Leaflet: information for the user

Amoxicilina/Ácido clavulánico NORMON 2.000 mg/200 mg powder for solution for infusion EFG

Amoxicilina/ácido clavulánico

Read this leaflet carefully before you start taking this 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 other people even if they have the same symptoms of illness 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 NORMON and what it is used for

2.What you need to know before starting to use Amoxicilina/Ácido clavulánico NORMON

3.How to use Amoxicilina/Ácido clavulánico NORMON

4.Possible side effects

1. Storage of Amoxicilina/Ácido clavulánico NORMON

Contents of the pack and additional information

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

Antibiotics are used to treat bacterial infections and do not work for viral infections such as the flu or a cold.

It is essential to follow the instructions regarding dosage, administration, and treatment duration as indicated by your doctor.

Do not store or reuse this medication. If you have leftover antibiotics after completing treatment, return them to the pharmacy for proper disposal. Do not dispose of medications through the drain or in the trash.

Amoxicilina/Ácido clavulánico NORMON 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 joint infections
• Intra-abdominal infections
• Genital infections in women

Amoxicilina/Ácido clavulánico NORMON is used in adults and children to prevent infections associated with major surgical procedures.

You should not take Amoxicilina/Ácido clavulánico NORMON:

•if you are allergic to amoxicilina, ácido clavulánico, penicilinas, or any of the other components of this medication (see 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 throat.

•if you have ever had liver problems or jaundice (yellowing of the skin) when taking an antibiotic.

?Do not take Amoxicilina/Ácido clavulánico NORMON 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 clavulánico 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 affect you, inform your doctor, pharmacist, or nurse before taking 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.

Symptoms to watch out for

Amoxicilina/ácido clavulánico may worsen 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 taking amoxicilina/ácido clavulánico to reduce the risk of problems. See “Symptoms to watch out for” in section4.

Blood and urine tests

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

Other medications and Amoxicilina/ácido clavulánico NORMON

Inform your doctor, pharmacist, or nurse if you are using, have used recently, or may need to use any other medication.

If you are taking allopurinol (used for gout) with amoxicilina/ácido clavulánico, you may be more likely to have a skin allergic reaction.

If you are taking probenecid (used for gout), your doctor may adjust the dose of Amoxicilina/ácido clavulánico.The 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.

Amoxicilina/ácido clavulánico may affect the way methotrexate (a medication for cancer and severe psoriasis) works.Penicillins may reduce the excretion of methotrexate and cause a potential increase in side effects.

Amoxicilina/ácido clavulánico may affect the way micofenolato de mofetilo (a medication used to prevent organ rejection in transplant patients) works.

Pregnancy, breastfeeding, and fertility

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

Driving and operating machinery

Amoxicilina/ácido clavulánico may cause side effects that may make you unable to drive.

Do not drive or operate machinery unless you feel well.

Amoxicilina/Ácido clavulánico NORMON contains sodium and potassium

•This medication contains 125.8 mg of sodium (main component of table salt/for cooking) in each vial. This is equivalent to 6.3% of the maximum daily sodium intake recommended for an adult.

•Patients with renal insufficiency or low-potassium diets should note that this medication contains 39.2 mg (1 mmol) of potassium per vial.

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

The recommended doses are:

Adults and children weighing40 kg or more

Children weighing less than40 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 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 NORMON 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 liquids while receiving amoxicilina/ácido clavulánico.

•Amoxicilina/ácido clavulánico will not be administered to you for more than 2 weeks without your doctor reviewing your treatment.

If you are given more Amoxicilina/Ácido clavulánico NORMON than recommended

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 this medication is administered, consult your doctor, pharmacist, or nurse.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

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 glands in the neck, armpits, or groin
• swelling, sometimes of the face or throat (angioedema), which causes difficulty breathing
• collapse
• chest painin the context of allergic reactions, which can be a symptom of an allergic-induced heart attack (Kounis syndrome).

Colitis

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

Acute pancreatitis

If you have intense and persistent pain in the stomach area, this could be a sign of acute pancreatitis.

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 taking the medication). Other symptoms may include abdominal pain, lethargy, diarrhea, and low blood pressure.

• Contact yourdoctor as soon as possibleso they can advise you if you experience these symptoms.

