AMOXICILLIN / CLAVULANIC ACID SANDOZ 250 mg/62.5 mg/5 ml ORAL SUSPENSION POWDER

Introduction

Package Leaflet: Information for Parents or Carers of Children

Amoxicillin/Clavulanic Acid Sandoz 250 mg/62.5 mg/5 ml Powder for Oral Suspension

EFG

Read all of this leaflet carefully before your child starts taking this medicine because it contains important information for them.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine is usually only prescribed for babies or 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 any side effects, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this leaflet. See section 4.

• If your child experiences any side effects, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this leaflet. See section 4.

Contents of the pack:

1. What Amoxicillin/Clavulanic Acid Sandoz is and what it is used for
2. What you need to know before you give Amoxicillin/Clavulanic Acid Sandoz to your child
3. How to give Amoxicillin/Clavulanic Acid Sandoz to your child
4. Possible side effects
5. Storing Amoxicillin/Clavulanic Acid Sandoz
6. Contents of the pack and further information

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

Amoxicillin/Clavulanic Acid Sandoz is an antibiotic that kills the bacteria that cause infections. It contains two different medicines called amoxicillin and clavulanic acid. Amoxicillin belongs to a group of medicines known as "penicillins" which sometimes may lose their effectiveness (become 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 the flu or the common cold.

It is important that you follow the instructions regarding the dose, the number of doses, and the duration of treatment indicated by your doctor.

Do not store or reuse this medicine. If, after finishing the treatment, there is any antibiotic left over, return it to the pharmacy for proper disposal. Do not throw away medicines via wastewater or household waste.

Amoxicillin/Clavulanic Acid is used in babies 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 you give Amoxicillin/Clavulanic Acid Sandoz to your child

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 severe allergic reaction to any other antibiotic. This could include a skin rash or rapid swelling of the face, lips, tongue, or throat,
• 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. If you are unsure, consult your doctor or pharmacist before starting treatment.

Warnings and precautions

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

• your child has infectious mononucleosis,
• they are receiving treatment for liver or kidney problems,
• they do not urinate regularly.

If you are unsure whether any of the above symptoms apply to your child, consult 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 be aware of

Amoxicillin/Clavulanic Acid can worsen certain existing conditions or cause serious side effects. These include allergic reactions, convulsions, 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 problems. See section 4.

Blood and urine tests

If your child is having blood tests (such as red blood cell status 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 amoxicillin/clavulanic acid can affect the results of these types of tests.

Using Amoxicillin/Clavulanic Acid Sandoz with other medicines

Tell your doctor or pharmacist if your child is using, has recently used, or might use any other medicines, including those obtained 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 a skin allergic reaction.

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

If your child is taking anticoagulants (such as warfarin) with amoxicillin/clavulanic acid, more frequent blood tests will be needed.

Methotrexate (a medicine used to treat cancer and severe psoriasis), 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 (to prevent organ transplant rejection).

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 side effects such as allergic reactions, dizziness, and convulsions. If this happens to your child, they should not drive or ride a bicycle and should not use tools or machines.

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

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

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 told you that your child has an intolerance to some sugars, consult them before giving this medicine.

It may cause tooth decay.

This medicine contains less than 23 mg of sodium (1 mmol) per ml; this is 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 can accumulate in the body and cause side effects (metabolic acidosis). Consult your doctor or pharmacist if your child has liver or kidney disease. This is because large amounts of benzyl alcohol can accumulate in the body and cause side effects (metabolic acidosis).

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

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

3. How to give Amoxicillin/Clavulanic Acid Sandoz to your child

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

Use in adults and children over 40 kg

It is not normally recommended for adults and children weighing over 40 kg.

Consult your doctor or pharmacist.

Use in children under 40 kg

All doses are expressed on the basis of 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, divided into three 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 measuring spoon. You should use this 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 formulation or another medicine.
• If your child has liver problems, they will have more frequent blood tests to check how their liver is working.

