Bronchostop Nite oral solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

BronchostopNite oral solution

Dry extract of marshmallow root

Dry extract of lime flower

Dry extract of lesser plantain

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

Follow exactly the instructions for use provided in this leaflet or as indicated 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 adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
• You should consult a doctor if your condition worsens or if you do not improve after 5 days.

Contents of the leaflet

1. What BronchostopNite is and what it is used for
2. What you need to know before taking BronchostopNite
3. How to take BronchostopNite
4. Possible adverse effects
5. How to store BronchostopNite
6. Contents of the pack and other information

1. What BronchostopNite is and what it is used for

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

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

It is beneficial for relieving nighttime cough, thereby helping to sleep.

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

You should consult a doctor if you do not feel better or if you feel worse after 5 days of treatment.

2. What you need to know before starting to take BronchostopNite

Do not take BronchostopNite:

If you are allergic to marshmallow root, lime blossom, or lesser plantain, 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 phlegm is yellowish-green 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 within 30 minutes to 1 hour before or after taking other medicines.

Children

Use in children under 6 years of age has not been established due to lack of data, and medical advice should be sought.

Other medicines and BronchostopNite

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

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

Theoretically, substances present in the three active ingredients could delay the absorption of other medicines taken simultaneously, especially those 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 for 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 might be pregnant, or are planning to become pregnant, 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

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

BronchostopNite contains methyl parahydroxybenzoate and propyl parahydroxybenzoate

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 exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

For 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 for 30 minutes to 1 hour after administration.

Recommended dose:

Adults and adolescents over 12 years of age:

Using the dosing cup provided in the package, take 15 ml of oral solution as needed. Do not take more than 4 doses (60 ml) within 24 hours.

Use in children

Children aged 6 to 12 years:

Using the dosing cup provided in the package, take 7.5 ml of oral solution as needed. Do not take more than 4 doses (30 ml) within 24 hours.

Children under 6 years of age:

Use is not recommended in children under 6 years of age.

For relief of nighttime cough:

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

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 a considerable overdose has been taken. 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 missed dose. Wait until the next scheduled dose.

If you stop treatment with BronchostopNite

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everybody will experience them.

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of BronchostopNite

Keep this medicine out of 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 on the label of the container. The expiry date refers to the last day of the month indicated.

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

6. Contents of the container and additional information

Composition of BronchostopNite

1 ml of oral solution contains:

• The active substances 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 (lime flower) (3-8:1). Extraction solvent: water

• 10.0 mg of extract (as dry extract) of Plantago lanceolata L., folium (lesser plantain leaf) (4-6:1). Extraction solvent: water

• Other ingredients are:

• Xylitol (E967)

• Maltodextrin

• Glycerol

• Xanthan gum

• Monohydrate citric acid

• Strawberry flavor (contains benzyl alcohol (E519), propylene glycol (E1520))

• Methyl p-hydroxybenzoate (E218)

• Anhydrous colloidal silica

• Propyl p-hydroxybenzoate (E216)

•Purified water

Appearance of the product and contents of the container

BronchostopNite is an opaque brown oral solution contained in a brown glass bottle with a pouring spout and a plastic screw cap, packaged in a cardboard box. It is supplied with a dosing cup with a scale from 2.5 ml to 20 ml to measure the recommended dose.

BronchostopNite is available in pack sizes of 120 ml, 200 ml, and 240 ml. Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Kwizda Pharma GmbH
Effingergasse 21
A-1160, Vienna
Austria

This medicinal product 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 most recent review of this leaflet: February 2025

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