Sumamed forte
Poland
Table of Contents
Package leaflet: Information for the patient
SUMAMED forte, 200 mg/5 ml, powder for oral suspension
Azithromycinum
Please read this leaflet carefully before taking 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 ask your doctor or pharmacist.
- This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
- If the patient experiences any adverse reactions, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.
Table of contents
- What Sumamed forte is and what it is used for
- Important information before taking Sumamed forte
- How to take Sumamed forte
- Possible side effects
- How to store Sumamed forte
- Contents of the pack and other information
1. What Sumamed forte is and what it is used for
Sumamed forte 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 forte 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 manifestation of Lyme borreliosis.
2. Information before using Sumamed forte
When not to use 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, discuss with your doctor or pharmacist if:
- the patient has conditions predisposing to development of cardiac arrhythmias (particularly relevant in women and elderly patients):
- congenital or previous history of cardiac arrhythmias (visible in ECG - electrocardiogram),
- severe heart failure,
- very slow heart rate (called bradycardia),
- electrolyte imbalances in the blood, especially low potassium or magnesium levels,
- taking other medicines that may prolong the QT interval on ECG (see section "Sumamed forte with other medicines");
- the patient has severe kidney dysfunction;
- the patient has severe liver dysfunction: the doctor may monitor liver function or discontinue treatment;
- the patient develops a new infection (this may indicate overgrowth of resistant microorganisms or fungal infection);
- the patient has neurological or psychiatric disorders;
- the patient has a sexually transmitted infection: the doctor should ensure that syphilis is ruled out;
- the patient is taking ergot derivatives (ergot alkaloids);
- the patient has infected burn wounds.
Please also refer to the warnings contained in section 4.
If, despite treatment, symptoms of infection do not improve or new symptoms of infection (e.g. fungal) appear, consult your doctor again.
Streptococcal infections
For treatment of streptococcal pharyngitis and tonsillitis, penicillin is usually the drug of choice.
Pseudomembranous colitis
If diarrhoea 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 by the doctor in patients who develop diarrhoea after starting azithromycin therapy. In case of pseudomembranous colitis due to azithromycin use, discontinuation of Sumamed forte and initiation of appropriate treatment may be necessary. Drugs inhibiting peristalsis are contraindicated.
Long-term use
There is lack of 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 gravis
Worsening of myasthenia gravis symptoms or occurrence 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 treatment or prevention of infections caused by the Mycobacterium avium complex in children have not been established.
Children and adolescents
Dosage is adjusted according to body weight (see section 3).
Sumamed forte with other medicines
Inform your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
It is especially important to inform your doctor or pharmacist if you are 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),
- antipsychotics, e.g. pimozide,
- antidepressants, e.g. citalopram,
- fluoroquinolones (used for infections), e.g. moxifloxacin, levofloxacin;
- antacids (Sumamed forte should be taken at least 1 hour before or 2 hours after antacids);
- oral anticoagulants, e.g. warfarin;
- ergot alkaloids (used for migraine or reducing blood flow), e.g. ergotamine: co-administration with azithromycin may lead to ergotism (symptoms: peripheral vasospasm and ischemia);
- digoxin (used for cardiac disorders) and colchicine (used to treat 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 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, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Pregnancy
This 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 during azithromycin treatment is not recommended unless otherwise advised by a doctor.
Fertility
Fertility studies in rodents showed a reduced pregnancy rate 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 forte 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 forte contains sucrose
5 ml of suspension contains 3.768 g of sucrose.
If the patient has previously been diagnosed with intolerance to certain sugars, he or she should consult a doctor before taking this medicine.
The medicine contains 9.8 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 forte contains sulphites in cherry, banana and vanilla flavours
The medicine may rarely cause severe hypersensitivity reactions and bronchospasm.
Sumamed forte 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 young children is associated with a risk of severe adverse reactions, including respiratory distress (so-called "gasping syndrome").
Do not administer to neonates (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's recommendation.
Pregnant or breastfeeding women should consult a doctor before using this medicine, as large 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 this medicine, as large amounts of benzyl alcohol may accumulate in their bodies and cause adverse effects (so-called metabolic acidosis).
Sumamed forte 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.
The maximum daily dose of the medicine (20 mg/kg body weight - 13 ml of suspension) contains 91.73 mg of sodium (main component of table salt). This corresponds to 4.59% of the maximum recommended daily sodium intake in adults.
3. How to use Sumamed forte
This medicine should always be used as directed by the physician. If in doubt, consult your doctor or pharmacist.
