Elmiron®
Elmiron is a hard gelatin capsule containing 100 mg of the active substance pentosan polysulfate sodium.
Prescription only. This page provides marketing authorisation particulars.
This is a prescription medicinal product authorised in the name of Aymed İlaç Sanayi. It is supplied as a white, opaque, hard gelatin capsule containing 100 mg of pentosan polysulfate sodium per capsule.
For information on the active substance, see What is pentosan polysulfate?. The Summary of Product Characteristics and patient information leaflet contain the authoritative information on use.
- Product name
- Elmiron 100 mg capsules
- Product category
- Medicinal product for human use
- Active substance
- Pentosan polysulfate sodium
- Pharmaceutical form
- Capsule
- Strength
- 100 mg
- Pack
- Bottle of 100 capsules
- ATC code
- G04BX15
- Marketing authorisation number
- 2017/274
- Date of first authorisation
- 28.04.2017
- Marketing authorisation holder
- Aymed İlaç Sanayi
- Supply status
- Prescription only
Composition and pharmaceutical characteristics
The information below is taken from the composition, pharmaceutical form and pharmaceutical particulars sections of the Summary of Product Characteristics.
- Composition
- Each capsule contains 100 mg of pentosan polysulfate sodium.
- Description of pharmaceutical form
- White, opaque, hard gelatin capsule, size 2.
- Excipients
- Capsule contents: microcrystalline cellulose, colloidal anhydrous silica. Capsule shell: bovine gelatin, titanium dioxide (E171).
- Shelf life
- 24 months
- Storage
- Store below 25 °C, in a dry place, protected from light.
Product documents
The Summary of Product Characteristics (SmPC) is intended for healthcare professionals; the patient information leaflet provides information for patients. This website asks you to confirm that you are a healthcare professional before accessing the Elmiron documents.
Translations are provided for information. The Turkish SmPC and patient leaflet contain the authoritative product information.
Frequently asked questions
Is Elmiron prescription only?
Yes. Elmiron is a medicinal product for human use and is supplied on prescription. A physician decides whether it should be used.
What is the active substance in Elmiron?
The active substance is pentosan polysulfate sodium; each capsule contains 100 mg.
How many capsules are in an Elmiron pack?
According to the Summary of Product Characteristics, the product is supplied in a bottle containing 100 capsules.
How can I access the Elmiron SmPC and patient leaflet?
The documents are in the Product documents section on this page. The SmPC is for healthcare professionals and the leaflet is for patients. Access on this website requires confirmation of healthcare professional status.
Who holds the marketing authorisation for Elmiron?
The marketing authorisation holder is Aymed İlaç Sanayi. The authorisation number is 2017/274 and the date of first authorisation is 28.04.2017.
The particulars on this page are taken from the Summary of Product Characteristics; authoritative information is contained in the SmPC and patient leaflet. Consult your physician about your medicine and your pharmacist about its use. Other medicinal products from Aymed İlaç Sanayi are listed on the Prescription medicines page.