Bronchosol Maxipuren Eucalypti Aetheroleum 200 mg Capsules 30 pcs.

Method and route of administration: Oral administration. Read the leaflet before using the drug.
Adults and adolescents 12 years and older: 1 capsule 2-3 times a day.
Children under 12 years: it is not recommended to use the product in children under 12 years.
Take the drug 15 minutes before a meal with a sip of water, swallow whole, do not bite.
Dimensions: height: 49 mm. Width: 103 mm. Depth: 22 mm.
Package: Box.

One capsule contains 200 mg of eucalyptus oil (Eucalypti aetheroleum), Excipients: the drug contains sorbitol and propylene glycol

Phytopharm Klęka S.A.

Name and address of the responsible entity:
Phytopharm Klęka S.A.,
Klęka 1,
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 sight and reach of children.

Number of units: 30

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

Table of contents of the leaflet:
1. what is the drug Bronchosol MAXIPUREN and for what purpose it is used.
2. important information before taking Bronchosol MAXIPUREN
3. how to take the drug Bronchosol MAXIPUREN
4 Possible side effects
5. how to store the drug Bronchosol MAXIPUREN
6. package contents and other information

1 What is the drug Bronchosol MAXIPUREN and for what purpose is it used?

Bronchosol MAXIPUREN is a herbal medicinal product, in the form of soft gastrointestinal capsules, containing 200 mg of eucalyptus oil in one capsule. Eucalyptus oil increases the secretion of normal mucus and causes the thinning of secretions lingering in the respiratory tract. Bronchosol MAXIPUREN has a secretomotor effect, i.e. that it increases the movement of epithelial cilia and facilitates their clearance. The drug has an expectorant effect.

The drug Bronchosol MAXIPUREN is used:

- supportively in colds and inflammation of the upper respiratory tract accompanied by cough, runny nose and difficulty with expectoration of sticky mucus,
- Supportively in non-purulent inflammation of the paranasal sinuses.
The product is intended for adults and adolescents 12 years and older.

If there is no improvement after 7 days or the patient feels worse, contact your doctor.

2 Important information before using Bronchosol MAXIPUREN.
When not to use Bronchosol MAXIPUREN drug
If the patient is allergic to eucalyptus oil, its components (1,8-cyneol) or any of the other ingredients of this drug (listed in section 6).

Warnings and precautions
Discuss with your doctor or pharmacist before taking Bronchosol MAXIPUREN.
If symptoms persist for more than a week or if you experience shortness of breath, elevated body temperature, expectoration of purulent or bloody secretions, you should contact your doctor immediately.
Eucalyptus oil may be irritating to the gastrointestinal tract, especially in people with inflammatory conditions of the gastrointestinal tract.

Children
Bronchosol MAXIPUREN is not recommended for use in children under 12 years of age.

Bronchosol MAXIPUREN 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.
At the recommended doses, clinically significant interactions with other drugs have not been observed.

Use of Bronchosol MAXIPUREN with food, drink and alcohol.
No data available.

Pregnancy, breastfeeding and effects on fertility
If you are pregnant or breastfeeding, suspect that you may be pregnant, or if you are planning to have a child, you should consult your doctor or pharmacist before taking this drug.
It is not recommended to use the drug in pregnant or breastfeeding women. The effect of the drug on fertility has not been established.

Driving and operating machines
The effect of the drug on the ability to drive and operate mechanical devices in motion has not been studied.

Bronchosol MAXIPUREN, contains up to 14.77 mg of sorbitol in 1 capsule.


3 How to use the drug Bronchosol MAXIPUREN.
This drug should always be used exactly as described in the leaflet for patients, or as prescribed by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

Use orally.
The recommended dose is:
- adults and adolescents 12 years and older: 1 capsule 2-3 times a day,
- Children under 12 years: the product is not recommended for children under 12 years.

Take Bronchosol MAXIPUREN 15 minutes before a meal, drinking water, swallow whole, do not chew.
Bronchosol MAXIPUREN should be used until symptoms resolve, usually for 1 week.

Use in children and adolescents
The product is not recommended for use in children under 12 years of age.

Use of a higher than recommended dose of Bronchosol MAXIPUREN.

Poisoning manifests itself as violent burning pain in the epigastrium and abdominal pain, spontaneous vomiting, respiratory distress, bronchospasm, respiratory depression, accelerated breathing and pupil constriction; unconsciousness may also occur, especially in children. This poisoning may resemble opiate poisoning, but in the case of eucalyptus oil poisoning, the characteristic eucalyptus odor is noticeable in the breath.

If symptoms of poisoning occur, call a doctor immediately, activated charcoal and sorbitol can be administered.

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

4 Possible side effects
Like any drug, this medication may cause side effects, although they will not occur in everyone.

Nausea, vomiting and diarrhea may occur rarely (less than 1 in 1,000 patients) while taking Bronchosol MAXIPUREN. Other side effects, the exact incidence of which is unknown, include allergic reactions.

Reporting side effects
If you experience any side effects, including any side effects not listed in the leaflet, tell your doctor or pharmacist. 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 Avenue 181 C, 02-222 Warsaw,
tel. + 48 22 49 21 301, fax + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions 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 MAXIPUREN.
Store the drug out of sight and reach of children.
Store at a temperature below 25°C.
Do not use Bronchosol MAXIPUREN after the expiration date on the package. The 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 MAXIPUREN contains.
The active substance of the drug Bronchosol MAXIPUREN is eucalyptus oil (Eucalypti aetheroleum).
1 capsule contains 200 mg of Eucalyptus globulus Labill, Eucalyptus polybractea R.T. Baker, Eucalyptus smithii R.T. Baker, aetheroleum (eucalyptus oil).

The other ingredients (excipients) are: gelatin succinate, glycerol 85%, liquid sorbitol, non-crystallizing, methacrylic acid and ethyl acrylate copolymer (1:1) with polysorbate 80 and sodium lauryl sulfate, propylene glycol, polysorbate 80, glycerol monostearate 40-55.

What the drug Bronchosol MAXIPUREN looks like and what the package contains.
The immediate packaging of Bronchosol MAXIPUREN is a PVC/PE/PVDC-Aluminum blister containing 15 soft capsules. The outer packaging is a cardboard box containing 1 or 2 blisters.

Responsible party and manufacturer
Phytopharm Klęka S.A.
Klęka 1, 63 - 040 Nowe Miasto nad Wartą
Tel: + 48 61 28 68 000
Fax: + 48 61 28 68 529
e-mail: info@europlant-group.pl

3 How to use the drug Bronchosol MAXIPUREN.
This drug should always be used exactly as described in the leaflet for patients, or as prescribed by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

Use orally.
The recommended dose is:
- adults and adolescents 12 years and older: 1 capsule 2-3 times a day,
- Children under 12 years: the product is not recommended for children under 12 years.

Take Bronchosol MAXIPUREN 15 minutes before a meal, drinking water, swallow whole, do not chew.
Bronchosol MAXIPUREN should be used until symptoms resolve, usually for 1 week.

Use in children and adolescents
The product is not recommended for use in children under 12 years of age.

Use of a higher than recommended dose of Bronchosol MAXIPUREN.

Poisoning manifests itself as violent burning pain in the epigastrium and abdominal pain, spontaneous vomiting, respiratory distress, bronchospasm, respiratory depression, accelerated breathing and pupil constriction; unconsciousness may also occur, especially in children. This poisoning may resemble opiate poisoning, but in the case of eucalyptus oil poisoning, the characteristic eucalyptus odor is noticeable in the breath.

If symptoms of poisoning occur, call a doctor immediately, activated charcoal and sorbitol can be administered.

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

5 How to store the drug Bronchosol MAXIPUREN.
Store the drug out of sight and reach of children.
Store at a temperature below 25°C.
Do not use Bronchosol MAXIPUREN after the expiration date on the package. The 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.

4 Possible side effects
Like any drug, this medicine may cause side effects, although they will not occur in everyone.

Nausea, vomiting and diarrhea may occur rarely (less often than in 1 in 1000 patients) while taking Bronchosol MAXIPUREN. Other side effects, the exact incidence of which is unknown, include allergic reactions.

Reporting side effects
If you experience any side effects, including any side effects not listed in the leaflet, tell your doctor or pharmacist. 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 Avenue 181 C, 02-222 Warsaw,
tel. + 48 22 49 21 301, fax + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the responsible party.
By reporting side effects, more information on the safety of the drug can be gathered.

6 Package contents and other information
What does the drug Bronchosol MAXIPUREN contain?
The active substance of the drug Bronchosol MAXIPUREN is eucalyptus oil (Eucalypti aetheroleum).
1 capsule contains 200 mg of Eucalyptus globulus Labill, Eucalyptus polybractea R.T. Baker, Eucalyptus smithii R.T. Baker, aetheroleum (eucalyptus oil).

The other ingredients (excipients) are: gelatin succinate, glycerol 85%, liquid sorbitol, non-crystallizing, methacrylic acid and ethyl acrylate copolymer (1:1) with polysorbate 80 and sodium lauryl sulfate, propylene glycol, polysorbate 80, glycerol monostearate 40-55.

What the drug Bronchosol MAXIPUREN looks like and what the package contains.
The immediate packaging of Bronchosol MAXIPUREN is a PVC/PE/PVDC-Aluminum blister containing 15 soft capsules. The outer packaging is a cardboard box containing 1 or 2 blisters.

Responsible party and manufacturer
Phytopharm Klęka S.A.
Klęka 1, 63 - 040 Nowe Miasto nad Wartą
Tel: + 48 61 28 68 000
Fax: + 48 61 28 68 529
e-mail: info@europlant-group.pl

2 Important information before using Bronchosol MAXIPUREN

When not to use the drug Bronchosol MAXIPUREN
If the patient is allergic to eucalyptus oil, its components (1,8-cyneol) or any of the other ingredients of this drug (listed in section 6).

Warnings and precautions
Discuss with your doctor or pharmacist before taking Bronchosol MAXIPUREN.
If symptoms persist for more than a week or if you experience shortness of breath, elevated body temperature, expectoration of purulent or bloody secretions, you should contact your doctor immediately.
Eucalyptus oil may be irritating to the gastrointestinal tract, especially in people with inflammatory conditions of the gastrointestinal tract.

Children
Bronchosol MAXIPUREN is not recommended for use in children under 12 years of age.

Bronchosol MAXIPUREN 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.
At the recommended doses, clinically significant interactions with other drugs have not been observed.

Use of Bronchosol MAXIPUREN with food, drink and alcohol.
No data available.

Pregnancy, breastfeeding and effects on fertility
If you are pregnant or breastfeeding, suspect that you may be pregnant, or if you are planning to have a child, you should consult your doctor or pharmacist before taking this drug.
It is not recommended to use the drug in pregnant or breastfeeding women. The effect of the drug on fertility has not been established.

Driving and operating machines
The effect of the drug on the ability to drive and operate mechanical devices in motion has not been studied.

Bronchosol MAXIPUREN, contains up to 14.77 mg of sorbitol in 1 capsule.