Amoxicillin/clavulanic acid Tevagen 500 mg/125 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Amoxicillin/Clavulanic acid Tevagen 500mg/125mg film-coated tablets EFG

Read the entire 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms, as 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.

Contents of this leaflet:

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

1. What Amoxicillin/Clavulanic Acid Tevagen is and what it is used for

Amoxicillin/Clavulanic Acid Tevagen is an antibiotic that kills bacteria causing infections. It contains two different medicines called amoxicillin and clavulanic acid. Amoxicillin belongs to a group of medicines known as "penicillins," which can sometimes lose their effectiveness (become inactivated). The other component (clavulanic acid) prevents this from happening.

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 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.

Amoxicillin/Clavulanic Acid is used in adults and children to treat the following infections:

• Middle ear and sinus infections
• Respiratory tract infections
• Urinary tract infections
• Skin and soft tissue infections, including dental infections
• Bone and joint infections.

2. What you need to know before taking Amoxicillin/Clavulanic Acid Tevagen

Do not take Amoxicillin/Clavulanic Acid:

• if you are allergic to amoxicillin, clavulanic acid, penicillins, or to any of the other ingredients of this medicine (listed in section 6)
• if you have ever had a severe allergic reaction to any other antibiotic. This could include skin rash or swelling of the face or throat
• if you have ever had liver problems or jaundice (yellowing of the skin) while taking an antibiotic.

Do not take this medicine if any of the above apply to you. Before starting treatment with Amoxicillin/Clavulanic Acid, if you are unsure, consult your doctor or pharmacist.

Warnings and precautions

Talk to your doctor or pharmacist before taking Amoxicillin/Clavulanic Acid if:

• you have infectious mononucleosis
• you are receiving treatment for liver or 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/Clavulanic Acid.

In some cases, your doctor may investigate the type of bacteria causing your infection. Depending on the results, they may prescribe a different formulation of Amoxicillin/Clavulanic Acid or another medicine.

Symptoms to watch for

Amoxicillin/Clavulanic Acid may worsen certain existing conditions or cause serious adverse effects. These include allergic reactions, seizures, and inflammation of the large intestine. You should be aware of certain symptoms while taking Amoxicillin/Clavulanic Acid to reduce the risk of complications. See "Symptoms to watch for" in section 4.

Blood and urine tests

If you are undergoing blood tests (such as studies of red blood cell status or liver function tests) or urine tests (to monitor glucose levels), inform your doctor or nurse that you are taking Amoxicillin/Clavulanic Acid. This is because Amoxicillin/Clavulanic Acid may alter the results of these types of tests.

Taking Amoxicillin/Clavulanic Acid Tevagen with other medicines

Inform 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/Clavulanic Acid, you may be more likely to experience a skin allergic reaction.

• If you are taking probenecid (used for gout), your doctor may adjust your dose of Amoxicillin/Clavulanic Acid.

• If anticoagulants (such as warfarin) are taken with Amoxicillin/Clavulanic Acid, additional blood tests may be required.

• Amoxicillin/Clavulanic Acid may affect the action of methotrexate (a medicine used to treat cancer or rheumatic diseases). Amoxicillin/Clavulanic Acid may affect how mycophenolate mofetil (a medicine used to prevent organ rejection in transplant patients) works.

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/Clavulanic Acid may cause adverse effects, and symptoms may make it unsafe for you to drive.

Do not drive or operate machinery unless you feel well.

Amoxicillin/Clavulanic Acid Tevagen contains sodium

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

3. How to take Amoxicillin/Clavulanic Acid Tevagen

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

Adults and children weighing 40 kg or more

The recommended dose is:

• 1 tablet three times a day

Children weighing less than 40 kg

It is preferable to treat children aged 6 years or younger with amoxicillin/clavulanic acid oral suspension or sachets.

Consult your doctor or pharmacist before administering this medicine to children weighing less than 40 kg. The tablets are not suitable for children weighing less than 25 kg.

Patients with kidney or liver problems

• If you have kidney problems, your dose may be adjusted. Your doctor may choose a different formulation or another medicine.
• If you have liver problems, you will have blood tests more frequently to monitor liver function.

How to take Amoxicillin/Clavulanic Acid Tevagen

• Take with meals.
• Swallow the tablets whole with a glass of water.
• Space the doses throughout the day, at least 4 hours apart. Do not take 2 doses within 1 hour.
• Do not take this medicine for longer than 2 weeks. If you still feel unwell, consult your doctor.

If you take more Amoxicillin/Clavulanic Acid Tevagen than you should

If you take too much amoxicillin/clavulanic acid, symptoms such as stomach discomfort (nausea, vomiting, or diarrhea) or seizures may occur. Contact your doctor as soon as possible. Bring the package with you to show the doctor.

You may also contact your pharmacist immediately or call the Toxicology Information Service at telephone (91) 562 04 20, indicating the medicine and the amount ingested. It is recommended to bring the medicine’s packaging and leaflet to the healthcare professional.

If you forget to take Amoxicillin/Clavulanic Acid Tevagen

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.

If you stop taking Amoxicillin/Clavulanic Acid Tevagen

Continue taking this medicine for the full duration of treatment, even if you feel better. You need to complete the full course to cure the infection. If you do not, surviving bacteria may cause the infection to return. If you have any further questions about the use of this product, ask your doctor or pharmacist.

