AMOXICILINA 500 mg/125 mg Film-Coated Tablets

Contents of the leaflet

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

Introduction

Package Leaflet: Information for the Patient

Amoxicillin/Clavulanic Acid Viatris 500 mg/125 mg

film-coated tablets EFG

Read all of this 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.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What Amoxicillin/Clavulanic Acid Viatris is and what it is used for
2. What you need to know before you take Amoxicillin/Clavulanic Acid Viatris
3. How to take Amoxicillin/Clavulanic Acid Viatris
4. Possible side effects
5. Storage of 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 eliminates the bacteria that cause infections. It contains two active substances called amoxicillin and clavulanic acid. Amoxicillin belongs to a group of medicines known as "penicillins" that 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 the flu or the common cold.

It is essential that you follow the instructions regarding dosage, administration interval, and treatment duration indicated by your doctor.

Do not store or reuse this medicine. If you have any leftover antibiotic after finishing the treatment, return it to the pharmacy for proper disposal. Do not throw away medicines via wastewater or 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 you take Amoxicillin/Clavulanic Acid Viatris

Do not take Amoxicillin/Clavulanic Acid Viatris:

• If you are allergic to amoxicillin, clavulanic acid, 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.
• If you have ever had liver problems or jaundice (yellowing of the skin) when taking an antibiotic.

Do not take Amoxicillin/Clavulanic Acid Viatris if you are included in any of the above points. 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 symptoms affect 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, you may be prescribed a different formulation of amoxicillin/clavulanic acid or another medicine.

Symptoms to be aware of

Amoxicillin/clavulanic acid can worsen certain existing conditions or cause serious side 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 problems. See section 4.

Blood and urine tests

If you are having blood tests (such as red blood cell status or liver function studies) or urine tests (to check glucose levels), inform your doctor or nurse that you are taking amoxicillin/clavulanic acid. This is because Amoxicillin/Clavulanic Acid Viatris can 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 take any other medicines, including those obtained without a prescription and herbal medicines.

Amoxicillin/Clavulanic Acid Viatris may affect the functioning of mycophenolate mofetil, a medicine used to prevent organ rejection after transplants.

If you are taking allopurinol (used for gout) with Amoxicillin/Clavulanic Acid Viatris, you may be more likely to suffer a skin allergic reaction.

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

If you are taking anticoagulants (such as warfarin) 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 the excretion of methotrexate and cause a potential increase in side 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 have side effects such as dizziness and seizures, and these symptoms may make you unfit to drive. Do not drive or operate machinery unless you feel well.

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

3. How to take Amoxicillin/Clavulanic Acid Viatris

Follow exactly the administration instructions of this medicine indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Use in adults and children over 40 kg

The recommended dose is:

• 1 tablet three times a day.

Use in children under 40 kg

It is preferable to treat children under 6 years with the oral suspension of amoxicillin/clavulanic acid or sachets.

Ask your doctor or pharmacist for advice when administering Amoxicillin/Clavulanic Acid Viatris tablets to children who weigh less than 40 kg. The tablets are not suitable for children who weigh less than 25 kg.

Patients with kidney and liver problems

• If you have kidney problems, your dose may be changed. Your doctor may choose a different formulation or another medicine.
• If you have liver problems, you will have more frequent blood tests to check how your liver is working.

How to take Amoxicillin/Clavulanic Acid Viatris

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

The tablets have a score line so that they can be broken, making them easier to swallow. You should take both halves of the tablet at the same time.

• Space out the doses during the day, at least 4 hours apart. Do not take two doses in one hour.
• Do not take Amoxicillin/Clavulanic Acid Viatris for more than 2 weeks. If you are still feeling unwell, consult your doctor.

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

If you take too much amoxicillin/clavulanic acid, you may experience symptoms such as stomach upset (nausea, vomiting, or diarrhea) or seizures. Consult your doctor as soon as possible. Bring the package with you to show the doctor. You can also call the Toxicology Information Service, phone 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 forgotten doses.

