Sumamed

Patient Information Leaflet

Sumamed, 250 mg, tablets for oral suspension
Sumamed, 500 mg, tablets for oral suspension
Sumamed, 1000 mg, tablets for oral suspension
Azithromycinum
Please read this leaflet carefully before using the medicine, because it contains important information for you.

• Keep this leaflet so that you can read it again if necessary.
• If you have any 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 someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any 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 antibiotic belonging to a group called macrolides. It is used to treat infections caused by microorganisms such as bacteria sensitive to azithromycin. These infections include:

• Upper respiratory tract infections, e.g. of the sinuses, throat and tonsils (see also "Warnings and precautions" in section 2)
• Acute otitis media (middle ear infection)
• Chest infections (lower respiratory tract infections), such as acute bronchitis, exacerbation of chronic bronchitis, and mild to moderately severe community-acquired pneumonia, including interstitial pneumonia
• Skin and soft tissue infections of mild to moderate severity, e.g. folliculitis (infection of hair follicles in the skin), cellulitis (infection of deeper skin layers and underlying tissues), and erysipelas (infection of the upper layer of skin)
• Lyme disease – Erythema migrans (the first sign of Lyme disease) when antibiotics such as doxycycline, amoxicillin or cefuroxime axetil cannot be used (see also section 2 "Warnings and precautions")
• Uncomplicated infections caused by the bacterium Chlamydia trachomatis, which may cause urethritis (infection of the urethra) or cervicitis (infection of the cervix, where the uterus connects to the vagina)

2. Important information before using Sumamed

When NOT to use Sumamed:

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

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

• if the patient develops symptoms of an allergic reaction, such as red or white patches on the skin, itching and skin irritation, skin swelling, swelling of the larynx (throat) or tongue, and breathing difficulties, use of Sumamed must be discontinued
• if the patient has liver function disorders, as liver function monitoring by a physician or discontinuation of treatment may be necessary
• if the patient has kidney function disorders, as the physician may need to adjust the dose
• if the patient is taking medicines known as ergotamine derivatives, e.g. ergotamine or dihydroergotamine (used to treat migraine), because azithromycin is not recommended in this combination (see also section "Sumamed with other medicines")
• if the patient develops symptoms of another infection
• if the patient develops diarrhoea or loose stools during or after treatment. In some cases, there is a risk of developing severe intestinal inflammation known as Clostridioides difficile-associated diarrhoea. Do not take any anti-diarrhoeal medicine without first consulting a doctor.
• if the patient has conditions predisposing to cardiac arrhythmias (particularly relevant in women and elderly patients):
• if the patient has prolonged QT interval (a heart condition)
• if the patient is taking medicines that prolong the QT interval (see section "Sumamed with other medicines")
• if the patient has low blood potassium or magnesium levels
• if the patient has heart diseases, such as slow or irregular heartbeat or reduced cardiac function
• if the patient has a certain type of muscle weakness known as myasthenia gravis. Sumamed may worsen or trigger symptoms of myasthenia.
• if the patient has neurological disorders or mental (psychiatric) conditions
• if the patient has a sexually transmitted disease caused by a specific pathogen (T. pallidum, including the pathogen causing syphilis).

Treatment of erythema migrans with azithromycin should be carefully monitored by a physician,
as it may fail.
If symptoms persist after completion of azithromycin treatment, or if the patient notices any new and persistent symptoms, medical advice should be sought.
Sumamed with other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take.
If the patient is taking or has recently taken any of the following medicines, inform the doctor:

