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

Package leaflet: Information for the user

Introduction

Package leaflet: information for parents or caregivers of children

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

EFG

Read the entire leaflet carefully before starting to give 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 babies 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 adverse reactions, consult your doctor, pharmacist, or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet:

1. What Amoxicillin/Clavulanic acid Sandoz is and what it is used for
2. What you need to know before starting Amoxicillin/Clavulanic acid Sandoz
3. How to administer Amoxicillin/Clavulanic acid Sandoz
4. Possible adverse effects
5. How to store Amoxicillin/Clavulanic acid Sandoz
6. Contents of the pack and other information

1. What Amoxicilina/Ácido clavulánico Sandoz is and what it is used for

Amoxicilina/Ácido clavulánico Sandoz 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, frequency, and duration of treatment.

Do not store or reuse this medicine. If you have any antibiotic left 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 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 using Amoxicillin/Clavulanic Acid Sandoz

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

• if they are allergic to amoxicillin, clavulanic acid, penicillins, or any of the other ingredients of this medicine (listed in section 6),
• if they have ever had a serious allergic reaction to any other antibiotic. This could include 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 an antibiotic.

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

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

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting amoxicillin/clavulanic acid if:

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

If you are not sure whether any of the above conditions affect your child, consult your doctor or pharmacist before administering 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 be given 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 be aware of 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 your child is taking amoxicillin/clavulanic acid. This is because amoxicillin/clavulanic acid may alter the results of these types of tests.

Using Amoxicillin/Clavulanic Acid Sandoz with other medicines

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 allopurinol (used to treat gout) is taken with amoxicillin/clavulanic acid, there may be an increased likelihood of developing a skin allergic reaction.

Probenecid (used to treat gout): 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.

Methotrexate (a medicine used to treat cancer and severe psoriasis): penicillins may reduce the excretion of methotrexate and potentially increase adverse effects.

Amoxicillin/Clavulanic Acid may affect the function of mycophenolate mofetil (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 taking this medicine.

Driving and using machines

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

Amoxicillin/Clavulanic Acid Sandoz contains aspartame (E951), sorbitol (E420), benzyl benzoate, glucose, sodium, benzyl alcohol, sulfur dioxide (E220), and butylated hydroxyanisole (E320).

This medicine contains 1.7 mg of aspartame per ml of oral suspension. Aspartame contains a source of phenylalanine, which may be harmful in individuals with phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot properly eliminate it.

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

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

This medicine contains glucose. If your doctor has informed you that your child has an intolerance to certain sugars, consult with them before taking this medicine.

May cause dental caries.

This medicine contains less than 23 mg of sodium (1 mmol) per ml, i.e., essentially "sodium-free".

This medicine 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 the 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 the body and cause adverse effects (metabolic acidosis).

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

This medicine may cause local reactions on mucous membranes because it contains butylated hydroxyanisole.

3. How to take Amoxicillin/Clavulanic Acid Sandoz

Follow exactly the instructions given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Use in adults and children weighing 40 kg or more

It is not usually recommended for adults and children weighing more than 40 kg.

Please consult 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.

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

• Your doctor will advise you on how much amoxicillin/clavulanic acid 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. Instructions for preparing the suspension from the powder are provided at the end of this leaflet.

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 Sandoz

• 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 Sandoz to your child for longer than 2 weeks.

If your child continues to feel unwell, you should see your doctor again.

If you give 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 diarrhoea) or seizures may occur.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount taken. It is recommended to bring the medicine packaging and leaflet to the healthcare professional.

If you forget to give Amoxicillin/Clavulanic Acid Sandoz

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 Sandoz

Continue giving your child amoxicillin/clavulanic acid until the treatment is complete, even if they start to feel better.

Your child needs to complete the full course of treatment to help clear 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 will experience them. The adverse effects described below may occur when taking this medicine.

Symptoms to watch for

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,

• swelling, sometimes of the face or throat (angioedema), causing difficulty breathing or collapse.

• Contact your doctor immediately if you experience any of these symptoms. Stop taking Amoxicillin/Clavulanic Acid Sandoz.

Inflammation of the large intestine

Inflammation of the large intestine, causing watery diarrhoea, usually with blood and mucus, stomach pain and/or fever.

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

Very common adverse effects (may affect more than 1 in 10 people)

• diarrhoea (in adults).

