Bambec 20mg tablets

Nazione: Regno Unito

Lingua: inglese

Fonte: MHRA (Medicines & Healthcare Products Regulatory Agency)

Principio attivo:

Bambuterol hydrochloride

Commercializzato da:

Sigma Pharmaceuticals Plc

Codice ATC:

R03CC12

INN (Nome Internazionale):

Bambuterol hydrochloride

Dosaggio:

20mg

Forma farmaceutica:

Oral tablet

Via di somministrazione:

Oral

Classe:

No Controlled Drug Status

Tipo di ricetta:

Valid as a prescribable product

Dettagli prodotto:

BNF: 03010101

Foglio illustrativo

PACKAGE LEAFLET: INFORMATION FOR THE USER
BAMBEC
®
Tablets 10 mg and 20 mg
bambuterol hydrochloride
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.
WHAT IS IN THIS LEAFLET
1. What Bambec Tablets are and what they are used for
2. What you need to know before you take Bambec Tablets
3. How to take Bambec Tablets
4. Possible side effects
5. How to store Bambec Tablets
6. Contents of the pack and other information
1. 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.
2. 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:
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Scheda tecnica

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Bambec Tablets 20mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 20 mg Bambuterol hydrochloride
Excipient(s) with known effect
Each tablet contains 125 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 o