Bronchiclear oral solution

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET

Package leaflet: information for the patient

Bronchiclear oral solution

Liquid extract of thyme

Liquid extract of ivy leaves

Read this 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 those given 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 any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.
• You should consult a doctor if you get worse or do not improve after 7 days.

Contents of this leaflet

1. What Bronchiclear is and what it is used for

2. What you need to know before taking Bronchiclear

3. How to take Bronchiclear

4. Possible side effects

   1. Storage of Bronchiclear

5. Contents of the pack and other information

1. What Bronchiclear is and what it is used for

A herbal medicinal product used as an expectorant in productive cough.

Bronchiclear is indicated for adults and adolescents aged 12 years and older.

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

2. What you need to know before starting Bronchiclear

Do not take Bronchiclear

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Bronchiclear if:

• symptoms persist for more than 7 days
• symptoms worsen during treatment
• you have difficulty breathing, fever, or purulent or bloody sputum
• you suffer from gastritis or gastric ulcer

Children

Use in children aged 2 to 12 years is not recommended. This medicine must not be administered to children under 2 years of age.

Other medicines and Bronchiclear

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

Pregnancy and breastfeeding

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

The safety of use during pregnancy and breastfeeding has not been established. In the absence of sufficient data, the use of Bronchiclear during pregnancy is not recommended.

It is unknown whether the active substances or metabolites of Bronchiclear are excreted in human milk. A risk to the newborn or breastfed child cannot be ruled out. Therefore, Bronchiclear must not be used during breastfeeding.

Driving and using machines

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

Bronchiclear contains up to 15% m/m, equivalent to up to 21% v/v ethanol (alcohol)

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

The small amount of alcohol contained in this medicine does not produce any perceptible effect.

Bronchiclear contains liquid maltitol (contains sorbitol)

If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

This medicine contains 34.20 mg of sorbitol in each 1.85 ml, which corresponds to 18.5 mg/ml.

3. How to take Bronchiclear

Follow exactly the instructions for administration of this medicine provided in this leaflet or those indicated by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Recommended dose:

Adults and adolescents aged 12 years and older: 1.85 ml three times daily.

The maximum daily dose is 5.55 ml.

Use the dosing cup provided to take Bronchiclear three times daily. Swallow Bronchiclear undiluted. Drink some liquid (preferably water) after taking the medicine. Shake well before each use.

If symptoms persist for more than 7 days during treatment with this medicine, you should consult a doctor or pharmacist.

There are insufficient data available to make dosage recommendations for patients with impaired renal or hepatic function.

Use in children

Use is not recommended in children aged 2 to 12 years. This medicine must 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Bronchiclear

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

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

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

If you notice the first symptoms of hypersensitivity/allergic reaction, stop taking the product immediately and seek urgent medical attention.

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

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

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

Hypersensitivity/allergic reactions with skin rash.

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 Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Bronchiclear

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the carton and on the bottle after “EXP”. The expiry date is the last day of the month indicated.

This medicine, originally in a closed container, requires no special storage conditions.

Period of validity after first opening: 6 months.

After first opening: store below 25°C.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. 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 other information

Composition of Bronchiclear

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

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

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

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

The medicine contains up to 15 % m/m ethanol, equivalent to up to 21 % v/v ethanol.

Appearance of the product and contents of the container

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

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

It is available in the following pack sizes:

50 ml oral solution

100 ml oral solution

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

BIONORICA SE

Kerschensteinerstraße 11-15

92318 Neumarkt

Germany

Tel.: +49 (0)9181 231-90

Fax: +49 (0)9181 231-265

E-mail: [email protected]

This medicinal product is authorized in the European Economic Area member states under the following names:

Date of the most recent review of this leaflet: August 2024.

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