Amotaks

Leaflet attached to the packaging: patient information

Amotaks, 1 g, tablets

Amoxicillin

Please read carefully the contents of the leaflet before using the medicine, as it contains

important information for the patient.

• Please keep this leaflet, so that you can read it again if you need to.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to you (or your child). 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 those 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 and what is it used for

• 2. Important information before taking Amotaks
• 3. How to take Amotaks
• 4. Possible side effects
• 5. How to store Amotaks
• 6. Contents of the packaging and other information

1. What is Amotaks and what is it used for

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

What is Amotaks used for

Amotaks is used to treat infections caused by bacteria that are sensitive to amoxicillin. Amotaks 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
• gastric ulcer disease caused by Helicobacter pylori bacteria
• Lyme disease (borreliosis).

Amotaks can also be used to prevent endocarditis.

2. Important information before taking Amotaks

When not to take Amotaks:

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 a skin rash or swelling of the face or throat.
If any of these conditions apply to the patient, they should not take Amotaks. In case of doubt, the patient should consult their doctor or pharmacist before taking Amotaks.

Warnings and precautions

Before taking Amotaks, 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 any of these conditions apply to the patient, they should consult their doctor or pharmacist before taking Amotaks.

Blood and urine tests

If the patient is to undergo:

• 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. Amoxicillin may affect the results of these tests.

Amotaks 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 is taking allopurinol (used to treat gout) at the same time as Amotaks, they may be more likely to experience skin allergic reactions.
• If the patient is taking probenecid (used to treat gout) - taking probenecid at the same time 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 Amotaks.
• If the patient is taking blood-thinning medicines (such as warfarin) at the same time as Amotaks, they may need to have additional blood tests.
• If the patient is taking other antibiotics (such as tetracycline) at the same time as Amotaks, Amotaks may be less effective.
• If the patient is taking 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 consult their doctor or pharmacist before taking this medicine.

Driving and using machines

Amotaks 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.

Amotaks contains sodium

Amotaks contains less than 1 mmol (23 mg) of sodium per tablet, which means that the medicine is considered "sodium-free".

3. How to take Amotaks

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

• The Amotaks tablet should be swallowed with water. The tablet can be divided into two equal doses at the visible break line. Amotaks can be taken before, during, or after meals.
• The patient should maintain 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 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 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 (early stage - 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.
• Gastric ulcer disease:750 mg or 1 g twice a day for 7 days in combination with other antibiotics and medicines used to treat gastric 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 consult 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 may be lower than usual.

Taking a higher dose of Amotaks than recommended

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

• 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 the missed dose.

How long to take Amotaks

• The patient should continue taking Amotaks 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 a relapse of the infection.
• If the patient does not feel better after finishing the treatment with Amotaks, they should consult their doctor.

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

4. Possible side effects

Like all medicines, Amotaks 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 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 punctate, 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, usually occurring 7 to 12 days after taking Amotaks, 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 palms or soles, swelling of the skin (resembling hives), sensitive areas in the mouth, eyes, or genitals. Fever and fatigue may also occur.
• 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. They may be accompanied by 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]; 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 to treat Lyme disease (borreliosis), the patient may experience fever, chills, muscle and headache, and a rash on the skin.
• Colitis (inflammation of the large intestine), which can cause diarrhea (sometimes with blood), abdominal pain, and fever.
• Severe liver reactions can occur, usually in patients treated for a long 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).
• A skin rash with blisters arranged in a ring shape with crusts in the center or like a string of pearls (linear IgA dermatosis).
• Inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis).
• Drug-induced colitis (DIES) Drug-induced colitis occurred mainly in children receiving 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 immediately inform their doctor if they experience:
severe diarrhea with blood
blisters, redness, or bruising on 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 that may cause jaundice.
These 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 Amotaks and contact their doctor immediately.

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

• mildly itchy rash (round, pinkish-red patches), resembling hives, swelling on the forearms, legs, hands, feet, or face. 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.

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
• 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 those 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 Monitoring of the 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, it is possible to gather more information on the safety of the medicine.

5. How to store Amotaks

The medicine should be stored out of sight and reach of children.
Store in a temperature 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.
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 contains

The active substance of the medicine is amoxicillin (in the form of amoxicillin trihydrate).
Each tablet contains 1 g of amoxicillin.
The other ingredients are: sodium carboxymethyl cellulose, corn starch, microcrystalline cellulose, stearic acid, magnesium stearate.

What Amotaks looks like and contents of the pack

White to light cream-colored tablets, oval, convex on both sides with a score line to facilitate breaking the tablet into two equal doses.
Packaging:16 or 20 tablets.

Marketing authorization holder and manufacturer

Tarchomińskie Zakłady Farmaceutyczne "Polfa" S.A.
ul. A. Fleminga 2
03-176 Warsaw
Phone number: 22 811-18-14
For more 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 against 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 that 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, 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 advised by the doctor, the patient should return them to the pharmacy, which will accept them for proper disposal.