Amotaks dis

Package leaflet: Information for the patient

Amotaks Dis, 500 mg, tablets
Amotaks Dis, 750 mg, tablets
Amotaks Dis, 1 g, tablets
Amoxicillin
Please read this leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for the adult patient (or child). Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

1. What Amotaks Dis is and what it is 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 pack and other information

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

Amotaks Dis is an antibiotic. The active substance is amoxicillin. Amoxicillin belongs to a group of medicines called "penicillins".
What Amotaks Dis is used for
Amotaks Dis is used to treat bacterial infections caused by bacteria sensitive to amoxicillin.
Amotaks Dis is used in the treatment of:

• acute bacterial sinusitis
• acute otitis media
• acute streptococcal tonsillitis and pharyngitis
• acute exacerbation of chronic bronchitis
• community-acquired pneumonia
• acute cystitis
• asymptomatic bacteriuria during pregnancy
• acute pyelonephritis
• typhoid fever and paratyphoid fever
• perimandibular abscess with spreading cellulitis
• infections associated with joint prostheses
• peptic ulcer disease caused by Helicobacter pylori bacteria
• Lyme disease (borreliosis).

Amotaks Dis may also be used for the prevention of infective endocarditis.

2. Information before using Amotaks Dis

When not to use 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 had an allergic reaction to any other antibiotic. This may include skin rash or swelling of the face or throat.

If any of the above apply to the patient, Amotaks Dis must not be taken. In case of doubt, consult the
treating physician or pharmacist before starting treatment with Amotaks Dis.
Warnings and precautions
Before starting treatment with Amotaks Dis, discuss with a doctor or pharmacist if the patient:

• has infectious mononucleosis (fever, sore throat, swollen lymph nodes, and extreme fatigue);
• has kidney disease;
• urinates irregularly. If in doubt whether any of the above apply, consult the treating physician or pharmacist before starting treatment with Amotaks Dis.

Blood and urine tests
If the patient is due to have:

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

Amotaks Dis and other medicines
Tell the doctor or pharmacist about all medicines currently or recently used, as well as any medicines the patient plans to use.

• If the patient is taking allopurinol (used for gout), skin allergic reactions may be more likely when taken together with Amotaks Dis.
• If the patient is taking probenecid (used to treat gout), concomitant use may reduce amoxicillin excretion and is not recommended. If the doctor considers it necessary to use both medicinal products, the doctor may decide to adjust the dose of Amotaks Dis.
• If the patient is taking anticoagulant medicines (such as warfarin) together with Amotaks Dis, additional blood tests may be required.
• If the patient is also taking other antibiotics (such as tetracyclines), Amotaks Dis may be less effective.
• If the patient is taking methotrexate (used in the treatment of cancer and severe psoriasis), penicillins may increase 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
child, she should consult a doctor or pharmacist before using this medicine.
Driving and operating machinery
Amotaks Dis may cause adverse effects and symptoms (such as allergic reactions, dizziness, and
seizures) that may impair the ability to drive.
The patient should not drive or operate machinery unless feeling 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 for patients with phenylketonuria.
This is a rare genetic disorder in which phenylalanine accumulates in the body due to impaired excretion.
Considering the dosing regimen described in section 3, the maximum amount of aspartame that
may be administered in a single maximum dose is 20.4 mg, and in the maximum daily dose is 40.8 mg.
Amotaks Dis contains glucose (as one of the ingredients of strawberry, raspberry, and tropical flavour)
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 certain sugars, the patient should consult
a doctor before taking this medicine.
3. How to use Amotaks Dis
This medicine should be used as directed by the doctor or pharmacist. In case of doubt, consult the doctor or pharmacist.

• Amotaks Dis tablets may be divided into two equal doses at the visible indentation. Tablets may be swallowed whole or crushed and taken with a glass of water, sucked, or taken as a suspension.

How to prepare a suspension
Place the appropriate number of tablets into a glass containing a small amount of cooled boiled water,
mix well until evenly dispersed, and drink immediately after preparation.

• Amotaks Dis may be taken before, during, or after meals.
• Maintain regular intervals of at least 4 hours between doses administered during the day.

Usual dosage
Children weighing less than 40 kg
All doses are based on the child's body weight (expressed in kilograms).

• The treating physician will determine the dose of Amotaks Dis to be administered 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 patients, and children weighing 40 kg or more
The usual dose of Amotaks Dis 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 – pink-red rash): 4 g per day.
  • Systemic symptoms (late stage – more severe symptoms or when multiple organs are affected): 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.

• Prevention of endocarditis during surgical procedures: the dose may vary depending on the type of surgery. Other medicines may be administered simultaneously. For more detailed information, consult the doctor, pharmacist, or nurse.

• The maximum recommended daily dose is 6 g.

Kidney disease
If the patient has kidney disease, the dose of the medicine may be lower than the usual dose.
Taking more Amotaks Dis than recommended
If the patient takes more Amotaks Dis than recommended, symptoms such as stomach and intestinal irritation (nausea, vomiting, or diarrhoea) or crystals in the urine (which may appear as cloudy urine or difficulty urinating) may occur. Contact the treating physician as soon as possible. Bring the medicine along to show the doctor.
Missing a dose of Amotaks Dis

• If the patient forgets to take a dose, take it 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 to use Amotaks

• Continue taking Amotaks for as long as directed by the doctor, even if the patient feels better. All doses are necessary to eliminate the infection. If some bacteria survive, they may cause the infection to recur.
• If the patient still does not feel better after completing treatment with Amotaks, consult the doctor.

