Amoxicillin/clavulanic acid Viatris 125 mg/5 mg +31.25 mg/5 ml powder for oral suspension EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet: Information for Parents or Caregivers of Children

Amoxicillin/Clavulanic Acid Viatris 125 mg/5 ml + 31.25 mg/5 ml powder for oral suspension EFG

Read the entire leaflet carefully before starting 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, consult your doctor, pharmacist, or nurse.
• This medicine is usually prescribed only for infants or children and should not be given to other people, even if they have the same symptoms as your child, as it could harm them.
• If your child experiences any side effects, consult your doctor, pharmacist, or nurse, even if they are side 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 administer 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 Amoxicillin/Clavulanic Acid Viatris is and what it is used for

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

It is important that you follow the instructions regarding dose, dosing interval, and duration of treatment as directed by your doctor.

Do not store or reuse this medicine. If you have leftover antibiotic after completing the treatment, return it to the pharmacy for proper disposal. Do not dispose of medicines via the sink or in household waste.

Amoxicillin/clavulanic acid is used in infants and children to treat the following infections:

• Middle ear and paranasal 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 starting Amoxicillin/Clavulanic Acid Viatris

Do not give Amoxicillin/Clavulanic Acid Viatris to your child:

• If they are allergic to amoxicillin, clavulanic acid, penicillin, or any of the other ingredients of this medicine (see section 6).
• If they have ever had a severe allergic reaction to any other antibiotic. This could include a skin rash or rapid swelling of the face, lips, mouth, tongue, or throat.
• If they have ever had liver problems or jaundice (yellowing of the skin) while taking this antibiotic.

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

Warnings and precautions

Tell your doctor, pharmacist, or nurse before starting to administer this medicine to your child if:

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

If you are unsure whether any of the above conditions apply to your child, inform your doctor or pharmacist before taking amoxicillin/clavulanic acid.

In some cases, your doctor may investigate the type of bacteria causing your child's infection. Depending on the results, your child may receive a different formulation of amoxicillin/clavulanic acid or another medicine.

Symptoms to watch for

Amoxicillin/clavulanic acid may worsen certain pre-existing conditions or cause serious adverse effects. These include allergic reactions, seizures, and inflammation of the large intestine. You should watch for certain symptoms while your child is taking amoxicillin/clavulanic acid to reduce the risk of complications. See section 4.

Blood and urine tests

If your child is undergoing blood tests (such as studies of red blood cell status or tests to check liver function) or urine tests (to monitor glucose levels), inform your doctor or nurse that they are taking amoxicillin/clavulanic acid. This is because amoxicillin/clavulanic acid may alter the results of these types of tests.

Other medicines and Amoxicillin/Clavulanic Acid Viatris

Inform your doctor or pharmacist if your child is taking, has recently taken, or might need to take any other medicines, including those obtained without a prescription and herbal medicines.

If your child is taking allopurinol (used for gout) with amoxicillin/clavulanic acid, they may be more likely to develop a skin allergic reaction.

If your child is taking probenecid (used for gout), your doctor may adjust the dose of amoxicillin/clavulanic acid. Concomitant use of 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.

Amoxicillin/clavulanic acid may affect the action of methotrexate (a medicine used to treat cancer, severe psoriasis, or rheumatic diseases). Penicillins may reduce methotrexate excretion and cause a potential increase in adverse effects.

Amoxicillin/clavulanic acid may affect the function of mycophenolate mofetil (a medicine used to prevent rejection of transplanted organs).

Pregnancy and breastfeeding

If your daughter is pregnant or breastfeeding, thinks she may be pregnant, or plans to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

Amoxicillin/clavulanic acid may cause adverse effects such as allergic reactions, dizziness, and seizures. If this happens to your child, they must not drive or ride a bicycle and should avoid using tools or machinery.

Amoxicillin/Clavulanic Acid Viatris contains aspartame (E-951), glucose (dextrose), corn maltodextrin, sorbitol (E-420), benzyl alcohol, sulfur dioxide (E-220), benzyl benzoate, and sodium benzoate

Each 5 ml dose of this medicine contains 8.5 mg of aspartame, 1.8 mg of lemon flavour (containing glucose (dextrose), sorbitol, benzyl alcohol, and sulfur dioxide), 4.3 mg of peach-apricot flavour (containing sorbitol, benzyl benzoate, sulfur dioxide, and benzyl alcohol), and 20 mg of orange flavour (containing corn maltodextrin).

Aspartame is a source of phenylalanine. This may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot eliminate it properly.

