Amotaks Dis

Leaflet attached to the packaging: patient information

Amotaks Dis, 500 mg, tablets

Amotaks Dis, 750 mg, tablets

Amotaks Dis, 1 g, tablets

Amoxicillin

Read the leaflet carefully before taking the medicine, as it contains

important information for the patient.

• The leaflet should be kept in case it needs to be read again.
• In case of any doubts, the doctor or pharmacist should be consulted.
• This medicine has been prescribed to the patient (or child). It should not be passed on to others. The medicine may harm another person, even if the symptoms of their illness 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 Amotaks Dis and what is it used for
• 2. Important information before taking Amotaks Dis
• 3. How to take Amotaks Dis
• 4. Possible side effects
• 5. How to store Amotaks Dis
• 6. Contents of the packaging and other information

1. What is Amotaks Dis and what is it used for

Amotaks Dis is an antibiotic. The active substance of the medicine is amoxicillin. Amoxicillin belongs to
a group of medicines called "penicillins".

What is Amotaks Dis used for

Amotaks Dis is used to treat infections caused by bacteria that are sensitive to amoxicillin.
Amotaks Dis is used to treat:

• acute bacterial sinusitis
• acute otitis media
• acute streptococcal pharyngitis and tonsillitis
• exacerbation of chronic bronchitis
• community-acquired pneumonia
• acute urinary tract infections
• asymptomatic bacteriuria during pregnancy
• acute pyelonephritis
• typhoid and paratyphoid fever
• dental abscess with spreading cellulitis
• infections related to joint prosthetics
• peptic ulcer disease caused by Helicobacter pylori bacteria
• Lyme disease.

Amotaks Dis can also be used to prevent endocarditis.

2. Important information before taking Amotaks Dis

When not to take Amotaks Dis:

• 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 been allergic to any other antibiotic. This may include a skin rash or swelling of the face or throat.

If the above circumstances apply to the patient, they should not take Amotaks Dis. In case of doubt, before starting to take the medicine, the patient should consult their doctor or pharmacist before starting to take Amotaks Dis.

Warnings and precautions

Before starting to take Amotaks Dis, 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 starting to take Amotaks Dis.

Blood and urine tests

If the patient is to have:

• urine tests (to detect 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 Amotaks Dis. Amoxicillin may affect the results of these tests.

Amotaks Dis and other medicines

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

• If the patient takes allopurinol (used to treat gout) at the same time as Amotaks Dis, they may be more likely to get a skin rash.
• If the patient takes probenecid (used to treat gout) - taking probenecid at the same time as Amotaks Dis may reduce the excretion of amoxicillin and is not recommended. If, in the doctor's opinion, it is necessary to take both medicines, the doctor may decide to adjust the dose of Amotaks Dis.
• If the patient takes blood-thinning medicines (such as warfarin) at the same time as Amotaks Dis, they may need to have extra blood tests.
• If the patient takes other antibiotics (such as tetracycline) at the same time as Amotaks Dis, Amotaks Dis may be less effective.
• If the patient takes methotrexate (used to treat cancer and severe psoriasis), penicillins may increase the risk of side effects.

Pregnancy and breastfeeding

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

Driving and using machines

Amotaks Dis may cause side effects (such as allergic reactions, dizziness, and convulsions) that may affect the patient's ability to drive or use machines.
The patient should not drive or use machines unless they feel well.

Amotaks Dis contains aspartame (E 951)

Each 500 mg tablet contains 3.40 mg of aspartame
Each 750 mg tablet contains 5.10 mg of aspartame
Each 1 g tablet contains 6.80 mg of aspartame
Aspartame is a source of phenylalanine. It may be harmful to patients with phenylketonuria.
This is a rare genetic disorder in which phenylalanine builds up in the body because the body cannot break it down properly.
Considering the dosage regimen presented in section 3, the maximum amount of aspartame that can be administered to a patient in a single dose is 20.4 mg, and in a daily dose, it is 40.8 mg.
Amotaks Dis contains glucose(as one of the ingredients of the strawberry, raspberry, and tropical flavors)
Each 500 mg tablet contains 1.6 mg of glucose.
Each 750 mg tablet contains 2.4 mg of glucose.
Each 1 g tablet contains 3.1 mg of glucose.
If the patient has previously been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.

