Frovex
- Name:
Frovex
- Company:
A. Menarini Pharmaceuticals Ireland Ltd
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may be renewed (B)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 01/08/19

XPIL
Package leaflet: information for the user
Package leaflet: information for the user
1. What FROVEX is and what it is used for
1. What FROVEX is and what it is used for
2. What you need to know before you take FROVEX
2. What you need to know before you take FROVEX
3. How to take FROVEX
3. How to take FROVEX
4. Possible side effects
4. Possible side effects
5. How to store FROVEX
5. How to store FROVEX
6. Contents of the pack and other information
6. Contents of the pack and other information
Click on this link to Download PDF directly
A. Menarini Pharmaceuticals Ireland Ltd

Company Products
When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.
Updated on 1 August 2019 PIL
Reasons for updating
- XPIL Created
Updated on 1 August 2019 SPC
Reasons for updating
- File format updated to PDF
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
File format updated to pdf
Updated on 2 May 2019 PIL
Reasons for updating
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 24 August 2017 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 24 August 2017 PIL
Reasons for updating
- New PIL for new product
Updated on 24 August 2017 PIL
Reasons for updating
- Improved presentation of PIL
Updated on 24 August 2017 SPC
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- 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 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 10 - Date of revision of the text
- Improved presentation of SPC
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 18 December 2014 PIL
Reasons for updating
- Change of contraindications
- Change to storage instructions
- Addition of information on reporting a side effect.
Updated on 4 December 2014 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to date of revision
- Change to improve clarity and readability
Updated on 4 December 2014 SPC
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 3 - Pharmaceutical form
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- 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 4.8 - 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 6.1 - List of excipients
- Change to section 6.4 - Special precautions for storage
- 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 be renewed (B)
Free text change information supplied by the pharmaceutical company
Administrative amendments (to align to the current QRD template)
Sections 2, 3, 4.1, 4.2, 4.3, 4.5, 4.6, 5.2, 6.1, 6.4, 6.6, 8.
Section 4.4 Special warnings and precautions for use
Warning on hypersensitivity added.
Section 4.8 Undesirable effects
Adverse reactions collected in the post-marketing experience - hypersensitivity reactions (including cutaneous disorders, angioedema and anaphylaxis); myocardial infarction and arteriospasm coronary added under ‘not known’ category.
Reporting of side-effects details added.
Section 10 Date of revision of the text
Updated to November 2014
Updated on 17 December 2013 PIL
Reasons for updating
- Change to date of revision
Updated on 17 September 2009 PIL
Reasons for updating
- Addition of manufacturer
Updated on 18 November 2008 PIL
Reasons for updating
- Change to side-effects
Updated on 19 August 2008 SPC
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Update to section 4.8 - adverse event table
Updated on 8 November 2007 PIL
Reasons for updating
- Change due to user-testing of patient information
- Change due to harmonisation of patient information leaflet
Updated on 8 November 2007 SPC
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 4.9 - Overdose
- Change to section 6.1 - List of excipients
- 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 be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 2 – Include excipient details for lactose
Sections 4.4 - Update warning on prolonged use of painkillers for headaches, add reference to lactose.
Section 4.9 – Update information on overdose
Section 6.1 – Update details for the film coat (Macrogel 3000)
Sections 9 and 10 – Update date of renewal and revision of the text
Updated on 20 March 2007 PIL
Reasons for updating
- Change to name of manufacturer
Updated on 9 May 2006 PIL
Reasons for updating
- Change of manufacturer
Updated on 29 March 2005 SPC
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 10 August 2004 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 5 August 2004 PIL
Reasons for updating
- New PIL for new product