Zerseos 0.5 mg/2.5 mg per 2.5 ml nebuliser solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Ipratropium bromide monohydrate; SALBUTAMOL SULFATE

Available from:

Cipla Europe NV

ATC code:

R03AK; R03AK04

INN (International Name):

Ipratropium bromide monohydrate; SALBUTAMOL SULFATE

Dosage:

0.5mg/2.5 milligram(s)

Pharmaceutical form:

Nebuliser solution

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics; salbutamol and sodium cromoglicate

Authorization status:

Not marketed

Authorization date:

2017-03-10

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
[INVENTED NAME] 0.5 MG/2.5 MG PER 2.5 ML NEBULISER SOLUTION
Ipratropium bromide and salbutamol
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, pharmacist, or
nurse.
-
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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What [Invented name] is and what it is used for
2.
What you need to know before you use [Invented name]
3.
How to use [Invented name]
4.
Possible side effects
5.
How to store [Invented name]
6.
Contents of the pack and other information
1.
WHAT [INVENTED NAME] IS AND WHAT IT IS USED FOR
Your medicine is called [Invented name]. The active ingredients are
ipratropium bromide and
salbutamol. Ipratropium bromide and salbutamol both belong to a group
of medicines called
bronchodilators, which help to improve your breathing by opening up
your airways. This is achieved
by preventing the contraction of the smooth muscles surrounding the
airways, therefore allowing the
airways to remain open. Ipratropium bromide acts by blocking the nerve
signals that go to the muscles
surrounding the airways, and salbutamol acts by stimulating the beta
2
receptors in the muscles.
[Invented name] is used to treat breathing problems in patients over
12 years of age with long-standing
breathing difficulties (chronic obstructive pulmonary disease such as
chronic bronchitis, emphysema).
[Invented name] will relieve wheezing, shortness of breath and chest
tightness.
You use it with a device called a ‘nebuliser’. This changes your
medicine into a mist for you to breathe
in.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE [INVENTED NAME]
D

Summary of Product characteristics

Health Products Regulatory Authority
19 September 2019
CRN008JN4
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zerseos 0.5 mg/2.5 mg per 2.5 ml nebuliser solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 2.5 ml single dose ampoule contains 0.5 mg ipratropium bromide
(as 525 micrograms ipratropium bromide monohydrate)
and 2.5 mg salbutamol (as sulphate).
Excipient with known effects
Each 2.5 ml single dose ampoule contains 8.8 mg sodium
For the full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Nebuliser solution.
Apolyethylene ampoule containing clear, colourless solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Zerseos is indicated in the treatment of bronchospasm in patients
older than 12 years of age with chronic obstructive
pulmonary disease who require symptomatic treatment with both
ipratropium bromide and salbutamol.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
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 Zerseos nebuliser solution should always be started
with the recommended dose. (1 Unit Dose Ampoules).
In very severe cases, two unit dose ampules may be required for
symptom relief. The patient should be instructed to consult a
doctor immediately in the event of acute, rapidly worsening dyspnoea.
In addition, the patient should be warned to seek
medical advice should a reduced response become apparent.
Administration should be stopped when sufficient symptom relief
is achieved.
_The recommended dose is_
_Adults (including elderly patients and children over 12 years)_
The contents of one ampoule three or four times daily.
Repeated administration should be done at the earliest after 6 hours