Prospect: information for parents or caregivers of children

Amoxicillin/Clavulanate Sandoz 250 mg/62.5 mg/5 ml powder for oral suspension

EFG

Read this prospect carefully before starting to take the medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medicine is usually only prescribed for babies or children and should not be given to others

people, even if they have the same symptoms as your child, as it may harm them.

• If your child experiences any adverse effect, consult your doctor, pharmacist, or nurse, even if it is an adverse effect that does not appear in this prospect. See section 4.

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

2. What you need to know before starting to administer Amoxicillin/Clavulanate Sandoz

3. How to administer Amoxicillin/Clavulanate Sandoz

4. Possible adverse effects

5. Storage of Amoxicillin/Clavulanate Sandoz

6. Contents of the package and additional informationl

Amoxicilina/Ácido clavulánico Sandoz is an antibiotic that eliminates bacteria that cause infections.

It contains two different medications called amoxicilina and ácido clavulánico. Amoxicilina belongs to a group of medications known as “penicilinas” that sometimes may lose its effectiveness (become inactive). The other component (ácido clavulánico) prevents this from happening.

Amoxicilina/ácido clavulánico is used in babies 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 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 to any other antibiotic. This could include skin rash or rapid swelling in the face, lips, mouth, tongue or throat,
• 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

to him.Before starting treatment if you are unsure, consult with your doctor or pharmacist.

Warnings and precautions

Consult your doctor, pharmacist or nurse before starting to use amoxicilina/ácido clavulánico if:

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

If you are unsure whether any of the above symptoms affect your child, consult your doctor or pharmacist before taking amoxicilina/ácido clavulánico.

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

Be aware of the following symptoms

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 the following symptoms while your child is taking amoxicilina/ácido clavulánico 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 studies to check liver function) or urine tests (to control glucose levels), inform your doctor or nurse that your child is taking amoxicilina/ácido clavulánico. This is because amoxicilina/ácido clavulánico may alter the results of these types of tests.

Use of Amoxicilina/Ácido clavulánico Sandoz with other medications

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

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

Probenecid (used to treat gout), concomitant use of probenecid may reduce the excretion of amoxicilina and is not recommended.

If anticoagulants (such as warfarin) are taken with amoxicilina/ácido clavulánico, they will need more blood tests.

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

Amoxicilina/Ácido clavulánico may affect the functioning of micofenolato mofetilo (to prevent organ transplant rejection).

Pregnancy and breastfeeding

If your daughter is pregnant or breastfeeding, or if you think she may be pregnant or intend to become pregnant, consult your doctor or pharmacist before taking this medication.

Driving and operating machinery

Amoxicilina/ácido clavulánico may cause side effects, such as allergic reactions, dizziness and convulsions. If this happens to your child, he should not drive or ride a bicycle and should not use tools or machinery.

Amoxicilina/Ácido clavulánico Sandoz contains aspartamo (E951), sorbitol (E420), benzoate of benzyl, glucose, sodium, benzyl alcohol, sulfur dioxide (E220) and butylhydroxyanisole (E320).

This medication contains 1.7 mg of aspartamo per ml of oral suspension. Aspartamo contains a source of phenylalanine that may be harmful in the case of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it correctly.

This medication contains up to 0.0881 mg of sorbitol per ml of oral suspension.

This medication contains up to 0.000086 mg of benzoate of benzyl per ml of oral suspension. Benzyl benzoate may increase the risk of jaundice (yellow discoloration of the skin and eyes) in newborns (up to 4 weeks of age).

This medication contains glucose. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medication.

This medication may cause tooth decay.

This medication contains less than 23 mg of sodium (1 mmol) per ml; it is essentially "sodium-free".

This medication contains up to 0.125 mg of benzyl alcohol per ml of oral suspension.

Benzyl alcohol may cause allergic reactions. Consult your doctor or pharmacist if you are pregnant or breastfeeding. This is because large amounts of benzyl alcohol may accumulate in your body and cause adverse effects (metabolic acidosis). Consult your doctor or pharmacist if you have liver or kidney disease. This is because large amounts of benzyl alcohol may accumulate in your body and cause adverse effects (metabolic acidosis).

This medication may cause severe allergic reactions and bronchospasm (sudden sensation of choking) because it contains sulfur dioxide.

This medication may cause local reactions in mucous membranes because it contains butylhydroxyanisole.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist.In case of doubt, consult your doctor or pharmacist again.

Use in 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.

Use in children weighing less than 40 kg

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

The recommended dose is 20 mg/5 mg to 60 mg/15 mg per kilogram of body weight per day, administered in three divided doses.

• Your doctor will advise you how much amoxicillin/clavulanic acid to give to your baby or child.
• You will be provided with a plastic dosing spoon. You must use it to give the correct dose to your baby or child. The instructions for preparing the suspension from the powder are provided at the end of this leaflet.

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 administer Amoxicilina/Ácido clavulánico Sandoz

• Always shake the bottle well before each dose.
• Administer with meals.
• Space doses throughout the day, at least 4 hours apart. Do not take 2 doses in 1 hour.
• Do not administer Amoxicilina/Ácido clavulánico Sandoz to your child for more than 2 weeks.

If your child continues to feel unwell, they should return to see the doctor.

If you administer more Amoxicilina/Ácido clavulánico 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.

