BRONCHOSTOP DUO lozenges x 20
BRIEF DESCRIPTION OF THE PRODUCT
1. NAME OF THE MEDICINAL PRODUCT
BRONCHOSTOP 59.5 mg lozenges
BRONCHOSTOP ® 59 . 5 mg lozenges
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
1 lozenge of BRONCHOSTOP lozenges contains:
59.5 mg Garden thyme ( Thymus vulg ./ Thymus zyg . ) dry stem extract ((7-13:1) extractant: water).
Excipients with known effect: 523 mg sorbitol (E420), 300 mg fructose, 5.53 mg propylene glycol (E1520) and 0.0018 mg benzyl alcohol (E1519).
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Lozenges.
Hexagonal brown lozenges.
4. CLINICAL DATA
4.1 Therapeutic indications
A traditional herbal medicinal product that is used as an expectorant for coughs associated with colds.
The product is a traditional herbal medicinal product for use in the specified indications based entirely on long-term use.
4.2 Dosage and method of administration
Dosage
Adults and adolescents over 12 years of age :
When needed, 1 to 2 lozenges in the mouth to suck every 3 to 4 hours (4 to 6 times a day).
Children aged 6 to 12 years :
When needed, 1 lozenge in the mouth to suck every 3 to 4 hours (4 to 6 times a day).
Children under 6 years of age :
Due to the lack of data and due to the risk of accidentally swallowing the entire lozenge, use in children under 6 years of age is not recommended.
Duration of application
If symptoms worsen or do not improve for up to 7 days, a doctor's consultation is necessary.
4.3 Contraindications
Hypersensitivity to the active substances, to other plants of the Lamiaceae family or to any of the excipients listed in point 6.1.
4.4 Special warnings and precautions for use
In case of fever, shortness of breath or purulent expectoration, a doctor's consultation is necessary.
This medicine contains 523 mg of sorbitol and 300 mg of fructose in each lozenge, corresponding to approximately 0.1 carbohydrate units. This should be considered in patients with diabetes mellitus. This medicinal product should not be taken by patients with hereditary intolerance
to fructose. The additive effect of concomitantly administered products containing sorbitol (or fructose) as well as the dietary intake of sorbitol (or fructose) should be considered.
The sorbitol content of medicinal products for oral administration may affect the bioavailability of other oral medicinal products that are administered concomitantly.
Sorbitol can cause gastrointestinal discomfort and a mild laxative effect.
This medicine contains 5.53 mg of propylene glycol in each lozenge.
This medicine contains 0.0018 mg of benzyl alcohol (E1519) in each lozenge. Benzyl alcohol can cause allergic reactions.
This medicine contains less than 1 mmol sodium (23 mg) per lozenge, i.e. it can be said to be practically sodium-free.
Children under 6 years of age :
Due to the lack of data and due to the risk of accidentally swallowing the entire lozenge, use in children under 6 years of age is not recommended.
4.5 Interaction with other medicinal products and other forms of interaction
No interaction studies have been conducted.
4.6 Fertility, pregnancy and lactation
Due to lack of sufficient data, use during pregnancy and breastfeeding is not recommended.
There are no data on effects on fertility.
4.7 Effects on the ability to drive and use machines
It does not affect the ability to drive and operate machinery.
- Adverse drug reactions
Hypersensitivity reactions and gastric disorders have been observed when using medicinal products containing thyme. The frequency is not known.
Reporting of suspected adverse reactions
Post-marketing reporting of suspected adverse reactions is important. This allows continued monitoring of the benefit/risk ratio of the medicinal product. Healthcare professionals are required to report any suspected adverse reaction via
Medicines Executive Agency
8 Damyan Gruev St
1303 Sofia
Tel.: +359 2 8903417
website: www.bda.bg
4.9 Overdose
No cases of overdose have been reported.
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Expectorants, ATC code: R05CA
The constituents of thyme aid in the expectoration of tough, viscous mucus through their secretolytic, secretomotor, and bronchospasmolytic properties. Thyme essential oil, which is also contained in the dry extract, has antiseptic properties.
5.2 Pharmacokinetic properties
They are not required.
5.3 Preclinical safety data
No particular risk to humans is expected with proper use.
6. PHARMACEUTICAL DATA
6.1 List of excipients
Gum Arabic (E 414)
Fructose
Sorbitol 70%, liquid (non-crystallizing) (E 420)
Maltodextrin
Citric acid, anhydrous (E 330)
Saccharin sodium (E 954)
Aronia flavor (containing propylene glycol (E1520))
Berry flavor (containing propylene glycol (E1520) and benzyl alcohol (E1519)) Paraffin, light liquid
Purified water
6.2 Incompatibilities
Not applicable
6.3 Expiry Date
3 years
6.4 Special storage conditions
To be stored below 25°C.
Store in the original packaging in a place protected from light and moisture.
To be stored in a place out of reach of children.
- Type and contents of packaging
PVC/PE/PVdC/Alu blister packs of 20 or 40 lozenges. Not all types of packaging can be put on sale.
6.6 Special precautions for disposal and handling
There are no special requirements.
7. HOLDER OF THE USE AUTHORIZATION
Kwizda Pharma GmbH
Effingergasse 21
1160 Vienna
Austria
8. USE AUTHORIZATION NUMBER(S).
No. II - UR - 38085/07.06.2017
Reg. No. 20120188
9. DATE OF FIRST AUTHORIZATION/RENEWAL OF THE MARKETING AUTHORIZATION
30 Mar 2012/07 Jun 2017
10. TEXT UPDATE DATE
07/2021
