Combivent nebuliser liquid 2.5ml UDVs

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Ipratropium bromide; Salbutamol sulfate

Available from:

Boehringer Ingelheim Ltd

ATC code:

R03AL02

INN (International Name):

Ipratropium bromide; Salbutamol sulfate

Dosage:

200microgram/1ml ; 1mg/1ml

Pharmaceutical form:

Nebuliser liquid

Administration route:

Inhalation

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 03010400; GTIN: 5012816000124

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START
TAKING THIS MEDICINE
• Keep this leaflet. You may need to read it
again.
• If you have any further questions, ask your
doctor, pharmacist or practice nurse.
• This medicine has been prescribed for you.
Do not pass it on to others. It may harm them,
even if their symptoms are the same as yours.
• If any of the side effects gets troublesome
or serious, or if you notice any side effects not
listed in this leaflet, please tell your doctor or
pharmacist.
IN THIS LEAFLET:
1. What COMBIVENT UDVs is and what it is
used for
2. Before you use COMBIVENT UDVs
3. How to use COMBIVENT UDVs
4. Possible side effects
5. How to store COMBIVENT UDVs
6. Further information
1. WHAT COMBIVENT UDVS IS AND WHAT IT IS
USED FOR
The name of your medicine is COMBIVENT
UDVs. You use it with a device called a
‘nebuliser’. This changes your medicine into a
mist for you to breathe in. COMBIVENT contains
two different medicines called:
• Ipratropium bromide and
• Salbutamol sulfate
Both belong to a group of medicines called
bronchodilators. They are used to make
breathing easier in an illness called ‘chronic
obstructive pulmonary disease’ or COPD. They
work by opening up your airways.
2. BEFORE YOU USE COMBIVENT UDVS
DO NOT USE COMBIVENT IF:
• You are allergic (hypersensitive) to ipratropium
or salbutamol or any of the other ingredients
in COMBIVENT. (Listed in section 6: Further
information)
• You are allergic to similar medicines which
contain atropine or medicines like atropine
• You have a heart problem called ‘hypertrophic
obstructive cardiomyopathy’.
This is where the wall between the two sides of
the heart gets bigger and blocks the blood flow
• You have a very fast heart beat (called
‘tachyarrythmia’)
• You are pregnant, likely to get pregnant or are
breast-feeding
Do not use if any of the above apply to you.
If you are not sure, talk to your doctor or
pharmacist before using COMBIVENT.
TAKE SPECIAL CARE WIT

Summary of Product characteristics

OBJECT 1
COMBIVENT UDVS
Summary of Product Characteristics Updated 29-Jan-2018 | Boehringer
Ingelheim Limited
1. Name of the medicinal product
Combivent
®
UDVs
®
2. Qualitative and quantitative composition
Each 2.5 ml single dose unit contains 500 micrograms ipratropium
bromide (as 520 micrograms
ipratropium bromide monohydrate) and 3 mg salbutamol sulfate
(corresponds to 2.5mg salbutamol base).
For excipients, see 6.1.
3. Pharmaceutical form
Nebuliser solution.
A clear, colourless or almost colourless solution.
4. Clinical particulars
4.1 Therapeutic indications
The management of bronchospasm in patients suffering from chronic
obstructive pulmonary disease who
require regular treatment with both ipratropium and salbutamol.
4.2 Posology and method of administration
COMBIVENT UDVs are intended for inhalation only and may be
administered from a suitable nebuliser
or an intermittent positive pressure ventilator. The single dose units
must not be taken orally or
administered parenterally.
Treatment should be initiated and administered under medical
supervision, e.g. in the hospital setting.
Home based treatment can be recommended in exceptional cases (severe
symptoms or experienced
patients requiring higher doses) when a low dose rapid acting
beta-agonist bronchodilator has been
insufficient in providing relief after consultation with an
experienced physician.
The treatment with the nebuliser solution in UDVs should always be
started with the lowest
recommended dose (1 UDV). In very severe cases two unit dose vials may
be required for symptom
relief. Administration should be stopped when sufficient symptom
relief is achieved.
The recommended dose is:
_Adults (including elderly patients and children over 12 years):_
1 single dose unit three or four times daily.
_Children under 12 years:_
There is no experience of the use of COMBIVENT UDVs in children under
12 years.
Administration:
Please refer to the patient information leaflet for instructions for
use with a nebuliser.
Since the single dose units contain no preser