Hotex – Medicinal Product Register of Latvia

Paracetamolum, Guaifenesinum, Phenylephrini hydrochloridum

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Medicinal product name	Hotex 500 mg/200 mg/10 mg powder for oral solution
Pharmaceutical form	Powder for oral solution
Strength	500 mg/200 mg/10 mg
Information from the MAH on shortages	Not notified
Legal status	OTC OTC
Package leaflet	31-08-2023
Summary of product characteristics	31-08-2023
ATC code	N02BE51 – Analgesics
Information for Marketing authorisation holders	View

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

Package leaflet	31-08-2023
Summary of product characteristics	31-08-2023

Medicinal products (6)

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	Product No.	Labelling
Not available (according to the information provided by wholesalers)	currently no information on availability from any wholesaler	N5 (1 UD)	Paper/LDPE/Al/ionomer sachet	18-0105-01	Labelling text Aug 31, 2023 Labelling text Aug 31, 2023
Not available (according to the information provided by wholesalers)	currently no information on availability from any wholesaler	N6 (1 UD)	Paper/LDPE/Al/ionomer sachet	18-0105-02	Labelling text Aug 31, 2023 Labelling text Aug 31, 2023
Not available (according to the information provided by wholesalers)	currently no information on availability from any wholesaler	N10 (1 UD)	Paper/LDPE/Al/ionomer sachet	18-0105-03	Labelling text Aug 31, 2023 Labelling text Aug 31, 2023
Not available (according to the information provided by wholesalers)	currently no information on availability from any wholesaler	N14 (1 UD)	Paper/LDPE/Al/ionomer sachet	18-0105-04	Labelling text Aug 31, 2023 Labelling text Aug 31, 2023
Not available (according to the information provided by wholesalers)	currently no information on availability from any wholesaler	N15 (1 UD)	Paper/LDPE/Al/ionomer sachet	18-0105-05	Labelling text Aug 31, 2023 Labelling text Aug 31, 2023
Not available (according to the information provided by wholesalers)	currently no information on availability from any wholesaler	N20 (1 UD)	Paper/LDPE/Al/ionomer sachet	18-0105-06	Labelling text Aug 31, 2023 Labelling text Aug 31, 2023

Registration information

Marketing authorisation No.	18-0105
Date of authorisation	Jun 18, 2018
Marketing authorisation holder, country	Richard Bittner AG, Austria

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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 18, 2024.