Amoxicillin Aurovitas

Leaflet accompanying the packaging: patient information

Amoxicillin Aurovitas, 1000 mg, film-coated tablets

Amoxicillin

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same.
• If the patient experiences any side effects, including those 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 in various parts of the body. Amoxicillin Aurovitas can also be used in combination with other medicines to treat stomach ulcers.

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 had an allergic reaction to any other antibiotic, which may have caused symptoms such as a skin rash or swelling of the face or throat. If these circumstances apply to the patient, they should not take Amoxicillin Aurovitas. In case of doubt, consult a doctor or pharmacist before taking Amoxicillin Aurovitas.

Warnings and precautions

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

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

In case of doubt whether these circumstances apply to the patient, they should consult their doctor or pharmacist before taking 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 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) with 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, breastfeeding, thinks they may be pregnant, or plans to have a baby, they should ask their doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Amoxicillin Aurovitas may cause side effects such as allergic reactions, dizziness, and convulsions that may affect the ability to drive or use machines. The patient should not drive or use machines unless they feel well.

Amoxicillin Aurovitas contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, which means it is essentially "sodium-free".

3. How to take Amoxicillin Aurovitas

The patient should always take this medicine exactly as their doctor or pharmacist has told them. If they are not sure, they should ask their doctor or pharmacist.

• The tablets should be swallowed whole without chewing or crushing, with a glass of water.
• The patient should keep equal intervals of at least 4 hours between doses taken in a 24-hour period.

Amoxicillin Aurovitas is available as 1000 mg film-coated tablets. To obtain doses that cannot be achieved with this product, the patient should use an appropriate medicinal product available on the market containing amoxicillin.

Children with a body weight of less than 40 kg

The dosage depends on the child's body weight in kilograms.

• The doctor will prescribe the dose of Amoxicillin Aurovitas for 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 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 - tick-borne infection):single migrating erythema (early stage - red or pink rash around the bite): 4 g per day. Systemic symptoms (late stage - more severe symptoms or when the disease affects multiple organs): up to 6 g per day.
• Stomach ulcers: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 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 Amoxicillin Aurovitas may be lower than usual.

Taking more than the recommended dose of Amoxicillin Aurovitas

If the patient takes more than the recommended dose of Amoxicillin Aurovitas, 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 a missed dose.

How long to take Amoxicillin Aurovitas

• The patient should continue taking Amoxicillin Aurovitas for as long as their doctor has prescribed, even if they 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 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 recommend additional tests to check kidney, liver, and blood function. If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Amoxicillin Aurovitas 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 and, in rare cases, may lead to death.
• rash or punctate, flat, red, round spots under the skin surface or bruising of the skin, which may be a sign of allergic vasculitis.
• late allergic reactions occurring usually 7 to 12 days after taking Amoxicillin Aurovitas; 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 palms or soles, swelling of the skin (resembling hives), irritation around the mouth, eyes, or genitals. Fever and a feeling of tiredness may also occur.
• other severe skin reactions such as changes in skin color, lumps under the skin, blisters, ulcers, skin peeling, redness, pain, itching, and skin shedding; 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 increased liver enzyme activity]; drug reaction with eosinophilia and systemic symptoms (DRESS).
• fever, chills, sore throat, and other signs of infection or a 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 (diarrhea, sometimes with blood, abdominal pain, and fever).
• very severe liver reactions, which can be life-threatening, requiring liver transplantation or causing death. These reactions are very rare and can occur in patients taking this medicine for a short or long period.

The above symptoms may occur during or up to a few weeks after stopping treatment with Amoxicillin Aurovitas.

If the patient experiences any of these symptoms, they should stop taking the medicine and contact their doctor immediately.

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

• mildly itchy rash (round, red-pink patches), resembling hives, swelling of the forearms, legs, hands, or feet. This occurs uncommonly (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 treatment
• kidney problems
• seizures, especially in patients taking high doses or having 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 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 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 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)
• Meningitis (inflammation of the membranes surrounding the brain and spinal cord) without infection.

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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. Side effects can also be reported to the marketing authorization holder. By reporting side effects, the patient can help provide more information on the safety of the medicine.

5. How to store Amoxicillin Aurovitas

The medicine should be stored out of sight and reach of children. There are no special precautions for storage. The patient should not take Amoxicillin Aurovitas after the expiry date stated on the packaging after "Expiry date (EXP):". The expiry date refers to the last day of the month stated. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. 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 in the form of amoxicillin trihydrate. Each Amoxicillin Aurovitas tablet contains 1000 mg of amoxicillin.
• The other ingredients are: Core: microcrystalline cellulose (type - 101), sodium carboxymethyl cellulose (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, oblong, biconvex film-coated tablets with the inscription "A1000" on one side and a score line on the other side.
The score line on the tablet is only to facilitate breaking and not to divide the tablet into equal doses.
Amoxicillin Aurovitas is available in blisters, in a cardboard box.
Pack sizes:
The pack contains 8, 10, 16, 20, 24, or 30 film-coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

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

This medicinal product is authorized in the Member States of 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

Date of last revision of the leaflet: 02/2024

General notes 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 phenomenon is that bacteria are resistant to the administered antibiotic. This means that bacteria can survive or multiply despite the use of the antibiotic. Bacteria can become resistant to antibiotics for many reasons. The responsible 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 disease. Following the guidelines below will help prevent the development of resistant bacteria, which 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 correct number of days. The patient should read the instructions in the patient information leaflet and, if they do not understand any of them, 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 it was prescribed.
• 3. The patient should not take an antibiotic prescribed for someone else, even if they have a similar infection.

• 4. The patient should not give their antibiotics to others.
• 5. If, after completing the treatment as recommended by the doctor, there are any remaining antibiotics, the patient should return them to the pharmacy for proper disposal.