Amotaks

Package leaflet: Information for the patient

AMOTAKS, 500 mg, hard capsules
Amoxicillin
Please read carefully all the information in this leaflet 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. This 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 of the leaflet

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

1. What Amotaks is and what it is used for

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

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

2. Important information before using Amotaks

When not to use 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 skin rash or swelling of the face or throat.
If any of the above apply to the patient, Amotaks should not be taken. If in doubt, consult the doctor
or pharmacist before starting treatment with Amotaks.

Warnings and precautions
Before starting treatment with Amotaks, discuss with the 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 conditions apply, consult the doctor or pharmacist before starting Amotaks.

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

• urine tests (to detect glucose) or blood tests to assess liver function,
• estriol level tests (performed during pregnancy to check whether the baby is developing normally),
  inform the doctor or pharmacist that the patient is taking Amotaks. Amoxicillin may affect the results of these tests.

Amotaks and other medicines
Tell the doctor or pharmacist about all medicines currently taken, recently taken, or planned to be taken.

• If allopurinol (used in gout) is taken together with Amotaks, skin allergic reactions may be more likely.
• If probenecid (used in the treatment of gout) is taken, the doctor may decide to adjust the dose of Amotaks.
• If medicines that reduce blood clotting (such as warfarin) are taken together with Amotaks, additional blood tests may be required.
• If other antibiotics (such as tetracyclines) are taken simultaneously, Amotaks may be less effective.
• If methotrexate (used in cancer and severe psoriasis treatment) is taken, 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 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.

3. How to use Amotaks
This medicine should always be used exactly as directed by the doctor or pharmacist. If in doubt, consult the doctor or pharmacist.

• Swallow the Amotaks capsule whole (without opening it) with water. Amotaks may be taken before, during, or after meals.
• Maintain equal intervals of at least 4 hours between doses administered during the day.

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

• The doctor will prescribe the dose of Amotaks appropriate for 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 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.
• Urinary tract infections: 3 g twice daily for one day.
• Lyme disease (borreliosis - tick-borne infection):
  • Early localized stage (migratory erythema - pink-red rash): 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 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 also be administered. For more detailed 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 the medicine may be lower than usual.

Taking more Amotaks than recommended
If the patient takes more Amotaks than prescribed, symptoms such as stomach and intestinal irritation (nausea, vomiting, or diarrhea) or crystals in the urine (which may appear as cloudy urine or difficulty urinating) may occur. Contact the doctor as soon as possible. Bring the medicine with you to show the doctor.

Missed dose of Amotaks

• If a dose is missed, 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 prescribed by the doctor, even if the patient feels better. All doses are necessary to eliminate the infection. If some bacteria survive, the infection may return.
• If the patient still does not feel better after completing treatment with Amotaks, consult the doctor.

Prolonged use of Amotaks may lead to fungal infections (candidiasis – yeast infections of mucous membranes causing local pain, itching, and white discharge). In such cases, consult the doctor.
If Amotaks is taken for a prolonged period, the doctor may recommend 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 experiences them.
If the patient experiences any of the following serious adverse reactions,
treatment with Amotaks must be stopped immediately and medical advice sought, as
immediate medical assistance may be required.
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 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; observed symptoms may include rashes, fever, joint pain and enlarged lymph nodes, especially in the armpits.
• 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 urticaria), and painful areas in the mouth, eyes or genital organs. Fever and fatigue may also occur.
• Other serious skin reactions include changes in skin color, subcutaneous nodules, blisters, pustules, skin peeling, redness, pain, itching and flaking. These may be accompanied by fever, headache and body aches.
• Influenza-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 easily. These may be symptoms of blood disorders.
• Jarisch-Herxheimer reaction. During treatment with Amotaks for Lyme disease (borreliosis), fever, chills, muscle and headache pain, 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 individuals.
Adverse reactions with unknown frequency (frequency cannot be estimated from
available data)

• Chest pain related to an allergic reaction, which may indicate an allergy leading to myocardial infarction (Kounis syndrome).
• Blistering rash arranged in a ring-shaped pattern with crusts in the center or appearing like 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 mainly been reported in children receiving amoxicillin. It is a type of allergic reaction where recurrent vomiting (1-4 hours after taking the medicine) is the main symptom. Further symptoms may include abdominal pain, lethargy, diarrhoea and low blood pressure.

Immediately inform a doctor if the patient experiences:

• severe diarrhoea accompanied by bleeding
• blisters, redness or bruising on the skin
• dark urine or pale stools
• yellowing of the skin and whites of the eyes (jaundice). Also read the information below regarding anaemia which may cause jaundice. These 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 a doctor contacted.
Less severe skin reactions may sometimes occur, such as:

• moderately itchy rash (round, pink-red lesions), resembling urticaria, with swelling on the forearms, legs, hands or feet. This occurs uncommonly (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.
Other possible 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 (yeast infections of the vagina, mouth or skin folds); consult your doctor or pharmacist for treatment advice
• kidney function disorders
• seizures, especially in patients receiving high doses or with kidney problems
• dizziness
• hyperactivity
• yellow, brown or black hairy tongue
• 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 (blood cells involved in blood clotting)
• blood may take longer than usual to clot; this may be noticeable as nosebleeds or prolonged bleeding from 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 your doctor, pharmacist or nurse. Adverse reactions
can be reported directly to the Department of Monitoring Adverse Drug Reactions of the 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
e-mail: 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

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 specified month.
Do not use this medicine if signs of damage are visible.
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 contains
The active substance is amoxicillin (in the form of amoxicillin trihydrate).
Each hard capsule contains 500 mg of amoxicillin.
Other ingredients: magnesium stearate, microcrystalline cellulose, iron oxide yellow (E 172),
titanium dioxide (E 171), gelatin.

What Amotaks looks like and contents of the pack
Hard, opaque, cream-coloured capsules containing white to cream-coloured granules.
Pack size: 16 or 20 hard capsules

Marketing Authorisation Holder and Manufacturer
Tarchomin Pharmaceutical Works "Polfa" Joint Stock Company
A. Fleminga 2 Street
03-176 Warsaw
Phone number: 22 811-18-14
For further information on 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 antibiotic treatment.

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 compromise 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. Do not take an antibiotic unless it has been prescribed specifically for you. You should take it only to treat the infection for which it was prescribed.
3. Do 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.