Orthoplasm syrup 125 g

USE
Traditional herbal medicinal product with a coating effect, used in the symptomatic relief of irritation of the mucous membrane of the mouth and throat and accompanying dry cough.
Traditional herbal medicinal product for use for specific indications arising only from its long-term use.
If there is no improvement after 7 days or if the patient feels worse, contact your doctor.

INDICATIONS
Symptomatic relief of irritation of the oral and pharyngeal mucosa and accompanying dry cough.

ACTION
Traditional herbal medicinal product with a coating effect.

COMPOSITION
100 g of the syrup contains 32,9 g of macerate from the root of the valerian (Althaea officinalis L., radix), (DER 1:6-7), extractant - a mixture of water and ethanol (40:1).
32.9 g of the macerate from the root of the valerian corresponds to 5 g of the root of the valerian.
Ethanol content in the product up to 1% (m/m).
Excipients: sucrose, benzoic acid, purified water.

DIRECTIONS FOR USE.
This drug should always be taken as prescribed by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.
Oral administration.
The recommended dose is:
Adults and adolescents over 12 years of age: ad hoc, 1 tablespoon (about 15 ml) of syrup 3-4 times a day.
Maximum daily dose: 5 times a day.
If symptoms persist for more than 7 days while taking the product, consult a doctor or pharmacist.
Use in children and adolescents:
Children under 3 years: use is not recommended.
Children 3-6 years: ad hoc, ½ -1 teaspoon (2.5-5 ml) of syrup 3-4 times a day.
Children 6-12 years: ad hoc, 1 teaspoon (about 5 ml) of syrup 3-4 times a day.
Taking more than the recommended dose of the drug Amara Orthoplasm Syrup:
No case of overdose has been reported.
Omission of taking the drug Amara Legalise Syrup:
Do not use a double dose to make up for a missed dose.
Treatment should be continued by following the dosage regimen.
Discontinuation of the drug Amara Legalise Syrup:
If you have any further doubts about the use of this drug, ask your doctor, pharmacist or nurse.

CONTRAINDICATIONS
When not to use the drug Amara Legalise Syrup
- If the patient has hypersensitivity to the active substance or any of the other components of this drug.
UNDESIRED EFFECTS
Like any drug, this medicine may cause side effects, although they will not occur in everyone. To date, no adverse reactions have been described in literature reports.

Reporting of side effects:
If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor, pharmacist or nurse. Adverse reactions may be reported directly to the Adverse Drug Reactions Monitoring Department of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Jerozolimskie Avenue 181C, 02-222 Warsaw, tel: 22 49 21 301, fax: 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Adverse reactions can also be reported to the responsible party.
By reporting side effects, more information on the safety of the drug will be gathered

WARNINGS
You should discuss this with your doctor, pharmacist, or nurse before taking Amara Legalise Syrup.
If shortness of breath, fever or purulent sputum develops, seek immediate medical advice.
Children and adolescents:
Do not use in children under 3 years of age.
The drug Amara legalosa syrup and other drugs.
Tell your doctor or pharmacist about all medications you are currently or recently taking, as well as medications you plan to take.
There are no reports of interactions of Amara Legalise Syrup with other drugs.
The product may reduce the absorption of some drugs, so it is recommended to maintain a time interval of about 1 hour between Amara Orthrosylla Syrup and other drugs.
Pregnancy, breastfeeding and effects on fertility:
If you are pregnant or breastfeeding, suspect that you may be pregnant, or if you are planning to have a
a child, she should consult her doctor or pharmacist before taking this drug.
The safety of use during pregnancy and lactation has not been established. Therefore, the use
during pregnancy and lactation is not recommended.
Driving and operating machinery:
No studies have been conducted on the effects on the ability to drive and operate mechanical
operating mechanical devices in motion.
The drug Amara Legalise Syrup contains ethanol, sucrose and benzoic acid
Ethanol
This drug contains 189 mg of ethanol in each 15 ml of syrup (1% m/m). The amount of alcohol in 15 ml of syrup
is equivalent to 5 ml of beer or 2 ml of wine.
Doses used in children contain small amounts of ethanol, less than 100 mg per dose. 5 ml of syrup
contains 63 mg of ethanol, 2.5 ml of syrup contains 31.5 mg of ethanol.
The amount of alcohol in this drug is unlikely to affect adults and adolescents, and its
effect in children is unlikely to be noticeable. It may cause some effects in
younger children, such as a feeling of drowsiness.
The alcohol in this drug may alter the effects of other drugs. If the patient is taking other drugs,
should consult your doctor or pharmacist.
If the patient is pregnant or breastfeeding, she should advise her doctor or pharmacist before taking
taking this drug. If the patient is addicted to alcohol, she should advise her doctor or pharmacist
pharmacist before taking this medicine.

Sucrose
The drug contains about 12.5 g of sucrose in 15 ml of syrup, about 8.3 g of sucrose in 10 ml of syrup, about 4.2 g of
sucrose in 5 ml of syrup, about 2.1 g of sucrose in 2.5 ml of syrup. This should be taken into account in
patients with diabetes mellitus. If the patient has previously been diagnosed with intolerance to certain sugars,
patient should contact a doctor before taking the drug.

Benzoic acid
The drug contains 19.5 mg of benzoic acid in each 15 ml of syrup. Benzoic acid may
increase the risk of jaundice (yellowing of the skin and whites of the eyes) in newborns (up to 4 weeks of age).
Store the drug out of sight and reach of children.
Storage:
Store the drug out of sight and reach of children.
Store in closed containers, at a temperature not higher than 25°C. Protect from light.
Do not use this drug after the expiration date on the package. The expiration date means the last day of the stated month.
Medicines should not be disposed of in sewage or household waste containers. Ask your pharmacist how to dispose of medicines that you no longer use. Doing so will help protect the environment.

RESPONSIBLE PARTY
Pharmaceutical Plant "Amara" Ltd.
5 Stacyjna St., 30-851 Krakow

NET CONTENT
125g

PHARMACEUTICAL FORM
Syrup

REGISTRATION
Medicinal product

ACTIVE SUBSTANCE
Althaeae radicis maceratio (1:6.58) extractant - mixture of water and ethanol (40:1)

PERMISSION NUMBER
IL-4746/LN

ADDITIONAL INFORMATION:
This is a drug. For safety, use it according to the package insert.
Do not exceed the maximum dose of the drug. If in doubt, consult your doctor or pharmacist.