Amoxicillin Aurovitas 1000 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Amoxicillin Aurovitas 1000 mg film-coated tablets EFG

Amoxicillin

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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 adverse effects
5. How to store Amoxicillin Aurovitas
6. Contents of the pack and other information

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

Amoxicilina Aurovitas is an antibiotic. The active substance is amoxicillin. It belongs to a group of medicines called "penicillins".

Antibiotics are used to treat bacterial infections and are not effective against viral infections such as influenza or the common cold.

It is important to follow your doctor's instructions regarding dose, dosing interval, and duration of treatment.

Do not store or reuse this medicine. If you have any antibiotic left over after completing treatment, return it to the pharmacy for proper disposal. Do not dispose of medicines via wastewater or household waste.

This medicine is used to treat bacterial infections in different parts of the body. Amoxicilina Aurovitas may also be used in combination with other medicines to treat stomach ulcers.

2. What you need to know before taking Amoxicillin Aurovitas

Do not take Amoxicillin Aurovitas:

• if you are allergic to amoxicillin, penicillins, or any of the other ingredients of this medicine (listed in section 6).
• if you have ever had an allergic reaction to any other antibiotic. This could include skin rash or swelling of the face or throat.

Do not take amoxicillin if any of the above apply to you. If you are unsure, consult your doctor or pharmacist before taking Amoxicillin Aurovitas.

Warnings and precautions

Consult your doctor or pharmacist before starting Amoxicillin Aurovitas if:

• you have infectious mononucleosis (fever, sore throat, swollen glands, and extreme tiredness)
• you have kidney problems
• you do not urinate regularly.

If you are unsure whether any of the above symptoms apply to you, inform your doctor or pharmacist before taking Amoxicillin.

Blood and urine tests

If you are undergoing

• urine tests (urine glucose) or blood tests for liver function
• estriol tests (used during pregnancy to check whether the baby is developing normally)

Inform your doctor or pharmacist that you are taking amoxicillin. This is because amoxicillin may alter the results of these types of tests.

Other medicines and Amoxicillin Aurovitas

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

• Methotrexate (a medicine used to treat cancer and severe psoriasis): penicillins can reduce the excretion of methotrexate and potentially increase adverse effects.
• Probenecid (used to treat gout): concomitant use with probenecid may reduce the excretion of amoxicillin and is not recommended.
• If you are taking allopurinol (used for gout), you may be more likely to develop a skin allergic reaction.
• If you are taking anticoagulants (such as warfarin), you may need more frequent blood tests.
• If you are taking other antibiotics (such as tetracycline), amoxicillin may be less effective.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

Amoxicillin may cause adverse effects and symptoms (such as allergic reactions, dizziness, and seizures) that could impair your ability to drive.

Do not drive or operate machinery unless you feel well.

Amoxicillin Aurovitas contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; therefore, it is essentially "sodium-free".

3. How to take Amoxicilina Aurovitas

Follow exactly the instructions for using this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

• Swallow the tablet with water without crushing or chewing it.
• Space the doses evenly throughout the day, at least 4 hours apart.

Children weighing less than 40 kg

All doses are based on the child's body weight in kilograms.

• Your doctor will tell you how much amoxicillin to give your baby or 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 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 infection: 3 g twice a day for one day.
• Lyme disease (an infection caused by parasites called ticks): isolated erythema migrans (early stage – single pink or red circular rash): 4 g per day; systemic manifestations (late stage – more severe symptoms or when the disease spreads throughout the body): up to 6 g per day.
• Stomach ulcers: a dose of 750 mg or 1 g twice a day for 7 days, in combination with other antibiotics and medications for treating stomach ulcers.
• To prevent heart infection during surgery: the dose will vary depending on the type of surgery. Other medications may be given at the same time. Your doctor, pharmacist, or nurse can provide further details.
• The maximum recommended dose is 6 g per day.

Kidney problems

If you have kidney problems, the dose may be lower than the usual dose.

If you take more Amoxicilina Aurovitas than you should

If you have taken more amoxicillin than you should, symptoms may include stomach upset (nausea, vomiting, or diarrhea) or crystals in the urine, which may appear as cloudy urine or difficulty urinating. In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Amoxicilina Aurovitas

• If you forget to take a dose, take it as soon as you remember.
• Do not take the next dose too soon; wait at least 4 hours before taking the next dose.
• Do not take a double dose to make up for a missed dose.

How long should you take Amoxicilina Aurovitas

• Continue taking amoxicillin for as long as your doctor has instructed, even if you feel better. You need to take all doses to completely eliminate the infection. If some bacteria survive, the infection may return.
• After completing the treatment, if you still feel unwell, you should see your doctor again.

Candidiasis (a fungal infection affecting moist areas of the body that may cause pain, itching, and white discharge) may occur if amoxicillin is taken for a prolonged period. If this happens, consult your doctor.