The medicine is taken orally.
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
Dosage in children depends on body weight, as follows:
| Body weight | Dose of azithromycin (volume of suspension) |
| 10-14 kg | 100 mg (2.5 ml) |
| 15-24 kg | 200 mg (5 ml) |
| 25-34 kg | 300 mg (7.5 ml) |
| 35-44 kg | 400 mg (10 ml) |
| ≥45 kg | Adult dose should be used |
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, 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
In the treatment of pharyngitis caused by Streptococcus pyogenes in patients with body weight up to 25 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 taken by the patient should equal 60 mg/kg body weight. The maximum daily dose of azithromycin is 500 mg.
In adults and children with body weight above 25 kg, azithromycin is administered at a dose of 500 mg once daily for 3 days, or for 5 days with 500 mg on the first day and 250 mg from day 2 to day 5.
The dosing of the 200 mg/5 ml suspension for children weighing 10–25 kg is shown in the table below:
| Body weight | Dosage
| Dosage
| Bottle content in ml |
| Days 1–3 20 mg/kg body weight/day | Days 1–5 12 mg/kg body weight/day | ||
| Azithromycin dose (suspension volume) | Azithromycin dose (suspension volume) | ||
| 10 kg | 200 mg (5 ml) | 120 mg (3 ml) | 20 ml |
| 11 kg | 220 mg (5.5 ml) | 132 mg (3.3 ml) | 20 ml |
| 12 kg | 240 mg (6 ml) | 144 mg (3.6 ml) | 20 ml |
| 13 kg | 260 mg (6.5 ml) | 156 mg (3.9 ml) | 20 ml |
| 14 kg | 280 mg (7 ml) | 168 mg (4.2 ml) | 30 ml |
| 15 kg | 300 mg (7.5 ml) | 180 mg (4.5 ml) | 30 ml |
| 16 kg | 320 mg (8 ml) | 192 mg (4.8 ml) | 30 ml |
| 17 kg | 340 mg (8.5 ml) | 204 mg (5.1 ml) | 30 ml |
| 18 kg | 360 mg (9 ml) | 216 mg (5.4 ml) | 30 ml |
| 19 kg | 380 mg (9.5 ml) | 228 mg (5.7 ml) | 30 ml |
| 20 kg | 400 mg (10 ml) | 240 mg (6 ml) | 30 ml |
| 21 kg | 420 mg (10.5 ml) | 252 mg (6.3 ml) | 37.5 ml |
| 22 kg | 440 mg (11 ml) | 264 mg (6.6 ml) | 37.5 ml |
| 23 kg | 460 mg (11.5 ml) | 276 mg (6.9 ml) | 37.5 ml |
| 24 kg | 480 mg (12 ml) | 288 mg (7.2 ml) | 37.5 ml |
| 25 kg | 500 mg (12.5 ml) | 300 mg (7.5 ml) | 37.5 ml |
Elderly patients
The same dose is used in elderly patients as in other adult patients. Due to the risk of heart disease, caution is recommended when administering the drug to elderly patients.
Patients with renal or hepatic impairment
If a patient has impaired kidney or liver function, this should be reported to the physician, as the physician may reduce the usual dose of the drug. The drug should not be used in patients with severe hepatic insufficiency.
Method of administration
Azithromycin should be administered orally, once daily.
The prepared 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 medicine to a child, give the child some tea or juice to drink to ensure the medicine 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 forte
Adverse reactions observed after administration of doses higher than recommended were similar to those reported after correct doses. Characteristic symptoms following overdose of macrolide antibiotics include transient hearing loss, severe nausea, vomiting, and diarrhea.
In case of ingestion of a higher than recommended dose, seek immediate medical advice from a doctor or pharmacist. In the event 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 forte
If a dose is missed, it should be administered as soon as possible, and subsequent doses should be given according to the prescribed 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, treatment with
Sumamed forte must be discontinued and you should immediately contact a doctor or go to the
nearest hospital emergency department:
- Severe hypersensitivity reaction (sudden breathing and swallowing difficulties, 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 indicate "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 levels 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 forte 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 a serious intestinal inflammation.
- Weakness, yellowing of the skin or whites of the eyes, and dark-coloured urine.
- Unusual tendency to bruise or bleed.
