VANGOZYR 125 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the Patient

Vangozyr 125 mg Hard Capsules

Vangozyr 250 mg Hard Capsules

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 further questions, ask your doctor or pharmacist.
• 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Vangozyr and what is it used for
2. What you need to know before you take Vangozyr
3. How to take Vangozyr
4. Possible side effects
5. Storage of Vangozyr
6. Contents of the pack and other information

1. What is Vangozyr and what is it used for

• 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 that you follow the instructions regarding the dose, administration interval, and treatment duration indicated by your doctor.
• Do not store or reuse this medicine. If you have any leftover antibiotic after finishing the treatment, return it to the pharmacy for proper disposal. Do not throw away medicines via wastewater or household waste.

Vancomycin is an antibiotic that belongs to the group of "glycopeptides" and works by eliminating certain bacteria that cause infections.

It is used in adults and adolescents from 12 years of age for the treatment of infections of the mucosa of the small intestine and the large intestine (pseudomembranous colitis), caused by the bacterium Clostridium difficile.

2. What you need to know before you take Vangozyr

Do not take Vancomycin

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

Warnings and precautions

Talk to your doctor or pharmacist before taking vancomycin:

• If you have kidney problems, especially if you are currently taking other medicines that may affect the kidneys (see "Other medicines and vancomycin" below), because vancomycin can cause kidney damage;
• If you have an inflammatory disorder of the digestive tract (you may be at risk of experiencing side effects, especially if you also have a kidney disorder).
• If you have a hearing disorder (you may need a hearing test during treatment);
• If you are taking vancomycin for a long time (you may develop another type of infection)
• If you have ever developed a severe skin rash or skin peeling, blistering and/or sores in the mouth after taking vancomycin. Serious skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash 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 medical attention immediately if you notice any of the symptoms described in section 4.

Children and adolescents

Vancomycin capsules are not suitable for children under 12 years of age or for adolescents who are unable to swallow them. Other formulations of this medicine may be more suitable for children; consult your doctor or pharmacist.

Other medicines and vancomycin

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

In particular, tell your doctor if you are currently taking the following medicines, as they may interact with vancomycin:

• medicines that may affect the kidneys, because vancomycin can cause kidney damage
• medicines such as proton pump inhibitors (omeprazole, lansoprazole, etc.) and anti-motility agents (loperamide, diphenoxylate, etc.)
• medicines that may affect hearing (aminoglycosides, etc.)

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Talk to your doctor before starting treatment with this medicine if you are breastfeeding. This is because vancomycin passes into breast milk.

Driving and using machines

On rare occasions, vancomycin may cause dizziness and drowsiness. Do not drive or operate machinery if you experience any of these effects.

3. How to take Vangozyr

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose is:

Adults and adolescents (from 12 years and older)

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

If you have previously suffered other episodes (mucosal infection), the dose and treatment duration may be different.

Method of administration

For oral use.

Take the capsules whole with water.

The usual treatment duration is 10 days, but it may be different depending on the individual response of each patient.

If you take more Vangozyr than you should

If you take more capsules than prescribed, seek medical attention immediately.

If you forget to take Vangozyr

Do not take a double dose to make up for forgotten doses. Simply continue taking the capsules as before.

If you stop taking Vangozyr

You must continue treatment with vancomycin as prescribed by your doctor or pharmacist. If you stop taking vancomycin without completing the treatment, there may be a risk that you will feel worse again.

If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

The absorption of oral vancomycin from the gastrointestinal tract is insignificant. Therefore, side effects after ingestion of capsules are unlikely.

However, if you have an inflammatory disorder of the digestive tract and especially if you also have a kidney disorder, the side effects are similar to those that occur when administered by intravenous infusion. Therefore, the side effects and their frequencies reported for vancomycin administered as an infusion are included.

Stop taking vancomycin and seek medical attention immediately if you notice any of the following symptoms:

• Reddish patches, not raised, in a target or circular shape on the trunk, often with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome and toxic epidermal necrolysis).
• Widespread rash, high body temperature, and enlarged lymph nodes (DRESS or drug hypersensitivity syndrome).
• Red, scaly, and widespread rash with bumps under the skin and blisters, accompanied by fever at the start of treatment (acute generalized exanthematous pustulosis).

