AMOXICILLIN/CLAVULANIC ACID SANDOZ 600 mg/42.9 mg/5 ml ORAL SUSPENSION POWDER

Introduction

Leaflet: Information for the patient

Amoxicillin/Clavulanic Acid Sandoz 600 mg/42.9 mg/5 ml powder for oral suspension EFG

Read the entire leaflet carefully before starting to give this medicine to your child, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.

• This medicine is usually prescribed for babies or children. Do not give it to other people, even if they have the same symptoms as your child, as it may harm them.
• If they experience side effects, consult a doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. Package contents and additional information

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

Amoxicillin/Clavulanic Acid Sandoz is an antibiotic that eliminates the bacteria that cause infections. It contains two different active ingredients called amoxicillin and clavulanic acid. Amoxicillin belongs to the group of medicines known as "penicillins" which can sometimes 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 essential to follow the instructions regarding dosage, administration, and treatment duration indicated by your doctor.

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

Amoxicillin/Clavulanic Acid is used in babies and children to treat the following infections:

• middle ear infections,
• lung 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 to amoxicillin, clavulanic acid, penicillins, or any of the other components 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 swelling of the face 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 points apply to them.If you are unsure, consult with your doctor or pharmacist before administering amoxicillin/clavulanic acid.

Warnings and precautions

Consult your doctor or pharmacist before administering amoxicillin/clavulanic acid to your child if:

• they have 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 affect your child, inform 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 receive a different dose of amoxicillin/clavulanic acid or another medicine.

Symptoms to be aware of

Amoxicillin/Clavulanic Acid can worsen certain existing conditions or cause severe 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 any problems. See Symptoms to be aware ofin section 4.

Blood and urine tests

If your child is having 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 amoxicillin/clavulanic acid can alter the results of these types of tests.

Other medicines 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 medicine.

If your child is taking allopurinol(used to treat gout) with amoxicillin/clavulanic acid, they may be more likely to have a skin allergic 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.

If your child is taking anticoagulants (such as warfarin) 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 cause a potential increase in side effects.

Amoxicillin/Clavulanic Acid can affect the functioning of mycophenolate mofetil(a medicine used to prevent organ rejection after transplantation).

Pregnancy and breastfeeding

If your daughter, who is going to take this medicine, is pregnant or breastfeeding, thinks she may be pregnant, or plans to become pregnant, consult a doctor or pharmacist before using this medicine.

Amoxicillin/Clavulanic Acid Sandoz contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per maximum daily dose; it is essentially "sodium-free".

Amoxicillin/Clavulanic Acid Sandoz contains benzyl alcohol

This medicine contains 0.017 mg of benzyl alcohol in each 5 ml (equivalent to 1.5 g of powder) of suspension. Benzyl alcohol may cause allergic reactions. This product should not be used for more than one week in children under 3 years of age unless indicated by your doctor or pharmacist.

Consult your doctor or pharmacist if your child has liver or kidney disease. Consult your doctor or pharmacist if your daughter is pregnant or breastfeeding. This is because large amounts of benzyl alcohol can accumulate in the body and cause side effects (metabolic acidosis).

Amoxicillin/Clavulanic Acid Sandoz contains ethanol

This medicine contains less than 0.004 mg of alcohol (ethanol) per 5 ml (equivalent to 1.5 g of powder) of suspension. The amount in 5 ml of this medicine is equivalent to less than 1 ml of beer or 1 ml of wine. The small amount of alcohol in this medicine does not produce any noticeable effect.

Amoxicillin/Clavulanic Acid Sandoz contains sulfite

This medicine contains less than 0.000017 mg of sulfite per 5 ml (equivalent to 1.5 g of powder) of suspension. It can rarely cause severe hypersensitivity reactions and bronchospasm.

3. How to take Amoxicillin/Clavulanic Acid Sandoz

Follow the administration instructions for this medicine exactly as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

Use in adults and children over 40 kg

• This suspension is not normally recommended for adults and children weighing over 40 kg. Ask your doctor or pharmacist for advice.