Common side effects

May affectup to 1 in 10 people

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

Uncommon side effects

May affect up to1 in 100 people

• skin rash, itching
• increased pruritic rash (urticarial hives)
• nausea, especially whenhigh doses are administered

?if this happensadministeramoxicillin/clavulanic acid before meals

• vomiting
• indigestion
• dizziness
• headache.

Uncommon side effects that may appear in blood tests:

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

Rare side effects

May affect up to1 in 1,000 people

• skin rash, whichmayform 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 symptomscontact a doctor urgently

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

Uncommon side effects that may appear in blood tests:

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

Unknown frequency

The frequency cannot be estimated from the available data.

• allergic reactions (see above)
• colitis (see above)
• inflammation of the protective membrane surrounding the brain (aseptic meningitis)
• severe skin reactions:

• generalized 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)

• generalized rash with small blisters containing pus (exfoliative bullous dermatitis)

• red rash with bumps under the skin and blisters (pustular exanthema)
• flu-like symptoms with skin rash, fever, swollen glands, and abnormal blood test results (such as increased eosinophils and elevated liver enzymes) (drug reaction with eosinophilia and systemic symptoms (DRESS)).

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

• inflammation of the liver (hepatitis)
• jaundice, caused by increased bilirubin in the blood (a substance produced by the liver) that can turn the skin and white of the eyes yellow
• inflammation of the kidney tubules
• delayed blood clotting
• seizures (in patients taking high doses of Amoxicilina/ácido clavulánico or with kidney problems)
• rash with blistersarranged in a circle with a central crust or as a pearl necklace (IgA linear disease)
• inflammationof the membranes surrounding the brain and spinal cord (aseptic meningitis)

Side 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 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 the Spanish System for the 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, nurse, or pharmacist. The doctor, pharmacist, or nurse will reconstitute the medication, which must be used within 20 minutes after reconstitution.

Do not store at a temperature above25ºC. Store in the original packaging to protect it from light.

Keep out of the sight and reach of children.

Do not use Amoxicilina/Ácido clavulánico NORMON 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. Dispose of packaging and unused medications at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. In this way, you will help protect the environment.

Composition ofAmoxicillin/Clavulanic Acid NORMON

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

No excipients are present.However, see section 2 for important information on the sodium and potassium content of Amoxicillin/Clavulanic Acid NORMON.

The doctor, nurse, or pharmacist will prepare the injection before administration, using an appropriate liquid (such as water for injection or a liquid for injection and infusion).

Appearance of the product and contents of the package

Vials containing a sterile white to off-white powder.

Packages of 1 and 100 vials.

Holder of the marketing authorization and responsible for manufacturing

Laboratorios Normon, S.A.

Ronda de Valdecarrizo, 6 – 28760

Tres Cantos – Madrid (SPAIN)

Date of the last review of this leaflet:April 2023

The detailed and updated information on this medication 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 solely for doctors or healthcare professionals:

Please see the Technical Dossier for additional information

Administration

Amoxicillin/Clavulanic Acid NORMON2,000 mg/200 mg powder for solution for infusion,should be administered by infusion over 30 - 40 minutes. Amoxicillin/Clavulanic Acid NORMON is not suitable for intramuscular administration.

Reconstitution

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

Amoxicillin/Clavulanic Acid NORMON 2,000 mg/200 mg should be reconstituted in 20 ml of water for injection (this is a minimum volume). A pinkish color may be observed during reconstitution. The reconstituted solutions are normally colorless or pale yellow.

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

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 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 NORMON SHOULD NOT BE MIXED IN THE SAME SYRINGE WITH AMINOGLYCOSIDE ANTIBIOTICS, AS IT MAY RESULT IN A LOSS OF ACTIVITY OF THE AMINOGLYCOSIDE.

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

Stability of prepared solutions

Reconstituted vials (before dilution for infusion)

The solution obtained after reconstituting the vial with20ml ofwater for injection, has been demonstrated to be chemically and physically stable for20minutes at25°C?2°C/ 60%?5% HR.

Reconstituted and diluted vials for infusion

The solution obtained by immediately dilutingthe reconstituted vialwith100ml ofwater for injectionorNaCl 0.9% or lactate 1/6M or Ringer's solution or Hartmann's solutionhas been demonstrated to be chemically and physically stable for60minutes at25°C?2°C/ 60%?5% HR.