AMOXICILLIN/CLAVULANIC ACID NORMON 500 mg/50 mg POWDER FOR INJECTABLE SOLUTION AND FOR INFUSION

Introduction

Package Leaflet: Information for the User

Amoxicillin/Clavulanic Acid NORMON 500 mg/50 mg Powder for Solution for Injection and Infusion EFG

Amoxicillin/Clavulanic Acid

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 others. It may harm them, even if their signs of illness are the same as yours.
• 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 Package Leaflet:

1. What is Amoxicillin/Clavulanic Acid NORMON and what is it used for
2. What you need to know before you use Amoxicillin/Clavulanic Acid NORMON
3. How to use Amoxicillin/Clavulanic Acid NORMON
4. Possible side effects
   1. Storage of Amoxicillin/Clavulanic Acid NORMON

Contents of the pack and other information

1. What is AMOXICILLIN/CLAVULANIC ACID NORMON and what is it used for

Amoxicillin/Clavulanic Acid NORMON is an antibiotic that eliminates the bacteria that cause infections. It contains two different drugs called amoxicillin and clavulanic acid. Amoxicillin belongs to the group of medicines known as "penicillins" which can sometimes lose their effectiveness (become 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 the flu or the common cold.

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

Do not store or reuse this medicine. If you have any leftover antibiotic after completing treatment, return it to the pharmacy for proper disposal. Do not throw medicines down the drain or in the trash.

Amoxicillin/Clavulanic Acid 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

Amoxicillin/Clavulanic Acid NORMON is used in adults and children to prevent infections associated with major surgical procedures.

2. What you need to know before you use AMOXICILLIN/CLAVULANIC ACID NORMON

Do not use Amoxicillin/Clavulanic Acid NORMON:

Do not receive Amoxicillin/Clavulanic Acid NORMON if any of the above applies to you. If you are unsure, consult your doctor, pharmacist, or nurse.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before receiving 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 if any of the above symptoms affect 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 be aware of

Amoxicillin/Clavulanic Acid can worsen certain existing conditions or cause serious side effects. These include allergic reactions, seizures, and inflammation of the large intestine. You should be aware of certain symptoms while taking amoxicillin/clavulanic acid 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 tests) or urine tests (to check glucose levels), inform your doctor or nurse that you are being given amoxicillin/clavulanic acid. This is because amoxicillin/clavulanic acid can alter the results of these types of tests.

Other medicines and Amoxicillin/Clavulanic Acid NORMON

Tell your doctor, pharmacist, or nurse if you are using, have recently used, or might use any other medicines.

If you are taking allopurinol (used for gout) with amoxicillin/clavulanic acid, 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 amoxicillin/clavulanic acid. Concomitant use of probenecid can reduce the excretion of amoxicillin and is not recommended.

If you are taking anticoagulants (such as warfarin) with amoxicillin/clavulanic acid, more blood tests will be needed.

Amoxicillin/Clavulanic Acid can affect the way metotrexate (a medicine used to treat cancer and severe psoriasis) works. Penicillins can reduce the excretion of metotrexate and cause a potential increase in side effects.

Amoxicillin/Clavulanic Acid can affect the way mycophenolate mofetil (a medicine 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 are planning to have a baby, ask your doctor, pharmacist, or nurse for advice before using this medicine.

Driving and using machines

Amoxicillin/Clavulanic Acid can have side effects that may make you unfit to drive or use machines.

Do not drive or operate machinery unless you are feeling well.

Amoxicillin/Clavulanic Acid NORMONcontains sodium and potassium

• This medicine contains 31.5 mg of sodium (a major component of cooking/table salt) per vial. This is equivalent to 1.6% of the maximum recommended daily intake of sodium for an adult.

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

3. How to use AMOXICILLIN/CLAVULANIC ACID NORMON

You will never administer this medicine to yourself. A qualified person, such as a doctor or nurse, will administer it to you.

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 formulation or another medicine.
• If you have liver problems, you will have more frequent blood tests to check how your liver is working.

How Amoxicillin/Clavulanic Acid NORMON will be administered to you

• Amoxicillin/Clavulanic Acid will be administered to you as an injection into a vein or by intravenous infusion.
• Make sure to drink plenty of fluids while receiving amoxicillin/clavulanic acid.
• Amoxicillin/Clavulanic Acid will not be administered to you for more than two weeks without your treatment being reviewed by your doctor.

If you are given more Amoxicillin/Clavulanic Acid NORMON than recommended

It is very unlikely that you will be given too much amoxicillin/clavulanic acid, but if you think you have been given too much, tell your doctor, pharmacist, or nurse immediately. Symptoms may include stomach upset (nausea, vomiting, or diarrhea) or seizures.

