SPC, UK: BAMBEC Tablets (2017)

Product Name and Form

Bambec Tablets 10 mg.

Pharmaceutical form

Tablet.

Qualitative and Quantitative Composition

Each tablet contains 10 mg Bambuterol hydrochloride.

Excipient(s) with known effect: Each tablet contains 63 mg of lactose (as monohydrate).

For the full list of excipients, see section 6.1.

List of excipients

Lactose monohydrate
Maize starch
Povidone
Microcrystalline cellulose
Magnesium stearate
Water, purified

Pack sizes and Marketing

Amber glass bottle with LD-polyethene cap: 7, 14, 28, 30, 56 or 100 tablets.
HDPE container with LD-polyethene cap: 7, 14, 28, 30, 56 or 100 tablets.
HDPE container with polypropylene cap: 7, 14, 28, 30, 56 or 100 tablets.
PVC blisters: 7, 14, 28, 30, 56 or 100 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder
Authorization dates

AstraZeneca UK Ltd., 600 Capability Green, Luton, LU1 3LU, UK

Date of first authorisation: 4th August 1992

Date of latest renewal: 21st May 2002

Marketing authorization number:

PL 17901/0103