Buttercup Bronchostop Berry Flavour Cough Pastilles

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Thyme herb dry extract 7-13:1, native extraction solvent: water

Available from:

Kwizda Pharma GmbH

ATC code:

R05CA; R05CA10

INN (International Name):

Thyme herb dry extract 7-13:1, native extraction solvent: water

Dosage:

.

Pharmaceutical form:

Pastille

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Expectorants; combinations

Authorization status:

Authorised

Authorization date:

2015-03-13

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE USER
BUTTERCUP BRONCHOSTOP BERRY FLAVOUR COUGH PASTILLES
Thyme herb dry extract
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
Always use 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 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® Berry Flavour Cough Pastilles are and
what they are used for
2.
What you need to know before you take Buttercup Bronchostop® Berry
Flavour Cough
Pastilles
3.
How to take Buttercup Bronchostop® Berry Flavour Cough Pastilles
4.
Possible side effects
5.
How to store Buttercup Bronchostop® Berry Flavour Cough Pastilles
6.
Contents of the pack and other information
1.
WHAT BUTTERCUP BRONCHOSTOP® BERRY FLAVOUR
COUGH PASTILLES
ARE AND WHAT THEY ARE USED FOR
Buttercup Bronchostop® Berry Flavour Cough Pastilles are a
traditional herbal medicinal
product used for the relief of coughs, such as chesty, dry, tickly,
irritating coughs and catarrh
exclusively based on long standing use.
Buttercup Bronchostop® Berry Flavour Pastilles are for use in adults
and adolescents over 12
years of age.
You must talk to a doctor if you do not feel better or if you feel
worse after 7 days.
2.
WHAT
YOU
NEED
TO
KNOW
BEFORE
YOU
TAKE
BUTTERCUP
BRONCHOSTOP® BERRY FLAVOUR
COUGH PASTILLES
DO NOT TAKE BUTTERCUP BRONCHOSTOP® BERRY FLAVOUR
COUGH PASTILLES

If you are allergic to Thyme or 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).

If you are pregnant or breast-feeding.
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WARNINGS AND PRECAU

Summary of Product characteristics

Health Products Regulatory Authority
11 February 2022
CRN00CPZV
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Buttercup Bronchostop Berry Flavour Cough Pastilles
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each pastille contains:
59.5 mg of dry extract from _Thymus vulgaris_ L. and _Thymus zygis _L.
herba (thyme herb) (7-13:1). Extraction solvent: water
Excipients with known effect:
Each pastille contains 523 mg sorbitol (E420), 300 mg fructose, 5.53
mg propylene-glycol (E1520) which is contained in the
aronia and fruit of the forest flavours, 0.0018 mg benzyl-alcohol
(E1519) which is contained in the fruit of the forest flavour and
0.224 mg of sodium.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Pastille.
Hexagonal, brown pastilles with a fruity taste.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Traditional herbal medicinal product used for the relief of coughs,
such as chesty, dry, tickly, irritating coughs and catarrh
exclusively based on long standing use.
Buttercup Bronchostop Berry Flavour Pastilles are indicated in adults
and children aged 12 years and over.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_Posology:_
For oral short-term use only.
Adults, the elderly and children over 12 years:
1-2 pastilles to be taken every 4 hours, 4 times a day. If required,
up to a maximum of 12 pastilles can be taken per day.
_Method of administration:_
For oral use (allow to dissolve in the mouth through sucking).
This product is not recommended for use in children under 12 years of
age (See Section 4.4)
_Duration of use:_
If symptoms persist, worsen or do not improve after 7 days use of
Buttercup Bronchostop Berry Flavour Pastilles, a qualified
healthcare professional e.g a doctor or pharmacist should be
consulted.
4.3 CONTRAINDICATIONS
Hypersensitivity to thyme or to other members of the _Lamiaceae
_(mint) family, or to any of the excipients listed in section 6.1.
Health Products Regulatory Authority
11 February 2022
CRN00CPZV
Page 2 of 4
4.4 SPECIAL WARNI