Drynol 2.5 mg/ml oral solution
*Company:
A. Menarini Pharmaceuticals Ireland LtdStatus:
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 02 April 2025
File name
ie-spc Drynol OS Clean Mar 25.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 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Update to extend the indication to children aged from 2 to 5 years old
Updated on 02 April 2025
File name
ie-spc Drynol OS Clean Mar 25.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 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Update to extend the indication to children aged from 2 to 5 years old
Updated on 02 April 2025
File name
ie-spc Drynol OS Clean Mar 25.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 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Update to extend the indication to children aged from 2 to 5 years old
Updated on 02 April 2025
File name
ie-pl Drynol OS Clean Approved April 25.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - use in children and adolescents
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 3 - use in children/adolescents
- Change to section 4 - possible side effects
Free text change information supplied by the pharmaceutical company
Update to extend the indication to children aged from 2 to 5 years old
Updated on 02 April 2025
File name
ie-pl Drynol OS Clean Approved April 25.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - use in children and adolescents
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 3 - use in children/adolescents
- Change to section 4 - possible side effects
Free text change information supplied by the pharmaceutical company
Update to extend the indication to children aged from 2 to 5 years old
Updated on 02 March 2023
File name
ie-spc Drynol OS - Clean Approved Feb 23.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 6.1 - List of excipients
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 2 - Ethanol content added
Section 4.4 - Ethanol content warnings added
Section 4.8 - Rare and Very Rare headers updated for accuracy
Section 4.8 - AE reporting details updated
Section 6.1 - E Number added
Section 10 - Date of revision updated
Updated on 02 March 2023
File name
ie-pl OS - Clean Apporoved Feb 23.pdf
Reasons for updating
- Change to section 2 - excipient warnings
- Change to section 6 - what the product contains
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Excipient warnings added for Ethanol content, E numbers added and date of revision updated
Updated on 13 July 2022
File name
ie-spc Drynol OS Renewal clean July 22.pdf
Reasons for updating
- Correction of spelling/typing errors
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 13 July 2022
File name
ie-spc Drynol OS Renewal clean July 22.pdf
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Section 2 - Updated information for interactions with Diltiazem
Section 6 - Date of revision updated
Updated on 05 May 2021
File name
ie-spc Drynol OS Sodium Warning Clean Dec 20.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 4.4 - Information added regarding sodium content
Section 10 - Date of revision updated
Updated on 05 May 2021
File name
ie-pl OS Sodium Warning Clean Dec 20.pdf
Reasons for updating
- Change to section 2 - excipient warnings
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Section 2 - Excipient warning for Sodium Content Added
Section 6 - Date of revision updated
Updated on 18 August 2020
File name
ie-pl OS clean 15-7-20.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
The change is to update the Patient Leaflet by listing serious or life-threatening side effects at the beginning of section 4 - Possible side effects, irrespective of the frequency.
Updated on 11 June 2019
File name
ie-spc Drynol OS clean 8-3-19.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 21 May 2019
File name
ie-pl OS clean 8-3-19.pdf
Reasons for updating
- New PIL for new product
A. Menarini Pharmaceuticals Ireland Ltd
Address:
Castlecourt, Monkstown Farm, Monsktown, Glenageary, Co. Dublin, IrelandMedical Information E-mail:
medinfo@menarini.ieTelephone:
+353 1 284 6744Fax:
+353 1 284 6769Medical Information Direct Line:
1800 283 045