Buttercup Bronchostop Day & Night Oral Solution

Nchi: Ayalandi

Lugha: Kiingereza

Chanzo: HPRA (Health Products Regulatory Authority)

Inapatikana kutoka:

Kwizda Pharma GmbH

ATC kanuni:

R05X

Dawa fomu:

Oral solution

Eneo la matibabu:

OTHER COLD PREPARATIONS

Idhini hali ya:

Not marketed

Idhini ya tarehe:

2021-02-26

Taarifa za kipeperushi

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
BUTTERCUP BRONCHOSTOP DAY & NIGHT ORAL SOLUTION
Marshmallow root dry extract
Lime flower dry extract
Ribwort plantain dry 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 a doctor if you do not feel better or if you feel
worse after 7 days.
WHAT IS IN THIS LEAFLET
1.
What Buttercup Bronchostop Day & Night oral solution
is and what it is used for
2.
What you need to know before you take Buttercup Bronchostop Day &
Night oral
solution
3.
How to take Buttercup Bronchostop Day & Night oral solution
4.
Possible side effects
5.
How to store Buttercup Bronchostop Day & Night oral solution
6.
Contents of the pack and other information
1.
WHAT BUTTERCUP BRONCHOSTOP DAY & NIGHT ORAL SOLUTION IS AND WHAT IT IS
USED FOR
Buttercup Bronchostop Day & Night oral solution contains the active
substances
marshmallow root, lime flower and ribwort plantain extracts.
Traditional herbal medicinal product used in adults and adolescents
aged 12 years and older
for the symptomatic treatment of throat irritation and dry cough,
associated with common
cold.
The product is a traditional herbal medicinal product for use in the
specified indication
exclusively based upon long-standing use..
If the symptoms worsen, persist or do not improve after 7 days, a a
doctor should be
consulted.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE BUTTERCUP BRONCHOSTOP DAY &
NIGHT ORAL
SOLUTION
_ _
DO NOT TAKE BUTTERCUP BRONCHOSTOP DAY & NIGHT ORAL SOLUTION
-
if you are allergic to marshmallow root, lime flower or ribwort
plantain or any of the
other ingredie

Tabia za bidhaa

Health Products Regulatory Authority
10 June 2022
CRN00CX74
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Buttercup Bronchostop Day & Night Oral Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 15 ml (= 16.3 g) of oral solution contains:
187.5 mg of extract (as dry extract) from _Althaea officinalis _L._,
_radix (Marshmallow root) (7- 9:1). Extraction solvent: water
136.4 mg of extract (as dry extract) from _Tilia cordata _Miller,
_Tilia platyphyllos _Scop., _Tilia _x _europaea _L. or their mixtures,
flos
(Lime flower) (3-8:1). Extraction solvent: water
150.0 mg of extract (as dry extract) from _Plantago lanceolata _L.,
folium (Ribwort plantain leaf) (4-6:1). Extraction solvent: water
Excipients with known effect:
Each 15 ml of oral solution contains 2.76 g xylitol (E967), 11.3 mg
methyl- parahydroxybenzoate (E 218), 6.6 mg propyl
parahydroxybenzoate (E216) and strawberry flavour (containing 13.6 mg
propylene-glycol and 0.0018 mg benzyl-alcohol)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral solution.
Brown opaque liquid.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Traditional herbal medicinal product used in adults and adolescents
aged 12 years and older for the symptomatic treatment of
throat irritation and dry cough, associated with common 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
Start at the first sign of the common cold (throat irritation and dry
cough).
Posology
_Adults and adolescents aged 12 years and above:_
Using the measuring cup provided, 15 ml of oral solution should be
taken as required up to four times daily (the maximum
recommended dose is 60 ml in 24 hours). The last dose should be taken
directly before bedtime.
_Paediatric population_
Children under 12 years:
The use in children under 12 years of age is not recommended.
Method of administration
For oral use (undiluted).
Due to the p