3. How to take Amotaks Dis

This medicine should be taken as directed by the doctor or pharmacist. If the patient is in doubt, they should ask their doctor or pharmacist.

• Amotaks Dis tablets can be divided into two equal doses at the visible notch. The tablets can be swallowed whole or crushed and taken with a glass of water, sucked, or drunk after preparing a suspension.

How to prepare the suspension
Put the required number of tablets into a glass with a small amount of boiled, cooled water, mix well until evenly distributed, and drink immediately after preparation.

• Amotaks Dis can be taken before, during, or after a meal.
• The patient should keep equal intervals of at least 4 hours between doses taken during the day.

Usual dose

Children with a body weight of less than 40 kg

All doses are determined based on the child's body weight (in kilograms).

• The doctor will recommend the dose of Amotaks Dis 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 Amotaks Dis 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 urinary tract infections:3 g twice a day for one day.
• Lyme disease (borreliosis - tick-borne infection):single migrating erythema

wandering (early stage - a pinkish-red spot): 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 detailed information, the patient should ask their doctor, pharmacist, or nurse.
• The maximum recommended dose is 6 g per day.

Kidney disease

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

Taking a higher dose of Amotaks Dis than recommended

If the patient takes a higher dose of Amotaks Dis than recommended, they may experience symptoms such as stomach and intestinal irritation (nausea, vomiting, or diarrhea) or crystals in the urine, which may appear as cloudy urine or problems urinating. 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 Amotaks Dis

• 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 Amotaks Dis

• The patient should continue taking Amotaks Dis for as long as their 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 Amotaks Dis, they should consult their doctor.

If the patient takes Amotaks Dis for a longer period, 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 Amotaks Dis for a longer period, their doctor may order additional tests to check their kidney, liver, and blood function.
If the patient has any further doubts about taking this medicine, they should ask their doctor or pharmacist.

4. Possible side effects

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

If the patient experiences any of the following serious side effects, they should stop taking Amotaks Dis and contact their doctor immediately, as 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 vasculitis due to an allergic reaction. This may be associated with joint pain (arthritis) and kidney disease.
• Delayed allergic reactions, which usually occur between 7 and 12 days after taking Amotaks Dis, some of the observed symptoms include: rash, fever, joint pain, and swollen lymph nodes, especially in the armpits.
• A skin reaction called erythema multiforme, characterized by itchy, reddish-purple patches on the skin, especially on the palms or soles, swelling of the skin (resembling hives), sensitive areas in the mouth, eyes, or genitals. The patient may also have a fever and feel tired.
• Other severe skin reactions include: changes in skin color, lumps under the skin, blisters, pustules, peeling of the skin, redness, pain, itching, and flaking of the skin. These may be accompanied by fever, headache, and body aches.
• Symptoms similar to flu with rash, fever, swollen lymph nodes, and abnormal blood test results [including increased white blood cell count (eosinophilia) and increased liver enzyme activity]; 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 disorders.
• Jarisch-Herxheimer reaction. When taking Amotaks Dis to treat Lyme disease (borreliosis), the patient may experience fever, chills, muscle and headache, and skin rash.
• Colitis (inflammation of the colon), which can cause diarrhea (sometimes with blood), abdominal pain, and fever.
• Severe liver reactions can occur. These usually occur in patients who have been treated for a longer period, men, and the elderly.

