PATIENT ADVICE

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

This medication may negatively affect your ability to drive. Avoid driving until you know the medication does not significantly affect you.

CONTRAINDICATIONS

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

ADVANCED AGE

No specific problems have been described in the elderly that would require a dosage adjustment. However, the use of sedatives should be undertaken with caution in older adults, as they may increase the risk of falls.

EFFECTS ON DRIVING

- It may substantially impair the ability to drive. Patients should avoid driving until they are reasonably certain that the drug treatment does not adversely affect them.

PREGNANCY

Animal safety : no data available.

Safety in humans : There are no adequate and well-controlled studies in humans. Its use is 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 potentiating nervous depression when combined with alcohol or other sedative substances, such as antihistamines, narcotic analgesics, benzodiazepines or antidepressants, among others.

LACTATION

Animal safety : no data available.

Safety in humans : It is unknown whether it is excreted in breast milk, and the consequences it could have for the infant. Its use is not recommended.

CHILDREN

Passionflower is indicated for adolescents from 12 years of age, at the same doses as adults.

Safety and efficacy have not been evaluated in children < 12 years, therefore its use is not recommended.

GUIDELINES FOR PROPER ADMINISTRATION

- Tablets: swallow whole with enough liquid.

POSOLOGY

“SEDISTRESS”

- Adults:

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

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

- Children and adolescents < 18 years:

* Adolescents aged 12 and over: 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 : Take the missed dose as soon as possible, unless it is almost time for the next dose. Take the next dose at the usual time. Do not double the next dose.

DOSAGE IN HEPATIC INSUFFICIENCY

No specific dosage recommendations have been made.

DOSAGE IN RENAL INSUFFICIENCY

No specific dosage recommendations have been made.

ADVERSE REACTIONS

Adverse reactions are described according to each frequency interval, being considered very common (>10%), common (1-10%), uncommon (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], [SKIN RASHES].

OVERDOSE

Symptoms : no clinical experience available.

Measures to take : symptomatic treatment