Broncophen for cough and cold

Package leaflet: information for the patient

Broncophen cough and cold oral solution

Dry extract of Althaeae radix
Dry extract of Tiliae flos
Dry extract of Plantaginis lanceolatae herba

Please read all of this leaflet carefully before taking this medicine because 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 advice or information, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Contact your doctor if you do not notice any improvement or if you notice a worsening of symptoms after 5 days of treatment.

If symptoms persist during use of the medicinal product, or if you notice the occurrence of any side effect not listed in this package leaflet, inform your doctor or pharmacist.

Contents of this leaflet

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

1. What Broncophen cough and cold is and what it is used for

Broncophen cough and cold contains the active ingredient dry extract of Althea root, Linden flower and Plantago lanceolata.
Broncophen cough and cold is a traditional herbal medicinal product used for the relief of symptoms of a cold in the early stage, such as sore throat and associated dry cough.
This medicine is intended for use in adults and adolescents over 12 years of age.
The use of this traditional herbal medicinal product for the aforementioned therapeutic indications is based exclusively on long-standing use.
Consult a physician if you do not feel better or if you feel worse after 5 days.

2. What you need to know before taking Broncophen cough and cold

Do not take Broncophen cough and cold

• if you are allergic to the active substances: Althaeae radix (marshmallow root), Tiliae flos (lime flower), and Plantaginis folium (plantain leaf), or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before taking Broncophen cough and cold

• if you do not feel better or feel worse
• if you have difficulty breathing (dyspnea)
• if you have a fever
• if your mucus is yellow-green or brown (purulent sputum), or if such symptoms appear during treatment.

Theoretically, this medicine may delay the absorption of other medicines taken concomitantly. It is advisable not to take this medicine from half an hour to one hour before or after taking other medicines.

Children
Use in children under 12 years of age is not recommended due to insufficient available data.

Other medicines and Broncophen cough and cold
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
The active ingredient in lime flower (Tiliae flos) may cause drowsiness. Therefore, this medicine may increase drowsiness caused by other medicines such as antihistamines (medicines that block the action of histamine, used in treating allergic reactions and colds), antidepressants (medicines used to treat depression), other sedatives (calming medicines or medicines used to reduce anxiety), or alcohol.
The absorption of concomitantly administered medicines may be delayed. It is advisable not to take this medicine from half an hour to one hour before or after taking other medicines.

Broncophen cough and cold with food and drink
Due to the mechanism of action of the medicine, avoid drinking for about one hour after administration.

Pregnancy and breastfeeding
The safety of this medicine during pregnancy and breastfeeding has not been established. Since there are no available data, its use during pregnancy and breastfeeding is not recommended.
If you are pregnant, think you might be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Driving and using machines
No studies have been conducted on the effects on the ability to drive vehicles and use machinery.
Due to the mild sedative effect of lime flower (Tiliae flos), this medicine may cause drowsiness.

Broncophen cough and cold contains xylitol (E 967)
The maximum daily dose of this medicine (60 ml) contains 11.04 g of xylitol (calorific value of xylitol: 2.4 kcal/g). Xylitol may have a laxative effect.

Broncophen cough and cold contains methyl-parahydroxybenzoate (E216) and propyl-parahydroxybenzoate (E218)
This medicine contains methyl-parahydroxybenzoate and propyl-parahydroxybenzoate, used as preservatives, which may cause allergic reactions (including delayed reactions).

Broncophen cough and cold contains 13.6 mg of propylene glycol (E 1520) and 0.002 mg of benzyl alcohol (E 1519)
Benzyl alcohol may cause allergic reactions.

3. How to take Broncophen cough and cold

Take 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.
Oral use (undiluted).
Due to the mechanism of action of this medicine, avoid drinking liquids for at least one hour before and after taking the medicine.
Recommended dose:
Adults and adolescents over 12 years of age:
Use the dosing cup provided in the package. Take 15 ml as needed, up to a maximum of 60 ml (4 doses of 15 ml) within 24 hours.
Children under 12 years of age:
Use is not recommended in children under 12 years of age.
Broncophen cough and cold should be used for the shortest duration necessary to relieve symptoms. If symptoms worsen or persist for more than 5 days during treatment, consult a doctor or qualified healthcare professional.
If you take more Broncophen cough and cold than you should
In case of overdose, known side effects may occur with increased intensity. In such a case, contact your doctor. The doctor will determine the appropriate measures to take.
If you forget to take Broncophen cough and cold
Do not take a double dose to make up for the missed dose. Take the next recommended dose as scheduled.
If you stop taking Broncophen cough and cold
No special precautions are required.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any side effects for which the frequency is unknown, consult your doctor or
pharmacist.
Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly through 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 Broncophen cough and cold

Keep this medicine out of the sight and reach of children.
After first opening, do not store above 25 °C. Store the bottle tightly closed in the original packaging to protect the medicine from light.
Keep the bottle tightly closed after use.
After first opening of the bottle, the medicine must be used within 2 months.
Do not use this medicine after the expiry date stated on the carton and label on the bottle after “Exp”. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Broncophen cough and cold contains

• Active substances:

15 ml (= 16.3 g) of solution now contains:

• 187.5 mg of extract (as dry extract) of Althaea officinalis L., root (marshmallow root) (7-9:1). Extraction solvent: water

• 136.4 mg of extract (as dry extract) of Tilia cordata Miller, Tilia platyphyllos Scop., Tilia x vulgaris Heyne or their mixtures, flower (lime flower) (3-8:1). Extraction solvent: water

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

• Excipients are:

• Xylitol (E 967)

• Maltodextrin

• Glycerol

• Xanthan gum

• Citric acid monohydrate (E 330)

• Strawberry flavour (contains benzyl alcohol (E 1519) and propylene glycol (E 1520))

• Methyl 4-hydroxybenzoate (E218)

• Anhydrous colloidal silica

• Propyl 4-hydroxybenzoate (E216)

• Purified water

Description of the appearance of Broncophen cough and cold and contents of the pack
Broncophen cough and cold is a brown, viscous oral solution. The medicine
is contained in a brown glass bottle with a pouring spout and a screw cap, packaged in
a cardboard box. The dosing cup supplied with the pack has a graduated scale from 2.5
ml to 20 ml for measuring the required dose.
Broncophen cough and cold is available in 120 ml, 200 ml and 240 ml bottles. Not all pack sizes may be marketed.

Marketing Authorisation Holder
Kwizda Pharma GmbH
Effingergasse 21, 1160 Vienna – Austria

Marketing Authorisation Holder in Italy
Perrigo Italia S.r.l - FITOTERAPIA DIVISION
BRONCHENOLO®
Viale dell’Arte, 25 00144 Roma, Italia