Amotaks

Package leaflet: Information for the user

Amotaks, 500 mg/5 ml, granules for the preparation of oral suspension
Amoxicillinum
Please read all of this leaflet carefully before taking this medicine, because 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 a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

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

2. Important information before taking Amotaks

When not to take Amotaks:
if the patient is allergic to amoxicillin, penicillin, or to any of the other ingredients of the 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, the patient should not take Amotaks. If in doubt, consult your doctor or pharmacist.
Warnings and precautions
Before starting treatment with Amotaks, discuss with your 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 your doctor or pharmacist before taking 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 with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.

• If allopurinol (used in gout) is taken at the same time as Amotaks, skin allergic reactions may be more likely.
• If probenecid (used in the treatment of gout) is taken, concomitant use may reduce amoxicillin excretion and is not recommended. If, in the doctor's opinion, it is necessary to use both medicinal products, the doctor may decide to adjust the dose of Amotaks.
• If anticoagulant medicines (such as warfarin) are taken together with Amotaks, additional blood tests may be required.
• If the patient is also taking other antibiotics (such as tetracyclines), Amotaks may be less effective.
• If the patient is taking methotrexate (used in the treatment of cancer and severe psoriasis), penicillins may increase the severity of its 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 her doctor or pharmacist before using this medicine.
Driving and operating machinery
Amotaks may cause side effects and symptoms (such as allergic reactions, dizziness, and seizures) that may impair the ability to drive.
Do not drive or operate machinery unless the patient feels well.
Amotaks contains approximately 2.6 g of sucrose in 5 ml of suspension and glucose (as one of the components of strawberry and raspberry flavouring)
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact the doctor before taking the medicine.
Considering the dosing regimen described in section 3, the maximum amount of sucrose that may be administered to the patient in the maximum single dose is 15,927 mg, and in the maximum daily dose is 31,854 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 dosing regimen described in section 3, the maximum amount of sodium benzoate that may be administered to the patient in the maximum single dose is 150 mg, and in the maximum 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, meaning the medicine is considered "sodium-free".
The medicine contains 72.14 mg of sodium (main component of table salt) in the maximum single dose.
This corresponds to 3.6% of the maximum recommended daily sodium intake in the diet of adults.
The medicine contains 144.28 mg of sodium (main component of table salt) in the maximum daily dose.
This corresponds to 7.2% of the maximum recommended daily sodium intake in the diet of adults.
The medicine at the maximum daily dose is considered to be high in sodium. This is particularly important for patients on a low-sodium diet.
If Amotaks is taken at the maximum daily dose for a prolonged period, patients, especially those monitoring sodium intake in their diet, should consult their doctor or pharmacist.

3. How to use Amotaks

This medicine should always be used as directed by the doctor or pharmacist. If in doubt,
consult the doctor or pharmacist.

• Always shake the bottle well before each dose.
• Maintain equal intervals of at least 4 hours between doses administered 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).

• The attending 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 weighing 40 kg or more
This oral suspension is not usually recommended for use in adults and children weighing more than
40 kg. Consult the attending doctor or pharmacist for advice.
Amotaks is also available as 1 g tablets, 500 mg capsules, and tablets for preparing an oral suspension, available in strengths of 500 mg, 750 mg, and 1 g (Amotaks Dis).
Kidney disease
If the patient has kidney disease, the dose of this medicine may be lower than the usual dose.
Taking more Amotaks than recommended
If the patient takes more Amotaks than recommended, symptoms such as stomach and intestinal irritation (nausea, vomiting, or diarrhoea) or crystals in the urine may occur, which may be noticed as cloudy urine or difficulty passing urine. Contact the doctor as quickly as possible. Take the medicine along to show the doctor.
If you miss a dose of Amotaks

• If the patient forgets to take a dose, take it as soon as remembered.
• 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 directed by the doctor, even if the patient feels better. All doses are necessary to eliminate the infection. If some bacteria survive, they may cause the infection to return.
• If the patient still does not feel better after completing treatment with Amotaks, consult the doctor.

When Amotaks is used for a prolonged period, fungal infections (candidiasis – yeast infections of mucous membranes causing local pain, itching, and white discharge) may occur. In such cases, consult the doctor.
If the patient takes Amotaks for a prolonged period, the doctor may order additional tests to monitor kidney and liver function and blood parameters.
If there are any further doubts concerning 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 will experience them.
If the patient experiences any of the following severe adverse reactions, treatment with Amotaks must be stopped immediately and the patient should contact a doctor – the patient may require immediate medical attention.

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.

• Rash or small, flat, red, round spots under the skin or skin bruising, which may indicate vasculitis (inflammation of blood vessels) 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. Some observed symptoms 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), irritation around the mouth, eyes, or genital organs.
  Fever and fatigue may also occur.

