Persen^® Night (Capsules) Instructions for Use

Marketing Authorization Holder

Zentiva, k.s. (Czech Republic)

Manufactured By

Adipharm, EAD (Bulgaria)

ATC Code

N05CM (Other hypnotic and sedative drugs)

Active Substances

Valerian (BP British Pharmacopoeia)

Melissa (DAB German Pharmacopoeia)

Peppermint (USAN United States Adopted Name)

Dosage Form

Persen® Night

Capsules 125 mg+25 mg+25 mg: 20 pcs.

Dosage Form, Packaging, and Composition

Capsules size No. 2, (body and cap) reddish-brown in color; the capsule contents are granules or a compressed mass from greenish-brown to brown in color with inclusions.

Excipients: magnesium oxide – 6 mg, lactose monohydrate – 85.5 mg, magnesium hydrosilicate – 8.1 mg, magnesium stearate – 2.2 mg, colloidal anhydrous silicon dioxide – 3.2 mg.

Capsule shell composition: titanium dioxide (E171) – 1.369%, iron oxide red (E172) – 0.7527%, quinoline yellow (E104) – 0.0153%, sunset yellow (E110) – 0.0368%, azorubine (E122) – 0.0438%, methylparaben (E128) – 0.2945%, propylparaben (E216) – 0.1241%, gelatin – 97.3638%.

10 pcs. – blisters (2) – cardboard packs.

Clinical-Pharmacological Group

Sedative herbal preparation

Pharmacotherapeutic Group

Psycholeptics; hypnotics and sedatives; hypnotics and sedatives, combinations excluding barbiturates

Pharmacological Action

The drug has a sedative and antispasmodic effect.

Extract of valerian rhizomes with roots has a sedative effect.

Lemon balm leaf extract has a sedative and antispasmodic effect.

Peppermint leaf extract has an antispasmodic, moderate sedative effect.

Indications

• Insomnia (difficulty falling asleep) associated with increased nervous excitability.

ICD codes

Dosage Regimen

Take orally with a small amount of water, regardless of meals.

For adults and children over 12 years of age with insomnia, 1-2 capsules are prescribed 1 hour before bedtime.

The course of treatment is 2-4 weeks. The drug should not be used continuously for more than 1.5-2 months. To increase the duration of the treatment course, the patient should consult a doctor.

Withdrawal syndrome does not develop upon discontinuation of treatment.

Adverse Reactions

Allergic reactions (hyperemia, skin rash, peripheral edema, allergic dermatitis), bronchospasm are possible; with prolonged use – constipation.

Contraindications

• Hypersensitivity to the components of the drug;
• Lactase deficiency, lactose intolerance, glucose-galactose malabsorption;
• Arterial hypotension;
• Cholangitis, cholelithiasis and other diseases of the biliary tract;
• Pregnancy;
• Breastfeeding period;
• Children under 12 years of age.

With caution, the drug should be prescribed to patients with gastroesophageal reflux disease (GERD).

Use in Pregnancy and Lactation

The use of the drug during pregnancy and lactation is contraindicated.

Pediatric Use

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

Special Precautions

In patients with GERD, a worsening of symptoms is possible.

If symptoms persist or worsen during the use of the drug, the patient should consult a doctor.

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

Effect on the ability to drive vehicles and machinery

During treatment with the drug, caution should be exercised when engaging in potentially hazardous activities that require increased concentration and speed of psychomotor reactions (driving vehicles, working with moving mechanisms, work of a dispatcher, operator).

Overdose

Symptoms: a single dose of 20 g of valerian rhizomes with roots (approximately 39 capsules of Persen^® Night) may cause a feeling of fatigue, stomach cramps, a feeling of tightness in the chest, dizziness, hand tremors, dilated pupils, which may resolve on their own within 24 hours.

Treatment: gastric lavage is recommended.

In case of overdose symptoms, the patient should consult a doctor.

Drug Interactions

With simultaneous use of the drug with other drugs that depress the central nervous system (including hypnotics, centrally acting antihypertensive drugs, analgesics), an enhancement of the effect on the central nervous system is possible (dose adjustment may be required).

Storage Conditions

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

Shelf Life

Shelf life – 3 years.

Dispensing Status

The drug is available without a prescription.

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.