Amoxicillin/clavulanic acid Viatris 250 mg/5ml + 62.5 mg/5 ml powder for oral suspension EFG

Package leaflet: Information for parents or caregivers of children

Introduction

Package leaflet: Information for the user

Amoxicillin/Clavulanic acid Viatris 250 mg/5 ml + 62.5 mg/5 ml powder for oral suspension EFG

Read the entire leaflet carefully before your child starts taking 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, 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 may 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 your child takes 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 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 active substances called amoxicillin and clavulanic acid. Amoxicillin belongs to a group of medicines known as "penicillins," which can sometimes become ineffective (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 flu or the common cold.

It is important that you follow your doctor's instructions regarding dosage, 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.

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

• Middle ear infections 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 starting Amoxicillin/Clavulanic Acid Viatris

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

• If he or she is allergic to amoxicillin, clavulanic acid, penicillin, or any of the other components of this medicine (see section 6).
• If he or she has ever had a serious allergic reaction to any other antibiotic. This could include a skin rash or rapid swelling of the face, lips, mouth, tongue, or throat.
• If he or she has 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

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

• He or she has infectious mononucleosis.
• He or she is receiving treatment for liver or kidney problems.
• He or she does not urinate regularly.

If you are unsure whether any of the above symptoms affect 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 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 problems. 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 he or she is 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, he or she 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 potentially increase 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 going to take this medicine and 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, he or she must not drive or ride a bicycle and should not use tools or machinery.

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

Per 5 ml dose, 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 of intolerance to certain sugars (such as glucose, dextrose, and maltodextrin), consult with him 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 (called “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 (called “metabolic acidosis”).

Rarely, 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 provided by your doctor or pharmacist when taking this medicine. If you are unsure, consult your doctor or pharmacist.

Use in adults and children weighing 40 kg or more

• This medicine is not normally 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 based on 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 this to give the correct dose to your baby or child.
• Recommended dose – 20 mg/5 mg to 60 mg/15 mg per kilogram of body weight per day, given 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 administer 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 administer Amoxicillin/Clavulanic Acid Viatris to your child for longer than two weeks. If your child still feels unwell, you should see the 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 diarrhoea), 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 medicine container to show the doctor. You may also call the Toxicology Information Service at telephone number 915620420, stating the medicine and the amount ingested.

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 eliminate 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 (pustular exanthem).
• 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 observed 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 mainly been reported 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, with 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 short of breath with pale skin, which may be caused by a low number of red blood cells (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 the number of white blood cells.

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 high doses are taken.

→ 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 weals).
• 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 central spot 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 circle with central crusting 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 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.

Before reconstitution: Do not store above 25°C.

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

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 must 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 container and other information

Composition of Amoxicillin/Clavulanic Acid Viatris

The active substances are amoxicillin and clavulanic acid.

• 5 ml contain 250 mg of amoxicillin, corresponding to 287 mg of amoxicillin trihydrate, and 62.5 mg of clavulanic acid, corresponding to 74.45 mg of potassium clavulanate.
• Other components are: anhydrous citric acid, anhydrous trisodium citrate, aspartame (E-951), talc, guar gum, anhydrous silicon dioxide, lemon flavour (contains glucose (dextrose), sorbitol (E-420), benzyl alcohol, sulfur dioxide (E-220) and sodium), peach-apricot flavour (contains sorbitol (E-420), benzyl benzoate, sulfur dioxide (E-220), benzyl alcohol and sodium), and orange flavour (contains 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".

Appearance of the product and contents of the container

Colourless oral suspension powder.

Bottle containing powder to prepare 60 ml of oral suspension.

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

Bottle containing powder to prepare 80 ml of oral suspension.

Bottle containing powder to prepare 100 ml of oral suspension.

Bottle containing powder to prepare 120 ml of oral suspension.

Only some container 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 by contacting 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 250/62.5 mg

Spain Amoxicillin/Clavulanic Acid Viatris 250 mg/5 ml + 62.5 mg/5 ml powder for oral suspension EFG

Date of latest review of this leaflet: September 2025

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (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 bottle rim. 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 or almost white.

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

Shake the bottle well before administering each dose.