Amotaks

Leaflet attached to the packaging: information for the user

Amotaks, 500 mg/5 ml, granules for oral suspension

Amoxicillin

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please tell your 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 pack and other information

1. What is Amotaks and what is it used for

What is Amotaks

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

What is it 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 you are allergic to amoxicillin, penicillin, or any of the other ingredients of the medicine (listed in section 6).
if you have ever had an allergic reaction to any other antibiotic. This can include a skin rash or swelling of the face or throat.
If any of these apply to you, do not take Amotaks. If you are unsure, consult your doctor or pharmacist.

Warnings and precautions

Before taking Amotaks, you should discuss it with your doctor or pharmacist if you:

have infectious mononucleosis (fever, sore throat, swollen lymph nodes, and extreme fatigue);
have kidney disease;
have irregular urination.
If you are unsure whether any of these apply to you, consult your doctor or pharmacist before taking Amotaks.

Blood and urine tests

If you are going 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 normally), you should 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 the medicines you are taking now or have taken recently, and about any medicines you plan to take.

• If you are taking allopurinol (used to treat gout) at the same time as Amotaks, you may be more likely to experience skin allergic reactions.
• If you are taking probenecid (used to treat gout) - taking probenecid at the same time as Amotaks may reduce the excretion of amoxicillin and is not recommended. If your doctor thinks it is necessary to take both medicines, your doctor may adjust the dose of Amotaks.
• If you are taking blood-thinning medicines (such as warfarin) at the same time as Amotaks, you may need to have additional blood tests.
• If you are taking other antibiotics (such as tetracycline) at the same time as Amotaks, Amotaks may be less effective.
• If you are taking methotrexate (used to treat cancer and severe psoriasis), penicillins may increase the risk of side effects.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Amotaks may cause side effects that can affect your ability to drive or use machines, such as allergic reactions, dizziness, and seizures.
Do not drive or use machines unless you feel well.
Amotaks contains about 2.6 g of sucrose in 5 ml of suspension and glucose(as one of the ingredients of the strawberry and raspberry flavor)
If you have previously been diagnosed with intolerance to some sugars, you should consult your doctor before taking the medicine.
Considering the dosage schedule presented in section 3, the maximum amount of sucrose that can be administered to a patient in a single dose is 15927 mg, and in a daily dose is 31854 mg. This should be taken into account in patients with diabetes.

Amotaks contains sodium benzoate (E 211)

Amotaks contains 25 mg of sodium benzoate (E 211) in 5 ml of suspension.
Sodium benzoate may increase the risk of jaundice (yellowing of the skin and whites of the eyes) in newborns (up to 4 weeks of age).
Considering the dosage schedule presented in section 3, the maximum amount of sodium benzoate that can be administered to a patient in a single dose is 150 mg, and in a daily dose is 300 mg.

Amotaks contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium in 5 ml of prepared oral suspension, i.e., the medicine is considered "sodium-free".
The medicine contains 72.14 mg of sodium (main component of table salt) in a single maximum dose.
This corresponds to 3.6% of the maximum recommended daily dose of sodium in the diet for adults.
The medicine contains 144.28 mg of sodium (main component of table salt) in a daily maximum dose.
This corresponds to 7.2% of the maximum recommended daily dose of sodium in the diet for adults.
The medicine is considered a high-sodium medicine in the maximum daily dose. This is particularly important for patients on a low-sodium diet.
If the medicine is taken in the maximum daily dose for a long time, patients, especially those controlling sodium intake in their diet, should consult their doctor or pharmacist.

3. How to take Amotaks

This medicine should always be taken exactly as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.

• Before administering each dose, the bottle should always be shaken well.
• Equal intervals of at least 4 hours should be maintained between doses administered during the day.

The usual dose is:

Children with a body weight of less than 40 kg

All doses are determined based on the child's body weight (in kilograms).

• Your 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 patients, and children with a body weight of 40 kg or more

This suspension is not usually recommended for use in adults and children with a body weight of more than 40 kg. Consult your doctor or pharmacist for advice.
Amotaks is also available in the form of 1 g tablets, 500 mg capsules, and 500 mg, 750 mg, and 1 g tablets for oral suspension (Amotaks Dis).

Kidney disease

If you have kidney disease, the dose of the medicine may be lower than usual.

Overdose of Amotaks

If you take more Amotaks than you should, you may experience 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. Contact your doctor as soon as possible. Take the medicine with you to show to the doctor.

Missed dose of Amotaks

• If you forget to take a dose, take it as soon as you remember.
• Do not take the next dose too early, wait about 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

• You should continue taking Amotaks for as long as your doctor recommends, even if you feel better. All doses of the medicine are necessary to fight the infection. If some bacteria survive, they may cause a relapse of the infection.
• If you do not feel better after finishing the treatment with Amotaks, consult your doctor.

If you take Amotaks for a long time, you may experience thrush (candidiasis - fungal infections of the mucous membranes causing local pain, itching, and white discharge). In this case, consult your doctor.
If you take Amotaks for a long time, your doctor may order additional tests of kidney, liver, and blood function.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Amotaks can cause side effects, although not everybody gets them.

If you experience any of the following serious side effects, stop taking Amotaks and contact your doctor immediately - you 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, life-threatening.
• rash or flat, red, round patches under the skin or bruising of the skin, which may be a sign of allergic vasculitis. This can be associated with joint pain (arthritis) and kidney disease.
• late allergic reactions occurring usually 7 to 12 days after taking Amotaks, some of the observed symptoms are: rash, 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 hands or soles of the feet, skin swelling (resembling hives), irritation around the mouth, eyes, or genitals.
  There may be fever and a feeling of tiredness.

