Label: information for the patient

Amoxicilina/Ácido clavulánico Viatris 500 mg/125 mg

film-coated tablets EFG

Read the label carefully before starting to take the medication,because it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only to you and should not be given to other people, even if they have the same symptoms, as it may harm them.
• Experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

Amoxicilina/Ácido clavulánico Viatrisis an antibiotic that eliminates the bacteria that cause infections. It contains two active ingredients called amoxicilina and ácido clavulánico. Amoxicilina belongs to a group of medicines known as “penicilinas” that sometimes may lose its effectiveness (become inactivated). The other component (ácido clavulánico) prevents this from happening.

Amoxicilina/Ácido clavulánico Viatrisis used in children and adults to treat the following infections:

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

Do not take Amoxicilina/Ácido clavulánico Viatris:

• If you are allergic to amoxicilina, ácido clavulánico, penicilinas, or any of the other components of this medication (see 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 neck.
• If you have ever had liver problems or jaundice (yellowing of the skin) when taking an antibiotic.

Do not take Amoxicilina/Ácido clavulánico Viatris if you are included in any of the above points. Before starting treatment withthis medication, if you are unsure, consult your doctor or pharmacist.

Warnings and precautions

Inform your doctor or pharmacist before taking this medication 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 takingAmoxicilina/Ácido clavulánico Viatris.

Your doctor may investigate the type of bacteria causing your infection. Depending on the results, they may prescribe a different presentation ofamoxicilina/ácido clavulánicoor another medication.

Be aware of the following symptoms

Amoxicilina/ácido clavulánicomay worsen existing conditions or cause serious side effects. These include allergic reactions, convulsions, and inflammation of the large intestine. Be aware of certain symptoms while takingAmoxicilina/Ácido clavulánico Viatristo reduce the risk of problems. See section4.

Blood and urine analysis

If you are having blood tests (such as red blood cell studies or liver function studies) or urine tests (to control glucose levels), inform your doctor or nurse that you are takingamoxicilina/ácido clavulánico. This is becauseAmoxicilina/Ácido clavulánico Viatrismay alter the results of these types of tests.

Other medications and Amoxicilina/Ácido clavulánico Viatris

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including those purchased without a prescription and herbal medications.

Amoxicilina/Ácido clavulánico Viatris may affect the functioning of mycophenolate mofetil, a medication used to prevent organ transplant rejection.

If you are taking allopurinol (used for gout) withAmoxicilina/Ácido clavulánico Viatris, you may be more likely to experience a skin allergic reaction.

If you are taking probenecid (used for gout), your doctor may adjust the dose ofAmoxicilina/Ácido clavulánico Viatris. Concomitant use of probenecid may reduce amoxicilina excretion and is not recommended.

If you are taking anticoagulants (such as warfarin) withAmoxicilina/Ácido clavulánico Viatrisyou will need more blood tests.

Amoxicilina/Ácido clavulánico Viatrismay affect the action of methotrexate (a medication used to treat cancer, severe psoriasis, or rheumatic diseases). Penicillins may reduce methotrexate excretion and cause a potential increase in side effects.

Pregnancy and breastfeeding

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

Driving and operating machinery

Amoxicilina/ácido clavulánicomay cause side effects such as dizziness and convulsions, and symptoms may make you unable to drive. Do not drive or operate machinery unless you are feeling well.

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

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

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 6 years old or less with oral suspension ofamoxicillin/clavulanic acidor the sachets.

Ask your doctor or pharmacist for advice when administeringAmoxicillin/Clavulanic Acid Viatristablets to children weighing less than 40 kg.The tablets are not suitable for children weighing 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 presentation or another medication.
• 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 groove that can be split to make them easier to swallow. You should take the two halves of the tablet at the same time.

• Space out your doses throughout 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 continue to feel unwell, consult your doctor.

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

If you take too muchAmoxicillin/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 packaging with you to show your doctor. You can also call the Toxicology Information Service, phone 915620420, indicating the medication 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 the missed doses.

