Amotaks

Package leaflet: Information for the user

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

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for the adult patient (or child). Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Leaflet contents

1. What Amotaks is and what it is used for

2. What you need to know 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".
For what purpose is Amotaks used?
Amotaks is used to treat bacterial infections caused by bacteria sensitive to amoxicillin.
Amotaks is used to treat:

• 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. What you need to know before taking Amotaks

When not to take Amotaks:
if you are allergic to amoxicillin, penicillin, or any of the other ingredients of this medicine (listed in section 6);
if you have 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 you, do not take Amotaks. If in doubt, consult your doctor or pharmacist before starting treatment with Amotaks.
Warnings and precautions
Before taking Amotaks, talk to your doctor or pharmacist if you:

• have infectious mononucleosis (fever, sore throat, swollen lymph nodes, and extreme fatigue);
• have kidney disease;
• urinate irregularly.

If you are unsure whether any of the above apply to you, consult your doctor or pharmacist before starting Amotaks.
Blood and urine tests
If you are 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), please inform your doctor or pharmacist that you are taking Amotaks. Amoxicillin may affect the results of these tests.

Amotaks and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.

• If you are taking allopurinol (used for gout), you may be more likely to develop skin allergic reactions.
• If you are taking probenecid (used to treat gout), concomitant use may reduce the elimination of amoxicillin and is not recommended. If your doctor considers it necessary to use both medicines, the doctor may decide to adjust the dose of Amotaks.
• If you are taking anticoagulants (such as warfarin) together with Amotaks, additional blood tests may be required.
• If you are taking other antibiotics (such as tetracyclines), Amotaks may be less effective.
• If you are taking methotrexate (used to treat cancer and severe psoriasis), penicillins may increase the risk of adverse effects.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your 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 may impair your ability to drive or operate machinery.
Do not drive or operate machinery unless you feel well.
Amotaks contains sodium
Amotaks contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".
3. How to take Amotaks
Always take this medicine exactly as your doctor or pharmacist has told you. If in doubt, consult your doctor or pharmacist.

• Swallow the Amotaks tablet with water. The tablet may be divided into two equal doses along the visible break line. Amotaks may be taken before, during, or after meals.
• Maintain regular intervals of at least 4 hours between doses taken during the day.

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

• Your doctor will advise 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, divided into two or three 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.
• Acute cystitis: 3 g twice daily for one day.
• Lyme disease (tick-borne infection): erythema migrans (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-treating medicines.
• 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 your doctor, pharmacist, or nurse.
• The maximum recommended daily dose is 6 g.

Kidney disease
If you have kidney disease, your dose may be lower than usual.
Taking more Amotaks than recommended
If you take more Amotaks than recommended, you may experience 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. Contact your doctor as soon as possible. Take the medicine with you to show to the doctor.
If you forget to take Amotaks

• If you forget a dose, take it as soon as you remember.
• Do not take the next dose too soon; 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 take Amotaks

• Continue taking Amotaks for as long as your doctor advises, even if you feel better. All doses are necessary to eliminate the infection. If some bacteria survive, the infection may return.
• If you still do not feel better after completing treatment with Amotaks, consult your 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 your doctor.
If you take Amotaks for a prolonged period, your doctor may recommend additional tests to monitor kidney and liver function and blood counts.
If you have any further questions about using this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicinal product can cause adverse reactions, although not everyone experiences them.
If the patient experiences any of the serious adverse reactions listed below,
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 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), painful or sensitive areas inside 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 of the skin. These may be accompanied by fever, headache and body aches.
• Influenza-like symptoms 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 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, 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 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 ring-like patterns with central crusts or resembling a string of pearls (linear IgA dermatosis).
• Inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis).
• Drug-induced enterocolitis (DIES). Drug-induced enterocolitis has occurred mainly in children receiving amoxicillin. It is a type of allergic reaction, the main symptom of which is recurrent vomiting (1-4 hours after taking the drug). Further symptoms may include abdominal pain, lethargy, diarrhoea and low blood pressure.

Immediately inform a doctor if the patient experiences:
o severe diarrhoea associated with bleeding
o blisters, redness or bruising of 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 anaemia that may cause jaundice.
The above symptoms may occur during treatment or up to several weeks after discontinuation of the medicine.
If the patient experiences any of these symptoms, treatment must be stopped immediately and
a doctor must be contacted.
Sometimes less severe skin reactions may occur, such as:

• Moderately itchy rash (round, pink-red lesions) resembling hives, swelling on 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.

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); 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
• 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 evident in nosebleeds or prolonged bleeding from cuts

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

• Crystals in 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 adverse reactions not listed in
this leaflet, tell your doctor, pharmacist or nurse. Adverse reactions
can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products 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
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 the 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures 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 tablet contains 1 g of amoxicillin.
The other ingredients are: sodium carboxymethyl starch, maize starch, microcrystalline cellulose, stearic acid, magnesium stearate.

What Amotaks looks like and contents of the pack
White to light cream coloured tablets, oval, biconvex, with a score line allowing division of the tablet into two equal doses.

Pack:
The pack contains blisters or an HDPE bottle.
Blisters in a cardboard box – 16 or 20 tablets.
HDPE bottle in a cardboard box – 20 tablets.

Marketing Authorisation Holder and Manufacturer
Tarchomińskie Zakłady Farmaceutyczne „Polfa” Spółka Akcyjna
ul. A. Fleminga 2
03-176 Warszawa
Telephone 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 the use of antibiotics.

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 impair 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 recommended by your doctor, return it to a pharmacy for proper disposal.