Respontin 250micrograms/1ml Nebules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Ipratropium bromide

Available from:

GlaxoSmithKline UK Ltd

ATC code:

R03BB01

INN (International Name):

Ipratropium bromide

Dosage:

250microgram/1ml

Pharmaceutical form:

Nebuliser liquid

Administration route:

Inhalation

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 03010200; GTIN: 5000124440206

Patient Information leaflet

1
_ _
PACKAGE LEAFLET: INFORMATION FOR THE USER
RESPONTIN
® Nebules
®
IPRATROPIUM BROMIDE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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, nurse 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, nurse or pharmacist.
This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1
What Respontin Nebules are and what they are used for
2
What you need to know before you use Respontin Nebules
3
How to use Respontin Nebules
4
Possible side effects
5
How to store Respontin Nebules
6
Contents of the pack and other information
1
WHAT RESPONTIN NEBULES ARE AND WHAT ARE THEY USED FOR
Respontin Nebules contain a medicine called ipratropium. This belongs
to a group of medicines called
‘relievers’ or bronchodilators. They relax the muscles in the
airways of your lungs. This helps to:
•
open your airways
•
relieve chest tightness, wheezing and coughing so that you can breathe
more easily.
Respontin Nebules are used to treat:
•
asthma
•
other breathing difficulties in adults, such as Chronic Obstructive
Pulmonary Disease (COPD).
They are usually given to people who have these conditions when other
treatments have not helped enough.
A Nebule
®
is a small plastic container that contains a liquid. The liquid is put
into a machine called a
nebuliser. This machine makes a fine mist for you to breathe in
through a face mask.
2
WHAT YOU NEED TO KNOW BEFORE YOU USE RESPONTIN NEBULES
DO NOT USE RESPONTIN NEBULES IF:
•
you are allergic to ipratropium bromide or any of the other
ingredients of this medicine (listed in section
6)
•
you are allergic (hypersensitive) to atropine.
Do not use if any of the above apply to you. If yo

Summary of Product characteristics

OBJECT 1
RESPONTIN NEBULES
Summary of Product Characteristics Updated 23-Nov-2015 |
GlaxoSmithKline UK
1. Name of the medicinal product
Respontin® Nebules®
2. Qualitative and quantitative composition
1ml or 2ml plastic ampoules containing 0.25mg/ml of Ipratropium
Bromide Ph.Eur.
3. Pharmaceutical form
Oral inhalation solution via a nebuliser.
4. Clinical particulars
4.1 Therapeutic indications
Respontin Nebules are indicated for the treatment of reversible
airways obstruction.
4.2 Posology and method of administration
The dosage should be adapted to the individual needs of the patient.
In children aged 12 years and under,
only 1ml ampoules should be used.
For inhalation use.
ADULTS (INCLUDING THE ELDERLY) AND CHILDREN OVER 12 YEARS OF AGE
The recommended dose is 250-500 micrograms (i.e. one vial of 250
micrograms in 1 ml or 1 vial of 500
micrograms in 2 ml) 3 to 4 times daily.
For treatment of acute bronchospasm, 500mcg. Repeated doses can be
administered until the patient is
stable. The time interval between the doses may be determined by the
physician.
It is advisable not to exceed the recommended daily dose during either
acute or maintenance treatment.
Daily doses exceeding 2 mg in adults and children over 12 years of age
should only be given under
medical supervision.
PAEDIATRIC POPULATION
_Children 6-12 years of age_
The recommended dose is 250 micrograms (i.e. one vial of 250
micrograms in 1 ml) up to a total daily
dose of 1mg (4 vials).
The time interval between doses may be determined by the physician.
_Children 0–5 years of age (for treatment of acute asthma only)_
The recommended dose is 125-250 micrograms (i.e. half to one vial of
250 micrograms in 1 ml) up to a
total daily dose of 1 mg (4 vials).
Ipratropium bromide should be administered no more frequently than 6
hourly in children under 5 years
of age.
For acute bronchospasm, repeated doses may be administered until the
patient is stable.
Respontin may be combined with a short-acting beta
2
-agonist in the same nebuliser chamber, for
simultaneous