Mycostatin 100,000 units/ml Oral Suspension (Ready-Mixed)
*Company:
SUBSTIPHARMStatus:
No Recent UpdateLegal 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 04 October 2024
File name
ie_spc mycostatin_clean.pdf
Reasons for updating
- Change to section 6.5 - Nature and contents of container
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Change in any part of the (primary) packaging material not in contact with the finished product formulation - Change that affects the product information - addition of a high-density polyethylene cap
Updated on 27 September 2023
File name
ie-pil-mycostatin_clean.pdf
Reasons for updating
- Change to section 3 - how to take/use
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - manufacturer
Free text change information supplied by the pharmaceutical company
Replacement of a manufacturing site for part or all of the manufacturing process of the finished product
Change in immediate packaging of the finished product
Updated on 12 September 2023
File name
ie_spc mycostatin_clean.pdf
Reasons for updating
- Change to section 6.5 - Nature and contents of container
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Change in immediate packaging of the finished product
Updated on 12 September 2023
File name
ie_spc mycostatin_clean.pdf
Reasons for updating
- Change to section 6.5 - Nature and contents of container
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Change in immediate packaging of the finished product
Updated on 10 February 2023
File name
ie_spc mycostatin_clean.pdf
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.5 - Nature and contents of container
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Change ATC code
Updated graduation of dropper and rubber bulb
Updated on 10 February 2023
File name
ie-pil-mycostatin-clean.pdf
Reasons for updating
- Change to section 3 - how to take/use
- Change to section 6 - what the product looks like and pack contents
Free text change information supplied by the pharmaceutical company
Graduation dropper
Updated on 01 April 2022
File name
ie_mycostatin-pil_clean.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.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.pdf
Reasons for updating
- Change to section 2 - excipient warnings
Updated on 29 November 2019
File name
2018 12 ie-spc-mycostatin-original-Substipharm.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.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
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
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.
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
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
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)