AMOXICILLIN/CLAVULANIC ACID SANDOZ 100 mg/mL + 12.5 mg/mL ORAL SUSPENSION POWDER

Introduction

Package Leaflet: Information for the Patient

Amoxicillin/Clavulanic Acid Sandoz 100 mg/ml + 12.5 mg/ml Powder for Oral Suspension EFG

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication is normally prescribed to infants and children, and should not be given to others even if they have the same symptoms as your child, as it may harm them.
• If your child experiences side effects, consult your doctor, pharmacist, or nurse, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What Amoxicillin/Clavulanic Acid Sandoz is and what it is used for
2. What you need to know before taking Amoxicillin/Clavulanic Acid Sandoz
3. How to take Amoxicillin/Clavulanic Acid Sandoz
4. Possible side effects
5. Storage of Amoxicillin/Clavulanic Acid Sandoz
6. Package Contents and Additional Information

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

Pharmaceutical form: Combination of penicillins, including beta-lactamase inhibitors, ATC code: J01CR02.

Amoxicillin/Clavulanic Acid is an antibiotic that eliminates bacteria that cause infections. It contains two different medications called amoxicillin and clavulanic acid. Amoxicillin belongs to a group of medications known as "penicillins" that can sometimes lose their effectiveness (become inactivated). The other medication (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 common cold.

It is essential to follow the instructions regarding dosage, administration, and treatment duration indicated by your doctor.

Do not store or reuse this medication. If you have any leftover antibiotic after completing treatment, return it to the pharmacy for proper disposal. Do not throw medications down the drain or in the trash.

Amoxicillin/Clavulanic Acid 100 mg/ml + 12.5 mg/ml powder for oral suspension is used in infants and children for the treatment of 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 taking Amoxicillin/Clavulanic Acid Sandoz

Do not administer Amoxicillin/Clavulanic Acid Sandoz to your child:if they are allergic (hypersensitive) to amoxicillin, clavulanic acid, penicillins, or any of the other components of this medication (listed in section 6),

• if they have ever had a severe allergic reaction (hypersensitivity) to any other antibiotic. This could include skin rash or swelling of the face or neck,
• if they have ever had liver problems or jaundice (yellowing of the skin) when taking an antibiotic.

Do not give Amoxicillin/Clavulanic Acid Sandoz to your child if any of the above applies.

Before starting treatment with this medication, if you are unsure, consult your child's doctor, pharmacist, or nurse.

Warnings and Precautions

Consult your child's doctor or pharmacist before administering amoxicillin/clavulanic acid to the child, if the child:

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

If you are unsure whether any of the above symptoms affect your child, inform your doctor or pharmacist before administering amoxicillin/clavulanic acid to your child.

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 dose of amoxicillin/clavulanic acid or another medication.

Symptoms to be aware of

Amoxicillin/Clavulanic Acid may worsen certain existing conditions or cause severe side effects. These include allergic reactions, seizures, and inflammation of the large intestine. You should be aware of certain symptoms while your child is taking this medication to reduce the risk of problems. See "Symptoms to be aware of"in section 4.

Blood and urine tests

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

Other medications and Amoxicillin/Clavulanic Acid Sandoz

Inform your doctor or pharmacist if your child is using, has recently used, or may need to use any other medication, including those purchased without a prescription and herbal medicines.

If your child is taking allopurinol (for the treatment of gout) with amoxicillin/clavulanic acid, they may be more likely to have an allergic skin reaction.

If your child is taking probenecid (used to treat gout), concomitant use of probenecid may reduce the excretion of amoxicillin and is not recommended; your doctor may adjust the dose of amoxicillin/clavulanic acid.

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 medication used to treat cancer and severe psoriasis), as penicillins may reduce the excretion of methotrexate and cause a potential increase in side effects.

Amoxicillin/Clavulanic Acid may affect the functioning of mycophenolate mofetil (a medication used to prevent organ rejection in transplant patients).

Pregnancy and Breastfeeding

This subsection does not apply to Amoxicillin/Clavulanic Acid Sandoz, as this medication is intended for use in children weighing less than 40 kg; however, the following information applies to the active ingredients, amoxicillin/clavulanic acid.

Pregnancy

This medication should only be used during pregnancy under the advice of your doctor. If you discover that you are pregnant during treatment, consult your doctor, as only they can decide whether you should continue.

An increased risk of intestinal inflammation (enterocolitis) has been observed in neonates in women with imminent childbirth who receive amoxicillin/clavulanic acid.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Breastfeeding

Breastfeeding is possible when taking this medication. If your newborn develops problems such as diarrhea, skin rash, or candidiasis (a condition caused by certain microscopic fungi), inform your doctor immediately, who will advise you on what to do, as these effects in your child may be due to this medication.

