otc use in sweden for lansoprazole, ATC-code: A02BC03
1 Introduction
This is the current national position of the OTC use for lansoprazole.
Please note that this summary only presents the current position of the OTC-use in Sweden for lansoprazole. Whether your application is within the range of what is already approved as a non-prescription medicinal product according to this summary other OTC-use must be applied for and assessed in accordance to “A guideline on changing the classification for the supply of a medicinal product for human use” prior to approval.
Please note that when implemented in the PIL and labelling the OTC-information must be amended within the range for OTC-use specified in this document base upon the information in the SPC for the specific product.
Gastro-resistant capsule, hard
15 mg
30 mg
Orodispersible tablet
15 mg
2 Package leaflet
This should appear in the package leaflet:
2.1 Indication
{Trade name} används vid tillfällig behandling av halsbränna och sura uppstötningar.
2.2 Dosage:
In the dosing instructions the quantity should be transformed from mg to the number of entities to be taken (e.g. 1-2 capsules…).
Vuxna: 15-30 mg vid behov. Ta inte mer än 30 mg per dygn.
Om symptomen inte har försvunnit efter 14 dagars behandling, bör du kontakta läkare, eftersom dina besvär kan ha en annan orsak. Det är också mycket viktigt att du kontaktar läkare vid ofta återkommande besvär.
{Trade name} får ej användas av barn och ungdomar under 18 år utan läkares ordination.
2.3 Other information:
Not applicable
3 labelling
This should appear on the labelling:
3.1 Indication:
Vid tillfällig halsbränna och sura uppstötningar.
In exceptional cases the short form may be sufficient.
3.2 Dosage:
Vuxna: 15-30 mg vid behov. Ta inte mer än 30 mg per dygn.
Kontakta läkare om symtomen inte försvunnit efter 14 dagar eller vid ofta återkommande besvär.
{Trade name} får ej användas av barn och ungdomar under 18 år utan läkares ordination.
3.3 Other information:
Not applicable
4 package size
Gastro-resistant capsule, hard, 15 mg / Blister (up to pack size) / Jar (up to pack size)Pharmacy / 28 gastro-resistant capsules / 28 gastro-resistant capsules
Unrestricted sale in retail trade* / No / No
Gastro-resistant capsule, hard, 30 mg / Blister (up to pack size) / Jar (up to pack size)
Pharmacy / 14 gastro-resistant capsules / 14 gastro-resistant capsules
Unrestricted sale in retail trade* / No / No
Orodispersible tablet / Blister (up to pack size)
Pharmacy / 14
Unrestricted sale in retail trade* / No
*Medical products within this class (proton pump inhibitors) can interact with drugs containing clopidogrel, and pharmaceutical advice must be available to avoid misuse. With reference to this background and with concern for patient safety, the Medical Products Agency finds it reasonable to allow this product to be sold in pharmacies only.
Approved (date): 13 July 2011
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