Duomox

Leaflet attached to the packaging: patient information

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

Amoxicillin

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Duomox and what is it 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 is Duomox and what is it used for

What is Duomox

Duomox is an antibiotic. The active substance of the medicine is amoxicillin. Amoxicillin belongs to a group of medicines called 'penicillins'.

What is Duomox used for

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

• Infections of the chest, ear, throat, and nose (acute sinusitis, acute otitis media, community-acquired pneumonia, exacerbation of chronic bronchitis, acute streptococcal pharyngitis, and tonsillitis)
• Urinary tract infections (cystitis, acute pyelonephritis, asymptomatic bacteriuria during pregnancy)
• Infection caused by a tick bite (Lyme disease)
• Infections caused by Salmonella typhi and paratyphi (typhoid and paratyphoid fever)
• Dental abscess with spreading infection of the connective tissue
• Infections related to joint prosthetics
• 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. Important information before taking Duomox

When not to take 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 caused symptoms such as a skin rash or swelling of the face or throat.

If the above circumstances apply to the patient, they should not take Duomox. In case of doubt, consult your doctor or pharmacist before taking Duomox.

Warnings and precautions

Before taking Duomox, the patient should discuss it with their doctor or pharmacist if they:

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

In case of doubt whether the above circumstances apply to the patient, they should consult their doctor or pharmacist before taking Duomox.

Blood and urine tests

If the patient is to have:

• urine tests (for glucose) or blood tests to check liver function
• estriol tests (performed during pregnancy to check if the baby is developing properly), they should inform their doctor or pharmacist that they are taking Duomox. Duomox may affect the results of these tests.

Duomox and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or plan to take.

• If the patient takes allopurinol (used for gout) at the same time as Duomox, they may be more likely to experience skin allergic reactions.
• Taking probenecid (used for gout) at the same time as Duomox may reduce the excretion of amoxicillin and is not recommended. If the doctor thinks it is necessary to take both medicines, they may decide to adjust the dose of Duomox.
• If the patient is taking blood-thinning medicines (such as warfarin), they may need to have additional blood tests.
• If the patient is taking other antibiotics (such as tetracycline), Duomox may be less effective.
• If the patient is taking methotrexate (used for cancer and severe psoriasis), penicillins may reduce the excretion of methotrexate, which may increase the risk of side effects.

Pregnancy and breastfeeding

If the patient is pregnant, breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine.

Driving and using machines

Duomox may cause side effects and symptoms (such as allergic reactions, dizziness, and seizures) that can affect the ability to drive or operate machinery. The patient should not drive or operate machinery unless they feel well.

Duomox contains sodium

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

3. How to take Duomox

This medicine should always be taken exactly as advised by the doctor or pharmacist. In case of doubt, consult the doctor or pharmacist.

• Place the tablet for oral suspension in a glass of water and stir well to evenly distribute. The mixture should be taken immediately after preparation.
• Keep equal intervals of at least 4 hours between doses taken during the day

The usual dose is:

Children with a body weight of less than 40 kg

The dosage depends on the child's body weight in kilograms.

• The doctor will recommend the dose of Duomox to be given to 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, and children with a body weight of 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 (borreliosis - tick-borne infection):single migrating erythema (early stage - red or pink rash around the bite): up to 4 g per day. Systemic symptoms (late stage - more severe symptoms or when the disease affects multiple organs): 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 medicines used to treat ulcers
• Prevention of endocarditis during surgical procedures:the dose may vary depending on the type of surgical procedure. Other medicines may be given at the same time. For more information, consult the doctor, pharmacist, or nurse.
• The maximum recommended dose is 6 g per day.

Kidney disease

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

Taking more Duomox than recommended

If the patient takes more Duomox than recommended, they may experience symptoms such as stomach and intestine irritation (nausea, vomiting, or diarrhea) or crystals in the urine, which may appear as cloudy urine or problems with urination. The patient should contact their doctor as soon as possible. They should take the medicine with them to show it to the doctor.