Driving and Using Machines

This subsection does not apply to Amoxicillin/Clavulanic Acid Sandoz, as this medication is intended for use in children weighing less than 40 kg; however, the following information applies to the active ingredients, amoxicillin/clavulanic acid.

This medication may cause side effects, whose symptoms may affect your ability to drive. Do not drive a vehicle or operate machinery unless you feel perfectly well.

Amoxicillin/Clavulanic Acid Sandoz contains 3 mg of aspartame in each ml of reconstituted solution

Aspartame contains a source of phenylalanine that may be harmful in case of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it properly.

Amoxicillin/Clavulanic Acid Sandoz contains maltodextrin (a source of glucose)

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication. It may be harmful to teeth.

Amoxicillin/Clavulanic Acid Sandoz contains potassium

This medication contains 0.68 mg of potassium per dose, i.e., 2.5 mg per ml of oral suspension, which should be taken into account in patients with renal insufficiency or in patients with low-potassium diets.

3. How to take Amoxicillin/Clavulanic Acid Sandoz

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

Dosage

Adults and children weighing 40 kg or more

It is not normally recommended for adults and children weighing more than 40 kg. Consult your doctor or pharmacist.

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 to give to your baby or child.
• You will be provided with a plastic dosing syringe. You should use it to give the correct dose to your baby or child.
• The recommended dose is 40 mg/5 mg to 80 mg/10 mg per kilogram of body weight per day, administered in three divided doses.

Patients with kidney and liver problems

• If your child has kidney problems, the dose may be reduced. Your doctor may choose a different presentation or medication.
• If your child has liver problems, they will have more frequent blood tests to check how their liver is functioning.

How to administer Amoxicillin/Clavulanic Acid Sandoz

Oral route.

Administer the medication to your child preferably at the start of a meal or a little before.

As soon as you add water and between uses, keep the bottle refrigerated.

Shake the bottle well before each use.

It is administered using an oral syringe graduated in kg of body weight.

Distribute the doses evenly throughout the day, with at least 4 hours between them. Do not administer 2 doses in 1 hour.

Do not give amoxicillin/clavulanic acid to your child for more than 2 weeks. If your child's symptoms persist, consult a doctor again.

INSTRUCTIONS FOR USE OF THE ORAL SYRINGE

The dose amount is indicated on the plunger of the oral syringe, graduated in kg, according to the child's weight. Therefore, the dose can be read directly from the syringe graduations. The indicated weight corresponds to a single dose. It should be taken three times a day.

For example, the 20 graduation corresponds to the amount to be administered per dose to a child weighing 20 kg, three times a day.

For the first use

1. Fill with non-carbonated water up to the fill level. Shake well to obtain a homogeneous liquid. Refill with water if necessary.
2. Insert the oral syringe into the bottle.
3. Pull the plunger up to the graduation corresponding to the child's weight. Read the weight in kg on the neck of the syringe. Remove the syringe from the bottle to administer. Note: do not pull the plunger again.
4. Place the medication directly into the child's mouth or with a spoon.
5. After each use, rinse the oral syringe well with water. Close the bottle carefully after each use.
6. Return the bottle to the refrigerator after each use.

For each new use

1. Shake the bottle well before each use.
2. Repeat steps 2 to 6 (see above).

3 doses per day.

For this antibiotic to be effective, it must be used regularly in the prescribed doses and for the duration indicated by your doctor.

The disappearance of fever or any other symptom does not mean that your child is completely cured. Any feeling of fatigue is not due to the antibiotic treatment but to the infection itself. Reducing or suspending your child's treatment would have no effect on this feeling and would delay your child's recovery.

If you administer more Amoxicillin/Clavulanic Acid Sandoz than you should

If you give your child too much amoxicillin/clavulanic acid, symptoms such as stomach upset (nausea, vomiting, or diarrhea) or seizures may occur. Consult your child's doctor as soon as possible. Bring the bottle to show the doctor.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to administer amoxicillin/clavulanic acid to your child

If you forget to give your child a dose, give it as soon as you remember. Wait at least 4 hours before giving the next dose. Do not give a double dose to make up for forgotten doses.

If your child stops treatment with amoxicillin/clavulanic acid

Continue administering amoxicillin/clavulanic acid to your child until the treatment is finished, even if they feel better. All doses are important to combat the infection. If some bacteria survive, they could cause a recurrence of the infection.

