AMOXICILLIN/CLAVULANIC ACID VIATRIS 875/125 mg FILM-COATED TABLETS

Introduction

Patient Information Leaflet

Amoxicillin/Clavulanic Acid Viatris 875 mg/125 mg film-coated tablets EFG

Read the entire leaflet carefully before starting to take this medicine, as 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 to you only, and you should not give it to others, even if they have the same symptoms, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet

1. What is Amoxicillin/Clavulanic Acid Viatris and what is it 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. Storage of Amoxicillin/Clavulanic Acid Viatris
6. Package contents and additional information

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

Amoxicillin/Clavulanic Acid Viatris is an antibiotic that eliminates the bacteria that cause infections. It contains two different active substances called amoxicillin and clavulanic acid. Amoxicillin belongs to the 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 the flu or the common cold.

It is essential to 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 completing treatment, return it to the pharmacy for proper disposal. Do not throw medicines down the drain or in the trash.

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 taking 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 components of this medicine (listed in section 6).
• If you have ever had a severe allergic reaction (hypersensitivity) to any other antibiotic. This could include a skin rash or swelling of the face or throat.
• If you have ever had liver problems or jaundice (yellowing of the skin) when taking an antibiotic.

Do not take amoxicillin/clavulanic acid if you are included in any of the above points. Before starting treatment with amoxicillin/clavulanic acid, if you are unsure, consult your doctor or pharmacist.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Amoxicillin/Clavulanic Acid 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 whether you are affected by any of the above symptoms, 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, you may be prescribed a different formulation of amoxicillin/clavulanic acid or another medicine.

Symptoms to be aware of

Amoxicillin/Clavulanic Acid Viatris 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 to reduce the risk of problems. See "Symptoms to be aware of" in 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 about taking this medicine, as amoxicillin/clavulanic acid may alter the results of these 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.

• 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 to treat gout), 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, more blood tests will be needed.
• If you are taking methotrexate (a medicine used to treat cancer and severe psoriasis), penicillins may reduce the excretion of methotrexate and cause a potential increase in side effects.
• Amoxicillin/Clavulanic Acid Viatris may affect how mycophenolate mofetil (a medicine used to prevent organ rejection in transplant patients) works.

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 taking this medicine.

Driving and using machines

Amoxicillin/Clavulanic Acid Viatris may have side effects, and the symptoms may make you unfit to drive. Do not drive or operate machinery unless you feel well.

Amoxicillin/Clavulanic Acid Viatris contains sodium

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

3. How to take Amoxicillin/Clavulanic Acid Viatris

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

Adults and children over 40 kg

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

Children under 40 kg

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

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 whole with a glass of water.
• The score line is only to facilitate breaking the tablet if you find it difficult to swallow whole.
• 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 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 more amoxicillin/clavulanic acid than you should, symptoms such as stomach upset (nausea, vomiting, or diarrhea) or seizures may occur. Consult your doctor as soon as possible. Take the package with you to show the doctor. You can also call the Toxicology Information Service, phone 91 562 04 20, 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 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 surviving bacteria may cause the infection to return.

If you have any further questions about the use of this medicine, 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:

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

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 pancreatitis

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

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

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

• Diarrhea (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 acid before meals.

• Vomiting.
• Diarrhea (in children).

Uncommon(may affect up to 1 in 100 people)

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

• Skin rash, which can form blisters that look like small targets (central dark spot surrounded by a paler area, with a dark ring around the edge - erythema multiforme).

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

Rare 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).
• Inflammation of the large intestine (see above).
• Inflammation of the protective 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 the body surface - toxic epidermal necrolysis).
• Widespread red rash with small blisters containing pus (bullous exfoliative dermatitis).
• Red rash with bumps under the skin and blisters (pustular exanthematous eruption).
• Flu-like symptoms with skin rash, fever, gland inflammation, 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 usually observed on both sides of the buttocks, on the upper inner thighs, in the armpits, and on the neck (Symmetrical Drug-Related Intertriginous and Flexural Exanthema (SDRIFE)).

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

• Rash with blisters arranged in a circle with a central crust or like a necklace (linear IgA disease).
• Liver inflammation (hepatitis).
• Jaundice, caused by increased 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.
• Delayed blood clotting.
• Hyperactivity.
• Seizures (in patients taking high doses of amoxicillin/clavulanic acid or with kidney problems).
• Black hairy tongue.

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

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

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System: 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 this medicine out of the sight and reach of children.

Do not store above 25°C. Store in the original packaging to protect from light and moisture.

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

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

6. Package contents and additional information

Composition of Amoxicillin/Clavulanic Acid Viatris

• The active substances are amoxicillin trihydrate and potassium clavulanate. Each film-coated tablet contains 1.005 mg of amoxicillin trihydrate, equivalent to 875 mg of amoxicillin, and 149 mg of potassium clavulanate, equivalent to 125 mg of clavulanic acid.
• The other ingredients (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 package contents

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

Al/PVC/Al blisters.

Available in packs of 20, 30, or 500 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

General Aranaz Street, 86

28027 - Madrid

Spain

Manufacturer:

Sandoz GmbH

Biochemiestrasse, 10

6250 - Kundl

Austria

Date of last revision of this leaflet:October 2024

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