Sirop pravoshlazovi Alte Forte 6 h. kozhenia pravoshlazu

Leaflet attached to the packaging: patient information

SYROP PRAWOŚLAZOWY ALTE FORTE 6 CZ. KORZENIA PRAWOŚLAZU

2.36 g/5ml, syrup
Althaeae radicis maceratio

Please read carefully the contents of the 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 advised by
the doctor or pharmacist.

• Please keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist. See section 4.
• If after 7 days there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet:

• 1. What is S 6 and what is it used for
• 2. Important information before using S 6
• 3. How to use S 6
• 4. Possible side effects
• 5. How to store S 6
• 6. Package contents and other information

1. What is S 6 and what is it used for

it is used for
The syrup contains an extract (macerate) of the marshmallow root. The marshmallow root macerate
acts protectively on the mucous membrane of the mouth and throat, relieving irritation symptoms. This
action is related to the content of plant mucus from the marshmallow root, the consistency of the medicine,
and its viscosity. The mucus of the marshmallow root creates colloidal solutions that cover the mucous
membranes with a thin layer and act protectively on them. Additionally, the mucus acts protectively on the
changed mucous membrane of the throat and relieves cough.
This is a medicinal product used traditionally for the indicated purposes, and its effectiveness is based
solely on long-term use and experience.
Indications for use
The syrup is traditionally used as an auxiliary agent for symptoms of inflammatory conditions of the
mouth and throat: hoarseness, cough, e.g., in the course of a cold. Auxiliary in irritations of the mucous
membrane of the mouth and throat.

2. Important information before using S 6

When not to use S 6

• if the patient is allergic (hypersensitive) to the active substance or any of the other ingredients of the medicine (listed in section 6), including benzoic acid and its derivatives.

Warnings and precautions

Due to the presence of benzoic acid, caution is recommended in patients with asthma.
If the patient experiences shortness of breath, fever, or purulent discharge, they should immediately inform
their doctor.

Children

It is not recommended to administer to children under 3 years of age.

SYROP PRAWOŚLAZOWY ALTE FORTE 6 CZ. KORZENIA PRAWOŚLAZU and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have
recently taken, as well as any medicines they plan to take.
No interactions with other medicines are known. The marshmallow syrup contained in the medicine may
delay the absorption of some medicines, so it is recommended to maintain a ½ to 1-hour interval when
taking other medicinal products.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should
consult their doctor or pharmacist before using this medicine.
Due to the lack of sufficient data, the use of the syrup during pregnancy and breastfeeding is not recommended.

Driving and using machines

The effect of the medicine on psychophysical abilities has not been studied.

Important information about some ingredients of S 6

This medicine contains sucrose. 5 ml of the syrup contains 4.2 g of sucrose. 10 ml of the 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 some sugars, they should consult their doctor before taking the medicine.
The medicine contains a small amount of ethanol (alcohol), less than 100 mg per dose (no 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 advised by the doctor
or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist.
The product should not be used for more than a week.
If the symptoms persist for more than a week during the use of the product, the patient should consult their
doctor.
The medicine is administered orally. The syrup should be dosed using the measuring cup attached to the
packaging.
Children from 3 to 6 years old: 5 ml dose, repeated according to the severity of irritation symptoms (up to
3 times a day).
Children from 7 to 12 years old: 5 ml dose, repeated according to the severity of irritation symptoms (up to
5 times a day).
Adolescents over 12 years old and adults: 10 ml dose, repeated according to the severity of irritation symptoms
(up to 6 times a day).

Using a higher dose of S 6 than recommended

No cases of overdose of this medicine have been reported.
In case of taking a higher dose of the medicine than recommended, the patient should consult their doctor or
pharmacist.

Missing a dose of S 6

The patient should take the next dose of the medicine. They should not take a double dose to make up for the
missed dose.

Stopping the use of S 6

In case of any further doubts related to the use of this medicine, the patient should consult their doctor or
pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
In people particularly sensitive to benzoic acid, increased salivation and stomach irritation may occur.
With too frequent dosing of the syrup, above the recommended dosing schedule, a laxative effect may occur.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the patient should inform their doctor,
pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse
Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and
Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
e-mail: ndl@urpl.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store S 6

The medicine should be stored in a place invisible and inaccessible to children.
The medicine should not be used after the expiry date stated on the packaging.
The expiry date means the last day of the specified month.
Store in a closed packaging, at a temperature not exceeding 25°C. Protect from light.
Medicines should not be disposed of via wastewater or household waste containers. The patient should ask
their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What S 6 contains

The active substance in the medicine is marshmallow root macerate. 100 g of the syrup (76 ml) contains 36.6 g
of macerate from 6 g of Althaea officinalisL., radix (marshmallow root) (DER 6:36). Extractant: a 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 packaging contains

The syrup is a viscous liquid, yellow to light brown in color, with a characteristic smell and taste, without
sediment. The packaging of the medicine consists of a brown glass or brown polyethylene terephthalate
bottle containing 125 g of the syrup with a screw cap, placed in a cardboard box with the patient leaflet and
a measuring cup for administering the medicine.

Marketing authorization holder and manufacturer:

Przedsiębiorstwo Produkcji Farmaceutycznej „GEMI” Grzegorz Nowakowski
ul. Mickiewicza 36
05-480 Karczew
tel. +48 22 780 83 05 w. 70
e-mail: gemi@gemi.pl

Date of the last update of the leaflet: