Lazea capsules 80 mg blister No. 14

Instructions for Lazea capsules 80 mg blister No. 14

Composition

active ingredient: lavender oil; 1 capsule contains 80 mg of lavender oil Silexan® (Lavandula angustifolia) WS® 1265;

excipients: succinic gelatin, glycerin 85%, refined rapeseed oil, non-crystallizing sorbitol solution, carmine lake (E 120), titanium dioxide (E 171), patent blue V (E 131).

Dosage form

Capsules.

Main physicochemical properties: oval, purple, opaque, soft gelatin capsules. Capsule contents - transparent oil with a characteristic odor.

Pharmacotherapeutic group

Other anxiolytics. ATX code N05B X.

Pharmacological properties

Pharmacodynamics

Lazea, which contains lavender oil Silexan®, has antidepressant, anxiolytic and sedative effects after oral administration. In vitro studies have shown that Silexan® interacts with voltage-gated calcium channels (VOCCs), mainly of the P/Q type, but the mechanism of action or binding site on calcium channels is not clear. Lavender oil has been reported to affect GABA receptors by potentiating GABA responses. Linalool, the main component of lavender oil, interacts with glutamate receptors, inhibits glutamate uptake and release, and modulates GABA receptors.

Pharmacokinetics

When 80 mg Silexan® was administered orally in a phase 1 study 30 minutes after administration, the concentration of the main component of the essential oil, linalool, was recorded at 22 ng/mL. The plasma concentration of linalool decreased within 5 hours after administration with a mean area under the curve (AUC) of 33 ng h/mL.

Indication

Treatment of mild to moderate anxiety disorders with symptoms such as nervous tension, irritability and restlessness.

Contraindication

Hypersensitivity to lavender oil or any of the components of the drug. Children under 12 years of age.

Interaction with other medicinal products and other types of interactions

Unknown.

Application features

Patients with rare hereditary problems of fructose intolerance should not take Lazea.

Use during pregnancy and breastfeeding

There are no clinical data on the use of lavender oil during pregnancy. Lazeya is not recommended for use during pregnancy. The safety of use during breastfeeding has not been studied. It is not known whether the components of lavender oil or their metabolites penetrate into breast milk. Lazeya is not recommended for use during lactation.

Ability to influence reaction speed when driving vehicles or other mechanisms

Not known.

Method of administration and doses

Adults and children over 12 years of age: 1 capsule per day (corresponding to 80 mg of lavender oil).

Capsules should be taken without chewing, with sufficient liquid (preferably a glass of drinking water). Lazeya is not recommended to be taken in a lying position.

Children

Prescribed for children aged 12 and over.

Overdose

There have been no reports of overdose.

Adverse reactions

From the gastrointestinal tract:

common: gastrointestinal disorders (mainly belching).

Skin and subcutaneous tissue disorders/immune system disorders:

common: allergic skin reactions.

Expiration date

5 years.

Do not use the drug after the expiration date indicated on the package.

Storage conditions

Store at a temperature not exceeding 30 °C out of the reach of children.

Packaging

14 capsules in a blister. 1, 2 or 4 blisters in a pack.

Vacation category

Without a prescription.

Producer

Dr. Wilmar Schwabe GmbH & Co. KG.

Location of the manufacturer and address of its place of business

Wilmar-Schwabe-Strasse, 4,

76227 Karlsruhe, Germany.