AMOXICILLIN/CLAVULANIC ACID SANDOZ 2000mg/200mg POWDER FOR SOLUTION FOR INFUSION

Introduction

Package Leaflet: Information for the User

Amoxicillin/Clavulanic Acid Sandoz 2000mg/200mg Powder for Solution for Infusion EFG

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects 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 use Amoxicillin/Clavulanic Acid Sandoz
3. How to use Amoxicillin/Clavulanic Acid Sandoz
4. Possible side effects
5. Storage of 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 is an antibiotic that eliminates 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 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 important that you follow the instructions regarding dosage, administration, and duration of treatment as indicated by your doctor.

Do not store or reuse this medicine. If you have any leftover antibiotic after completing 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 adults and children to treat the following infections:

• Acute ear, nose, and throat infections,
• Respiratory tract infections,
• Urinary tract infections,
• Skin and soft tissue infections including dental infections,
• Bone and skin infections,
• Intra-abdominal infections,
• Genital infections in women.

Amoxicillin/Clavulanic Acid is used in adults to prevent infections associated with major surgical procedures.

2. What you need to know before you use Amoxicillin/Clavulanic Acid Sandoz

Do not use Amoxicillin/Clavulanic Acid Sandoz:

• if you are allergic to the active substances or any of the other ingredients of this medicine (listed in section 6)
• if you have ever had a severe allergic reaction (hypersensitivity) to any other antibiotic. This could include a skin rash or swelling of the face or neck,
• if you have ever had liver problems or jaundice (yellowing of the skin) when taking an antibiotic.

Do not receive Amoxicillin/Clavulanic Acid Sandoz if any of the above applies to you.If you are not sure, consult your doctor, pharmacist, or nurse.

Warnings and precautions

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

• you have infectious mononucleosis,
• you are receiving treatment for liver or kidney problems,
• you do not urinate regularly.

If you are not sure if any of the above applies to you, inform your doctor, pharmacist, or nurse before receiving Amoxicillin/Clavulanic Acid.

In some cases, your doctor may investigate the type of bacteria causing your infection. Depending on the results, you may be prescribed 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, seizures, and inflammation of the large intestine. You should be aware of certain symptoms while being administered amoxicillin/clavulanic acid to reduce the risk of problems. See "Symptoms to be aware of" in section4.

Blood and urine tests

If you are having blood tests (such as red blood cell status or liver function studies) or urine tests (to check glucose levels), inform your doctor or nurse that you are being administered amoxicillin/clavulanic acid. This is because amoxicillin/clavulanic acid can alter the results of these types of tests.

Use of Amoxicillin/Clavulanic Acid Sandoz with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines, including those obtained without a prescription and herbal medicines.

If you are taking allopurinol (used for gout) with amoxicillin/clavulanic acid, you 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 you are 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 may affect how mycophenolate mofetil (a medicine used to prevent organ rejection in transplant patients) works.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor, pharmacist, or nurse before using this medicine.

Amoxicillin/Clavulanic Acid Sandoz contains sodium and potassium

This medicine contains 118 mg of sodium per vial, equivalent to 5.9% of the maximum daily intake of 2 g of sodium recommended by the WHO for an adult.

This medicine contains less than 39 mg (1 mmol) of potassium per vial, so it is considered essentially "potassium-free"

3. How to use Amoxicillin/Clavulanic Acid Sandoz

You will never administer this medicine to yourself. A qualified person, such as a doctor or nurse, will administer it to you.

The usual doses are:

Adults and children weighing 40 kg or more

Children weighing less than 40 kg

• All doses are calculated based on the child's body weight in kilograms.

Patients with kidney and liver problems

• if you have kidney problems, your dose may be changed. Your doctor may choose a different formulation or another medicine,
• if you have liver problems, you will have more frequent blood tests to check how your liver is working.

How Amoxicillin/Clavulanic Acid Sandoz will be administered to you

• amoxicillin/clavulanic acid will be administered to you as an intravenous infusion,
• make sure to drink plenty of fluids while receiving amoxicillin/clavulanic acid,
• amoxicillin/clavulanic acid will not be administered to you for more than two weeks without your doctor reviewing your treatment.

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

It is very unlikely that you will be given too much amoxicillin/clavulanic acid, but if you think you have been given too much, tell your doctor, pharmacist, or nurse immediately. Symptoms may include stomach upset (nausea, vomiting, or diarrhea) or seizures.

If you have any further questions on how this product is administered, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects may occur with 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 mouth (angioedema), which can cause difficulty breathing,
• collapse,
• 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 administering the medicine). Other symptoms may include abdominal pain, lethargy, diarrhea, and low blood pressure.

Contact your doctor immediatelyif you experience any of these symptoms. Stop administering Amoxicillin/Clavulanic Acid Sandoz.

Inflammation of the large intestine

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

Contact your doctor as soon as possiblefor advice if you have these symptoms.

Common side effects (may affect up to 1 in 10 people)

• thrush (candida - fungal infection of the vagina, mouth, or mucous membranes),
• diarrhea.