How to give Amoxicillin/Clavulanic Acid Sandoz

• Always shake the bottle well before each dose.
• Give with food.
• Space out the doses during the day, at least 4 hours apart. Do not give 2 doses in 1 hour.
• Do not give Amoxicillin/Clavulanic Acid Sandoz to your child for more than 2 weeks.

If your child is still feeling unwell, they should see the doctor again.

If you give your child more Amoxicillin/Clavulanic Acid Sandoz than they should

If you give your child too much amoxicillin/clavulanic acid, they may experience symptoms such as stomach upset (nausea, vomiting, or diarrhea) or convulsions.

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

If you forget to give Amoxicillin/Clavulanic Acid Sandoz to your child

If you forget to give a dose to your child, 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 forgotten doses.

If your child stops taking Amoxicillin/Clavulanic Acid Sandoz

Continue giving amoxicillin/clavulanic acid to your child until the treatment is finished, even if they are feeling better.

Your child needs to take the full treatment to help combat the infection. If bacteria survive, the infection will return.

If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets 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) which can 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 can cause difficulty breathing or collapse.

• Contact your doctor immediatelyif your child experiences any of these symptoms. Stop taking Amoxicillin/Clavulanic Acid Sandoz.

Inflammation of the large intestine

Inflammation of the large intestine, which causes watery diarrhea, usually with blood and mucus, stomach pain, and/or fever.

• Contact your doctor immediatelyif your child experiences 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 Amoxicillin/Clavulanic Acid Sandoz before meals

• vomiting,
• diarrhea (in children).

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

• skin rash, itching,
• increased pruritic rash (urticaria),
• 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 rash, which can form blisters that look like small targets (central dark spot surrounded by a paler area, with a dark ring around the edge - erythema multiforme),

• If your child has any of these symptoms, consult a doctor urgently.

Rare side effects that may appear in blood tests:

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

Frequency not known(cannot be estimated from the available data)

• allergic reactions (see above),
• chest pain in the context of allergic reactions, which can be a symptom of allergy-induced heart attack (Kounis syndrome),
• Drug-induced enterocolitis syndrome (DIES): DIES has been reported mainly in children receiving 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,
• inflammation of the large intestine (see above),
• crystals in the urine that cause acute kidney injury,
• inflammation of the protective membrane surrounding the brain (aseptic meningitis),
• blistering skin rash, arranged in a circle with a central crust or like 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 your child has severe and persistent stomach pain, this could be a sign of acute pancreatitis,
• serious skin reactions:
• widespread skin 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 peeling of the skin (more than 30% of the body surface - toxic epidermal necrolysis),
• widespread skin rash with small blisters containing pus (bullous exfoliative dermatitis),
• red rash, with bumps under the skin and blisters (pustular exanthematous eruption) - 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 your child has any of these symptoms.

• inflammation of the liver (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,
• convulsions (in patients taking high doses of Augmentin or with kidney problems),
• black hairy tongue,
• 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 count of red blood cells (hemolytic anemia).

Reporting of side effects

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

5. Storing 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 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 medicine out of the sight and reach of children.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Container Content and Additional Information

Composition of Amoxicillin/Clavulanic Acid Sandoz

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

Product Appearance and Container Content

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

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Sandoz Pharmaceutical, S.A. Business Center Parque Norte

Roble Building

Serrano Galvache Street, 56

28033 Madrid

Spain

Manufacturer:

Sandoz GmbH

Biochemiestrasse, 10

A-6250 Kundl

Austria

Date of the Last Revision of thisProspectus:February 2023

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS)

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

Instructions for the Correct Administration of the Preparation

Check that the seal is intact before using the product. Shake the bottle to loosen the adhered powder. After opening the screw cap, ensure that the seal of the bottle cap is intact and firmly attached to the edge of the bottle. Do not use it if it is not intact. Add a volume of water (indicated below), invert the contents, and shake well.

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

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

Another possibility is to shake the bottle to loosen the adhered powder and then fill it with water up to just below the notch on the bottle. Invert the contents and shake well, and then add water until it reaches exactly the notch. Invert the contents and shake well again.

Shake the bottle well before administering each dose.

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