Rubital forte

Package leaflet: Information for the patient

RUBITAL FORTE
1.73 g/5 ml, syrup
Althaeae radicis maceratio
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by a
physician or pharmacist.

• Keep this leaflet for future reference.
• If you need advice or further information, consult your pharmacist.
• If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 7 days, or if you feel worse, consult your doctor.

Table of contents:

1. What R F is and what it is 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. Contents of the package and other information

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

R F contains an extract (macerate) from marshmallow root. The marshmallow root macerate acts protectively on the mucous membranes of the mouth and throat, soothing irritation symptoms.
This effect is due to the plant mucilage content from marshmallow root, the formulation's consistency, and its viscosity. The mucilage from marshmallow root forms colloidal solutions that coat the mucous membranes with a thin protective layer. Furthermore, the mucilage exerts a soothing, protective effect on the inflamed mucous membranes of the throat and helps relieve cough.
This is a medicinal product traditionally used for the indications listed, with efficacy based solely on long-term use and experience.
Indications
Traditionally used as an adjunctive treatment for cough associated with inflammatory conditions of the mouth and throat: hoarseness, cough, e.g., during common cold.
Adjunctively in irritation of the mucous membranes of the mouth and throat.
If there is no improvement after 7 days, or if you feel worse, consult your doctor.

2. Important information before using the medicinal product R F

When not to use R F

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

Warnings and precautions
Exercise particular caution when using this medicinal product:

• if the patient suffers from asthma – due to the presence of sodium benzoate in the medicinal product;
• if the patient has diabetes;
• if the patient has intolerance to certain sugars;
• if the patient develops shortness of breath, fever or purulent discharge, medical advice must be sought immediately.

Children and adolescents
Use of this medicinal product is not recommended in children under 3 years of age.
R F and other medicinal products
Inform your doctor or pharmacist about all medicinal products currently used, recently used, or which are planned to be used.
No interactions with other medicinal products or other types of interactions are known. However, the marshmallow syrup contained in this medicinal product may delay the absorption of certain drugs; therefore, it is recommended to maintain an interval of ½ to 1 hour when taking other medicinal products.
Pregnancy, breastfeeding and fertility
Before using any medicinal product, consult your doctor or pharmacist.
Due to insufficient data, the use of the syrup during pregnancy and breastfeeding is not recommended.
Driving and operating machinery
The effect of the medicinal product on psycho-motor performance has not been studied.
Important information on certain excipients in RUBITAL FORTE
This medicinal product contains sucrose; therefore, it should be used with caution in patients with diabetes. 10 ml of syrup contains 7.8 g of sucrose. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicinal product.
This medicinal product contains up to 0.5% v/v ethanol (alcohol). The dose administered contains a small amount of alcohol – less than 100 mg per dose.
The natural raspberry syrup, included as an excipient, contains raspberry juice and improves the taste and masks the odor of marshmallow syrup, which is particularly important when administering the medicinal product to children.

3. How to use R F

This medicine should always be used exactly as described in the patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Do not use the product for longer than one week.
If symptoms persist for longer than one week during use of the product, consult a doctor.
Dosage:
Children aged 3–12 years: 10 ml, the dose may be taken up to 3 times daily.
Adolescents over 12 years and adults: 10 ml, the dose may be taken 3 to 4 times daily.
Children and adolescents
The medicinal product is not recommended for children under 3 years of age.
If the effect of the medicine seems too strong or too weak, consult a doctor.
Use of more than the recommended dose of R F
No cases of overdose with R F have been reported.
If more medicine has been taken than recommended, consult a doctor or pharmacist.
Missed dose of R F
Take the next dose as scheduled. Do not take a double dose to make up for a missed dose.

4. Possible adverse reactions

Like any medicine, R F may cause adverse reactions, although not everyone experiences them.
In individuals particularly sensitive to sodium benzoate, increased salivation and gastric irritation may occur.
When the syrup is administered too frequently, exceeding the recommended dosage regimen, the medicine may have a laxative effect.

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse effects not listed in this leaflet, tell your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
e-mail: [email protected]

Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions allows the collection of additional information on the safety of the medicine.

5. How to store R F

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the stated month.
Store below 25°C. Keep the bottle in the outer packaging to protect from light.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What the medicine contains

• The active substance is marshmallow root extract. 100 g of the medicine (77 ml) contains 26.6 g of extract (9:40) from Althaea officinalis L., radix (marshmallow root). Extraction solvent: a mixture of water and ethanol with added 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 Rubital Forte looks like and contents of the pack
Rubital Forte is a syrup which is a viscous, transparent raspberry-coloured liquid, with a characteristic odour and taste. The medicine is packed in a brown glass bottle or in a brown polyethylene terephthalate (PET) bottle, containing 125 g of syrup, placed in a cardboard box together with the patient leaflet and a dosing spoon.
Marketing Authorisation Holder and Manufacturer:
Pharmaceutical Production Enterprise „GEMI” Grzegorz Nowakowski
ul. Mickiewicza 36
05-480 Karczew
tel. (+48 22) 780 83 05 ext. 70
e-mail: [email protected]