Vancomycin Normon 1000 mg powder for concentrate for infusion solution EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Vancomycin Normon 1000 mg powder for concentrate for solution for infusion EFG

Vancomycin hydrochloride

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you consider any of the side effects you experience to be severe, or if you notice any side effect not mentioned in this leaflet, see section 4.

Leaflet contents

1. What Vancomycin Normon is and what it is used for
2. What you need to know before using Vancomycin Normon
3. How to use Vancomycin Normon
4. Possible side effects
5. How to store Vancomycin Normon
6. Contents of the pack and other information

1. What Vancomicina Normon is and what it is used for

This medicine is an antibiotic belonging to the "glycopeptides" group and works by eliminating certain bacteria that cause infections.

Vancomycin powder is converted into a solution for infusion or an oral solution.

Antibiotics are used to treat bacterial infections and are not effective against viral infections such as influenza or the common cold. It is important to follow your doctor's instructions regarding dosage, dosing intervals, and duration of treatment. Do not store or reuse this medicine. If you have leftover antibiotics after completing the treatment, return them to the pharmacy for proper disposal. Do not dispose of medicines by flushing them down the drain or throwing them in the trash.

Vancomycin is used in all age groups by intravenous infusion for the treatment of the following serious infections:

• Skin and soft tissue infections.
• Bone and joint infections.
• A lung infection called "pneumonia".
• Infection of the inner lining of the heart (endocarditis), and for prevention of endocarditis in at-risk patients undergoing major surgical procedures.
• Infection of the central nervous system.
• Bloodstream infection associated with the infections listed above.

Vancomycin may be administered orally in adults and children for the treatment of infection of the intestinal mucosa, small intestine, and large intestine with mucosal damage (pseudomembranous colitis), caused by the bacterium Clostridioides difficile.

2. What you need to know before using Vancomycin Normon

Do not use Vancomycin Normon

• If you are allergic to vancomycin or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Serious side effects leading to vision loss have been reported following injection of vancomycin into the eyes.

Consult your doctor, hospital pharmacist, or nurse before starting to use vancomycin if:

• You have had an allergic reaction to teicoplanin, as this may mean you are also allergic to vancomycin.
• You have a hearing problem, especially if you are elderly (you may need hearing tests during treatment).
• You have kidney problems (you may need blood tests and kidney function tests during treatment).
• You are receiving vancomycin by infusion for the treatment of Clostridioides difficile-associated diarrhea rather than orally.
• You have ever developed a severe rash or skin peeling, blisters, and/or mouth sores after taking vancomycin.

Serious skin reactions including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP) have been reported in association with vancomycin treatment. Stop using vancomycin and seek immediate medical attention if you notice any of the symptoms described in section 4.

Allergic reactions to this medicine, including breathing difficulties and chest pain, have been reported with vancomycin. Stop taking vancomycin immediately and contact your doctor or medical emergency services right away if you experience any of these signs.

Consult your doctor, hospital pharmacist, or nurse during treatment with vancomycin if:

• You are receiving vancomycin for a prolonged period (you may need blood tests and tests to monitor liver or kidney function during treatment).
• You develop any skin reaction during treatment.
• Contact your doctor immediately if you develop severe or chronic diarrhea during or after taking vancomycin. This may be a sign of intestinal inflammation (pseudomembranous colitis), which can occur after antibiotic treatment.

Children

Vancomycin is used with special caution in premature infants and young babies because their kidneys are not fully developed and vancomycin may accumulate in the blood. Blood tests are performed to monitor vancomycin levels in this age group.

Concurrent administration of vancomycin and anesthetic agents has been associated with skin redness (erythema) and allergic reactions in children. Similarly, concomitant use with other medicines such as aminoglycoside antibiotics, non-steroidal anti-inflammatory drugs (NSAIDs, e.g., ibuprofen), or amphotericin B (a medicine used to treat fungal infections) may increase the risk of kidney damage; therefore, more frequent kidney and blood tests may be required.

Using Vancomycin with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This is especially important for the following medicines, as they may interact with vancomycin:

• Anesthetic agents – may cause flushing, redness, dizziness, fainting, or even cardiac arrest.

Therefore, you should inform your doctor that you are taking vancomycin if you are undergoing surgery.

• Any medicine affecting the nerves or kidneys, for example, amphotericin B (for treating fungal infections), aminoglycosides, bacitracin, polymyxin B, colistin, viomycin, piperacillin/tazobactam (antibiotics), or cisplatin (a chemotherapeutic agent).
• Potent diuretics (strong medicines used to stimulate urine production), such as furosemide.

It may still be appropriate for you to continue receiving vancomycin, and your doctor will decide what is best for you.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before taking this medicine.

Driving and using machines

Vancomycin is not expected to affect your ability to drive or operate machinery.

