Bronchosan dry, tickly cough syrup

Nazione: Irlanda

Lingua: inglese

Fonte: HPRA (Health Products Regulatory Authority)

Commercializzato da:

A. Vogel Ireland Ltd,

Dosaggio:

.

Forma farmaceutica:

Syrup

Stato dell'autorizzazione:

Marketed

Data dell'autorizzazione:

2014-03-07

Foglio illustrativo

A.Vogel Ireland
Santasapina Syrup
IE - Dublin
CTD Module 1
July 2022
___________________________________________________________________________________
PACKAGE LEAFLET
PIL2576. e04
Page 1 of 5
Santasapina Sirup (3)
Art. no. 01148900
PACKAGE LEAFLET: INFORMATION FOR THE USER
BRONCHOSAN
DRY, TICKLY COUGH SYRUP
Norway Spruce extract
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
PRODUCT BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
Always take this product exactly as described in this leaflet or as
your doctor,
pharmacist or nurse has told you.
•
Keep this leaflet. You may need to read it again.
•
Ask your pharmacist if you need more information or advice.
•
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.
•
You must talk to a doctor if you do not feel better or if you feel
worse
after 7 days.
WHAT IS IN THIS LEAFLET:
1.
What Bronchosan is and what it is used for
2.
What you need to know before you take Bronchosan
3.
How to take Bronchosan
4.
Possible side effects
5.
How to store Bronchosan
6.
Contents of the pack and other information
1.
WHAT BRONCHOSAN IS AND WHAT IT IS USED FOR
Bronchosan is a traditional herbal medicinal product containing the
extract of
fresh Norway Spruce shoots.
It is used for the relief of coughs in adults and adolescents over 12
years of
age. This is exclusively based on long-standing use.
Used to relieve:
•
Dry coughs
•
Tickly coughs
•
Irritating coughs
A.Vogel Ireland
Santasapina Syrup
IE - Dublin
CTD Module 1
July 2022
___________________________________________________________________________________
PACKAGE LEAFLET
PIL2576. e04
Page 2 of 5
Santasapina Sirup (3)
Art. no. 01148900
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE BRONCHOSAN
DO NOT TAKE BRONCHOSAN
•
If you are allergic to:
o
Spruce (_Picea abies_). This product contains Spruce shoots.
o
Pine species
o
Colophony (pine resin)
o
Any of the other ingredients of this product (listed in section

Scheda tecnica

Health Products Regulatory Authority
09 September 2022
CRN00D4GN
Page 1 of 3
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Bronchosan dry, tickly cough syrup
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
5 ml (6.95 g) of syrup contains 1,445 mg of extract (as soft extract)
from _Picea abies _(L.) Karsten (Norway Spruce) shoots (0.9 -
1.2:1). Extraction solvent: water.
Excipients with known effect:
Each 5 ml of syrup contains 5.25 g of sugar mainly present as sucrose,
glucose and fructose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Syrup
It is a brown syrup.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
A traditional herbal medicinal product for the relief of coughs, such
as dry, tickly, irritating coughs exclusively based on
long-standing use.
This medicine is indicated for use in adults and adolescents over 12
years.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Adults and adolescents over 12 years:
5-10 ml 2-4 times daily
The use in children below 12 years of age is not recommended (see 4.4
Special warnings and precautions for use).
METHOD OF ADMINISTRATION
If symptoms worsen or do not improve during the use of Bronchosan or
persist for more than 7 days, a qualified healthcare
professional e.g. a doctor or pharmacist should be consulted.
For oral short-term use only.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active ingredient, Pine species, colophony or
to any of the excipients listed in section 6.1.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
If symptoms worsen or do not improve during the use of Bronchosan or
persist for more than 7 days a qualified healthcare
professional e.g. a doctor or pharmacist should be consulted.
If dyspnoea, fever or purulent sputum occurs a doctor should be
consulted.
Contains sucrose as well as sources of glucose and fructose (honey and
concentrated pear juice). Patients with rare hereditary
problems of fructose intolerance, glucose-galactose malabsorption or
sucrase-isomaltase insufficiency should not take this
medicine