RELAXIL

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

Composition:

Active substances: 1 capsule contains 125 mg of dry aqueous-alcoholic extract of valerian (0.8%), 25 mg of dry extract of peppermint, 25 mg of dry extract of lemon balm;

Excipients: microcrystalline cellulose, potato starch, heavy magnesium oxide, colloidal anhydrous silicon dioxide, magnesium stearate;

Capsule shell: gelatin, azorubine (E 122), diamond black BN (E 151), patent blue V (E 131), quinoline yellow (E 104), titanium dioxide (E 171).

Pharmaceutical form. Hard capsules.

Main physicochemical properties: hard gelatin capsules with green body and cap. The capsule contents are a powder or compacted mass ranging from brownish to grayish-brown in color, with specks.

Pharmacotherapeutic group. Sedatives and hypnotics. ATC code N05CM.

Pharmacological properties.

Pharmacodynamics.

Relaxil is a herbal medicinal product with mild sedative properties.

The combination exerts a calming effect and is indicated for the relief of transient nervous tension (as a daily sedative agent in cases of mental stress, excitability, and irritability).

Valerian exerts a sedative effect. It positively influences well-being in symptoms of irritability such as restlessness, excitability, and tension due to nervous overstrain. In insomnia, it promotes faster onset of sleep.

Melissa also exerts sedative and spasmolytic effects.

Peppermint is traditionally used in combination with valerian in sedative medicinal products.

The medicinal product is used in neuroses when the use of potent sedatives is inappropriate. The indications for its use are based solely on long-standing experience of use.

Pharmacokinetics.

Data not available.

Clinical characteristics.

Indications.

Neuroses accompanied by the following symptoms:

• nervous excitement;
• restlessness;
• stress-induced tension;
• sleep disorders.

Contraindications.

Hypersensitivity to valerian, lemon balm, peppermint, or to any other component of the medicinal product. Severe arterial hypotension, bronchial asthma. Depression or other conditions associated with central nervous system depression.

Interaction with other medicinal products and other forms of interaction.

Data regarding interactions with other medicinal products are limited. Prior to using this medicinal product concomitantly with other medicinal products, consult a physician.

Clinically significant interactions with active substances metabolized via CYP 2D6, CYP 3A4/5, CYP 1A2, or CYP 2E1 have not been observed.

Concomitant use with synthetic sedative medicinal products (benzodiazepines) is not recommended without medical consultation.

Concomitant use may enhance the effects of other sedatives and hypnotics, spasmolytics, analgesics, anxiolytics, and alcohol.

Special precautions for use

The medicinal product should be used with caution in patients with severe hepatic impairment or a history of severe liver disease.

Patients with gastroesophageal reflux (heartburn) should avoid using medicinal products containing peppermint leaves, as this may worsen their condition.

Medicinal products containing peppermint leaves should be prescribed with particular caution to patients with cholelithiasis or other diseases of the bile ducts and gallbladder.

Alcoholic beverages should be avoided during treatment with this medicinal product.

Due to the presence of colorants azorubine (E 122) and patent blue V (E 151) in the formulation, allergic reactions are possible.

Use during pregnancy or breastfeeding

The efficacy and safety of the medicinal product during pregnancy or breastfeeding have not been established; therefore, Relaxil is not recommended for use during these periods.

Ability to affect reaction speed when driving or operating machinery

The medicinal product may affect the ability to drive or operate machinery. Therefore, during treatment, patients are advised to refrain from driving or operating machinery until individual sensitivity is determined.

Method of Administration and Dosage.

Adults and children aged 12 years and older:
For mental strain, excited state, or irritability, it is recommended to take 2 capsules twice daily; for sleep disorders – 2 capsules 1 hour before bedtime.

Capsules should be swallowed whole with water. Can be taken regardless of food intake.

The medicinal product has a gradual onset of action. To achieve optimal therapeutic effect, it should be used for at least 14 days.

Duration of treatment is not limited. No dependence has been observed even with prolonged use. No withdrawal syndrome occurs after discontinuation.

If no improvement is observed within 14 days after starting treatment, consult a physician.

Children.

There is no data available on the use of the medicinal product in children under 12 years of age; therefore, its use is not recommended in this patient group.

Overdose.

Symptoms. A single dose of approximately 20 g of valerian root, equivalent to approximately 42 capsules of Relaxil, may cause mild symptoms such as increased fatigue, abdominal cramps, chest tightness, dizziness, hand tremor, and pupil dilation. These symptoms resolve within 24 hours. In overdose of valerian-containing medicinal products, additional symptoms may include headache, drowsiness, lethargy, general weakness, abdominal pain, nausea, decreased hearing and visual acuity, bradycardia/tachycardia, reduced attention span, and enhanced sedative effect.

There are no reports of overdose cases associated with the use of lemon balm leaf or peppermint.

Treatment: symptomatic therapy (gastric lavage, administration of activated charcoal).

Side effects.

Gastrointestinal disorders: nausea, abdominal cramps; exacerbation of heartburn.

Immune system disorders: allergic reactions.

Very rarely somnolence, asthenic symptoms (weakness, depressed mood and reduced work capacity, suppression of emotional responses), dizziness, depression have been observed. If other adverse effects occur (e.g., hypersensitivity reactions including rash, itching, urticaria, redness and swelling of the skin), consult a physician.

Shelf life. 2 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25°C.

Keep out of reach of children.

Packaging.

10 capsules in a blister pack, 2 blisters per carton.

Supply category. Over-the-counter.

Manufacturer: JSC "KYIV VITAMIN PLANT".

Manufacturer's address and place of business:

38 Kopilivska Street, Kyiv, 04073, Ukraine.

Web-site: www.vitamin.com.ua