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

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Amoxicillin/Clavulanic acid Viatris 500 mg/125 mg

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, 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 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 not listed in this leaflet. See section 4.

Leaflet contents

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

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

Amoxicillin/Clavulanic Acid Viatris is an antibiotic that kills bacteria causing infections. It contains two active substances 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 influenza or the common cold.

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

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 down the drain or in household waste.

Amoxicillin/Clavulanic Acid Viatris is used in children and adults 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 starting to take Amoxicillin/Clavulanic Acid Viatris

Do not take Amoxicillin/Clavulanic Acid Viatris:

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

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

Warnings and precautions

Tell your doctor or pharmacist before taking this medicine 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 Viatris.

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 Viatris to reduce the risk of complications. See section 4.

Blood and urine tests

If you are having 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 Viatris may alter the results of these types of tests.

Other medicines and Amoxicillin/Clavulanic Acid Viatris

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription and herbal medicines.

Amoxicillin/Clavulanic Acid Viatris may affect the action of mycophenolate mofetil, a medicine used to prevent rejection of transplanted organs.

If you are taking allopurinol (used for gout) with Amoxicillin/Clavulanic Acid Viatris, 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 Viatris. Concomitant use of probenecid may reduce the excretion of amoxicillin and is not recommended.

If anticoagulants (such as warfarin) are taken with Amoxicillin/Clavulanic Acid Viatris, more blood tests will be needed.

Amoxicillin/Clavulanic Acid Viatris may affect the action of methotrexate (a medicine used to treat cancer, severe psoriasis, or rheumatic diseases). Penicillins may reduce methotrexate excretion and potentially increase adverse effects.

Pregnancy and breastfeeding

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

Driving and using machines

Amoxicillin/clavulanic acid may cause adverse effects such as dizziness and seizures, and these symptoms may mean you should not drive. Do not drive or operate machinery unless you feel well.

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

3. How to take Amoxicillin/Clavulanic Acid Viatris

Follow exactly the instructions for use of this medicine as given by your doctor. Consult your doctor or pharmacist if you have any doubts.

Use in adults and children weighing 40 kg or more

The recommended dose is:

• 1 tablet three times a day.

Use in 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.

Seek advice from your doctor or pharmacist when administering Amoxicillin/Clavulanic Acid Viatris tablets 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 Viatris

• Take with food.
• Swallow the tablets with a glass of water.

The tablets have a score line which allows them to be split, making them easier to swallow. You should take both halves of the tablet at the same time.

• Space your doses evenly throughout the day, at least 4 hours apart. Do not take two doses within one hour.
• Do not take Amoxicillin/Clavulanic Acid Viatris for longer than 2 weeks. If you still feel unwell, consult your doctor.

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

If you take too much Amoxicillin/Clavulanic Acid, symptoms such as stomach upset (nausea, vomiting, or diarrhea) or seizures may occur. Contact your doctor as soon as possible. Take the packaging with you to show your doctor. You may also call the Toxicology Information Service at telephone number 915620420, indicating the medicine and the amount taken.

If you forget to take Amoxicillin/Clavulanic Acid Viatris

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 missed doses.

If you stop taking Amoxicillin/Clavulanic Acid Viatris

Continue taking Amoxicillin/Clavulanic Acid Viatris until the end of the 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 experiences 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 mouth (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 Viatris.

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 skin peeling (more than 30% of body surface area – toxic epidermal necrolysis).
• Widespread rash with small pus-filled blisters (bullous exfoliative 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 (including 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 (drug-related symmetric intertriginous and flexural exanthema (SDRIFE)).
• Skin rash with blisters and resembling small targets (dark center surrounded by a paler area, with a dark ring around the edge – erythema multiforme).

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

Inflammation of the large intestine:

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

• Drug-induced enterocolitis syndrome (DIES):

DIES has been reported mainly in children receiving amoxicillin/clavulanate. 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, diarrhea, and low blood pressure.