• medicines that prolong the QT interval, such as antiarrhythmics (used to treat heart rhythm disorders, e.g. quinidine, procainamide, dofetilide, amiodarone, sotalol), hydroxychloroquine (used to treat rheumatological diseases or malaria), cisapride (used for stomach disorders), terfenadine (used to treat allergies), pimozide, phenothiazines (used to treat certain psychiatric/mood disorders), citalopram (used to treat depression), and antibacterial agents such as moxifloxacin, levofloxacin (see also section "Warnings and precautions")
• antacids (used to treat heartburn and indigestion, e.g. aluminium hydroxide). Sumamed should be taken at least 1 hour before or 2 hours after antacids
• digoxin (used in heart failure), as digoxin blood levels may increase
• colchicine (used in gout and familial Mediterranean fever), as colchicine blood levels may increase
• zidovudine (used in HIV treatment), as zidovudine levels may increase
• nelfinavir (used in HIV treatment), as azithromycin levels may increase
• ergot alkaloids, e.g. ergotamine (used to treat migraine). Azithromycin should not be taken concurrently due to the risk of ergotism (potentially serious adverse effects including numbness or tingling of extremities, muscle cramps, headache, seizures, abdominal or chest pain) (see also section "Warnings and precautions")
• astemizole (an antihistamine), as its effects may be enhanced
• alfentanil (a painkiller), as its effects may be enhanced
• atorvastatin (a medicine used to lower cholesterol levels), as cases of rhabdomyolysis (increased risk of muscle tissue damage) have been reported in patients taking azithromycin concurrently
• hydroxychloroquine (used to treat rheumatological diseases or malaria), which may increase the risk of heart problems
• cisapride (used to treat stomach disorders), which may increase the risk of heart problems
• coumarin derivatives, e.g. warfarin (used to prevent blood clots), as the risk of bleeding may increase
• cyclosporine (used to prevent organ transplant rejection), as cyclosporine levels may be elevated and regular monitoring of cyclosporine blood levels may be required
• theophylline (used to treat breathing problems), as azithromycin may increase its levels.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a
child, she should consult a doctor or pharmacist before using this medicine.
Sumamed should not be used during pregnancy unless absolutely necessary. The medicine should
be used during pregnancy only if, in the opinion of the physician, it is essential.
Breastfeeding should be avoided if the patient is taking azithromycin, as it may cause adverse effects, including diarrhoea and infection in the infant. Breastfeeding may be resumed two days after stopping azithromycin treatment.
Driving and operating machinery
There are no data on the effect of azithromycin on the ability to drive and operate machinery. However, Sumamed may cause adverse effects such as dizziness and convulsions, which may alter reaction time and impair the ability to actively participate in road traffic or operate machinery. If such adverse effects occur, do not drive or operate machinery.
Sumamed contains aspartame
Sumamed 250 mg, oral suspension tablets:
This medicine contains 19.5 mg of aspartame in each oral suspension tablet.
Aspartame is a source of phenylalanine. It may be harmful to patients with phenylketonuria. This is a rare genetic disorder in which phenylalanine accumulates in the body due to improper excretion.
Sumamed 500 mg, oral suspension tablets:
This medicine contains 39.0 mg of aspartame in each oral suspension tablet.
Aspartame is a source of phenylalanine. It may be harmful to patients with phenylketonuria. This is a rare genetic disorder in which phenylalanine accumulates in the body due to improper excretion.
Sumamed 1000 mg, oral suspension tablets:
This medicine contains 78.0 mg of aspartame in each oral suspension tablet.
Aspartame is a source of phenylalanine. It may be harmful to patients with phenylketonuria. This is a rare genetic disorder in which phenylalanine accumulates in the body due to improper excretion.
Sumamed contains benzyl alcohol
This medicine contains less than 1 mg of benzyl alcohol in each oral suspension tablet. Benzyl alcohol may cause allergic reactions.
Do not administer to young children (under 3 years of age) for longer than one week without medical or pharmacist advice.
Pregnant or breastfeeding women and patients with liver or kidney disease should consult a doctor before use, as large amounts of benzyl alcohol may accumulate in their bodies and cause adverse effects (so-called metabolic acidosis).
Sumamed contains glucose (component of maltodextrin)
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
Sumamed contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to take Sumamed

This medicine should always be taken exactly as directed by your doctor. In case of doubt, consult
your doctor or pharmacist.
Recommended dose:
Dosage in adults, including elderly patients, and in children and adolescents with body weight
45 kg or more:
Treatment of upper and lower respiratory tract infections, otitis media, skin and soft tissue
infections
The total dose of 1500 mg of azithromycin may be administered according to either a 3-day
treatment regimen or a 5-day treatment regimen.
3-day treatment regimen
500 mg of azithromycin taken as a single daily dose for 3 days.
5-day treatment regimen
For the 5-day treatment regimen, take 500 mg of azithromycin on the first day, followed by
250 mg of azithromycin once daily from day 2 to day 5.
Treatment of uncomplicated genital infections caused by Chlamydia trachomatis
The total dose is 1000 mg of azithromycin taken as a single dose.
Treatment of erythema migrans (the first manifestation of Lyme disease)
For the treatment of erythema migrans, the total dose of azithromycin is 3000 mg, administered
as follows: 1000 mg on day 1, followed by 500 mg once daily on days 2 to 5.
Elderly patients
In elderly patients, the recommended dose is the same as for other adult patients.
It should be considered that elderly patients may be more susceptible to severe cardiac arrhythmias
(such as torsade de pointes) than younger patients (see also section 2, "Warnings and precautions").
Patients with renal or hepatic impairment:
If the patient has impaired kidney or liver function, this should be reported to the doctor before
taking Sumamed. The doctor will decide whether dose adjustment is necessary.
Dosage in children and adolescents with body weight below 45 kg:

• The doctor will determine the most appropriate dose for the child based on body weight.
• Depending on the child's body weight, this medicine may not be suitable. In such cases, the doctor will prescribe azithromycin in another formulation, such as a suspension.
• The recommended dose is 10 mg/kg body weight, given as a single daily dose for 3 days. Alternatively, the same total dose may be administered over 5 days: 10 mg/kg body weight on day 1, followed by 5 mg/kg body weight once daily for the next four days.
• The maximum dose in these patients is 1500 mg.

