Prospect: information for the patient

BronchostopNite oral solution

Dry extract of marshmallow root

Dry extract of lime flower

Dry extract of lesser plantain

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

Follow exactly the medication administration instructions contained in this prospect or those indicated by your doctor or pharmacist.

• Keep this prospect, 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 not listed in this prospect. See section 4.
• You should consult a doctor if you worsen or do not improve after 5 days.

1. What isBronchostopNiteand for what it is used

2. What you need to know before starting to takeBronchostopNite

3. How to takeBronchostopNite

4. Possible adverse effects

5. Storage ofBronchostopNite

6. Contents of the package and additional information

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

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

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

It is a traditional herbal medicine for the specified indications. Based exclusively on its traditional use.

Consult a doctor if it does not improve or worsens after 5 days of treatment.

Do not takeBronchostopNite:

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

Warnings and precautions

Consult your doctor or pharmacist if while taking BronchostopNite:

• you do not feel better or feel worse

• you have difficulty breathing (dyspnea)

• you have a fever

• your mucus is greenish-yellow or brown (purulent sputum)

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

Children

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

Other medications and BronchostopNite

Taking BronchostopNite with other medications. Inform your doctor or pharmacist if you are taking, have taken recently, or may have to take any other medication.

Based on the empirically observed sedative activity of meadowsweet, this medication may increase drowsiness caused by sedative medications (medications to calm or reduce anxiety) and alcohol.

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

Taking BronchostopNite with food and drinksandbeverages

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

Pregnancy and breastfeeding

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

If you are pregnant or breastfeeding, believe you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machinery

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

BronchostopNite contains xylitol

It may cause 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 containsmethyl parahydroxybenzoate and propyl parahydroxybenzoate

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

BronchostopNite containspropylene glycoland benzyl alcohol

This medication contains13.6 mg of propylene glycoland 0.002 mg of benzyl alcoholin each 15 ml. Benzyl alcohol may cause allergic reactions.

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

Oral use (undiluted).

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

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

The recommended dose is:

Adults and adolescents over 12 years:

Using the dosing 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 6 to 12 years:

Using the dosing 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:

Use is not recommended in children under 6 years.

For nighttime cough relief:

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

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

If you takemore BronchostopNite than you should

No cases of overdose have been reported. However, known laxative effects may occur more intensely if you have taken a considerable overdose of this medication. In this case, please notify your doctor, who may decide on any necessary measures.

If you forgot to take BronchostopNite

Do not take a double dose to compensate for the missed dose. Wait for the next dose.

If you interrupt treatment with BronchostopNite

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

Like all medications, this medication may produce adverse effects, although not all people will experience them.

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

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctororpharmacist. Even if it is possible adverse effects that do not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

Do not store at a temperature above 25°C. Use within 2 months after opening.

Keep the container tightly closed after use.

Do not use this medication after the expiration date shown on the box and on the container label. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and unused medicines. This will help protect the environment.

Composition of BronchostopNite

1 ml of oral solution contains:

- The active principles are:

• 12.5 mg of extract (as dry extract) ofAlthaea officinalisL., radix (marshmallow root) (7-9: 1). Extraction solvent: water

• 9.09 mg of extract (as dry extract) ofTilia cordataMiller,Tilia platyphyllosScop.,Tilia x vulgarisHeyne or their mixtures, flos (linden flower) (3-8: 1). Extraction solvent: water

• 10.0 mg of extract (as dry extract) ofPlantago lanceolataL., folium (lesser 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 of the product and contents of the packaging

BronchostopNite is a brown, opaque oral solution contained in a brown glass bottle with a plastic screw cap in a cardboard box. It is supplied with a measuring cup with a scale of 2.5 ml to 20 ml to measure the recommended dose.

BronchostopNite is available in 120 ml, 200 ml, and 240 ml packaging sizes. Only some packaging sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Kwizda Pharma GmbH

Effingergasse 21

A-1160, Vienna

Austria

This medicine is authorized in the member states of the European Economic Area with the following names:

Greece BRONCHONIGHT® π?σιμο δι?λυμα

Norway Bronwel Natt mikstur, oppløsning

Portugal Bronchodual Night & Day, oral solution

Last review date of this leaflet:February 2025

The detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/