Side effects with unknown frequency(frequency cannot be estimated from available data)

• chest pain associated with an allergic reaction, which can be a sign of an allergy leading to a heart attack (Kounis syndrome).
• rash with blisters arranged in a ring shape with crusts in the center or as a string of pearls (linear IgA dermatosis).
• aseptic meningitis (inflammation of the membranes surrounding the brain and spinal cord).
• Drug-induced enteritis (DIES) Drug-induced enteritis 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.

Tell your doctor immediately if you 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). Also, read the information below about anemia that can cause jaundice. The above symptoms can occur during or up to a few weeks after stopping the medicine.

If you experience any of these symptoms, stop taking Amotaks and contact your doctor immediately.

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

• mildly itchy rash (round, red-pink patches), resembling hives, swelling on the forearms, legs, hands, or feet. This occurs uncommonly (may occur in less than 1 in 100 patients).

If you experience any of these symptoms, contact your doctor and stop taking Amotaks.

Other 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), your doctor or pharmacist will advise on treatment
• kidney problems
• seizures, especially in patients taking high doses or having 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 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 (cells involved in blood clotting)
• blood may take longer to clot than usual. This can be seen in the case of nosebleeds or cuts.

Side effect with unknown frequency(frequency cannot be estimated from 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, you should drink plenty of fluids.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please tell your doctor or pharmacist. 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, you can help provide more information on the safety of this medicine.

5. How to store Amotaks

Keep the medicine out of the sight and reach of children.
Granules- store in a temperature below 25°C. Protect from moisture.
Suspension- store in a refrigerator, at a temperature between 2°C and 8°C, for no more than 14 days.
Do not take this medicine after the expiry date 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. Ask your pharmacist how to dispose of medicines that are no longer needed. 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 5 ml of oral suspension contains 500 mg of amoxicillin (100 mg in 1 ml) in the form of amoxicillin trihydrate.
Other ingredients of the medicine are: guar gum, sucrose, sodium benzoate, anhydrous trisodium citrate, simethicone, strawberry flavor [maltodextrin, glucose, arabic gum (E 414), pectin (E 440)], raspberry flavor [maltodextrin, glucose, arabic gum (E 414), pectin (E 440)].

What Amotaks looks like and contents of the pack

White or yellow granules; after adding water, a uniform suspension is formed.

Packaging

One bottle, with a capacity of 100 ml, containing 39.2 g of granules in a cardboard box.
One bottle, with a capacity of 200 ml, containing 65.3 g of granules in a cardboard box.
A measuring spoon with a scale, allowing the administration of 1.25 ml, 2.5 ml, and 5 ml of suspension, and a syringe dispenser, allowing the administration of up to 5 ml of suspension with an accuracy of 0.1 ml, are attached to the packaging.

Marketing authorization holder and manufacturer

Tarchomińskie Zakłady Farmaceutyczne "Polfa" Spółka Akcyjna
ul. A. Fleminga 2
03-176 Warsaw
Phone number: 22-811-18-14
For more detailed information about this medicine, please 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 bacteria are resistant to the antibiotic. This means that bacteria can survive or multiply despite the use of antibiotics.
Bacteria can become resistant to antibiotics for many reasons. Careful use of antibiotics can help reduce the possibility of bacteria developing resistance.
The antibiotic prescribed by your doctor is intended only to treat 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. Read the instructions in the leaflet and if any of them are unclear, ask your doctor or pharmacist to explain.
• 2. You should not take an antibiotic if it was not prescribed specifically for you. You should only take it to treat the infection for which the antibiotic was prescribed.
• 3. You should not take an antibiotic prescribed for someone else, even if they had a similar infection.
• 4. Do not give antibiotics prescribed for you to other people.
• 5. If you have any leftover antibiotic after completing the treatment as recommended by your doctor, return it to the pharmacy, which will accept it for proper disposal.

Instructions for preparing the medicine for use

Before use, check that the cap seal has not been broken.
Before adding water, shake the bottle with the medicine to loosen the granules.
Bottle containing 39.2 g of granules, with a capacity of 100 ml
Add boiled, cooled water to the bottle with the granules to the mark on the label (34 ml). Shake until a uniform suspension is obtained. After settling (sedimentation of foam), if necessary, fill with water to the mark. You will get 60 ml of suspension.
Bottle containing 65.3 g of granules, with a capacity of 200 ml
Add boiled, cooled water to the bottle with the granules to the mark on the label (57 ml). Shake until a uniform suspension is obtained. After settling (sedimentation of foam), if necessary, fill with water to the mark. You will get 100 ml of suspension.
Shake the bottle with the prepared suspension well before each use.
The prepared oral suspension should be measured with a measuring spoon or a syringe dispenser.
A measuring spoon with a scale is attached to the packaging, allowing the administration of 1.25 ml, 2.5 ml, and 5 ml of suspension, and a syringe dispenser, allowing the administration of up to 5 ml of suspension with an accuracy of 0.1 ml.
5 ml of suspension contains 500 mg of amoxicillin;
2.5 ml of suspension contains 250 mg of amoxicillin;
1.25 ml of suspension contains 125 mg of amoxicillin;
0.1 ml of suspension contains 10 mg of amoxicillin.