Ibuprofenum, Pseudoephedrini hydrochloridum

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 leafletPDF 22-09-2022
Summary of product characteristicsPDF 22-09-2022
ATC code M01AE51 Antiinflammatory and antirheumatic products
Information for Marketing authorisation holdersView

Important notice

Additional information regarding the use for persons aged 75+

If used as "ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS"
SubstanceClassComment
IbuprofenumCSuitable 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)

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 N6
(200 mg/30 mg)
PVC/Al blister    22-0168-01 Labelling text 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 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 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 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 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