If you have any further questions on how this medicine is administered, ask your doctor, pharmacist, or nurse.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may occur with this medicine.

Symptoms to be aware of

Allergic reactions:

• skin rash
• inflammation of blood vessels (vasculitis) that can 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 can cause difficulty breathing
• collapse
• chest pain in the context of allergic reactions, which can be a symptom of allergy-induced heart attack (Kounis syndrome).

• Contact your doctor immediatelyif you experience any of these symptoms. Stop using Amoxicillin/Clavulanic Acid NORMON.

Inflammation of the large intestine

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

Acute inflammation of the pancreas (acute pancreatitis)

If you have severe and persistent stomach pain, this could be a sign of acute pancreatitis.

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 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 possiblefor advice if you have these symptoms.

Frequent side effects

May affect up to 1 in 10 people

• thrush (candida - fungal infection of the vagina, mouth, or mucous membranes)
• diarrhea

Uncommon side effects

May affect up to 1 in 100 people

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

If this happens, administer amoxicillin/clavulanic acid before meals

• vomiting
• indigestion
• dizziness
• headache.

Uncommon side effects that may appear in your blood tests:

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

Rare side effects

May affect up to 1 in 1,000 people

• skin rash, which can form blisters that look like small targets (central dark 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 side effects that may appear in your blood or urine tests:

• significant decrease in the number of white blood cells
• low red blood cell count (hemolytic anemia)

Unknown frequency

• The frequency cannot be estimated from the available data.
• allergic reactions (see above)
• inflammation of the protective membrane surrounding the brain (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 peeling of the skin (more than 30% of the body surface - toxic epidermal necrolysis)

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

• red rash with bumps under the skin and blisters (pustular exanthematous rash)
• flu-like symptoms with skin rash, fever, gland inflammation, and abnormal blood test results (such as increased white blood cells (eosinophilia) and elevated liver enzymes) (Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)).

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

• inflammation of the liver (hepatitis)
• jaundice, caused by an increase in bilirubin in the blood (a substance produced by the liver) that can make the skin and the whites of the eyes turn yellow
• inflammation of the kidney ducts
• delayed blood clotting
• seizures (in patients taking high doses of Amoxicillin/Clavulanic Acid or with kidney problems)
• skin rash with blisters arranged in a circle with a central crust or like a necklace (linear IgA disease)
• inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis).

Side effects that may appear in your blood or urine tests:

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

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of AMOXICILLIN/CLAVULANIC ACID NORMON

The expiry date and storage instructions on the label are for the information of the doctor, nurse, or pharmacist. The doctor, pharmacist, or nurse will reconstitute your medicine, which must be used within 20 minutes of reconstitution.

Do not store above 25°C. Keep in the original packaging to protect from light.

Keep out of the sight and reach of children.

Do not use Amoxicillin/Clavulanic Acid NORMON after the expiry date stated on the pack. The expiry date is the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. Return the packaging and any unused medicine to a pharmacy for proper disposal. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Container Content and Additional Information

Composition ofAmoxicillin/Clavulanic Acid NORMON

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

It does not contain excipients. However, see section 2 for important information about the sodium and potassium content of Amoxicillin/Clavulanic Acid NORMON.

The doctor, nurse, or pharmacist will prepare the injection before administration, using a suitable liquid (such as water for injectables or a liquid for injectables and perfusion).

Appearance of the Product and Container Content

Vials containing a sterile white to off-white powder.

Packaging of 1 vial.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760

Tres Cantos – Madrid (SPAIN)

Date of the Last Revision of this Prospectus:April 2023

Detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (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 solution for injection and perfusion can be administered by slow intravenous injection over a period of 3 to 4 minutes directly into a vein or by a drip for perfusion over 30 - 40 minutes. Amoxicillin/Clavulanic Acid NORMON is not suitable for intramuscular administration.

Reconstitution

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

Preparation of solutions for intravenous injection

The usual solvent is water for injectable preparations. 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 pale pink coloration may be observed during reconstitution. The reconstituted solutions are normally colorless or with a pale straw color.

Amoxicillin/Clavulanic Acid NORMON should be administered within 20 minutes after reconstitution.

Preparation of solutions for intravenous perfusion

Amoxicillin/Clavulanic Acid NORMON should be reconstituted as described above for injection. Immediatelyafter reconstitution, the solution should be added to 50 ml of perfusion fluid using a minibag or in-line burette.

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

In general, it is recommended not to mix it with any other product in the same syringe or perfusion 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 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 perfusion)

The solution obtained after reconstituting the vial with 10 ml of water for injectables 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 perfusion

Reconstitution of the vial (see previous section).

The solution obtained by diluting immediatelythe reconstituted vial with 50 ml of water for injectables Ph. Eur. or NaCl 0.9% or sodium 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.