Package Leaflet: Information for the User

Amoxicilina Teva 1.000 mg TabletsEFG

Read this 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 (or your child) only. Do 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, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2. What you need to know before you take Amoxicilina Teva

3. How to take Amoxicilina Teva

4. Possible side effects

5. Storage of Amoxicilina Teva

6. Contents of the pack and additional information

What is Amoxicilina Teva

Amoxicilina Teva is an antibiotic. The active ingredient is amoxicilina. This belongs to a group of medicines called “penicillins”.

What is Amoxicilina Teva used for

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

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Do not take Amoxicilina Teva

• 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 Amoxicilina Teva if any of the above applies to you. If you are unsure, consult your doctor or pharmacist before taking Amoxicilina Teva.

Warnings and precautions

Consult your doctor or pharmacist before taking Amoxicilina Teva if:

• 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 situations apply to you, inform your doctor or pharmacist before taking Amoxicilina Teva.

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 Amoxicilina Teva. This is because Amoxicilina Teva may affect the results of these types of tests.

Use of Amoxicilina Teva with other medications

Inform your doctor or pharmacist if you are using, have used recently or may need to use any other medication.

• If you are taking allopurinol (used for gout) with Amoxicilina Teva, you may be more likely to have a skin rash.
• If you are taking anticoagulants (such as warfarin) with Amoxicilina Teva, you may need more blood tests.
• methotrexate (a medication used to treat cancer and severe psoriasis), penicillins may reduce the excretion of methotrexate and cause a potential increase in adverse effects.
• probenecid (used to treat gout), the concomitant use of probenecid may reduce the excretion of amoxicillin and is not recommended.
• If you are taking other antibiotics (such as tetracycline), Amoxicilina Teva may be less effective.

Pregnancy and breastfeeding

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

Driving and operating machinery

Amoxicilina Teva may have adverse effects and symptoms (such as allergic reactions, dizziness and seizures) that may make it unsafe to drive.

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

Amoxicilina Teva contains glucose and sodium

This medication contains glucose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

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

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

• The tablets can be dissolved in a little water or taken whole.
• Space the doses uniformly throughout the day, at least 4 hours apart.

The usual dose is:

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 Amoxicilina Teva to 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 recommended dose is 100 mg per kilogram of body weight per day.

Adults, elderly patients, and children 40 kg or more in weight

The usual dose of Amoxicilina Teva 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 certain parasites called ticks):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: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 Teva than you should

If you have taken more Amoxicilina Teva than you should, the signs may be stomach upset (nausea, vomiting, or diarrhea) or crystals in the urine, which may be observed as cloudy urine or difficulty urinating. Talk to your doctor as soon as possible. Bring the medication to show them.

You can also call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Amoxicilina Teva

• 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 Teva

• Continue taking Amoxicilina Teva 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 Amoxicilina Teva for a prolonged period. If this happens, consult your doctor.

If you take Amoxicilina Teva 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 everyone elsethese medicationscan cause side effects, although not everyone will experience them.

Stop taking Amoxicilina Teva 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
• •skin rash 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 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 Amoxicilina Teva, 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 your hands or soles of your feet, swollen areas on the skin, soft tissues on the surface of your mouth, eyes, and genitals. You may have a fever and feel very tired
• other severe skin reactions may be: changes in skin color, lumps under the skin, blisters, pustules, peeling, redness, pain, itching, exfoliation. These may be accompanied by fever, headache, and body aches.
• flu-like symptoms with skin rash, fever, gland inflammation, and abnormal blood test results (such as increased eosinophils (eosinophilia) and elevated liver enzymes (drug-induced reaction with eosinophilia and systemic symptoms (DRESS))• fever, chills, sore throat, or other signs of infection, or appearance of bruises easily. These may be signs of a problem with your blood cells
• Jarisch-Herxheimer reaction that occurs during treatment with Amoxicilina Teva 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. Inform your doctor immediately if you have:

• severe diarrhea with bleeding
• blisters, redness, or bruises on the skin
• dark urine or pale stools
• yellowing of the skin and white of the eyes (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 medication and see your doctor immediately.

At times, you may experience milder skin reactions such as:

• a moderate rash with itching (round, pink-red spots), swollen areas with blister-like appearance on 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 Amoxicilina Teva.

Other possible side effects are:

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

• skin rash
• nausea
• diarrhea.

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

• vomiting.

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

• candidiasis (vaginal, oral, or skin fungal infection), 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
• hyperactivity
• crystals in the urine, which cause acute kidney damage. They may appear as cloudy urine or difficulty or discomfort urinating. Make sure to drink plenty of fluids to reduce the likelihood of these symptoms
• alteration in tooth color, 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 red blood cell rupture that causes a type of anemia. Symptoms include: fatigue, headache, difficulty breathing, dizziness, paleness, and yellowing 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 your nose or cut yourself.

Unknown(cannot be estimated from available data)

• chest pain in the context of allergic reactions, which may be a symptom of allergic-induced 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 of repeated vomiting (1-4 hours after taking the medication). Other symptoms may include abdominal pain, lethargy, diarrhea, and low blood pressure.

• 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 not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

No special storage conditions are required.

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

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition ofAmoxicilina Teva

- The active ingredient is amoxicilina (trihydrate). Each tablet contains 1,000 mg of amoxicilina.

- The other components are:Polivinilpirrolidona (povidona), sacarina sódica (E954), estearato de magnesio, laurilsulfato de sodio, celulosa microcristalina(E460), aroma de frambuesa(contains glucosa and cornstarch).

Appearance of the product and contents of the package

Amoxicilina Teva1,000 mg tablets are presented in a box with 20 or 30 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Teva Pharma, S.L.U.

C/Anabel Segura, 11. Edificio Albatros B, 1st floor.

28.108, Alcobendas. Madrid

Spain

Responsible for manufacturing:

LaboratoryReig Jofré S.A.

C/Jarama 111

45007 Toledo

Spain

Last review date of this leaflet: August 2024

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