Duomox

Package leaflet: Information for the patient

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, as you may need to read it again.
• If you have any further questions, 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 someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

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 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 fever 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 to prevent 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 have included symptoms such as skin rash or swelling of the face or throat.

If any of the above situations apply, the patient should not take Duomox. 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
• Passes urine irregularly.

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 check whether the baby is developing normally), 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 the patient is taking allopurinol (used for gout) at the same time as Duomox, skin allergic reactions may be more likely.
• Concomitant use of probenecid (used for gout) may reduce the elimination of amoxicillin and is not recommended. If the doctor considers it necessary to use both medicinal products, the doctor may decide to adjust 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 treatment and severe psoriasis), penicillins may reduce methotrexate elimination, 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 have a baby, 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. 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 the medicine is considered "sodium-free".

3. How to use Duomox

This medicine should always be used exactly as your doctor or pharmacist has advised. If in doubt,
consult your doctor or pharmacist.

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

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

• Your doctor will determine the dose of Duomox appropriate for your 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 a day 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 a day
• Acute cystitis: 3 g twice a day for one day
• Lyme disease (tick-borne borreliosis):
  • Early localized stage (migratory erythema – red or pink rash around the tick bite): up to 4 g per day
  • Systemic symptoms (late stage – more severe symptoms or multi-organ involvement): up to 6 g per day
• Peptic ulcer disease: 750 mg or 1 g twice a day for 7 days, in combination with other antibiotics and ulcer medications
• Prophylaxis of infective endocarditis during surgical procedures: The dose may vary depending on the type of surgery. Other medications may also be administered. For detailed information, consult your doctor, pharmacist, or nurse.
• The maximum recommended dose is 6 g per day.

Renal disease
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 diarrhea) or crystals in the urine (which may appear as cloudy urine or difficulty urinating) may occur.
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 used?

• Continue taking Duomox for as long as your doctor has instructed, even if you start to feel better. All doses are necessary to eliminate the infection. If some bacteria survive, the infection may 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, liver, and blood function.
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, treatment with Duomox must be stopped immediately and the patient should contact a doctor immediately – the patient may require urgent medical attention:

Very rare adverse reactions (may occur in not 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.

• Skin rash or flat, red, round spots under the skin surface, 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 enlarged lymph nodes, especially under the arms.

• A skin reaction called erythema multiforme, characterized by itchy red-purple skin lesions, especially on palms or soles, skin swelling (resembling hives), irritation around the mouth, eyes, or genital organs. Fever and fatigue may also occur.

• Other severe skin reactions include: skin discoloration, subcutaneous nodules, blisters,
  pustules, skin peeling, redness, pain, itching, and skin desquamation;
  these may be associated with fever, headache, and body aches.

• Flu-like symptoms with rash, fever, enlarged 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, or other signs of infection, or tendency to bruise easily. These may be symptoms of blood cell disorders.

• Jarisch-Herxheimer reaction. During treatment with Duomox for 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 prolonged periods, in men, and in elderly patients. The doctor should be informed immediately if the patient experiences:

  • severe diarrhoea accompanied by bleeding
  • blisters, redness, or bruising of the skin
  • darker urine or pale stools
  • yellowing of the skin and whites of the eyes (jaundice).
    Please also read the information below regarding anaemia that may cause jaundice.
    The above symptoms may occur during treatment or up to several weeks after discontinuation of the medicine.

Adverse reactions with unknown frequency (frequency cannot be determined from available data):

• Chest pain associated with an allergic reaction, which may be a symptom of an allergy leading to heart attack (Kounis syndrome). Symptoms include discomfort, pressure, heaviness, tightness, squeezing, or pain in the central part of the chest. The pain may be accompanied by shortness of breath or breathlessness, sweating, nausea, vomiting, pale skin, fatigue, weakness, fainting, loss of consciousness, increased pulse, or high blood pressure.
• Drug-induced enteritis (DIES): drug-induced enteritis 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). Further 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 (light sensitivity), neck stiffness and pain, persistent headache, confusion, seizures.
• Photosensitivity (increased skin sensitivity 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, treatment with the medicine must be stopped immediately and the patient should contact a doctor without delay.

Less severe skin reactions may sometimes occur, such as:

• Moderately itchy rash (round, red-pink lesions), resembling hives, and swelling of the forearms, legs, hands, or feet. This occurs not very frequently (may occur in not more than 1 in 100 patients).

If the patient experiences any of these symptoms, treatment with the medicine must be stopped and the patient should contact a doctor immediately.

Other adverse reactions:
Common adverse reactions (may occur in not more than 1 in 10 patients):

• Skin rash
• Nausea
• Diarrhoea

Uncommon adverse reactions (may occur in not more than 1 in 100 patients):

• Vomiting

Very rare adverse reactions (may occur in not more than 1 in 10,000 patients):

• Fungal infections (candidiasis of the vagina, mouth, or skin folds); a doctor or pharmacist can advise on treatment options.
• Kidney problems
• Seizures, especially in patients receiving high doses or with pre-existing kidney problems
• Dizziness
• Excessive activity
• 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 evident in nosebleeds or cuts.

Adverse reactions with unknown frequency (frequency cannot be determined from available data):

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

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, the patient should inform their doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +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 to provide more information on the safety of the medicine.

5. How to store Duomox

Keep this medicine out of the 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. These measures 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 contained in a cardboard carton.
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 particular antibiotic.
One of the most common reasons for this is that bacteria are resistant to the antibiotic used.
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.
The antibiotic prescribed by your doctor is intended solely for the treatment of your current illness. Following the recommendations below will help prevent the development of resistant bacteria, which could 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, and 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 your prescribed antibiotics to other people.
5. If any antibiotic remains after completing the treatment as directed by your doctor, return it to a pharmacy for proper disposal.