed forte

Leaflet attached to the packaging: patient information

SUMAMED forte, 200 mg/5 ml, powder for oral suspension

Azithromycin

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

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a 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.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Sumamed forte and what is it used for
• 2. Important information before taking Sumamed forte
• 3. How to take Sumamed forte
• 4. Possible side effects
• 5. How to store Sumamed forte
• 6. Contents of the packaging and other information

1. What is Sumamed forte and what is it used for

Sumamed forte contains the active substance azithromycin, which is an azalide antibiotic from the macrolide group with a broad spectrum of action. It has a bactericidal effect on susceptible microorganisms. Sumamed forte in the form of powder for oral suspension 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 pneumonia, including interstitial pneumonia.
• Skin and soft tissue infections: erysipelas, impetigo, and secondary pyogenic skin infection; erythema migrans - the first symptom of Lyme disease.

2. Important information before taking Sumamed forte

When not to take Sumamed forte

• 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 forte, the patient should discuss with their doctor or pharmacist if:

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

Also, read the warnings in section 4. If symptoms of infection do not improve or new infection symptoms appear, e.g. fungal infection, the patient should consult their doctor again. Streptococcal infectionsIn the treatment of pharyngitis and tonsillitis caused by streptococci, penicillin is usually the drug of choice. Pseudomembranous colitisIf diarrhea occurs, it should be reported to the doctor immediately, as it may be a sign of pseudomembranous colitis - a complication that sometimes occurs during the use of macrolide antibiotics. Such a diagnosis should be considered in patients who develop diarrhea after starting treatment with azithromycin. In the case of pseudomembranous colitis caused by azithromycin, it may be necessary to discontinue Sumamed forte and use appropriate treatment. It is contraindicated to administer anti-peristaltic agents. Long-term useThere is no data on the safety and efficacy of azithromycin used for a long time in the above indications. In the case of rapidly recurring infections, the doctor will consider treatment with another antibacterial agent. MyastheniaDuring treatment with azithromycin, exacerbation of myasthenia symptoms or the occurrence of a myasthenic syndrome (see "Possible side effects") has been observed. Treatment of Mycobacterium avium complex infections in childrenThe safety and efficacy of azithromycin in the treatment of Mycobacterium avium complex infections or in the prevention of such infections in children have not been established.

Children and adolescents

The dose is modified depending on body weight (see section 3).

Sumamed forte and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. If the patient is taking any of the following medicines, it is especially important to tell their 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 in infections), e.g. moxifloxacin, levofloxacin;
• antacids (Sumamed forte should be administered at least 1 hour before or 2 hours after taking antacids);
• oral anticoagulants, e.g. warfarin;
• ergot alkaloids (used in migraine or to reduce blood flow), e.g. ergotamine, which can cause ergotism (symptoms - spasm of peripheral blood vessels and ischemia) when used with azithromycin;
• digoxin (used in heart function disorders) and colchicine (used in the treatment of gout and familial Mediterranean fever);
• cyclosporin (used in skin diseases, rheumatoid arthritis, or after organ transplantation);
• atorvastatin (a medicine used to lower cholesterol levels);
• rifabutin (used in the treatment of HIV or tuberculosis).

Sumamed forte with food and drink

Sumamed forte can be taken independently of meals.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, or thinks they may be pregnant or plans to have a child, they should consult their doctor or pharmacist before taking this medicine. PregnancyThe medicine may be used during pregnancy only if the doctor believes that the benefit to the mother outweighs the risk to the child. BreastfeedingAzithromycin passes into breast milk. It is recommended that breastfeeding be avoided during treatment with azithromycin, unless the doctor advises otherwise. FertilityIn fertility studies conducted in rodents, a decrease in the fertility index was observed after administration of azithromycin. The significance of these study results for humans is unknown.

Driving and using machines

There is no data on the effect of Sumamed forte on the ability to drive and use machines. However, when performing such activities, the possibility of side effects such as dizziness and seizures should be taken into account.

Sumamed forte contains sucrose

5 ml of the suspension contains 3.768 g of sucrose. If the patient has previously been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine. The medicine contains 9.8 g of sucrose in the maximum daily dose (20 mg/kg body weight - 13 ml suspension). This should be taken into account in patients with diabetes.

Sumamed forte contains sulfites in cherry, banana, and vanilla flavors

The medicine may rarely cause severe hypersensitivity reactions and bronchospasm.

Sumamed forte contains benzyl alcohol in cherry flavor

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 young children is associated with the risk of severe side effects, including respiratory disorders (so-called "gasping syndrome"). Do not administer to newborns (up to 4 weeks of age) without a doctor's recommendation. Do not administer to young children (under 3 years of age) for more than a week without a doctor's or pharmacist's recommendation. Pregnant or breastfeeding women should consult their doctor before taking the medicine, as a large amount of benzyl alcohol may accumulate in their body and cause side effects (so-called metabolic acidosis). Patients with liver or kidney disease should consult their doctor before taking the medicine, as a large amount of benzyl alcohol may accumulate in their body and cause side effects (so-called metabolic acidosis).

