Benactuss dry cough and soothing for sore throat
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Patient Information Leaflet
Benactuss dry cough and soothing throat 30 mg/mL syrup
Dried extract of plantain leaves
( Plantaginis lanceolatae folii extractum siccum )
Please read all of this leaflet carefully before you start 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 effect, 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 your symptoms worsen after 7 days.
Contents of this leaflet
- What Benactuss dry cough and soothing throat is and what it is used for
- What you need to know before taking Benactuss dry cough and soothing throat
- How to take Benactuss dry cough and soothing throat
- Possible side effects
- How to store Benactuss dry cough and soothing throat
- Contents of the pack and other information
1. What Benactuss dry cough and soothing throat is and what it is used for
Benactuss dry cough and soothing throat is a traditional herbal medicinal product used to
relieve symptoms of irritation of the mouth or throat and associated dry cough.
This product is a traditionally used herbal medicinal product, intended for specific indications based
solely on long-standing use.
Benactuss dry cough and soothing throat is indicated for adults, adolescents, and children from the age of 3 years.
Consult a doctor if you do not feel better or if you feel worse after 7 days.
2. What you need to know before taking Benactuss Dry Cough and Soothing Throat
Do not take Benactuss Dry Cough and Soothing Throat:
- if you are allergic to plantain 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 Benactuss Dry Cough and Soothing Throat.
Contact a doctor immediately if your symptoms worsen during treatment, or if you develop shortness of breath, fever, or purulent mucus (yellowish phlegm).
Use in patients with impaired renal and/or hepatic function
If you suffer from renal insufficiency or have impaired liver function, consult your doctor or pharmacist before taking Benactuss Dry Cough and Soothing Throat syrup. There are no data available to establish dosing recommendations for these patients.
Children
The use of Benactuss Dry Cough and Soothing Throat in children under 3 years of age is not recommended due to aspects requiring medical advice and the lack of adequate data.
Other medicines and Benactuss Dry Cough and Soothing Throat
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
No interaction studies have been conducted. However, no interactions with other medicines have been reported.
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.
Pregnancy
The safety of this medicine during pregnancy has not been established. In the absence of sufficient data, the use of this medicine during pregnancy is not recommended.
Breastfeeding
It is not known whether the active substance or its metabolites are excreted in human breast milk. The risk to the newborn/infant cannot be excluded. Therefore, Benactuss Dry Cough and Soothing Throat should not be used during breastfeeding.
Driving and using machines
No studies have been performed regarding the ability to drive or operate machinery.
Benactuss Dry Cough and Soothing Throat contains liquid maltitol (with maltitol and sorbitol)
This medicine contains up to 225 mg of sorbitol in 5 mL, equivalent to 45 mg/mL. If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.
A mild laxative effect may occur. The caloric value of liquid maltitol is 2.3 kcal/g.
Benactuss Dry Cough and Soothing Throat contains ethanol (alcohol)
This medicine contains 78.5 mg of alcohol (ethanol) per dose unit, equivalent to 7.85 mg/mL (0.785% w/v). The amount in 10 mL of this medicine is equivalent to less than 2 mL of beer or 1 mL of wine.
The small amount of alcohol in this medicine will not produce significant effects.
3. How to take Benactuss dry cough and soothing throat syrup
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.
The recommended dose is:
Adolescents from 12 years of age, adults and elderly:
10 mL of syrup 3 to 4 times daily
Children from 5 to 11 years of age:
10 mL of syrup 3 times daily
Children from 3 to 4 years of age:
5 mL of syrup 3 times daily
Use in children
The use of Benactuss dry cough and soothing throat syrup in children under 3 years of age is not recommended due to aspects requiring medical advice and the lack of adequate data.
Use in patients with reduced renal and/or hepatic function
See section 2.
Method of administration
For oral use.
To ensure correct dosing, use the dosing spoon provided, referring to the graduated markings of 2.5 mL and 5 mL.
Shake the bottle well before use.
Duration of treatment
Consult your doctor if you do not feel better, feel worse, or if symptoms persist beyond 7 days.
If you take more Benactuss dry cough and soothing throat syrup than you should
No cases of overdose have been reported.
If you forget to take Benactuss dry cough and soothing throat syrup
Do not take a double dose to make up for the missed 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 experiences them.
No known side effects.
If adverse reactions occur, consult your doctor.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist.
You can also report side effects directly via the national reporting system at the following website: 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 Benactuss dry cough and soothing throat
Keep this medicine out of the sight and reach of children.
A sediment may form during storage. This does not affect the quality of the product.
Store below 25 °C after first opening.
Do not use this medicine after the expiry date stated on the packaging and bottle. The expiry date refers to the last day of that month.
This medicine should not be used for more than 3 months after the first opening of the bottle.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.
6. Package contents and other information
What Benactuss Dry Cough and Soothing Throat contains
- The active substance is dry extract of plantain. Each ml (equivalent to 1.2 g) of syrup contains 30 mg of extract (as dry extract) from Plantago lanceolata L. s.l., folium (Plantain) (DER 3-5:1). Extraction solvent: ethanol 20% (m/m).
- The other components are: maltodextrin, liquid maltitol (E 965), xanthan gum (E 415), potassium sorbate (E 202), citric acid (E 330), natural flavour Honey - Lemon - Verbena (containing ethanol), purified water.
Description of the appearance of Benactuss Dry Cough and Soothing Throat and contents of the pack
The syrup is a brown-coloured liquid with a characteristic odour, supplied in bottles with a volume of 100 mL or 200 mL. The bottles are further packaged in folding cartons containing a patient information leaflet and a measuring device.
100 mL and 200 mL pack: The dosing spoon shows two different graduated scales including specific markings for 2.5 ml and 5 ml.
It is possible that not all pack sizes will be marketed.
Marketing Authorization Holder
Reckitt Benckiser Healthcare (Italia) S.p.A., via G. Spadolini 7, 20141 Milano
Manufacturer
Phytopharm Klęka S.A., Klęka 1, 63-040 Nowe Miasto nad Wartą, Poland
This medicinal product is authorized in the European Economic Area (EEA) Member States under the following names:
Austria: StrepHustan Hustenstiller 30 mg/ml Sirup
Belgium:
Bulgaria:
Croatia: Streptusan sirup
Denmark: StrepHost Tør
Estonia: Septils
Finland: Streptus Dry
France:
Germany: Dobendan Hustenstiller
Greece: StrepCough Plaintain
Iceland: StrepHost Tør
Latvia: Lettonia: Septils sīrups
Lithuania:
Norway: Streplieve
Netherlands:
Poland: Strepsils Natur kaszel suchy i podrażnione gardło
Portugal: Streptosse Active Naturals Tosse Seca xarope
Czech Republic: Strevox
Romania: StrepTuss pătlagină 30 mg/ml sirop
Spain: Streptos llantén 30 mg/ml jarabe
Sweden: Streplieve
Slovenia: Streptusan sirup
Slovakia:
Hungary: Streptuss 30 mg/ml szirup