Appetistim

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT APESTIM

Composition:

Active substances: 100 g of syrup contains a complex liquid extract (1:2) from: yarrow herb (Achillea millefolium L. herba), white horehound herb (Marrubium vulgare L. herba), lemon balm leaves (Melissae officinalis L. folium), fennel fruits (Foeniculum vulgare Mill., fructus) (3/2/3/2), extraction agent — purified water — 15.0 g;

Excipients: orange concentrate, sodium benzoate, sucrose, purified water.

Pharmaceutical form. Syrup.

Main physicochemical properties: liquid, yellowish in color, with sweet-bitter taste and characteristic odor.

Pharmacotherapeutic group. Agents affecting the digestive system and metabolism. Appetite stimulants. ATC code A15.

Pharmacological properties.

The syrup contains an extract of medicinal herbs containing bitter compounds (centaury herb, lemon balm leaves, yarrow herb) and fennel fruits, which enhance gastric juice secretion via reflex pathways. This type of preparation is traditionally used for loss of appetite.

Clinical characteristics.

Indications.

The medicinal product Appetistim is traditionally used in the absence of appetite.

Contraindications.

Hypersensitivity to the active substances, to any excipient, or to plants of the Asteraceae family, for example chamomile, calendula.

Interaction with other medicinal products and other forms of interaction.

Interaction studies have not been performed.

Special precautions for use

Patients with rare hereditary disorders such as fructose intolerance, glucose-galactose malabsorption syndrome, or sucrase-isomaltase deficiency must not take this medicinal product.

Use during pregnancy or breastfeeding

Pregnancy and breastfeeding

Due to the lack of clinical safety data, the syrup should not be used during pregnancy or breastfeeding.

Fertility

No data available.

Ability to influence reaction speed when driving or operating machinery

The medicinal product Apetistim does not affect the ability to drive vehicles or operate machinery.

Method of Administration and Dosage.

Take the syrup orally, approximately half an hour before meals.

A measuring cup is provided in the package to facilitate dosing.

When administering to children, the dose of syrup should be diluted in a small amount of weak tea or water.

Dosage

Children aged 3 to 6 years — 2.5 ml twice daily (using the measuring cup).

Children aged 6 years and adolescents (up to 18 years) — 5 ml 2–3 times daily (using the measuring cup).

Adults — 15 ml 3–4 times daily (using the measuring cup).

Duration of Use

If symptoms worsen or do not resolve within 10 days, consider changing the treatment.

Children.

Do not use in children under 3 years of age.

Overdose.

Cases of overdose have not been reported.

Side effects

The side effects are listed by system organ classes according to the MedDRA classification and by frequency of occurrence: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1000 to < 1/100); rare (≥ 1/10,000 to < 1/1000); very rare (< 1/10,000); frequency not known (cannot be estimated based on available data).

The following may occur during the use of Apetistym:

• Skin and subcutaneous tissue disorders (allergic skin reactions) – frequency not known;
• Respiratory, thoracic and mediastinal disorders (allergic reactions of the respiratory system) – frequency not known.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorization of the medicinal product is important, as it allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals should report any suspected adverse reactions via the national pharmacovigilance system.

Shelf life. 3 years.

Storage conditions.

Store at temperatures not exceeding 25°C. Keep out of the reach of children.

Packaging.

A colored glass bottle containing 125 g of syrup, with an HDPE cap, a measuring cup, and patient leaflet, all packed in a cardboard box.

Authorization category.

Over-the-counter (without prescription).

Manufacturer.

Herbapol Wrocław Pharmaceutical Plant Sp. z o.o.

Manufacturer's address and location of operations.

50-951 Wrocław, ul. Świętego Mikołaja 65/68, Poland.