If your doctor has advised you that you have an intolerance to certain sugars (such as glucose, dextrose, and maltodextrin), consult with them before taking this medicine.

Benzyl alcohol may cause allergic reactions. Benzyl alcohol has been associated with the risk of serious side effects, including breathing problems (known as “gasping syndrome”) in young children. Do not give it to your newborn baby (up to 4 weeks of age) unless recommended by your doctor. Do not use for more than one week in young children (under 3 years of age) unless recommended by your doctor or pharmacist. Seek advice from your doctor or pharmacist if you are pregnant, breastfeeding, or have liver or kidney disease. This is because large amounts of benzyl alcohol may accumulate in the body and cause side effects (known as “metabolic acidosis”).

In rare cases, sulfur dioxide may cause severe hypersensitivity reactions and bronchospasm.

Benzyl benzoate may increase jaundice (yellowing of the skin and eyes) in newborns (up to 4 weeks of age).

This medicine contains less than 23 mg of sodium (1 mmol) per tablet, which means it is essentially “sodium-free”.

3. How to take Amoxicillin/Clavulanic Acid Viatris

Always follow exactly the instructions given by your doctor or pharmacist. Consult your doctor or pharmacist if you have any doubts.

Use in adults and children weighing 40 kg or more

• This medicine is not usually recommended for adults and children weighing more than 40 kg.

Please seek advice from your doctor or pharmacist.

Use in children weighing less than 40 kg

All doses are expressed according to the child's body weight in kilograms.

• Your doctor will advise you on how much Amoxicillin/Clavulanic Acid Viatris to give your baby or child.
• A plastic dosing spoon will be provided. You must use it to give the correct dose to your baby or child.
• Recommended dose – from 20 mg/5 mg to 60 mg/15 mg per kilogram of body weight per day, administered in three divided doses.

Patients with kidney or liver problems

• If your child has kidney problems, the dose may be reduced. Your doctor may choose a different formulation or another medicine.
• If your child has liver problems, blood tests will be performed more frequently to monitor liver function.

How to take Amoxicillin/Clavulanic Acid Viatris

• Always shake the bottle well before each dose.
• Take with meals.
• Space the doses evenly throughout the day, at least 4 hours apart. Do not take two doses within one hour.
• Do not give Amoxicillin/Clavulanic Acid Viatris to your child for longer than two weeks. If your child still feels unwell, you should see your doctor again.

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

If you give your child too much amoxicillin/clavulanic acid, symptoms such as stomach upset (nausea, vomiting, or diarrhea), disturbances in fluid and electrolyte balance (muscle twitching or spasms, numbness, irregular heartbeat, or seizures), or amoxicillin crystalluria (crystals found in urine during urine tests) may occur. Contact your doctor as soon as possible. Bring the bottle with you to show the doctor. You may also call the Toxicology Information Service at 915620420, stating the name of the medicine and the amount taken.

If you forget to give Amoxicillin/Clavulanic Acid Viatris

If you forget to give your child a dose, give it as soon as you remember. Do not give the next dose too soon; wait at least 4 hours before giving the next dose.

Do not give a double dose to make up for a missed dose.

If your child stops taking Amoxicillin/Clavulanic Acid Viatris

Continue giving your child amoxicillin/clavulanic acid for the full duration of the treatment, even if they start to feel better.

Your child needs to complete the full course of treatment to help fight the infection. If bacteria survive, the infection may return.

If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them. The effects described below may occur with this medicine.

Contact a doctor immediately if your child experiences any of these symptoms. Stop giving amoxicillin/clavulanic acid:

Allergic reactions:

• Skin rash.
• Inflammation of blood vessels (vasculitis), which may appear as red or purple spots on the skin, but may affect other parts of the body.
• Fever, joint pain, swollen glands in the neck, armpits, or groin.
• Rapid swelling of the face, lips, mouth, tongue, or throat, which may cause difficulty swallowing or breathing (angioedema).
• Collapse.
• Chest pain in the context of allergic reactions, which may be a symptom of a heart attack triggered by allergy (Kounis Syndrome).

Serious 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 skin peeling (more than 30% of body surface area – toxic epidermal necrolysis).
• Widespread rash with small pus-filled blisters (exfoliative bullous dermatitis).
• Red rash with lumps under the skin and blisters (exanthematous pustulosis).
• Flu-like symptoms with skin rash, fever, swollen glands, and abnormal blood test results (including 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 (drug-related symmetric intertriginous and flexural exanthema (SDRIFE)).

