Amoxicillin aurovitas

Patient Information Leaflet

Amoxicillin Aurovitas, 1000 mg, coated tablets
Amoxicillinum
Please read all of this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult 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 adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Amoxicillin Aurovitas is and what it is used for
2. Important information before taking Amoxicillin Aurovitas
3. How to take Amoxicillin Aurovitas
4. Possible side effects
5. How to store Amoxicillin Aurovitas
6. Contents of the pack and other information

1. What Amoxicillin Aurovitas is and what it is used for

What Amoxicillin Aurovitas is
Amoxicillin Aurovitas is an antibiotic. The active substance is amoxicillin. Amoxicillin belongs to a group of medicines known as "penicillins".
What Amoxicillin Aurovitas is used for
Amoxicillin Aurovitas is used to treat bacterial infections in various parts of the body.
Amoxicillin Aurovitas may also be used in combination with other medicines in the treatment of peptic ulcer disease.

2. Important information before using Amoxicillin Aurovitas

When not to use Amoxicillin Aurovitas:

• 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, which may include symptoms such as skin rash or swelling of the face or throat. If any of the above apply, the patient should not take Amoxicillin Aurovitas. In case of doubt, consult the doctor or pharmacist before starting treatment with Amoxicillin Aurovitas.

Warnings and precautions
Before starting treatment with Amoxicillin Aurovitas, discuss with the doctor or pharmacist if the patient:

• Has infectious mononucleosis (fever, sore throat, swollen lymph nodes, and severe fatigue)
• Has kidney disease
• Has irregular urination.

If in doubt whether any of the above conditions apply, consult the doctor or pharmacist before starting treatment with Amoxicillin Aurovitas.
Blood and urine tests
If the patient is due to have:

• Urine tests (for glucose) or blood tests to assess liver function
• Tests measuring estriol levels (performed during pregnancy to monitor fetal development), inform the doctor or pharmacist that the patient is taking Amoxicillin Aurovitas. Amoxicillin Aurovitas may affect the results of these tests. Amoxicillin Aurovitas and other medicines Inform the doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines the patient plans to take.
• Methotrexate (used in the treatment of cancer and severe psoriasis) – penicillins may reduce methotrexate excretion, increasing the risk of adverse effects.
• Probenecid (used in the treatment of gout) – concomitant use of probenecid may reduce amoxicillin excretion and is not recommended.
• If the patient is taking allopurinol (used for gout), the risk of skin allergic reactions may be increased when used together with Amoxicillin Aurovitas.
• If the patient is taking anticoagulant medicines (such as warfarin), additional blood tests may be required.
• If the patient is taking other antibiotics (such as tetracyclines), Amoxicillin Aurovitas may be less effective.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Driving and operating machinery
Amoxicillin Aurovitas may cause adverse effects and symptoms (such as allergic reactions, dizziness, and seizures) that may impair the ability to drive or operate machinery.
Do not drive or operate machinery unless the patient feels well.
Amoxicillin Aurovitas contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, i.e. the medicine is considered "sodium-free".

3. How to use Amoxicillin Aurovitas

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

• Tablets should be swallowed whole, without crushing or chewing, with water.
• Maintain regular intervals of at least 4 hours between doses administered during the day.

The medicinal product Amoxicillin Aurovitas is available as 1000 mg coated tablets. To achieve doses that cannot be obtained using this product, an appropriate medicinal product containing amoxicillin available on the market should be used.
Children with body weight less than 40 kg
Dosage depends on the child's body weight in kilograms.

• The prescribing doctor will determine the dose of Amoxicillin Aurovitas to be given to the child.
• The usual dose is 40 mg to 90 mg per kilogram of body weight per day, administered 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 and above
The usual dose of Amoxicillin Aurovitas 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 daily for one day.
• Lyme disease (borreliosis - tick-borne infection): Migratory erythema (early stage - red or pink rash around the bite site): 4 g per day. Systemic symptoms (late stage - more severe symptoms or when multiple organs are involved): 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 medications used in ulcer treatment.
• Prevention of endocarditis during surgical procedures: The dose may vary depending on the type of surgical procedure. Other medications may also be administered simultaneously. For detailed information, consult the doctor, pharmacist, or nurse.
• The maximum recommended dose is 6 g per day.

Renal impairment
If the patient has kidney disease, the dose of Amoxicillin Aurovitas may be lower than usual.
Overdose of Amoxicillin Aurovitas
If a patient has taken more than the recommended dose of Amoxicillin Aurovitas, symptoms such as
gastrointestinal irritation (nausea, vomiting, or diarrhoea) or crystals in the urine, which may be observed as cloudy urine or difficulty urinating, may occur.
Contact the doctor as soon as possible. Bring the medicine along to show to the doctor.
Missed dose of Amoxicillin Aurovitas

• If a patient forgets to take a dose, it should be taken 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 should Amoxicillin Aurovitas be taken?

• Continue taking Amoxicillin Aurovitas 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 recurrence of the infection.
• If the patient still does not feel better after completing treatment with Amoxicillin Aurovitas, consult the doctor.

Prolonged use of Amoxicillin Aurovitas 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 Amoxicillin Aurovitas 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 will experience them.
If the patient experiences any of the following severe adverse reactions, stop using Amoxicillin Aurovitas immediately and contact a doctor –
the patient may require immediate medical attention:
Very rare adverse reactions (may occur in no 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 flat, red, round spots under the skin surface, 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 Amoxicillin Aurovitas; 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: changes in skin color, subcutaneous nodules, blisters, pustules, skin peeling, redness, pain, itching, and skin flaking; these may be accompanied by fever, headache, and body aches.

