Arkocapsulas Passionflower 300 Mg 45 Capsules

[ACTION AND MECHANISM].
- Hypnotic. Passionflower has been shown to exert sedative effects in experimental animals, although no human studies have been conducted to date.

    
[INDICATIONS]
- Treatment of moderate symptoms due to nervous tension, such as [ANXIETY], emotionality and [STRESS], as well as to facilitate sleep in adults and children over 12 years of age with [INSOMNIA].
Its use is based exclusively on traditional use.

    
[DOSAGE].
DOSAGE:
- Adults, oral:
* Sleep disorders: 3 capsules during the evening meal, and 3 more before bedtime.
* Nervousness: 3 capsules with breakfast and 3 capsules in the evening with a glass of water.
- Children, oral:
* Children from 12 years of age: same as adults.
* Children under 12 years of age: Safety and efficacy have not been evaluated.
If symptoms continue or worsen during treatment, it is advisable to consult a doctor and/or pharmacist.
INSTRUCTIONS FOR CORRECT ADMINISTRATION:
Swallow capsules whole with a glass of water.

    
[CONTRAINDICATIONS]
- Hypersensitivity to passionflower or to any component of the medicinal product.

    
WARNINGS/ADVICE] [WARNINGS/ADVICE
ADVICE TO THE PATIENT:
- If after several days of treatment the symptoms continue or worsen, it is advisable to consult a doctor and/or pharmacist.
- It is advisable not to drink alcohol during treatment.
- It may cause drowsiness, so caution is advised when driving.
- Insomnia in children should be treated only under medical prescription.

    
[INTERACTIONS]
- Alcohol. Alcohol may potentiate the sedative effects of passionflower. As a general recommendation, it is advisable to avoid the consumption of alcoholic beverages in people treated with sedative substances.
- Hypnotics. Passionflower may potentiate the effects of other hypnosedative drugs, such as benzodiazepines, opioid analgesics or H1 antihistamines.

    
[PREGNANCY]
There are no adequate and well-controlled studies available in pregnant women, so the use of passionflower during pregnancy is only accepted if the benefits outweigh the possible risks in the absence of safer therapeutic alternatives.

    
[BREASTFEEDING]
It is not known whether the components of passionflower are excreted in breast milk, and the possible consequences for the infant. It is advisable to discontinue breast-feeding or to avoid the use of passionflower during lactation. If used, it is advisable to monitor the child, and if excessive drowsiness occurs, it is advisable to discontinue treatment.

    
[CHILDREN]
The safety and efficacy in children under 12 years of age have not been evaluated, therefore it is recommended to avoid its use.

    
[ELDERLY]
Although no specific problems have been reported in the elderly, it is advisable to use sedative plants such as passionflower with great caution, as the drowsiness they cause could lead to falls, with the consequent risk of fracture.

    
[EFFECTS ON DRIVING]
Passionflower may substantially affect the ability to drive and/or operate machinery. Patients should avoid operating dangerous machinery, including automobiles, until they are reasonably certain that they are not adversely affected by drug treatment.

    
[ADVERSE REACTIONS]
- Digestive. [Nausea] and [VOMITING].
- Cardiovascular. [TACHYCARDIA].
- Neurological/psychological. Some [SEDATION] is normal.
- Allergic. Cases of [HYPERSENSITIVITY REACTIONS] have been reported, with [VASCULITIS].

    
[OVERDOSAGE].
Symptoms: No clinical experience of overdose with passionflower is available.
Treatment: Symptomatic treatment should be instituted.
In case of overdose or accidental ingestion, seek medical attention or contact the Poisons Information Service, indicating the product and the amount ingested.

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