Use in children under 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 dosing syringe. You must use it to give the correct dose to your baby or child.
• The usual dose is 90 mg/6.4 mg per kilogram of body weight per day, administered in two divided doses.
• Amoxicillin/Clavulanic Acid is not recommended in children under 3 months.

Patients with kidney and liver problems

• If your child has kidney problems, the dose may be changed. Your doctor may choose a different dose 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 administer Amoxicillin/Clavulanic Acid Sandoz

• Administer with meals.
• Drink a glass of water after taking the suspension.
• Always shake the bottle well before each dose.
• Space the doses evenly throughout the day, at least 4 hours apart. Do not take 2 doses in 1 hour.
• Do not administer Amoxicillin/Clavulanic Acid Sandoz to your child for more than 2 weeks. If your child is still feeling unwell, they should see a doctor again.

If you administer more Amoxicillin/Clavulanic Acid Sandoz than you 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. Contact your doctor as soon as possible. Take the medicine bottle to the doctor to show them.

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 medicine and the amount ingested. It is recommended to take the medicine package and leaflet to the healthcare professional.

If you forget to administer Amoxicillin/Clavulanic Acid Sandoz

If you forget to give your child a dose, give it to them 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 missed doses.

If your child stops taking Amoxicillin/Clavulanic Acid Sandoz

Continue to administer amoxicillin/clavulanic acid to your child until the treatment is finished, even if they are feeling better. Your child needs to take the complete treatment to help combat the infection. If bacteria survive, they may become infected again.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The side effects described below can occur when taking this medicine.

Symptoms to be aware of

Allergic reactions:

• skin rash,
• inflammation of blood vessels (vasculitis) that can appear as red or purple spots on the skin, but can also 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,
• collapse,
• chest pain in the context of allergic reactions, which can be a symptom of an allergy-induced heart attack (Kounis syndrome).

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.

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 receiving amoxicillin/clavulanate. It is a certain type of allergic reaction with the main symptom of repeated vomiting (1-4 hours after administering the medicine). Other symptoms may include abdominal pain, lethargy, diarrhea, and low blood pressure.

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, a fungal infection in the vagina, mouth, or mucous membranes),
• discomfort (nausea), especially when taking high doses, if this happens, take amoxicillin/clavulanic acid with meals,
• vomiting,
• diarrhea (in children).

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

• skin rash, itching,
• increased pruritic rash (urticarial wheal),
• 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 that 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 you experience any of these symptoms, consult your doctor urgently.

Rare side effects that may appear in blood tests:

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

Frequency not known(cannot be estimated from available data)

• allergic reactions (see above),
• crystals in the urine that cause acute kidney injury,
• rash with blisters arranged in a circle with a central crust or like a string of pearls (linear IgA disease),
• 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 peeling of the skin (more than 30% of the body surface: toxic epidermal necrolysis),
  • widespread red rash with small blisters containing pus (bullous exfoliative dermatitis),
  • red, scaly 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)).

Contact a doctor immediately if your child experiences any of 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,
• delayed blood clotting,
• hyperactivity,
• convulsions (in patients taking high doses of amoxicillin/clavulanic acid or with kidney problems),
• black hairy tongue,
• stained teeth (in children), which usually disappears with brushing.

Side effects that may appear in blood tests:

• significant reduction in the number of white blood cells,
• low count of red blood cells (hemolytic anemia).

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. You can also report them 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. 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 stated on the carton and on the bottle after CAD/EXP. The expiration date is the last day of the month indicated.

Store below 25°C. Store in the original packaging to protect from moisture.

