Sumamed

Package leaflet: Information for the patient

Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
Sumamed (Azimed) , 250 mg, hard capsules
Azithromycinum
Sumamed and Azimed are different trade names for the same medicine.
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the 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 azithromycin as the active substance, which is an azalide antibiotic belonging to the macrolide group with a broad spectrum of activity. It acts bactericidally against susceptible microorganisms.
Sumamed 250 mg hard capsules are 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, cellulitis, and secondary bacterial skin infections; erythema migrans – the first sign of Lyme disease.
• Sexually transmitted infections: uncomplicated infections caused by Chlamydia trachomatis.

2. Important information before using Sumamed

When not to use Sumamed

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

Warnings and precautions
Before starting treatment with Sumamed, discuss with your doctor or pharmacist if:

• the patient has conditions predisposing to cardiac rhythm disturbances (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 blood, especially low potassium or magnesium levels,
• taking other medicines that may cause QT interval prolongation 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 (which may indicate overgrowth of resistant microorganisms or fungal infection);
• the patient has neurological or psychiatric disorders;
• the patient has a sexually transmitted disease: the doctor should ensure that syphilis is not 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, despite treatment, symptoms of infection do not improve or new infection symptoms appear,
e.g. fungal infection, consult your doctor again.
Streptococcal infections
For 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. The doctor should consider this diagnosis in patients who develop diarrhea after starting azithromycin. In case of pseudomembranous colitis due to azithromycin use, discontinuation of Sumamed and initiation of appropriate treatment may be necessary. Antiperistaltic agents are contraindicated.
Long-term use
There is lack of data on the safety and efficacy of long-term use of azithromycin for the above-mentioned indications. 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").
Children and adolescents
Sumamed hard capsules 250 mg are recommended for use in children only if body weight is at least 45 kg. For other pediatric groups, Sumamed oral suspension or 125 mg coated tablets are recommended.
Sumamed with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines planned for use.
If the patient is taking any of the following medicines, it is especially important to inform the doctor or pharmacist:

• 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),
• antipsychotics, 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 vasoconstriction), e.g. ergotamine: co-administration with azithromycin may lead to ergotism (symptoms: peripheral vasoconstriction and ischemia);
• digoxin (used for cardiac 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 in HIV or tuberculosis treatment).

Sumamed with food and drink
Sumamed hard capsules 250 mg should be taken at least 1 hour before food or 2 hours after a meal.
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 doctor's opinion, 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 conception rates after administration of azithromycin. The relevance of these findings to humans is unknown.
Driving and using machines
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 adverse effects such as dizziness and convulsions.
Sumamed contains sodium and sulfur dioxide
The medicine contains less than 1 mmol (23 mg) of sodium per dose, meaning it is considered "sodium-free".
The medicine may rarely cause severe hypersensitivity reactions and bronchospasm.

3. How to use Sumamed

This medicine should always be used as directed by the physician. If in doubt, consult your doctor or pharmacist.
The medicine is administered orally.
Dosage in adults and in children and adolescents with body weight above 45 kg
Upper and lower respiratory tract infections, otitis media, skin and soft tissue infections (except 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) may be administered over 5 days: 500 mg on the first day of treatment and 250 mg daily from the second to the fifth day of treatment.
Erythema migrans
The total dose is 3 g, to be taken according to the following regimen: 1 g (4 capsules of 250 mg) on the first day, followed by 500 mg (2 capsules) from the second to the fifth day, as single daily doses.
Uncomplicated infections caused by Chlamydia trachomatis
1 g (4 capsules of 250 mg) as a single dose.
Elderly patients
In elderly patients, the same dosage should be used as in other adult patients. Due to the risk of cardiac disorders, caution is recommended when administering the medicine to these patients.
Patients with renal or hepatic impairment
If the patient has renal or hepatic impairment, this should be reported to the physician, as dose reduction may be necessary. The medicine should not be used in patients with severe hepatic insufficiency.
Administration method
Azithromycin should be taken orally once daily.
Sumamed 250 mg hard capsules should be swallowed whole, at least 1 hour before or 2 hours after a meal. The capsules should be swallowed whole.
Use of a higher than recommended dose of Sumamed
Adverse effects observed after administration of doses higher than recommended were similar to those reported with recommended doses. Characteristic symptoms following overdose of macrolide antibiotics include transient hearing loss, severe nausea, vomiting, and diarrhea.
If a higher than recommended dose has been taken, seek immediate medical advice from a doctor or pharmacist. In case of overdose, administration of activated charcoal is recommended, along with symptomatic treatment and, if necessary, supportive measures to maintain vital functions.
Missed dose of Sumamed
If a dose is missed, it should be taken as soon as possible, and subsequent doses should be taken according to the recommended dosing schedule. A double dose should not be taken to make up for the missed dose.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the following adverse reactions occur, stop using the medicine
Sumamed and immediately contact a doctor or go to the emergency department
of the nearest hospital:

