Resistol-tab

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT RESISTOL®-TAB

Composition:

One film-coated tablet contains:

Active ingredient: Dry extract from roots of Pelargonium sidoides DC and/or Pelargonium reniforme Curt., radix (4–7:1), (extraction solvent — ethanol 14% v/v) — 20 mg;

Excipients:

for the dry extract: microcrystalline cellulose, colloidal anhydrous silicon dioxide;

for the tablet core: lactose monohydrate; silicified microcrystalline cellulose; sodium croscarmellose; colloidal anhydrous silicon dioxide; calcium stearate;

film-coating mixture contains: partially hydrolyzed polyvinyl alcohol, polyethylene glycol (macrogol) 3350, talc, titanium dioxide (E 171), yellow azo dye FCF (E 110), red azo dye AG (E 129), indigocarmine dye (E 132).

Pharmaceutical form. Film-coated tablets.

Main physicochemical properties: Film-coated tablets, brown with reddish hue, round-shaped, biconvex.

Pharmacotherapeutic group.

Medicinal products used for cough and common cold.

ATC code R05.

Pharmacological properties.

REZISTOL®-TAB is a traditional herbal medicinal product for use according to indications supported by long-term use.

Pharmacodynamics.

The medicinal product contains an extract from the roots of Pelargonium sidoides DC and/or Pelargonium reniforme Curt., which stimulates non-specific defense mechanisms of the body, has moderate antibacterial and antiviral properties (direct and indirect mechanisms), and cytoprotective effects. In addition, the extract from pelargonium roots stimulates the mucociliary system and alleviates the course of the disease.

Pharmacokinetics. Data on the pharmacokinetics of the medicinal product are not required.

Clinical characteristics.

Indications.

Symptomatic treatment of colds.

Contraindications.

Hypersensitivity to the active substance of the medicinal product or to excipients. Increased tendency to bleeding, concomitant use of medicinal products that slow down blood coagulation; severe liver and 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.

Unknown. Since the medicinal product may alter blood coagulation parameters, the possibility of influencing the effect of indirect anticoagulants such as warfarin cannot be excluded.

The patient should inform the physician about all medicinal products he is currently taking or has recently taken, as well as about medicinal products he plans to use.

Special precautions for use.

Do not exceed the recommended daily dose.

If symptoms do not resolve within one week, elevated body temperature persists for more than 3 days, or general condition worsens, or if dyspnea or hemoptysis occurs, seek immediate medical advice.

Cases of liver function disorders and hepatitis associated with the use of the medicinal product have been reported. If signs of hepatotoxicity occur, discontinue the medicinal product immediately and consult a physician.

If you have known sugar intolerance, consult your doctor before taking this medicinal product.

The medicinal product contains the yellow sunset dye (E 110), which may cause allergic reactions.

Use during pregnancy or breastfeeding.

There are no data on the effect on fertility.

There are no data on the safety of use during pregnancy and lactation.

Due to the lack of data, the use of the medicinal product is not recommended during pregnancy or breastfeeding.

Ability to influence reaction rate while driving or operating machinery.

Studies on the influence of the medicinal product on the ability to drive or operate machinery have not been conducted.

Method of Administration and Dosage

For adults and children aged 12 years and older: 1 tablet 3 times daily (in the morning, afternoon, and evening); for children aged 6 to 12 years: 1 tablet 2 times daily (in the morning and evening).

REZISTOL®-TAB should be taken without chewing, with a small amount of liquid.

The duration of treatment depends on the severity and course of the disease and is determined individually by a physician.

If symptoms persist for more than 1 week despite adherence to the prescribed dosage, the patient should consult a doctor.

Children

The medication is indicated for children aged 6 years and older. Efficacy and safety of use in children under 6 years of age have not been established.

Overdose

No cases of overdose have been reported to date.

Side effects.

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

Respiratory system: mild nosebleeds.

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

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

Shelf life.

2 years.

Storage conditions.

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

Keep out of reach of children.

Packaging.

10 tablets in a blister, 2 blisters in a pack.

Availability.

Over-the-counter (without prescription).

Manufacturer: JSC "Kyivmedpreparat".

Manufacturer's address and place of business.

139 Saksaganskogo Street, Kyiv, 01032, Ukraine.