Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2021 Publisher: Glenmark Pharmaceuticals Europe Limited, Laxmi House, 2B Draycott Avenue, Kenton, Middlesex, HA3 0BU, United Kingdom
Tiogiva 18 microgram, inhalation powder, hard capsule.
| Pharmaceutical Form |
|---|
|
Inhalation powder, hard capsule. Transparent colourless hard capsules containing the inhalation powder with ‘T10’ printed on the capsule. |
Each capsule contains 21.7 microgram tiotropium bromide, anhydrous (amorphous) equivalent to 18 microgram tiotropium.
The delivered dose (the dose that leaves the mouthpiece) is 12.1 microgram tiotropium bromide, anhydrous (amorphous) equivalent to10 microgram tiotropium.
Excipient with known effect:
Each capsule contains 5.2 milligram of lactose (corresponding to 5.5 milligram 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). Capsule composed of hydroxypropylmethylcellulose (HPMC), commonly known as Hypromellose. Capsule printing ink: Shellac, black iron oxide, propylene glycol, strong ammonia solution, potassium hydroxide |
Alu/Alu peel-off blister containing 10 capsules. The blisters are supplied in a cardboard box, depending on the pack the box will also contain a dry powder inhaler.
The dry powder inhaler is a single dose inhalation device made from acrylonitrile butadiene styrene (ABS) plastic materials and stainless steel.
Package sizes:
Not all pack sizes may be marketed.
Glenmark Pharmaceuticals Europe Limited, Laxmi House, 2B Draycott Avenue, Kenton, Middlesex, HA3 0BU, United Kingdom
PL 25258/0370
07/04/2021
| Drug | Countries | |
|---|---|---|
| TIOGIVA | Austria, Finland, Ireland, United Kingdom |
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