Sanason LEK (Tablets) Instructions for Use

Marketing Authorization Holder

Lek d.d. (Slovenia)

ATC Code

N05CM (Other hypnotic and sedative drugs)

Active Substances

Hop strobile (Ph.Eur.)

Valerian (BP)

Dosage Form

Sanason LEK

Film-coated tablets, 60 mg+100 mg: 20 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets blue in color, round, biconvex.

Excipients: lactose monohydrate, povidone, sodium starch glycolate, carmellose sodium, corn starch, microcrystalline cellulose, talc, magnesium stearate, colloidal anhydrous silica, eudragit (E100), hydroxypropylcellulose, macrogol 400, sucrose, indigo carmine (E132), titanium dioxide, vanillin, carnauba wax.

10 pcs. – contour cell packs (2) – cardboard packs.

Clinical-Pharmacological Group

Sedative herbal preparation

Pharmacotherapeutic Group

Herbal sedative

Pharmacological Action

A combined herbal preparation. Due to the active components in its composition – extracts of valerian rhizomes with roots and hop strobiles – it has a sedative effect.

Indications

Mild insomnia characterized by difficulty falling asleep and frequent awakenings at night and early in the morning, caused by increased nervous excitement, anxiety, fear, or irritation.

ICD codes

Dosage Regimen

Administer orally.

For adults and children over 12 years: take 2-3 film-coated tablets as a single dose, approximately 1 hour before bedtime.

For children from 6 to 12 years: use only under direct medical supervision.

Determine the pediatric dose according to body weight; the recommended dose is 1-2 tablets taken one hour before sleep.

Do not administer to children under 6 years of age due to contraindication.

Swallow the tablets whole with a small amount of water.

Avoid concomitant use with other sedative and hypnotic drugs or alcoholic beverages.

Do not use the drug continuously for more than 1.5-2 months.

Discontinuation of treatment does not cause a withdrawal syndrome.

Adverse Reactions

Allergic reactions, increased fatigue, with prolonged use – constipation.

Contraindications

• Hypersensitivity to the drug components;
• Children under 6 years of age;
• Arterial hypotension.

Use in Pregnancy and Lactation

It is not recommended to use the drug during pregnancy (hop preparations shift the hormonal balance towards the predominance of estrogens). Prescribing the drug during breastfeeding is possible if the intended benefit to the mother outweighs the potential risk to the infant.

Pediatric Use

Use of the drug in children 6-12 years old under medical supervision.

Special Precautions

It is not recommended to take the drug simultaneously with other sedative and hypnotic drugs, as well as beverages containing alcohol.

Use of the drug in children 6-12 years old under medical supervision.

The drug should not be used continuously for more than 1.5-2 months.

Overdose

A single dose of 20 g of valerian rhizomes with roots (approximately 123 Sanason Lek tablets) may cause feelings of fatigue, stomach cramps, a feeling of tightness in the chest, dizziness, hand tremors, dilated pupils, which may disappear on their own within 24 hours.

In case of overdose of galenic preparations of hop strobiles, nausea, vomiting, abdominal pain, headache, a feeling of general fatigue and malaise are possible.

In case of overdose symptoms, it is advisable to perform gastric lavage and consult a doctor.

Drug Interactions

The drug enhances the effect of medicinal products that depress the CNS, hypotensive drugs (particularly those of central action), and analgesics, which requires dose adjustment.

Storage Conditions

Store the drug at a temperature not exceeding 25°C (77°F) in a dry place, out of the reach of children.

Shelf Life

Shelf life – 2 years. Do not use after the expiration date printed on the package.

Dispensing Status

The drug is approved for use as an over-the-counter product.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.