Macrodantin 100mg Capsules, hard
*Company:
ADVANZ PharmaStatus:
UpdatedLegal Category:
Product subject to medical prescription which may be renewed (B)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 07 September 2026
File name
1.3.1 SPC-Ireland-English-clean-Macrodantin 100mg.pdf
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 5.1 - Pharmacodynamic properties
- 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 be renewed (B)
Updated on 07 September 2026
File name
1.3.1 PIL-Brand-Luso-Ireland-English-clean-Macrodantin 100mg.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
1. What Macrodantin Capsules are and what they are used for
Nitrofurantoin (the active substance in Macrodantin Capsules) is an antibiotic.
It is used to prevent and treat infections of the bladder and lower urinary tract.
Updated on 03 December 2025
File name
Macrodantin 50mg and 100mg Capsules, hard.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 03 December 2025
File name
1.3.1 SPC-Ireland-English-clean-Macrodantin 100mg.pdf
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 be renewed (B)
Updated on 19 May 2025
File name
1.3.1 SPC-Ireland-English-clean-Macrodantin 100mg.pdf
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
- Change to section 5.3 - Preclinical safety data
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 28 May 2021
File name
Macrodantin - Nitrofurantoin 100mg capsules_SPC_IE.pdf
Reasons for updating
- Updated inline with QRD template and/or excipient guideline
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 12 May 2021
File name
Macrodantin 50mg and 100mg caps PIL IE.pdf
Reasons for updating
- Change due to harmonisation of PIL
Updated on 12 May 2021
File name
Macrodantin 50mg and 100mg caps PIL IE.pdf
Reasons for updating
- New PIL for new product
Updated on 24 May 2019
File name
Approved SPC (008).pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
ADVANZ Pharma
Address:
Unit 17 Northwood House Northwood Crescent Northwood, Dublin 9, D09 V504, IrelandMedical Information E-mail:
medicalinformation@advanzpharma.comTelephone:
+44 (0)208 588 9131Website:
https://www.advanzpharma.comMedical Information Direct Line:
+353 1800 851 119Customer Care direct line:
+353 1 5294 230