AMOXICILLIN Aurovitas 500 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Amoxicillin Aurovitas 500 mg Film-Coated Tablets EFG

Amoxicillin

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

Amoxicillin 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 flu or the common cold.

It is important that you follow the instructions regarding dose, administration interval, and treatment duration as indicated by your doctor.

Do not store or reuse this medication. If you have any leftover antibiotic after completing treatment, return it to the pharmacy for proper disposal. Do not throw medicines down the drain or in the trash.

This medication is used to treat infections caused by bacteria in different parts of the body. Amoxicillin Aurovitas can also be used in combination with other medications to treat stomach ulcers.

2. What you need to know before you take 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 a skin rash or swelling of the face or throat.

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Amoxicillin Aurovitas if:

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

If you are not sure if any of the above symptoms apply to you, inform your doctor or pharmacist before taking Amoxicillin.

Blood and urine tests

If you are having

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

Tell 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

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

• Methotrexate (a medicine used to treat cancer and severe psoriasis), penicillins may reduce the excretion of methotrexate and cause a potential increase in side effects.
• Probenecid (used to treat gout), concomitant use of 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 suffer a skin allergic reaction.
• If you are taking anticoagulants (such as warfarin), you may need more 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 have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Amoxicillin may cause side effects such as allergic reactions, dizziness, and convulsions, which may impair your ability to drive or operate machinery.

Do not drive or operate machinery unless you are feeling well.

Amoxicillin Aurovitas contains sodium

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

3. How to take Amoxicillin Aurovitas

Follow exactly the administration instructions of this medicine as indicated by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

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

Children under 40 kg in weight

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

• Your doctor will tell you how much amoxicillin to give to 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 over 40 kg in weight

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 - circular pink or red rash): 4 g per day; systemic manifestations (late stage - with 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 a dose of 1 g twice a day for 7 days, with other antibiotics and medications to treat stomach ulcers.
• To prevent heart infection during surgery: the dose will vary depending on the type of surgery. Other medications may be administered at the same time. Your doctor, pharmacist, or nurse can provide more 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 Amoxicillin Aurovitas than you should

If you have taken more Amoxicillin than you should, the signs may be 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, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

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 at least 4 hours before taking the next dose.
• Do not take a double dose to make up for forgotten doses.

How long to take Amoxicillin Aurovitas

• Continue taking amoxicillin for the duration indicated by your doctor, even if you feel better. You need to take all the doses to overcome the infection. If some bacteria survive, they may cause the infection to recur.
• Once you finish the treatment, if you continue to feel unwell, you should go back to see your doctor.

Thrush (a fungal infection of the moist parts of the body that can cause pain, itching, and white discharge) may occur if you take amoxicillin for a long time. If this happens, consult your doctor.

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

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

4. Possible side effects

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

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

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

• allergic reactions, the signs may include: itching of the skin or rash, swelling of the face, lips, tongue, body, or difficulty breathing. These can be serious and, in some cases, have been fatal
• skin rash or round, flat, red spots under the skin surface or bruising of the skin. This is due to inflammation of the blood vessel walls due to 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 swelling of the lymph nodes, especially under the arms
• a skin reaction called 'erythema multiforme' in which you may develop: purple or reddish patches with itching on the skin, especially on the palms of the hands or soles of the feet, swollen areas with a blister-like appearance on the skin, soft tissues on the surface of the mouth, eyes, or genitals. You may have a fever and feel very tired
• other serious skin reactions may include: change in skin color, lumps under the skin, blisters, pimples with pus, peeling, redness, pain, itching. These may be associated with fever, headache, and body pain
• flu-like symptoms with skin rash, fever, gland inflammation, 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, which occurs during treatment with amoxicillin for Lyme disease and causes fever, chills, headache, muscle pain, and skin rash
• inflammation of the large intestine (colon) with diarrhea (sometimes with blood), pain, and fever
• serious liver effects may occur. These are mainly associated with prolonged treatments, males, and the elderly. You should tell your doctor immediately if you have:
• • severe diarrhea with bleeding
  • blisters, redness, or bruising of the skin
  • dark urine or pale stools
  • yellowing of the skin and the whites of the eyes (jaundice). See also anemia below, which can cause jaundice.

These can occur during treatment or up to several weeks after.

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

Sometimes you may experience less severe skin reactions such as:

• a moderate rash with itching (round, pink-red patches), swollen areas with a blister-like appearance on the skin, especially on the forearms, legs, palms, hands, or feet. This is uncommon (may affect up to 1 in 100 people).

If you experience any of these, talk to your doctor as you will need to stop your treatment with Amoxicillin Aurovitas.

Other possible side effects are:

Common(may affect up to 1 in 10 people)

• skin rash,
• feeling sick (nausea),
• diarrhea.

Uncommon(may affect up to 1 in 100 people)

• being sick (vomiting).

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

• thrush (fungal infection of the vagina, mouth, or skin folds), you can get treatment for thrush from your doctor or pharmacist,
• kidney problems,
• seizures (convulsions), observed in patients treated with high doses or with kidney problems,
• dizziness,
• hyperactivity,
• discoloration of the teeth, which usually disappears with brushing (this has been reported in children),
• the tongue may change color to yellow, brown, or black and may have a hairy appearance,
• a excessive breakdown of red blood cells that causes a type of anemia. The signs include: tiredness, headache, difficulty breathing, dizziness, paleness, and yellowing of the skin and the whites of the eyes,
• low white blood cell count,
• low number of cells involved in blood clotting,
• the blood may take longer than normal to clot. You may notice this if you have nosebleeds or cut yourself.

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

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

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

• crystals in the urine that cause acute kidney injury,
• a skin rash with blisters arranged in a circle with a central crust or like a string of pearls (linear IgA disease),
• inflammation of the membranes that surround the brain and spinal cord (aseptic meningitis).

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side 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 which is stated on the carton and blister after EXP. The expiry date is the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. Return the containers and any unused medicines to the pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

6. Container Content and Additional Information

Composition ofAmoxicillin Aurovitas

• The active ingredient is amoxicillin trihydrate.

Each film-coated tablet contains amoxicillin trihydrate equivalent to 500 mg of amoxicillin.

• The other components are:

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

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

Appearance of the Product and Container Content

Amoxicillin Aurovitas 500 mg film-coated tablets EFG[Size: 17.2 mm x 8.7 mm]:

Film-coated tablets of elongated shape, white to off-white in color, biconvex, engraved with "A500" on one side and with a score line on the other.

The score line is for breaking and facilitating swallowing, not for dividing into equal doses.

Amoxicillin Aurovitas is available in blister packs.

Container Sizes:

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

Only some container 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 under the Following Names:

Belgium: Amoxicillin AB 500 mg filmomhulde tabletten/comprimés pelliculés/Filmtabletten

Czech Republic: Amoxicillin Aurovitas

Germany: Amoxicillin PUREN 500 mg Filmtabletten

Poland: Amoxicillin Aurovitas

Portugal: Amoxicilina Generis

Spain: Amoxicilina Aurovitas 500 mg film-coated tablets EFG

Romania: Amoxicilina Aurobindo 500 mg comprimate filmate

Date of the Last Revision of this Leaflet:May 2023

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