Prospect: information for the user

Amoxicillin/Clavulanic Acid NORMON 500 mg/50 mg powder for injectable solution and for infusion EFG

Amoxicillin/clavulanic acid

Read this prospect carefully before starting to use this medicine, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed only for you, and you must not give it to other people even if they present the same symptoms of illness as you, as it may harm them.
• If you experience adverse effects, consult your doctor, pharmacist, or nurse, even if they do not appear in this prospect. See section 4.

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

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

3.How to use Amoxicillin/Clavulanic Acid NORMON

4.Possible adverse effects

1. Storage of Amoxicillin/Clavulanic Acid NORMON

Contents of the package 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 may sometimes 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 the dosage, administration, and duration of treatment as indicated by your doctor.

Do not store or reuse this medication. If you have leftover antibiotic after completing treatment, return it to the pharmacy for proper disposal. Do not dispose of the medication 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 points apply to you.. If you are unsure, consult your doctor, pharmacist, or nurse.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before receiving 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, they may prescribe 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 receiving amoxicilina/ácido clavulánico. This is because amoxicilina/ácido clavulánico may affect 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 alopurinol (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, you will need more blood tests.

Amoxicilina/ácido clavulánico may affect the way metotrexato (a medication for cancer and severe psoriasis) works.Penicilinas may reduce the excretion of metotrexato 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, think you may be pregnant, or plan 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 are feeling well.

Amoxicilina/Ácido clavulánico NORMONcontains sodium and potassium

•This medication contains 31.5 mg of sodium (main component of table salt/for cooking) in each vial. This is equivalent to 1.6% of the maximum daily sodium intake recommended for an adult.

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•This medication contains less than 39 mg (1 mmol) of potassium per vial, so it is considered “potassium-free”.

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 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 two weeks without your doctor reviewing your treatment.

If you are administered more Amoxicilina/Ácido clavulánico NORMONthan recommended

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

If you have more 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 these 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 pain in the context of allergic reactions, which may be a symptom of an allergic-induced heart attack (Kounis syndrome).

Colitis

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

Acute pancreatitis

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

Drug-induced enterocolitis syndrome (DIES):

DIES has been mainly reported in children taking amoxicilina. 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 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 when high doses are administered

?if this happensadministeramoxicilina/ácido clavulánico before meals

• vomiting
• indigestion
• dizziness
• headache.

Uncommon side effects that may appear in blood tests:

• increase in some 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 available data.
• allergic reactions (see above)
• colitis (see above)
• information from the protective membrane surrounding the brain (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 (more than 30% of the body surface –toxic epidermal necrolysis)

• generalized rash with small blisters with 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.

• liver inflammation (hepatitis)
• jaundice, caused by increased bilirubin in the blood (a substance produced by the liver) that may 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 rashwith blisters arranged in a circle with a central crust or as a string of pearls (IgA linear disease)
• inflammation of the membranessurrounding 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 prospectus. You can also report them directly through the Spanish System for the Vigilance 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 the packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Amoxicillin/Clavulanic Acid NORMON

Cada vial contains as active ingredients 500 mg of amoxicillin ( as amoxicillin sodium ) and 50 mg of clavulanic acid (as potassium clavulanate).

No contains excipients. 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 vial.

Holder of the marketing authorization and responsible for manufacturing

Laboratorios NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760

Tres Cantos – Madrid (SPAIN)

Last review date of this leaflet: April 2023

The detailed and updated information on 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 Data Sheet for additional information

Administration

Amoxicillin/Clavulanic Acid NORMON 500 mg/50 mg powder for injection and infusion, 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 injection solution for intravenous administration 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 500 mg/50 mg should be dissolved in 10 ml of solvent. This results in approximately 10.5 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 50 ml of infusion fluid using a minibag or burette in line.

Do not use solutions for injection of glucose (dextrose), sodium bicarbonate, or dextran as solvents.

Generally, it is 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.

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

Stability of prepared solutions

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

The solution obtained after reconstitution of the vial with 10 ml of water for injection , has been shown to be stable from a chemical and physical point of view for 20 minutes at 25 °C ? 2°C/ 60% ? 5% HR.

Reconstituted and diluted vials for infusion

Reconstitution of the vial (see previous section).

The solution obtained by diluting immediately the reconstituted vial, with 50 ml of water for injection Ph. Eur. or NaCl 0.9% or lactate 1/6 M 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% HR.