Amoxicillin aurovitas

Patient Information Leaflet

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
Please read all of this leaflet carefully before taking this medicine, as it contains
important information for you.

• Keep this leaflet. 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 you only. Do not pass it on to other people. It may harm them even if their symptoms are the same as yours.
• 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 Amoxicillin Aurovitas is and what it is used for
2. What you need to know 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 called "penicillins".

What Amoxicillin Aurovitas is used for
Amoxicillin Aurovitas is used to treat bacterial infections in different parts of the body. Amoxicillin Aurovitas may also be used, together 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. This may include skin rash or swelling of the face or throat.

If any of the above apply to the patient, Amoxicillin Aurovitas must not be taken. If in doubt, consult the doctor or pharmacist before starting treatment with Amoxicillin Aurovitas.

Warnings and precautions

Talk to a doctor or pharmacist before taking Amoxicillin Aurovitas if the patient:

• has infectious mononucleosis (fever, sore throat, swollen lymph nodes, and extreme fatigue),
• has kidney disease,
• passes urine irregularly.

If in doubt whether any of the above 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 check 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. This medicine may affect the results of these tests.

Amoxicillin Aurovitas and other medicines

Tell the doctor or pharmacist about all medicines currently used, recently used, or planned to be used.

• Methotrexate (used to treat cancer and severe psoriasis) – penicillins may reduce methotrexate excretion, increasing the risk of adverse effects.
• Probenecid (used to treat gout) – concomitant use may reduce amoxicillin excretion and is not recommended.
• If allopurinol (used for gout) is taken together with Amoxicillin Aurovitas, skin allergic reactions may be more likely.
• 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 have a baby, 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 convulsions) that may impair the ability to drive or operate machinery. Do not drive or operate machinery unless the patient feels well.

Amoxicillin Aurovitas, oral suspension powder 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 for patients with phenylketonuria (PKU). This is a rare genetic disorder in which phenylalanine accumulates in the body due to impaired excretion.

Maltodextrin is absorbed like glucose. If the patient has previously been diagnosed with intolerance to certain sugars, consult a doctor before taking this medicine.

Amoxicillin Aurovitas contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Amoxicillin Aurovitas

This medicine should always be taken according to the instructions given by your doctor or pharmacist. If you have any doubts,
you should consult your doctor or pharmacist.

• The tablet for oral suspension should be placed in a glass of water and stirred well until evenly dispersed. The mixture should be taken immediately after preparation.
• Doses should be taken at regular intervals of at least 4 hours apart during the day.

Usual dose:
Children weighing less than 40 kg
All doses are determined according to the child's body weight in kilograms.

• Your doctor will advise you on the dose of Amoxicillin Aurovitas to give 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 weighing 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): erythema migrans (early stage - pink-red rash): 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 a day for 7 days, in combination with other antibiotics and ulcer medications.
• Prevention of endocarditis during surgical procedures: the dose may vary depending on the type of surgery. Other medicines may also be administered. For more detailed information, consult your doctor, pharmacist or nurse.
• The maximum recommended dose is 6 g per day.

Kidney disease
If the patient has kidney problems, the dose of the medicine may be lower than usual.
The tablet may be divided into equal doses.
Taking more Amoxicillin Aurovitas than recommended
If you take more Amoxicillin Aurovitas than you should, symptoms such as stomach and intestinal irritation (nausea, vomiting or diarrhoea), crystals in the urine (which may appear as cloudy urine), or difficulty passing urine may occur.
You should contact your doctor as soon as possible. Take the medicine with you to show the doctor.
If you forget to take Amoxicillin Aurovitas

• If you forget to take a dose, take it as soon as you remember.
• 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 forgotten dose.

How long to take Amoxicillin Aurovitas

• You should continue taking Amoxicillin Aurovitas for as long as your doctor has instructed, even if you start to feel better. All doses are necessary to eliminate the infection. If some bacteria survive, the infection may return.
• If you still do not feel better after completing treatment with Amoxicillin Aurovitas, consult your doctor.

