BELISA

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT BELISA (BELISA)

Composition:

Active substances: 1 capsule contains: Bellis dry extract obtained from aqueous-ethanolic extract (1:3) (extraction solvent — 40% ethanol) of a mixture: Passiflora herb (Passiflorae herba) 100 mg; Tilia flowers (Tiliae flores) 100 mg; Marjoram herb (Origanivulgaris herba) 66.7 mg; Sage leaves (Salviae officinalis folia) 33.3 mg; Lemon balm herb (Melissae herba) 33.3 mg, calculated to 5% moisture (4.3–5.3% maltodextrin, 4.3–5.3% colloidal anhydrous silicon dioxide) — 51.2 mg;

Excipients: magnesium stearate; lactose monohydrate;

Hard gelatin capsule: gelatin, patent blue V (E 131), titanium dioxide (E 171), iron oxide yellow (E 172), indigotine (E 132).

Pharmaceutical form. Capsules.

Main physicochemical properties: hard gelatin capsules with a green cap and a greenish body. The capsule contents are a powder ranging from reddish-brown to brown in color, containing small particles from light to dark. Agglomeration of particles is permissible.

Pharmacotherapeutic group.

Hypnotics and sedatives. ATC code N05CM.

Pharmacological properties.

A combined herbal medicinal product. Bellisa exerts sedative, hypotensive, spasmolytic, and anti-inflammatory effects. The drug promotes increased diuresis and choleresis, regulates metabolism (carbohydrates and fats), and improves the general condition of the body.

Clinical characteristics.

Indications.

As part of complex therapy for nervous system disorders (in neurasthenia, headache, sleep disorders, asthenic condition); in arterial hypertension (mild and moderate forms).

Contraindications.

Hypersensitivity to the components of the medicinal product, increased gastrointestinal tract secretion, arterial hypotension. Pollinosis.

Interaction with other medicinal products and other types of interactions.

When used concomitantly with central nervous system depressants such as barbiturates and tranquilizers, an enhanced sedative and hypnotic effect is possible.

Concomitant use may enhance the effects of antihypertensive and anti-inflammatory agents. Concurrent use with synthetic sedatives and benzodiazepines is not recommended. Concomitant use with disulfiram should be avoided.

Sage enhances the effect of other anti-inflammatory agents.

If simultaneous use with any other medicinal products is necessary, consult a physician.

Special precautions for use.

In elderly patients, treatment should be initiated at the lowest dose, using Belisa oral drops.

The medicinal product contains lactose; therefore, if a patient has been diagnosed with intolerance to certain sugars, medical advice must be sought before administration.

Use with caution in patients with severe organic gastrointestinal disorders.

Use during pregnancy or breastfeeding.

Belisa medicinal product must not be used during pregnancy or breastfeeding.

Ability to influence reaction speed when driving or operating machinery.

During treatment with Belisa, patients should refrain from driving or operating potentially hazardous machinery.

Dosage and Administration.

Take orally, 1 capsule three times a day, 30 minutes before meals or 1 hour after a meal.

The duration of treatment depends on the severity of the disease and concomitant therapy and lasts from 14 days to 1 month. If necessary, the course of treatment may be repeated.

Children.

Belisa medicinal product is not recommended for children under 12 years of age.

Overdose.

When doses exceeding the recommended dose are used, drowsiness may occur. In case of overdose, dizziness, lethargy, and decreased concentration of attention are possible. Treatment: discontinue the drug and seek medical advice.

Adverse reactions.

Possible:

Gastrointestinal tract: nausea, vomiting.

Cardiovascular system: tachycardia, bradycardia.

Nervous system: dizziness, drowsiness.

Immune system: vasculitis, allergic reactions including rash, itching, swelling, redness of the skin.

If adverse reactions occur, discontinue use of the drug and consult a physician.

Shelf life.

3 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 ºC. Keep out of reach of children.

Packaging.

10 capsules in a blister; 3 or 9 blisters per carton.

Availability category.

Over-the-counter.

Manufacturer: LLC "DKP "Pharmaceutical Factory".

Manufacturer's address and location of business activity:

Ukraine, 12430, Zhytomyr region, Zhytomyr district, village Stanishivka, Korolova St., bld. 4.

Marketing Authorization Holder: Limited Liability Company "Representation Baumann Pharm GmbH".

Address of the Marketing Authorization Holder: Ukraine, 79052, Lviv, Shyroka St., bld. 66.