PATIENT INFORMATION LEAFLET

Amoxicillin/Clavulanic Acid NORMON 1.000 mg/200 mg Powder for Injection and Infusion EFG

Amoxicillin/clavulanic acid

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 others 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.

Amoxicilina/Ácido clavulánico NORMON is an antibiotic that eliminates 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 inactive). 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, intake, 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.

Do not use 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 applies. 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 receiving amoxicilina/ácido clavulánico.

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

Symptoms to be aware of

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 certain symptoms while taking amoxicilina/ácido clavulánico to reduce the risk of problems. See “Symptoms to be aware of” 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 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 or have used recently or may have 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. Concomitant use of probenecid may reduce amoxicilina excretion 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 metotrexato (a medication for cancer and severe psoriasis) works. Penicilins may reduce metotrexato excretion and cause a potential increase in side effects.

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or intend to become 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 62.9 mg of sodium (main component of table salt/for cooking) in each vial. This is equivalent to 3.1% 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 (1.0 mmol) of potassium per vial.

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

The recommended 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 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 to administer this medication, 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 lymph nodes in the neck, armpits, or groin
• swelling 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 allergic-induced heart attack (Kounis syndrome).

• Contact your doctor immediatelyif you experience any of these symptoms.Stop administering Amoxicilina/ácido clavulánico NORMON.

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 abdominal area, this could be a sign of acute pancreatitis.

Drug-induced enterocolitis syndrome (DIES):

DIES has mainly been reported in children taking amoxicilina/clavulánico. It is a certain type of allergic reaction with the main symptom of repeated vomiting (1-4 hours after taking the medicine). Other symptoms may include abdominal pain, lethargy, diarrhea, and low blood pressure.

• Contact your doctor as soon as possibleso that they can advise you if you experience these symptoms.

Common side effects

May affect up to 1 in 10 people

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

Uncommon side effects

May affect up to 1 in 100 people

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

• ifyou experience this, administer Amoxicilina/Ácido clavulánico NORMON 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 to 1 in 1,000 people

• skin eruption, which may form blisters that appear as small dianas (point central dark area 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 the vein, which is extremely sensitive to the touch

Rare side effects that may appear in blood tests:

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

Unknown frequency

The frequency cannot be estimated from the available data.

• Allergic reactions (see above)
• Colitis (see above)
• 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 bumps under the skin and blisters (pustular exanthem)
  • 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)).

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

• Liver inflammation (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 tubes
• delayed blood clotting
• seizures (in patients taking high doses of Amoxicilina/ácido clavulánico or with kidney problems)
• skin eruption with blisters arranged in a circle with a central crust or as a pearl necklace (IgA linear disease)
• inflammation of 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 count of red blood cells (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 Pharmacovigilance of Medicines for Human Use:http://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 above 25°C. Store in the original packaging to protect it from light.

Keep out of the sight and reach of children.

Do not use Amoxicilina/Clavulanic Acid 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 of Amoxicillin/clavulanic acid NORMON

Each vial contains as active ingredients 1,000 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.

Marketing authorization holder and responsible manufacturer

Laboratorios NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760

Tres Cantos – Madrid (SPAIN)

Last review date of this prospectus: October 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 medical professionals or healthcare professionals:

Please see the Technical Data Sheet for additional information

Administration

Amoxicillin/clavulanic acid NORMON 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 NORMON is not suitable for intramuscular administration.

Reconstitution

The reconstitution of the intravenous injection solution or the reconstitution and dilution of the infusion solution should be performed at the time of administration.

Preparation of solutions for intravenous injection

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

Amoxicillin/clavulanic acid NORMON should be administered within 20 minutes after reconstitution.

Preparation of solutions for intravenous infusion

Amoxicillin/clavulanic acid NORMON 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 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 NORMON 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 NORMON are not suitable for multiple-dose use.

Stability of prepared solutions

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

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

Reconstituted and diluted vials for infusion

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