SPIRIVA Inhalation powder, hard capsule Ref.[7493] Active ingredients: Tiotropium

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2023  Publisher: Boehringer Ingelheim International GmbH, Binger Straße 173, D-55216 Ingelheim am Rhein, Germany

Product name and form

Spiriva 18 microgram, inhalation powder, hard capsule.

Pharmaceutical Form

Inhalation powder, hard capsule.

Light green hard capsules containing the inhalation powder with the product code TI 01 and company logo printed on the capsule.

Qualitative and quantitative composition

Each capsule contains 22.5 microgram tiotropium bromide monohydrate equivalent to 18 microgram tiotropium.

The delivered dose (the dose that leaves the mouthpiece of the HandiHaler device) is 10 microgram tiotropium.

Excipient with known effect: Each capsule contains 5.5 milligram of lactose (as monohydrate).

For the full list of excipients, see section 6.1.

Active Ingredient Description
Tiotropium

Tiotropium is a long-acting, specific, muscarinic receptor antagonist, in clinical medicine often called an anticholinergic. By binding to the muscarinic receptors in the bronchial smooth musculature, tiotropium inhibits the cholinergic (bronchoconstrictive) effects of acetylcholine, released from parasympathetic nerve endings.
List of Excipients

Lactose monohydrate (which may contain small amounts of milk proteins)

Pack sizes and marketing

Aluminium/PVC/Aluminium peel-off blister containing 10 capsules.

The HandiHaler is a single dose inhalation device made from acrylonitrile butadiene styrene (ABS) plastic materials and stainless steel. The capsule chamber is made from methyl-methacrylate-acrylonitrile-butadiene-styrene (MABS) or polycarbonate (PC) plastic material.

Package sizes and devices supplied:

  • Cardboard box containing 30 capsules (3 blisters).
  • Cardboard box containing 60 capsules (6 blisters).
  • Cardboard box containing 90 capsules (9 blisters).
  • Cardboard box containing HandiHaler device and 10 capsules (1 blister).
  • Cardboard box containing HandiHaler device and 30 capsules (3 blisters).
  • Hospital pack: Bundle pack containing 5 cardboard boxes of 30 capsules plus HandiHaler device.
  • Hospital pack: Bundle pack containing 5 cardboard boxes of 60 capsules.

The HandiHaler device is packed/available in a cardboard box.

Not all pack sizes may be marketed.

Marketing authorization holder

Boehringer Ingelheim International GmbH, Binger Straße 173, D-55216 Ingelheim am Rhein, Germany

Marketing authorization dates and numbers

PL 14598/0062

09/10/2016

Drugs

Drug Countries
SPIRIVA Austria, Australia, Brazil, Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Malta, Mexico, Netherlands, New Zealand, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States, South Africa
 
Next: Usage >

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.

⇈