Package Leaflet: Information for the Patient

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

Read this package leaflet carefully before you start taking this medicine because 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 medicine is normally prescribed for infants and 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 not listed in this package leaflet. See section 4.

Pharmacotherapeutic group: Combination of penicillins, including beta-lactamase inhibitors, ATC code: J01CR02.

Amoxicilina/Ácido clavulánico is an antibiotic that eliminates bacteria that cause infections. It contains two different medicines called amoxicilina and ácido clavulánico. Amoxicilina belongs to a group of medicines known as “penicillins” that sometimes may lose its effectiveness (become inactive). The other medicine (ácido clavulánico) prevents this from happening.

Amoxicilina/Ácido clavulánico100 mg/ml + 12.5 mg/ml powder for oral suspensionis 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.

Do not administer Amoxicilina/Ácido clavulánico Sandoz to your child:if he is allergic (hypersensitive) to amoxicilina, ácido clavulánico, penicilinas or to any of the other components of this medication (listed in section 6),

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

Do not give Amoxicilina/Ácido clavulánico Sandoz to your child if any of the above points apply.

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 amoxicilina/ácido clavulánico 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 child's doctor or pharmacist before administering amoxicilina/ácido clavulánico to your child.

In some cases, your child's doctor may investigate the type of bacteria causing the infection in your child. Depending on the results, your child may receive a different dose of amoxicilina/ácido clavulánico or another medication.

Symptoms to be aware of

Amoxicilina/ácido clavulánico may worsen existing conditions or cause severe side effects. These include allergic reactions, convulsions and inflammation of the large intestine. 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 studies of red blood cell status or studies to check liver function) or urine tests (to control glucose levels), inform your child's doctor or nurse that your child is taking amoxicilina/ácido clavulánico. This is because this medication may alter the results of these types of tests.

Other medications andAmoxicilina/Ácido clavulánico Sandoz

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

If your child is taking allopurinol (for the treatment of gout) with amoxicilina/ácido clavulánico, it may be more likely that he will have a skin allergic reaction.

If your child is taking probenecid (used to treat gout), concurrent use of probenecid may reduce amoxicilina excretion and is not recommended,your child's doctor may adjust the dose ofamoxicilina/ácido clavulánico.

If amoxicilina/ácido clavulánico is taken with anticoagulants (such as warfarin), more blood tests will be required.

Amoxicilina/ácido clavulánico may affect the action of methotrexate (a medication used to treat cancer and severe psoriasis), penicilinas may reduce methotrexate excretion and cause a potential increase in side effects.

Amoxicilina/ácido clavulánico may affect the functioning of micofenolato de mofetilo (a medication to prevent organ rejection in transplant patients).

Pregnancyandbreastfeeding

This subheading does not apply to Amoxicilina/Ácido clavulánico Sandoz as this medication is intended to be used in children weighing less than 40 kg; however, the following information applies to the active ingredients, amoxicilina/ácido clavulánico.

Pregnancy

This medication should only be used during pregnancy on the advice of your child's doctor. If you discover that you are pregnant during treatment, consult your child's doctor, as only they or she can decide whether to continue.

A higher risk of intestinal inflammation (enterocolitis) has been observed in newborns in women at risk of imminent delivery who receive amoxicilina/ácido clavulánico.

If you are pregnant or breastfeeding, believe you may be pregnant or intend to become pregnant, consult your child's doctor or pharmacist before using this medication.

Breastfeeding

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

Driving and operating machinery

This subheading does not apply to Amoxicilina/Ácido clavulánico Sandoz as this medication is intended to be used in children weighing less than 40 kg; however, the following information applies to the active ingredients, amoxicilina/ácido clavulánico.

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.

Amoxicilina/Ácido clavulánico Sandozcontains 3 mg of aspartamo in each ml of reconstituted solution

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

Amoxicilina/Ácido clavulánico Sandoz contains maltodextrin (glucose source)

If your child's doctor has indicated that he has an intolerance to certain sugars, consult with him before taking this medication. It may harm the teeth.

Amoxicilina/Ácido clavulánico Sandozcontains potassium

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

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, 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 in relation to the child's body weight in kilograms.

• Your doctor will advise you how much amoxicillin/clavulanic acid to give to your baby or child.
• You will be provided with a plastic syringe dosifier. You must 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 another medication.
• If your child has liver problems, blood tests will be performed more frequently to check how their liver is functioning.

How to administerAmoxicillin/Clavulanic Acid Sandoz

Oral route.

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

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

Shake the bottle before each use.

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

Distribute the doses uniformly throughout the day, with at least 4 hours of difference. Do not administer 2 doses in 1 hour.

Do not administer 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

For the first use

1.Fill with non-carbonated water up to the filling level. Shake well to obtain a homogeneous liquid. Refill if necessary.

2.Insert the oral syringe into the bottle.

3.Pull the plunger until the graduation corresponding to the child's weight is reached. Read the weight in kg on the syringe's neck. Remove the syringe from the bottle to administer it. Note: do not pull the plunger again.

4.Place the medication directly in the child's mouth or with a spoon.

5.After each use, thoroughly rinse the oral syringe with water. Close the bottle carefully after each use.

