Amoxicillin Aurovitas

Leaflet attached to the packaging: patient information

Amoxicillin Aurovitas, 500 mg, tablets for oral suspension

Amoxicillin Aurovitas, 750 mg, tablets for oral suspension

Amoxicillin Aurovitas, 1000 mg, tablets 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 necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for a particular person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Amoxicillin Aurovitas and what is it 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 packaging and other information

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

What is Amoxicillin Aurovitas

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

What is Amoxicillin Aurovitas used for

Amoxicillin Aurovitas is used to treat bacterial infections of various parts of the body. Amoxicillin Aurovitas can also be used, in combination with other medicines, to treat stomach ulcer disease.

2. Important information before taking Amoxicillin Aurovitas

When not to take 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 been diagnosed with an allergy to any other antibiotic. This may include a skin rash or swelling of the face or throat.

If the above circumstances apply to the patient, they should not take Amoxicillin Aurovitas. In case of doubts, the patient should consult their doctor or pharmacist before starting to take Amoxicillin Aurovitas.

Warnings and precautions

Before starting to take Amoxicillin Aurovitas, the patient should discuss it with their doctor or pharmacist if they:

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

In case of doubts whether the above circumstances apply to the patient, they should consult their doctor or pharmacist before starting to take Amoxicillin Aurovitas.

Blood and urine tests

If the patient is to have:

• urine tests (for 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 Amoxicillin Aurovitas. Amoxicillin Aurovitas may affect the results of these tests.

Amoxicillin Aurovitas and other medicines

The patient should tell their doctor or pharmacist about all the medicines they are taking, have recently taken or might take.

• Methotrexate (used to treat cancer and severe psoriasis) - penicillins may decrease the excretion of methotrexate, which may increase the risk of side effects.
• Probenecid (used to treat gout) - concurrent use of probenecid may decrease the excretion of amoxicillin and is not recommended.
• If the patient is taking allopurinol (used to treat gout) at the same time as Amoxicillin Aurovitas, they may be more likely to experience skin allergic reactions.
• If the patient is taking blood-thinning medicines (such as warfarin), they may need to have additional blood tests.
• If the patient is taking other antibiotics (such as tetracycline), Amoxicillin Aurovitas may be less effective.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant or are planning to have a baby, they should consult their doctor or pharmacist before taking this medicine.

Driving and using machines

Amoxicillin Aurovitas may cause side effects and symptoms (such as allergic reactions, dizziness and seizures) that may affect the ability to drive or operate machinery.
The patient should not drive or operate machinery unless they feel well.

Amoxicillin Aurovitas, powder for oral suspension contains aspartame and maltodextrin (glucose).

Each 500 mg tablet for oral suspension contains 2.4 mg of aspartame.
Each 750 mg tablet for oral suspension contains 3.6 mg of aspartame.
Each 1000 mg tablet for oral suspension contains 4.8 mg of aspartame.
Aspartame (E 951) is a source of phenylalanine. It may be harmful to patients with phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates in the body due to its improper excretion.
Maltodextrin is absorbed like glucose. If the patient has previously been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.

Amoxicillin Aurovitas contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means that it is considered "sodium-free".

3. How to take Amoxicillin Aurovitas

This medicine should always be taken exactly as advised by the doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist.

• The tablet for oral suspension should be placed in a glass of water and stirred well until it is evenly distributed. The mixture should be swallowed immediately after preparation.
• The patient should maintain equal intervals of at least 4 hours between doses taken 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.

• The doctor will recommend 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, given in two or three divided doses.
• The maximum 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

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 a day for one day.
• Lyme disease (borreliosis - infection transmitted by ticks):single migrating erythema (early stage - a pinkish-red spot): 4 g per day. Systemic symptoms (late stage - more serious symptoms or when the disease affects multiple organs): up to 6 g per day.
• Stomach ulcer disease:750 mg or 1 g twice a day for 7 days in combination with other antibiotics and medicines used to treat stomach 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 the medicine may be lower than usual.
The tablet can be divided into equal doses.

Taking a higher dose of Amoxicillin Aurovitas than recommended

If the patient has taken a higher dose of Amoxicillin Aurovitas 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 with urination. 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 Amoxicillin Aurovitas

• 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 Amoxicillin Aurovitas

• The patient should continue taking Amoxicillin Aurovitas for as long as their doctor recommends, even if they feel better. All doses of the medicine are necessary to fight the infection. If some bacteria survive, they may cause the infection to recur.
• If the patient does not feel better after finishing the treatment with Amoxicillin Aurovitas, they should consult their doctor.

