Bronchoforce chesty cough oral drops

Valsts: Īrija

Valoda: angļu

Klimata pārmaiņas: HPRA (Health Products Regulatory Authority)

Aktīvā sastāvdaļa:

Tincture from fresh ivy herb (hedera helix l.) (1:5.7-6.0) extraction solvent: ethanol 51% v/v.; Tincture from fresh aerial parts of thyme (thymus vulgaris l.) (1:8.0-8.2) extraction solvent: ethanol 51% v/v; Tincture from liquorice root (glycyrrhiza glabra l.) (1:10-11) extraction solvent: ethanol 51% v/v.

Pieejams no:

A. Vogel Ireland Ltd,

SNN (starptautisko nepatentēto nosaukumu):

Tincture from fresh ivy herb (hedera helix l.) (1:5.7-6.0) extraction solvent: ethanol 51% v/v.; Tincture from fresh aerial parts of thyme (thymus vulgaris l.) (1:8.0-8.2) extraction solvent: ethanol 51% v/v; Tincture from liquorice root (glycyrrhiza glabra l.) (1:10-11) extraction solvent: ethanol 51% v/v.

Deva:

.

Zāļu forma:

Oral drops, solution

Receptes veids:

Product not subject to medical prescription

Autorizācija statuss:

Marketed

Autorizācija datums:

2015-02-27

Lietošanas instrukcija

A.Vogel Ireland
Bronchosan drops
IE - Dublin
CTD Module 1
July 2022
___________________________________________________________________________________
PACKAGE LEAFLET
PIL2584.e08
Page 1 of 6
Husten-Komplex (2)
Art. no. 01602000
PACKAGE LEAFLET: INFORMATION FOR THE USER
BRONCHOFORCE
Chesty Cough
oral drops
Tinctures of Ivy, Thyme & Liquorice
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 Bronchoforce is and what it is used for
2.
What you need to know before you take Bronchoforce
3.
How to take Bronchoforce
4.
Possible side effects
5.
How to store Bronchoforce
6.
Contents of the pack and other information
1.
WHAT BRONCHOFORCE IS AND WHAT IT IS USED FOR
Bronchoforce is a traditional herbal medicinal product containing the
tinctures of Ivy, Thyme and Liquorice.
It is used as an expectorant to relieve a chesty cough associated with
a cold.
This is exclusively based on long-standing use.
Bronchoforce is for use in adults and adolescents over 12 years of
age.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE BRONCHOFORCE
DO NOT TAKE BRONCHOFORCE
•
If you are allergic to:
A.Vogel Ireland
Bronchosan drops
IE - Dublin
CTD Module 1
July 2022
___________________________________________________________________________________
PACKAGE LEAFLET
PIL2584.e08
Page 2 of 6
Husten-Komplex (2)
Art. no. 01602000
o
Ivy or plants of the Araliaceae family. Ivy is a member of the
Araliaceae family.
o
Thyme or plants of the Lamiaceae family e.g. basil, rosemary or
sag

Produkta apraksts

Health Products Regulatory Authority
29 August 2022
CRN00D15V
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Bronchoforce chesty cough oral drops
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 20 drop dose contains:
198 mg of tincture from _Hedera helix_ L. herba (fresh Ivy herb) (1:
5.7 – 6.0)
Extraction solvent: Ethanol 51 % v/v
173 mg of tincture from _Thymus vulgaris_ L. herba (fresh aerial parts
of Thyme) (1: 8.0 – 8.2)
Extraction solvent: Ethanol 51 % v/v
123 mg of tincture from _Glycyrrhiza glabra_ L. radix (Liquorice root)
(1: 10 – 11).
Extraction solvent: Ethanol 51 % v/v
1 ml is equivalent to 38 drops
Excipient with a known effect: A maximum dose of 20 drops contains
approximately 212 mg of ethanol (alcohol).
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral drops, solution (oral drops)
It is a clear brown liquid.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
A traditional herbal medicinal product used as an expectorant for the
relief of chesty coughs associated with cold, 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: Take 20 drops 3-5 times daily
The use is not recommended in children under 12 years of age (see 4.4
Special warnings and precautions for use).
DURATION OF USE
If symptoms persist, worsen or do not improve after 7 days use of
Bronchoforce a qualified healthcare professional e.g. a
doctor or pharmacist should be consulted.
METHOD OF ADMINISTRATION
For oral short-term use only.
4.3 CONTRAINDICATIONS
Hypersensitivity to ivy, thyme or liquorice preparations, to plants of
the Araliaceae or Lamiaceae (Labiatae) families, or to any of
the excipients listed in section 6.1.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Do not exceed stated dose.
The use is not recommended in children under 12 years of age because
no data on safety are available.
Health Products Regulatory Auth