Amotaks

Leaflet attached to the packaging: patient information

AMOTAKS, 500 mg, hard capsules

Amoxicillin

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

important information for the patient.

• This 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 their symptoms are the same.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform 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
• peptic ulcer disease caused by Helicobacter pylori bacteria
• Lyme disease.

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:

suffer from infectious mononucleosis (fever, sore throat, swollen lymph nodes and extreme fatigue);
have kidney disease;
have irregular urination.
In case of doubt whether 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 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. Amoxicillin may affect the results of these tests.

Amotaks and other medicines

The patient should tell their doctor or pharmacist about all the medicines they are taking, have recently taken or might 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), their doctor 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, breastfeeding or thinks they may be pregnant, they should consult their doctor or pharmacist before taking this medicine.

Driving and using machines

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

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 capsule should be swallowed whole (without opening it) with a glass of water. Amotaks 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 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.
• Urinary tract infections:3 g twice a day for one day.
• Lyme disease (borreliosis - tick-borne infection):single migrating erythema (early stage - pink-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 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 still does not feel better after finishing the treatment with Amotaks, they should consult their doctor.

If the patient takes Amotaks 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 for a longer period, their doctor may order additional tests to check kidney, liver and blood function.
In case of any further doubts about the use of 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 may 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 (inflammation of blood vessels) due to an allergic reaction. This may be associated with joint pain (arthritis) and kidney disease.
• Late 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.
• Skin reaction called erythema multiforme, characterized by itchy, red-purple patches on the skin, especially on the hands or soles of the feet, skin swelling (resembling urticaria), sensitive to touch 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, skin peeling, redness, pain, itching and flaking of the skin. They 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 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 skin rash.
• Colitis (inflammation of the colon), which can cause diarrhea (sometimes with blood), abdominal pain and fever.

Severe liver reactions may occur. They 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 a heart attack (Kounis syndrome).
• 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 of 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. The above symptoms may occur during or up to several 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, pink-red patches), resembling urticaria, swelling on the forearms, legs, hands, feet or face. This occurs not very often (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 the treatment
• kidney problems
• seizures, especially in patients taking high doses or having kidney problems
• dizziness
• excessive activity
• 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 inform 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
email: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this 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.
Do not use this medicine if signs of damage are visible.
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 hard capsule contains 500 mg of amoxicillin.
The other ingredients are: magnesium stearate, microcrystalline cellulose, yellow iron oxide (E 172),
titanium dioxide (171), gelatin.

What Amotaks looks like and contents of the pack

Hard, opaque capsules of cream color containing white to cream-colored granules.
Packaging:16 or 20 hard capsules

Marketing authorization holder and manufacturer

Tarchomińskie Zakłady Farmaceutyczne „Polfa” Spółka Akcyjna
ul. A. Fleminga 2
03-176 Warszawa
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 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 that could render the antibiotic ineffective.

• 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, which will dispose of them properly.