Alte forte with honey
Poland
Table of Contents
You must read the entire leaflet carefully, as it contains important information for the patient.
This medicine is available without a prescription so that certain conditions can be treated without a doctor's assistance. However, to achieve a good treatment outcome, ALTE FORTE Z MIODEM must be used carefully and in accordance with the information provided in this leaflet.
- Keep this leaflet, as you may need to read it again.
- Consult your doctor or pharmacist if you need advice or additional information.
- If symptoms worsen or do not improve, you should contact a doctor.
ALTE FORTE WITH HONEY
Althaeae radicis maceratio
syrup, 2.25 g/5 ml
Composition:
Active substance: 100 g of syrup contains 36 g of macerate from 9 g of marshmallow root
(Althaeae radicis maceratio (9:54), extractant – mixture of water and ethanol with added sodium benzoate (71.7:1.5:0.3)).
Excipients: purified honey (Mel depuratum), vanillin glycolic flavor, sodium benzoate.
Ethanol content: less than 0.5% (v/v).
Available packaging: 125 g bottle with a 10 ml measuring cup.
Marketing Authorization Holder:
Grzegorz Nowakowski Pharmaceutical Production Enterprise "GEMI"
ul. Mickiewicza 36
05-480 Karczew, Poland
Leaflet Contents:
- What ALTE FORTE WITH HONEY is and what it is used for
- Before you use ALTE FORTE WITH HONEY
- How to use ALTE FORTE WITH HONEY
- Possible side effects
- How to store ALTE FORTE WITH HONEY
- Other necessary information about ALTE FORTE WITH HONEY
1. What ALTE FORTE WITH HONEY is and what it is used for
ALTE FORTE WITH HONEY contains an aqueous macerate of marshmallow root, which has a soothing effect on cough and protects the mucous membranes of the mouth and throat. This effect is due to the presence of plant mucilage from marshmallow root, the formulation’s consistency, and its viscosity. The mucilage from marshmallow root forms colloidal solutions that cover mucous membranes with a thin protective layer. Furthermore, by forming a protective coating over inflamed, congested, and swollen throat mucosa, the mucilage also soothes the cough reflex.
This is a medicinal product traditionally used for the indications listed, with efficacy based on long-standing use and experience.
Therapeutic indications:
ALTE FORTE WITH HONEY is traditionally used as an adjunctive remedy in symptoms of inflammatory conditions of the mouth and throat: hoarseness, cough, e.g., associated with the common cold.
Also used as an adjunct in irritations and inflammatory conditions of the mucous membranes of the mouth and throat.
2. Before using ALTE FORTE WITH HONEY.
Do not use the syrup if you have a diagnosed hypersensitivity to sodium benzoate and its
derivatives, or an allergy to honey and bee products.
Exercise particular caution when using ALTE FORTE WITH HONEY because:
Due to the presence of sodium benzoate, caution is recommended in patients with asthma.
Use of ALTE FORTE WITH HONEY in children.
Not recommended for children under 3 years of age.
Pregnancy. Breast-feeding.
Due to lack of data demonstrating safety of use, ALTE FORTE WITH HONEY is not recommended during pregnancy and breast-feeding.
Driving and operating machinery.
No data available.
Important information about some ingredients of ALTE FORTE WITH HONEY syrup:
The syrup contains 64% purified linden honey.
Use with other medicines.
Inform your doctor about all medicines you have recently taken, including those obtained without a prescription.
3. How to use ALTE FORTE WITH HONEY
The medicine is taken orally.
The usual dose of ALTE FORTE WITH HONEY is:
Children over 3 years of age up to 6 years of age: ½ measuring spoon (5 ml); repeat the dose according to
the severity of irritation symptoms (up to 3 times daily).
Children over 6 years of age: ½ measuring spoon (5 ml); repeat the dose according to the severity of irritation symptoms (up to 5 times daily).
Adolescents from 13 years of age and adults: 1 measuring spoon (10 ml); repeat the dose according to the severity of irritation symptoms (up to 6 times daily).
In case of taking a higher dose of ALTE FORTE WITH HONEY than recommended:
Symptoms of overdose are not known. When using preparations containing mucilage for prolonged periods (over 3 weeks) or in case of abuse, there is a risk of reduced absorption of vitamins, minerals, or other compounds from the gastrointestinal tract.
If a dose of ALTE FORTE WITH HONEY is missed:
Take the next dose as scheduled. Do not take a double dose to make up for the missed dose.
4. Possible adverse reactions.
Like any medicinal product, ALTE FORTE WITH HONEY may cause adverse reactions.
If any of the symptoms listed below occur, discontinue use of the product and inform your doctor.
In particularly sensitive individuals, sodium benzoate may cause increased salivation and gastric irritation.
If other adverse symptoms occur, inform your doctor about them.
5. Storage instructions for ALTE FORTE WITH HONEY.
Keep out of reach and sight of children.
Do not use ALTE FORTE WITH HONEY after the expiry date stated on the packaging.
Store in a tightly closed container, at a temperature not exceeding 25°C. Protect from light.
6. Other information.
For more detailed information, please contact the marketing authorisation holder.
Grzegorz Nowakowski Pharmaceutical Production Enterprise "GEMI"
ul. Mickiewicza 36
05-480 Karczew
tel. (+48 022) 780 83 05 ext. 70
e-mail: [email protected]
Leaflet preparation date: