Label: Information for the Patient

Amoxicilina/Ácido clavulánico Viatris 875 mg/125 mg Film-Coated Tablets EFG

Read this label carefully before taking this medicine, as it contains important information for you.

• Keep this label, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you experience any side 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 different medications called amoxicilina and ácido clavulánico. Amoxicilina belongs to a group of medications known as “penicilinas”, which 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 (listed in section 6).
• If you have ever had a severe allergic reaction (hypersensitivity) 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 (yellow discoloration of the skin) when taking an antibiotic.

Do not take amoxicilina/ácido clavulánico if you are included in any of the above points. Before starting treatment withamoxicilina/ácido clavulánico, if you are unsure, consult your doctor or pharmacist.

Warnings and precautions

Consult your doctor or pharmacist before starting to takeAmoxicilina/Ácido clavulánico Viatris:

• If you have infectious mononucleosis.
• If you are receiving treatment for liver or kidney problems.
• If you do not urinate regularly.

If you are unsure if you are affected by any of the above symptoms, inform your doctor or pharmacist before takingamoxicilina/ácido clavulánico.

In some cases, your doctor may investigate the type of bacteria causing your infection. Depending on the results, you may be prescribed a different presentation ofamoxicilina/ácido clavulánicoor another medication.

Symptoms to be aware of

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 clavulánicoto reduce the risk of problems. See “Symptoms to be aware of” insection 4.

Blood and urine tests

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 about takingthis medication,becauseamoxicilina/ácido clavulánicomay 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.

• If you are taking alopurinol (used for gout) withamoxicilina/ácido clavulánico, you may be more likely to suffer a skin allergy reaction.
• If you are taking probenecid (used to treat gout), concomitant use of probenecid may reduce the excretion ofamoxicilina and is not recommended.
• If you are taking anticoagulants (such as warfarin) withamoxicilina/ácido clavulánico,more blood tests will be needed.
• If you are takingmetotrexato (a medication used to treat cancer and severe psoriasis), penicilinas may reduce the excretion of metrotexato and cause a potential increase in side effects.
• Amoxicilina/ácido clavulánicomay affect the way micofenolato de mofetilo (a medication used to prevent organ rejection in transplant patients) works.

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 taking this medication.

Driving and operating machinery

Amoxicilina/ácido clavulánicomay cause side effects and symptoms that may make you unable to drive. Do not drive or operate machinery unless you feel well.

Amoxicilina/Ácido clavulánico Viatris contains sodium

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

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Adults and children 40 kg or more

•Usual dose: 1 tablet administered twice a day.

•Higher dose: 1 tablet administered three times a day.

Children under 40 kg of weight

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

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 functioning.

How to take Amoxicilina/Ácido clavulánico Viatris

• Take with meals.
• Swallow the tablets whole with a glass of water.
• The groove is only for breaking the tablet if it is difficult to swallow it whole.
• Space the doses throughout the day, at least 4 hours apart. Do not take two doses in one hour.
• Do not take amoxicilina/ácido clavulánico for more than 2 weeks. If you continue to feel unwell, consult your doctor.

If you take more Amoxicilina/Ácido clavulánico Viatris than you should

If you take more amoxicilina/ácido clavulánico than you should, 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 the doctor. You can also call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount taken.

If you forget to take Amoxicilina/Ácido clavulánico 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 interrupt the treatment with Amoxicilina/Ácido clavulánico Viatris

Continue taking amoxicilina/ácido clavulánico until you complete the treatment, even if you feel better. You need to take the complete treatment to cure the infection. If you do not, the surviving bacteria may cause the infection to return.

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

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

Symptoms you should be aware of

Allergic reactions:

• Skin rash.
• Inflammation of blood vessels (vasculitis), which can appear as red or purple spots on the skin or 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), which causes difficulty breathing.
• Collapsing.
• Chest pain in the context of allergic reactions, which can be a syndrome of allergic-induced heart attack (Kounis syndrome).
• Drug-induced enterocolitis syndrome (DIES): DIES has mainly been reported in children taking amoxicillin. 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 immediately if you experience any of these symptoms.Stop taking amoxicillin/clavulanic acid.

Colitis

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

Acute pancreatitis

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

Contact your doctor as soon as possible,so they can advise you, if you experience these symptoms.

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

• Diarhea (in adults).

Common(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 happens, take amoxicillin/clavulanic acidbefore meals.

• Vomiting.
• Diarhea (in children).

Poco common(may affect up to 1 in 100 people)

• Skin rash, itching.
• Increased pruritic eruption (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(may affect up to 1 in 1,000 people)

• Skin eruption, which may form blisters that look like small darts (erythema multiforme).

→If you experience any of these symptoms, consult a doctor urgently.

Side effects that may appear in your blood tests:

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

Frequency not known(cannot be estimated from available data)

• Allergic reactions (see above).
• Colitis (see above).
• Inflammation of the protective membranes surrounding the brain and spinal cord (aseptic meningitis).
• Severe skin reactions:

• Generalized eruption 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 red eruption with small blisters with pus (exfoliative bullous dermatitis).
• Red exfoliative eruption with lumps under the skin and blisters (pustular exanthema).
• Symptoms of a flu-like illness with skin eruption, fever, swollen glands, and abnormal blood test results (such as increased eosinophils and elevated liver enzymes) (drug reaction with eosinophilia and systemic symptoms (DRESS)).
• Red eruption observed on both sides of the buttocks, on the upper inner thighs, in the armpits, neck (exanthema intertriginous and flexural symmetric related to drugs (SDRIFE)).

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

• Eruption with blisters arranged in a circle with a central crust or like a pearl necklace (IgA linear disease).
• Liver inflammation(hepatitis).
• Jaundice, caused byincreased bilirubin in the blood (a substance produced by the liver), which can make the skin and the white of the eyes turn yellow.
• Inflammation of the kidney tubules.
• Delayed blood clotting.
• Hyperactivity.
• Seizures (in patients taking high doses of amoxicillin/clavulanic acid or those with kidney problems).
• Black tongue that looks hairy.

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

• Significant reduction in the number of white blood cells.
• Low count of red blood cells(hemolytic anemia).
• Crystals in the urine that cause acute kidney injury.

Reporting ofside effects

If you experience any type of side effect, consult your doctor or pharmacist, 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 this medication out of the sight and reach of children.

Do not store at a temperature above 25°C. Store in the original packaging to protect it from light and humidity.

Do not usethis medicationafter the expiration date that appears on the packaging after the abbreviation CAD or EXP. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.

Composition of Amoxicilina/Ácido clavulánico Viatris

• The active principles are amoxicilina trihydrate and potassium clavulanate. Each film-coated tablet contains 1.005 mg of amoxicilina trihydrate, equivalent to 875 mg of amoxicilina, and 149 mg of potassium clavulanate, equivalent to 125 mg of clavulanic acid.
• The other components (excipients) are: anhydrous colloidal silica, magnesium stearate (E-572), talc (E-553B), povidone (E-1201), sodium croscarmellose, microcrystalline cellulose (E-460), triethyl citrate (E-1505), ethylcellulose (E-462), sodium lauryl sulfate, cetyl alcohol, hypromellose (E-464), titanium dioxide (E-171).

Appearance of the product and content of the container

Film-coated tablets, oblong, scored, and white to pale yellow in color.

Aluminum/PVC/Al blisters.

It is presented in containers with 20, 30, or 500 film-coated tablets.

Only some container sizes may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

Responsible for manufacturing:

Sandoz GmbH

Biochemiestrasse, 10

6250 - Kundl

Austria

Last review date of this prospectus: October 2024

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) https://www.aemps.gob.es/