Apilac tablets 0,01 (Tablets) Instructions for Use
ATC Code
A13A (General tonic preparations)
Active Substance
Royal jelly (BP British Pharmacopoeia)
Clinical-Pharmacological Group
Drug with general tonic action
Pharmacotherapeutic Group
Natural origin biostimulating agent
Pharmacological Action
Biogenic stimulant. It has a general tonic effect, stimulates cellular metabolism and regenerative processes, and improves tissue trophism.
Indications
- For oral administration: during convalescence after past illnesses, for lactation disorders (hypogalactia) in the postpartum period.
- As an auxiliary agent in the treatment of neurotic disorders and arterial hypotension.
- For external use: facial seborrhea, skin itching, intertrigo.
ICD codes
| ICD-10 code | Indication |
| F48.9 | Unspecified neurotic disorder |
| I95 | Hypotension |
| L21 | Seborrheic dermatitis |
| L29 | Pruritus |
| L30.4 | Erythematous intertrigo |
| O92.4 | Hypogalactia |
| Z54 | Convalescence |
| ICD-11 code | Indication |
| 6B6Z | Dissociative disorders, unspecified |
| BA2Z | Hypotension, unspecified |
| EA81.Z | Seborrheic dermatitis, unspecified |
| EC90.Z | Itching, unspecified |
| EK02.20 | Intertriginous dermatitis due to friction, sweating or contact with body fluids |
| JB46.4 | Hypogalactia |
| QB7Z | Convalescence, unspecified |
Dosage Regimen
| The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen. |
Administer tablets sublingually or use externally as directed.
Determine the exact dose, method, and schedule of application individually based on the specific indication and clinical presentation.
Follow the prescribing physician’s instructions precisely regarding the frequency and duration of treatment.
Adverse Reactions
Monitor for allergic reactions, which may manifest as skin rash, itching, or skin redness.
Observe for the development of sleep disorders during the course of treatment.
Discontinue use immediately upon the appearance of any adverse effects and seek medical advice.
Drug Interactions
Exercise caution with concurrent use of other central nervous system stimulants due to potential additive effects.
Be aware of possible interactions with other bee products or natural origin biostimulants.
Consult a healthcare professional before combining with any other prescription or over-the-counter medications.
Contraindications
- Hypersensitivity to royal jelly or any other bee products.
- Diagnosis of Addison’s disease (adrenal insufficiency).
- For oral administration: age under 18 years due to the lack of sufficient clinical data establishing safety and efficacy in this population.
Overdose
Symptoms of overdose may include a significant exacerbation of described adverse reactions, particularly severe allergic manifestations and profound sleep disturbances.
In case of suspected overdose, immediately discontinue the medication and initiate symptomatic and supportive care.
Seek immediate medical attention for management of severe allergic or other systemic reactions.
Use in Pregnancy and Lactation
Use during pregnancy and breastfeeding is possible after consultation with a doctor. During breastfeeding, the ointment should not be applied to the breast area.
Pediatric Use
Contraindicated for use in children and adolescents under 18 years of age (due to the lack of sufficient clinical data).
Special Precautions
If allergic reactions develop, treatment should be discontinued.
If sleep disorders occur, the dose should be reduced or the agent should be discontinued.
Storage Conditions
Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.
Dispensing Status
Over-the-Counter
Important Safety Information
This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.
Medical DisclaimerBrand (or Active Substance), Marketing Authorisation Holder, Dosage Form
Tablets 10 mg: 25 or 30 pcs.
Marketing Authorization Holder
Vifitech, CJSC (Russia)
Dosage Form
| Apilac tablets 0,01 | Tablets 10 mg: 25 or 30 pcs. |
Dosage Form, Packaging, and Composition
| Tablets | 1 tab. |
| Apilac lyophilized (powder of natural royal jelly of bees) | 10 mg |
25 pcs. – contour cell packs (1) – cardboard packs.
30 pcs. – contour cell packs (1) – cardboard packs.
Tablets 10 mg: 25 or 30 pcs.
Marketing Authorization Holder
Novosibirsk Medical Preparations Plant JSC (Russia)
Dosage Form
| Apilac tablets 0,01 | Tablets 10 mg: 25 or 30 pcs. |
Dosage Form, Packaging, and Composition
| Tablets | 1 tab. |
| Apilac lyophilized (powder of natural royal jelly of bees) | 10 mg |
25 pcs. – contour cell packs (1) – cardboard packs.
30 pcs. – contour cell packs (1) – cardboard packs.
Sublingual tablets 10 mg: 10, 20, or 30 pcs.
Marketing Authorization Holder
Vifitech, CJSC (Russia)
Dosage Form
| Apilac | Sublingual tablets 10 mg: 10, 20, or 30 pcs. |
Dosage Form, Packaging, and Composition
Sublingual tablets from white to white with a yellowish tint with small inclusions, round, flat-cylindrical in shape with a bevel.
| 1 tab. | |
| Apilac lyophilized (royal jelly)* | 10 mg |
* bee royal jelly lyophilized with a content of the sum of unsaturated fatty acids in terms of 10-hydroxy-2-decenoic acid and dry matter 5%.
Excipients : lactose monohydrate (milk sugar) – 127.5 mg, potato starch – 8 mg, talc – 3 mg, calcium stearate – 1.5 mg.
10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.
