Package Leaflet: Information for the User

Amoxicilina/Ácido clavulánico Sandoz 1.000 mg/200 mg Powder for Injection and Infusion EFG

Read this leaflet carefully before you start using the medicine, because 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 has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

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

2. What you need to know before using Amoxicilina/Ácido clavulánico Sandoz

3. How to use Amoxicilina/Ácido clavulánico Sandoz

4. Possible side effects

5. Storage of Amoxicilina/Ácido clavulánico Sandoz

6. Contents of the pack and additional information.

Amoxicilina/ácido clavulánico is an antibiotic that eliminates the bacteria that cause infections. It contains two different medicines called amoxicilina and ácido clavulánico.Amoxicilina belongs to a group of medicines known as “penicilinas” that sometimes may lose its effectiveness (become inactive). The other component (ácido clavulánico) prevents this from happening..

Amoxicilina/ácido clavulánico 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.

Amoxicilina/ácido clavulánico is used in adults to prevent infections associated with major surgical procedures.

No use Amoxicilina/Ácido clavulánico Sandoz:

• if you are allergic to the active ingredients or any of the other components of this medication (listed in section 6),
• if you have ever had a severe 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 (yellow discoloration of the skin) when taking an antibiotic.

? Do not take Amoxicilina/Ácido clavulánico Sandoz if any of the above points apply to you. If you are unsure, consult your doctor, pharmacist, or nurse.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use amoxicilina/ácido clavulánicoif:

• 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 affect you, inform your doctor, pharmacist, or nurse before receiving amoxicilina/ácido clavulánico.

In some cases, your doctor may investigate the type of bacteria causing your infection. Depending on the results, they may prescribe a different presentation of amoxicilina/ácido clavulánico or another medication.

Be aware of the following symptoms

Amoxicilina/ácido clavulánico may worsen existing conditions or cause serious side effects. These include allergic reactions, convulsions, and inflammation of the large intestine. Be aware of the following symptoms while receiving amoxicilina/ácido clavulánico to reduce the risk of problems. See “Be aware of the following symptoms” in section 4.

Blood and urine tests

If you are having blood tests (such as red blood cell studies or liver function studies) or urine tests (to control glucose levels), inform your doctor or nurse that you are receiving amoxicilina/ácido clavulánico. This is because amoxicilina/ácido clavulánico may alter the results of these types of tests.

Use of Amoxicilina/Ácido clavulánico Sandoz with other medications

Inform your doctor or pharmacist if you are using or have used recently or may need to use any other medication, including those purchased without a prescription and herbal medications.

If you are taking allopurinol (used for gout) with amoxicilina/ácido clavulánico, 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 amoxicilina and is not recommended.

If you are taking anticoagulants (such as warfarin) with amoxicilina/ácido clavulánico, more blood tests will be required.

Methotrexate (a medication used to treat cancer and severe psoriasis), penicillins may reduce the excretion of methotrexate and cause a potential increase in side effects.

Amoxicilina/ácido clavulánico may affect how micophenolate mofetil (a medication used to prevent organ rejection in transplant patients) works.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor, pharmacist, or nurse before using this medication.

Amoxicilina/Ácido clavulánico Sandoz contains sodium and potassium

This medication contains 59.3 mg of sodium per vial, equivalent to 2.9% of the maximum daily sodium intake of 2 g recommended by the WHO for an adult.

This medication contains less than 39 mg (1 mmol) of potassium per vial, making it essentially “potassium-free”.

This medication will not be self-administered. A qualified person, such as a doctor or nurse, will administer it.

The usual doses are:

Adults and children weighing 40kg or more

Children weighing less than 40kg

• 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 presentation or another medication,
• If you have liver problems, you will have more frequent blood tests to check how your liver is functioning.

How Amoxicilina/Ácido clavulánico Sandoz will be administered to you

• Amoxicilina/Ácido clavulánico will be administered to you as an intravenous injection or by intravenous infusion,
• Make sure to drink plenty of liquid while receiving amoxicilina/Ácido clavulánico,
• Amoxicilina/Ácido clavulánico will not be administered to you for more than two weeks without your doctor reviewing your treatment.

If you use moreAmoxicilina/Ácido clavulánico Sandozthan you should

It is very unlikely that you will be given too much amoxicilina/Ácido clavulánico, but if you think you have been given too much, tell your doctor, pharmacist, or nurse immediately. The symptoms may be stomach upset (nausea, vomiting, or diarrhea) or seizures.

If you have any further questions about how to administer this product, consult your doctor, pharmacist, or nurse.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

The following side effects may occur with this medicine.

