Apilac grinex

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT APILAC GRINDEKS (APILAC GRINDEKS)

Composition:

Active substance: apilacum;

One tablet contains 10 mg of lyophilized apilac;

Excipients: lactose monohydrate; potato starch; talc; calcium stearate.

Pharmaceutical form. Sublingual tablets.

Main physicochemical properties: tablets are white or white with a yellowish tint on the surface and in cross-section, with small yellow specks, flat cylindrical in shape.

Pharmacotherapeutic group.

Agents affecting the digestive system and metabolic processes. ATC code A16AX.

Pharmacological properties.

Pharmacodynamics.

Apilac, also known as royal jelly, is a secretion produced by the hypopharyngeal and mandibular glands of worker bees. It exerts a general tonic and antispasmodic effect, enhances the body's resistance, stress tolerance, and stimulates metabolism. The drug regulates vascular tone and arterial blood pressure levels. Apilac reduces blood cholesterol levels and promotes improvement in the general condition in atherosclerosis. It has a stimulating effect on the central nervous system.

Pharmacokinetics.

Not studied.

Clinical characteristics.

Indications.

In case of impaired lactation in the postpartum period (hypogalactia).

In children with inadequate nutrition, hypotrophy, and lack of appetite.

As an adjunctive agent in the treatment of neurotic disorders, arterial hypotension, and coronary atherosclerosis.

Digestive disturbances during convalescence following illnesses.

Contraindications.

• Hypersensitivity to bee products or to any component of the medicinal product;
• Addison's disease.

Interaction with other medicinal products and other forms of interaction.

Unknown.

Special precautions for use.

The medicinal product contains lactose; therefore, it should not be used in patients with rare hereditary forms of galactose intolerance, lactase deficiency, or glucose-galactose malabsorption.

In case of sleep disturbances, the dose should be reduced or the drug discontinued.

Use during pregnancy or breastfeeding.

There are no clinical data on the negative impact of apilac on the fetus during pregnancy or on the infant during breastfeeding.

Ability to affect reaction speed when driving or operating machinery. No effect.

Method of Administration and Dosage

Tablets should be taken sublingually. The tablet should be placed under the tongue and held until completely dissolved, since gastric juice destroys royal jelly if the drug is taken orally.

For hypogalactia: it is recommended to take 1 tablet 3 times a day; duration of treatment course – 10–15 days.

Adults and adolescents: 1 tablet 3 times a day. Duration of treatment course – 10–15 days.

Children from 2 years of age: 1 tablet 2 times a day (under adult supervision). Duration of treatment course – 10–15 days.

Do not exceed the recommended daily doses.

Children.

Do not use in children under 2 years of age.

Overdose.

Only small amounts of royal jelly exert a therapeutic effect.

Symptoms: exceeding the recommended dosage may inhibit metabolic processes; for example, administration of 2.5 g of apilac per day may cause lethargy.

Treatment: there is no specific antidote. In case of overdose, treatment with apilac should be discontinued. Symptomatic therapy should be administered.

Side effects.

Allergic reactions may occur, which disappear after discontinuation of the drug. In case of hypersensitivity to the components of the drug, dry mouth, increased pulse rate, and sleep disturbances may be observed. These symptoms resolve after dose reduction or discontinuation of the drug.

Shelf life. 2 years.

Do not use after the expiry date stated on the packaging.

Storage conditions.

Store at a temperature not exceeding 25 °C.

Keep in the original packaging to protect from moisture and light.

Keep out of reach of children.

Packaging.

25 tablets in a blister; 1 or 2 blisters in a cardboard box.

Supply category. Over-the-counter.

Manufacturer.

JSC "Grindeks".

Manufacturer's address.

53 Krustpils Street, Riga, LV-1057, Latvia.

Marketing Authorization Holder.

JSC "Grindeks".

Address of the Marketing Authorization Holder and/or its representative.

53 Krustpils Street, Riga, LV-1057, Latvia.

Tel./Fax: +371 67083205 / +371 67083505

E-mail: [email protected]