Prospecto: information for the user

MYCOSTATIN 100,000 UI/ml oral suspension

Nistatina

Read this prospect carefully before starting to take this medicine, because it contains important information for you.

-Keep this prospect, as you may need to read it again.

-If you have any doubts, consult your doctor or pharmacist.

-This medicine has been prescribed only for you, and you should not give it to other people even if they have the same symptoms as you, as it may harm them.

-If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

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

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

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

4.Possible adverse effects

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

6.Contents of the package and additional information

Mycostatin is an antifungal medication indicated for the treatment of oral and intestinal infections caused by a species of fungus calledCandida.

Do not take MYCOSTATIN

-if you are allergic to nystatin or any of the other components of this medication (listed in section 6).

-for the treatment of generalized body infections.

Warnings and precautions

Consult your doctor or pharmacist before starting to take MYCOSTATIN.

In case of irritation or sensitization, consult your doctor immediately.

If you do not obtain a therapeutic response after 14 days of taking this medication, consult your doctor.

Although symptoms may improve in the first few days of treatment, do not interrupt the administration of this medication until the treatment indicated by your doctor is completed.

Taking MYCOSTATIN with other medications

Inform your doctor or pharmacist ifyouaretaking, havetakenrecentlyor may need to take any other medication.

After taking MYCOSTATIN, do not take substances that modify intestinal movement or that may isolate the intestinal mucosa from nystatin, as the action of nystatin may be reduced.

Taking MYCOSTATIN with food and drinks

No interactions with food or drinks have been described; however, it should be avoided that, after taking this medication, substances that may affect intestinal movement or isolate the intestinal mucosa and, thereby, reduce the action of nystatin are ingested.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant or intend to become pregnant, consult your doctor before using this medication.

Driving and operating machines

MYCOSTATIN does not affect the ability to drive and operate machines.

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

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

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

The small amount of alcohol contained in this medication does not produce any perceptible effect.

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

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

Follow exactly the administration instructions of this medication as indicated by your doctor.This medication should be used exactly as directed by your doctor.In case of doubt, consult your doctor or pharmacist again.

Your doctor will inform you of the duration of your treatment with MYCOSTATIN.The treatment should be continued for at least 48 hours after the disappearance of symptoms.

If symptoms worsen or persist after 14 days of treatment, the patient should be reevaluated and alternative treatment should be considered.

The recommended dose is:

Adults:

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

Pediatric population:

• Oral candidiasis
• • Infants over one year, children and adolescents: 2.5 - 5 ml (250,000 - 500,000 UI) every 6-12 hours.
  • Infants less than or equal to one year: 2.5 ml (250,000 UI) every 6 hours.
  • Newborns and low-birth-weight infants: 1 ml (100,000 UI) every 6 hours.

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

Administration form:

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

Administration form with the adapter:

First use:

1. Remove the adapter from the syringe (see image 1)
2. Remove the cap from the vial
3. Insert the adapter into the vial (see image 2)
4. Replace the vial cap.

Each time you use it:

• Preparation of the supply device

1. Shake the suspension before each use
2. Remove the cap from the vial
3. Place the syringe in the adapter (see image 3)
4. Turn the vial/syringe combination (see image 4)
5. Fill the syringe with a small amount of medication by pulling the plunger and then pushing the plunger up to avoid air bubble formation.

• Preparation of the dose

1. Ensure the plunger is at the bottom of the syringe (see image 5)
2. Pull the plunger slowly to extract the required dose with the dosing syringe
3. Once the dose is extracted, turn the vial/syringe combination and remove it by gently turning the syringe containing the dose to be administered
4. Insert the syringe tip directly into the mouth
5. Administer the entire volume extracted immediately by pressing the plunger slowly.

After each use:

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

The syringe dosing device should never be separated from the other elements of the medication package (box, leaflet).

Image 1 Image 2 Image 3

Image 4 Image 5

The suspension can be administered alone, with the help of water or mixed with a soft liquid or food that is not acidic, such as milk, honey, jam, etc.

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

If you take more MYCOSTATIN than you should

Given the low absorption of this medication, the possibility of intoxication, even by accidental ingestion, is very unlikely.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take MYCOSTATIN

If you forget to take a dose, and it is not close to the next one, wait to take it. Do not take a double dose to compensate for the missed doses.

If you interrupt the treatment with MYCOSTATIN

Do not discontinue treatment before the indicated time by your doctor, as it may cause resistance to the medication, making subsequent treatment of occasional reinfections difficult.

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

Like all medications, this medication may produce adverse effects, although not all people will experience them.

The following adverse effects have been observed:

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

In some cases, the appearance of a rash (skin eruption), including urticaria, has been reported. In rare instances, the Stevens-Johnson syndrome (characterized by skin, mucous membrane, and eye alterations) has manifested. Cases of hypersensitivity (allergy) and angioedema (inflammation of the deeper skin layers), including facial edema (fluid accumulation in the face), have also been reported.

Reporting Adverse Effects

If you experienceany type of adverse effect, consult your doctor or pharmacist, even if it is apossibleadverse effect not listed in this prospectus.You can also report them directly through theSpanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

Before opening the bottle for the first time, store below 30°C.

Once the bottle is opened, store below 25°C; under these conditions, note that the expiration date is 7 days.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not use this medication if you observe any visible signs of deterioration (for example: change in the appearance of the suspension or its color, odor, or taste).

Medications should not be disposed of through drains or in the trash. Dispose of the containers and medications you do not needat the SIGREcollection point at the pharmacy. If in doubtask your pharmacist how to dispose of the containers and medications you do not need. By doing so, you will help protect the environment.

Composition of MYCOSTATIN

-The active principle is nystatin. Each ml of oral suspension contains 100,000 IU of nystatin.

-The other components are sucrose, ethanol at 96%, sodium carmellose (E-466), cinnamaldehyde, peppermint essence, cherry aroma, anhydrous disodium phosphate, glycerol (E-422), methyl parahydroxybenzoate (E-218), propyl parahydroxybenzoate (E-216), sodium hydroxide, hydrochloric acid, and purified water.

Appearance of the product and contents of the packaging

MYCOSTATIN is presented in the form of a yellowish, opaque, and homogeneous oral suspension, with a cherry and mint odor.

Each package contains a bottle with 30 or 60 ml of suspension,accompanied by a graduated dosing syringeof 0.5 to 5 mlor 1 to 5 ml(for oral use). The graduated dosing syringe of 0.5 to 5 ml is accompanied by an adapter to attach it to the bottle.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

SUBSTIPHARM

24 rue Erlanger

75016 Paris

France

Responsible for manufacturing:

Vetprom AD

The Vpharma site,

Otets Paisiy Str.

Radomir, 2400,

Bulgaria

Date of the last review of this leaflet: January 2022.

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.