BRONCHOSTOP NITE ORAL SOLUTION

Introduction

Patient Information Leaflet

BronchostopNite Oral Solution

Dry extract of marshmallow root

Dry extract of linden flower

Dry extract of plantain leaf

Read this leaflet carefully before starting to take this medicine, as it contains important information for you.

Follow the administration instructions for this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if your symptoms worsen or do not improve after 5 days.

Contents of the Leaflet

1. What is BronchostopNite and what is it used for
2. What you need to know before taking BronchostopNite
3. How to take BronchostopNite
4. Possible side effects
5. Storage of BronchostopNite
6. Package contents and additional information

1. What is BronchostopNite and what is it used for

BronchostopNite contains extracts of marshmallow root, linden flower, and plantain leaf.

BronchostopNite is a traditional herbal medicinal product for the relief of common cold symptoms, such as chills, throat and pharyngeal irritation, and cough.

It is beneficial for the relief of nocturnal cough, helping you to sleep.

It is a traditional herbal medicinal product for the specified indications, based solely on long-standing use.

You should consult a doctor if your symptoms do not improve or worsen after 5 days of treatment.

2. What you need to know before taking BronchostopNite

Do not takeBronchostopNite:

If you are allergic to marshmallow root, linden flower, or plantain leaf, or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist if, while taking BronchostopNite:

• you do not feel better or if you feel worse
• you have difficulty breathing (dyspnea)
• you have a fever
• your sputum is greenish-yellow or brown (purulent sputum)

Theoretically, this medicine could delay the absorption of other medicines taken at the same time. As a precaution, do not take this medicine 30 minutes to 1 hour before or after taking other medicines.

Children

The use of this medicine in children under 6 years of age has not been established due to lack of data, and because a doctor should be consulted.

Other medicines and BronchostopNite

Taking BronchostopNite with other medicines. Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.

Based on the empirically observed sedative activity of linden flower, this medicine may increase drowsiness caused by sedative medicines (medicines to calm or reduce anxiety) and alcohol.

Theoretically, the substances present in the three active ingredients could delay the absorption of other medicines taken at the same time, especially if administered at low doses (such as hormones).

Taking BronchostopNite with food and drinks

Since this medicine also acts physically and locally, you should avoid drinking 30 minutes to 1 hour after administration.

Pregnancy and breastfeeding

The safety of taking this medicine during pregnancy and breastfeeding is unknown. Therefore, it is not recommended to take this medicine if you are pregnant or breastfeeding.

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medicine.

Driving and using machines

No studies have been conducted on the effects on the ability to drive and use machinery.

BronchostopNite contains xylitol

It may have a mild laxative effect because it contains 11.04 g of xylitol per 60 ml (the maximum daily dose). Caloric value: 2.4 kcal/g of xylitol, corresponding to 26.5 kcal.

BronchostopNite contains methyl parahydroxybenzoate and propyl parahydroxybenzoate

It may cause allergic reactions (possibly delayed) because it contains methyl parahydroxybenzoate and propyl parahydroxybenzoate.

BronchostopNite contains propylene glycol and benzyl alcohol

This medicine contains 13.6 mg of propylene glycol and 0.002 mg of benzyl alcohol in each 15 ml. Benzyl alcohol may cause allergic reactions.

3. How to take BronchostopNite

Follow the administration instructions for this medicine exactly as stated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Oral use (undiluted).

Start taking the medicine when the first symptoms of the common cold appear.

Since this medicine also acts physically and locally, avoid drinking 30 minutes to 1 hour after administration.

The recommended dose is:

Adults and adolescents over 12 years:

Using the measuring cup included in the box, take 15 ml of oral solution as needed. Do not take more than 4 doses (60 ml) in 24 hours.

Use in children

Children from 6 to 12 years:

Using the measuring cup included in the box, take 7.5 ml of oral solution as needed. Do not take more than 4 doses (30 ml) in 24 hours.

Children under 6 years:

The use of this medicine in children under 6 years is not recommended.

For the relief of nocturnal cough:

It is recommended to take one dose before dinner and the last one just before bedtime.

If symptoms persist for more than 5 days while taking the medicine, consult a doctor or pharmacist.

If you take more BronchostopNite than you should

No cases of overdose have been reported. However, the known laxative effects may occur with greater intensity if you have taken a considerable overdose of this medicine. In this case, please inform your doctor, who will decide on any necessary measures.

If you forget to take BronchostopNite

Do not take a double dose to make up for the forgotten dose. Wait for the next dose.

If you stop taking BronchostopNite

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

No side effects are known. If adverse reactions occur, consult a doctor or healthcare professional.

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines Agency's website: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of BronchostopNite

Keep this medicine out of the sight and reach of children.

Do not store above 25°C. After opening, use within 2 months.

Keep the container tightly closed after use.

Do not use this medicine after the expiry date stated on the carton and label. The expiry date is the last day of the month stated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and additional information

Composition of BronchostopNite

1 ml of oral solution contains:

• The active ingredients are:

• 12.5 mg of extract (as dry extract) of Althaea officinalis L., radix (marshmallow root) (7-9: 1). Extraction solvent: water
• 9.09 mg of extract (as dry extract) of Tilia cordata Miller, Tilia platyphyllos Scop., Tilia x vulgaris Heyne or their mixtures, flos (linden flower) (3-8: 1). Extraction solvent: water
• 10.0 mg of extract (as dry extract) of Plantago lanceolata L., folium (plantain leaf) (4-6: 1). Extraction solvent: water

• The other ingredients are:

• Xylitol (E967)
• Maltodextrin
• Glycerol
• Xanthan gum
• Citric acid monohydrate
• Strawberry flavor (contains benzyl alcohol (E519), propylene glycol (E1520))
• Methyl parahydroxybenzoate (E218)
• Colloidal anhydrous silica
• Propyl parahydroxybenzoate (E216)

Purified water

Appearance and package contents

BronchostopNite is a brown, opaque oral solution contained in a brown glass bottle with a plastic screw cap and a measuring cup in a cardboard box.

BronchostopNite is available in 120 ml, 200 ml, and 240 ml packs. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Kwizda Pharma GmbH

Effingergasse 21

A-1160, Vienna

Austria

This medicine is authorized in the Member States of the European Economic Area under the following names:

Greece BRONCHONIGHT® π?σιμο δι?λυμα

Norway Bronwel Natt mikstur, oppløsning

Portugal Bronchodual Night & Day, solução oral

Date of the last revision of this leaflet:February 2025

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/