Tonufen – Medicinal Product Register of Latvia

Ibuprofenum, Pseudoephedrini hydrochloridum

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Medicinal product name	Tonufen 200 mg/30 mg coated tablets
Pharmaceutical form	Coated tablet
Strength	200 mg/30 mg
Information from the MAH on shortages	Not notified
Legal status	OTC OTC
Package leaflet	22-09-2022
Summary of product characteristics	22-09-2022
ATC code	M01AE51 – Antiinflammatory and antirheumatic products
Information for Marketing authorisation holders	View

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

Package leaflet	22-09-2022
Summary of product characteristics	22-09-2022

Important notice

Additional information regarding the use for persons aged 75+

If used as "ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS"
Substance	Class	Comment
Ibuprofenum	C	Suitable for older persons, with specific cautions. For short-term use only. May decrease renal function. Avoid use in severe renal insufficiency. May increase blood pressure, worsen cardiac insuffiency and cause cardiovascular events. Increases risk of gastrointestinal bleeding. Take interactions into account, especially with anticoagulants. Remember that anti-inflammatory analgesics are commonly used in self-care.
Pseudoephedrini hydrochloridum		No data on active substance.

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	Product No.	Labelling
Not available (according to the information provided by wholesalers)	currently no information on availability from any wholesaler	N6 (200 mg/30 mg)	PVC/Al blister	22-0168-01	Labelling text Sep 22, 2022
Not available (according to the information provided by wholesalers)	currently no information on availability from any wholesaler	N10 (200 mg/30 mg)	PVC/Al blister	22-0168-02	Labelling text Sep 22, 2022
Not available (according to the information provided by wholesalers)	currently no information on availability from any wholesaler	N12 (200 mg/30 mg)	PVC/Al blister	22-0168-03	Labelling text Sep 22, 2022
Not available (according to the information provided by wholesalers)	currently no information on availability from any wholesaler	N20: 10 × 2 (200 mg/30 mg)	PVC/Al blister	22-0168-04	Labelling text Sep 22, 2022
Not available (according to the information provided by wholesalers)	currently no information on availability from any wholesaler	N24: 12 × 2 (200 mg/30 mg)	PVC/Al blister	22-0168-05	Labelling text Sep 22, 2022

Registration information

Marketing authorisation No.	22-0168
Date of authorisation	Sep 28, 2022
Marketing authorisation holder, country	US Pharmacia Sp. z o.o., 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 Mar 30, 2021.