Clocinol – Medicinal Product Register of Latvia

Tramadoli hydrochloridum, Paracetamolum

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Medicinal product name

Clocinol 37.5 mg/325 mg film-coated tablets

Pharmaceutical form

Film-coated tablet

Strength

37.5 mg/325 mg

Information from the MAH on shortages

No information on expected shortages

Availability of medicinal product

Product No.	Package size	Wholesalers' stock state
10-0252-01	N10	Is available

Legal status

Rx Prescription (Pr.III)

Package leaflet

16-06-2022

Summary of product characteristics

16-06-2022

ATC code

N02AJ13 – Analgesics

Medicinal products (5)

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
Is available (according to the information provided by wholesalers) (867 containers)	Magnum Medical, Tamro, Recipe Plus	N10 (37,5 mg/325 mg)	PVC/Al blister	€ 7.21	10-0252-01	Labelling text Jul 1, 2021
Not available (according to the information provided by wholesalers)	currently no information on availability from any wholesaler	N20 (37,5 mg/325 mg)	PVC/Al blister		10-0252-02	Labelling text Jul 1, 2021
Not available (according to the information provided by wholesalers)	currently no information on availability from any wholesaler	N30 (37,5 mg/325 mg)	PVC/Al blister		10-0252-03	Labelling text Jul 1, 2021
Not available (according to the information provided by wholesalers)	currently no information on availability from any wholesaler	N60 (37,5 mg/325 mg)	PVC/Al blister		10-0252-04	Labelling text Jul 1, 2021
Not available (according to the information provided by wholesalers)	currently no information on availability from any wholesaler	N90 (37,5 mg/325 mg)	PVC/Al blister		10-0252-05	Labelling text Jul 1, 2021

Registration information

Marketing authorisation No.	10-0252
Date of authorisation	May 21, 2010
Marketing authorisation holder, country	Zaklady Farmaceutyczne Polpharma S.A., Poland

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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 Apr 15, 2024.