Prolonged use of Amotaks Dis may lead to fungal infections (candidiasis – yeast infections of mucous membranes causing local pain, itching, and white discharge). In such cases, consult a doctor.
If the patient is taking Amotaks Dis for a prolonged period, the doctor may order additional tests to monitor kidney, liver, and blood function.
If there are any further doubts regarding the use of this medicine, consult the 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 serious adverse reactions listed below,
treatment with Amotaks Dis must be stopped immediately and medical advice sought, as
immediate medical intervention may be necessary.
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 Amotaks Dis. 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 the palms or soles of the feet, skin swelling (resembling hives), areas sensitive to touch in the mouth, eyes or genital organs. Fever and fatigue may also occur.
• Other severe skin reactions include: changes in skin color, subcutaneous nodules, blisters, pustules, skin peeling, redness, pain, itching and skin desquamation. These may be accompanied by 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 increased liver enzyme activity]; drug reaction with eosinophilia and systemic symptoms (DRESS).
• Fever, chills, sore throat and other signs of infection or tendency to bruise. These may be symptoms of blood disorders.
• Jarisch-Herxheimer reaction. During treatment with Amotaks Dis for Lyme disease (borreliosis), fever, chills, muscle and headache, and skin rash may occur.
• Colitis (inflammation of the large intestine), causing diarrhea (sometimes with blood), abdominal pain and fever.
• Severe adverse reactions affecting the liver may occur. These usually occur in patients undergoing long-term treatment, in men and in elderly patients.

Adverse reactions occurring with unknown frequency (frequency cannot be estimated from
available data)

• Chest pain associated with an allergic reaction, which may indicate an allergy leading to myocardial infarction (Kounis syndrome).
• Blistering rash arranged in a ring-shaped pattern with central crusting or resembling a string of pearls (linear IgA dermatosis).
• Inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis).
• 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 drug). Other symptoms may include abdominal pain, lethargy, diarrhea and low blood pressure.

Immediately inform a doctor if the patient experiences:
o severe diarrhea associated with bleeding
o blisters, redness or bruising on the skin
o dark urine or pale stools
o yellowing of the skin and whites of the eyes (jaundice).
Also read the information below regarding anemia that may be the cause of jaundice.
The above symptoms may occur during treatment or up to several weeks after stopping the medicine.
If the patient experiences any of these symptoms, treatment must be stopped immediately and
medical advice sought.
Sometimes less severe skin reactions may occur, such as:

• Moderately itchy rash (round, pink-red lesions), resembling hives, with swelling on 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, contact a doctor and discontinue
treatment with Amotaks Dis.
Other possible adverse reactions
Common adverse reactions (may occur in not more than 1 in 10 patients)

• skin rash
• nausea
• diarrhea.

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 (vaginal, oral or skin fold candidiasis); a doctor or pharmacist can advise on treatment
• kidney function disorders
• seizures, especially in patients receiving high doses or with kidney problems
• dizziness
• excessive activity
• tooth discoloration (in children), which can usually be removed by brushing
• yellow, brown or black hairy tongue
• excessive breakdown of red blood cells, which may lead to anemia; 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 (blood cells involved in blood clotting)
• blood may clot longer than usual; this may be observed as nosebleeds or prolonged bleeding after minor cuts. Adverse reaction with 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 a doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products, 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 this medicine.

5. How to store Amotaks Dis

Keep this medicine out of sight and reach of children.
Store below 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 indicated.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Amotaks Dis contains
The active substance 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 are: microcrystalline cellulose, crospovidone, magnesium stearate, strawberry flavour [maltodextrin, glucose, arabic gum (E 414), pectin (E 440)], raspberry flavour [maltodextrin, glucose, arabic gum (E 414), pectin (E 440)], tropical flavour [maltodextrin, glucose, arabic gum (E 414), pectin (E 440)], aspartame (E 951).

What Amotaks Dis looks like and contents of the pack
Tablets are almost white to cream-coloured, oval, biconvex, with a central groove allowing division into two equal doses.

Packaging
Amotaks Dis 500 mg, 750 mg: 16 or 20 tablets packed in blisters.
Amotaks Dis 1 g: 16 tablets packed in blisters or 20 tablets packed in blisters or HDPE bottles with screw cap.

Marketing Authorisation Holder and Manufacturer
Tarchomin Pharmaceutical Works "Polfa" Joint Stock Company
ul. A. Fleminga 2
03-176 Warsaw
Telephone number: 22 811-18-14
For further information about this medicinal product, please contact the Marketing Authorisation Holder.

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 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. Careful 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. Observing the following advice will help prevent the development of resistant bacteria that could hinder the effectiveness of antibiotics.

1. It is very important to take the antibiotic at the correct dose, at the right time, and for the correct number of days. Please read the instructions in the leaflet carefully 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 specifically prescribed 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 the treatment as directed by your doctor, return it to a pharmacy for proper disposal.