Zecatrin – Medicinal Product Register of Latvia

Fesoterodini fumaras

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Medicinal product name

Zecatrin 8 mg prolonged-release tablets

Pharmaceutical form

Prolonged-release tablet

Strength

8 mg

Information from the MAH on shortages

No information on expected shortages

Availability of medicinal product

Product No.	Package size	Wholesalers' stock state
21-0084-03	N30	Is available

Legal status

Rx Prescription (Pr.)

Summary of product characteristics

13-04-2023

Package leaflet

22-04-2021

ATC code

G04BD11 – Urologicals

Information for Marketing authorisation holders

View

Product information leaflet and summary of product characteristics in MS Word format.

Summary of product characteristics	13-04-2023

Important notice

Additional information regarding the use for persons aged 75+

If used as "UROLOGICALS"
Substance	Class	Comment
Fesoterodini fumaras	D	Avoid use in older persons. Anticholinergic. Reduce the dose in even moderate renal insufficiency. Significant adverse reactions include dry mouth, constipation, urinary difficulties, confusion and cognitive disorder. Take several interactions into account. Weakens the efficacy of anti-Alzheimer`s drugs. Avoid consuming grapefruit during treatment.

Medicinal products (10)

Display only medicinal products with a declared price

Display only medicinal products available in wholesalers' stock

Availability of medicinal product	Wholesalers	Package size, content	Primary packaging	Maximum admissible pharmacy price (€ incl. VAT)	Product No.	Labelling
Not available (according to the information provided by wholesalers)	currently no information on availability from any wholesaler	N14 (8 mg)	OPA/Al/PVC/Al blister		21-0084-01	Labelling text Apr 22, 2021
Not available (according to the information provided by wholesalers)	currently no information on availability from any wholesaler	N28 (8 mg)	OPA/Al/PVC/Al blister		21-0084-02	Labelling text Apr 22, 2021
Is available (according to the information provided by wholesalers) (55 containers)	Tamro, Recipe Plus, Magnum Medical	N30 (8 mg)	OPA/Al/PVC/Al blister	€ 31.09	21-0084-03	Labelling text Apr 22, 2021
Not available (according to the information provided by wholesalers)	currently no information on availability from any wholesaler	N84 (8 mg)	OPA/Al/PVC/Al blister		21-0084-04	Labelling text Apr 22, 2021
Not available (according to the information provided by wholesalers)	currently no information on availability from any wholesaler	N100 (8 mg)	OPA/Al/PVC/Al blister		21-0084-05	Labelling text Apr 22, 2021
Not available (according to the information provided by wholesalers)	currently no information on availability from any wholesaler	N14: 14 × 1 (8 mg)	OPA/Al/PVC/Al perforated unit dose blister		21-0084-06	Labelling text Apr 22, 2021
Not available (according to the information provided by wholesalers)	currently no information on availability from any wholesaler	N28: 28 × 1 (8 mg)	OPA/Al/PVC/Al perforated unit dose blister		21-0084-07	Labelling text Apr 22, 2021
Not available (according to the information provided by wholesalers)	currently no information on availability from any wholesaler	N30: 30 × 1 (8 mg)	OPA/Al/PVC/Al perforated unit dose blister		21-0084-08	Labelling text Apr 22, 2021
Not available (according to the information provided by wholesalers)	currently no information on availability from any wholesaler	N84: 84 × 1 (8 mg)	OPA/Al/PVC/Al perforated unit dose blister		21-0084-09	Labelling text Apr 22, 2021
Not available (according to the information provided by wholesalers)	currently no information on availability from any wholesaler	N100: 100 × 1 (8 mg)	OPA/Al/PVC/Al perforated unit dose blister		21-0084-10	Labelling text Apr 22, 2021

Registration information

Marketing authorisation No.	21-0084
Date of authorisation	Apr 23, 2021
Marketing authorisation holder, country	Zentiva, k.s., Czech Republic

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Icon explanation

– Medicine is available
– Medicine is not available
– Distribution permitted for a limited time span
– Without a prescription
– Prescription medicine

– Medicine is listed on the Latvian National Health Service (NHS) list of state reimbursed medicines. (source of the information – the NHS)
– Reference medicine on the NHS List of state reimbursed medicines
– Lowest cost medicine within its therapeutic effectiveness class in cases where no reference medicine is available
- – Next lowest cost medicine after or (in ascending order)

Class A A (green): Suitable for the older persons. The medicinal substance can be used as in younger patients. Changes due to aging do not affect the dose or frequency of administration, and the adverse reaction profile is not different from that of younger patients.

Class B B (grey): There is little research evidence, practical experience or efficacy in older persons.

Class C C (yellow): Suitable for older persons, with specific cautions. The medicinal substance can be used by older persons, but the dose might either have to be reduced, or the frequency of administration decreased due to mild or moderate renal insufficiency or a significant risk of interactions or adverse reactions.

Class D D (red): Avoid use in older persons. Use is possible only in exceptional cases or on a one-off basis. Changes due to aging predispose older persons to adverse or dangerous reactions to the drug. The risk of adverse reactions typically exceeds the benefits.

Meds75+ data source is Finnish Medicines Agency Fimea (licensed under CC BY 4.0).
Data updated on Mar 30, 2021.