Rubital Forte

Leaflet attached to the packaging: patient information

RUBITAL FORTE
1.73 g/5 ml, syrup
Althaeae radicis maceratio

Please read the contents of the leaflet carefully 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
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, please contact your 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 there is no improvement after 7 days or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet:

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

1. What is R F and what is it used for

R F contains an extract (macerate) of the marshmallow root. The macerate of the marshmallow root acts protectively on the mucous membrane of the mouth and throat, soothing 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 altered mucous membrane of the throat and soothes 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
Traditionally used as an auxiliary agent in coughs in the course 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.
If there is no improvement after 7 days or the patient feels worse, they should consult their doctor.

2. Important information before using R F

When not to use R F

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

Warnings and precautions

Particular caution should be exercised when using this medicine:

• if the patient has asthma - due to the presence of sodium benzoate in the medicine;
• if the patient has diabetes;
• if the patient has intolerance to some sugars;
• if the patient experiences shortness of breath, fever, or purulent discharge, they should consult their doctor immediately.

Children and adolescents

The use of the medicinal product in children under 3 years of age is not recommended.

R F 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 and other types of interactions are known. The marshmallow syrup contained in the medicine may delay the absorption of some medicines, so it is recommended to maintain a gap of ½ to 1 hour when taking other medicinal products.

Pregnancy, breastfeeding, and fertility

Before using any medicine, the patient should consult their doctor or pharmacist.
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 RUBITAL FORTE

The medicine contains sucrose, so it should be used with caution in patients with diabetes. 10 ml of the syrup contains 7.8 g of sucrose. If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.
The medicine contains up to 0.5% (v/v) ethanol (alcohol). The administered dose contains a small amount of alcohol - less than 100 mg per dose.
The natural raspberry syrup, which is an auxiliary substance, contains raspberry juice, improves the taste, and soothes the smell of the marshmallow syrup, which is particularly important when using the medicine in children.

3. How to use R F

This medicine should always be used exactly as described in the patient leaflet or as directed 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.

Dosage:

Children aged 3-12: 10 ml, the dose can be used up to 3 times a day.
Adolescents over 12 and adults: 10 ml, the dose can be used from 3 to 4 times a day.

Children and adolescents

The use of the medicinal product in children under 3 years of age is not recommended.
If the patient feels that the effect of the medicine is too strong or too weak, they should consult their doctor.

Using a higher dose of R F than recommended

No cases of overdose of R F have been reported.
In the event of using a higher dose of the medicine than recommended, the patient should consult their doctor or pharmacist.

Missing a dose of R F

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

4. Possible side effects

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

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the patient should inform their doctor or 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.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store R F

The medicine should be stored out of sight and reach of children.
The medicine should not be used after the expiry date stated on the packaging.
The expiry date means the last day of the given month.
Store in a temperature below 25°C. Store the bottle in the outer packaging to protect it 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 R F contains

• The active substance of the medicine is a macerate of the marshmallow root. 100 g of the medicine (77 ml) contains 26.6 g of macerate (9:40) from Althaea officinalisL., radix (marshmallow root). Extractant: a mixture of water and ethanol with the addition of sodium benzoate (46.7:1:0.3).
• Other ingredients: sucrose, sodium benzoate, raspberry syrup (composition: raspberry juice, sucrose). The medicine contains less than 0.5% (v/v) ethanol.

What R F looks like and what the package contains

R F is a syrup that is a viscous, clear liquid with a raspberry color,
with a characteristic smell and taste. The packaging of the medicine consists of a brown or brown-colored polyethylene terephthalate bottle containing 125 g of syrup, 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
phone: (+48 22) 780 83 05 w. 70
e-mail: gemi@gemi.pl

Date of the last update of the leaflet: