Resistol

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT REZISTOL® (RESISTOL)

Composition:

Active substance:

1 g of solution contains Pelargonii radix extract liquid (Pelargoniiradixextractumliquidum) (extractants: ethanol 40% (v/v), ethanol 10% (v/v)) (1:8--10) -- 800 mg;

Excipient: glycerol (85%).

Pharmaceutical form. Oral drops.

Main physicochemical properties: liquid ranging in color from light brown to reddish-brown. During storage, formation of sediment and slight turbidity may occur.

Pharmacotherapeutic group. Cough and cold preparations. ATC code R05.

Pharmacological properties.

Pharmacodynamics. The medicinal product contains an extract of the roots of Pelargonium sidoides.

The agent affects the mechanism of bacterial and viral attachment to the mucous membrane, thereby preventing the penetration of viruses and bacteria into the body. The drug has a pronounced immunomodulatory effect, which leads to rapid suppression of viral infection. It also prevents the multiplication of bacteria that have already entered the body, thus inhibiting the development of complications. The drug promotes activation of the respiratory tract clearance mechanisms, improving the removal of viscous mucus and eliminating conditions for further proliferation of pathogenic bacteria.

Treatment with the drug rapidly alleviates symptoms such as cough, difficult expectoration of sputum, general malaise, fever, and nasal congestion. It significantly shortens the duration of illness and suppresses the development of microbial resistance.

The drug is a complex mixture of numerous components, which is considered as the active substance in its entirety.

Pharmacokinetics. Pharmacokinetic data for the drug are not available.

Clinical characteristics.

Indications. Acute and chronic respiratory and ENT infections (bronchitis, sinusitis, tonsillar angina, rhinopharyngitis).

Contraindications. Hypersensitivity to any ingredient of the medicinal product, predisposition to bleeding, concomitant use of medicinal products that slow down blood coagulation, severe liver or kidney diseases (due to lack of sufficient experience with the use of this medicinal product in such cases).

Interaction with other medicinal products and other forms of interaction.

No reports of interactions available.

Due to the potential effect of the medicinal product Resistol® on blood coagulation, the possibility cannot be excluded that when used concomitantly, it may influence the action of indirect anticoagulants such as warfarin. No interactions between Resistol® and penicillin V have been observed.

Special precautions for use.

If symptoms persist for more than 1 week, elevated body temperature lasts for over 3 days, or general condition worsens, as well as in case of impaired liver function of any origin, dyspnea, or hemoptysis, medical advice should be sought.

Use during pregnancy or breastfeeding.

The drug is not recommended during pregnancy or breastfeeding due to insufficient clinical experience with its use in these patient groups.

Ability to influence reaction rate when driving or operating machinery.

The effect of the drug on reaction speed during driving or operating machinery has not been studied; however, it should be noted that the drug contains 12% v/v ethanol.

Method of Administration and Dosage.

The solution should be taken with a small amount of liquid, 30 minutes before meals, in the morning, afternoon, and evening.

In the acute phase of the disease, the usual dosage is:

• Adults and children aged 12 years and older: 30 drops three times daily;
• Children aged 6 to 12 years: 20 drops three times daily;
• Children aged 1 to 6 years: 10 drops three times daily.

For prevention of relapses and continued treatment of chronic conditions, adults and children aged 12 years and older should take 10–20 drops of the preparation three times daily.

The average duration of treatment for acute illness and prevention of relapses is 7–10 days. The total duration of treatment should not exceed 3 weeks.

Hold the bottle vertically and, if necessary, gently tap the bottom.

Children.

Due to insufficient data on the use of the preparation in infants, Resistol® should not be used in children under 1 year of age. The use of Resistol® for the treatment of younger children (aged 1 to 6 years) is recommended under medical supervision.

Overdose.

There have been no reports of overdose. Overdose may result in an increased risk of adverse reactions.

Side effects.

Gastrointestinal system: gastrointestinal disorders (including stomach pain, heartburn, nausea, diarrhea), slight bleeding of the gums.

Respiratory system: slight nosebleeds.

Skin/immune system: hypersensitivity reactions (including skin rash, urticaria, itching of the skin and mucous membranes). In extremely rare cases, severe hypersensitivity reactions with facial swelling, shortness of breath, and decreased blood pressure may occur.

Hepatobiliary system: increased liver function test values. A causal relationship between these elevated values and the use of the medicinal product has not been established.

Shelf life. 3 years.

Shelf life after opening the container – 3 months.

Storage conditions. Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging. 20 ml or 50 ml in a bottle closed with a dropper stopper and a cap with a tamper-evident seal; 1 bottle per carton.

Supply classification. Over-the-counter.

Manufacturer. JSC "Halychpharm".

Manufacturer's address and place of business.

6/8 Opryshkivska St., Lviv, 79024, Ukraine.