Contact your doctor as soon as possible for advice if you have these symptoms.

Other possible serious adverse effects

• 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 yellowish.

• Inflammation of the kidney tubules.

Inflammation of the protective membrane surrounding the brain and spinal cord (aseptic meningitis).

• Seizures (in patients taking high doses of amoxicillin/clavulanic acid or who have kidney problems).

Drastic reduction in the number of white blood cells (agranulocytosis), which may lead to increased infections, such as sore throat, mouth ulcers, fever, etc.

• Reduced number of red blood cells (hemolytic anemia), which may cause fatigue, difficulty breathing, or abnormally pale skin.

Inform your doctor as soon as possible to obtain advice if you experience these symptoms.

Other adverse effects

Very common adverse effects (may affect more than 1 in 10 people):

• Diarrhea (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 affects you, take Amoxicillin/Clavulanic Acid with food)
• Vomiting.
• Diarrhea (in children).

Uncommon adverse effects (may affect 1 in 100 people):

• Skin rash.
• Itching.
• Increased itchy rash (urticarial wheals).
• Indigestion.
• Dizziness.
• Headache.

Uncommon adverse effects that may appear in blood tests:

• Increase in certain substances (enzymes) produced by the liver.

Rare adverse effects (may affect up to 1 in 1,000 people):

• Low count of cells involved in blood clotting.
• Low white blood cell count.

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

Other adverse effects that have occurred in a very small number of patients and whose exact frequency is unknown.

• Delayed blood clotting.
• Hyperactivity.
• Black, hairy-looking tongue.
• Blistering rash arranged in circles with central crusts or resembling a "string of pearls" (linear IgA disease).

Adverse effects that may appear in blood or urine tests:

• Crystals in the urine causing acute kidney injury.

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor, pharmacist, or nurse, 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: https://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 Viatris

Keep out of sight and reach of children.

Do not store above 25 °C. Store in the original packaging.

Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE Point located at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Amoxicilina/Ácido clavulánico Viatris

• The active substances are:

Amoxicillin, 500 mg (equivalent to 574 mg of amoxicillin trihydrate) and clavulanic acid 125 mg (equivalent to 148.9 mg of potassium clavulanate).

• The other components are: magnesium stearate, talc, povidone, microcrystalline cellulose, sodium croscarmellose, triethyl citrate, hypromellose, ethylcellulose, sodium lauryl sulfate, cetyl alcohol, titanium dioxide (E171).

Appearance of the medicine and contents of the pack

The film-coated tablets are whitish in colour, oval-shaped, biconvex, and have a score line on both sides.

Amoxicilina/Ácido clavulánico Viatris is available in packs containing 3, 10, 12, 14, 15, 16, 20, 21, 24, 30 and 50 film-coated tablets. Hospital pack containing 100 tablets.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Viatris Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
Dublin
Ireland

Manufacturer:

Sandoz GmbH
Biochemiestrasse, 10
A-6250 Kundl
Austria

or

McDermott Laboratories Limited t/a Gerard Laboratories t/a Mylan Dublin
35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13
Ireland

For further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Viatris Pharmaceuticals, S.L.
C/ General Aranaz, 86
28027 - Madrid
Spain

This medicine is authorised in the EEA Member States under the following names:

Germany amoxidura plus 500/125 mg
Belgium Amoxiclav Mylan 500 mg filmomhulde tabletten
Spain Amoxicilina/Ácido clavulánico Viatris 500 mg/125 mg film-coated tablets EFG
Greece Co-Amoxiclav/Mylan επικαλυμμ?να με λεπτ? υμ?νιο δισκ?α (500+125) mg/TAB
Ireland Germentin film coated tablets 500/125
Netherlands Amoxicilline/clavulaanzuur Mylan 500/125mg, tabletten 500 + 125mg

Date of the most recent review of this leaflet: September 2025

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (Agencia Española de Medicamentos y Productos Sanitarios - AEMPS) http://www.aemps.gob.es