Patient Information Leaflet

BRONCHODUAL Cough Suppressant and Expectorant Oral Solution

Dry extract of Thyme (leaf and flower), Liquid extract of Marshmallow (root)
Please read this entire leaflet carefully before taking this medicine, as it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.

Keep this leaflet. You may need to read it again.
If you need more information or advice, consult your pharmacist.
Consult your doctor if you do not notice any improvement or if your symptoms worsen after 5 days of treatment.
If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

What BRONCHODUAL Cough Suppressant and Expectorant is and what it is used for
What you need to know before using BRONCHODUAL Cough Suppressant and Expectorant
How to use BRONCHODUAL Cough Suppressant and Expectorant
Possible side effects
How to store BRONCHODUAL Cough Suppressant and Expectorant
Further information

1. What BRONCHODUAL Sedative and Fluidifying Agent Is and What It Is Used For

BRONCHODUAL Sedative and Fluidifying Agent is a traditional herbal medicinal product containing dry extract of Thyme (leaf and flower) and liquid extract of Marshmallow root. It is indicated in adults and children from 3 years of age for productive cough associated with the common cold and for the treatment of pharyngeal irritation and associated dry cough.
The use of this traditional herbal medicinal product for the specified therapeutic indications is based solely on long-standing use.
Consult a doctor if you do not feel better or if you feel worse after 5 days.

2. What you need to know before using BRONCHODUAL Cough Suppressant and Expectorant

Do not use BRONCHODUAL Cough Suppressant and Expectorant
if you are allergic to the active substances, to any other component of the Lamiaceae family, or to any
of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before using BRONCHODUAL Cough Suppressant and Expectorant.
If you have fever, difficulty breathing, or are producing purulent sputum, consult your doctor or
pharmacist.
If you or your child have previously suffered from asthma (a condition causing narrowing and inflammation of the bronchi) or have experienced allergic reactions, contact your doctor before using this medicine (see "Possible side effects").
The absorption of concomitantly administered medicines may be delayed.
Avoid taking BRONCHODUAL Cough Suppressant and Expectorant at the same time as other
medicines: the absorption of concomitantly administered medicines may be
delayed. As a precautionary measure, this product should not be taken from 30 minutes to 1
hour before or after taking other medicines.
Children
The safety and efficacy in children under 3 years of age have not been established.
Other medicines and BRONCHODUAL Cough Suppressant and Expectorant
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
No interaction studies with other medicines have been conducted.
Pregnancy, breastfeeding and fertility
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning a pregnancy, or are breastfeeding, ask your doctor or pharmacist for advice before using this medicine. Since there are no available data, the use of BRONCHODUAL Cough Suppressant and Expectorant during pregnancy and breastfeeding is not recommended.
Fertility
No data are available.
Driving and using machines
No studies have been performed on the ability to drive or use machinery.
BRONCHODUAL Cough Suppressant and Expectorant contains methyl parahydroxybenzoate (E218) and
propyl parahydroxybenzoate (E216)
These may cause allergic reactions (including delayed reactions).
BRONCHODUAL Cough Suppressant and Expectorant contains sucrose, glucose and fructose (in the
raspberry juice concentrate).
This medicine contains approximately 60 mg of fructose per 15 ml dose.
If your doctor has informed you (or your child) that you have an intolerance to certain sugars, or if you have been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which patients cannot metabolize fructose, speak with your doctor before you (or your child) use this medicine.
BRONCHODUAL Cough Suppressant and Expectorant contains propylene glycol (in the raspberry flavour).
This medicine contains 38.9 mg of propylene glycol in each 15 ml.
BRONCHODUAL Cough Suppressant and Expectorant contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per 15 ml dose, i.e. essentially "sodium-free".

3. How to take BRONCHODUAL Sedative and Fluidifying

Use this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Dosage

Adults and adolescents over 12 years of age
The recommended dose is 15 ml every 4 hours (4 times daily).
If necessary, the doses may be increased up to 6 times daily.
The maximum daily dose is 90 ml (in 6 doses per day).
Do not exceed the recommended maximum daily dose.
A single dose of 15 ml of oral solution contains:
117 mg of dry extract of Thyme (leaf and flower)
830 mg of liquid extract of Marshmallow root

Children aged between 6 and 12 years
The recommended dose is 7.5 ml every 3–4 hours (4 times daily).
If necessary, the doses may be increased up to 6 times daily.
The maximum daily dose is 45 ml (in 6 doses per day).
Do not exceed the recommended maximum daily dose.

