Extrasedyl

Extrasedyl is available in the form of tablets, packaged in boxes of 40 units.

Each tablet contains:

• Dry extract of valerian – 60 mg
• Dry extract of Passiflora incarnata – 30 mg
• Dry extract of hawthorn – 30 mg

Extrasedyl tablets are recommended as an adjunct in the management of the following functional disorders or psychological conditions:

• Mild anxiety and states of psychomotor agitation
• Sleep disorders caused by stress or emotional imbalances
• States of nervous tension, irritability, restlessness
• Nervous hyperexcitability associated with mental exhaustion
• Neurovegetative manifestations associated with menopause
• Periods of mental overload and professional or family stress

The product helps to calm the mind, induce a state of relaxation and improve sleep quality without causing dependence or residual drowsiness in the morning.

The recommended dose is 1 tablet taken orally, 3 times a day, accompanied by a glass of water. Alternatively, it can be taken only in the evening, before bedtime, if the product is used exclusively to induce sleep.

The duration of treatment may vary depending on the severity of symptoms, but generally 2–4 weeks of treatment followed by a break is recommended.

Extrasedyl is contraindicated in the following situations:

• Children under 14 years of age, due to the lack of safety studies in this age group
• Pregnant or breastfeeding women, due to the possible impact of sedative plants on the foetus or infant
• People with known hypersensitivity to any of the active ingredients or excipients

It is recommended to avoid using it in parallel with other sedatives or alcoholic beverages, as potentiation of the depressant effect on the central nervous system may lead to excessive drowsiness or coordination disorders.

Extrasedyl should be used with caution by drivers or those operating dangerous machinery, as the product may temporarily reduce concentration and reaction times.

Medical supervision is necessary in people with cardiovascular disease, as hawthorn extract may enhance the action of digitalis or antihypertensive drugs, leading to excessive hypotension or bradycardia.

Extrasedyl is generally well tolerated. However, mild side effects may occur, especially in sensitive individuals or with prolonged use:

• Daytime drowsiness
• Mild gastrointestinal disorders (nausea, bloating)
• Skin allergic reactions (rare)
• Feeling tired or dizzy in case of overdose

If unusual or persistent symptoms occur, it is recommended to discontinue treatment and consult a doctor.

Extrasedyl may interact pharmacodynamically with:

• Other sedatives (including benzodiazepines, antipsychotics) – increased risk of drowsiness and excessive sedation
• Alcohol, which potentiates the sedative effects of valerian and passionflower
• Cardiotonic or antihypertensive drugs – hawthorn may amplify their effects.

Overdose with Extrasedyl is rare, but may cause intense drowsiness, dizziness, hypotension or transient confusion. In case of accidental ingestion of a large dose, emergency medical attention should be sought and symptomatic measures should be taken: hydration, rest, possibly gastric lavage if ingestion is recent.

Extrasedyl should be stored in its original packaging at temperatures below 25°C, away from moisture, direct light and heat. Keep out of the reach and sight of children. The expiry date is printed on the packaging and must be strictly observed.

• WebMD, Hawthorn
• NIH, Hawthorn
• Healthline, The calming effects of passion flower
• PubMed, Valerian root in the treatment of sleep problems and associated disorders - a systematic review and meta-analysis