Method of administration
The tablet for oral suspension should be dissolved by mixing in a sufficient amount of liquid, such as water, apple juice, or orange juice (at least 30 ml), to form a fine suspension. After swallowing the suspension, any residue should be resuspended in a small amount of water and swallowed.
The tablet for oral suspension may be taken with or without food.
The break line on the tablet is not intended for splitting the tablet.
Taking more Sumamed than prescribed
If you take more Sumamed than prescribed, you must immediately contact your doctor or go to
the nearest hospital. Symptoms of overdose are similar to the adverse reactions observed with
normal doses of the medicine (see section 4). Typical symptoms of overdose include transient
hearing loss, severe nausea, vomiting, and diarrhoea.
When going to the hospital or seeing a doctor, bring this leaflet and the medicine packaging,
including any remaining medicine, so that it is clear which medicine has been taken.
If you miss a dose of Sumamed
Take the missed dose as soon as you remember, unless it is almost time for the next dose. Do not
take a double dose to make up for a missed dose.
Take the next dose at the scheduled time. If in doubt, consult your doctor or pharmacist.
Even if a dose is missed, all prescribed tablets should be taken. This means that the treatment
will end one day later.
Stopping Sumamed treatment
Do not stop taking Sumamed without first consulting your doctor, even if you feel better. If the
prescribed course of treatment is not completed, the infection may recur.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody gets 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 reactions (such as anaphylactic reaction or angioedema), which may include sudden difficulty breathing or swallowing, swelling of the lips, tongue, face and neck, itchy rash, especially if widespread throughout 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 of the lips, eyes, mouth, nose and genital organs, associated with high fever and joint pain. These may be "acute generalized exanthematous pustulosis" (AGEP), "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)).
• Severe or prolonged diarrhoea with blood or mucus. This symptom may occur during or after treatment and may indicate serious intestinal inflammation.
• Severe liver disorders or liver failure (rarely life-threatening): symptoms may include fatigue associated with yellowing of the skin or whites of the eyes (cholestatic jaundice), dark urine, tendency to bleed.
• Kidney inflammation or kidney failure: symptoms may include increased need to urinate at night, tremors and muscle cramps, loss of appetite, nausea or vomiting, unpleasant taste in the mouth.
• Unusual tendency to bruise or bleed: these may be symptoms of a blood formation disorder characterized by reduced platelet count (thrombocytopenia).
• 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 other adverse reactions have been reported:
Very common (may occur in more than 1 in 10 patients):

• diarrhoea.

Common (may occur in no more than 1 in 10 patients):

• headache,
• vomiting, abdominal pain, nausea,
• changes in white blood cell count and blood bicarbonate concentration.

Uncommon (may occur in no more than 1 in 100 patients):

• fungal and/or bacterial infections:
• oral candidiasis, fungal infection caused by Candida
• vaginal infection
• pneumonia
• sore throat
• gastritis
• shortness of breath, chest pain, wheezing and cough (respiratory disorders)
• runny nose or nasal congestion (rhinitis)
  • decreased white blood cell count,
  • hypersensitivity,
  • loss of appetite (anorexia),
  • nervousness, difficulty sleeping (insomnia),
  • dizziness, drowsiness, taste disturbances, tingling and numbness in limbs (paraesthesia),
  • visual disturbances,
  • ear disorders, sensation of spinning,
  • rapid heartbeat, which may be fast or irregular,
  • hot flushes,
  • shortness of breath (dyspnoea), nosebleeds,
  • constipation, bloating with gas passage, dyspepsia, inflammation of the gastric mucosa, difficulty swallowing (dysphagia), abdominal distension, dry mouth, belching with regurgitation of gastric contents or gas, oral ulcers, excessive salivation,
  • rash, itching, urticaria, dermatitis, dry skin, excessive sweating,
  • pain, swelling and reduced mobility of joints (arthralgia), muscle pain (myalgia), back pain, neck pain,
  • pain or difficulty urinating (dysuria), pain in the upper back (kidney pain),
  • spotting (uterine bleeding), testicular disorders,
  • weakness (asthenia), malaise, fatigue, swelling of face, arms and legs, chest pain, fever, pain,
  • changes in liver enzyme levels and blood laboratory test results, increased blood urea levels,
  • complications following procedures.

