Vancomycin Normon 500 mg powder for concentrate for solution for infusion EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Vancomycin Normon 500 mg powder for concentrate for solution for infusion EFG

Hydrochloride vancomycin

Read all of this 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, ask your doctor or pharmacist.
• 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 think any of the side effects you experience is severe or if you notice any side effects not mentioned in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of the leaflet

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 group of "glycopeptides" 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 the flu or the common cold. It is important to follow your doctor's instructions regarding dosage, dosing interval, and duration of treatment. Do not store or reuse this medicine. If you have any antibiotic left over after completing the treatment, return it to the pharmacy for proper disposal. Medicines must not be disposed of via wastewater or household waste.

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 mucosal infection of the intestine, small intestine, and large intestine with mucosal damage (pseudomembranous colitis) caused by the bacterium Clostridioides difficile.

2. What you need to know before starting to use 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

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

Talk to your doctor, hospital pharmacist, or nurse before starting 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 will need blood tests and kidney function tests during treatment).
• You are receiving vancomycin by intravenous 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 have been reported, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP), associated 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 emergency medical services right away if you experience any of these signs.

Talk to 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 treatment with 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 may accumulate vancomycin 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, and therefore more frequent kidney and blood tests may be required.

Using vancomycin with other medicines

Tell 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, itching, hypotension, fainting, or even cardiac arrest.

Therefore, you must inform your doctor that you are taking vancomycin if you are scheduled for surgery.

• Any medicine that affects the nerves or kidneys, for example, amphotericin B (to treat 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 safe to continue receiving vancomycin, and your doctor will decide what is appropriate 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 must 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 must not exceed 2 g.

If you have experienced previous 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 must 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 is administered intravenously over at least 60 minutes.

If it is administered to treat gastrointestinal disorders (called pseudomembranous colitis), the medication must 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 to you during your hospital stay, it is unlikely that you will receive too little or too much medication; however, inform your doctor or nurse if you have any concerns.

If you have any further questions about the use of this medicine, 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 serious 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:

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

• Generalized rash, elevated 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 (generalized pustular eruption).

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

Vancomycin absorption from the gastrointestinal tract is negligible. However, if you have an inflammatory disorder of the digestive tract, especially if you also have renal impairment, 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).
• Skin 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.
• Chest and back muscle pain.
• 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.
• Intestinal inflammation 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. Conservation of Vancomycin Normon

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

Do not use this medicine after the expiry date stated on the container. The expiry date refers to the last day of that month.

Special storage precautions:

Vancomycin Norm combustible be stored under refrigeration (2°C – 8°C). Keep the vial in the outer carton to protect from light.

For storage conditions after reconstitution of the medicinal product, see section 6.3.

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 refers to the last day of the month indicated.

Before reconstitution, store below 30 °C.

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

After reconstitution, 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 portion of this medicine after your dose has been administered.

Medicines must not be disposed of via wastewater or household waste. Return unused containers and medicines to your pharmacy’s SIGRE collection point. 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 500 mg of vancomycin hydrochloride, equivalent to 500,000 IU of vancomycin. It also contains hydrochloric acid.

Appearance of the product and contents of the pack

12 ml vials with rubber stoppers containing 500 mg of vancomycin hydrochloride as a white or almost white lyophilized powder. Pack sizes: 1 or 100 vials.

Only certain pack sizes may be commercially available.

After reconstitution with water, the solution of this medicine is transparent, colorless or slightly colored.

Marketing Authorization Holder and Manufacturer

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

Date of latest revision of this leaflet: January 2026

Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).

You can access detailed information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/85652/P_85652.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 antibiotics, 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 the appropriate:

• dosage,
• schedule,
• 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 10 ml of sterile water for injection. Dilute the reconstituted solution with at least 100 ml of sodium chloride 9 mg/ml (0.9%) for injection or glucose 50 mg/ml (5%) for injection.

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

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

Before administration, reconstituted solutions should be visually inspected for the presence of particles or discoloration. Only clear, colorless solutions without particles should be used.

The infusion must not be mixed with other medicines.

Oral route:

The oral dose 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:

The dose should 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 in 2 to 4 divided doses.

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

Oral route:

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 it 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 route:

Should be taken immediately after reconstitution.