Bronchosol Syrup 200 ml

Method and route of administration
Drug used orally.
Administer to children aged 4-6 years 3 times a day for 2,5 ml; children aged 6-12 years 3 times for 5 ml of the drug, adolescents aged 12-18 years 3 times a day for 10 ml, adults 3 times for 15 ml of the drug. Give the last dose of the drug no later than 3 hours before going to bed.
Administer the syrup measured with the attached measuring cup.
Shake before use!

Read the leaflet before using the drug.
Storage: Store at ambient temperature.
Dimensions: Height: 160 mm. Width: 61 mm. Depth: 61 mm.
Packaging: Box

100 ml of syrup contains: 4360 mg of thick compound extract (3:1; water) of thyme herb and primula root (7.6/1 parts) (Extractum compositum spissum ex: Thymi herba et Primulae radice) and 19.8 mg of thymol (Thymolum), Excipients: sugar, purified water, orange flavor, A single dose contains 4.2 g of sugar which corresponds to 0.35 bread units, The drug contains no more than 0.5% (m/m) ethanol

Phytopharm Klęka S.A.

Name and address of the responsible entity
Phytopharm Klęka S.A.
Klęka1
63-040 Nowe Miasto nad Warta
Poland
Tel: +48 61 28 68 000
Fax: +48 61 28 68 529
info@europlant-group.pl

Keep the drug out of reach and sight of children.

Carefully read the leaflet before using the drug, as it contains important information for the patient.
Always use this medicine exactly as described in this patient leaflet, or as directed by your doctor, pharmacist or nurse.
- Keep this leaflet so that you can read it again if needed.
- If you need advice or additional information, ask your pharmacist.
- If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.
- If there is no improvement after 7 days, or if you feel worse, contact your doctor.

Table of contents of the leaflet
1 What is Bronchosol drug and what is it used for?
2. important information before using Bronchosol drug
3. how to use Bronchosol drug
4 Possible side effects
5. how to store Bronchosol drug
6. package contents and other information

1 What is the drug Bronchosol and for what purpose it is used.
Bronchosol syrup is traditionally intended for the treatment of cough. It contains a compound extract of thyme herb and primrose root and thymol. It is traditionally used as an expectorant and to stimulate the secretion of liquid mucus in the bronchi.
Indications for use
Traditionally in cough and difficult expectoration in the course of upper respiratory tract infections.
Bronchosol is a herbal medicine used traditionally and its effectiveness is based solely on the experience of a long period of use of the drug.

(2) Information important before using Bronchosol.
When not to use the drug Bronchosol
- if the patient is allergic to the active substance or to thymol, primrose, thyme or any of the other components of this drug (listed in section 6),
- in case of hypersensitivity to plants of the light family (Lamiaceae), also called labiate (Labiatae),
- in children with a history of acute croup laryngitis (acute obstructive laryngitis), including in the past,
- in asthma.
Consult your doctor, even if the above warnings apply to past situations.

Warnings and precautions
Discuss with your doctor, pharmacist or nurse before taking Bronchosol.
If symptoms worsen, do not disappear after 7 days, shortness of breath, fever or purulent discharge occur, consult a doctor.
Bronchosol is not recommended for people with symptoms of gastric irritation (nausea) and in inflammation and gastric ulcers.
The drug Bronchosol contains sucrose.
A dose of 5 ml contains 4.2 g of sugar, equivalent to 0.35 bread units. A dose of 15 ml contains 12.7 g of sugar, equivalent to 1.06 bread units. This should be taken into account in patients with diabetes.
If you have previously been diagnosed with intolerance to certain sugars, you should contact your doctor before taking the drug.
This drug contains no more than 100 mg of alcohol (ethanol) in a dose of 15 ml. The amount of alcohol in a 15 ml dose of this drug is equivalent to less than 3 ml of beer or 1 ml of wine.
A small amount of alcohol in this drug will not cause noticeable effects.
Children and adolescents
The drug can be used in children over 4 years of age. In children under 4 years of age, do not use.

Bronchosol drug and other drugs
Tell your doctor or pharmacist about all medications you are currently or recently taking, as well as medications you plan to take.
Interactions with other drugs are not known.

Use of Bronchosol with food, drink and alcohol.
Food does not affect the effect of the drug.

Pregnancy, breastfeeding and effect on fertility.
The safety of the drug during pregnancy and lactation has not been established, so it is not recommended for use in women during this period. Consult a doctor before using the product.

Driving and operating machinery
So far, the effect of the product on the ability to drive and operate moving machinery has not been established.

3 How to use the drug Bronchosol
This drug should always be used exactly as described in this patient leaflet, or as directed by your doctor, pharmacist or nurse. If in doubt, ask your doctor, pharmacist or nurse.
Unless otherwise instructed by your doctor, the following regimen should be used:
children aged 4-6 years 3 times a day 2.5 ml;
children aged 6-12 years 3 times a day, 5 ml of the drug;
adolescents aged 12-18 years 3 times a day, 10 ml each;
adults 3 times a day after 15 ml of the drug.
Give the last dose of the drug no later than 3 hours before going to bed.
Administer orally. Shake before use. Administer the syrup measured with the attached measuring cup.
Children under 4 years of age: do not use.
If you feel that the effect of Bronchosol is too strong or too weak, consult your doctor or pharmacist.
Duration of use:
If symptoms persist for more than 7 days, contact your doctor or pharmacist.
Using more than the recommended dose of Bronchosol.
Stomach pain, vomiting or diarrhea may occur.
Omission of use of Bronchosol drug
Continue the recommended dosage, do not use a double dose to make up for a missed dose.

4 Possible side effects
Like any drug, Bronchosol may cause side effects, although they will not occur in everyone.
So far, no adverse reactions have been reported after the use of Bronchosol syrup. However, such side effects as gastrointestinal disorders, nausea, vomiting, allergic reactions may occur. The incidence is not known.
Reporting of side effects
If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Adverse Drug Reactions Monitoring Department of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,

Jerozolimskie Al. 181 C,

02-222 Warsaw,

phone: + 48 22 49 21 301,

fax: + 48 22 49 21 309, website: https://smz.ezdrowie.gov.pl

Side effects can also be reported to the responsible party.

By reporting side effects, it will be possible to gather more information on the safety of the drug.

5 How to store the drug Bronchosol
Store the drug out of sight and reach of children.
Store the medicinal product at a temperature below 25 ° C.
After the first opening of the bottle, store at a temperature below 25°C.
Do not use Bronchosol drug after the expiration date on the package. Expiration date
Expiration date after the first opening of the bottle: 3 months.
Expiration date means the last day of the stated month.

Medicines should not be disposed of in sewage or household waste containers. Ask your pharmacist how to dispose of medicines that you no longer use. Such treatment will help protect the environment.

6 Contents of the package and other information
What the drug Bronchosol contains
- 1 ml of syrup contains:
43.6 mg of a dense complex extract (3:1) of: Thyme herb Thymus vulgaris (L) (Thymus zygis (L)) and primrose root Primula veris (L) (Primula elatior (L)) (7.6/1), (Extractum compositum spissum ex: Thymi herba et Primulae radice),
Extraction solvent: water, and 0.198 mg thymol (Thymolum).
- Excipients: natural orange flavor (contains limonene, citral and linalool), sucrose, purified water.
The drug contains no more than 0.5% (m/m) ethanol.
What the drug Bronchosol looks like and what the package contains.
The immediate packaging of the medicinal product is a 100 ml or 200 ml bottle in a cardboard box. The package comes with a measuring cup.

Responsible entity and manufacturer
Phytopharm Klęka S.A.
Klęka 1, 63-040 Nowe Miasto nad Wartą
Poland
Tel: + 48 61 28 68 000
Fax: + 48 61 28 68 529 info@europlant-group.pl
For more detailed information on this drug, contact the responsible entity.

How to use the drug Bronchosol
Always use this drug exactly as described in this leaflet for patients, or as directed by your doctor, pharmacist or nurse. If in doubt, ask your doctor, pharmacist or nurse.

Unless otherwise instructed by your doctor, the following regimen should be used:
children aged 4-6 years 3 times a day 2.5 ml;
children aged 6-12 years 3 times a day, 5 ml of the drug;
adolescents aged 12-18 years 3 times a day, 10 ml each;
adults 3 times a day after 15 ml of the drug.

Give the last dose of the drug no later than 3 hours before going to bed.
Administer orally. Shake before use. Administer the syrup measured with the attached measuring cup.

Children under 4 years of age: do not use.

If you feel that the effect of Bronchosol is too strong or too weak, consult your doctor or pharmacist.
Duration of use:
If symptoms persist for more than 7 days, contact your doctor or pharmacist.

Using more than the recommended dose of Bronchosol.

