Amoxicillin/clavulanic acid Sandoz 1000 mg/200 mg powder for solution for injection and for infusion EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Amoxicillin/Clavulanic acid Sandoz 1000 mg/200 mg powder for solution for injection and 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 other people, even if they have the same symptoms as you, because it may harm them.
• 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 leaflet

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

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

Amoxicillin/clavulanic acid is an antibiotic that kills bacteria causing infections. It contains two different medicines 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, administration, and duration of treatment.

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

Do not use Amoxicillin/Clavulanic Acid Sandoz:

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

?Do not take Amoxicillin/Clavulanic Acid Sandoz if any of the above apply to you. If you are unsure, consult your doctor, pharmacist, or nurse.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting 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 unsure whether any of the above symptoms apply 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 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 being treated with amoxicillin/clavulanic acid to reduce the risk of complications. See “Symptoms to watch for” in section 4.

Blood and urine tests

If you are undergoing blood tests (such as studies of red blood cell status or liver function tests) or urine tests (to monitor glucose levels), inform your doctor or nurse that you are receiving amoxicillin/clavulanic acid. This is because amoxicillin/clavulanic acid may 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 or have recently used 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 develop 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 methotrexate excretion and potentially increase adverse 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 might be pregnant, or are planning to become pregnant, consult your doctor, pharmacist, or nurse before using this medicine.

Amoxicillin/Clavulanic Acid Sandoz contains sodium and potassium

This medicine contains 59.3 mg of sodium per vial, equivalent to 2.9% 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 and is therefore considered essentially “potassium-free”.

3. How to use Amoxicillin/Clavulanic Acid Sandoz

This medicine will never be administered by 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 adjusted. Your doctor may choose a different formulation or another medicine,
• if you have liver problems, you will have blood tests more frequently to monitor how your liver is functioning.

How Amoxicillin/Clavulanic Acid Sandoz will be administered to you

• amoxicillin/clavulanic acid will be given to you as an injection into a vein or by intravenous infusion,
• make sure you drink plenty of fluids while receiving amoxicillin/clavulanic acid,
• amoxicillin/clavulanic acid will not be administered for longer than two weeks without your doctor reviewing your treatment.

If you are given more Amoxicillin/Clavulanic Acid Sandoz than you should

It is highly unlikely that you will be given too much amoxicillin/clavulanic acid, but if you think an overdose has occurred, tell your doctor, pharmacist, or nurse immediately. Symptoms may include stomach discomfort (nausea, vomiting, or diarrhea) or seizures.

If you have further questions about how this medicine is administered, 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 following adverse effects may occur with 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 mouth (angioedema), causing difficulty breathing,
• collapse,
• chest pain in the context of allergic reactions, which may be a symptom of a heart attack triggered by allergy (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 being repeated vomiting (1–4 hours after administration of the medicine). Other symptoms may include abdominal pain, lethargy, diarrhea, and low blood pressure.

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

Inflammation of the large intestine

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

?Contact your doctor as soon as possible so they can advise you if you have these symptoms.

Frequent adverse effects (may affect up to 1 in 10 patients)

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

Uncommon adverse effects (may affect up to 1 in 100 patients)

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

?if this occurs, take amoxicillin/clavulanic acid before meals

• vomiting,
• 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 patients)

• skin rash, which may form blisters resembling 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, contact a doctor urgently.

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

Rare adverse effects that may appear in blood tests:

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

Other adverse effects

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

• allergic reactions (see above),

• inflammation of the large intestine (see above),

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

• 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 (pustular exanthem).

• 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)),

• blistering rash arranged in circles with a central crust or resembling a string of beads (linear IgA disease).

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

• inflammation of the liver (hepatitis),
• 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,
• 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 the kidney ducts,
• delayed blood clotting,
• seizures (in patients taking high doses of amoxicillin/clavulanic acid or who have kidney problems).

Adverse 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),
• crystals in the urine causing acute kidney injury.

Reporting of adverse effects

If you experience any adverse effect, consult 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

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 container. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of any unused medicine and its packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Amoxicillin/Clavulanic acid Sandoz

Each vial contains as active ingredients 1,000 mg of amoxicillin (as sodium amoxicillin) and 200 mg of clavulanic acid (as potassium clavulanate).

It contains no excipients.

Appearance of the medicinal product and contents of the pack

Vials containing a sterile white to off-white powder.

Pack sizes of 1 vial, 10 vials or 100 vials of 20 ml.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Sandoz Farmacéutica, S.A.

Parque Norte Business Park

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: July 2020

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

This information is intended for medical or healthcare professionals only:

Please refer to the Summary of Product Characteristics for additional information

Administration

Amoxicillin/Clavulanic acid Sandoz may be administered by slow intravenous injection over a period of 3 to 4 minutes directly into a vein or by infusion over 30–40 minutes. Amoxicillin/Clavulanic acid Sandoz is not suitable for intramuscular administration.

Reconstitution

For single use only. Any unused solution must be discarded.

Reconstitution/dilution must be carried out under aseptic conditions. The solution should be inspected visually before administration for the presence of foreign particles and discoloration. The solution should only be used if it is clear and free from particles. Reconstitution of the solution for intravenous injection or reconstitution and dilution of the solution for infusion must be performed at the time of administration.

Preparation of solutions for intravenous injection

The usual solvent is water for injections. Amoxicillin/Clavulanic acid Sandoz 1,000 mg/200 mg should be dissolved in 20 ml of solvent. This yields approximately 20.9 ml of solution for single-dose use. A pale pink coloration may be observed during reconstitution. Reconstituted solutions are normally colorless or pale yellow.

Amoxicillin/Clavulanic acid Sandoz must be administered within 15 minutes after reconstitution.

Preparation of solutions for intravenous infusion

Amoxicillin/Clavulanic acid Sandoz should be reconstituted as described above for injection.

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

Solutions of glucose (dextrose), sodium bicarbonate, or dextran must not be used as solvents.

In general, it is recommended not to mix this product with any other medicinal product in the same syringe or infusion bag. 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 must not be mixed in the same syringe with aminoglycoside antibiotics, as this may result in loss of aminoglycoside activity.

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

Stability of prepared solutions

Reconstituted vials (for intravenous injection or prior to dilution for infusion)

The solution obtained after reconstitution of the vial (1 vial with 20 ml of water for injections Ph. Eur.) has been shown to be chemically and physically stable 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 injections Ph. Eur., 0.9% sodium chloride, 1/6 M sodium lactate, Ringer's solution, or Hartmann's solution has been shown to be chemically and physically stable for 60 minutes at 25°C ± 2°C / 60% ±5% RH.

Any unused antibiotic solution must be discarded.