Amoxicillin/clavulanic acid Normon 1000 mg/200 mg powder for solution for injection and for infusion EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Amoxicillin/Clavulanic acid NORMON 1,000 mg/200 mg powder for injectable solution and for infusion EFG

Amoxicillin/clavulanic acid

Read the entire 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 be harmful to them.
• If you experience any side effects, talk to your doctor, pharmacist or nurse, even if they are side effects not listed in this leaflet. See section 4.

Leaflet contents

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
5. How to store Amoxicillin/Clavulanic acid NORMON
6. Contents of the pack and other information

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

Amoxicillin/Clavulanic Acid 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 can sometimes become ineffective (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 your treatment, return it to the pharmacy for proper disposal. Medicines should not be disposed of via wastewater or household waste.

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 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 components 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 starting 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, you may be prescribed a different formulation of amoxicillin/clavulanic acid or another medicine.

Symptoms to watch out 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 out for” in section 4.

Blood and urine tests

If you are having 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

Tell your doctor, pharmacist, or nurse if you are using, have recently used, or might need to use 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 62.9 mg of sodium (the main component of table/cooking salt) per vial. This corresponds to 3.1% of the maximum recommended daily sodium intake for an adult.
• Patients with renal impairment or those on potassium-restricted diets should be aware that this medicine contains 39.2 mg (1.0 mmol) of potassium per vial.

3. How to use Amoxicillin/Clavulanic Acid Normon

This medication must never be self-administered. It will be administered by a qualified person, such as a doctor or nurse.

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 your liver is functioning.

How Amoxicillin/Clavulanic Acid NORMON will be administered

• 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 2 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 an overdose has occurred, tell your doctor, pharmacist, or nurse immediately. Symptoms may include gastrointestinal discomfort (nausea, vomiting, or diarrhea) or seizures.

If you have 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 91 562 04 20, indicating the medicine and the amount ingested.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences 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 administering 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/clavulanate. It is a certain 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 so they can advise you if you experience these symptoms.

Frequent 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 occurs, take Amoxicillin/Clavulanic acid NORMON before meals

• vomiting

• indigestion

• dizziness

• headache

Uncommon adverse effects that may appear in your 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 form blisters resembling small targets (dark central 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 adverse effects that may appear in your 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)

• 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 body surface – toxic epidermal necrolysis)
  • widespread rash with small pus-filled blisters (exfoliative bullous dermatitis)
  • red rash with bumps under the skin and blisters (exanthematic 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 have 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 kidney ducts

• delayed blood clotting

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

• blistering rash arranged in a ring 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 reduction 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 type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: http://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. Your medicine will be reconstituted by the physician, pharmacist, or nurse and 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 container. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point in your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.

6. Package Contents and Other Information

Composition of Amoxicillin/Clavulanic Acid NORMON

Each vial contains as active ingredients 1,000 mg of amoxicillin (as sodium amoxicillin) and 200 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 injection and infusion).

Appearance of the product and pack contents

Vials containing a sterile white to off-white powder.

Pack sizes: 1 and 100 vials.

Marketing Authorization Holder and Manufacturer

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

Date of the most recent review of this leaflet: October 2023

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of 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 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 performed immediately before administration.

Preparation of solutions for intravenous injection

The usual solvent is water for injectable preparations. 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 pale pink coloration may be observed during reconstitution. Reconstituted solutions are typically 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 in-line burette.

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

In general, it is recommended not to mix this product with any other medicine 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.

The vials of Amoxicillin/Clavulanic Acid NORMON 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 20 ml of Water for Injections Ph. Eur. has been shown to be chemically and physically stable for 20 minutes at 25°C ± 2°C / 60% ± 5% relative humidity.

Reconstituted and diluted vials for infusion

The solution obtained by immediately diluting the reconstituted vial with 100 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% relative humidity.