If the patient takes Amoxicillin Aurovitas for a long time, 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 Amoxicillin Aurovitas for a long time, their doctor may order additional tests to check kidney, liver and blood function.
In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

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

If the patient experiences any of the following serious side effects, they should stop taking Amoxicillin Aurovitas and contact their doctor immediately - 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, in rare cases they may lead to death
• rash or spot-like, flat, red, round spots under the skin or bruising of the skin, which may be a sign of vasculitis due to an allergic reaction. This may be associated with joint pain (arthritis) and kidney disease.
• late allergic reactions occurring usually 7 to 12 days after taking Amoxicillin Aurovitas, some of the observed symptoms include: rash, 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, swelling of the skin (resembling hives), irritation around the mouth, eyes or genitals. Fever and fatigue may occur.
• other serious skin reactions such as: changes in skin color, lumps under the skin, blisters, pustules, peeling of the skin, redness, pain, itching, flaking of the skin; they 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 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 cell problems.
• Jarisch-Herxheimer reaction. When taking Amoxicillin Aurovitas to treat Lyme disease (borreliosis), the patient may experience fever, chills, muscle and headache, and skin rash.
• colitis, causing diarrhea (sometimes with blood), abdominal pain and fever
• very serious liver side effects. These occur usually in patients treated for a longer period, men and elderly patients. The patient should immediately inform their doctor if they experience: o severe diarrhea with blood o blisters, redness or bruising of the skin o dark urine or pale stools o yellowing of the skin and 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 the medicine and contact their doctor immediately.

Sometimes less serious skin reactions may occur, such as:

• mildly itchy rash (round, red-pink patches), resembling hives, swelling of the forearms, legs, hands, arms or feet. 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 Amoxicillin Aurovitas.

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), the doctor or pharmacist will advise on the treatment
• kidney problems
• seizures, especially in patients taking high doses or having kidney problems;
• dizziness
• hyperactivity
• 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 anemia. Symptoms include: fatigue, headaches, shortness of breath, dizziness, pallor and yellowing of the skin and eyes.
• decreased white blood cell count
• decreased platelet count (cells involved in blood clotting)
• blood may take longer to clot than usual. This may be noticeable in case of nosebleeds or cuts.

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

• -chest pain associated with an allergic reaction, which may be a sign of an allergy leading to a heart attack (Kounis syndrome)
• 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.
• crystals in the urine leading to acute kidney damage
• 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).

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their 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, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
By reporting side effects, more information can be collected on the safety of the medicine.
Side effects can also be reported to the marketing authorization holder.

5. How to store Amoxicillin Aurovitas

The medicine should be stored out of sight and reach of children.
The medicine should not be taken after the expiry date stated on the carton after "EXP". The expiry date refers to the last day of the month stated.
There are no special precautions for storing the medicine.
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 Amoxicillin Aurovitas contains

• The active substance of the medicine is amoxicillin. Each tablet for oral suspension contains 500 mg, 750 mg or 1000 mg of amoxicillin in the form of amoxicillin trihydrate.
• Other ingredients are: microcrystalline cellulose (101), colloidal silica, anhydrous, aspartame, sodium croscarmellose, mannitol, talc, magnesium stearate, peach flavor (flavoring substances, flavoring preparations, natural flavoring substances, corn maltodextrin, glycerol triacetate, water), orange flavor (flavoring substances, flavoring preparations, natural flavoring substances, corn maltodextrin, α-tocopherol, water). The coating has the following composition: aspartame (E 951), mannitol, maltodextrin, corn starch, titanium dioxide (E 171), talc.

What Amoxicillin Aurovitas looks like and contents of the pack

Tablets for oral suspension.
Amoxicillin Aurovitas, 500 mg, tablets for oral suspension: [dimensions: 17.8 mm x 8.8
mm]
White or almost white, elongated, coated tablets, convex on both sides, with the inscription "C 500" on one side and a dividing line on the other side of the tablet.
Amoxicillin Aurovitas, 750 mg, tablets for oral suspension: [dimensions: 19.8 mm x 9.8
mm]
White or almost white, elongated, coated tablets, convex on both sides, with the inscription "C 750" on one side and a dividing line on the other side of the tablet.
Amoxicillin Aurovitas, 1000 mg, tablets for oral suspension: [dimensions: 22.3 mm x
10.3 mm]
White or almost white, elongated, coated tablets, convex on both sides, with the inscription "C 1000" on one side and a dividing line on the other side of the tablet.
Pack sizes:
Blisters: 6, 12, 14, 16, 20, 24 or 30 tablets
Not all pack sizes may be marketed.

Marketing authorization holder:

Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lokal 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
Arrow Generiques
26 avenue Tony Garnier
69007 Lyon
France

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Countries:

Belgium:
Amoxicillin AB 500 mg/750 mg/1000 mg, dispergeerbare tabletten
France:
Amoxicilline Arrow Lab 1000 mg, comprimé dispersible sécable
Italy:
Amoxicillina Aurobindo Italia
Poland:
Amoxicillin Aurovitas
Portugal:
Amoxicilina Aurobindo
Netherlands:
Amoxicilline Aurobindo Disper 375 mg/500 mg/750 mg, dispergeerbare tabletten

Date of last revision of the leaflet: 06/2025

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 phenomenon is that bacteria are resistant to the administered antibiotic. This means that bacteria can survive or multiply despite the use of an antibiotic.
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 the doctor is intended solely for the treatment of the current illness. Paying attention to the following tips 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. 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 if it was not prescribed specifically for them. They should take it only to treat the infection for which the antibiotic was prescribed.
• 3. The patient should not take an antibiotic prescribed for another person, even if they had a similar infection.
• 4. The patient should not give their antibiotics to other people.
• 5. If there are any leftover antibiotics after completing the treatment as recommended by the doctor, the patient should return them to the pharmacy for proper disposal.