DUOMOX

Patient Information Leaflet

Duomox, 250 mg, tablets for oral suspension
Duomox, 375 mg, tablets for oral suspension
Duomox, 500 mg, tablets for oral suspension
Duomox, 750 mg, tablets for oral suspension
Duomox, 1 g, tablets for oral suspension
Amoxicillinum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet. 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. It may harm someone else, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents

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

1. What Duomox is and what it is used for

What Duomox is
Duomox is an antibiotic. The active substance is amoxicillin. Amoxicillin belongs to a group of medicines known as 'penicillins'.

What Duomox is used for
Duomox is used to treat bacterial infections caused by bacteria sensitive to amoxicillin in various parts of the body:

• Infections affecting the chest, ear, throat and nose (acute sinusitis, acute otitis media, community-acquired pneumonia, acute exacerbation of chronic bronchitis, acute streptococcal tonsillitis and pharyngitis)
• Urinary tract infections (cystitis, acute pyelonephritis, asymptomatic bacteriuria during pregnancy)
• Infection caused by a bite from an infected tick (Lyme disease)
• Infections caused by Salmonella typhi and paratyphi (typhoid and paratyphoid fever)
• Periapical abscess with spreading connective tissue infection
• Infections associated with joint prostheses
• Treatment of peptic ulcer disease caused by Helicobacter pylori, in combination with other medicines

Duomox may also be used for the prevention of endocarditis (infection of the inner lining of the heart).

2. Information before using Duomox

When not to use Duomox:

• If the patient is allergic to amoxicillin, penicillin, or any of the other ingredients of this medicine (listed in section 6).
• If the patient has ever had an allergic reaction to any other antibiotic, which may include symptoms such as skin rash or swelling of the face or throat.

If any of the above apply to the patient, Duomox should not be taken. In case of doubt, consult the doctor or pharmacist before starting treatment with Duomox.

Warnings and precautions

Talk to your doctor or pharmacist before taking Duomox if the patient:

• Has infectious mononucleosis (fever, sore throat, swollen lymph nodes, and severe fatigue)
• Has kidney disease
• Has irregular urination.

If in doubt whether any of the above apply, consult the doctor or pharmacist before starting treatment with Duomox.

Blood and urine tests

If the patient is due to have:

• Urine tests (for glucose) or blood tests to assess liver function
• Tests measuring estriol levels (performed during pregnancy to monitor fetal development), inform the doctor or pharmacist that the patient is taking Duomox. Duomox may affect the results of these tests.

Duomox with other medicines

Tell the doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.

• If allopurinol (used for gout) is taken at the same time as Duomox, skin allergic reactions may be more likely.
• Concomitant use of probenecid (used for gout) may reduce the excretion of amoxicillin and is not recommended. If, in the doctor's opinion, both medicines must be used, the doctor may consider adjusting the dose of Duomox.
• If the patient is taking anticoagulant medicines (such as warfarin), additional blood tests may be required.
• If the patient is taking other antibiotics (such as tetracyclines), Duomox may be less effective.
• If the patient is taking methotrexate (used in cancer and severe psoriasis treatment), penicillins may reduce methotrexate excretion, increasing the risk of adverse effects.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.

Driving and operating machinery

Duomox may cause adverse effects and symptoms (such as allergic reactions, dizziness, and seizures) that may impair the ability to drive or operate machinery. Do not drive or operate machinery unless the patient feels well.

Duomox contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per oral suspension tablet, meaning it is considered "sodium-free".

3. How to take Duomox

This medicine should always be taken exactly as directed by your doctor or pharmacist. If you are unsure,
you should consult your doctor or pharmacist.

• Place the tablet for oral suspension in a glass of water and mix thoroughly until evenly dispersed. The mixture should be consumed immediately in its entirety after preparation.
• Maintain regular intervals of at least 4 hours between doses administered during the day.

Usual dosage:
Children weighing less than 40 kg
Dosage depends on the child's body weight in kilograms.

• Your doctor will determine the appropriate dose of Duomox for the child.
• The usual dose is 40 mg to 90 mg per kilogram of body weight per day, given in two or three divided doses.
• The maximum recommended dose is 100 mg per kilogram of body weight per day.

Adults, elderly patients, and children weighing 40 kg or more
The usual dose of Duomox is 250 mg to 500 mg three times daily, or 750 mg to 1 g every 12 hours,
depending on the severity and type of infection.

• Severe infections: 750 mg to 1 g three times daily
• Acute cystitis: 3 g twice daily for one day
• Lyme disease (borreliosis - tick-borne infection):
  • Migratory erythema (early stage - red or pink rash around the tick bite): up to 4 g per day
  • Systemic symptoms (late stage - more severe symptoms or when multiple organs are involved): up to 6 g per day
• Peptic ulcer disease: 750 mg or 1 g twice daily for 7 days, in combination with other antibiotics and ulcer medications
• Prophylaxis of endocarditis during surgical procedures: dosage may vary depending on the type of surgical procedure. Other medications may be administered concurrently. For detailed information, consult your doctor, pharmacist, or nurse.
• The maximum recommended daily dose is 6 g.