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. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you forgot to administer Amoxicilina/Ácido clavulánico Sandoz

If you forget to administer a dose to your child, give it as soon as you remember. Do not give your child the next dose too soon, 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 stops taking Amoxicilina/Ácido clavulánico Sandoz

Continue administering amoxicillin/clavulanic acid to your child until the treatment is completed, even if they feel better.

Your child needs to complete the treatment to help them fight the infection. If bacteria survive, they will get the infection again.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them. The side effects described below may occur when taking 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 or collapse.

• Contact your doctor immediatelyif you experience any of these symptoms.Stop taking Amoxicilina/Acido clavulanico Sandoz.

Colitis

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

• Contact your doctor immediately if you experience any of 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)

• thrush (Candida – fungal infection of the vagina, mouth, or mucous membranes),
• nausea, especially when taking high doses,

→if this happens, take Amoxicilina/Acido clavulanico Sandoz before meals

• vomiting,
• diarrhea (in children).

Uncommon side effects(may affect up to 1 in 100 people)

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

Uncommon side effects that may appear in blood tests:

• increase in some 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 dianas (central dark spot surrounded by a lighter area, with a dark ring around the edge –erythema multiforme),

• If you haveanyof these symptoms, consult your doctor urgently.

Rare side effects that may appear in blood tests:

• low count of cells involved in blood clotting,
• low white blood cell count.

Unknown frequency(cannot be estimated from available data)

• allergic reactions (see above),
• chest pain in the context of allergic reactions, which may be a symptom of allergic-induced heart attack (Kounis syndrome),
• Drug-induced enterocolitis syndrome (DIES): DIES has been reported mainly in children taking amoxicillin. It is a certain type of allergic reaction with the main symptom of repeated vomiting (1-4 hours after taking the medicine). Other symptoms may include abdominal pain, lethargy, diarrhea, and low blood pressure,
• colitis (see above),
• kidney stones that cause acute kidney damage,
• inflammation of the protective membrane surrounding the brain (aseptic meningitis),
• skin eruption with blisters arranged in a circle with a central crust or as a string of pearls (IgA linear disease),
• inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis),
• acute pancreatitis. If you have intense and persistent pain in the stomach area, this could be a sign of acute pancreatitis,
• severe skin reactions:
• generalized eruption with blisters and skin peeling, particularly around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), and in its most severe form, causing generalized skin peeling (more than 30% of the body surface –toxic epidermal necrolysis),
• generalized eruption with small blisters with pus (exfoliative bullous dermatitis),
• red eruption, with bumps under the skin and blisters (pustular exanthema)-flu-like symptoms with skin eruption, 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)).

• Contact a doctor immediately if you experience any of these symptoms.

• liver inflammation (hepatitis),
• jaundice, caused by increased bilirubin in the blood (a substance produced by the liver) that may turn the skin and white of the eyes yellow,
• inflammation of the kidney tubes,
• 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 the number of white blood cells,
• low red blood cell count (hemolytic anemia).

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.

Dry Powder

Do not store above 25 °C.

Store in the original packaging to protect it from light and moisture.

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

Liquid Suspension

Store in the refrigerator (between 2 °C and 8 °C). Do not freeze.

Once reconstituted, the suspension should be used within the first 7 days.

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

Medicines should not be disposed of through drains or in the trash. Dispose of the containers and

medicines that you no longer need at the SIGRE collection point at the pharmacy. If in doubt

ask your pharmacist how to dispose of the containers and medicines that you no longer need. By doing so, you will help protect the environment.

Composition of Amoxicillin/Clavulanic Acid Sandoz

The active ingredients are amoxicillin and clavulanic acid. Each milliliter of reconstituted suspension

contains 50 mg of amoxicillin (as amoxicillin trihydrate) and 12.5 mg of clavulanic acid

(as potassium clavulanate).

The other components are: talc, sodium citrate tribasic, anhydrous citric acid, aspartame (E-951), anhydrous colloidal silica, orange flavoring (contains cornstarch maltodextrin, benzyl alcohol, and sodium), lemon flavoring (contains cornstarch maltodextrin, glucose, sorbitol (E420), sulfur dioxide (E220), and butylhydroxyanisole (E320)), apricot-peach flavoring (contains cornstarch maltodextrin, sorbitol (E420), benzyl benzoate, benzyl alcohol, sulfur dioxide (E220), butylhydroxyanisole (E320), and sodium), and guar gum.

Appearance of the product and contents of the package

White powder with a fruity odor.

Amoxicillin/Clavulanic Acid Sandoz is presented in containers with powder to prepare 80, 100, and 120 ml of suspension. The containers include a spoon, to facilitate the administration of the product.

Only some package sizes may be marketed.

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

A-6250 -Kundl

Austria

Date of the last review of thisleaflet:February 2023

The detailed and updated information on this medication is available on the website

of the Spanish Agency for Medicines and Medical Devices (AEMPS)

http://www.aemps.gob.es/

Instructions for the correct administration of the prepared product

Check that the closure is intact before using the product. Shake the bottle to release the powder adhering. After opening the screw cap, make sure the seal on the bottle cap is intact and firmly attached to the edge of the bottle. Do not use it if it is not intact. Add the indicated volume of water, invert the contents, and shake well.

Do not use this medication if you see lumps in the bottle before reconstitution.

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

Another option is to shake the bottle to release the powder adhering and, then, fill it with water up to just below the bottle's notch. Invert the contents and shake well, and then add water up to exactly the notch. Invert the contents and shake well again.

Shake the bottle well before administering each dose.

Use the spoon included in the package to administer the dose indicated by the doctor. After use, rinse the spoon.