AMARA Marshmallow syrup, 125g

Important! Before use, read the leaflet, which contains indications, contraindications, data on side effects and dosage, as well as information on the use of the medicinal product, or consult a doctor or pharmacist, because any medicine used incorrectly poses a threat to your life or health.

Package leaflet: information for the patient

Amara marshmallow syrup

32.9 g/ 100 g, syrup

Althaeae radicis maceratio

Read this leaflet carefully before taking Amara Marshmallow Syrup

because it contains important information for you.

Always use this medicine exactly as described in this leaflet, or as

as told to by your doctor, pharmacist or nurse.

- Keep this leaflet for future reference. you can read it again if you need to.

- If you need advice or more information, ask your pharmacist.

- If you get any side effects, including any effects not listed

in this leaflet, tell your doctor, pharmacist or nurse.

- If you do not feel better or if you feel worse after 7 days, contact your doctor

doctor.

Table of contents of this leaflet:

1. What is Amara Marshmallow Syrup and what is it used for

2. Important information before taking the medicine Amara marshmallow syrup

3. How to take Amara Marshmallow Syrup

4. Possible side effects

5. How to store Amara Marshmallow Syrup

6. Package contents and other information

1. What is the drug Amara marshmallow syrup and what is it used for

A traditional herbal medicinal product with a coating effect, used for symptomatic

relief of irritation of the mucous membrane of the mouth and throat and associated with a dry cough.

Traditional herbal medicinal product for use in specific indications arising

only from its long-term use.

If after 7 days there is no improvement or If you feel worse, contact your doctor.

2. Important information before taking Amara marshmallow syrup

When not to use Amara marshmallow syrup

- if the patient is hypersensitive to the active substance or any of the other ingredients

this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before using Amara Marshmallow Syrup. or nurse.

If you experience shortness of breath, fever or purulent sputum, seek immediate medical advice

.

Children and adolescents

Do not use in children under 3 years of age.

Amara marshmallow syrup and other medicines

Tell your doctor or pharmacist if you are taking any other medicines

currently or recently , as well as about the drugs that the patient plans to take.

There are no reports on the interaction of Amara marshmallow syrup with other drugs.

The product may reduce the absorption of some drugs, therefore it is recommended to keep a distance

approximately 1 hour between Amara Marshmallow Syrup and other medicines.

Pregnancy, breast-feeding and effects on fertility

If you are pregnant or breast-feeding, you think you may be pregnant or are planning to have

a baby, ask your doctor or pharmacist for advice before taking this medicine.

The safety of use during pregnancy and lactation has not been established. Therefore, use

during pregnancy and lactation is not recommended.

Driving and using machines

No studies on the effect on the ability to drive and use machines have been performed.

operate moving machinery.

The medicine Amara marshmallow syrup contains ethanol, sucrose and benzoic acid

Ethanol

This medicine contains 189 mg of ethanol in every 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.

The 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 medicine is unlikely to affect adults and adolescents, and its

effects in children will probably not be noticeable. It may cause some effects in

younger children, such as feeling sleepy.

The alcohol in this medicine may change the effect of other medicines. If you are taking other medicines,

should ask your doctor or pharmacist for advice.

If you are pregnant or breast-feeding, ask your doctor or pharmacist for advice before

using this medicine. If you are alcohol dependent, ask your doctor or

pharmacist for advice before taking this medicine.

Sucrose

The medicine contains approx. 12.5 g of sucrose per 15 ml of syrup, approx. 8.3 g of sucrose in 10 ml of syrup, approx. 4.2 g

sucrose in 5 ml of syrup, approx. 2.1 g of sucrose in 2.5 ml of syrup. This should be taken into consideration in

diabetic patients. If you have been told by your doctor that you have an intolerance to some sugars,

the patient should contact your doctor before taking this medicine.

Benzoic acid

The medicine contains 19.5 mg of benzoic acid. in every 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).

3. How to take Amara Marshmallow Syrup

Always take this medicine exactly as your doctor or pharmacist has told you. If

if you have any doubts, please ask your doctor or pharmacist.

Oral use.

The recommended dose is:

Adults and adolescents over 12 years of age: as needed, 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 your doctor or pharmacist.

Use in children and adolescents

Children under 3 years of age: Not recommended for use.

Children 3-6 years old: as needed, ½ -1 teaspoon (2.5-5 ml) of syrup 3-4 times a day.

Children from 6- 12 years: as needed, 1 teaspoon (approximately 5 ml) of syrup 3-4 times a day.

If you take more than the recommended dose of Amara Marshmallow Syrup

No case of overdose has been reported.

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If you forget to take Amara Marshmallow Syrup

Do not take a double dose to make up for a missed dose.

Treatment should continue following the dosage instructions.

If you stop taking Amara Marshmallow Syrup

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

To date, no side effects have been reported in the literature.

Reporting side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any side effects not listed

in this leaflet. Adverse reactions

can be reported directly to the Department for Monitoring Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

You can also report side effects to the Marketing Authorization Holder.

By reporting side effects, you will be able to gather more information about

the safety of the medicine.

5. How to store Amara marshmallow syrup

Keep the medicine out of the sight and reach of children.

Store in closed packaging at a temperature not higher than 25°C. Protect from

light.

Do not use this medicine after the expiry date which is stated on the package.

The expiry date means the last day of that month.

Medicines should not be disposed of via wastewater or household waste. Ask

your pharmacist how to dispose of medicines you no longer use. Doing so will help protect

the environment.

6. Package contents and other information

What the drug contains Amara marshmallow syrup

100 g of syrup contains 32.9 g of marshmallow root macerate (Althaea officinalis L., radix),

(DER 1:6-7), extractant - a mixture of water and ethanol (40:1).

32.9 g of marshmallow root macerate corresponds to 5 g of marshmallow root.

Ethanol content in the product up to 1% (m/m).

Excipients:

- sucrose,

- benzoic acid,

- purified water.

What does Amara marshmallow syrup look like and what does the package contain

Amara marshmallow syrup is a thick, viscous, transparent or slightly opalescent liquid with

yellowish color and specific odor.

The drug packaging is a colored glass bottle with a polyethylene cap, 125 g, 200 g, 1.25 kg in a

cardboard box with the attached patient leaflet.

Important information about the medicine

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