Bambec 10mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Bambuterol hydrochloride

Available from:

AstraZeneca UK Ltd

ATC code:

R03CC12

INN (International Name):

Bambuterol hydrochloride

Dosage:

10mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 03010101; GTIN: 5014162008427 5000456026352

Patient Information leaflet

BAMBEC
®
10MG TABLETS
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE
BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU.
*
Keep this leaflet. You may need to read it again.
*
If you have any further questions, ask your doctor or pharmacist.
*
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if their signs of illness are the same
as
yours.
*
If you get any side effects, talk to your doctor or pharmacist. This
includes
any possible side effects not listed in this leaflet. See section 4.
Your medicine is called Bambec 10mg Tablets but will be referred to as
Bambec Tablets throughout the leaflet.
WHAT IS IN THIS LEAFLET:
What Bambec Tablets are and what they are used for
What you need to know before you take Bambec Tablets
How to take Bambec Tablets
Possible side effects
How to store Bambec Tablets
Contents of the pack and other information
WHAT BAMBEC TABLETS ARE AND WHAT THEY ARE USED FOR
Bambec Tablets contain bambuterol hydrochloride. They belong to a
group of
medicines called bronchodilators.
* Bronchodilators work by relaxing the airways of your lungs, making
them
wider.
* Bambec Tablets are used to treat breathing problems in people with
asthma and similar conditions. Bambec Tablets are used as regular
treatment to prevent expected breathing problems. Bambec Tablets
should
not be used alone for the regular treatment of asthma or other
breathing
conditions. Bambec tablets must only be used when your doctor has
prescribed you another type of medication such as an “inhaled
corticosteroid”, which helps reduce the swelling and inflammation in
your
lungs. HOWEVER, BAMBEC TABLETS WILL NOT RELIEVE AN ACUTE ASTHMA
ATTACK THAT HAS ALREADY STARTED.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE BAMBEC
TABLETS
DO NOT TAKE BAMBEC TABLETS:
If you are allergic to bambuterol hydrochloride or any of the other
ingredients
of this medicine (listed in section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Bambec Tablets if:
*
You

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Bambec Tablets 10mg
2
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
3
PHARMACEUTICAL FORM
Tablet.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Management of asthma, bronchospasm and/or reversible airways
obstruction.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Bambec is formulated as a tablet and should be taken once daily,
shortly
before bedtime. The dose should be individualised.
Patients must receive optimal anti-inflammatory therapy (e.g. inhaled
corticosteroids, leukotriene receptor antagonists) when using Bambec
for
management of asthma.
Adults:
The recommended starting doses are 10 mg–20 mg. The 10 mg dose may
be
increased to 20 mg if necessary after 1–2 weeks, depending on the
clinical
effect.
In patients who have previously tolerated
β
2
-agonists well, the recommended
starting dose, as well as maintenance dose, is 20 mg.
Elderly:
Dose adjustment is not required in the elderly.
Hepatic Impairment:
SIGNIFICANT HEPATIC DYSFUNCTION: Not recommended because of
unpredictable
conversion to terbutaline.
Renal impairment:
MODERATE TO SEVERELY IMPAIRED RENAL FUNCTION (GFR < 50 ML/MIN): It is
recommended that the starting dose of Bambec should be halved in these
patients.
Paediatric population:
Until the clinical documentation has been completed, Bambec should not
be
used in children.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in
section 6.1. Bambec is presently not recommended for children due to
limited
clinical data in this age group.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
As terbutaline is excreted mainly via the kidneys, the dose of Bambec
should be
halved in patients with an impaired renal function (GFR
≤
50 mL/min).
In patients with liver cirrhosis, and probably in patients with ot