Rare (may occur in no more than 1 in 1000 patients):

• restlessness,
• liver function disorders, yellowing of the skin or whites of the eyes (jaundice),
• photosensitivity.

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

• reduced number of red blood cells (haemolytic anaemia),
• aggressive behaviour, anxiety, delirium, hallucinations,
• loss of consciousness (fainting), seizures, sensory disturbances (hypoesthesia), excessive psychomotor activity, change in sense of smell (loss of smell, smell disturbances), loss of taste, worsening or increased muscle fatigue (myasthenia),
• hearing loss or tinnitus,
• low blood pressure,
• pancreatitis, tongue discoloration,
• hepatitis,
• joint pain.

The following adverse reactions have been reported in connection with prevention and treatment of infections caused by mycobacteria belonging to the Mycobacterium avium complex:
Very common (may occur in more than 1 in 10 patients):

• diarrhoea, abdominal pain, nausea, bloating with gas passage, loose stools.

Common (may occur in no more than 1 in 10 patients):

• loss of appetite (anorexia),
• dizziness, headache, tingling and numbness in limbs (paraesthesia), altered taste sensation,
• visual disturbances,
• deafness,
• rash, itching,
• joint pain,
• fatigue.

Uncommon (may occur in less than 1 in 100 patients):

• sensory disturbances (hypoesthesia),
• hearing disorders or tinnitus,
• rapid heartbeat, which may be fast or irregular,
• hepatitis,
• severe skin reaction (Stevens-Johnson syndrome), photosensitivity,
• malaise, weakness (asthenia).

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 helps provide more information on the safety of this medicine.

5. How to store Sumamed

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the outer carton and blister after "EXP". The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Sumamed contains

• The active substance is azithromycin (in the form of azithromycin dihydrate). Each 250 mg tablet for oral suspension contains 250 mg of azithromycin (as azithromycin dihydrate).

Each 500 mg tablet for oral suspension contains 500 mg of azithromycin
(as azithromycin dihydrate).
Each 1000 mg tablet for oral suspension contains 1000 mg of
azithromycin (as azithromycin dihydrate).

• Other ingredients are: sodium saccharin, microcrystalline cellulose PH101, microcrystalline cellulose PH102, crospovidone type A, povidone K30, sodium lauryl sulfate, anhydrous colloidal silica, magnesium stearate, aspartame (E 951), orange flavour (contains flavouring substances, corn maltodextrin (contains glucose), benzyl alcohol and α-tocopherol) (see also section 2. "Sumamed contains aspartame, benzyl alcohol, glucose and sodium").

What Sumamed looks like and contents of the pack
Sumamed 250 mg tablets for oral suspension are white to almost white, round, flat tablets with bevelled edges, having a breakline on one side and engraved marking ‘TEVA 250’ on the other side. Each tablet has a diameter of approximately 12.5 mm.
Sumamed 500 mg tablets for oral suspension are white to almost white, round, flat tablets with bevelled edges, having a breakline on one side and engraved marking ‘TEVA 500’ on the other side. Each tablet has a diameter of approximately 17 mm.
Sumamed 1000 mg tablets for oral suspension are white to almost white, round, flat tablets with bevelled edges, having two perpendicular breaklines on one side and engraved marking ‘TEVA 1000’ on the other side. Each tablet has a diameter of approximately 22 mm.
Sumamed 250 mg and 500 mg are available in PVC/PE/PVDC/PE/PVC/Aluminium foil blisters containing 3, 6, 12 or 24 tablets for oral suspension.
Sumamed 1000 mg is available in PVC/PE/PVDC/PE/PVC/Aluminium foil blisters containing 1, 2, 3 or 6 tablets for oral suspension.

Marketing Authorisation Holder
Teva Pharmaceuticals Polska Sp. z o.o.
ul. Emilii Plater 53, 00-113 Warsaw, Poland
tel.: (22) 345 93 00

Manufacturer
Teva Operations Poland Sp. z o.o.
ul. Mogilska 80, 31-546 Kraków, Poland
Pliva Hrvatska d.o.o. (Pliva Croatia Ltd.)
Prilaz Baruna Filipoviča 25, 10000 Zagreb, Croatia

This medicinal product is authorised in the member states of the European Economic Area under the following names:
Spain Azitromicina Teva
Lithuania Azithromycin Teva
Poland Sumamed
Portugal Sumamed