Missing a dose of Duomox

• If the patient forgets to take a dose, they should take it as soon as they remember.
• The patient should not take the next dose too early; they should wait about 4 hours before taking the next dose.
• The patient should not take a double dose to make up for a missed dose.

How long to take Duomox

• The patient should continue taking Duomox for as long as the doctor recommends, even if they feel better. All doses of the medicine are needed to fight the infection. If some bacteria survive, they may cause the infection to come back.
• If the patient does not feel better after finishing the treatment with Duomox, they should consult their doctor.

If the patient takes Duomox for a long time, they may experience thrush (candidiasis - fungal infections of the mucous membranes causing local pain, itching, and white discharge). In this case, the patient should consult their doctor. If the patient takes Duomox for a long time, their doctor may recommend additional tests to check kidney, liver, and blood function. If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Duomox can cause side effects, although not everybody gets them.

If the patient experiences any of the following serious side effects, they should stop taking Duomox and contact their doctor immediately - they may need urgent medical attention:

Very rare side effects (may occur in less 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 can be severe and, in rare cases, may be life-threatening.
• rash or pinpoint, flat, red, round spots under the skin or bruising of the skin, which may be a sign of allergic vasculitis. This may be associated with joint pain (arthritis) and kidney disease
• late allergic reactions occurring usually 7 to 12 days after taking Duomox; some of the observed symptoms include: rashes, fever, joint pain, and swollen lymph nodes, especially in the armpits.
• a skin reaction called erythema multiforme characterized by itchy, red-purple patches on the skin, especially on the hands or soles of the feet, swelling of the skin (resembling hives), irritation around the mouth, eyes, or genitals. Fever and fatigue may also occur.
• other severe skin reactions such as: changes in skin color, lumps under the skin, blisters, pustules, peeling of the skin, redness, pain, itching, and scaling of the skin; these may be associated with fever, headache, and body aches.

symptoms similar to flu with a rash, fever, swollen lymph nodes, and abnormal blood test results [including increased white blood cell count (eosinophilia) and increased liver enzyme activity]; this is known as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS).

• fever, chills, sore throat, and other signs of infection or a tendency to bruise. These may be signs of blood cell problems.
• Jarisch-Herxheimer reaction. When taking Duomox to treat Lyme disease (borreliosis), the patient may experience fever, chills, muscle pain, and headache, as well as a rash on the skin.
• colitis (inflammation of the colon) causing diarrhea (sometimes with blood), abdominal pain, and fever.
• severe liver reactions, which are more common in patients treated for a longer period, men, and the elderly. The patient should immediately inform their doctor if they experience: severe diarrhea with blood, blisters, or redness of the skin, dark urine or pale stools, yellowing of the skin and whites of the eyes (jaundice). The patient should also read the information below about anemia, which can cause jaundice. These symptoms may occur during or up to several weeks after stopping Duomox. Side effects with unknown frequency (frequency cannot be estimated from available data)
• Chest pain associated with an allergic reaction, which may be a sign of an allergy leading to a heart attack (Kounis syndrome), with symptoms including discomfort, pressure, heaviness, tightness, squeezing, or pain in the middle of the chest. The pain may be accompanied by a feeling of suffocation or shortness of breath, sweating, nausea, vomiting, paleness, feeling of fatigue, weakness, fainting, loss of consciousness, increased heart rate or blood pressure.
• Drug-induced enteritis (DIES): drug-induced enteritis occurred mainly in children receiving amoxicillin. It is a type of allergic reaction, with recurring vomiting (1-4 hours after taking the medicine) as the leading symptom. Further symptoms may include abdominal pain, lethargy, diarrhea, and low blood pressure.
• aseptic meningitis (inflammation of the membranes surrounding the brain and spinal cord) characterized by: fever, chills, body aches, loss of appetite, vomiting, fatigue, increased sensitivity to light or photophobia, stiffness and pain in the neck, persistent headache, confusion, seizures.
• increased sensitivity to light (increased sensitivity of the patient's skin to sunlight or ultraviolet radiation)
• rash with blisters arranged in a ring shape with crusts in the center or like a string of pearls (linear IgA dermatosis)

If the patient experiences any of these symptoms, they should stop taking Duomox and contact their doctor immediately.

