ACTION AND MECHANISM

[HYPNOTIC]. Valerian has been shown in animal and human studies to induce and improve sleep. Although not known for certain, the effects appear to be due to valerenic acid and valepotriates. The mechanism of action of these compounds is also not fully understood. It is speculated that they may decrease the degradation of gamma-aminobutyric acid (GABA), increase its release into the synaptic spaces, and decrease its reuptake. In addition, large amounts of glutamine have been detected in valerian, which could be taken up by neurons and transformed into gamma-aminobutyric acid. Furthermore, in vitro studies have shown that hydroxypinoresinol is capable of binding to the benzodiazepine receptor.

- [ANTISPASMODIC]. Valerian produces relaxation of smooth muscle. The effects could be due to inhibition of calcium channels in the cell or to binding of valepotriates to the muscle fiber itself.

SPECIAL WARNINGS

- Monitoring liver function is recommended in patients with liver failure.

PATIENT ADVICE

- It can cause drowsiness, so caution is advised when driving.
- It is recommended to take this medicine at least 2 hours before bedtime. - The effectiveness of valerian root is achieved gradually; therefore, it is not suitable for treating acute nervous tension or sleep disorders.

CONTRAINDICATIONS

- Hypersensitivity to any component of the medication.

EFFECTS ON DRIVING

Valerian can cause drowsiness, so patients should avoid operating dangerous machinery, including automobiles, until they are reasonably certain that the drug treatment does not adversely affect them.

PREGNANCY

No clinical trials have been conducted in humans, so the use of valerian is only accepted in the absence of safer therapeutic alternatives.

INDICATIONS

- [NERVOUSNESS], [INSOMNIA]: Relief from mild nervous tension and sleep disorders. Based exclusively on its traditional use.

INTERACTIONS

- Barbiturates, benzodiazepines, H1 antihistamines. Valerian may potentiate the sedative effect produced by barbiturates, benzodiazepines or H1 antihistamines.

LACTATION

It is unknown whether the components of valerian are excreted in significant quantities in breast milk, and if so, whether this could affect the infant. It is recommended to discontinue breastfeeding or avoid administering this medication.

CHILDREN

The safety and efficacy of valerian in children have not been evaluated. However, traditional use of valerian has not produced adverse reactions in children, so it can be used. Nevertheless, valepotriates may cause adverse reactions in children under 12 years of age, so valerian is not recommended for this age group.

GUIDELINES FOR PROPER ADMINISTRATION

The tablets should be taken whole with a glass of water.

POSOLOGY

- Adults and children over 12 years old:

PRECAUTIONS

- [HEPATIC INSUFFICIENCY]. Valerian may contain hepatotoxic compounds, therefore it should be used with caution in patients with liver damage. Monitoring of liver transaminase levels is advised, and if a significant increase occurs, treatment should be discontinued until the cause of the increase is determined.

PRECAUTIONS RELATING TO EXCIPIENTS

This medicine contains lactose. Patients with hereditary lactose or galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicine.

ADVERSE REACTIONS

Adverse reactions to valerian are rare and do not usually require discontinuation of treatment. - Digestive: Nausea or vomiting may occur rarely. - Cardiovascular: Cardiac arrhythmia may occur very rarely. - Neurological/psychological: With continued use, headache, nervousness, or insomnia may occasionally occur. - Ocular: Mydriasis may occasionally occur after continued use. - Musculoskeletal: Myasthenia may occur rarely. In addition to these adverse reactions, other possible adverse reactions have been recorded in the FEDRA database (Spanish Pharmacovigilance, Adverse Reaction Data) of the Spanish Pharmacovigilance System, although a cause-and-effect relationship with valerian has not been demonstrated: - Hepatic: Kidney damage and increased transaminase levels. - General: Asthenia and excessive sweating.

OVERDOSE

Symptoms: After ingestion of doses exceeding 20 g of root, a mild condition occurred with symptoms such as abdominal spasms, chest tightness, fatigue, hand tremors, and mydriasis, which resolved within 24 hours. At very high doses, intestinal atony and cardiac arrhythmias such as bradycardia may occur. Treatment: Treatment will be symptomatic, with standard measures such as gastric lavage and administration of activated charcoal and sodium sulfate. In case of overdose or accidental ingestion, seek medical attention or consult the Poison Control Center, indicating the product and the amount ingested.

COMPOSITION

VALERIAN: 45 MILLIGRAMS - DRY EXTRACT
LACTOSE (EXCIPIENT): 7.8 MILLIGRAMS
SUCROSE (EXCIPIENT): 47.43 MILLIGRAMS