Solpadeine PK – Medicinal Product Register of Latvia

Paracetamolum, Coffeinum

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Medicinal product name

Solpadeine PK 500 mg/65 mg effervescent tablets

Pharmaceutical form

Effervescent tablet

Strength

500 mg/65 mg

Information from the MAH on shortages

No information on expected shortages

Availability of medicinal product

Product No.	Package size	Wholesalers' stock state
17-0038-04	N16	Is available

Legal status

OTC OTC

Package leaflet

29-06-2021

Summary of product characteristics

03-12-2020

ATC code

N02BE51 – Analgesics

Important notice

Additional information regarding the use for persons aged 75+

If used as "ANALGESICS"
Substance	Class	Comment
Paracetamolum	A	Suitable for older persons. Maximum dose in regular use 2-3 g/day. Note paracetamol in OTC drugs and combination products. Overdose is hepatotoxic. Concurrent use with warfarin is possible if INR values are monitored.
Coffeinum	A	Suitable for older persons.

Medicinal products (9)

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	N4 (500 mg/65 mg)	Paper/PE/Al/PE strip		17-0038-01	Labelling text Dec 3, 2020
Not available (according to the information provided by wholesalers)	currently no information on availability from any wholesaler	N6 (500 mg/65 mg)	Paper/PE/Al/PE strip		17-0038-02	Labelling text Dec 3, 2020
Not available (according to the information provided by wholesalers)	currently no information on availability from any wholesaler	N12 (500 mg/65 mg)	Paper/PE/Al/PE strip		17-0038-03	Labelling text Dec 3, 2020
Is available (according to the information provided by wholesalers) (1652 containers)	Jelgavfarm, Tamro, Recipe Plus, Olainfarm, Laurus MED, Magnum Medical, Baltfarm "Vita-Farm", Euroaptieka, Medelens+, Oribalt Rīga	N16 (500 mg/65 mg)	Paper/PE/Al/PE strip	€ 5.48	17-0038-04	Labelling text Dec 3, 2020
Not available (according to the information provided by wholesalers)	currently no information on availability from any wholesaler	N18 (500 mg/65 mg)	Paper/PE/Al/PE strip		17-0038-05	Labelling text Dec 3, 2020
Not available (according to the information provided by wholesalers)	currently no information on availability from any wholesaler	N24 (500 mg/65 mg)	Paper/PE/Al/PE strip		17-0038-06	Labelling text Dec 3, 2020
Not available (according to the information provided by wholesalers)	currently no information on availability from any wholesaler	N30 (500 mg/65 mg)	Paper/PE/Al/PE strip		17-0038-07	Labelling text Dec 3, 2020
Not available (according to the information provided by wholesalers)	currently no information on availability from any wholesaler	N48 (500 mg/65 mg)	Paper/PE/Al/PE strip		17-0038-08	Labelling text Dec 3, 2020
Not available (according to the information provided by wholesalers)	currently no information on availability from any wholesaler	N60 (500 mg/65 mg)	Paper/PE/Al/PE strip		17-0038-09	Labelling text Dec 3, 2020

Registration information

Marketing authorisation No.	17-0038
Date of authorisation	Feb 15, 2017
MA valid until	Feb 14, 2022
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 Mar 30, 2021.