Amoxicillin Teva 1,000 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Amoxicillin Teva 1,000 mg tablets EFG

Read the entire 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 (or your child) only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents:

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

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

What Amoxicilina Teva is

Amoxicilina Teva is an antibiotic. The active substance is amoxicillin. This belongs to a group of medicines known as "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 that you follow your doctor's instructions regarding dosage, dosing intervals, and duration of treatment.

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

What Amoxicilina Teva is used for

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

2. What you need to know before starting to take Amoxicillin Teva

Do not take Amoxicillin Teva

• if you are allergic to amoxicillin, penicillins, or any of the other components 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 Teva if any of the above apply to you. If you are unsure, consult your doctor or pharmacist before taking Amoxicillin Teva.

Warnings and precautions

Talk to your doctor or pharmacist before taking Amoxicillin Teva 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 unsure whether any of the above conditions apply to you, inform your doctor or pharmacist before taking Amoxicillin Teva.

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 Teva. This is because Amoxicillin Teva may alter the results of these types of tests.

Taking Amoxicillin Teva with other medicines

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

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

Pregnancy and breastfeeding

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 Teva may cause adverse effects, and symptoms (such as allergic reactions, dizziness, and seizures) may mean you should not drive.

Do not drive or operate machinery unless you feel well.

Amoxicillin Teva contains glucose and sodium

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

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

3. How to take Amoxicillin Teva

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

• The tablets may be dissolved in a small amount of water or swallowed whole.
• Space the doses evenly throughout the day, with at least 4 hours between doses.

The usual dose is:

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 Teva 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 recommended 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 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 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 also be administered 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 Amoxicillin Teva than you should

If you have taken more Amoxicillin Teva 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. Contact your doctor as soon as possible. Take the medicine with you to show it.

You may also call the Toxicology Information Service at telephone number 91 562 04 20, stating the medicine and the amount ingested.

If you forget to take Amoxicillin Teva

• If you forget to take a dose, take it as soon as you remember.
• Do not take the next dose too early; 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 Teva

• Continue taking Amoxicillin Teva for the length of time prescribed by your doctor, even if you feel better. You need to take all the 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 of moist body areas that may cause pain, itching, and white discharge) may occur if Amoxicillin Teva is taken for a prolonged period. If this happens, consult your doctor.

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

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

4. Possible adverse effects

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

Stop taking Amoxicillin Teva 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 can be severe and, in some cases, have led to death

• skin rash or flat, round red spots like the tip of a pin beneath the skin surface, or skin bruising. This is due to inflammation of the walls of blood vessels 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 Teva; 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: itchy purple or reddish spots on the skin, especially on the palms of the hands or soles of the feet, swollen raised areas on the skin, soft tissue lesions on the surface of the mouth, eyes, and genitals. You may also have fever and feel very tired

• other serious skin reactions may include: changes in skin color, lumps under the skin, blisters, pustules, peeling, redness, pain, itching, exfoliation. These may be accompanied by 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, which occurs during treatment with Amoxicillin 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), abdominal pain, and fever

• serious adverse effects in the liver may occur. These are mainly associated with patients undergoing prolonged treatment, males, and elderly individuals. You should inform your doctor immediately if you experience:

• severe diarrhea with bleeding

• blisters, redness, or bruising on the skin

• dark urine or pale stools

• yellowing of the skin and whites of the eyes (jaundice). See also anemia below, which may lead to jaundice.

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

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 rash with itching (round, pink-red spots), swollen areas resembling blisters 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, speak to your doctor, as you will need to discontinue treatment with Amoxicillin Teva.

Other possible adverse effects are:

Frequent (may affect up to 1 in 10 people)

• skin rash
• nausea
• diarrhea.

Uncommon (may affect up to 1 in 100 people)

• 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
• crystals in the urine, leading to acute kidney injury. These may appear as cloudy urine or difficulty or discomfort when urinating. Make sure to drink plenty of fluids to reduce the likelihood of these symptoms
• changes in tooth coloration, which usually disappear 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 anemia. Signs include: fatigue, 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.

Not known (cannot be estimated from available data)

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

• blistering rash arranged in a circular pattern with a central crust or resembling a "pearl necklace" (linear IgA disease)
• inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis).

Reporting of adverse effects:

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may 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 Teva

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

No special storage conditions are required.

Do not use this medicine after the expiry date stated on the packaging and blister, following “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 unused medicines and their containers at the SIGRE point in your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Package contents and other information

Composition of Amoxicillin Teva

• The active substance is amoxicillin (trihydrate). Each tablet contains 1,000 mg of amoxicillin.
• The other components are: polyvinylpyrrolidone (povidone), sodium saccharin (E954), magnesium stearate, sodium lauryl sulfate, microcrystalline cellulose (E460), raspberry flavour (contains glucose and maize starch).

Appearance of the product and contents of the container

Amoxicillin Teva 1,000 mg tablets are supplied in a carton containing 20 or 30 tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Teva Pharma, S.L.U.

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

28,108 Alcobendas, Madrid

Spain

Manufacturer:

Laboratorio Reig Jofré S.A.

C/Jarama 111

45007 Toledo

Spain

Date of the most recent review of this leaflet: August 2024

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

General advice regarding the use of antibiotics

Antibiotics are used to treat bacterial infections. They are not effective against viral infections.

Sometimes a bacterial infection does not respond to antibiotic treatment. One of the most common reasons this occurs is because the bacteria causing the infection are resistant to the antibiotic being taken. This means that the bacteria can survive or grow despite the antibiotic.

Bacteria can become resistant to antibiotics for many reasons. Using antibiotics appropriately can reduce the likelihood of bacteria becoming resistant to them.

When your doctor prescribes an antibiotic, it is intended solely for the treatment of your current illness. Following the advice below will help you prevent the emergence of resistant bacteria, which could render antibiotics ineffective:

1. It is very important that you take the antibiotic at the correct dose, at the prescribed times, and for the full duration of treatment. Read the instructions in the leaflet carefully, and if you do not understand something, ask your doctor or pharmacist.
2. You should not take an antibiotic unless it has been specifically prescribed for you, and you should use it only for the infection for which it was prescribed.
3. You should not take antibiotics that have been prescribed for other people, even if they had an infection similar to yours.
4. You should not give antibiotics prescribed for you to other people.
5. If you have any antibiotic left after completing your treatment, return all unused medicines to your pharmacy to ensure they are disposed of properly.