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

The following adverse effects may occur with this medicine:

Symptoms to which you should pay attention

Allergic reactions:

• skin rash,
• inflammation of the blood vessels (vasculitis) that may appear as red or purple spots on the skin, but 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 causes difficulty breathing
• sudden discomfort with a drop in blood pressure,
• chest pain in the context of allergic reactions, which can be a symptom of an allergy-triggered heart attack (Kounis syndrome).

Contact your doctor immediately if your child experiences any of these symptoms.

Stop administering amoxicillin/clavulanic acid.

Colitis

Inflammation of the colon, 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.

Drug-induced enterocolitis syndrome (DIES)

DIES has been reported mainly in children who receive amoxicillin/clavulanic acid. It is a certain type of allergic reaction with the main symptom of repeated vomiting (1 to 4 hours after administering the medicine). Other symptoms may include abdominal pain, lethargy, diarrhea, and low blood pressure.

Contact your doctor as soon as possible for adviceif your child has these symptoms.

Very common adverse effects

May affect more than 1 in 10 people:

• diarrhea (in adults).

Common adverse effects

May affect up to 1 in 10 people:

• thrush (caused by a fungus, Candida, that causes infections in the vagina, mouth, or mucous membranes),
• nausea, especially when taking high doses,

If your child experiences these adverse effects, administer Amoxicillin/Clavulanic acid Sandoz before meals

• vomiting,
• diarrhea (in children).

Uncommon adverse effects

May affect up to 1 in 100 people:

• skin rash, itching,
• increased pruritic rash (urticarial wheal),
• indigestion,
• dizziness,
• headache.

Uncommon adverse effects that may appear in blood tests

• increase in some substances (enzymes) produced by the liver.

Rare adverse effects

May affect up to 1 in 1,000 people:

• skin rash, which can form blisters that look like small targets (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 your doctor urgently.

Rare adverse effects that may appear in blood tests

• low count of cells involved in blood clotting (platelets),
• low count of white blood cells.

Frequency not known

Cannot be estimated from the available data.

• allergic reactions (see above),
• colitis (see above),
• inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis),
• severe skin reactions:
• • widespread rash 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 (more than 30% of the body surface – toxic epidermal necrolysis),
  • widespread rash with small blisters with pus (bullous exfoliative dermatitis),
  • red rash with bumps under the skin and blisters (pustular exanthematous)
• 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)).
• rash with blisters arranged in a circle with a central crust or like a necklace (linear IgA disease),

Contact your doctor immediately for adviceif your child has these symptoms.

• liver inflammation (hepatitis),
• jaundice, caused by an increase in bilirubin in the blood (a substance produced by the liver) that 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 Augmentine or with kidney problems),
• black hairy tongue,
• spots on the teeth (in children), which usually disappear with brushing.

Adverse effects that may appear in 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 of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Amoxicillin/Clavulanic acid Sandoz

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiration date that appears on the packaging and blister after CAD/EXP. The expiration date is the last day of the month indicated.

Before reconstitution:

Do not store at a temperature above 30 °C.

After reconstitution:

The suspension can be stored for a maximum of 7 days at a temperature between 2 °C and 8 °C (in the refrigerator).

After opening the cap, make sure the inner seal of the bottle is intact and firmly attached to the edge. Do not use it if it is not intact.

Do not use this medicine if powder aggregates are visible in the vial before reconstitution.

Do not use the reconstituted suspension if the color is not off-white.

Do not use this medicine if you notice a change in the color of the suspension after reconstitution. This is due to non-compliance with the special precautions for storing the reconstituted suspension: this change indicates a loss of medicine activity.

IT IS ESSENTIAL IN THIS CASE TO USE A NEW BOTTLE.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Amoxicillin/Clavulanic acid Sandoz 100 mg/ml + 12.5 mg/ml powder for oral suspension EFG

• The active ingredients are: amoxicillin 100 mg in the form of amoxicillin trihydrate and clavulanic acid 12.5 mg in the form of potassium clavulanate per ml of reconstituted suspension.
• The other ingredients (excipients) are: succinic acid, xanthan gum, anhydrous colloidal silica, aspartame (E951), aroma E99-294-55 (contains maltodextrin = glucose), hydrated colloidal silica.

Appearance of the product and package contents

This medicine is presented in the form of powder for oral suspension in a bottle [10.5 g of powder is equivalent to 60 ml of reconstituted oral suspension, i.e., 224 dose graduations (1 dose = 1 kg)] with an oral syringe for administration.

Marketing authorization holder and manufacturer

Marketing authorization holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Sandoz GmbH

Biochemiestrasse, 10

6250 Kundl

Austria

or

SANDOZ S.A.S.,

49 Av. Georges Pompidou,

92300 Levallois-Perret

France

Date of the last revision of this prospectus: March 2024

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