Ryeqo 40 mg/1 mg/0.5 mg film-coated tablets
*Company:
Gedeon Richter IrelandStatus:
UpdatedLegal 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 11 June 2026
File name
Ryeqo PIL_en_EU-1-21-1565-001-004.pdf
Reasons for updating
- Change to section 2 - excipient warnings
- Change to section 4 - possible side effects
- Change to section 6 - what the product contains
- Change to section 6 - date of revision
- Removal of Black Inverted Triangle
Free text change information supplied by the pharmaceutical company
Removal of inverted black triangle.
Section 2 - Updated to include information that the medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.
Section 4 - Update to information regarding allergic reaction and inclusion of high blood pressure as a potential rare side effect.
Section 6 - Inclusion of E numbers to ingredient listing.
Updated on 11 June 2026
File name
Ryeqo SmPC_en_EU-1-21-1565-001-004.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.2 - Posology and method of administration
- Change to section 4.3 - 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 5.2 - Pharmacokinetic properties
- Change to section 6.1 - List of excipients
- Change to section 6.5 - Nature and contents of container
- Change to section 10 - Date of revision of the text
- Removal of Black Inverted Triangle
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Removal of black triangle.
Section 2 - delete 'of'
Section 4.2 - Editorial updates to aid readability and inclusion of wording that pregnancy must be ruled out prior to initiating treatment.
Section 4.3 - Inclusion of reference to section 4.4
Section 4.4 - Reference to product name updated to this medicinal product. Reference that Ryeqo must only be prescribed after careful diagnosis deleted & moved to section 4.2. Inclusion of subheading 'Excipients with known effect' and information regarding the content of sodium.
Section 4.5 - Editorial updates that include reference to product name updated to 'this medicinal product' and co‑administration of Ryeqo replaced with term 'concomitant use'.
Section 4.6 - Editorial updates
Section 4.7 - Update in wording from Ryeqo has no or negliible influence on the ability to drive to to minor influence on the ability to drive and use machines. Addition of the wording that when driving vehicles or operating machines it should be taken into account that dizziness may occur occasionally.
Section 4.8 - Update or wording from adverse drug reactions to adverse reactions. Addition of hypotension as a potential adverse effect to Table 4.
Section 4.9 - Editorial update from reference to drug product to medicinal product.
Section 5.1 - Editorial updates that including reference to product name updated to 'this medicinal product'. Under the subheading Efficacy and safety over 24 weeks addition years to the age range 18‑50.
Table 5 updated to include Number (%) of patients with > 1.24 mmol/L (2 g/dL) improvement in haemoglobin levels d where d is in patients with a baseline Haemoglobin level ≤ 6.52 mmol/L (10.5 g/dL).
Section 5.2 - typographical update to Table 10. Editorial update from reference to 'Ryeqo' to 'medicinal product'.
Section 6.1 - Addition of E numbers to excipients.
Section 6.5 - Addition of subheadings 'Bottle' and 'Blister'.
Section 10 - Update to date of revision.
Updated on 01 February 2024
File name
Ryeqo SmPC_en_EU-1-21-1565-001-004.pdf
Reasons for updating
- Change to section 6.5 - Nature and contents of container
- Change to section 8 - Marketing authorisation number(s)
- 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
Addition of a pack type; addition of MA numbers for the new pack type and an update to the date of revision of the text.
Updated on 01 February 2024
File name
Ryeqo PIL_en_EU-1-21-1565-001-004.pdf
Reasons for updating
- Change to section 6 - what the product looks like and pack contents
- Change to date of revision
Free text change information supplied by the pharmaceutical company
Addition of a pack type.
Updated on 01 February 2024
File name
Ryeqo SmPC_en_EU-1-21-1565-001-004.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
Addition of a pack type.
Updated on 21 December 2023
File name
Ryeqo PIL_en_EU-1-21-1565-001-002.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 3 - overdose, missed or forgotten doses
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 21 December 2023
File name
Ryeqo SmPC_en_EU-1-21-1565-001-002.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 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- 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
Addition of an indication and related changes.
Updated on 04 May 2023
File name
Ryeqo_UK-IE_PIL_K-31407-1.8_march_clean.pdf
Reasons for updating
- Change to side-effects
Updated on 04 May 2023
File name
Ryeqo SmPC_en_EU-1-21-1565-001-002 IE-NI.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 16 December 2022
File name
Ryeqo PIL_en_EU-1-21-1565-001-002 IE-NI.pdf
Reasons for updating
- New PIL for new product
Updated on 16 December 2022
File name
Ryeqo SmPC_en_EU-1-21-1565-001-002 IE-NI.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Gedeon Richter Ireland
 Ltd.webp)
Address:
4045 Kingswood Road, Citywest Business Campus, Dublin 24, IrelandMedical Information E-mail:
medinfo.uk@gedeonrichter.euTelephone:
00 44 207 604 8800Medical Information Direct Line:
00 44 207 604 8806