Sumamed forte contains sodium

The medicine contains 35.28 mg of sodium (the main component of common salt) in 5 ml of suspension. This corresponds to 1.76% of the maximum recommended daily intake of sodium in the diet for adults. The maximum daily dose of the medicine (20 mg/kg body weight - 13 ml suspension) contains 91.73 mg of sodium (the main component of common salt). This corresponds to 4.59% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to take Sumamed forte

This medicine should always be taken according to the doctor's instructions. In case of doubts, consult a doctor or pharmacist. The medicine is taken orally. In upper and lower respiratory tract infections, otitis media, skin and soft tissue infections (except for erythema migrans), the total dose is 30 mg/kg body weight, i.e. 10 mg/kg body weight once a day for 3 days.

Dosing in children and adolescents

Dosing in children depends on body weight, as follows:

In 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, then 10 mg/kg body weight once a day from the 2nd to the 5th day of treatment. Treatment of pharyngitis and tonsillitis caused by Streptococcus pyogenes

In the treatment of pharyngitis caused by bacterial streptococci in patients with a body weight of up to 25 kg, azithromycin is administered either for 3 days at a dose of 20 mg/kg body weight once a day or for 5 days at a dose of 12 mg/kg body weight once a day. Both in the 3-day and 5-day treatment, the total amount of azithromycin taken by the patient should be 60 mg/kg body weight. The maximum daily dose of azithromycin is 500 mg. In adults and children with a body weight over 25 kg, azithromycin is administered at a dose of 500 mg once a day for 3 days or for 5 days, with 500 mg on the first day and 250 mg from the 2nd to the 5th day. The dosing of the 200 mg/5 ml suspension for children with a body weight of 10-25 kg is presented in the following table:

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 elderly patients.

Patients with kidney or liver function disorders

If the patient has kidney or liver function disorders, they should inform their doctor, as they may need 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 administered orally, once a day. The prepared suspension can be taken independently of meals. The prepared suspension should be administered orally using the measuring syringe provided with the packaging. Shake before each use! After administering the medicine to a child, give them some tea or juice to drink to prevent the medicine from staying in their mouth.

Method of preparing the suspension

According to the attached instructions.

Using a higher dose of Sumamed forte than recommended

Side effects that occurred after taking the medicine in higher doses than recommended were similar to those described after taking the correct doses. Characteristic symptoms of overdose of macrolide antibiotics include: transient hearing loss, severe nausea, vomiting, and diarrhea. In case of taking a higher dose of the medicine than recommended, the patient should immediately consult a doctor or pharmacist. In case of overdose, it is recommended to administer activated charcoal and use symptomatic treatment, and if necessary, life-supporting treatment.

Missing a dose of Sumamed forte

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, this medicine can cause side effects, although not everybody gets them.

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

• Severe hypersensitivity reaction (sudden difficulty breathing and swallowing, swelling of the lips, tongue, face, and throat, 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 (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), "erythema multiforme", "Stevens-Johnson syndrome", or "toxic epidermal necrolysis".
• Severe hypersensitivity reaction that may include fever, skin rash, swelling of organs, increased number of certain white blood cells (eosinophilia), and inflammation of internal organs (drug reaction with eosinophilia and systemic symptoms, DRESS).

Also, stop taking Sumamed forte and immediately consult a doctor if you notice:

• Severe or chronic 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 or irregular heartbeat or changes in heart rhythm in the electrocardiogram (prolongation of the QT interval and torsades de pointes arrhythmia).

The following side effects have been reported:
Very common(may occur in more than 1 in 10 patients) :

• diarrhea.

Common(may occur in up to 1 in 10 patients):

• headache;
• vomiting, abdominal pain, nausea;
• change in white blood cell count;
• decrease in bicarbonate levels in the blood.

Uncommon(may occur in up to 1 in 100 patients):

• fungal infections (candidiasis), vaginal infection, pneumonia, fungal infection, bacterial infection, pharyngitis, gastrointestinal disorders, respiratory disorders, rhinitis, genital infection, blood disorders;
• change in white blood cell count (leukopenia, neutropenia, eosinophilia);
• angioedema (swelling in the face and throat, which can cause breathing difficulties), hypersensitivity;
• loss of appetite (anorexia);
• restlessness, insomnia; dizziness, drowsiness, taste disorders, abnormal skin sensations, e.g. tingling and numbness of limbs (paresthesia);
• vision disorders;
• hearing disorders, balance disorders;
• palpitations;
• hot flashes;
• shortness of breath, nosebleeds;
• constipation, bloating with gas, indigestion, gastritis, swallowing disorders (dysphagia), bloated stomach, dry mouth, belching, oral ulcers, excessive salivation;
• rash, itching, hives, skin inflammation, dry skin, excessive sweating;
• joint disease, muscle pain, back pain, neck pain;
• urination disorders (dysuria), kidney pain;
• menstrual bleeding, genital disorders;
• edema, weakness (asthenia), malaise (apathy), fatigue, facial swelling, chest pain, fever, pain, peripheral edema;
• abnormal laboratory test results (e.g. blood, liver function, glucose, electrolytes);
• post-procedure complications.