Renal impairment
If the patient has kidney disease, the dose of Duomox may be lower than the usual recommended dose.

Overdose of Duomox
If a patient takes more than the recommended dose of Duomox, symptoms such as gastrointestinal
irritation (nausea, vomiting, or diarrhoea) or crystals in the urine may occur, which may be observed as
cloudy urine or difficulty urinating.
Contact your doctor as soon as possible. Bring the medicine with you to show the doctor.

Missed dose of Duomox

• If a patient forgets to take a dose, it should be taken as soon as remembered.
• Do not take the next dose too early; wait approximately 4 hours before taking the next dose.
• Do not take a double dose to make up for a missed dose.

How long should Duomox be taken?

• Continue taking Duomox for as long as prescribed by your doctor, even if you start to feel better. All doses are necessary to eliminate the infection. If some bacteria survive, they may cause the infection to recur.
• If you do not feel better after completing treatment with Duomox, consult your doctor.

Prolonged use of Duomox may lead to fungal infections (candidiasis – yeast infections of mucous membranes causing local pain, itching, and white discharge). In such cases, consult your doctor.
If Duomox is taken for a prolonged period, your doctor may recommend additional tests to monitor kidney and liver function, as well as blood tests.
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 everyone will experience them.
If the patient experiences any of the following serious adverse reactions, stop using Duomox immediately and contact a doctor – the patient may require immediate medical attention:

Very rare adverse reactions (may occur in no more than 1 in 10,000 patients):

• Allergic reactions, including: itching and skin rash, swelling of the face, lips, tongue, body, or difficulty breathing. These symptoms may be severe and, in rare cases, may lead to death.
• Rash or flat, red, round spots under the skin or skin bruising, which may indicate vasculitis (inflammation of blood vessels) due to an allergic reaction. This may be associated with joint pain (arthritis) and kidney disease.
• Delayed-type allergic reactions, usually occurring 7 to 12 days after taking Duomox; some observed symptoms include: rashes, fever, joint pain, and swollen lymph nodes, especially under the arms.
• A skin reaction called erythema multiforme, characterized by itchy red-purple skin lesions, especially on the palms or soles of the feet, skin swelling (resembling hives), irritation around the mouth, eyes, or genital organs. Fever and fatigue may also occur.
• Other severe skin reactions such as: skin discoloration, subcutaneous nodules, blisters, pustules, skin peeling, redness, pain, itching, and flaking of the skin; these may be associated with fever, headache, and body aches.
• Flu-like symptoms with rash, fever, swollen lymph nodes, and abnormal blood test results [including increased white blood cell count (eosinophilia) and elevated liver enzyme activity]; drug reaction with eosinophilia and systemic symptoms (DRESS).
• Fever, chills, sore throat, and other signs of infection or tendency to bruise easily. These may be symptoms of blood cell disorders.
• Jarisch-Herxheimer reaction. When Duomox is used to treat Lyme disease (borreliosis), fever, chills, muscle and headache, and skin rash may occur.
• Inflammation of the large intestine causing diarrhoea (sometimes with blood), abdominal pain, and fever.
• Severe adverse reactions affecting the liver may occur. These usually occur in patients treated for a prolonged period, in men, and in elderly patients. Inform the doctor immediately if the patient experiences: severe diarrhoea with bleeding, blisters, redness or bruising of the skin, darker urine or pale stools, or yellowing of the skin and whites of the eyes (jaundice). Also read the information below regarding anaemia that may cause jaundice. These symptoms may occur during or up to several weeks after stopping the medicine.

Adverse reactions of unknown frequency (frequency cannot be estimated from available data):

• Chest pain associated with an allergic reaction, which may indicate an allergy leading to heart attack (Kounis syndrome). Symptoms include discomfort, pressure, heaviness, tightness, squeezing, or pain in the central part of the chest. This may be accompanied by shortness of breath or difficulty breathing, sweating, nausea, vomiting, pale skin, fatigue, weakness, fainting, loss of consciousness, rapid pulse, or high blood pressure.
• Drug-induced enterocolitis (DIES): drug-induced enterocolitis has occurred mainly in children receiving amoxicillin. This is a type of allergic reaction, the main symptom of which is recurrent vomiting (1–4 hours after taking the medicine). Other symptoms may include abdominal pain, lethargy, diarrhoea, and low blood pressure.
• Inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis), presenting with: fever, chills, body aches, loss of appetite, vomiting, fatigue, photophobia or sensitivity to light, neck stiffness and pain, persistent headache, confusion, seizures.
• Photosensitivity (increased sensitivity of the patient's skin to sunlight or ultraviolet radiation).
• Blistering rash arranged in a ring-like pattern with scabs in the center or resembling a string of pearls (linear IgA dermatosis).

