BRONCHICLEAR ORAL SOLUTION

Introduction

PACKAGE LEAFLET

Package Leaflet: Information for the Patient

Bronchiclear Oral Solution

Liquid Extract of Thyme

Liquid Extract of Ivy Leaves

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

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

• Keep this package 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 package leaflet. See section 4.
• You should consult a doctor if your symptoms worsen or do not improve after 7 days.

Contents of the Package Leaflet

1. What is Bronchiclear and what is it used for
2. What you need to know before taking Bronchiclear
3. How to take Bronchiclear
4. Possible side effects
   1. Storage of Bronchiclear

1. Package Contents and Additional Information

1. What is Bronchiclear and what is it used for

Herbal medicine used as an expectorant in cases of productive cough.

Bronchiclear is indicated for adults and adolescents from 12 years of age.

You should consult a doctor if your symptoms worsen or do not improve after 7 days.

2. What you need to know before taking Bronchiclear

Do not take Bronchiclear

• if you are allergic (hypersensitive) to thyme or ivy leaves, or to other plants of the Lamiaceae (Labiatae) or Araliaceae families, or to any of the other components of this medication (listed in section 6).
• Bronchiclear should not be used in children under 2 years of age.

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Bronchiclear and

• if symptoms persist for more than 7 days
• if symptoms worsen during use of the medication
• if you have difficulty breathing, fever, or purulent or bloody sputum
• if you have gastritis or gastric ulcers

Children

Use is not recommended in children from 2 to 12 years of age. This medication should not be administered to children under 2 years of age.

Other Medications and Bronchiclear

Tell your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication. The effects of concomitant use of other medications have not been studied. To date, interactions with other medications are unknown.

Pregnancy and Breastfeeding

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

The safety of its use during pregnancy and breastfeeding has not been established. Due to the lack of sufficient data, the use of Bronchiclear is not recommended during pregnancy.

It is unknown whether the active ingredients or metabolites of Bronchiclear are excreted in breast milk. A risk to the newborn or breastfed child cannot be excluded. Therefore, Bronchiclear should not be used during breastfeeding.

Driving and Using Machines

No studies have been conducted on the effect on the ability to drive and use machines.

Bronchiclear containsmax. 15% m/m, equivalent to max. 21% v/v of ethanol (alcohol)

This medication contains approximately 310 mg of alcohol (ethanol) per 1.85 ml, which is equivalent to 168 mg/ml (15% m/m). The amount contained in 1.85 ml of this medication is equivalent to less than 8 ml of beer or 4 ml of wine.

The small amount of alcohol in this medication does not produce any noticeable effect.

Bronchiclear containsliquid maltitol (contains sorbitol)

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

This medication contains 34.20 mg of sorbitol per 1.85 ml, which is equivalent to 18.5 mg/ml.

3. How to take Bronchiclear

Follow the administration instructions for this medication exactly as stated in this package leaflet or as directed by your doctor or pharmacist. Consult your doctor or pharmacist if you have any doubts.

The recommended dose is:

Adults and adolescents from 12 years of age: 1.85 ml 3 times a day.

The maximum daily dose is 5.55 ml.

Use the included dosing cup to take Bronchiclear 3 times a day. Swallow Bronchiclear undiluted. Drink some liquid (preferably water) after taking the medication. Shake well before each use.

If symptoms persist for more than 7 days during use of the medication, you should consult a doctor or pharmacist.

There are not enough data to recommend dosage in patients with reduced renal or hepatic function.

Use in Children

Use is not recommended in children from 2 to 12 years of age. This medication should not be administered to children under 2 years of age.

If you take more Bronchiclear than you should

In case of overdose, gastrointestinal disorders such as nausea, vomiting, and diarrhea may occur.

If you have taken more Bronchiclear than you should, inform your doctor. Your doctor will decide on the necessary measures.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Bronchiclear

Do not take a double dose to make up for forgotten doses, but continue taking Bronchiclear as prescribed by your doctor or as described in this package leaflet.

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

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Side effects of unknown frequency (frequency cannot be estimated from available data):

Hypersensitivity/allergic reactions such as difficulty breathing, hives, swelling of the face, mouth, and/or throat, anaphylactic reaction.

If you observe the first symptoms of hypersensitivity/allergic reaction, stop taking the product immediately and urgently consult a doctor.

Uncommon side effects (may affect up to 1 in 100 people):

Gastrointestinal disorders such as cramps, nausea, vomiting, diarrhea.

Rare side effects (may affect up to 1 in 1,000 people):

Hypersensitivity/allergic reactions with skin rash.

Reporting Side Effects

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

5. Storage of Bronchiclear

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

Do not use this medication after the expiration date stated on the carton and bottle after "EXP". The expiration date is the last day of the month indicated.

This medication, originally sealed, does not require special storage conditions.

Shelf life after first opening: 6 months.

After first opening: store below 25°C.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the pharmacy's SIGRE collection point. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition ofBronchiclear

The active ingredients are: 1 ml (corresponding to 1.09 g) of Bronchiclear contains:

490 mg of liquid extract of Thymus vulgarisL. or Thymus zygisL., herba, or a mixture of both species (thyme herb) (1:2-2.5); extraction agent: 10% m/m ammonia solution / 85% m/m glycerol / 90% v/v ethanol / water (1/20/70/109).

49 mg of liquid extract of Hedera helixL., folium (ivy leaves) (1:1); extraction solvent: 70% v/v ethanol.

The other components are: 96% ethanol; hydroxypropylbetadex; levomenthol; liquid maltitol (contains sorbitol (E420)); purified water.

The medication contains a maximum of 15% m/m of ethanol, equivalent to a maximum of 21% v/v of ethanol.

Appearance of the Product and Package Contents

Bronchiclear is a clear, brown-colored liquid. During storage, a slight turbidity and/or resuspendable precipitates may occur.

Bronchiclear is presented in brown glass bottles equipped with a pouring aid (LDPE), screw cap (PP) with tamper-evident closure (HDPE), and a dosing cup (PP) with the corresponding graduation: 1.85 ml.

It is available in the following package sizes:

50 ml of oral solution

100 ml of oral solution

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

BIONORICA SE

Kerschensteinerstraße 11-15

92318 Neumarkt

Germany

Phone: +49 (0)9181 231-90

Fax: +49 (0)9181 231-265

Email: [email protected]

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

Date of the last revision of this package leaflet:August 2024.

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