Vangozyr 125 mg hard capsules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Vangozyr 125 mg hard capsules

Vangozyr 250 mg hard capsules

vancomycin

Read the entire leaflet carefully before you start taking 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 or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Vangozyr is and what it is used for

• Antibiotics are used to treat bacterial infections and are not effective against viral infections such as influenza or the common cold.
• It is important that you follow your doctor's instructions regarding dose, dosing interval, and duration of treatment.
• Do not store or reuse this medicine. If you have any antibiotic left over after finishing treatment, return it to the pharmacy for proper disposal. Do not dispose of medicines via wastewater or household waste.

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

It is used in adults and adolescents aged 12 years and older for the treatment of infections of the mucosa of the small intestine and large intestine (pseudomembranous colitis) caused by the bacterium Clostridioides difficile.

2. What you need to know before starting to take Vangozyr

Do not take Vancomycin

• If you are allergic to vancomycin or to any of the other ingredients 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 may cause kidney damage;
• If you have an inflammatory disorder of the digestive tract (this may increase the risk of 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 peeling skin, blistering 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 emergency medical services right away if you experience any of these signs.

Children and adolescents

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

Other medicines and vancomycin

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

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

• Medicines that may affect the kidneys because vancomycin may 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 become pregnant, consult your doctor or pharmacist 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

In rare cases, vancomycin may cause dizziness and vertigo. Do not drive or operate machinery if you experience any of these effects.

3. How to take Vangozyr

Follow exactly the instructions for using this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended usual dose is:

Adults and adolescents (from 12 years of age 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 must not exceed 2 g.

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

Method of administration

For oral use.

Take the capsules whole with water.

The usual duration of treatment is 10 days, but may vary 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 missed doses. Simply continue taking the capsules as before.

If you stop treatment with Vangozyr

You must continue treatment with vancomycin as prescribed by your doctor or pharmacist. If you stop taking vancomycin before completing the treatment, there is a risk that your condition may worsen again.

If you have any questions about using this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

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

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

Oral vancomycin is negligibly absorbed from the gastrointestinal tract. Therefore, adverse effects after ingestion of capsules are unlikely.

However, if you have an inflammatory disorder of the digestive tract, and especially if you also have renal impairment, side effects may occur similar to those observed when vancomycin is administered by intravenous infusion. Therefore, the adverse effects and their frequencies listed below are those reported for vancomycin administered as an intravenous infusion.

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

• Red, non-elevated, target-shaped or circular spots on the trunk, often with central blisters, skin peeling, and 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).
• Generalized skin 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.

Frequent (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)
• Inflammation and rash of the mucous membranes of the mouth, itching, itchy rash, hives
• Kidney problems detectable by blood tests
• Redness of the upper body and face
• Increased liver enzymes

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

• Temporary or permanent loss of hearing

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

• Decrease in white blood cells and platelets (cells responsible for blood clotting)
• Increase in certain white blood cells in the blood
• Loss of balance, ringing in the ears (tinnitus), dizziness
• Inflammation of blood vessels
• Nausea (feeling of discomfort)
• Kidney inflammation and renal failure
• Chest and back muscle pain
• Fever, chills

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

• Sudden onset of a severe skin allergic reaction with skin peeling and 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 (lymph node swelling), abnormal blood tests and liver function tests
• Rash with blisters and fever
• Excessive destruction of red blood cells leading to fatigue and pale skin (hemolytic anemia)

Reporting of adverse effects

If you experience any adverse effects, 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: https://www.notificaram.es. By reporting adverse 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 stated on the container, following "EXP". The expiry date refers to the last day of the month indicated.

Do not store above 25 °C.

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 will help protect the environment.

6. Package contents and additional 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, it is because you specifically need them for your current illness.

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

Improper use of antibiotics increases resistance. You yourself may contribute to bacteria becoming resistant, thereby delaying your recovery or reducing antibiotic effectiveness if you do not properly adhere to:

• the dosage
• the timing
• the duration of treatment

Therefore, to preserve the effectiveness of this medicine:

1. Use antibiotics only when prescribed by a healthcare professional.
2. Strictly follow the instructions provided in the prescription.
3. Do not reuse an antibiotic without medical prescription, even if you intend to treat a similar illness.
4. Never give your antibiotics to another person, as they may not be suitable for their condition.
5. After completing the treatment, return any unused medication to the pharmacy to ensure proper disposal.

Composition of Vangozyr

• The active substance is vancomycin hydrochloride.

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

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

Description of the product and package contents

The 125 mg capsules are hard gelatin capsules containing a white to off-white liquid mixture as a solid mass in size '2', with a grey cap and a pink body.

The 250 mg capsules are hard gelatin capsules containing a white to off-white liquid mixture as a solid mass in size '2', with a brown cap and a brown body.

Pack sizes containing 4, 12, 20, 28 or 30 hard capsules.

Only certain pack sizes may be commercially available.

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 medicinal product is authorized in the European Economic Area member states under the following names:

Denmark    Vancomycin Strides
Finland     Vancomycin Strides 125/250 mg kovat kapseli
Norway     Vancomycin Strides
Sweden     Vancomycin Strides 125/250 mg hårda kapslar
Austria     Vancomicina Dr. Eberth 125/250 mg Hartkapseln
Romania    Cedepos 125 mg capsule
Czech Republic Cedepos
Malta       Cedepos 125 mg hard capsules
Slovakia    Cedepos 125 mg tvrdé kapsuly
Spain      Vangozyr 125 mg hard capsules
          Vangozyr 250 mg hard capsules

Date of the most recent review of this leaflet: September 2025

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