SENIORS

No specific problems have been reported in the elderly that would require dosage adjustment. However, sedatives should be used with caution in the elderly, as they may increase the risk of falls.

PATIENT ADVICE

- Consult your doctor and/or pharmacist if symptoms continue or worsen after 2 weeks of treatment.

- Passionflower may affect driving ability.

CONTRAINDICATIONS

- Hypersensitivity to passionflower or any other component of the medication.

EFFECTS ON DRIVING

Passionflower may cause drowsiness, which could substantially impair the ability to drive and/or operate machinery. Patients should avoid operating hazardous machinery, including automobiles, until they are reasonably certain that drug treatment does not adversely affect them.

PREGNANCY

Animal safety : no data available.

Human safety : There are no adequate and well-controlled studies in humans. Not recommended.

Effects on fertility : No specific studies have been conducted in humans.

INDICATIONS

- Symptomatic and transient treatment of [NERVOUSNESS], [STRESS] and [IRRITABILITY], and as an aid to improve sleep in [INSOMNIA].

INTERACTIONS

- Sedatives. There is a theoretical risk of exacerbating nervous depression when combined with alcohol or other sedatives, such as antihistamines, narcotic analgesics, benzodiazepines, or antidepressants, among others.

LACTATION

Animal safety : no data available.

Human safety : It is unknown whether it is excreted in milk, and what consequences this could have for the infant. Its use is not recommended.

CHILDREN

Passionflower is indicated for adolescents 12 years and older, at the same doses as adults.

Safety and efficacy have not been evaluated in children under 12 years of age, so it is recommended to avoid its use.

RULES FOR CORRECT ADMINISTRATION

- Tablets: Swallow whole with sufficient liquid.

POSOLOGY

“Sedistress”

- Adults:

* Stress: 1-2 tablets twice a day, morning and evening. If necessary, the dose may be increased to a maximum of 8 tablets per day.

* Sleep aid: 1-2 tablets at night, 30 minutes before bedtime.

- Children and adolescents < 18 years:

* Teenagers from 12 years old: same as adults.

* Children < 12 years: not recommended.

- Elderly: no specific dosage recommendations have been made.

Duration of treatment : should not exceed 6 months continuously.

Missed dose : Administer the missed dose as soon as possible, unless it is almost time for the next dose. Administer the next dose at the regular time. Do not double the next dose.

DOSAGE IN LIVER FAILURE

No specific dosage recommendations have been made.

DOSAGE IN KIDNEY FAILURE

No specific dosage recommendations have been made.

ADVERSE REACTIONS

Adverse reactions are described according to each frequency interval, considering very frequent (>10%), frequent (1-10%), unfrequent (0.1-1%), rare (0.01-0.1%), very rare (<0.01%) or of unknown frequency (cannot be estimated from the available data).

- Immune system disorders: very rare [HYPERSENSITIVITY REACTIONS], with [ALLERGIC PURPURA], [URTICARIA], [NAUSEA], [TACHYCARDIA], [EXANTHEMATOUS ERUPTIONS].

OVERDOSE

Symptoms : No clinical experience is available.

Measures to be taken : symptomatic treatment