3. How to use Vancomycin Normon

Medical personnel will administer vancomycin to you during your hospital stay. Your doctor will decide the amount of medication you should receive each day and how long the treatment will last.

Dosage

The dose administered will depend on:

• your age,
• your weight,
• the infection you have,
• kidney function,
• your hearing ability,
• any other medications you are taking.

Intravenous administration

Adults and adolescents (12 years of age and older)

The dose will be calculated according to your body weight. The usual infusion dose is 15 to 20 mg per kg of body weight. It is generally administered every 8–12 hours. In some cases, the doctor may decide to give an initial dose of up to 30 mg per kg of body weight. The maximum daily dose should not exceed 2 g.

Use in children

Children between one month and less than 12 years of age

The dose will be calculated according to body weight. The usual infusion dose is 10 to 15 mg per kg of body weight. It is generally administered every 6 hours.

Premature newborns and full-term newborns (0 to 27 days of age)

The dose will be calculated according to postmenstrual age [time elapsed between the first day of the last menstrual period and birth (gestational age) plus the time elapsed after birth (postnatal age)].

Elderly patients, pregnant women, and patients with kidney disorders, including those on dialysis, may require a different dose.

Oral administration

Adults and adolescents (12 to 18 years of age)

The recommended dose is 125 mg every 6 hours. In some cases, the doctor may decide to increase the daily dose up to 500 mg every 6 hours. The maximum daily dose should not exceed 2 g.

If you have previously experienced other episodes (mucosal infection), you may require a different dose and duration of therapy.

Use in children

Neonates, infants, and children under 12 years of age

The recommended dose is 10 mg per kg of body weight. It is generally administered every 6 hours. The maximum daily dose should not exceed 2 g.

Method of administration

Intravenous infusion means that the medication flows from an infusion bottle or bag through a tube into one of your blood vessels and into your body. Your doctor or nurse will always administer vancomycin into the bloodstream and never into the muscle.

Vancomycin must be administered intravenously over at least 60 minutes.

If it is administered to treat gastrointestinal disorders (called pseudomembranous colitis), the medication should be given as an oral solution (you will take the medication by mouth).

Duration of treatment

The duration of treatment depends on the infection and may last several weeks.

The duration of treatment may vary depending on the individual patient's response to therapy.

During treatment, blood samples, urine samples, and possibly hearing tests should be performed to monitor for signs of potential side effects.

If you are given more vancomycin than you should

Since vancomycin will be administered during your hospital stay, it is unlikely that you will receive too little or too much. However, inform your doctor or nurse if you have any concerns.

If you have any further questions about the use of this medication, ask your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Vancomycin may cause allergic reactions, although severe allergic reactions (anaphylactic shock) are rare. Inform your doctor immediately if you notice sudden wheezing, difficulty breathing, redness of the upper body, skin rash, or itching.

Stop using vancomycin and seek immediate medical attention if you notice any of the following symptoms:

• Flat, red spots resembling targets or circles on the trunk, often with central blisters, skin peeling, mouth, throat, nose, genital, or eye ulcers. These severe skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome and toxic epidermal necrolysis).

• Generalized rash, high body temperature, and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

• Widespread red, scaly rash with bumps under the skin and blisters accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis).

• Chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome.

Absorption of vancomycin from the gastrointestinal tract is negligible. However, if you have an inflammatory disorder of the digestive tract, especially if you also have kidney problems, side effects may occur that are typically seen when vancomycin is administered by infusion.

Common adverse effects (may affect up to 1 in 10 people):

• Drop in blood pressure.
• Shortness of breath, noisy breathing (a high-pitched sound caused by obstruction of airflow in the upper airway).
• Rash and inflammation of the mouth mucosa, itching, itchy rash, hives.
• Kidney problems detectable by blood tests.
• Redness of the upper body and face, inflammation of a vein.
• Increased liver enzymes.

Uncommon adverse effects (may affect up to 1 in 100 people):

• Temporary or permanent hearing loss.

Rare adverse effects (may affect up to 1 in 1,000 people):

• Decrease in white blood cells, red blood cells, and platelets (cells responsible for blood clotting).
• Increase in certain white blood cells.
• Loss of balance, ringing in the ears, dizziness.
• Inflammation of blood vessels.
• Nausea (feeling unwell).
• Inflammation of the kidneys and kidney failure.
• Pain in the chest and back muscles.
• Fever, chills.

Very rare adverse effects (may affect up to 1 in 10,000 people):

• Sudden onset of a severe allergic skin reaction with skin peeling or blistering. This may be associated with high fever and joint pain.
• Cardiac arrest.
• Inflammation of the intestine causing abdominal pain and diarrhea (which may contain blood).