Children aged between 3 and 6 years
The recommended dose is 7.5 ml every 3–4 hours (4 times daily).
The maximum daily dose is 30 ml (in 4 doses per day).
Do not exceed the recommended maximum daily dose.
A single dose of 7.5 ml of oral solution contains:
58.5 mg of dry extract of Thyme (leaf and flower)
415 mg of liquid extract of Marshmallow root

Children under 3 years of age
The safety and efficacy in children under 3 years of age have not been established.

Duration of treatment
The maximum duration of treatment is 5 days.
Consult your doctor if you do not feel better or if you feel worse after 5 days.

Method of administration
For oral use.
Use the graduated dosing cup supplied with the package.
The oral solution can be taken undiluted or, if necessary, diluted in water or warm tea.

If you take more BRONCHODUAL Sedative and Fluidifying than you should
Cases of overdose have not been reported.
If you take large amounts of BRONCHODUAL Sedative and Fluidifying or if a child accidentally swallows the contents of the bottle, contact your doctor immediately or go to the nearest hospital.

If you forget to take BRONCHODUAL Sedative and Fluidifying
Do not take a double dose to make up for the forgotten dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
This medicine may cause serious hypersensitivity reactions (allergic reactions including anaphylactic shock and angioedema), which may present as difficulty breathing and/or swallowing, rapid heartbeat, pain and/or tightness in the chest, dizziness or fainting, itching or skin rashes, swelling of the face, lips, tongue, and/or throat, or blistering in the mouth and throat.
If you experience any of the above-mentioned side effects during treatment with BRONCHODUAL Sedative and Fluidifying, STOP the treatment immediately and consult your doctor.
Gastrointestinal disorders have also been reported with unknown frequency (frequency cannot be estimated from the available data).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. You may also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store BRONCHODUAL Sedative and Fluidifying

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label and the carton after "EXP". The expiry date refers to the last day of that month.
After the first opening of the bottle, the medicine must be used within 4 weeks.
After this period, any remaining medicine must be discarded.
Do not store above 25°C.
Keep the bottle tightly closed in the original packaging to protect the medicine from light.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Other information

What BRONCHODUAL Sedative and Fluidifying contains
1 ml of oral solution contains:
Active substances:
7.8 mg of extract (as dry extract) of Thymus vulgaris L. or Thymus zygis L. (Thyme, leaf
and flower) (DER 7-13:1). Essential oil content 0.12-0.16 mg (equivalent to 1.5-2.0%
in the extract).
55.3 mg of extract (as liquid extract) of Althaea officinalis L. (Marshmallow, root) (DER 1:12-
14). Extraction solvent: water.
Other components:
maltodextrin
acacia (gum arabic)
xylitol (E967)
methyl-4-hydroxybenzoate (E218)
raspberry juice concentrate (containing sucrose, glucose and fructose)
xanthan gum
monohydrate citric acid (E330)
propyl-4-hydroxybenzoate (E216)
raspberry flavour [synthetic and natural flavours, propylene glycol (E1520)]
glycerol (E422)
sodium saccharin (E954)
neohesperidin dihydrochalcone
purified water

Description of the appearance of BRONCHODUAL Sedative and Fluidifying and contents of the
pack
Viscous red-brown oral solution with the odour and taste of thyme and raspberry, in 120 ml, 200 ml and 240 ml glass bottles with polyethylene screw cap. A graduated dosing cup (from 2.5 ml to 20 ml) is included in the package.
It is possible that not all pack sizes are marketed.

Marketing Authorization Holder
Kwizda Pharma GmbH
Effingergasse 21, 1160 Vienna – Austria
Local representative:
Perrigo Italia S.r.l
Viale dell’Arte, 25 00144 Roma
FITOTERAPIA BRONCHENOLO DIVISION – Roma

Manufacturer
Kwizda Pharma GmbH
Effingergasse 21, 1160 Vienna - Austria
February 2024