Bronchodual cough and sore throat
Italy
Table of Contents
Patient Information Leaflet
BRONCHODUAL COUGH AND SORE THROAT Soft Tablets
Dry extract of thyme, dry extract of marshmallow root
Please read 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 information or advice, consult your pharmacist.
- If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.
- Consult your doctor if you do not notice improvement or if your symptoms worsen after 5 days.
Contents of this leaflet:
- What BRONCHODUAL COUGH AND SORE THOREAT is and what it is used for
- What you need to know before taking BRONCHODUAL COUGH AND SORE THROAT
- How to take BRONCHODUAL COUGH AND SORE THROAT
- Possible side effects
- How to store BRONCHODUAL COUGH AND SORE THROAT
- Contents of the pack and other information
1. WHAT BRONCHODUAL COUGH AND THROAT IS AND WHAT IT IS USED FOR
BRONCHODUAL COUGH AND THROAT contains the active substance dry extract of thyme and root of
Althaea officinalis.
BRONCHODUAL COUGH AND THROAT is a traditional herbal medicinal product used to help expectorate mucus in cough associated with colds, and for the symptomatic treatment of irritation of the oral or pharyngeal mucosa 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 your doctor if you do not feel better or if you feel worse after 5 days.
2. WHAT YOU SHOULD KNOW BEFORE TAKING BRONCHODUAL COUGH AND THROAT
Do not take BRONCHODUAL COUGH AND THROAT
If you are hypersensitive (allergic) to the active substances or to any of the other components of this
medicine or to components of the Lamiaceae family (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before using BRONCHODUAL COUGH AND THROAT.
If you have fever, difficulty breathing, or produce purulent sputum, consult your doctor or pharmacist.
If you or your child have previously suffered from asthma (a disease causing narrowing and
inflammation of the bronchi) or have experienced allergic reactions, contact your doctor before using
this medicine (see "Possible side effects").
Other medicines and BRONCHODUAL COUGH AND THROAT
Inform your doctor or pharmacist if you are currently taking, have recently taken, or might take any other medicines.
The absorption of concomitantly administered medicines may be delayed. As a precaution, this medicine should not be taken within ½ to 1 hour before or after taking other medicines.
No interactions with other medicines are known.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
No studies on fertility have been conducted.
The safety of BRONCHODUAL COUGH AND THROAT during pregnancy and breastfeeding has not been established. Your doctor will prescribe BRONCHODUAL COUGH AND THROAT only if clearly needed.
Driving and use of machines
No studies have been conducted on the effects on the ability to drive vehicles or operate machinery.
BRONCHODUAL COUGH AND THROAT contains sorbitol and maltitol
This medicine contains 615 mg of maltitol (E 965) and 210 mg of sorbitol (E 420) per tablet.
Sorbitol is a source of fructose. 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 taking this medicine.
One tablet corresponds approximately to 0.1 bread units. This should be taken into account in patients with diabetes mellitus.
BRONCHODUAL COUGH AND THROAT contains propylene glycol (E1520)
This medicine contains 6.42 mg of propylene glycol per tablet.
BRONCHODUAL COUGH AND THROAT contains benzyl alcohol (E1519)
This medicine contains 0.005 mg of benzyl alcohol (E1519) per tablet. Benzyl alcohol (E1519) may cause allergic reactions.
BRONCHODUAL COUGH AND THROAT contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., essentially "sodium-free".
3. HOW TO TAKE BRONCHODUAL COUGH AND SORE THROAT
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.
Recommended dose:
Adults and adolescents over 12 years of age:
1-2 soft tablets every 4 hours (4 to 6 times daily).
The maximum daily dose is 12 soft tablets.
Children aged 6 to 12 years:
1 soft tablet every 3–4 hours (4 to 6 times daily).
The maximum daily dose is 6 soft tablets.
Children under 6 years of age:
The safety and efficacy of BRONCHODUAL COUGH AND SORE THROAT in children under 6 years of age have not been established.
Method of administration:
For oromucosal use (allow to dissolve in the mouth).
Duration of treatment:
Do not use BRONCHODUAL COUGH AND SORE THROAT for more than 5 days.
If you do not notice any improvement, consult a doctor.
If you take more BRONCHODUAL COUGH AND SORE THROAT than you should
No cases of overdose have been reported.
If you forget to take BRONCHODUAL COUGH AND SORE THROAT
Do not take a double dose to make up for the missed dose.
If you stop using BRONCHODUAL COUGH AND SORE THROAT
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.
4. POSSIBLE ADVERSE REACTIONS
Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
This medicine can cause severe 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.
If you experience any of the adverse reactions listed above while taking BRONCHODUAL TOSSE E GOLA, DISCONTINUE treatment immediately and contact your doctor.
Gastrointestinal disturbances may also occur.
The frequency of the above-mentioned adverse reactions is unknown (frequency cannot be estimated from the available data).
Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist. You may also report adverse reactions directly via the national reporting system at the following website:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting adverse reactions, you can help provide further information on the safety of this medicine.
5. HOW TO STORE BRONCHODUAL COUGH AND SORE THROAT
Keep this medicine out of the sight and reach of children.
Do not store above 25°C.
Do not use this medicine after the expiry date stated on the packaging after “Exp.”. The expiry date refers to the last day of the month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.
6. PACKAGING CONTENTS AND OTHER INFORMATION
What BRONCHODUAL COUGH AND THROAT contains
One tablet contains:
Active ingredients:
51.1 mg of extract (as dry extract) of Thymus vulgaris L. or Thymus zygis L. herba (thyme leaf and
flower) (7-13:1), corresponding to 357.7-664.3 mg of thyme. Extraction solvent: water.
The extract contains 1.1-1.5 mg of thyme essential oil.
4.5 mg of extract (as dry extract) of Althaeae officinalis L. (marshmallow root) (7-9:1),
corresponding to 31.5-40.5 mg of marshmallow. Extraction solvent: water.
Excipients:
Acacia gum (E 414), liquid sorbitol 70% non-crystallizable (E 420), liquid maltitol (E 965), maltodextrin, anhydrous citric acid (E 330), sodium saccharin (E 954), aronia flavour (containing propylene glycol (E 1520)), mixed berry flavour (containing propylene glycol (E 1520) and benzyl alcohol (E 1519)), light liquid paraffin, purified water.
Description of the appearance of BRONCHODUAL COUGH AND THROAT and packaging contents
BRONCHODUAL COUGH AND THROAT are soft, round, brown tablets.
BRONCHODUAL COUGH AND THROAT is available in packages containing blisters of 10, 20, 30 or 40 soft tablets. Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Kwizda Pharma GmbH
Effingergasse 21
1160 Vienna,
Austria
Marketing authorization holder for sale:
Perrigo Italia S.r.l
Viale dell’Arte, 25 00144 Roma
FITOTERAPIA BRONCHENOLO DIVISION – Rome
Manufacturer
Kwizda Pharma GmbH
Effingergasse 21
1160 Vienna,
Austria