Mycostatin 100,000 IU/ml oral suspension

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

MYCOSTATIN 100,000 IU/ml oral suspension

Nystatin

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, 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 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.

Leaflet contents:

1. What MYCOSTATIN 100,000 IU/ml oral suspension is and what it is used for
2. What you need to know before taking MYCOSTATIN 100,000 IU/ml oral suspension
3. How to take MYCOSTATIN 100,000 IU/ml oral suspension
4. Possible adverse effects
5. How to store MYCOSTATIN 100,000 IU/ml oral suspension
6. Contents of the pack and other information

1. What MYCOSTATIN 100,000 IU/ml oral suspension is and what it is used for

MYCOSTATIN is an antifungal medicine indicated for the treatment of oral and intestinal infections caused by fungi of a species called Candida.

2. What you need to know before starting to take MYCOSTATIN 100,000 IU/ml oral suspension

Do not take MYCOSTATIN

• if you are allergic to nystatin or any of the other ingredients of this medicine (listed in section 6).
• for the treatment of systemic infections.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take MYCOSTATIN.

If irritation or sensitization occurs, consult your doctor immediately.

If there is no therapeutic response after 14 days of taking this medicine, consult your doctor.

Even if symptoms improve within the first few days of treatment, do not stop taking this medicine before completing the treatment course prescribed by your doctor.

Taking MYCOSTATIN with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

After taking MYCOSTATIN, substances that alter intestinal motility or that may isolate the intestinal mucosa from nystatin should not be taken, as the action of nystatin could be reduced.

Taking MYCOSTATIN with food and drink

No interactions with food or beverages have been reported; however, it should be avoided that substances which may affect intestinal motility or isolate the intestinal mucosa are ingested after taking this medicine, as this could reduce the action of nystatin.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

Driving and using machines

MYCOSTATIN does not affect the ability to drive or operate machinery.

MYCOSTATIN contains sucrose, ethanol, methyl parahydroxybenzoate (E-218), propyl parahydroxybenzoate (E-216), and sodium

This medicine contains 500 mg of sucrose per ml, which should be taken into account in patients with diabetes mellitus. If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.

This medicine contains 455 mg of alcohol (ethanol) in each 60 ml, corresponding to 0.76 g per 100 ml. The amount in 1 ml of this medicine is equivalent to less than 0.2 ml of beer or 0.1 ml of wine.

The small amount of alcohol contained in this medicine does not produce any noticeable effect.

It may cause allergic reactions (possibly delayed), as it contains methyl parahydroxybenzoate (E-218) and propyl parahydroxybenzoate (E-216).

This medicine contains less than 1 mmol of sodium (23 mg) per ml, which is essentially “sodium-free”.

3. How to take MYCOSTATIN 100,000 IU/ml oral suspension

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

Your doctor will determine the duration of your treatment with MYCOSTATIN. Treatment should be continued for at least 48 hours after the symptoms have disappeared.

If signs and symptoms worsen or persist after 14 days of treatment, the patient should be re-evaluated and consideration should be given to initiating an alternative treatment.

Recommended dose:

Adults:

• Oral candidiasis: 2.5 - 5 ml (250,000 - 500,000 International Units (IU)) every 6-12 hours.
• Intestinal candidiasis: 5 - 10 ml (500,000 - 1,000,000 IU) every 6 hours.

Paediatric population:

• Oral candidiasis

  • Infants over one year of age, children and adolescents: 2.5 - 5 ml (250,000 - 500,000 IU) every 6-12 hours.
  • Infants under or equal to one year of age: 2.5 ml (250,000 IU) every 6 hours.
  • Newborns and low-birth-weight infants: 1 ml (100,000 IU) every 6 hours.

• Intestinal candidiasis:

  • Children and adolescents: 2.5 - 7.5 ml (250,000 - 750,000 IU) every 6 hours.
  • Infants: 1 - 3 ml (100,000 - 300,000 IU) every 6 hours.

Method of administration:

A dosing syringe is included in the package for oral administration.