• Other severe skin reactions include: skin discoloration, subcutaneous nodules, blisters, pustules, skin peeling, redness, pain, itching, and flaking of the skin. These may be associated with fever, headache, and body aches.

• Flu-like symptoms with rash, fever, swollen lymph nodes, and abnormal blood test results [including increased white blood cell count (eosinophilia) and elevated 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 cell 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 with unknown frequency (frequency cannot be estimated from available data)

• Chest pain associated with an allergic reaction, which may indicate an allergy leading to heart attack (Kounis syndrome).
• Blistering rash arranged in ring-like patterns with central crusts or appearing as a string of pearls (linear IgA dermatosis).
• Inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis).
• Drug-induced enterocolitis syndrome (DIES). Drug-induced enterocolitis has occurred mainly in children receiving amoxicillin. This 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:

• Severe diarrhoea with bleeding
• Blisters, redness or bruising of the skin
• Darker urine or pale stools
• Yellowing of the skin and whites of the eyes (jaundice). Please 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 should be contacted.
Less severe skin reactions may sometimes occur, such as:

• Moderately itchy rash (round, red-pink 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 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 (vaginal, oral or skin fold candidiasis); a doctor or pharmacist can advise on treatment
• Kidney problems
• Seizures, especially in patients receiving high doses or with pre-existing 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 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 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 a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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 may also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store the medicine Amotaks

Keep the medicine out of sight and reach of children.
Granules – store below 25°C. Protect from moisture.
Oral suspension – store in the refrigerator, at a temperature between 2°C and 8°C, for no longer than 14 days.
Do not use this medicine after the expiry date 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 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 5 ml of oral suspension contains 500 mg of amoxicillin (100 mg per 1 ml) in the form of
amoxicillin trihydrate.
Other components of the medicine are: guar gum, sucrose, sodium benzoate, anhydrous trisodium citrate,
simethicone, strawberry flavour [maltodextrin, glucose, gum arabic (E 414), pectin (E 440)],
raspberry flavour [maltodextrin, glucose, gum arabic (E 414), pectin (E 440)].

What Amotaks looks like and contents of the pack
White or yellowish granules; after adding water, a homogeneous suspension is formed.

Packaging
One 100 ml bottle containing 39.2 g of granules, in a cardboard box.
One 200 ml bottle containing 65.3 g of granules, in a cardboard box.
Each package includes a measuring spoon graduated to deliver 1.25 ml, 2.5 ml, and 5 ml, and an oral syringe dispenser allowing administration of up to 5 ml of suspension with 0.1 ml accuracy.

Marketing Authorisation Holder and Manufacturer
Tarchomin Pharmaceutical Works "Polfa" Joint Stock Company
ul. A. Fleminga 2
03-176 Warsaw
Phone number: 22-811-18-14
For more detailed information about this medicine, 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 prescribed antibiotic. 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. Following the advice below may help prevent the development of resistant bacteria that could interfere with the effectiveness of antibiotics.

1. It is very important to take the antibiotic at the correct dose, at the right time, and for the prescribed number of days. Please read the instructions in this leaflet carefully, and if any are unclear, ask your doctor or pharmacist for clarification.
2. Do not take an antibiotic that has not been prescribed for you. Only take it to treat the infection for which it was prescribed.
3. Do not take an antibiotic prescribed for someone else, even if they had a similar infection.
4. Do not give your prescribed antibiotics to other people.
5. If you have any leftover antibiotic after completing the prescribed treatment, return it to a pharmacy for proper disposal.

Instructions for preparing the medicine for use
Before use, check that the closure seal has not been broken.
Before adding water, shake the bottle to loosen the granules.

Bottle containing 39.2 g granules, 100 ml capacity
Add previously boiled and cooled water to the mark indicated on the label (34 ml). Shake until a homogeneous suspension is obtained. After standing (once foam has settled), if necessary, top up with water to the mark. This yields 60 ml of suspension.

Bottle containing 65.3 g granules, 200 ml capacity
Add previously boiled and cooled water to the mark indicated on the label (57 ml). Shake until a homogeneous suspension is obtained. After standing (once foam has settled), if necessary, top up with water to the mark. This yields 100 ml of suspension.

Shake the bottle containing the prepared suspension vigorously before each use.
The prepared oral suspension should be measured using the provided measuring spoon or oral syringe dispenser.
Each package includes a measuring spoon graduated to deliver 1.25 ml, 2.5 ml, and 5 ml of suspension, and an oral syringe dispenser allowing accurate measurement up to 5 ml of suspension in increments 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.