Amoxicillin/clavulanic acid Normon 500 mg/50 mg powder for injection and for infusion EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Amoxicillin/Clavulanic acid NORMON 500 mg/50 mg powder for injectable solution and for 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, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if such effects are not listed in this leaflet. See section 4.

Contents of the leaflet:

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

Contents of the pack and other information

1. What AMOXICILINA/ÁCIDO CLAVULÁNICO NORMON is and what it is used for

Amoxicilina/Ácido clavulánico NORMON is an antibiotic that kills bacteria causing infections. It contains two different active substances called amoxicillin and clavulanic acid. Amoxicillin belongs to a group of medicines known as "penicillins," which sometimes may 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 flu or the common cold.

It is important that you follow your doctor's instructions regarding dosage, administration, and duration of treatment.

Do not store or reuse this medicine. If you have any antibiotic left over after completing treatment, return it to the pharmacy for proper disposal. Do not dispose of medicines via the sink or in household waste.

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.

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

Do not use Amoxicillin/Clavulanic Acid NORMON:

• if you are allergic to amoxicillin, clavulanic acid, penicillins, or any of the other ingredients of this medicine (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) while taking an antibiotic.

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

Warnings and precautions

Talk to 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 whether any of the above conditions 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, they may prescribe a different formulation of amoxicillin/clavulanic acid or another medicine.

Symptoms to watch for

Amoxicillin/clavulanic acid may worsen certain pre-existing conditions or cause serious adverse 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 complications. See “Symptoms to watch for” in section 4.

Blood and urine tests

If you are undergoing blood tests (such as studies of red blood cell status or liver function tests) or urine tests (to monitor glucose levels), inform your doctor or nurse that you are being administered amoxicillin/clavulanic acid. This is because amoxicillin/clavulanic acid may alter the results of these types of tests.

Other medicines and Amoxicillin/Clavulanic Acid NORMON

Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might need to take any other medicines.

If you are taking allopurinol (used for gout) with amoxicillin/clavulanic acid, you may be more likely to develop a skin allergic reaction.

If you are taking probenecid (used for gout), your doctor may adjust your dose of amoxicillin/clavulanic acid. Concomitant use of probenecid may reduce the excretion of amoxicillin and is not recommended.

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

Amoxicillin/clavulanic acid may affect how methotrexate (a medicine used to treat cancer and severe psoriasis) works. Penicillins may reduce methotrexate excretion and potentially increase adverse effects.

Amoxicillin/clavulanic acid may affect how 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 become pregnant, consult your doctor, pharmacist, or nurse before using this medicine.

Driving and using machines

Amoxicillin/clavulanic acid may cause adverse effects that could impair your ability to drive.

Do not drive or operate machinery unless you feel well.

Amoxicillin/Clavulanic Acid NORMON contains sodium and potassium

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

• This medicine contains less than 39 mg (1 mmol) of potassium per vial and is therefore considered “potassium-free”.

3. How to use AMOXICILLIN/CLAVULANIC ACID NORMON

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 adjusted. Your doctor may choose a different formulation or another medicine.
• If you have liver problems, you will have blood tests more frequently to monitor how well your liver is working.

How Amoxicillin/Clavulanic acid NORMON will be administered to you

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

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 received an overdose, tell your doctor, pharmacist, or nurse immediately. Symptoms may include stomach discomfort (nausea, vomiting, or diarrhoea) or seizures.

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them. The following adverse effects may occur with this medicine.

Symptoms to watch for

Allergic reactions:

• skin rash

• inflammation of blood vessels (vasculitis), which may appear as red or purple spots on the skin, but may 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), causing difficulty breathing

• collapse

• chest pain in the context of allergic reactions, which may be a symptom of a heart attack triggered by allergy (Kounis syndrome).

• Contact your doctor immediately if you experience any of these symptoms. Stop taking Amoxicillin/Clavulanic Acid NORMON.

Inflammation of the large intestine

Inflammation of the large intestine, causing watery diarrhoea, usually with blood and mucus, stomach pain and/or fever.

Acute inflammation of the pancreas (acute pancreatitis)

If you have severe and persistent pain in the stomach area, 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 type of allergic reaction with the main symptom being repeated vomiting (1–4 hours after taking the medicine). Other symptoms may include abdominal pain, lethargy, diarrhoea, and low blood pressure.

