Vamelan

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

Composition:

Active substances:

1 soft capsule contains:

Valerian root dry hydroalcoholic extract (Valeriana officinalis L., radix, extractum hydroalcoholic siccum) (3–5:1) (extraction solvent — 60% ethanol [v/v]) — 125.0 mg;

Lemon balm leaf dry extract (Melissa officinalis L., folium, extractum siccum) (4–6:1) (extraction solvent — 50% ethanol [v/v]) — 25.0 mg;

Peppermint leaf dry extract (Mentha piperita L., folium, extractum siccum) (3–6:1) (extraction solvent — 40% ethanol [v/v]) — 25.0 mg;

Excipients: soy lecithin, hydrogenated coconut oil, refined palm oil, yellow beeswax, purified soybean oil, maltodextrin, anhydrous colloidal silicon dioxide, powdered peppermint essence;

capsule shell: gelatin, glycerin, titanium dioxide (E 171), black iron oxide (E 172), chlorophyllin copper complex (E 141), quinoline yellow (E 104).

Pharmaceutical form. Soft capsules.

Main physicochemical properties: oval-shaped soft gelatin capsules of dark green color, containing a dark brown viscous oily liquid with a characteristic valerian odor.

Pharmacotherapeutic group.

Hypnotics and sedatives. ATC code N05CM.

Pharmacological properties.

Pharmacodynamics.

Vamelan is a herbal medicinal product with mild sedative properties.

The combination exerts a mild sedative effect and is indicated for the relief of mild 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 cases of insomnia, it promotes faster onset of sleep.

Melissa also exerts sedative and spasmolytic effects.

Peppermint is traditionally used in combination with valerian in sedative preparations.

Pharmacokinetics.

Data are lacking.

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 are limited. Before using the medicinal product Vamelan concomitantly with other drugs, consult your 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 of the medicinal product with synthetic sedatives (benzodiazepines) is not recommended without medical consultation.

When used concomitantly, an enhanced effect of other sedatives and hypnotics, spasmolytics, analgesics, anxiolytics, and alcohol is possible.

Special precautions for use.

Vamelan should be used with caution in patients who have severe liver function impairment or a history of severe liver disease.

The medicinal product should be avoided (due to the presence of peppermint leaves in the formulation) in patients with gastroesophageal reflux (heartburn), as it may worsen their condition.

Vamelan should be used with particular caution (due to the presence of peppermint leaves in the formulation) in patients with gallstones or other diseases of the bile ducts and gallbladder.

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

Vamelan contains soybean oil and therefore should not be administered to patients with allergy to peanuts or soy.

Vamelan is a traditional herbal medicinal product intended for use according to indications supported by long-term use.

If symptoms of the disease do not resolve during treatment with the medicinal product, or if adverse reactions occur that are not listed in the instructions for medical use, a physician should be consulted.

Use during pregnancy or breastfeeding.

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

Ability to influence reaction speed when driving or operating machinery.

The medicinal product may affect the ability to drive or operate machinery. Therefore, during its use, it is recommended to refrain from driving or operating machinery until individual sensitivity is determined.

Method of Administration and Dosage

The medicinal product is intended for oral administration. The capsules should be swallowed whole with water, regardless of food intake.

Adults and children aged 12 years and older.

For mental strain, excited state, or irritability, the recommended dose is 2 capsules twice daily.

For insomnia, the recommended dose is 2 capsules taken 1 hour before bedtime.

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

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

If no improvement is observed within 14 days from the start of treatment, a physician should be consulted.

Children.

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

Overdose.

Symptoms.

A single dose of approximately 20 g of valerian root may cause mild symptoms such as fatigue, abdominal cramps, chest tightness, dizziness, hand tremor, and pupil dilation. These symptoms resolve within 24 hours. Overdose of preparations containing valerian may also lead to 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 with lemon balm leaf or peppermint.

Treatment.

In case of overdose, symptomatic therapy is indicated (gastric lavage, use of adsorbents).

Adverse Reactions.

The following gastrointestinal adverse reactions have been reported: nausea, abdominal cramps, exacerbation of heartburn.

Very rarely observed were somnolence, asthenic manifestations (weakness, lowered mood and work capacity, suppression of emotional responses), dizziness, depression.

If other adverse reactions occur (e.g., hypersensitivity reactions, including rash, pruritus, urticaria, skin redness and swelling), consult a physician.

Reporting of suspected adverse reactions.

Reporting suspected adverse reactions after medicinal product authorization is highly important. It enables ongoing monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals and patients, as well as their legal representatives, are encouraged to report all suspected adverse reactions and lack of efficacy via the Automated Information System for Pharmacovigilance at the following link: https://aisf.dec.gov.ua.

Shelf life.

3 years.

Storage conditions.

Store at a temperature not exceeding 25 °C in the original packaging and in a place inaccessible to children.

Packaging.

15 capsules in a blister; 2 blisters per cardboard box.

Supply classification.

Over-the-counter (without prescription).

Manufacturer.

P.P.F. HASCO-LEK S.A. /
P.P.F. HASCO-LEK S.A.

WORLD MEDICINE ILAC SAN. VE TIC. A.S. /
WORLD MEDICINE ILAC SAN. VE TIC. A.S.

Manufacturer's address and location of operations.

242 E, Zmigrodzka Str, 51-131 Wroclaw, Poland /
242 E, Zmigrodzka Str, 51-131 Wroclaw, Poland.

15 Temmuz Mahallesi Cami Yolu Caddesi No:50 Gunesli Bagcilar/Istanbul, Turkey /
15 Temmuz Mahallesi Cami Yolu Caddesi No:50 Gunesli Bagcilar/Istanbul, Turkey.

Marketing Authorization Holder.

WORLD MEDICINE, LLC, Ukraine / WORLD MEDICINE, LLC, Ukraine.