Frequency not known (cannot be estimated from available data):

• Vomiting, diarrhea.
• Confusion, drowsiness, lack of energy, swelling, fluid retention, decreased urine output.
• Rash with swelling or pain behind the ears, neck, groin, under the chin, and armpits (swollen lymph nodes), abnormal blood tests and abnormal liver function tests.
• Rash with blisters and fever.
• Excessive destruction of red blood cells causing fatigue and pale skin (hemolytic anemia).

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: //www.notificaram.es/. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Vancomycin Normon

Vancomycin Normon should be stored at a temperature not exceeding 25°C. Keep the container tightly closed to protect from moisture. Keep the medicine out of the sight and reach of children. Do not use Vancomycin Normon after the expiry date stated on the container. The expiry date refers to the last day of the month indicated. Do not use if the packaging is damaged or shows signs of tampering. Store in the original packaging to protect from light. After reconstitution, the stability of the solution is as follows: use immediately or store under refrigeration (2°C–8°C) and use within 24 hours. Discard any unused portion. Keep the vial in the outer carton to protect from light.

Your doctor or pharmacist knows how to store this medicine.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the label after EXP. The expiry date is the last day of the month indicated.

Before preparation, store below 30 °C.

Keep the vial in the outer packaging to protect it from light.

After preparation, this intravenous medicine should be used immediately.

Your doctor will ensure that the solution is not discoloured and contains no particles.

Vials are for single use only, and your doctor will discard any unused solution of this medicine remaining after your dose has been administered.

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

6. Contents of the container and additional information

Composition of Vancomycin Normon

Each vial contains 1000 mg of vancomycin hydrochloride, equivalent to 1,000,000 IU of vancomycin. It also contains hydrochloric acid.

Appearance of the medicinal product and contents of the container

20 ml vials with a rubber stopper containing 1000 mg of vancomycin hydrochloride as a white or almost white lyophilized powder. Pack sizes: 1 or 100 vials.

Only certain pack sizes may be marketed.

After reconstitution with water, the solution of this medicine is transparent, colourless or slightly coloured.

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: January 2026

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).

You can access detailed information on this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer carton. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/

p/85651/P_85651.html

Other sources of information

Medical advice/education

Antibiotics are used to treat infections caused by bacteria. They are ineffective against infections caused by viruses.

If your doctor has prescribed antibiotics, you need them specifically to treat your current illness.

Despite antibiotic treatment, some bacteria may survive or grow. This phenomenon is known as resistance: some antibiotic treatments become ineffective.

Improper use of antibiotics increases resistance. You may even help bacteria become resistant and thus delay your recovery or reduce the effectiveness of antibiotics if you do not follow correctly:

• the dose,
• the schedule,
• the duration of treatment.

Therefore, to preserve the effectiveness of this medicine:

1. Use antibiotics only when prescribed.
2. Strictly follow the instructions provided in the prescription.
3. Do not reuse an antibiotic without a medical prescription, even if you wish to treat a similar illness.

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This information is intended for healthcare professionals only

Preparation

Dissolve the contents of the vial in 20 ml of sterile water for injection. Dilute the reconstituted solution with at least 200 ml of 9 mg/ml (0.9%) sodium chloride for injection or 50 mg/ml (5%) glucose for injection.

The concentration of vancomycin in the prepared infusion solution must not exceed 0.5% m/v (5 mg/ml).

In specific patients who require restriction of infused fluid volume, a concentration of 10 mg/ml may be used; however, administration of such higher concentrations may increase the risk of infusion-related adverse effects.

Before administration, reconstituted solutions should be inspected visually for particulate matter or discoloration. Only clear, colourless solutions without particles should be used.

The infusion must not be mixed with other medicinal products.

Oral administration:

The dose for oral administration may be reconstituted with 30 ml of water and given to the patient to drink.

Infusion

Must be administered by intravenous infusion over at least 60 minutes at a rate of 10 mg/min, equivalent to 2 ml/min for an infusion with a concentration of 5 mg/ml.

Dosage

Intravenous use:

Dosage must be individually adjusted according to renal function. The usual dosage is as follows:

Adults: 500 mg every 6 hours or 1 g every 12 hours administered by slow intravenous infusion, or 30 to 40 mg/kg/day given in 2 to 4 daily doses.

Children: 10 mg/kg body weight every 6 hours administered by slow intravenous infusion.

Oral use:

Adults: 125 mg every 6 hours or 500 mg every 6 hours administered orally.

Children: 10 mg/kg body weight every 6 hours.

Storage

Store below 30 °C. Keep the vial in the outer carton to protect from light.

Do not use this medicine after the expiry date stated on the packaging.

Reconstituted concentrate:

The reconstituted concentrate must be further diluted immediately after reconstitution.

Diluted product:

From a microbiological and physicochemical standpoint, the product should be used immediately.

Oral use:

Must be taken immediately after reconstitution.