For first use:

1. Remove the syringe adapter (see image 1)
2. Remove the vial stopper
3. Insert the adapter into the vial (see image 2)
4. Cover the vial.

Each time you use it:

• Preparation of the delivery device

1. Shake the suspension before each use
2. Remove the vial stopper
3. Attach the syringe to the adapter (see image 3)
4. Turn the vial/syringe assembly upside down (see image 4)
5. Draw a small amount of medicine into the syringe by pulling the plunger, then push the plunger upward to expel air bubbles.

• Preparation of the dose

1. Ensure the plunger is at the bottom of the syringe (see image 5)
2. Slowly pull the plunger to draw the required dose using the dosing syringe
3. Once the dose is drawn, turn the vial/syringe assembly upright and remove it by gently twisting the syringe containing the dose to be administered
4. Insert the tip of the syringe directly into the mouth
5. Immediately administer the entire drawn volume by slowly pressing the plunger.

After each use:

1. Close the vial with the stopper, leaving the adapter in the vial
2. Rinse the syringe with water, repeating the action
3. Store the syringe dry in the package.

Never separate the dosing syringe from the other components of the medicine packaging (box, leaflet).

Image 1 Image 2 Image 3

Image 4 Image 5

The suspension may be administered alone, with the aid of water, or mixed with a liquid or soft non-acidic food such as milk, honey, jelly, etc.

In cases of oral candidiasis, retain the suspension in the mouth for as long as possible (several minutes) before swallowing. For infants or young children, apply half of the dose to each side of the mouth.

If you take more MYCOSTATIN than you should

Due to the very low absorption of this medicine, the risk of intoxication, even following accidental ingestion, is highly unlikely.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take MYCOSTATIN

If you forget to take a dose and the next dose is not far off, wait and take the next dose at the scheduled time. Do not take a double dose to make up for the missed dose.

If you stop taking MYCOSTATIN

Do not stop treatment earlier than instructed by your doctor, as this could lead to development of resistance to the medicine, making subsequent treatment of occasional reinfections more difficult.

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

4. Possible adverse effects

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

The following adverse effects have been observed:

Uncommon (may affect up to 1 in 100 people): nausea, vomiting, gastrointestinal discomfort, and diarrhea, especially with high doses.

In some cases, rash (skin eruption), including urticaria, has been reported. Very rarely, Stevens-Johnson syndrome (characterized by skin, mucous membrane, and eye abnormalities) has occurred. Cases of hypersensitivity (allergy) and angioedema (swelling of the deeper layers of the skin), including facial edema (fluid accumulation in the face), have also been reported.

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 through the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of MYCOSTATIN 100,000 IU/ml oral suspension

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

Before first opening, store below 30°C.

After first opening, store below 25°C; under these conditions, note that the shelf life is 7 days.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Do not use this medicine if you notice any visible signs of deterioration (for example: change in the appearance, colour, odour or taste of the suspension).

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE point in 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. Contents of the pack and other information

Composition of MYCOSTATIN

• The active substance is nystatin. Each ml of oral suspension contains 100,000 IU of nystatin.
• The other components are sucrose, 96% ethanol, sodium carmellose (E-466), cinnamaldehyde, peppermint essence, cherry flavour, anhydrous disodium hydrogen phosphate, glycerol (E-422), methylparahydroxybenzoate (E-218), propylparahydroxybenzoate (E-216), sodium hydroxide, hydrochloric acid and purified water.

Appearance of the product and contents of the pack

MYCOSTATIN is presented as a yellowish, opaque and homogeneous oral suspension with a cherry and peppermint odour.

Each pack contains a bottle with 30 or 60 ml of suspension, accompanied by an oral dosing syringe graduated from 0.5 to 5 ml and a connector adapter to attach it to the bottle.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

SUBSTIPHARM

24 rue Erlanger

75016 Paris

France

Manufacturer:

Vetprom AD

The Vpharma site,

Otets Paisiy Str.

Radomir, 2400,

Bulgaria

Date of the most recent review of this leaflet: June 2025.

Detailed and up-to-date 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/.