Bronchostop Syrup

Kraj: Malta

Język: angielski

Źródło: Medicines Authority

Kup teraz

Pobierz Ulotka dla pacjenta (PIL)
25-02-2021

Składnik aktywny:

THYMI HERBA, ALTHAEAE RADIX

Dostępny od:

Kwizda Pharma GmbH Effingergasse 21, Vienna 1160, Austria

Kod ATC:

R05CA10

INN (International Nazwa):

THYMI HERBA 7.8 mg ALTHAEAE RADIX 55.3 mg

Forma farmaceutyczna:

SYRUP

Skład:

THYMI HERBA 7.8 mg ALTHAEAE RADIX 55.3 mg

Typ recepty:

POM

Dziedzina terapeutyczna:

COUGH AND COLD PREPARATIONS

Status autoryzacji:

Withdrawn

Data autoryzacji:

2018-06-11

Ulotka dla pacjenta

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PACKAGE LEAFLET: INFORMATION FOR THE USER
BRONCHOSTOP SYRUP
Active substances: thyme herb dry extract, marshmallow root liquid
extract
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
Always take this medicine exactly as described in this leaflet or as
your doctor or pharmacist 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 or pharmacist. This
includes any possible
side effects not listed in this leaflet. See section 4.
−
You must talk to your doctor if you do not feel better or if you feel
worse after 5 days.
WHAT IS IN THIS LEAFLET
1.
What Bronchostop syrup is and what it is used for
2.
What you need to know before you take Bronchostop syrup
3.
How to take Bronchostop syrup
4.
Possible side effects
5.
How to store Bronchostop syrup
6.
Contents of the pack and other information
1.
WHAT BRONCHOSTOP SYRUP_ _IS AND WHAT IT IS USED FOR
Bronchostop syrup
is a traditional herbal medicinal product used to relieve pharyngeal
irritation and
associated dry cough and to promote the expectoration of viscous mucus
in cough associated with
cold.
The product is a traditional herbal medicinal product for use in the
specified indication
exclusively based upon long-standing use.
Bronchostop syrup is intended for use in adults, adolescents and
children from 2 years of age.
Children between 2 and 4 years of age should use this product only
upon doctor’s
recommendation.
You must talk to a doctor if you do not feel better or if you feel
worse after 5 days.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE BRONCHOSTOP SYRUP
DO NOT TAKE BRONCHOSTOP SYRUP
if you are allergic to
Marshmallow root, Thyme
or to other members of the Lamiaceae family
(e.g. Basil, Rosemary, Sage) or to any of the other ingredients of
this medicine (listed in section
6).
2/5
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Bronch
                                
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Charakterystyka produktu

                                1/4
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Bronchostop syrup
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains:
7.8 mg of extract (as dry extract) from
_Thymus vulgaris_
L. and
_Thymus zygis_
L., herba
(Thymi herba) (7-13:1). Extraction solvent: water.
55.3 mg of extract (as liquid extract) from
_Althaea officinalis_
L., radix (Althaeae radix) (1:12-
14). Extraction solvent: water.
Excipients with known effect:
Xylitol (E967)
307.74 mg
methyl-4-hydroxybenzoate (E218)
0.84 mg
propyl-4-hydroxybenzoate (E216)
0.45 mg
sugars contained in raspberry juice concentrate:
fructose
app. 4 mg
glucose
app. 4 mg
sucrose
app. 0.4mg
propylene glycol (E1520)
2.22 mg
contained in raspberry aroma flavour
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Syrup.
Bronchostop syrup is a brown-red, viscous liquid with the scent and
taste of thyme and
raspberries.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Traditional herbal medicinal product used to relieve pharyngeal
irritation and associated dry
cough and to promote the expectoration of viscous mucus in cough
associated with cold.
The product is a traditional herbal medicinal product for use in the
specified indication
exclusively based upon long-standing use.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults and adolescents over 12 years of age:_
15 ml every 3 to 4 hours (4 to 6 times per day; maximum daily dose up
to 90 ml)
_Children between 4 – 12 years of age:_
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7.5 ml every 3 to 4 hours (4 to 6 times per day; maximum daily dose up
to 45 ml)
_Children between 2 – 4 years of age:_
After consultation with a doctor, 7.5 ml every 3 to 4 hours (4 to 6
times per day; maximum
daily dose up to 45 ml) may be administered.
_Children aged less than 2 years:_
The use in children under 2 years of age is not recommended.
Method of administration:
For oral use, undiluted.
If required,
Bronchostop syrup
_ _
may be administered diluted in water or warm tea.
Duration of use:
Self-medication with Bronchostop syrup
_
                                
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