If Amoxicillin Aurovitas is taken 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 your doctor.
If you are taking Amoxicillin Aurovitas for a prolonged period, your doctor may order
additional tests to monitor kidney and liver function and blood counts.
If you have any further doubts about using this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the following serious adverse reactions occur in the patient, treatment with Amoxicillin Aurovitas 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 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 beneath 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 from 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 such as changes in skin color, subcutaneous nodules, blisters, pustules, skin peeling, redness, pain, itching, or skin scaling; 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 increased tendency to bruise. These may be symptoms of blood cell disorders.
• Jarisch-Herxheimer reaction. When Amoxicillin Aurovitas is used to treat 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 effects affecting the liver may occur. These usually occur in patients undergoing prolonged treatment, in men, and in elderly patients. Inform the doctor immediately if the patient experiences: o severe diarrhoea accompanied by bleeding o blisters, redness, or bruising on the skin o dark urine or pale stools o yellowing of the skin and whites of the eyes (jaundice). Please also read the information below regarding anaemia 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, treatment must be stopped immediately and the doctor should be contacted.
Less severe skin reactions may sometimes occur, such as:

• moderately itchy rash (round, red-pink lesions), resembling hives, 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 the 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
• diarrhoea.

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)

• fungal infections (vaginal, oral or skin fold candidiasis); the doctor or pharmacist can advise on treatment
• kidney problems
• seizures, especially in patients receiving high doses or with 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 leading 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 clotting)
• blood may take longer than usual to clot. This may be noticeable during nosebleeds or cuts.

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)
• drug-induced enterocolitis (DIES): Drug-induced enterocolitis has occurred mainly in children receiving amoxicillin. This is a type of allergic reaction whose main symptom is recurrent vomiting (1-4 hours after taking the medicine). Further symptoms may include abdominal pain, lethargy, diarrhoea, 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 adverse reactions 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
Reporting adverse reactions helps provide more information on the safety of this medicine.
Adverse reactions can also be reported to the marketing authorization holder.

5. How to store Amoxicillin Aurovitas

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after "EXP". The expiry date refers to the last day of the stated month.
No special storage instructions apply.
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. Each tablet for oral suspension contains 500 mg, 750 mg or 1000 mg of amoxicillin as amoxicillin trihydrate.
• The other ingredients are: microcrystalline cellulose (101), colloidal anhydrous silica, aspartame, sodium croscarmellose, mannitol, talc, magnesium stearate, apricot flavour (flavouring substances, flavouring preparations, natural flavouring substances, corn maltodextrin, glyceryl triacetate, water), orange flavour (flavouring substances, flavouring preparations, natural flavouring substances, corn maltodextrin, α-tocopherol, water). The coating contains: 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, biconvex, with the imprint “C 500” on one side and a score 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, biconvex, with the imprint “C 750” on one side and a score 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, biconvex, with the imprint “C 1000” on one side and a score line on the other side of the tablet.
Pack sizes:
Blister packs: 6, 12, 14, 16, 20, 24 or 30 tablets
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lokal 27
01-909 Warszawa
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 authorised in the European Economic Area countries under the following names:
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

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 administered. This means that bacteria can survive or multiply despite the use of the antibiotic.
Bacteria may become resistant to antibiotics for various reasons. Careful use of antibiotics may help reduce the risk of development of bacterial resistance.
The antibiotic prescribed by your doctor is intended solely for the treatment of your current illness. Observing the following advice will help prevent the development of resistant bacteria that 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 correct number of days. Read the instructions in the leaflet carefully, and if any of them are unclear, ask your doctor or pharmacist for clarification.
2. Do not take an antibiotic unless it has been prescribed specifically for you. You should take it only to treat the infection for which it was prescribed.
3. Do not take an antibiotic prescribed for another person, even if they had a similar infection.
4. Do not give antibiotics prescribed for you to other people.
5. If any antibiotic remains after completing the treatment as directed by your doctor, return it to a pharmacy for proper disposal.