Stomach pain, vomiting or diarrhea may occur.

Omission of use of Bronchosol drug
Continue with the recommended dosage, do not use a double dose to make up for a missed dose.

Store the drug out of sight and reach of children.
Store the medicinal product at a temperature below 25°C.
After the first opening of the bottle, store at a temperature below 25°C.
Do not use the drug Bronchosol after the expiration date on the package. Expiration date
Expiration date after the first opening of the bottle: 3 months.

Expiration date means the last day of the stated month.

Medicines should not be disposed of in sewage or household waste containers. Ask your pharmacist how to dispose of medicines that you no longer use. Doing so will help protect the environment.

Possible side effects
Like any drug, Bronchosol may cause side effects, although they will not occur in everyone.
So far, no adverse reactions have been reported after the use of Bronchosol syrup. However, such side effects as gastrointestinal disorders, nausea, vomiting, allergic reactions may occur. The incidence is not known.
Reporting of side effects
If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Adverse Drug Reactions Monitoring Department of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
Jerozolimskie Al. 181 C,
02-222 Warsaw,
phone: + 48 22 49 21 301,
fax: + 48 22 49 21 309, website: https://smz.ezdrowie.gov.pl

Side effects can also be reported to the responsible party.

By reporting side effects, more information on the safety of the drug can be gathered.

Contents of the package and other information

What the drug Bronchosol contains
- 1 ml of syrup contains:
43.6 mg of a dense complex extract (3:1) of: Thyme herb Thymus vulgaris (L) (Thymus zygis (L)) and primrose root Primula veris (L) (Primula elatior (L)) (7.6/1), (Extractum compositum spissum ex: Thymi herba et Primulae radice),
Extraction solvent: water, and 0.198 mg thymol (Thymolum).
- Excipients: natural orange flavor (contains limonene, citral and linalool), sucrose, purified water.
The drug contains no more than 0.5% (m/m) ethanol.

What the drug Bronchosol looks like and what the package contains.
The immediate packaging of the medicinal product is a 100 ml or 200 ml bottle in a cardboard box. The package comes with a measuring cup.

Responsible entity and manufacturer
Phytopharm Klęka S.A.
Klęka 1, 63-040 Nowe Miasto nad Wartą
Poland
Tel: + 48 61 28 68 000
Fax: + 48 61 28 68 529 info@europlant-group.pl
For more detailed information on this drug, contact the responsible party.

Information important before using Bronchosol drug
When not to use Bronchosol drug
- if the patient is allergic to the active substance or to thymol, primrose, thyme or any of the other components of this drug (listed in section 6),
- in case of hypersensitivity to plants of the light family (Lamiaceae), also called labiate (Labiatae),
- in children with a history of acute croup laryngitis (acute obstructive laryngitis), including in the past,
- in asthma.

Consult your doctor, even if the above warnings apply to past situations.

Warnings and precautions
Discuss with your doctor, pharmacist or nurse before taking Bronchosol.
If symptoms worsen, do not disappear after 7 days, experience shortness of breath, fever or purulent discharge, consult a doctor.
Bronchosol is not recommended for people with symptoms of gastric irritation (nausea) and in inflammation and gastric ulcers.

The drug Bronchosol contains sucrose.
A dose of 5 ml contains 4.2 g of sugar, equivalent to 0.35 bread units. A dose of 15 ml contains 12.7 g of sugar, equivalent to 1.06 bread units. This should be taken into account in patients with diabetes.
If you have previously been diagnosed with intolerance to certain sugars, you should contact your doctor before taking the drug.
This drug contains no more than 100 mg of alcohol (ethanol) in a dose of 15 ml. The amount of alcohol in a 15 ml dose of this drug is equivalent to less than 3 ml of beer or 1 ml of wine.
A small amount of alcohol in this drug will not cause noticeable effects.

Children and adolescents
The drug can be used in children over 4 years of age. In children under 4 years of age, do not use.
Bronchosol drug and other drugs
Tell your doctor or pharmacist about all medications you are currently or recently taking, as well as medications you plan to take.

Interactions with other drugs are not known.

Use of Bronchosol with food, drink and alcohol.
Food does not affect the effect of the drug.

Pregnancy, breastfeeding and effect on fertility.
The safety of the drug during pregnancy and lactation has not been established, so it is not recommended for use in women during this period. Consult a doctor before using the product.

Driving and operating machinery
So far, no effect of the product on the ability to drive and operate moving machinery has been found.