Mycostatin 100,000 units/ml Oral Suspension (Ready-Mixed) *
Pharmacy Only: Prescription

  • Company:

    SUBSTIPHARM
  • Status:

    No Recent Update
  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)
  • Active Ingredient(s):

    *Additional information is available within the SPC or upon request to the company

Updated on 01 April 2022

File name

ie_mycostatin-pil_clean_1648823694.pdf

Reasons for updating

  • Change to marketing authorisation holder

Free text change information supplied by the pharmaceutical company

Change of Pharmacovigilance contact for the MAH, related to the phone number.

Updated on 26 January 2021

File name

ie_spc mycostatin-approved_1611670628.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 26 January 2021

File name

PIL Mycostatin IE_HPRA_1611670363.pdf

Reasons for updating

  • Change to section 2 - excipient warnings

Updated on 29 November 2019

File name

2018 12 ie-spc-mycostatin-original-Substipharm_1575016415.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 28 March 2019

File name

mycostatin-pil-clean-v2_1553771359.pdf

Reasons for updating

  • Change of licence holder

Updated on 06 December 2017

File name

PIL_14652_490.pdf

Reasons for updating

  • New PIL for new product

Updated on 06 December 2017

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 06 December 2017

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Change of name and address of MAH (Previous details: BMS Pharmaceuticals Ltd, Swords, Dublin).

Updated on 06 December 2017

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 11 July 2017

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Dosage in Infants (1 month to 2 years) has changed from 2ml (200,000U) 4 times daily (1 ml for each side of the mouth) to one to two mL (100,000 to 200,000units nystatin) four times daily
  • Dosage in children (over 2 years) and adults has changed from 4 - 6ml (100,000 - 600,000U) 4 times daily (half dose in each side of the mouth) to Dosage ranges of one to six mL (100,000 to 600,000 units nystatin) four times daily have been used

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

In section 4.1 (therapeutic indications),  a statement regarding consideration of official guidance on use of antifungal agents has been added

In section 4.2 (posology and method of administration), the following has changed:

  • Dosage in Infants (1 month to 2 years) has changed from 2ml (200,000U) 4 times daily (1 ml for each side of the mouth) to one to two mL (100,000 to 200,000units nystatin) four times daily
  • Dosage in children (over 2 years) and adults has changed from 4 - 6ml (100,000 - 600,000U) 4 times daily (half dose in each side of the mouth) to Dosage ranges of one to six mL (100,000 to 600,000 units nystatin) four times daily have been used

Updated on 06 July 2017

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 3 - dose and frequency
  • Change to section 3 - use in children/adolescents
  • Change to section 4 - possible side effects

Updated on 15 September 2015

Reasons for updating

  • Change to information about pregnancy or lactation
  • Change to dosage and administration
  • Addition of information on reporting a side effect.

Updated on 25 August 2015

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

In section 2 QUALITATIVE AND QUANTITATIVE COMPOSITION the following heading has been added

Excipient(s) with known effect:



In section 4.2 Posology and method of administration the following has been updated:

Posology

 

Prevention and treatment of oral candidiasis:

Neonates (from birth to 1 month):

Clinical studies of limited size in neonates, including preterm and babies of low weight at birth, indicate that 1 ml (100,000 U) four times daily is an effective regimen.

 

Infants (1 month to 2 years):

2 ml (200,000 U) 4 times daily (1 ml for each side of the mouth).

 

Children (over 2 years) and adults:

4 – 6 ml (400,000 – 600,000 U) 4 times daily (half dose in each side of the mouth). It is recommended to keep the medication in contact with the affected areas as long as possible.

 


Prevention and treatment of intestinal candidiasis:

Neonates (from birth to 1 month) and infants (1 month to 2 years):

1 – 2 ml four times daily administered with milk or other liquid.

If needed, the dose can be increased, even in the neonates. Treatment should be continued for at least 48 hours after clinical cure and/or normalisation of cultures to avoid a relapse.

 

Children (over 2 years) and adults:

4 – 6 ml (400,000 – 600,000 U) 4 times daily. The suspension should be retained in the mouth for as long as possible (e.g., several minutes) before swallowing. If needed, the dose can be increased. Treatment should be continued for at least 48 hours after clinical cure and/or normalisation of cultures to avoid a relapse.

 

Limited clinical studies in premature and low birth weight infants indicate that 1 mL four times daily is effective.

 

Older people:

No specific dosage recommendations or precautions.

 

In the prevention and treatment of candidiasis, the dosage regimen for Mycostatin should be continued for at least 48 hours after symptoms have disappeared. If signs and symptoms worsen or persist (beyond 14 days of treatment), the patient should be reevaluated, and alternate therapy considered.


In section 4.4 Special warnings and precautions for use the following text was removed:

The dosage regimen for Mycostatin should be continued for at least 48 hours after symptoms have disappeared. If signs and symptoms worsen or persist (beyond 14 days of treatment), the patient should be reevaluated, and alternate therapy considered.

 



In section 4.6 Fertility, pregnancy and lactation the following was updated:

Pregnancy

Animal reproductive studies have not been conducted with nystatin.

 

It is not known whether nystatin can cause foetal harm when administered to a pregnant woman or can affect reproductive capacity, however absorption of nystatin from the gastro-intestinal tract is negligible.  Nystatin should be prescribed during pregnancy only if the potential benefits to be derived outweigh the potential risk to the foetus.

 

Breast-feeding

It is not known whether nystatin is excreted in human milk. Although gastrointestinal absorption is insignificant, caution should be exercised when nystatin is prescribed for a nursing woman.

In section 4.8 Undesirable effects the table was updated in line with QRD and the following was updated:

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; e-mail: medsafety@hpra.ie


In section 5.2Pharmacokinetic properties the following was updated:

Absorption

Nystatin is formulated in oral and topical dosage forms and is not systemically absorbed from any of these preparations.

Gastrointestinal absorption of nystatin is insignificant.

 

Elimination

Most orally administered nystatin is passed unchanged in the stool.

In section 10:

DATE OF REVISION OF THE TEXT

 

August 2015

 

Updated on 17 July 2013

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.1 - List of excipients
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 8 - MA number
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 1, 2, 4.1, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 5.1, 5.3, 6.1, 6.4, 6.5, 6.6, 8.0, 10.0 -Updated to align with QRD

 Sections 4.8, 4.9 and 5.3 of the SmPC aligned with the Company Core Data Sheet (CCDS)- Hypersensitivity and angioedema inserted text

Updated on 12 July 2013

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to information about pregnancy or lactation
  • Change to information about driving or using machinery
  • Change to further information section
  • Change to date of revision

Updated on 12 April 2012

Reasons for updating

  • Change to section 8 - MA number
  • Addition of legal category

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 8 has been revised to include the full licence number:

PA 0002/007/007

Updated on 10 April 2012

Reasons for updating

  • Change to improve clarity and readability

Updated on 19 April 2010

Reasons for updating

  • New PIL for medicines.ie

Updated on 13 May 2009

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Standard warning regarding sucrose has been included

Updated on 16 March 2009

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Update to section 1, 2 9,10

Updated on 20 August 2003

Reasons for updating

  • New SPC for medicines.ie

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 30 May 2003

Reasons for updating

  • New SPC for medicines.ie

Legal category:Product subject to medical prescription which may not be renewed (A)