ACTION AND MECHANISM

Association with sleep-inducing properties (Melissa officinalis) and sedative properties (Valeriana officinalis).

COMPOSITION

- Dry extract, obtained with 70% v/v ethanol, of Valeriana officinalis (Valerian) root, 160 mg equivalent to approx. 720 mg of dry Valerian root. - Dry extract, obtained with 36% v/v ethanol, of Melissa officinalis (Lemon Balm) leaves, 80 mg equivalent to approx. 400 mg of dry Lemon Balm leaves.

CONTRAINDICATIONS

Do not administer to patients with a prior history of hypersensitivity to Valeriana officinalis (Valerian) root, Melissa officinalis (Melissa) leaves, or any other component of the product.

PREGNANCY

Adequate and well-controlled studies have not been conducted in pregnant women.

INDICATIONS

- [INSOMNIA], [NERVOUSNESS]: Symptomatic treatment of temporary and mild states of nervousness and occasional difficulty falling asleep of nervous origin.

INTERACTIONS

- CNS depressants (alcohol, etc.): Due to its activity, this medication may enhance the effects of other CNS depressants. Therefore, if the patient is being treated with any of these, the doctor should assess the need to administer this medication. Alcohol may potentiate its sedative effect, so it should not be taken with alcoholic beverages.

LACTATION

It is unknown whether it is excreted in breast milk.

CHILDREN

Because there is no clinical experience available, use in children under 12 years of age is not recommended.

GUIDELINES FOR PROPER ADMINISTRATION

The tablets should be swallowed whole, without chewing, and with plenty of water, preferably after meals.

POSOLOGY

Adults and children over 12 years, oral:* Nervousness: 1 tablet 3 times a day * Sleep aid: 2 tablets 30-60 minutes before bedtime. If necessary, 1 more tablet in the afternoon. Elderly: same as adults.

PRECAUTIONS

If symptoms worsen or persist for more than 2 weeks, the clinical situation should be evaluated. It should be administered with caution in patients with a history of liver disease. - Driving: the sedative effect may impair attention, especially during the first two hours after ingestion, so please do not drive until you know how the medication affects you.

PRECAUTIONS RELATING TO EXCIPIENTS

This medicine contains glucose. Patients with glucose or galactose malabsorption should not take this medicine.

ADVERSE REACTIONS

At the recommended doses and treatment period, no known adverse effects have been reported. However, chronic use of preparations containing Valeriana officinalis (Valerian) may cause headache, excitability, insomnia, and digestive disorders. Drowsiness may occur, which is considered an adverse effect when used for nervousness. Some cases of liver damage have been reported following the use of products containing Valeriana officinalis (Valerian), although the causal relationship with the ingestion of Valeriana officinalis (Valerian) is extremely doubtful.

OVERDOSE

- Symptoms: A dose of approximately 20g of Valeriana officinalis (Valerian) root caused mild symptoms (fatigue, abdominal cramps, chest tightness, dizziness, hand tremors, and mydriasis) that disappeared within 24 hours. At very high doses, bradycardia, arrhythmias, and decreased intestinal motility may occur. - Treatment: supportive symptomatic treatment, gastric lavage, administration of activated charcoal, and sodium sulfate.

COMPOSITION

LEMON BALM: 80 MILLIGRAMS - DRY EXTRACT
VALERIAN: 160 MILLIGRAMS - DRY EXTRACT
SUCROSE (EXCIPIENT): 133 MILLIGRAMS
GLUCOSE (EXCIPIENT): 0.4 MILLIGRAMS
CASTOR OIL (EXCIPIENT): 23 MILLIGRAMS - HYDROGENATED