Songa^® Night (Tablets) Instructions for Use

Marketing Authorization Holder

Ginsana, SA (Switzerland)

ATC Code

V30 (Not assigned)

Active Substances

Valerian (BP British Pharmacopoeia)

Melissa (DAB German Pharmacopoeia)

Dosage Form

Songa® Night

Coated tablets, 120 mg+80 mg: 30 or 60 pcs.

Dosage Form, Packaging, and Composition

Coated tablets sugar-coated, greyish-blue in color, round, biconvex in shape, shiny; the cross-section view shows a heterogeneous mass of mustard-brown color.

* Corresponding to 150 mg of the dry extract preparation, consisting of ethanol and 120 mg of native extract obtained by extraction using 70% (v/v) ethanol as the extraction solvent at a raw material to final product ratio (4.5:1), glucose syrup 25.5 mg, colloidal anhydrous silicon dioxide 4.5 mg. Source plant – Valeriana officinalis L., fam. Valerianaceae.
** Corresponding to 88.889 mg of the dry extract preparation (5:1), and consisting of 80 mg of native extract obtained by extraction using 30% (v/v) methanol as the extraction solvent at a raw material to final product ratio (5:1), glucose syrup 6.222 mg, colloidal anhydrous silicon dioxide 2.667 mg. Source plant – Melissa officinalis L., fam. Lamiaceae.

Excipients : microcrystalline cellulose – 89.111 mg, colloidal silicon dioxide – 9.667 mg, liquid dextrose [dextrose, oligo- and polysaccharides] – 31.722 mg, sodium carboxymethyl starch (type A) – 6 mg, magnesium stearate – 3.5 mg.

Coating composition sucrose – 111.41 mg, talc – 54.4 mg, acacia gum – 7.271 mg, titanium dioxide – 1.776 mg, macrogol 6000 – 0.03 mg, carnauba wax – 0.07 mg, indigo carmine (E132) – 0.043 mg.

15 pcs. – blisters (2) – cardboard packages.
15 pcs. – blisters (4) – cardboard packages.

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Clinical-Pharmacological Group

Sedative herbal preparation

Pharmacotherapeutic Group

Herbal sedative

Pharmacological Action

A combined herbal preparation; it has a moderately pronounced sedative and spasmolytic effect.

Indications

• Increased nervous excitability;
• Irritability;
• Sleep onset disorder.

ICD codes

Dosage Regimen

Orally; the tablets should be swallowed whole, without chewing, with a small amount of water.

Adults and children over 12 years

• For increased nervous excitability and irritability take 2-3 tablets up to 3 times/day;
• To facilitate sleep onset take a single dose of 2-3 tablets 30-60 minutes before bedtime, with the possibility of an additional single dose in the evening beforehand. The maximum daily dose is 9 tablets. The duration of therapy is 4 weeks; if necessary, a repeat course is possible on the recommendation of a doctor.

Adverse Reactions

Possible allergic reactions (skin rash); in this case, the drug should be discontinued and a doctor should be consulted. When used in high doses, drowsiness and decreased performance are possible; with prolonged use – constipation.

Contraindications

• Sucrase/isomaltase deficiency;
• Fructose intolerance;
• Glucose-galactose malabsorption;
• Children under 12 years of age;
• Hypersensitivity to the components of the drug.

Use in Pregnancy and Lactation

It is not recommended to take the drug during pregnancy and lactation (due to the lack of clinical data).

Pediatric Use

The drug is contraindicated in children under 12 years of age.

Special Precautions

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

The drug should be used with caution in patients suffering from diabetes mellitus. 1 tablet contains 111.41 mg of sucrose (0.009 XE). The maximum recommended daily dose (9 tablets) contains 1002.69 mg of sucrose (0.084 XE).

Effect on the ability to drive vehicles and operate machinery

During treatment, patients should avoid driving vehicles and engaging in other activities that require high concentration and speed of psychomotor reactions.

Overdose

No cases of overdose have been reported to date.

Drug Interactions

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

Storage Conditions

Store the drug in a dry place, at a temperature from 15°C (59°F) to 25°C (77°F). Keep out of reach of children.

Shelf Life

Shelf life 4 years.

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.