Rare(may occur in up to 1 in 1000 patients):

• agitation;
• liver function 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 (pseudopustules).

Frequency not known(frequency cannot be estimated from available data):

• pseudomembranous colitis;
• thrombocytopenia (decreased platelet count), hemolytic anemia (decreased red blood cell count);
• 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 hives);
• aggressive behavior, anxiety, hallucinations, delusions;
• loss of consciousness (syncope), seizures, sensory disorders (hypoesthesia), excessive psychomotor activity, loss of smell, loss of taste, taste disorders, smell disorders;
• hearing disorders, including deafness and/or tinnitus;
• heart rhythm disorders (including torsades de pointes and ventricular tachycardia), prolongation of the QT interval in 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, drug reaction with eosinophilia and systemic symptoms (DRESS);
• joint pain;
• acute kidney failure, interstitial nephritis.

Side effects probably or possibly related to the use of azithromycin in the treatment of Mycobacterium avium complex infections or in the prevention of such infections, observed during clinical trials and after the medicine was placed on the market

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

• diarrhea;
• abdominal pain;
• nausea;
• bloating;
• discomfort in the abdominal cavity;
• loose stools.

Common(may occur in up to 1 in 10 patients):

• loss of appetite;
• dizziness;
• headache;
• abnormal skin sensations, e.g. tingling and numbness of limbs (paresthesia);
• taste disorders;
• vision disorders;
• hearing loss;
• rash, itching;
• joint pain;
• fatigue.

Uncommon(may occur in up to 1 in 100 patients):

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

Reporting side effects

If side effects occur, including any not listed in this leaflet, the patient should tell their 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, more information can be collected on the safety of the medicine.

5. How to store Sumamed forte

• The medicine should be stored out of sight and reach of children.
• Store in a temperature below 25°C.
• The prepared Sumamed forte suspension, after reconstitution in water:
• packaging for preparing 20 ml of suspension: 5 days, at a temperature below 25°C;
• packaging for preparing 30 ml and 37.5 ml of suspension: 10 days, at 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 indicated. 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 packaging and other information

What Sumamed forte contains

• The active substance of the medicine is azithromycin in the form of azithromycin dihydrate. 5 ml of the suspension contains 200 mg of azithromycin.
• The other ingredients are: sucrose, anhydrous disodium phosphate, hydroxypropyl cellulose, xanthan gum, anhydrous colloidal silica, cherry flavor, banana flavor, vanilla flavor.

What Sumamed forte looks like and contents of the packaging

Sumamed forte is a white to yellowish-white powder. HDPE bottles for preparing 20 ml, 30 ml, and 37.5 ml of suspension. Each bottle has a child-resistant closure. Each bottle is packaged in a cardboard box. A measuring syringe is provided with the packaging.

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:April 2023.

INSTRUCTIONS FOR USE OF THE MEDICINE

Preparing the oral suspension

Water for preparing the suspension is best measured with the measuring syringe.

• 1. The bottle contains powder, from which a suspension for oral use is prepared after adding water.
• 2. Press the bottle cap and turn it counterclockwise.
• 3. For the packaging intended for preparing 20 ml of oral suspension, add 12 ml of boiled and cooled water. Measure with the attached syringe 4 times 3 ml of water and add to the bottle with the medicine.

For the packaging intended for preparing 30 ml of oral suspension, add 16.5 ml of boiled and cooled water. Measure with the attached syringe 3 times 5 ml and once 1.5 ml of water and add to the bottle with the medicine. For the packaging intended for preparing 37.5 ml of oral suspension, add 20 ml of boiled and cooled water. Measure with the attached syringe 5 times 4 ml of water and add to the bottle with the medicine. Each bottle then contains 5 ml of excess suspension to ensure complete dosing.

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

In the case of 20 ml packaging, the suspension is stable for 5 days. In the case of 30 ml and 37.5 ml packaging, the suspension is stable for 10 days.

Instructions for using the measuring syringe

Before administering the medicine to a child, read the following instructions carefully.
LOADING THE SYRINGE WITH MEDICINE

• 1. The suspension should be shaken before use
• 2. Press the syringe cap and turn it counterclockwise.
• 3. Dip the syringe tip into the suspension and, pulling the plunger up, draw the appropriate amount of suspension.

• 4. If an air bubble is visible in the syringe, inject the medicine back into the bottle and repeat the steps from point 3.

ADMINISTERING THE MEDICINE TO A CHILD
.

• 5. Place the child in a feeding position.
• 6. Insert the syringe tip into the child's mouth.
• 7. Slowly push the plunger so that the child can swallow the medicine gradually.

• 8. After the child has swallowed the medicine, give them some tea or juice to drink to prevent the medicine from staying in their mouth.

CLEANING AND STORAGE

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

• 10. After administering the last dose to the child, discard the syringe together with the bottle.

Warning!
The medicine and syringe should be stored in a place inaccessible to children.
The medicine should be used strictly according to the doctor's instructions.
In case of any doubts, consult a doctor or pharmacist.