If you stop taking Amoxicillin/Clavulanic Acid Viatris

Continue takingAmoxicillin/Clavulanic Acid Viatrisuntil you complete the treatment, even if you feel better. You need to take the full treatment to cure the infection. If you do not, the surviving bacteria may cause the infection to return.

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

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

Symptoms to be aware of

Allergic reactions:

• Skin rash.
• Swelling of blood vessels (vasculitis) that may appear as red or purple spots on the skin, but can affect other parts of the body.
• Fever, joint pain, swollen lymph nodes in the neck, armpits, or groin.
• Swelling, sometimes of the face or mouth (angioedema), which causes difficulty breathing.
• Loss of consciousness.
• Chest pain in the context of allergic reactions, which can be a symptom of an allergic-induced heart attack (Kounis syndrome).

Contact your doctor immediately if you experience any of these symptoms.Stop taking Amoxicilina/Ácido clavulánico Viatris.

Severe skin reactions::

• Generalized rash with blisters and skin peeling, particularly around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), and in its most severe form, causing widespread skin peeling (toxic epidermal necrolysis).
• Generalized rash with small blisters with pus (exfoliative bullous dermatitis).
• Red rash, with bumps under the skin and blisters (pustular exanthem).
• Symptoms similar to the flu with skin rash, fever, swollen lymph nodes, and abnormal blood test results (including eosinophilia and elevated liver enzymes (drug reaction with eosinophilia and systemic symptoms (DRESS)).
• Skin rash with blisters and appears as small targets (point central dark area surrounded by a lighter area, with a dark ring around the edge - erythema multiforme).

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

Colitis:

• Colitis, which causes watery diarrhea, usually with blood and mucus, stomach pain, and/or fever.
• Acute pancreatitis:

If you have intense 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 taking amoxicillin/clavulanic acid. 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.

Contact your doctor as soon as possible to advise you if you experience these symptoms.

Other possible severe side effects:

• Liver inflammation (hepatitis).

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

• Kidney tubule inflammation.

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

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

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

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

Inform your doctor as soon as possible to advise you 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 it affects you, take Amoxicilina / ácido clavulánico with a meal)
• Vomiting.
• Diarrhea (in children).

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

• Skin rash.
• Itching.
• Increased pruritic rash (urticarial hives).
• Indigestion.
• Dizziness.
• Headache.

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.

Unknown frequency(cannot be estimated from available data):

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

• Delayed blood clotting.
• Hyperactivity.
• Black tongue that appears hairy.
• Rash with blisters arranged in a circle with a central crust or as a pearl necklace (IgA linear disease).

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

• Crystals in the urine that cause acute kidney damage.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep out of the sight and reach of children.

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

Do not usethis medicationafter the expiration date that appears on the boxafter 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 packaging and medicines you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition ofAmoxicillin/Clavulanate Viatris

• The active ingredients are:

Amoxicillin, 500 mg (equivalent to 574 mg of amoxicillin trihydrate) and clavulanate, 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 product and contents of the package

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

Amoxicillin/Clavulanate Viatris is available in packages with 3, 10, 12, 14, 15, 16, 20, 21, 24, 30, and 50 film-coated tablets.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Responsible 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 more information about this medication, please contact the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

This medication is authorized in the EEA member states with the following names:

Germanyamoxidura plus 500/125 mg

BelgiumAmoxiclav Mylan 500 mg filmomhulde tabletten

SpainAmoxicillin/Clavulanate Viatris 500 mg/125 mg film-coated tablets EFG

GreeceCo-Amoxiclav/Mylan επικαλυμμ?να με λεπτ? υμ?νιο δισκ?α (500+125) mg/TAB

IrelandGermentin film coated tablets 500/125

NetherlandsAmoxicilline/clavulaanzuur Mylan 500/125mg, tabletten 500 + 125mg

This leaflet was approved in April 2023

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