Leaflet: information for the user

Amoxicillin Aurovitas 500 mg film-coated tablets EFG

Amoxicillin

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

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

1. What is Amoxicillin Aurovitas 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. Storage of Amoxicillin Aurovitas

6. Contents of the pack and additional information

Amoxicilina Aurovitasis an antibiotic. The active ingredient is amoxicilina. This belongs to a group of medicines called "penicillins".

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

Do not takeAmoxicilina Aurovitas:

• if you are allergic to amoxicillin, penicillins, or any of the other components of this medication (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 unsure, consult your doctor or pharmacist before taking Amoxicilina Aurovitas.

Warnings and precautions

Consult your doctor or pharmacist before starting to takeAmoxicilina Aurovitasif:

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

If you are unsure whether any of the above symptoms affect you, inform your doctor or pharmacist before taking Amoxicilina.

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).

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

Other medications andAmoxicilina Aurovitas

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

• Metotrexate (a medication used to treat cancer and severe psoriasis), penicillins may reduce the excretion of metotrexate and cause a potential increase in 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 alopurinol (used to treat gout), you may be more likely to experience 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 plan to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machinery

Amoxicillinmay have adverse effects and symptoms (such as allergic reactions, dizziness, and seizures) may incapacitate you from driving.

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

Amoxicilina Aurovitas contains sodium

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

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

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

Children under 40 kg of weight

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

• Your doctor will tell you how much amoxicillin you should administer to your baby or child.
• The usual dose is 40 mg to 90 mg per kilogram of body weight per day, administered in two or three divided doses.
• The maximum dose is 100 mg per kilogram of body weight per day.

Adults, elderly patients, and children 40 kg of weight 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 infections:3 g twice a day, for one day.
• Lyme disease (a disease caused by some parasites called ticks):erythema migrans isolated (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:one dose of 750 mg or one 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.

Renal problems

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

If you take more Amoxicilina Aurovitas than you should

If you have taken more Amoxicilina than you should, the signs may be stomach discomfort (nausea, vomiting, or diarrhea) or crystals in the urine, which may be observed as cloudy urine or difficulty urinating. In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot 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 compensate for the missed doses.

How long should you take Amoxicilina Aurovitas

• Continue taking amoxicillin for the time your doctor has told you, 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 have finished the treatment, if you continue to feel unwell, you should go back to see your doctor.

You may develop candidiasis (a fungal infection of the moist parts of the body that can cause pain, itching, and white discharge) if you take amoxicillin for a prolonged period. If this happens, consult your doctor.

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

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

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

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

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

• Allergic reactions, symptoms may include: skin itching or rash, facial swelling, lip, tongue, body, or difficulty breathing. These can be severe and, in some cases, have been fatal
• Rash on the skin or flat, round, red spots like the tip of a pin under the skin's surface or bruises on the skin. This is due to the inflammation of the blood vessel walls due to an allergic reaction. It may be associated with joint pain (arthritis) and kidney problems
• You may experience a delayed allergic reaction up to 7 to 12 days after taking amoxicillin, some symptoms include: rashes, fever, joint pain, and lymph node enlargement, especially under the arms
• A skin reaction called 'erythema multiforme' in which you may develop: purple or reddish rashes with itching on the skin, especially on the palms of the hands or soles of the feet, swollen areas on the skin, soft tissues on the surface of the mouth, eyes, and genitals. You may have a fever and feel very tired
• Other severe skin reactions may include: skin color change, lumps under the skin, blisters, pustules with pus, peeling, redness, pain, itching. These may be associated with fever, headache, and body pain
• Symptomsof a flu-like illness with skin rash, fever, gland inflammation, and abnormal blood test results (such as increased eosinophils (eosinophilia) and elevated liver enzymes) (drug reaction with eosinophilia and systemic symptoms (DRESS)).
• Fever, chills, sore throat, or other signs of infection, or the appearance of bruises easily. These may be signs of a problem with your blood cells
• Jarisch-Herxheimer reaction that 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
• You may experience severe side effects in the liver. These are mainly associated with prolonged treatments, men, and advanced age. You should inform your doctor immediately if you have:
• • Severe diarrhea with bleeding
  • Blisters, redness, or bruises on the skin
  • Dark urine or pale stools
  • The skin and white of the eyes turn yellow (jaundice). See anemia below, which may cause jaundice.

These may occur during treatment or several weeks after.

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

Occasionally, you may experience milder skin reactions such as:

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

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

Other possible side effects are:

Frequent(they may affect up to 1 in 10 people)

• Skin rash,
• Feeling unwell (nausea),
• Diarrhea.

Rare(they may affect up to 1 in 100 people)

• Being sick (vomiting).

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

• Candidiasis (fungal infection in the vagina, mouth, or skin folds), you can obtain treatment from your doctor or pharmacist for candidiasis,
• Kidney problems,
• Seizures (convulsions), observed in patients treated with high doses or kidney problems,
• Dizziness,
• Hypersensitivity,
• Discoloration of the teeth, which usually disappears with brushing (this has been reported in children),
• Your tongue may change color to yellow, brown, or black and may appear hairy,
• Excessive breaking of red blood cells that causes a type of anemia. Symptoms include: fatigue, headache, difficulty breathing, dizziness, paleness, and yellowish discoloration of the skin and white of the eyes,
• Low white blood cell count,
• Low count of cells involved in blood clotting,
• Blood may take longer than usual to clot. You may notice this if you bleed from the nose or cut yourself.

Unknown frequency(it cannot be estimated from the available data)

• Chest pain in the context of allergic reactions, which may be a symptom of an allergic-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,
• Rash with blisters arranged in a circle with a central crust or like a pearl necklace (IgA linear disease),
• Inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis).

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

This medication does not require any special storage temperature.

Do not use this medication after the expiration date that appears on the packaging and on the blister pack after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE collection point at the pharmacy.If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition ofAmoxicilina 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) (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 product and contents of the package

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

Film-coated tablets, elongated shape, white to off-white, biconvex, engraved with “A500” on one side and with a notch on the other.

The notch serves to break and facilitate swallowing, not to divide into equal doses.

Amoxicilina Aurovitas is available in type B blister packs.

Package sizes:

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

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Responsible for manufacturing:

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 medicine is authorized in the member states of the European Economic Area with 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 review of this leaflet:May 2023

The detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es)