Amoxicillin/clavulanic acid Viatris 875/125 mg film-coated tablets EFG

Package leaflet: Information for the patient

Introduction

Package leaflet: information for the patient

Amoxicillin/Clavulanic Acid Viatris 875 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 effects 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 Amoxicilina/Ácido clavulánico Viatris is and what it is used for

Amoxicilina/Ácido clavulánico Viatris is an antibiotic that kills bacteria causing infections. It contains two different medicines called amoxicillin and clavulanic acid. Amoxicillin belongs to a group of medicines known as “penicillins”, which sometimes may 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 your doctor's instructions regarding dose, dosing interval, and duration of treatment.

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. Do not dispose of medicines via wastewater or household waste.

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

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Amoxicillin/Clavulanic Acid Viatris 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.

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 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 to reduce the risk of complications. See "Symptoms to watch for" in 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 this medicine, as amoxicillin/clavulanic acid may alter the results of these tests.

Other medicines and Amoxicillin/Clavulanic Acid Viatris

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

• If you are taking allopurinol (used for gout) with amoxicillin/clavulanic acid, you may be more likely to develop a skin allergic reaction.
• If you are taking probenecid (used to treat gout), concomitant use with probenecid may reduce the excretion of amoxicillin and is not recommended.
• If anticoagulants (such as warfarin) are taken 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 methotrexate excretion and potentially increase adverse effects.
• Amoxicillin/clavulanic acid 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 are planning to become pregnant, consult your doctor or pharmacist before taking this medicine.

Driving and using machines

Amoxicillin/clavulanic acid may cause adverse effects, and symptoms may mean you should not 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; essentially "sodium-free".

3. How to take Amoxicillin/Clavulanic Acid Viatris

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If you are unsure, consult your doctor or pharmacist again.

Adults and children weighing 40 kg or more

• Usual dose: 1 tablet taken twice daily.
• Higher dose: 1 tablet taken three times daily.

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.

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 whole with a glass of water.
• The tablet score line is intended only for breaking the tablet if you have difficulty swallowing it whole.
• 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 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 more amoxicillin/clavulanic acid than you should, 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 91 562 04 20, stating 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 for the full duration of 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 medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience 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 or may 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), causing difficulty breathing.
• Collapse.
• Chest pain in the context of allergic reactions, which may be a heart attack syndrome triggered by allergy (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 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 immediately if you experience any of these symptoms. Stop taking amoxicillin/clavulanic acid.

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.

Contact your doctor as soon as possible so they can advise you 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 itchy rash (urticarial wheal).
• Indigestion.
• Dizziness.
• Headache.

Uncommon adverse effects that may appear in your blood tests:

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

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

• Skin rash that may blister and resemble small targets (a dark central spot surrounded by a paler area, with a dark ring around the edge – erythema multiforme).

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

Rare adverse effects that may appear in your blood tests:

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

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 blistering and peeling rash, 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 body surface – toxic epidermal necrolysis).

• Generalized red rash with small pus-filled blisters (exfoliative bullous dermatitis).

• Exfoliative red rash with bumps under the skin and blisters (pustular exanthem).

• Flu-like symptoms with skin rash, fever, swollen glands, 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 typically seen on both sides of the buttocks, upper inner thighs, armpits, and 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 ring with a central crust or resembling a string of pearls (IgA linear dermatosis).
• 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 kidney tubules.
• Delayed blood clotting.
• Hyperactivity.
• Seizures (in patients taking high doses of amoxicillin/clavulanic acid or who have kidney problems).
• Black, hairy-looking tongue.

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

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may 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 this medicine out of sight and reach of children.

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

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

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your 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 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 components (excipients) are: colloidal anhydrous 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 medicinal product and contents of the pack

Film-coated, oblong, scored tablets of white to pale yellow colour.

Al/PVC/Al blisters.

Pack sizes of 20, 30 or 500 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 - Madrid

Spain

Manufacturer:

Sandoz GmbH

Biochemiestrasse, 10

6250 - Kundl

Austria

Date of the most recent revision of this leaflet: October 2024

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