If you take amoxicillin for a prolonged period, your doctor may perform additional blood tests to check that your kidneys, liver, and blood are functioning normally.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Stop taking amoxicillin and see a doctor immediately if you experience any of the following serious adverse effects – you may need urgent medical treatment:

The following adverse effects are very rare (may affect up to 1 in 10,000 people):

• allergic reactions, signs may include: skin itching or rash, swelling of the face, lips, tongue, body, or difficulty breathing. These may be severe and, in some cases, have led to death
• skin rash or flat, round red spots like pinpricks beneath the skin surface, or bruising on the skin. This is due to inflammation of the blood vessel walls caused by an allergic reaction. It may be associated with joint pain (arthritis) and kidney problems
• a delayed allergic reaction may occur 7 to 12 days after taking amoxicillin, some signs include: rashes, fever, joint pain, and swollen lymph nodes, especially under the arms
• a skin reaction called 'erythema multiforme' in which you may develop: itchy purple or reddish spots on the skin, especially on the palms of the hands or soles of the feet, raised swollen areas on the skin, soft tissue lesions on the surface of the mouth, eyes, and genitals. You may have fever and feel very tired
• other serious skin reactions may include: change in skin color, lumps under the skin, blisters, pus-filled pimples, peeling, redness, pain, itching. These may be associated with fever, headache, and body pain
• flu-like symptoms with skin rash, fever, swollen glands, and abnormal blood test results (such as increased white blood cells (eosinophilia) and elevated liver enzymes) (drug reaction with eosinophilia and systemic symptoms (DRESS))
• fever, chills, sore throat or other signs of infection, or easy bruising. These may be signs of a problem with your blood cells
• Jarisch-Herxheimer reaction occurring during treatment with amoxicillin for Lyme disease, causing fever, chills, headache, muscle pain, and skin rash
• inflammation of the large intestine (colon) with diarrhoea (sometimes with blood), pain, and fever
• serious adverse effects in the liver may occur. These are mainly associated with prolonged treatment, male gender, and advanced age. You should inform your doctor immediately if you have:
  • severe diarrhoea with bleeding
  • blisters, redness, or bruising of the skin
  • dark urine or pale stools
  • yellowing of the skin and whites of the eyes (jaundice). See also anaemia below, which may lead to jaundice.

These may occur during treatment or up to several weeks afterwards.

If any of the above symptoms occur, stop taking the medicine and see your doctor immediately.

Sometimes you may experience less severe skin reactions such as:

• a moderate itchy rash (round, pink-red spots), swollen areas resembling blisters on forearms, legs, palms, hands, or feet. This is uncommon (may affect up to 1 in 100 people).

If you have any of these, speak to your doctor as you will need to discontinue treatment with Amoxicilina Aurovitas.

Other possible adverse effects are:

Common (may affect up to 1 in 10 people)

• skin rash,
• feeling unwell (nausea),
• diarrhoea.

Uncommon (may affect up to 1 in 100 people)

• being sick (vomiting).

Very rare (may affect up to 1 in 10,000 people)

• candidiasis (fungal infection in the vagina, mouth, or skin folds); treatment can be obtained from your doctor or pharmacist for candidiasis,
• kidney problems,
• seizures (convulsions), observed in patients treated with high doses or with kidney problems,
• dizziness,
• hyperactivity,
• change in tooth color, which usually disappears with brushing (this has been reported in children),
• the tongue may change color to yellow, brown, or black and may appear hairy,
• excessive breakdown of red blood cells causing a type of anaemia. Signs include: tiredness, headache, difficulty breathing, dizziness, paleness, and yellowing of the skin and whites of the eyes,
• low number of white blood cells,
• low number of cells involved in blood clotting,
• blood may take longer than normal to clot. You may notice this if you have nosebleeds or cuts that bleed excessively.

Frequency not known (cannot be estimated from available data)

• chest pain in the context of allergic reactions, which may be a symptom of allergy-triggered heart attack (Kounis syndrome),
• drug-induced enterocolitis syndrome (DIES):

DIES has mainly been reported in children receiving amoxicillin. It is a certain type of allergic reaction with the main symptom being repeated vomiting (1-4 hours after taking the medicine). Other symptoms may include abdominal pain, lethargy, diarrhoea, and low blood pressure,

• crystals in the urine causing acute kidney injury,
• blistering rash arranged in rings with central crusts or resembling a string of beads (linear IgA disease),
• inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis).

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Amoxicillin Aurovitas

Keep this medicine out of the sight and reach of children.

This medicine does not require any special storage temperature.

Do not use this medicine after the expiry date stated on the outer packaging and on the blister after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Amoxicilina Aurovitas

• The active substance is amoxicillin trihydrate.

Each film-coated tablet contains amoxicillin trihydrate equivalent to 1000 mg of amoxicillin.

• The other components are:

Core: Microcrystalline cellulose (grade – 101), sodium carboxymethyl starch (type A) (from potato), povidone (K-30), microcrystalline cellulose (grade – 102), magnesium stearate

Coating: Hypromellose 2910 (6CP) (E464), macrogol 6000 (E1521), titanium dioxide (E171)

Appearance of the medicinal product and contents of the pack

Amoxicilina Aurovitas 1000 mg film-coated tablets EFG [Size: 21.3 mm x 10.2 mm]:

Elongated, white to off-white, biconvex film-coated tablets, engraved with “A1000” on one side and a score line on the other.

The score line is intended to facilitate breaking the tablet for ease of swallowing and is not intended to divide the tablet into equal doses.

Amoxicilina Aurovitas is available in blister packs.

Pack sizes:

Blister packs: 8, 10, 16, 20, 24 and 30 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Or

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 (EEA) under the following names:

Belgium: Amoxicillin AB 1000 mg, filmomhulde tabletten/comprimés pelliculés/Filmtabletten

Czech Republic: Amoxicillin Aurovitas

Germany: Amoxicillin PUREN 1000 mg Filmtabletten

Poland: Amoxicillin Aurovitas

Portugal: Amoxicilina Generis

Spain: Amoxicilina Aurovitas 1000 mg comprimidos recubiertos con película EFG

Romania: Amoxicilina Aurobindo 1000 mg comprimate filmate

Date of the most recent revision of this leaflet: May 2023

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es)