Bisol cough and sore throat

Package leaflet: Information for the patient

Plantago Opella Healthcare 23.3 mg/ml syrup
Dry extract of Plantago lanceolata L., folium (plantain leaf)
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 information or advice, consult your pharmacist.
If you experience any adverse reaction, including those not listed in this leaflet,
contact your doctor or pharmacist. See section 4.
Contact your doctor if you do not notice improvement or if your symptoms worsen after 7
days.
Contents of this leaflet
What Plantago Opella Healthcare syrup is and what it is used for
What you need to know before taking Plantago Opella Healthcare syrup
How to take Plantago Opella Healthcare syrup
Possible side effects
How to store Plantago Opella Healthcare syrup
Contents of the pack and other information
What Plantago Opella Healthcare syrup is and what it is used for
Plantago Opella Healthcare syrup is a traditional herbal medicinal product used to
relieve symptoms of irritation of the mouth or throat and associated dry cough.
The use of this traditional herbal medicinal product for the indicated therapeutic
indications is based exclusively on long-standing use.
Plantago Opella Healthcare syrup is indicated for adults, adolescents and children from 3 years of age.
Contact your doctor if you do not feel better or if you feel worse after 7 days.
What you need to know before taking Plantago Opella Healthcare syrup
Do not take Plantago Opella Healthcare syrup:
if you are allergic to plantain, menthol or any of the other ingredients of this
medicine (listed in section 6);
in children under 2 years of age, as menthol may cause choking and sudden airway obstruction due to uncontrolled spasm of the laryngeal muscles
(laryngospasm).
Warnings and precautions
Consult your doctor or pharmacist before taking Plantago Opella Healthcare syrup.
Contact a doctor immediately if your symptoms worsen during treatment, or if you develop fever, shortness of breath or purulent mucus (yellowish-greenish phlegm).
Children
The use of Plantago Opella Healthcare syrup in children aged 2 years is not recommended due to conditions requiring medical evaluation and due to the lack of adequate data.
Do not use in children under 2 years of age because of the menthol content in Plantago Opella Healthcare syrup (see section “Do not take Plantago Opella Healthcare syrup”).
Other medicines and Plantago Opella Healthcare syrup
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
No pharmacological interactions are known. No studies on pharmacological interactions with Plantago Opella Healthcare syrup have been conducted.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy or breastfeeding,
consult your doctor or pharmacist before taking this medicine.
Safety during pregnancy and breastfeeding has not been established. Due to insufficient data, the use of this medicine during pregnancy and breastfeeding is not recommended.
Driving and using machines
No studies have been performed to evaluate the effect on the ability to drive vehicles and use machinery.
Plantago Opella Healthcare syrup contains sodium benzoate and sodium
This medicine contains 15 mg of sodium benzoate in each 5 ml dose and 30 mg of sodium benzoate in each 10 ml dose, equivalent to 3 mg/1 ml of Plantago Opella Healthcare syrup.
This medicine contains less than 1 mmol of sodium (23 mg) per dosage unit, thus it is essentially “sodium-free”.
How to take Plantago Opella Healthcare syrup
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you. If in doubt, consult your doctor or pharmacist.
The recommended dose is:
Adolescents from 12 years of age, adults and elderly:
10 ml three times daily.
Use in children:
Children aged 5 to 11 years:
10 ml two to three times daily.
Children aged 3 to 4 years:
5 ml three times daily.
The use of Plantago Opella Healthcare syrup in children aged 2 years is not recommended due to conditions requiring medical evaluation and due to the lack of adequate data.
Do not use in children under 2 years of age because of the menthol content in Plantago Opella Healthcare syrup (see “Do not take Plantago Opella Healthcare syrup” in section 2).
Patients with renal and/or hepatic impairment
Pharmacokinetic data in patients with renal and/or hepatic impairment are not available. Therefore, a recommended dose cannot be established.
Method of administration
For oral use.
To ensure correct dosing, use the dosing cup provided, referring to the graduated marks at 5 ml and 10 ml.
Shake the bottle before use.
Duration of treatment
Contact your doctor if you do not notice improvement or if your symptoms worsen after 7 days.
If you take more Plantago Opella Healthcare than you should
No specific symptoms of overdose have been reported in humans so far.
If you forget to take Plantago Opella Healthcare syrup
Do not take a double dose to make up for the missed dose.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.
Possible side effects
Menthol may cause reflex apnea and laryngospasm in children under 2 years of age.
If you experience any adverse reactions, consult a doctor.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, contact 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.
By reporting side effects, you can help provide more information on the safety of this medicine.
How to store Plantago Opella Healthcare syrup
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging and on the bottle after EXP. The expiry date refers to the last day of that month.
This medicine must not be used for more than 6 months after first opening of the bottle.
Do not store above 25°C after first opening.
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.
Contents of the pack and other information
What Plantago Opella Healthcare syrup contains
The active substance is:
1 ml (corresponding to 1.15 g) of syrup contains 23.3 mg of extract (in the form of dry extract) of Plantago lanceolata L., leaf (plantain) (DER 3-6:1).
Extraction solvent: water.
The other components are:
Maltodextrin
Anhydrous colloidal silica
Glycerol
Hydroxyethylcellulose (containing phosphate buffer)
Monohydrate citric acid
Potassium sorbate
Sodium benzoate (E-211)
Menthol flavour (containing natural menthol flavour, propylene glycol (E 1520))
Lemon flavour (containing natural flavours)
Purified water
Description of the appearance of Plantago Opella Healthcare syrup and contents of the pack
Plantago Opella Healthcare is a brown syrup available in amber glass bottles of 150 ml (hydrolytic class type III). The bottles are closed with child-resistant caps (PE/PP).
The bottles are further packaged in cartons containing a patient leaflet and a dosing cup made of polypropylene (PP).
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Opella Healthcare Italy S.r.l.
Viale Luigi Bodio
n. 37/B - 20158 Milano (Italy).
Manufacturer:
A. Nattermann & Cie. GmbH
Nattermannallee 1
50829 Cologne (Germany)
This medicine is authorised in the European Economic Area member states under the
following names:
Austria: Spitzwegerich Sanofi-Aventis Sirup
Belgium: Plantago lanceolata Sanofi siroop/sirop/Sirup
Czech Republic: Jitrocel Sanofi
Germany: Spitzwegerich-Trockenextrakt, Sirup
Spain: Plantago lanceolata Sanofi, jarabe
France: Extrait sec de Plantain Sanofi, sirop
Hungary: Plantago lanceolata Sanofi-Aventis szirup
Italy: Plantago Opella Healthcare
Luxembourg: Plantago lanceolata Sanofi siroop/sirop/Sirup
Netherlands: Weegbree siroop
Slovakia: Skorocelový sirup