Be aware of the following symptoms

Allergic reactions:

• skin rash,
• inflammation of blood vessels (vasculitis) that may appear as red or purple spots on the skin, but can affect other parts of the body,
• fever, joint pain, swollen lymph nodes in the neck, armpits, or groin,
• swelling 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 an allergic-induced heart attack (Kounis syndrome).
• Drug-induced enterocolitis syndrome (DIES): DIES has mainly been reported in children taking amoxicillin. It is a certain type of allergic reaction with the main symptom of repeated vomiting (1-4 hours after administering the medication). 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.

Colitis

Colitis, which causes watery diarrhea usually with blood and mucus, stomach pain, and/or fever.

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

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

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

Less common side effects(may affect up to 1 in 100 patients)

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

?if this happens, administer amoxicillin/clavulanic acid before meals

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

Less common side effects that may appear in blood tests:

• increase in certain substances (enzymes) produced by the liver.

Rare side effects (may affect up to 1 in 1,000 patients)

• skin rash, which may form blisters that appear as small dots (central dark spot surrounded by a lighter area, with a dark ring around the edge – erythema multiforme),

?If you experience any of these symptoms, contact a doctor urgently.

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

Less common side effects that may appear in blood tests:

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

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),
• colitis (see above),
• inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis),
• severe skin reactions:

• generalized rash with blisters and skin peeling, particularly around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), and in its most severe form, causing widespread skin peeling (toxic epidermal necrolysis),
• generalized rash with small blisters with pus (exfoliative bullous dermatitis),
• red rash, with lumps under the skin and blisters (pustular exanthema).
• flu-like symptoms with skin rash, fever, swollen lymph nodes, and abnormal blood test results (such as increased eosinophils and elevated liver enzymes) (drug reaction with eosinophilia and systemic symptoms (DRESS)),
• rash with blisters arranged in a circle with a central crust or as a string of pearls (IgA linear disease).

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

• liver inflammation (hepatitis),
• acute pancreatitis; if you have intense and persistent pain in the abdominal area, this could be a sign of acute pancreatitis,

• jaundice, caused by increased bilirubin in the blood (a substance produced by the liver), which can turn the skin and the white of the eyes yellow,
• inflammation of the kidney tubes,
• delayed blood clotting,
• seizures (in patients taking high doses of amoxicillin/clavulanic acid or those with kidney problems).

Side effects that may appear in blood tests or urine:

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

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not store above 25°C.

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

Do not use Amoxicilina/Clavulanic Acid Sandoz after the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and unused medications. This will help protect the environment.

Composition of Amoxicillin/Clavulanic Acid Sandoz

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

No contains excipients.

Appearance of the product and contents of the package

White to off-white sterile powder vials.

Packages of 1 vial, 10 vials or 100 vials of 20 ml.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible for manufacturing

Sandoz GmbH

Biochemiestrasse, 10

A-6250 Kundl

Austria

Last review date of this leaflet:July 2020

The detailed and updated information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

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This information is intended only for doctors or healthcare professionals:

Please see the Technical Dossier for additional information

Administration

Amoxicillin/Clavulanic Acid Sandoz can be administered by slow intravenous injection over a period of 3 to 4 minutes directly into a vein or by a drip over 30-40 minutes. Amoxicillin/Clavulanic Acid Sandoz is not suitable for intramuscular administration.

Reconstitution

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

The reconstitution/dilution should be carried out under aseptic conditions. The solution should be visually checked for any particulate matter or discoloration before administration. The solution should only be used if it is clear and free of particles.The reconstitution of the intravenous solution or the reconstitution and dilution of the perfusion solution should be carried out at the time of administration.

Preparation of solutions forintravenous injection

The usual solvent is water for injection. Amoxicillin/Clavulanic Acid Sandoz 1,000 mg/200 mg should be dissolved in 20 ml of solvent. This results in approximately 20.9 ml of solution for single use. A pinkish color may be observed during reconstitution. The reconstituted solutions are normally colorless or pale yellow.

Amoxicillin/Clavulanic Acid Sandoz should be administered within 15 minutes after reconstitution.

Preparation of solutions for perfusion intravenous

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

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

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

It is generally recommended not to mix it with any other 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 should not be mixed in the same syringe with aminoglycoside antibiotics, as this may result in a loss of activity of the aminoglycoside.

The vials of Amoxicillin/Clavulanic Acid Sandoz are not suitable for use in multiple doses.

Stability of prepared solutions

Reconstituted vials (for intravenous injection or before dilution for perfusion)

The solution obtained after reconstitution of the vial (1 vial with 20 ml of water for injection Ph. Eur.), has been shown to be chemically and physically stable for 15 minutes at 25°C ± 2°C/ 60% ±5% HR.

Reconstituted and diluted vials for perfusion

The solution obtained by dilutingimmediatelythe reconstituted vial, with 100 ml of water for injection Ph. Eur. or 0.9% NaCl or 1/6M sodium lactate or 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% HR.

Any unused antibiotic solution should be discarded.