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

• skin rash, itching,
• increased itchy rash (urticarial rash),
• nausea, especially when high doses are administered,

if this happens, administer amoxicillin/clavulanic acid before meals

• vomiting,
• indigestion,
• dizziness,
• headache.

Uncommon side effects that may appear in your 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),

Contact a doctor urgentlyif you have any of these symptoms.

• swelling and redness along the vein, which is extremely sensitive to touch.

Rare side effects that may appear in your blood tests:

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

Other side effects

Other side effects that have occurred in a very small number of patients and whose exact frequency is unknown:

• allergic reactions (see above),
• 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 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)),
• rash with blisters arranged in a circle with a central crust or like a string of pearls (linear IgA disease).

Contact a doctor immediatelyif you have any of these symptoms.

• inflammation of the liver (hepatitis),
• acute inflammation of the pancreas (acute pancreatitis); if you have severe and persistent stomach pain, this could be a sign of acute pancreatitis,

• jaundice, caused by an increase in bilirubin in the blood (a substance produced by the liver), which can cause the skin and the whites of the eyes to turn yellow,
• delayed blood clotting,
• seizures (in patients taking high doses of amoxicillin/clavulanic acid or with kidney problems).

Side effects that may appear in your blood or urine tests:

• significant decrease in the number of white blood cells,
• low count of red blood cells (hemolytic anemia),
• crystals in the urine that cause acute kidney injury.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects 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. Storage of Amoxicillin/Clavulanic Acid Sandoz

The expiry date and storage instructions on the label are for the information of the doctor or nurse. The doctor, pharmacist, or nurse will reconstitute your medicine, which must be used within 15 minutes of reconstitution.

Do not store above 25°C.

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

Do not use Amoxicillin/Clavulanic Acid Sandoz after the expiry date stated on the pack. The expiry date is the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Container Contents and Additional Information

Composition of Amoxicillin/Clavulanic Acid Sandoz

Each vial contains as active ingredients 2,000 mg of amoxicillin (as amoxicillin sodium) and 200 mg of clavulanic acid (as potassium clavulanate).

It does not contain excipients.

Appearance of the Product and Container Contents

Vials containing a sterile powder of white to off-white color.

Packages of 1 or 50 vials of 100 ml.

Packages of 1 or 10 vials of 20 ml.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Pharmaceutical, 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 the Last Revision of this Prospectus: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/

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This information is intended solely for doctors or healthcare professionals:

Please see the Technical Sheet for additional information

Administration

Amoxicillin/Clavulanic Acid Sandoz 2,000 mg/200 mg powder for solution for infusion should be administered by infusion over 30 to 40 minutes. Amoxicillin/Clavulanic Acid Sandoz is not suitable for intramuscular administration.

Reconstitution

For single use. Any unused solution should be discarded.

Reconstitution and dilution should be performed under aseptic conditions. The solution should be visually inspected before administration to detect any foreign particles and discoloration. The solution should only be used if it is clear and free of particles.

Reconstitution and dilution of the solution for intravenous infusion should be performed at the time of administration. Amoxicillin/Clavulanic Acid Sandoz 2000 mg/200 mg is not suitable for rapid intravenous injection (bolus).

Amoxicillin/Clavulanic Acid Sandoz 2,000 mg/200 mg should be reconstituted in 20 ml of water for injectable preparations (this is a minimum volume). A pale pink coloration may be observed during reconstitution. The reconstituted solutions are normally colorless or with a pale straw color.

Immediately, the reconstituted solution should be added to 100 ml of infusion fluid using a minibag or in-line burette.

Injectable solutions of glucose (dextrose), sodium bicarbonate, or dextran should not be used as solvents.

In general, it is recommended not to mix it with any other product in the same syringe or infusion bottle. The combination of amoxicillin and clavulanic acid is incompatible with: blood and plasma, hydrocortisone succinate, amino acid solutions, protein hydrolysates, lipid emulsions, phenylephrine HCl, mannitol solutions.

Amoxicillin/Clavulanic Acid Sandoz should not be mixed in the same syringe with aminoglycoside antibiotics, as this may result in a loss of aminoglycoside activity under these conditions.

The vials of Amoxicillin/Clavulanic Acid Sandoz are not suitable for multiple-dose use.

Stability of Prepared Solutions

Reconstituted vials (before dilution for infusion)

The solution obtained after reconstitution (1 vial with 20 ml of water for injectables) has been shown to be stable from a chemical and physical point of view for 15 minutes at 25 °C ± 2°C / 60% ± 5% RH.

Reconstituted and diluted vials for infusion

The solution obtained by immediately diluting the reconstituted vial with 100 ml of water for injectables or NaCl 0.9% or sodium lactate 1/6M or Ringer's solution or Hartmann's solution has been shown to be stable from a chemical and physical point of view for 60 minutes at 25°C ± 2°C / 60% ± 5% RH.

Any unused antibiotic solution should be discarded.