Frequent (may affect up to 1 in 10 people):

• Drop in blood pressure
• Shortness of breath, wheezing (a high-pitched sound produced by obstruction of air flow in the upper airway)
• Rash, inflammation of the mouth mucosa, itching, itchy rash, hives.
• Kidney problems that can be detected by blood tests.
• Reddening of the upper body and face.

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

• Temporary or permanent hearing loss

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

• Decrease in white blood cells and platelets (cells responsible for blood clotting)
• Increase in some white blood cells in the blood.
• Loss of balance, ringing in the ears, dizziness.
• Inflammation of blood vessels
• Nausea (feeling of discomfort)
• Inflammation of the kidneys and kidney failure.
• Chest and back muscle pain.
• Fever, chills

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

• Sudden appearance of a severe allergic reaction in the skin, with peeling and blistering. It may be associated with high fever and joint pain.
• Cardiac arrest
• Inflammation in the intestine, which causes abdominal pain and diarrhea (which may contain blood).

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

• Vomiting, diarrhea
• Confusion, drowsiness, lack of energy, swelling, fluid retention, decreased urine output.
• Rash with swelling or pain behind the ears, in the neck, groin, under the chin, and armpits (lymph node inflammation), abnormal blood and liver function tests
• Rash with blisters and fever.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Healthcare Products Agency's website: https://www.notificaram.es.By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Vancomycin

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

Do not use this medicine after the expiry date which is stated on the carton, after "EXP". The expiry date refers to the last day of the month shown.

Do not store above 25 °C.

Medicines should not be disposed of via wastewater or household waste. Return unused medicines to the pharmacy. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Medical advice/education

Antibiotics are used to cure bacterial infections. They are ineffective against viral infections. If your doctor has prescribed antibiotics, you need them precisely for your current illness.

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

Misuse of antibiotics increases resistance. You can contribute to bacteria becoming resistant and thus delay your recovery or reduce the effectiveness of antibiotics if you do not properly follow:

• the dose
• the schedule
• the treatment duration

Therefore, to preserve the effectiveness of this medicine:

1. Use antibiotics only when they are prescribed for you.
2. Follow the prescription instructions strictly.
3. Do not reuse an antibiotic without a medical prescription, even if you want to treat a similar illness.
4. Never give your antibiotic to another person; it may not be suitable for their illness.
5. After completing the treatment, return all unused medicines to the pharmacy to ensure they are disposed of correctly.

Composition of Vangozyr

• The active substance is vancomycin hydrochloride.

Each hard capsule contains 125 mg of vancomycin or 250 mg of vancomycin.

• The other ingredients are: polyethylene glycol (macrogol) 6000, the capsule shell is made of gelatin and colorants: yellow iron oxide (E172), red iron oxide (E172), titanium dioxide (E171), black iron oxide (E172).

Appearance of the product and pack contents

The 125 mg capsules are hard gelatin capsules of gray/pink color containing a white to off-white liquid mixture as a solid mass.

The 250 mg capsules are hard gelatin capsules of brown color containing a white to off-white liquid mixture as a solid mass.

Packs containing 4, 12, 20, 28, or 30 hard capsules.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

MABO-FARMA, S.A.

C/ Rejas 2, planta 1 - Coslada – 28821, Spain

Manufacturer

Dr. Friedrich Eberth Arzneimittel GmbH

Am Bahnhof 2

92289 Ursensollen, Germany

Or

Fairmed Healthcare GmbH,

Maria-Goeppert-Strasse 3, Luebeck,

Schleswig Holstein, 23562, Germany

This medicine is authorized in the Member States of the European Economic Area under the following names:

Denmark Vancomycin Strides

Finland Vancomycin Strides 125/250 mg hard capsules

Norway Vancomycin Strides

Sweden Vancomycin Strides

Austria Vancomycin Strides 125/250 mg hard capsules

Spain Vangozyr 125 mg hard capsules

Vangozyr 250 mg hard capsules

Date of last revision of this leaflet: February 2025

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