If you stop taking Amoxicillin/Clavulanic Acid Viatris

Continue taking Amoxicillin/Clavulanic Acid Viatris until you finish the treatment, even if you feel better. You need to take the complete treatment to cure the infection. If you do not, the bacteria that survive may cause you to have the infection again.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Symptoms to be aware of

Allergic reactions:

• Rash.
• Inflammation of blood vessels (vasculitis) that can appear as red or purple spots on the skin but can 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 can be a symptom of allergy-induced heart attack (Kounis syndrome).

Contact your doctor immediatelyif 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 peeling of the skin (more than 30% of the body surface - toxic epidermal necrolysis).
• Widespread rash with small blisters with pus (bullous exfoliative dermatitis).
• Red rash with bumps under the skin and blisters (pustular exanthematous).
• Flu-like symptoms with skin rash, fever, gland inflammation, and abnormal blood test results (including an increase in white blood cells (eosinophilia) and elevated liver enzymes (drug reaction with eosinophilia and systemic symptoms (DRESS))).
• Skin rash with blisters and looks like small targets (central dark spot surrounded by a paler area, with a dark ring around the edge - erythema multiforme).

Contact a doctor immediatelyif you have any of these symptoms.

Inflammation of the large intestine:

• Inflammation of the large intestine, which causes 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 stomach pain, this could be a sign of acute pancreatitis.

• Drug-induced enterocolitis syndrome (DIES):

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

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

Other possible serious side effects

• Inflammation of the liver (hepatitis).

Jaundice, caused by an increase in bilirubin in the blood (a substance produced by the liver), which can make the skin and the whites of the eyes turn yellow.

• Inflammation of the kidney ducts.

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

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

Drastic reduction in the number of white blood cells (agranulocytosis) that can cause an increased risk of infections, such as sore throat, mouth ulcers, fever, etc.

• Reduced number of red blood cells (hemolytic anemia) that can cause you to feel tired, have difficulty breathing, or have abnormally pale skin.

Tell your doctor as soon as possiblefor advice if you experience these symptoms.

Other side effects

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

• Diarrhea (in adults).

Common side 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 affected, take Amoxicillin/Clavulanic Acid Viatris with a meal)
• Vomiting.
• Diarrhea (in children).

Uncommon side effects(may affect up to 1 in 100 people):

• Rash.
• Itching.
• Increased itching rash (urticarial wheal).
• Indigestion.
• Dizziness.
• Headache.

Uncommon side effects that may appear in your blood tests:

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

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

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

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

Other side effects that have occurred in a very small number of patients and whose exact frequency is not known.

• Delayed blood clotting.
• Hyperactivity.
• Black hairy tongue.
• Rash with blisters arranged in a circle with a central crust or like a string of pearls (linear IgA disease).

Side effects that may appear in your blood or urine tests:

• Crystals in the urine that cause acute kidney injury.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side 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 package.

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

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Amoxicillin/Clavulanic Acid 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 ingredients are: magnesium stearate, talc, povidone, microcrystalline cellulose, sodium croscarmellose, triethyl citrate, hypromellose, ethylcellulose, sodium lauryl sulfate, cetyl alcohol, titanium dioxide (E171).

Appearance of the product and pack contents

The film-coated tablets are white, oval, and biconvex with a score line on both sides.

Amoxicillin/Clavulanic Acid Viatris is available in packs of 3, 10, 12, 14, 15, 16, 20, 21, 24, 30, and 50 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization 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

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

This medicine is authorized in the EEA Member States with the following names:

Germany amoxidura plus 500/125 mg

Belgium Amoxiclav Mylan 500 mg film-coated tablets

Spain Amoxicillin/Clavulanic Acid Viatris 500 mg/125 mg film-coated tablets EFG

Greece Co-Amoxiclav/Mylan film-coated tablets (500+125) mg/TAB

Ireland Germentin film-coated tablets 500/125

Netherlands Amoxicilline/clavulaanzuur Mylan 500/125mg, tablets 500 + 125mg

This leaflet was approved in April 2023

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