• Flu-like symptoms with rash, fever, enlarged lymph nodes, and abnormal blood test results [including increased white blood cells (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 cell disorders.

• Jarisch-Herxheimer reaction. During treatment with Amoxicillin Aurovitas for Lyme disease, fever, chills, muscle and headache, and skin rash may occur.

• Inflammation of the large intestine causing diarrhea (sometimes with blood), abdominal pain, and fever.

• Severe adverse effects affecting the liver may occur. These usually occur in patients undergoing prolonged treatment, males, and elderly patients. Inform the doctor immediately if the patient experiences: severe diarrhea with bleeding, blisters, redness or bruising of the skin, dark urine or pale stools, or yellowing of the skin and whites of the eyes (jaundice). Also read the information below regarding 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, stop using the medicine and contact a doctor immediately.
  Less severe skin reactions may sometimes occur, such as:

• Moderately itchy rash (round, red-pink lesions), resembling hives, with swelling on the forearms, legs, hands, or feet. This occurs uncommonly (may occur in no more than 1 in 100 patients). If the patient experiences any of these symptoms, contact a doctor and discontinue use of Amoxicillin Aurovitas. Other adverse reactions:

Common adverse reactions (may occur in no more than 1 in 10 patients)

• Skin rash
• Nausea
• Diarrhea.

Uncommon adverse reactions (may occur in no more than 1 in 100 patients)

• Vomiting. Very rare adverse reactions (may occur in no more than 1 in 10,000 patients)
• Candidiasis (yeast infections of the vagina, mouth, or skin folds); consult a doctor or pharmacist for treatment advice
• Kidney problems
• Seizures, especially in patients receiving high doses or with kidney problems
• Dizziness
• Excessive activity
• Yellow, brown, or black hairy tongue
• Tooth discoloration (in children), which can usually be removed by brushing
• Excessive breakdown of red blood cells, which may lead to anemia. 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 clotting)
• Blood may take longer than usual to clot. This may be evident in nosebleeds or cuts.

Frequency not known adverse reactions (frequency cannot be estimated from available data)

• Chest pain associated with an allergic reaction, which may be a sign of allergy leading to heart attack (Kounis syndrome)
• Drug-induced enterocolitis syndrome (DIES): Drug-induced enterocolitis has occurred mainly in children receiving amoxicillin. This is a type of allergic reaction characterized primarily by recurrent vomiting (1–4 hours after taking the medicine). Other symptoms may include abdominal pain, lethargy, diarrhea, and low blood pressure.
• Crystals in urine leading to acute kidney injury
• Blistering rash arranged in a ring-like pattern with central crusts or resembling a string of pearls (linear IgA dermatosis)
• Inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis).

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 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 Amoxicillin Aurovitas

Keep this medicine out of the sight and reach of children.
No special storage instructions apply to this medicine.
Do not use Amoxicillin Aurovitas after the expiry date stated on the packaging following
"Expiry date (EXP):". 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 Amoxicillin Aurovitas contains

• The active substance is amoxicillin in the form of amoxicillin trihydrate. Each Amoxicillin Aurovitas tablet contains 1000 mg of amoxicillin.
• Other ingredients are:
  Core: microcrystalline cellulose (type - 101), sodium carboxymethyl starch (type - A), povidone K 30, microcrystalline cellulose (type - 102), magnesium stearate.
  Coating: hypromellose 2910 (6 cP), macrogol 6000, titanium dioxide (E 171).

What Amoxicillin Aurovitas looks like and contents of the pack
Film-coated tablet
Amoxicillin Aurovitas 1000 mg film-coated tablets: (Size: 21.3 × 10.2 mm)
White or almost white, elongated, biconvex film-coated tablets, printed with the code
“A1000” on one side and a division line on the other side.
The division line on the tablet is intended only to facilitate breaking the tablet for easier swallowing and does not ensure equal dosing.
Amoxicillin Aurovitas is available in blister packs contained in a cardboard carton.
Pack sizes:
The pack contains 8, 10, 16, 20, 24 or 30 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Aurovitas Pharma Polska Sp. z o.o.
Sokratesa 13D, lok. 27
01-909 Warsaw
e-mail: [email protected]

Manufacturer/Importer:
APL Swift Services (Malta) Ltd
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
Generis Farmacêutica, S.A.
Rua João de Deus, 19
2700-487 Amadora
Portugal

This medicinal product is authorised for marketing in the European Economic Area under the following names:
Belgium: Amoxicillin AB 500 mg/1000 mg, filmomhulde tabletten/comprimés pelliculés/Filmtabletten
Czech Republic: Amoxicillin Aurovitas
Germany: Amoxicillin PUREN 500 mg/750 mg/1000 mg Filmtabletten
Poland: Amoxicillin Aurovitas
Portugal: Amoxicilina Generis
Spain: Amoxicilina Aurovitas 500 mg/750 mg/1000 mg comprimidos recubiertos con película EFG
Romania: Amoxicilină Aurobindo 500 mg comprimate filmate
Amoxicilină Aurobindo 1000 mg comprimate filmate

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 treatment with a particular antibiotic.
One of the most common reasons for this is that bacteria are resistant to the antibiotic used.
This means that bacteria can survive or multiply despite the use of the antibiotic.
Bacteria may become resistant to antibiotics for various reasons. Prudent 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 condition. Following the recommendations below will help prevent the development of resistant bacteria, which 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 prescribed duration. Please read the instructions provided in the package leaflet, 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 unused antibiotic remains after completing treatment as directed by your doctor, return it to a pharmacy for proper disposal.