Sedistress 200 Mg 98 Coated Tablets

Sedistress (200 Mg 98 Coated Tablets)

INDICATIONS

- Symptomatic and transitory treatment of [NERVIOSISM], [STRESS] and [IRRITABILITY], and as an aid to improve sleep in [INSOMNIUM].

Its use is based exclusively on a traditional use.

POSOLOGY

“Sedistress”

- Adults:

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

* Help to improve sleep: 1-2 tablets at night, 30 minutes before bedtime.

- Children and adolescents <18 years:

* Adolescents from 12 years: 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 there is little time left for the next. Administer the next dose at the usual time. Do not double the next dose.

POSOLOGY IN RENAL INSUFFICIENCY

No specific dosage recommendations have been made.

POSOLOGY IN HEPATIC INSUFFICIENCY

No specific dosage recommendations have been made.

RULES FOR THE CORRECT ADMINISTRATION

- Tablets: swallow whole with enough liquid.

Administration with food : can be taken with or without food.

CONTRAINDICATIONS

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

PATIENT ADVICE

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

- Passionflower can affect the ability to drive.

INTERACTIONS

- Sedatives. There is a theoretical risk of potentiating nervous depression by associating alcohol or other sedative substances, such as antihistamines, narcotic analgesics, benzodiazepines or antidepressants, among others.

PREGNANCY

Animal safety : no data available.

Safety in humans : adequate and well-controlled studies in humans are not available. Its use is not recommended.

Fertility effects : no specific studies have been conducted in humans.

LACTATION

Animal safety : no data available.

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

CHILDREN

Passionflower is indicated in adolescents from 12 years, at the same doses as adults.

The safety and efficacy in children <12 years have not been evaluated, so it is recommended to avoid its use.

Use in children between 3-11 years should be carried out exclusively in exceptional cases, and under strict medical supervision.

ELDERLY

No specific problems have been described in the elderly that require a dose adjustment. However, the use of sedative substances should be carried out with caution in older people, because they could increase the risk of falls.

EFFECTS ON DRIVING

Passionflower can lead to drowsiness, so it could substantially affect the ability to drive and / or operate machinery. Patients should avoid operating dangerous machinery, including cars, until they are reasonably certain that drug treatment does not adversely affect them.

ADVERSE REACTIONS

Adverse reactions are described according to each frequency range, being considered very frequent (> 10%), frequent (1-10%), rare (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 PURPLE], [URTICARY], [NAUSEAS], [TAQUICARDIA], [EXANTEMATIC ERUPTIONS].

OVERDOSE

Symptoms : clinical experience is not available.

Measures to be taken : symptomatic treatment

Sedistress 200 Mg Leaflet 98 Coated Tablets