6.Return the bottle to the refrigerator after each use.

With each new use

1.Shake the bottle well before each use.

2.Repeat steps 2 to 6 (above).

3 doses a day.

For this antibiotic to be effective, it must be used regularly in the prescribed doses and for the time 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 will have no effect on this feeling and will delay your child's recovery.

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

If you administer too much amoxicillin/clavulanic acid to your child, symptoms such as stomach upset (nausea, vomiting, or diarrhea) or convulsions may appear. 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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

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

If you forget to administer 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 compensate for the missed doses.

If your child interrupts the treatment with amoxicillin/clavulanic acid

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

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

The following side effects may occur with this medicine:

Symptoms to be aware of

Allergic reactions:

• skin rash,
• inflammation of 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 lymph nodes in the neck, armpits, or groin,
• swelling, sometimes of the face or throat (angioedema), which causes difficulty breathing
• sudden feeling of illness with a drop in blood pressure,
• chest pain in the context of allergic reactions, which can be a symptom of an allergic-induced heart attack (Kounis syndrome).

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

Stop administering amoxicillin/clavulanic acid.

Colitis

Colitis, which causes watery diarrhea, usually with blood and mucus, stomach pain, and/or fever.

Acute pancreatitis

If you have intense 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 taking amoxicillin/clavulanic acid. It is a certain type of allergic reaction with the main symptom of repeated vomiting (1-4 hours after administering the medication). Other symptoms may include abdominal pain, lethargy, diarrhea, and low blood pressure.

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

Very common side effects

May affect more than 1 in 10 people:

• diarrhea (in adults).

Common side effects

May affect up to 1 in 10 people:

• mouth ulcers (caused by a fungus, candida, which causes infections in the vagina, mouth, or mucous membranes),
• nausea, especially when taking high doses,

If your child experiences these side effects, administer Amoxicilina/Acido clavulánico Sandoz before meals:

• vomiting,
• diarrhea (in children).

Uncommon side effects

May affect up to 1 in 100 people:

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

Uncommon side effects that may appear in blood tests

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

Rare side effects

May affect up to 1 in 1,000 people:

• skin eruption, which may form blisters that appear as small dots (central dark spot surrounded by a lighter area, with a dark ring around the edge – erythema multiforme),

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

Rare side effects that may appear in blood tests

• low platelet count,
• low white blood cell count.

Frequency not known

Cannot be estimated from available data.

• allergic reactions (see above),
• colitis (see above),
• inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis),
• severe skin reactions:
• • generalized 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 (toxic epidermal necrolysis),
  • generalized rash with small blisters with pus (exfoliative bullous dermatitis),
  • red rash, with bumps under the skin and blisters (pustular exanthem)
• flu-like symptoms with skin rash, fever, swollen lymph nodes, and abnormal blood test results (such as increased eosinophils and elevated liver enzymes) (drug reaction with eosinophilia and systemic symptoms (DRESS)).
• skin rash with blisters arranged in a circle with a central crust or like a string of pearls (IgA linear disease),

Contact your doctor immediately for advice if your child has these symptoms.

• inflammation of the liver (hepatitis),
• jaundice, caused by increased bilirubin in the blood (a substance produced by the liver) that can make the skin and white of the eyes yellow,
• inflammation of the kidney tubules,
• delayed blood clotting,
• hyperactivity,
• seizures (in patients taking high doses of Augmentine or with kidney problems),
• black tongue that appears hairy,
• spots on the teeth (in children), which usually disappear with brushing.

Side effects that may appear in blood or urine tests

• significant reduction in white blood cell count,
• low red blood cell count (hemolytic anemia),
• crystals in the urine that cause acute kidney damage.

Reporting side effects

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

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

Do not use this medication after the expiration date that appears on the packaging and the blister pack 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 rim. Do not use it if it is not intact.

Do not use this medication if the 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 medication if you observe 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 medication activity.

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

Medicines should not be disposed of through the drains or in the trash. Dispose of the packaging and medications that you do not need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications that you do not need. In this way, you will help protect the environment.

Composition ofAmoxicilina/Ácido clavulánico Sandoz100 mg/ml + 12,5 mg/ml powder for oral suspension EFG

• The active ingredients are: amoxicilina 100 mg in the form of amoxicilina trihydrate and ácido clavulánico 12,5 mg in the form of clavulanato potásico per each ml of reconstituted suspension.
• The other components (excipients) are: ácido succínico, goma xantán, sílice coloidal anhidra, aspartamo (E951), aroma E99-294-55 (contains maltodextrina = glucosa), sílice coloidal hidratada.

Appearance of the product and contents of the package

This medicine is presented in the form of powder for oral suspension ina bottle [10,5 g of powder is equivalent to 60 ml of oral suspension reconstituted, that is, 224 graduations of dose (1 dose = 1 ml)] with an oral administration syringe.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible for manufacturing

Sandoz GmbH

Biochemiestrasse, 10

6250 -Kundl

Austria

or

SANDOZ S.A.S.,

49 Av. Georges Pompidou,

92300 Levallois-Perret

France

Last review date of this leaflet: March 2024

The detailed information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es.