Valdispert^® (Tablets) Instructions for Use

Marketing Authorization Holder

Vemedia Manufacturing B.V. (Netherlands)

Manufactured By

Vemedia Manufacturing B.V. (Netherlands)

ATC Code

N05CM09 (Valerian roots)

Active Substance

Valerian (BP British Pharmacopoeia)

Dosage Form

Valdispert®

Coated tablets, 125 mg: 25, 50, or 100 pcs.

Dosage Form, Packaging, and Composition

Coated tablets white in color, round, biconvex in shape; the cross-section view shows a light brown surface with uniformly distributed white inclusions.

Excipients: dextrin – 12.99 mg, microcrystalline cellulose – 41.85 mg, lactose monohydrate – 21.66 mg, macrogol 4000 – 16 mg, colloidal silicon dioxide – 1 mg, magnesium stearate – 1.5 mg.

Shell composition: shellac – 1.52 mg, hypromellose – 1.1 mg, talc – 18.65 mg, magnesium oxide – 4.4 mg, acacia gum – 0.7 mg, sucrose – 122.11 mg, povidone K25 – 3.11 mg, macrogol 6000 – 1.53 mg, titanium dioxide – 5.29 mg, sodium carboxymethylcellulose – 0.39 mg, beeswax – 0.004 mg, carnauba wax – 0.178 mg.

25 pcs. – blisters (1) – cardboard packs.
25 pcs. – blisters (2) – cardboard packs.
25 pcs. – blisters (4) – cardboard packs.

Clinical-Pharmacological Group

Sedative herbal preparation

Pharmacotherapeutic Group

Herbal sedative

Pharmacological Action

It has a sedative and spasmolytic effect. It facilitates the onset of natural sleep.

Indications

• Increased nervous excitability;
• Sleep disorders (difficulty falling asleep);
• Irritability.

ICD codes

Dosage Regimen

Orally, without chewing, with water.

Adults and children over 12 years

• To reduce nervous tension, 1-3 tablets 1-3 times a day;
• For difficulty falling asleep, a single dose of the drug is 1-3 tablets 30 minutes before bedtime; if necessary, an earlier intake of a single dose of the drug (1-3 tablets) during the evening is possible.

For elderly people dose adjustment is not required.

The course of treatment is 1.5-2 months.

Adverse Reactions

When following the recommendations for the use of the drug – Valdispert^®, no undesirable side effects associated with its use have been observed.

Allergic reactions are possible when taking the drug; with prolonged use – constipation.

Contraindications

• Sucrase/isomaltase deficiency, lactase deficiency, fructose intolerance, lactose intolerance, glucose-galactose malabsorption;
• Hypersensitivity to the components of the drug;
• Children under 12 years of age.

With caution: liver diseases, diabetes mellitus.

Use in Pregnancy and Lactation

Due to the lack of data on the effect of the drug during pregnancy and breastfeeding, its use is not recommended.

Use in Hepatic Impairment

Use with caution in liver diseases.

Pediatric Use

Contraindicated in children under 12 years of age.

Geriatric Use

For elderly people, dose adjustment is not required.

Special Precautions

The drug should not be taken daily for more than 1.5-2 months.

Information for patients with diabetes mellitus: one tablet contains 122.11 mg of sucrose and 21.85 mg of lactose, which is 0.012 bread units (BU).

Effect on the ability to drive vehicles and machinery

During treatment, caution must be exercised when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Overdose

When taking a dose exceeding the recommended daily dose, the following symptoms may occur: drowsiness, decreased performance, abdominal pain, chest tightness, dizziness, tremor, mydriasis. Treatment: gastric lavage, symptomatic.

Drug Interactions

It enhances the effect of hypnotics, sedatives, tranquilizers, ethanol and other drugs that depress the central nervous system, as well as spasmolytics, which requires dose adjustment when used concomitantly.

Storage Conditions

At a temperature not exceeding 30°C (86°F). Keep out of reach of children!

Shelf Life

The shelf life is 3 years.

Dispensing Status

Over-the-counter.

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.