Sometimes, less severe skin reactions may occur, such as:

• mildly itchy rash (round, red-pink patches), resembling hives, swelling on the forearms, legs, hands, or feet. This occurs uncommonly (in less than 1 in 100 patients).

If the patient experiences any of these symptoms, they should stop taking Duomox and contact their doctor immediately.

Other side effects:

Common side effects(may occur in less than 1 in 10 patients):

• skin rash
• nausea
• diarrhea

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

• vomiting

Very rare side effects(may occur in less than 1 in 10,000 patients):

• thrush (fungal infections of the vagina, mouth, or skin folds); the doctor or pharmacist will advise on treatment
• kidney problems
• seizures, especially in patients taking high doses or having kidney problems
• dizziness
• excessive activity
• yellow, brown, or black, hairy tongue
• discoloration of teeth (in children), which can usually be removed by brushing
• excessive breakdown of red blood cells, which can lead to anemia. Symptoms include: fatigue, headaches, shortness of breath, dizziness, paleness, and yellowing of the skin and whites of the eyes.
• decreased white blood cell count
• decreased platelet count (cells involved in blood clotting)
• blood may take longer to clot than usual. This may be noticeable in case of nosebleeds or cuts.

Side effects with unknown frequency(frequency cannot be estimated from available data)

• crystals in the urine leading to acute kidney damage, visible as cloudy urine or difficulty or discomfort while urinating. To avoid these symptoms, the patient should drink plenty of fluids.

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Ministry of Health, via the website https://smz.ezdrowie.gov.pl or to the marketing authorization holder. By reporting side effects, the patient can help provide more information on the safety of the medicine.

5. How to store Duomox

Keep the medicine out of the sight and reach of children. Do not take Duomox after the expiry date stated on the packaging after "EXP:". The expiry date refers to the last day of the month. Do not store above 25°C. Store in the original packaging. Store the blister in the outer packaging. Do not take this medicine if you notice signs of damage. Medicines should 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 of the medicine is amoxicillin in the form of amoxicillin trihydrate. Each tablet for oral suspension 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 carmellose (E466), crospovidone (E1201), vanillin, lemon flavor, orange flavor, 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, respectively (depending on the dose): '232' (250 mg), '233' (375 mg), '234' (500 mg), '235' (750 mg), or '236' (1 g) on one side and a dividing line on the other side. The dividing line is not intended for dividing the tablet into equal doses and is placed on the tablet for aesthetic reasons. Duomox is available in blisters, in a cardboard box. Each pack contains 20 tablets for oral suspension.

Marketing authorization holder

CHEPLAPHARM Arzneimittel GmbH, Ziegelhof 24, 17489 Greifswald, Germany

Manufacturer

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

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

Date of last revision of the leaflet:

Medical education

Antibiotics are used to treat bacterial infections. They are ineffective against viral infections. Sometimes, bacterial infections do not respond to treatment with a particular antibiotic. One of the most common reasons for this is that the bacteria are resistant to the antibiotic given. This means that the bacteria can survive or multiply despite the use of the antibiotic. Bacteria can become resistant to antibiotics for many reasons. The responsible use of antibiotics can help reduce the possibility of bacteria becoming resistant. The antibiotic prescribed by the doctor is intended only to treat the current illness. Following the recommendations below will help prevent the development of resistant bacteria, which could render the antibiotic ineffective.

• 1. It is very important to take the antibiotic in the right dose, at the right time, and for the right number of days. The patient should read the instructions in the patient information leaflet and ask their doctor or pharmacist to explain any parts they do not understand.
• 2. The patient should not take an antibiotic that was not prescribed specifically for them. They should only take it to treat the infection for which it was prescribed.
• 3. The patient should not take an antibiotic prescribed for someone else, even if they have a similar infection.
• 4. The patient should not give their antibiotic to others.
• 5. If there are any leftover antibiotics after completing the treatment as recommended by the doctor, the patient should return them to the pharmacy, which will dispose of them properly. This will help protect the environment.