After preparation of the ready-to-use suspension:

Store in the refrigerator (between 2°C and 8°C) and use within the next 10 days.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Container Contents and Additional Information

Composition of Amoxicillin/Clavulanic Acid Sandoz

• The active ingredients are amoxicillin and clavulanic acid.
• Each ml of reconstituted suspension (equivalent to 0.3 g of powder) contains 120 mg of amoxicillin (as amoxicillin trihydrate) and 8.58 mg of clavulanic acid (as potassium clavulanate).

5 ml of reconstituted suspension contain 600 mg of amoxicillin (as amoxicillin trihydrate) and 42.9 mg of clavulanic acid (as potassium clavulanate).

• The other components are: citric acid, sodium citrate, microcrystalline cellulose, sodium carmellose, xanthan gum, anhydrous colloidal silica, silicon dioxide, raspberry flavor (contains artificial flavor, corn maltodextrin, propylene glycol, glycerol triacetate, benzyl alcohol, ethanol, and sodium), orange flavor (contains natural and artificial flavor, corn maltodextrin, corn starch, sodium, and sulfites), caramel flavor (contains artificial flavor, corn maltodextrin, triethyl citrate, ethanol, and sodium), and sodium saccharin (E954).
• See section 2 for more information on benzyl alcohol, ethanol, and sulfites.

Product Appearance and Container Contents

Amoxicillin/Clavulanic Acid Sandoz 600 mg/42.9 mg/5 ml powder for oral suspension is a white to light yellow powder.

Container contents: amber glass bottles (type III) of 100 or 180 ml closed with a polypropylene screw cap sealed with a polypropylene/polyethylene ring and a polypropylene dosing syringe, with a plunger and polyethylene cap. The total range of the dosing syringe is from 0.5 to 5 ml. Each black mark represents 0.1 ml.

Package sizes:

1 bottle of 17.7 g of powder (to prepare 50 ml of suspension)

1 bottle of 33.8 g of powder (to prepare 100 ml of suspension)

Only some package sizes may be marketed.

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

A-6250 Kundl

Austria

Date of Last Revision of this Leaflet:June 2023

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

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Medical Advice/Education

Antibiotics are used to treat bacterial infections and are not effective against viral infections.

Sometimes bacterial infections do not respond to the effect of antibiotics. One of the most common reasons for this is that the bacteria causing the infection are resistant to the antibiotic being taken. That is, they can survive and even multiply despite the antibiotic.

Bacteria can become resistant to antibiotics for various reasons. Using antibiotics with caution can help reduce the likelihood of bacteria becoming resistant to antibiotics.

When your doctor prescribes antibiotic treatment, it is with the intention of treating only the current illness. Paying attention to the following advice helps prevent the emergence of resistant bacteria that can hinder the effect of the antibiotic.

1. It is essential to take the correct dose of antibiotic, at the right time, and for the correct number of days. Read the instructions in the leaflet, and if you do not understand something, ask your doctor or pharmacist to explain it to you.
2. You should not take an antibiotic unless it has been specifically prescribed for you, and it should only be used to treat the infection for which it was prescribed.
3. You should not take antibiotics that have been prescribed for other people, even if they have had a similar infection to yours.
4. You should not give antibiotics that have been prescribed for you to other people.
5. If you have any leftover antibiotic when you have finished your treatment as indicated by your doctor, you should take the leftover antibiotic to the pharmacy for proper disposal.

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Reconstitution Instructions

At the time of dosing, the dry powder should be reconstituted to form an oral suspension, as detailed below.

Check that the seal is intact before using the product. Shake the bottle until the powder flows freely. Add approximately 2/3 of the total amount of water for reconstitution (see table below) and shake vigorously to suspend the powder. Add the remaining water and shake vigorously again.

Alternative reconstitution: shake the bottle until the powder flows freely. Fill the bottle with water up to just below the mark on the bottle label. Close the cap again, turn the bottle, and shake vigorously.

Then add water to the bottle exactly up to the mark. Close the cap again, turn the bottle, and shake vigorously.

After reconstitution, the medication is a homogeneous suspension and is almost white to light yellow in color.

Shake the bottle properly before each dose.