• Severe hypersensitivity reaction (anaphylactic reaction): sudden difficulty breathing and swallowing, swelling of the lips, tongue, face and neck, itchy rash, particularly if widespread over the body.
• Severe skin reactions: skin eruption characterised 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 of the lips, eyes, mouth, nose and genital organs, associated with high fever and joint pain. This may be "acute generalised 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, increase in 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 using 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 and enteritis, respiratory disorders, rhinitis, oral candidiasis;
• Changes in white blood cell count (leukopenia, neutropenia, eosinophilia);
• Angioedema (swelling of the face and throat, which may cause breathing difficulties), hypersensitivity;
• Loss of appetite (anorexia);
• Nervousness, insomnia, dizziness, drowsiness, taste disturbances, unusual skin sensations such as tingling and numbness of limbs (paraesthesia);
• Visual disturbances;
• Ear disorders, balance disorders;
• Palpitations;
• Hot flushes;
• Shortness of breath, nosebleeds;
• Constipation, bloating with flatulence, indigestion, 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 haemorrhage, testicular disorders;
• Oedema, weakness (asthenia), malaise, fatigue, facial oedema, chest pain, fever, pain, peripheral oedema;
• Abnormal laboratory test results (e.g. blood tests, liver function parameters, glucose, electrolytes);
• Post-procedural complications.

Rare (may occur in less than 1 in 1000 patients):

• Restlessness;
• Liver function disorders, cholestatic jaundice (jaundice with bile stasis);
• Photosensitivity, severe skin reactions: skin eruption characterised 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 (haemolytic anaemia);
• Anaphylactic reaction (generalised 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, olfactory disturbances, rapid muscle fatigue (myasthenia);
• Hearing disorders including deafness and (or) tinnitus;
• Cardiac rhythm disorders (including torsade de pointes-type arrhythmias 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 (Lyell's syndrome, TEN), 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 species or in preventing them, 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;
• Paraesthesia, e.g. tingling and numbness of limbs;
• 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;
• Weakness (asthenia), malaise.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed
in this leaflet, inform your doctor or pharmacist. Adverse reactions can be
reported directly to the Department of Monitoring Adverse Drug Reactions 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.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Sumamed

• Keep this medicine out of sight and reach of children.
• Do not store above 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 stated month.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This helps protect the environment.

6. Contents of the packaging and other information

What Sumamed contains

• The active substance is azithromycin in the form of azithromycin dihydrate. Each hard capsule contains 250 mg of azithromycin.
• Other ingredients of the medicine are: microcrystalline cellulose, sodium lauryl sulfate, magnesium stearate. Capsule shell composition: gelatin, titanium dioxide (E 171), indigo carmine (E 132), sulfur dioxide.

What Sumamed looks like and contents of the pack
Hard, opaque capsules, light blue to dark blue in colour.
Packaging contains 6 capsules in a cardboard box.
For further detailed information, please contact the responsible party or the parallel importer.
Marketing Authorisation Holder in Croatia, country of export:
PLIVA HRVATSKA d.o.o.
Prilaz baruna Filipovića 25
10 000 Zagreb, Croatia
Manufacturer:
PLIVA HRVATSKA d.o.o.
Prilaz baruna Filipovića 25
10 000 Zagreb, Croatia
Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw, Poland
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw, Poland
Marketing Authorisation Number in Croatia, country of export: HR-H-560550238-01
Parallel Import Licence Number: 404/22