Espumisan – Medicinal Product Register of Latvia

Simeticonum

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Medicinal product name

Espumisan 40 mg soft capsules

Pharmaceutical form

Capsule, soft

Strength

40 mg

Information from the MAH on shortages

No information on expected shortages

Availability of medicinal product

Product No.	Package size	Wholesalers' stock state
97-0578-01	N50	Is available
97-0578-02	N25	Is available

Legal status

OTC OTC

Package leaflet

11-09-2014

Summary of product characteristics

11-09-2014

ATC code

A03AX13 – Drugs for functional gastrointestinal disorders

Important notice

Additional information regarding the use for persons aged 75+

If used as "DRUGS FOR FUNCTIONAL GASTROINTESTINAL DISORDERS"
Substance	Class	Comment
Simeticonum	A	Suitable for older persons.

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	Maximum admissible pharmacy price (€ incl. VAT)	Product No.	Labelling
Is available (according to the information provided by wholesalers) (3422 containers)	Tamro, Magnum Medical, Saules aptieka, Baltfarm "Vita-Farm", Euroaptieka, Jelgavfarm, Oribalt Rīga, Recipe Plus, Medelens+	N50 (40 mg)	PVC/Al blister	€ 5.96	97-0578-01	Labelling text Apr 18, 2019
Is available (according to the information provided by wholesalers) (1623 containers)	Tamro, Magnum Medical, Baltfarm "Vita-Farm", Euroaptieka, Jelgavfarm, Oribalt Rīga, Recipe Plus	N25 (40 mg)	PVC/Al blister	€ 3.42	97-0578-02	Labelling text Apr 18, 2019
Not available (according to the information provided by wholesalers)	currently no information on availability from any wholesaler	N100 (40 mg)	PVC/Al blister		97-0578-03	Labelling text Apr 18, 2019
Not available (according to the information provided by wholesalers)	currently no information on availability from any wholesaler	N25 (40 mg)	Glass bottle		97-0578-04	Labelling text Apr 18, 2019
Not available (according to the information provided by wholesalers)	currently no information on availability from any wholesaler	N50 (40 mg)	Glass bottle		97-0578-05	Labelling text Apr 18, 2019
Not available (according to the information provided by wholesalers)	currently no information on availability from any wholesaler	N100 (40 mg)	Glass bottle		97-0578-06	Labelling text Apr 18, 2019

Registration information

Marketing authorisation No.	97-0578
Date of authorisation	Dec 3, 1997
Marketing authorisation holder, country	Berlin-Chemie AG (Menarini Group), Germany

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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.