Althea officinalis syrup alte forte 6 parts root of althea
Poland
Table of Contents
Package leaflet: Information for the patient
ALTHEA ROOT SYRUP ALTE FORTE 6 PARTS OF ALTHEA ROOT
2.36 g/5ml, syrup
Althaeae radicis maceratio
Please read carefully the entire leaflet before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in the patient leaflet or as directed by a
physician or pharmacist.
- Keep this leaflet for future reference.
- If advice or additional information is needed, consult a pharmacist.
- If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform a physician or pharmacist. See section 4.
- If there is no improvement after 7 days or if the patient's condition worsens, consult a physician.
Table of contents of the leaflet:
- What S 6 . is and what it is used for
- Important information before using S 6 .
- How to use S 6 .
- Possible side effects
- How to store S 6 .
- Contents of the pack and other information
1. What S 6 . is and what it is used for
The syrup contains an extract (macerate) from the root of Althaea officinalis (marshmallow root). The althaea root macerate acts protectively on the mucous membranes of the oral cavity and throat, soothing irritation symptoms. This effect is due to the presence of plant mucilage from the althaea root, the formulation's consistency, and its viscosity. The mucilage from althaea root forms colloidal solutions that coat the mucous membranes with a thin layer, providing a protective action. Additionally, the mucilage exerts a soothing effect on the inflamed mucous membranes of the throat and helps relieve cough.
This is a medicinal product traditionally used for the indications listed, with its efficacy based solely on long-term use and experience.
Indications
The syrup is traditionally used as an adjunctive remedy in symptoms of inflammatory conditions of the mouth and throat: hoarseness, cough, e.g., associated with common cold. Also used adjunctively in irritation of the mucous membranes of the mouth and throat.
2. Important information before using the medicine S 6.
When not to use medicine S 6
- if the patient is allergic (hypersensitive) to the active substance or to any of the other ingredients of the medicine (listed in section 6), including benzoic acid and its derivatives.
Warnings and precautions
Due to the content of benzoic acid, caution is advised in patients with asthma.
If the patient develops shortness of breath, fever or purulent discharge, a doctor should be contacted immediately.
Children
It is not recommended for children under 3 years of age.
ALTHEA SYRUP ALTE FORTE 6 PARTS OF ALTHEA ROOT and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
No interactions with other medicines are known. The althea syrup contained in this medicine may delay the absorption of certain medicines; therefore, it is recommended to maintain an interval of ½ to 1 hour when taking other medicinal products.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Due to insufficient data, the use of the syrup during pregnancy and breastfeeding is not recommended.
Driving and operating machinery
The effect of the medicine on psychomotor performance has not been studied.
Important information about some ingredients of medicine S 6
This medicine contains sucrose. 5 ml of syrup contains 4.2 g of sucrose. 10 ml of syrup contains 8.4 g of sucrose. This should be taken into account in patients with diabetes. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
The medicine contains a small amount of ethanol (alcohol), less than 100 mg per dose (not more than 1.0% (v/v) ethanol).
3. How to use S 6.
This medicine should always be used exactly as described in the patient leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Do not use the product for longer than one week.
If symptoms persist for longer than one week during use of the product, consult a doctor.
The medicine is for oral use. The syrup should be dosed using the measuring device provided with the packaging.
Children from 3 to 6 years of age: 5 ml, repeat according to severity of irritation symptoms (up to 3 times daily).
Children from 7 to 12 years of age: 5 ml, repeat according to severity of irritation symptoms (up to 5 times daily).
Adolescents over 12 years of age and adults: 10 ml, repeat according to severity of irritation symptoms (up to 6 times daily).
Use of a higher than recommended dose of medicine S 6.
Cases of overdose have not been reported.
If more medicine has been taken than recommended, consult a doctor or pharmacist.
Missed dose of medicine S 6.
Take the next dose as scheduled. Do not take a double dose to make up for a missed dose.
Stopping treatment with medicine S 6.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everybody will experience them.
In individuals particularly sensitive to benzoic acid, increased salivation and gastric irritation may occur.
If the syrup is administered too frequently, exceeding the recommended dosage regimen, a laxative effect may occur.
Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
e-mail: [email protected]
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of this medicine.
5. How to store S 6 .
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the stated month.
Store in the closed container, at a temperature not exceeding 25°C. Protect from light.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.
6. Contents of the packaging and other information
What S 6 contains
The active substance in the medicine is Althaea root macerate. 100 g of syrup (76 ml) contains 36.6 g of macerate from 6 g of Althaea officinalis L., radix (Althaea root) (DER 6:36). Extraction solvent: mixture of water and ethanol (47.9:1), auxiliary substance: benzoic acid.
The medicine also contains sucrose and benzoic acid.
The medicine contains no more than 1.0% (v/v) ethanol.
What S 6 looks like and what the pack contains
The syrup is a viscous liquid, ranging in colour from light yellow to light brown, with a characteristic odour and taste, free from sediment. The packaging consists of a bottle made of amber glass or brown polyethylene terephthalate, containing 125 g of syrup with a screw cap, placed in a cardboard box together with the patient leaflet and a dosing device.
Marketing Authorisation Holder and Manufacturer:
Gemipharma Sp. z o.o.
Mickiewicza 36 Street
05-480 Karczew
tel. +48 22 780 83 05 ext. 70
e-mail: [email protected]