• Contact your doctor as soon as possible for advice if you experience these symptoms.

Common adverse effects

May affect up to 1 in 10 people

• thrush (Candida – fungal infection in the vagina, mouth, or mucous membranes)
• diarrhoea

Uncommon adverse effects

May affect up to 1 in 100 people

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

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

• vomiting
• indigestion
• dizziness
• headache

Uncommon adverse effects that may appear in blood tests:

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

Rare adverse effects

May affect up to 1 in 1,000 people

• skin rash, which may blister and resemble small targets (a dark central spot surrounded by a paler 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 tender to touch

Rare adverse effects that may appear in blood tests:

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

Frequency not known

• Frequency cannot be estimated from the available data.

• allergic reactions (see above)

• inflammation of the large intestine (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 skin peeling (more than 30% of body surface – toxic epidermal necrolysis)

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

• red rash with bumps under the skin and blisters (exanthematous pustulosis)

• flu-like symptoms with skin rash, fever, swollen glands, 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 experience any of these symptoms.

• inflammation of the liver (hepatitis)

• jaundice, caused by increased bilirubin in the blood (a substance produced by the liver), which may cause the skin and whites of the eyes to turn yellow

• inflammation of the kidney tubules

• delayed blood clotting

• seizures (in patients taking high doses of Amoxicillin/Clavulanic Acid or who have kidney problems)

• blistering rash arranged in circles with a central crust or resembling a string of pearls (linear IgA disease)

• inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis)

Adverse effects that may appear in blood or urine tests:

• significant decrease in the number of white blood cells
• low red blood cell count (haemolytic anaemia)
• crystals in the urine causing acute kidney injury.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaRAM.es. By reporting adverse 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 physician, nurse, or pharmacist. The physician, pharmacist, or nurse will reconstitute your medicine, which must be used within 20 minutes after 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 packaging. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This way, you will help protect the environment.

6. Contents of the container and other information

Composition of Amoxicillin/Clavulanic acid NORMON

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

It contains no excipients. However, see section 2 for important information regarding the sodium and potassium content of Amoxicillin/Clavulanic acid NORMON.

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

Appearance of the product and contents of the container

Vials containing a sterile white to off-white powder.

Packaging: 1 vial.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.
Ronda de Valdecarrizo, 6 – 28760
Tres Cantos – Madrid (SPAIN)

Date of the most recent revision of this leaflet: April 2023

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

This information is intended for healthcare professionals only:

Please refer to the Summary of Product Characteristics for additional information

Administration

Amoxicillin/Clavulanic acid NORMON 500 mg/50 mg powder for injectable solution and for infusion may be administered by slow intravenous injection over a period of 3 to 4 minutes directly into a vein or by infusion over 30–40 minutes. Amoxicillin/Clavulanic acid NORMON is not suitable for intramuscular administration.

Reconstitution

Reconstitution of the solution for intravenous injection or reconstitution and dilution of the solution for infusion must be carried out 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 yields approximately 10.5 mL of solution for single-dose use. A pale pink coloration may be observed during reconstitution. Reconstituted solutions are normally colorless or slightly 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 must be added to 50 mL of infusion fluid using a minibag or inline burette.

Glucose (dextrose), sodium bicarbonate, or dextran injectable solutions must not be used as solvents.

In general, it is recommended not to mix this product with any other medicinal 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, and mannitol solutions.

AMOXICILLIN/CLAVULANIC ACID NORMON MUST NOT BE MIXED IN THE SAME SYRINGE WITH AMINOGLYCOSIDE ANTIBIOTICS, AS THIS MAY RESULT IN LOSS OF AMINOGLYCOSIDE ACTIVITY.

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

Stability of prepared solutions

Reconstituted vials (for intravenous injection or prior to dilution for infusion)

The solution obtained after reconstitution of the vial with 10 mL of water for injections has been shown to be chemically and physically stable for 20 minutes at 25 °C ± 2°C / 60% ± 5% RH.

Reconstituted and diluted vials for infusion

Reconstitution of the vial (see previous section).

The solution obtained by immediately diluting the reconstituted vial with 50 mL of water for injections Ph. Eur., 0.9% NaCl, 1/6 M sodium lactate, 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% RH.