Other possible serious adverse effects

• 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. -

Drug-induced enterocolitis syndrome (DIES):

• DIES has been reported mainly in children receiving amoxicillin/clavulanate. It is a 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.
• 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.
• Seizures (in patients taking high doses of amoxicillin/clavulanic acid or who have kidney problems).
• Severe headache, neck stiffness, abnormal sensitivity to light, feeling unwell, which may be caused by inflammation of the protective covering of the brain and spinal cord (aseptic meningitis).
• Feeling tired and breathless with pale skin, which may be caused by low red blood cell count (hemolytic anemia).
• Inflammation of the kidney tubules.
• Increased number of infections, such as sore throat, mouth ulcers, fever, which may be caused by a severe reduction in white blood cell count.

Contact your doctor as soon as possible so they can advise you if your child has these symptoms.

Other possible adverse effects

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 with food

• Vomiting.
• Diarrhea (in children).

Uncommon (may affect up to 1 in 100 people)

• Skin rash, itching.
• Increased itchy rash (urticarial wheals).
• Indigestion.
• Dizziness.
• Headache.

Uncommon adverse effects that may appear in blood tests:

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

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

• Skin rash, which may form blisters resembling small targets (dark center surrounded by a paler area, with a dark ring around the edge – erythema multiforme).

Rare adverse effects that may appear in blood tests:

• Low count of cells involved in blood clotting.

Frequency not known (cannot be estimated from available data)

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

• Delayed blood clotting.
• Hyperactivity.
• Black, hairy-looking tongue.
• Stained teeth (in children), which usually disappear with brushing.

-Rash with blisters arranged in a ring with a central crust or resembling a string of pearls (linear IgA disease).

Adverse effects that may appear in blood or urine tests:

• 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 can 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.

Before reconstitution: Do not store above 25°C.

After reconstitution: Store in the refrigerator (between 2°C and 8°C). Use within 7 days of reconstitution. Indicate the date of reconstitution on the carton and on the label of the bottle.

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

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

6. Contents of the pack and other information

Composition of Amoxicilina/Ácido clavulánico Viatris

The active substances are amoxicillin and clavulanic acid.

• 5 ml contain 125 mg of amoxicillin, corresponding to 143.5 mg of amoxicillin trihydrate, and 31.25 mg of clavulanic acid, corresponding to 37.23 mg of potassium clavulanate.
• The other components are: anhydrous citric acid, anhydrous trisodium citrate, aspartame (E-951), talc, guar gum, anhydrous silicon dioxide, lemon flavour (containing glucose (dextrose), sorbitol (E-420), benzyl alcohol, sulfur dioxide (E-220) and sodium), peach-apricot flavour (containing sorbitol (E-420), benzyl benzoate, sulfur dioxide (E-220), benzyl alcohol and sodium), and orange flavour (containing corn maltodextrin).

See section 2, "Amoxicillin/Clavulanic acid contains aspartame (E-951), glucose (dextrose), corn maltodextrin, sorbitol (E-420), benzyl alcohol, sulfur dioxide (E-220), benzyl benzoate and sodium".

Nature of the product and pack contents

Colourless oral suspension powder.

Bottle with powder to prepare 60 ml of oral suspension.

2 Bottles with powder to prepare 2 x 60 ml of oral suspension.

Bottle with powder to prepare 100 ml of oral suspension.

Bottle with powder to prepare 120 ml of oral suspension.

Only some 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 Ltd, t/a Gerard Laboratories,
35/36 Baldoyle Industrial Estate,
Grange Road,
Dublin – 13,
Ireland.

Further information on this medicinal product is available from the local representative of the Marketing Authorization Holder:

Viatris Pharmaceuticals, S.L.
C/ General Aranaz, 86
28027 - Madrid
Spain

This medicinal product is authorized in the EEA Member States under the following names:

Germany Amoxidura Plus Saft 125/31.25mg
Spain Amoxicilina/Ácido clavulánico Viatris 125 mg/5 ml + 31.25 mg/5 ml powder for oral suspension EFG

Date of the most recent review of this leaflet: September 2025

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

Reconstitution instructions

After opening the screw cap, ensure that the seal on the bottle cap is intact and securely attached to the rim of the bottle. Do not use if not intact. Shake the bottle to loosen any adhering powder. Add the volume of water (as indicated below), invert the contents and shake well. Do not use the reconstituted suspension if the colour is not white.

Alternatively, shake the bottle to loosen any adhering powder, then fill with water up to just below the mark on the bottle or label. Invert and shake well, then add water up to exactly the mark. Invert again and shake well.

Shake the bottle well before administering each dose.