- Fast (ventricular tachycardia) or irregular heartbeat, or changes in heart rhythm on electrocardiogram (ECG) (prolongation of the 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, possibly causing breathing difficulties), hypersensitivity;
- Loss of appetite (anorexia);
- Restlessness, insomnia; dizziness, drowsiness, taste disturbances, abnormal 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 passage of gas, dyspepsia, inflammation of the gastric mucosa, swallowing difficulties (dysphagia), abdominal distension, dry mouth, regurgitation with belching, oral ulcers, excessive salivation;
- Rash, itching, urticaria, dermatitis, dry skin, excessive sweating;
- Degenerative joint disease, muscle pain, back pain, neck pain;
- Urinary disorders (dysuria), kidney pain;
- Uterine bleeding, testicular disorders;
- Edema, weakness (asthenia), malaise, 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):
- Excitation;
- 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), decreased 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 behavior, 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 arrhythmias (including torsade de pointes and ventricular tachycardia), QT interval prolongation on electrocardiogram;
- Hypotension;
- Pancreatitis, tongue discoloration;
- Liver failure (rarely leading to death), fulminant hepatitis, hepatic 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 renal 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 their prevention,
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 abdominal discomfort;
- Loose stools.
Common (may occur in up to 1 in 10 patients):
- Anorexia;
- Dizziness;
- Headache;
- Abnormal 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 not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions to Medicinal Products at 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.
5. How to store Sumamed forte
- Keep this medicine out of sight and reach of children.
- Store below 25°C.
- Prepared Sumamed forte suspension, after reconstitution with water:
- 20 ml suspension preparation pack: 5 days, stored below 25°C;
- 30 ml and 37.5 ml suspension preparation packs: 10 days, stored 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 specified month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. Proper disposal helps protect the environment.
6. Contents of the pack and other information
What Sumamed forte contains
- The active substance is azithromycin in the form of azithromycin dihydrate. 5 ml of suspension contains 200 mg of azithromycin.
- Other ingredients are: sucrose, trisodium phosphate anhydrous, hydroxypropylcellulose, xanthan gum, colloidal anhydrous silica, cherry flavour, banana flavour, vanilla flavour.
What Sumamed forte looks like and contents of the pack
Sumamed forte is a white to yellowish-white powder.
HDPE bottles containing powder for the preparation of 20 ml, 30 ml, and 37.5 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 pack.
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
Preparation of oral suspension
The water needed to prepare the suspension should preferably be measured using the provided dosing syringe.
- The bottle contains a powder which, when mixed with water, forms an oral suspension.
- Press down the cap and turn it counterclockwise.
- For the pack intended for the preparation of 20 ml of oral suspension, add 12 ml of boiled, cooled water. Measure 4 times 3 ml of water using the provided syringe and add to the bottle with the medicine.
For the pack intended for the preparation of 30 ml of oral suspension, add 16.5 ml of boiled, cooled water. Measure 3 times 5 ml and once 1.5 ml of water using the provided syringe and add to the bottle with the medicine.
For the pack intended for the preparation of 37.5 ml of oral suspension, add 20 ml of boiled, cooled water. Measure 5 times 4 ml of water using the provided syringe and add to the bottle with the medicine.
Each bottle will then contain 5 ml of excess suspension to ensure complete dosing.
- Shake vigorously until a uniform suspension is formed.
- The prepared suspension should be stored at a temperature below 25°C.
For the 20 ml pack, the suspension is stable for 5 days.
For the 30 ml and 37.5 ml packs, the suspension is stable for 10 days.
Instructions for using the dosing syringe
Before administering the medicine to the child, carefully read the instructions below.
FILLING THE SYRINGE WITH MEDICINE
- Shake the suspension well before use.
- Press down the cap and turn it counterclockwise.
- Immerse the tip of the syringe into the suspension and pull the plunger upwards to draw the required amount of suspension.
- If an air bubble is observed in the syringe, return the medicine to the bottle and repeat step 3.
ADMINISTERING THE MEDICINE TO THE CHILD
- Position the child as if for feeding.
- Place the tip of the syringe into the child's mouth.
- Slowly push the plunger to allow the child to gradually swallow the medicine.
- After the child has swallowed the medicine, give them some tea or juice to drink, to ensure the medicine does not remain in the mouth.
CLEANING AND STORAGE
- After use, disassemble the syringe, wash it under running water, dry it, and store it in a clean place together with the medicine.
- After the last dose has been administered to the child, dispose of the syringe together with the bottle.
Warning! Keep the medicine and syringe out of the reach of children.
Use the medicine strictly according to the doctor's instructions.
In case of any doubts, consult your doctor or pharmacist.