Common adverse effects (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 occurs, take Amoxicillin/Clavulanic Acid Sandoz before meals

• vomiting,
• diarrhoea (in children).

Uncommon adverse effects (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 adverse effects (may affect up to 1 in 1,000 people)

• skin rash that may blister and resemble small targets (a dark central spot surrounded by a paler area, with a dark ring around the edge – erythema multiforme),

• If you have 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,
• low white blood cell count.

Frequency not known (cannot be estimated from available data)

• allergic reactions (see above),

• chest pain in the context of allergic reactions, which may be a symptom of allergy-triggered heart attack (Kounis syndrome),

• Drug-Induced Enterocolitis Syndrome (DIES): DIES has been reported mainly in children receiving amoxicillin. 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, diarrhoea and low blood pressure,

• inflammation of the large intestine (see above),

• crystals in the urine causing acute kidney injury,

• inflammation of the protective membrane surrounding the brain (aseptic meningitis),

• blistering rash arranged in rings with central crust or resembling a string of pearls (linear IgA disease),

• inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis),

• 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,

• severe 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 – toxic epidermal necrolysis),

• widespread rash with small pus-filled blisters (exfoliative bullous dermatitis),

• red rash with bumps under the skin and blisters (exanthematous pustulosis) – flu-like symptoms with skin rash, fever, swollen glands and abnormal blood test results (such as increased white blood cells (eosinophilia) and elevated liver enzymes) (Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)).

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

• 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 yellow,

• inflammation of kidney tubules,

• delayed blood clotting,

• hyperactivity,

• seizures (in patients taking high doses of Augmentin or who have kidney problems),

• black, hairy-looking tongue,

• tooth staining (in children), which usually disappears with brushing.

Adverse effects that may appear in blood or urine tests:

• marked decrease in white blood cell count,
• low red blood cell count (haemolytic anaemia).

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect 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 Sandoz

Dry powder

Do not store above 25 °C.

Keep in the original packaging to protect from light and moisture.

Do not use this medicine after the expiry date stated on the packaging after CAD/EXP. The expiry date refers to 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 must be used within 7 days.

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

Medicines must not be disposed of via wastewater or household waste. Return any unused medicines and their packaging to the pharmacy’s SIGRE collection point . If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Package contents and other information

Composition of Amoxicillin/Clavulanic Acid Sandoz

The active substances are amoxicillin and clavulanic acid. Each ml 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, trisodium citrate, anhydrous citric acid, aspartame (E-951), anhydrous colloidal silica, orange flavouring (containing corn maltodextrin, benzyl alcohol and sodium), lemon flavouring (containing corn maltodextrin, glucose, sorbitol (E420), sulphur dioxide (E220) and butylhydroxyanisole (E320)), apricot-peach flavouring (containing corn maltodextrin, sorbitol (E420), benzyl benzoate, benzyl alcohol, sulphur dioxide (E220), butylhydroxyanisole (E320) and sodium), and guar gum.

Appearance of the medicine and contents of the pack

Whiteish powder with a fruity odour.

Amoxicillin/Clavulanic Acid Sandoz is available in containers of powder to prepare 80, 100 and 120 ml of suspension. The packs include a dosing spoon to facilitate administration of the medicine.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Sandoz Farmacéutica, S.A.
Parque Norte Business Centre
Roble Building
C/ Serrano Galvache, 56
28033 Madrid
Spain

Manufacturer:

Sandoz GmbH
Biochemiestrasse, 10
A-6250 - Kundl
Austria

Date of the most recent revision of this leaflet: February 2023

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

Instructions for correct administration of the preparation

Check that the closure is intact before using the product. Shake the bottle to loosen any adhered powder. After removing the screw cap, ensure that the seal on the bottle cap is intact and firmly attached to the rim of the bottle. Do not use if the seal is not intact. Add the volume of water indicated below, invert the container and shake well.

Do not use this medicine if lumps are visible in the bottle before reconstitution.

Do not use the reconstituted suspension if its colour is not whiteish.

Alternatively, shake the bottle to loosen the adhered powder, then fill it with water up to just below the mark on the bottle. Invert the container and shake well, then add water up to exactly the mark. Invert the container again and shake well.

Shake the bottle well before administering each dose.

Use the spoon provided in the package to administer the dose indicated by the doctor. Rinse the spoon after use.