If the patient experiences any of these symptoms, stop taking the medicine immediately and contact a doctor without delay.

Less severe skin reactions may sometimes occur, such as:

• Moderately itchy rash (round, red-pink lesions), resembling hives or swelling on the forearms, legs, hands, or feet. This occurs uncommonly (may affect no more than 1 in 100 patients).

If the patient experiences any of these symptoms, stop taking the medicine immediately and contact a doctor without delay.

Other adverse reactions:

Common adverse reactions (may affect up to 1 in 10 patients):

• Skin rash
• Nausea
• Diarrhoea

Uncommon adverse reactions (may affect up to 1 in 100 patients):

• Vomiting

Very rare adverse reactions (may affect up to 1 in 10,000 patients):

• Fungal infections (candidiasis of the vagina, mouth, or skin folds); consult your doctor or pharmacist for treatment advice.
• Kidney problems
• Seizures, especially in patients receiving high doses or with kidney problems
• Dizziness
• Hyperactivity
• Yellow, brown, or black hairy tongue
• Tooth discoloration (in children), which can usually be removed by brushing
• Excessive breakdown of red blood cells, which may lead to anaemia. Symptoms include: fatigue, headache, shortness of breath, dizziness, pallor, and yellowing of the skin and whites of the eyes.
• Decreased number of white blood cells
• Decreased number of platelets (cells involved in blood clotting)
• Blood may take longer than usual to clot. This may be noticeable in cases of nosebleeds or minor cuts.

Adverse reactions of unknown frequency (frequency cannot be estimated from available data):

• Crystals in the urine leading to acute kidney injury, visible as cloudy urine or difficulty or discomfort during urination. To avoid these symptoms, drink plenty of fluids.

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, 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 increase knowledge about the safety of this medicine.

5. How to store Duomox

Keep this medicine out of sight and reach of children.
Do not use Duomox after the expiry date stated on the pack following:
"Expiry date (EXP):". The expiry date refers to the last day of the stated month.
Do not store above 25°C. Store in the original packaging.
Keep the blister in the outer packaging.
Do not use this medicine if you notice any signs of damage.
Medicines must not be disposed of via wastewater 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 Duomox contains

• The active substance is amoxicillin in the form of amoxicillin trihydrate. Each oral suspension tablet of Duomox contains: 250 mg, 375 mg, 500 mg, 750 mg or 1 g of amoxicillin.
• The other ingredients are: microcrystalline cellulose (E460), microcrystalline cellulose and sodium carboxymethylcellulose (E466), crospovidone (E1201), vanillin, lemon flavour, mandarin flavour, saccharin (E954), magnesium stearate (E470b).

What Duomox looks like and contents of the pack

White or almost white, elongated tablets with a logo and marking on one side, respectively (depending on the dose): ‘232’ (250 mg), ‘233’ (375 mg), ‘234’ (500 mg), ‘235’ (750 mg) or ‘236’ (1 g), and a division line on the other side. The division line is not intended for dividing the tablet into equal doses and is included for aesthetic reasons.
Duomox is available in blister packs in a cardboard box.
Each pack contains 20 oral suspension tablets.

Marketing Authorisation Holder
CHEPLAPHARM Arzneimittel GmbH
Ziegelhof 24
17489 Greifswald
Germany

Manufacturer
Astellas Pharma Europe B.V.
Sylviusweg 62
2333 BE Leiden, The Netherlands
Haupt Pharma Latina S.R.L.
Strada Statale 156 KM 47,600 FR
Borgo San Michele LT
04100 - Latina
Italy

For further information about this medicine, please contact:
Komtur Polska sp. z o.o.
[email protected]

Medical education
Antibiotics are used to treat bacterial infections. They are ineffective in treating viral infections.
Sometimes bacterial infections do not respond to treatment with a specific antibiotic.
One of the most common reasons for this is that bacteria are resistant to the antibiotic administered.
This means that bacteria can survive or multiply despite the use of the antibiotic.
Bacteria may become resistant to antibiotics for various reasons. Prudent use of antibiotics may help reduce the development of bacterial resistance, which could otherwise impair the effectiveness of antibiotics.

1. It is very important to take the antibiotic at the correct dose, at the right time, and for the prescribed number of days. Please read the instructions provided in the package leaflet carefully. If any of them are unclear, ask your doctor or pharmacist for clarification.
2. The patient should not take an antibiotic unless it has been prescribed specifically for them. It should be taken only to treat the infection for which it was prescribed.
3. The patient should not take an antibiotic prescribed for another person, even if that person had a similar infection.
4. Do not give antibiotics prescribed for you to other people.
5. If any antibiotic remains after completing treatment as directed by your doctor, return it to a pharmacy for proper disposal.