BODRIN

 

TRADE NAME

Bodrin

 

INTERNATIONAL NON-PROPRIETARY NAME

−

 

PHARMACEUTICAL FORM

Hard gelatin capsules.

Description: Hard gelatin capsules, size №00, brown op. cap and ivory op. body, filled with powder mixture of dark gray-brown color with white particles; during the storage may form agglomerates.

 

COMPOSITION

1 capsule contains

Active ingredients:

Hipericum Perforatum flower dry extract	300 mg
Leunurus Cardiaca stem and leaf dry extract	100 mg
Paeonia lactiflora root dry extract	100 mg

Excipients: calcium carbonate, calcium hydrogen phosphate anhydrous, magnesium stearate, silica colloidal anhydrous.

Capsule shell composition: titanium dioxide, black iron oxide, yellow iron oxide, red iron oxide, gelatin.

 

ATC CODE OF THE DRUG   N07XX

 

PHARMACOTHERAPEUTIC GROUP

Other nervous system drugs.

 

PHARMACOLOGICAL PROPERTIES

PHARMACODYNAMICS

Bodrin produces antidepressant and sedative effects. The drug improves mood, increases mental and physical performance, and normalizes sleep. The action of the drug is determined by its components.

Hipericum Perforatum flower dry extract possesses antidepressant, anxiolytic and sedative action. It inhibits МАО activity, binds to benzodiazepine receptors, inhibits reuptake of serotonin, norepinephrine and dopamine. The extract has a favorable effect on the functional state of the central and the autonomic nervous system. It improves mood, increases mental and physical performance, normalizes sleep, and produces a spasmolytic effect.

Leunurus Cardiaca stem and leaf dry extract produces a sedative effect due to inhibition of excitation processes in the central nervous system. It also possesses cardiotonic and diuretic action.

Paeonia lactiflora root dry extract produces stress-protective, anxiolytic, anticonvulsant, membrane-stabilizing and antihypoxic action.

PHARMACOKINETICS

The action of Bodrin is determined by the cumulative properties of its components, which makes kinetic observations impossible.

 

 

therapeutic indicationS

- asthenic syndrome;

- depressive and anxiety disorders;

- sleep disorders;

- neuroses (including those accompanied with tachycardia and cardialgia);

- hyperexcitability, including in cases of skin diseases, pains, injuries and burns (as part of complex therapy);

- initial stage of arterial hypertention (as part of complex therapy).

 

Dosage and administration

Bodrin is administered orally, one capsule before bedtime, followed with a sufficient amount of fluid.

 

CONTRAINDICATIONS

- hypersensitivity to the components of the drug;

- gastric and duodenal ulcer, erosive gastritis in the exacerbation phase;

- pregnancy;

- lactation;

- children under 12 years old.

 

SIDE EFFECTS

Gastrointestinal disorders: nausea, abdominal pain (including epigastric pain), mouth dryness, flatulence, diarrhea or constipation.

Central nervous system disorders: anxiety, exhaustion, headache.

Hematopoietic system disorders: iron-deficiency anemia.

Allergic reactions: skin itching, skin rash, pigmentation, photosensibilization (more often in HIV-infected patients), increased sensibilization to animal hair.

 

SPECIAL INDICATIONS

During treatment patients (especially light-skinned ones) should avoid prolonged exposure to the sunlight and visiting of tanning salons.

Avoid concomitant administration of other drugs inducing sensibilization.

Simultaneous administration of Bodrin with MAO inhibitors is not recommended.

 

INFLUENCE ON ABILITY TO DRIVE AND OPERATE OTHER MECHANISMS

Exercise caution when driving and performing other potentially dangerous activities requiring increased attention and speed of psychomotor reactions during treatment.

 

Pregnancy and lactation

The drug is contraindicated in pregnancy and lactation.

 

PEDIATRIC USE

The drug is contraindicated to children under 12 years old.

 

DRUG INTERACTIONS

The drug increases the action of sleep medicines, analgesics and spasmolytics.

 

OVERDOSE

Overdose may cause depression of the central nervous system and somnolence.

Treatment: symptomatic.

 

PACKAGING

Hard gelatin capsules.

10 capsules in a blister.

3 blisters together with an enclosed leaflet in a carton box.

 

STORAGE CONDITIONS

Store in a protected from moisture and light place at temperature not exceeding  25°С.

Keep out of reach of children!

 

SHELF LIFE

3 years from the date of manufacture.

Do not apply after the expiry date.

 

SALES TERMS

Sold without prescription.

 

MANUFACTURER

The holder of trade mark and marketing authorization is

“DR SERTUS İLAÇ SANAYİ VE TİCARET LİMİTED ŞİRKETİ”, TURKEY.

Manufactured by

“ADIPHARM LTD”, 130 Simeonovsko shosse blvd., 1700 Sofia, Bulgaria.