4. Possible adverse effects

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

Symptoms to watch for

Allergic reactions:

• skin rash

• inflammation of blood vessels (vasculitis), which may appear as red or purple spots on the skin, but may affect other parts of the body

• fever, joint pain, swollen glands in the neck, armpits, or groin

• swelling, sometimes of the face or throat (angioedema), causing difficulty breathing

• collapse

• chest pain in the context of allergic reactions, which may be a symptom of an allergic-triggered heart attack (Kounis syndrome).

• Contact your doctor immediately if you experience any of these symptoms. Stop taking Amoxicillin/Clavulanic acid.

Inflammation of the large intestine

Inflammation of the large intestine, causing watery diarrhoea, usually with blood and mucus, stomach pain and/or fever.

Drug-induced enterocolitis syndrome (DIES)

DIES has been reported mainly in children receiving amoxicillin/clavulanic acid. It is a 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.

Acute inflammation of the pancreas (acute pancreatitis)

If you have severe and persistent pain in the stomach area, this could be a sign of acute pancreatitis.

• Contact your doctor immediately if you experience any of these symptoms.

Very common adverse effects

May affect more than 1 in 10 people

• diarrhoea (in adults)

Common adverse effects

May affect up to 1 in 10 people

• thrush (Candida – fungal infection in the vagina, mouth, or mucous membranes)
• nausea, especially when taking high doses
  • if this occurs, take Amoxicillin/Clavulanic acid before meals
• vomiting
• diarrhoea (in children)

Uncommon adverse effects

May affect up to 1 in 100 people

• skin rash, itching
• increased itchy rash (urticarial wheals)
• indigestion
• dizziness
• headache

Uncommon adverse effects that may appear in blood tests:

• increased levels of certain substances (enzymes) produced by the liver

Rare adverse effects

May affect up to 1 in 1,000 people

• skin rash that may blister and resemble small targets (a dark central spot surrounded by a paler area, with a dark ring around the edge – erythema multiforme)

• If you experience any of these symptoms, consult your doctor urgently.

Rare adverse effects that may appear in blood tests:

• low count of cells involved in blood clotting
• low white blood cell count

Frequency not known

The frequency cannot be estimated from the available data.

• allergic reactions (see above)

• inflammation of the large intestine (see above)

• inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis)

• severe skin reactions:

  • widespread rash with blisters and peeling of the skin, particularly around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), and in its most severe form, causing widespread peeling of the skin (more than 30% of body surface – toxic epidermal necrolysis)
  • widespread rash with small pus-filled blisters (exfoliative bullous dermatitis)
  • red rash with bumps under the skin and blisters (exanthematous pustulosis)
  • 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))
  • red rash typically seen on both sides of the buttocks, upper inner thighs, armpits, and neck (Symmetrical Drug-Related Intertriginous and Flexural Exanthema (SDRIFE))

• Contact a doctor immediately if you have any of these symptoms.

• blistering rash arranged in circles with a central crust or resembling a string of pearls (linear IgA disease)

• inflammation of the liver (hepatitis)

• jaundice, caused by increased bilirubin in the blood (a substance produced by the liver), which may cause the skin and whites of the eyes to turn yellow

• inflammation of the kidney tubules

• delayed blood clotting

• hyperactivity

• seizures (in patients taking high doses of Amoxicillin/Clavulanic acid or with kidney problems)

• black, hairy-looking tongue

Adverse effects that may appear in blood or urine tests:

• significant reduction in the number of white blood cells
• low red blood cell count (haemolytic anaemia)
• crystals in the urine, which may cause acute kidney injury

Reporting of adverse effects

If you experience any adverse effect, talk to 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: Website: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Amoxicillin/Clavulanic Acid Tevagen

Do not store above 25°C.

Keep in the original packaging to protect from moisture.

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

Do not use this medicine after the expiry date stated on the container and blister pack, after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, please 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 Amoxicillin/Clavulanic Acid Tevagen 500 mg/125 mg film-coated tablets

• The active substances are amoxicillin and clavulanic acid. Each tablet contains: 500 mg of amoxicillin (as amoxicillin trihydrate) and 125 mg of clavulanic acid (as potassium clavulanate).
• Other components: anhydrous colloidal silica, magnesium stearate (E-470 b), sodium carboxymethylstarch (type A) (derived from potato starch) and microcrystalline cellulose 112 (E460).

Coating: Opadry Oy-S-7300 (containing: hypromellose 5 cps, hypromellose 15 cps, macrogol 4000, macrogol 6000, titanium dioxide (E171)) and simethicone 500 cps.

Appearance of the product and pack contents

Film-coated, elongated, scored tablets, white in colour, marked with the inscription A/C.

Packs containing 30 film-coated tablets.

Marketing Authorisation Holder and Manufacturer

Holder:

Teva Pharma S.L.U.

C/ Anabel Segura 11, Edificio Albatros B, Planta 1ª

Alcobendas, 28108 Madrid

Spain

Manufacturer:

Laboratorios Reig Jofré S.A.

C/Jarama 111, Poligono Industrial

45007 Toledo

Spain

Date of the most recent review of this leaflet: December 2025.

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

• You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the packaging. You can also access this information at the following internet address:
• https://cima.aemps.es/cima/dochtml/p/65222/P_65222.html