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

• Chest pain associated with an allergic reaction, which may be a sign of an allergy leading to a heart attack (Kounis syndrome).
• Rash with blisters arranged in a ring shape with crusts in the center or as a string of pearls (linear IgA dermatosis).
• Aseptic meningitis (inflammation of the membranes surrounding the brain and spinal cord).
• Drug-induced enteritis (DIES) Drug-induced enteritis occurred mainly in children taking amoxicillin. It is a type of allergic reaction, the leading symptom of which is repeated vomiting (1-4 hours after taking the medicine). Further symptoms may include abdominal pain, lethargy, diarrhea, and low blood pressure.

The patient should tell their doctor immediately if they experience:
o severe diarrhea with blood
o blisters, redness, or bruising of the skin
o darker urine or pale stools
o yellowing of the skin and whites of the eyes (jaundice).
The patient should also read the information below about anemia that may cause jaundice.
The above symptoms may occur during or up to a few weeks after stopping the medicine.

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

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

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

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

Other possible 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
• hyperactivity
• discoloration of teeth (in children), which can usually be removed by brushing
• yellow, brown, or black, hairy tongue
• excessive breakdown of red blood cells, which can lead to anemia; symptoms include: fatigue, headaches, shortness of breath, dizziness, pallor, and yellowing of the skin and whites of the eyes
• decreased white blood cell count
• decreased platelet count (blood cells involved in blood clotting)
• blood may take longer to clot than usual; this may be noticeable in case of nosebleeds or cuts. Side effect with unknown frequency(frequency cannot be estimated from the 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, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, 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
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Amotaks Dis

The medicine should be stored out of sight and reach of children.
Store in a temperature not exceeding 25°C. Protect from moisture.
Do not use this medicine after the expiry date (EXP) stated on the packaging. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Amotaks Dis contains

The active substance of the medicine is amoxicillin (in the form of amoxicillin trihydrate).
Amotaks Dis, 500 mg: each tablet contains 500 mg of amoxicillin.
Amotaks Dis, 750 mg: each tablet contains 750 mg of amoxicillin.
Amotaks Dis, 1 g: each tablet contains 1 g of amoxicillin.
Other ingredients of the medicine are: microcrystalline cellulose, crospovidone, magnesium stearate, strawberry flavor [maltodextrin, glucose, gum arabic (E 414), pectin (E 440)], raspberry flavor [maltodextrin, glucose, gum arabic (E 414), pectin (E 440)], tropical flavor [maltodextrin, glucose, gum arabic (E 414), pectin (E 440)], aspartame (E 951).

What Amotaks Dis looks like and contents of the packaging

Tablets are almost white to creamy, oval, and biconvex with a notch in the middle allowing for division into two equal doses.
Packagingcontains 16 or 20 tablets.

Marketing authorization holder and manufacturer

Tarchomińskie Zakłady Farmaceutyczne „Polfa” Spółka Akcyjna
ul. A. Fleminga 2
03-176 Warszawa
Phone number: 22 811-18-14
To obtain more detailed information about this medicine, the patient should contact the marketing authorization holder.
Date of last revision of the leaflet:

General advice on the use of antibiotics

Antibiotics are used to treat bacterial infections. They are ineffective in treating viral infections.
Sometimes, bacterial infections do not respond to antibiotic treatment. One of the most common reasons for this is that the bacteria are resistant to the antibiotic. This means that the bacteria can survive or multiply despite the use of the antibiotic.
Bacteria can become resistant to antibiotics for many reasons. Careful use of antibiotics can help reduce the likelihood of bacteria developing resistance.
The antibiotic prescribed by the doctor is intended solely for the treatment of the current illness. Paying attention to the following advice will help prevent the development of resistant bacteria, which could reduce the effectiveness of the antibiotic.

• 1. It is very important to take the antibiotic in the correct dose, at the right time, and for the right number of days. The patient should read the instructions in the leaflet and if any of them are unclear, they should ask their doctor or pharmacist to explain.
• 2. The patient should not take an antibiotic that has not been prescribed specifically for them. They should only take it to treat the infection for which the antibiotic was prescribed.
• 3. The patient should not take an antibiotic prescribed for someone else, even if they had a similar infection.
• 4. The patient should not give their antibiotics 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 for proper disposal.