Bionatus

 

NPN :  80063840

 

PRESENTATION: BOTTLE of 120 ml oral solution

 

MEDICINAL INGREDIENTS (PER UNIT DOSE)

Passionflower (Passiflora incarnata, Aerial parts)............. 0.25 ml (1mg of total flavonoids expressed in vitexin)

 

NON-MEDICINAL INGREDIENTS: D-sorbitol, (p) methyl hydroxybenzoate, (p) propyl hydroxybenzoate, mint flavor, flavor of passion fruit, purified water, and ethyl alcohol.

  

INDICATION

Traditionally used in Herbal Medicine as a sleep aid (in cases of restlessness or insomnia due to mental stress).

 

DOSAGE

Adults and adolescents 13 and over: 20 ml, 1-3 times a day. Do not exceed 60 ml daily.

 

  

PRECAUTIONS

Consult a health care practitioner if symptoms persist or worsen.

Consult a health care practitioner if sleeplessness persists beyond 3 weeks (chronic insomnia)

Stop treatment in cases of hypersensitivity reactions and consult a doctor.

Do not take doses higher than those recommended.

This product should not be used in pregnant women, lactating women and children under 13 years. Consult a health care practitioner prior to use if you are pregnant or breastfeeding.

Treatment with Passipax may provoke somnolence. Patient should not drive a car or operate a machine since alertness could be reduced.

Passipax potentializes the sedative effects of pentobarbital and hexobarbital increasing the time patients sleep. Alcoholic beverages can potentialize the effect of the product. Consumption with alcohol, other medications or natural health products with sedative properties is not recommended.

There are indications that, coumarins present in the species have a potential anticoagulant effect and could then interact with warfarin, but the studies are not conclusive.

The use of this product with inhibitors of monoamine oxidase (Isocarboxazid, Phenelzine and Tranylcypromine) may cause an additive effect. 

 

CONTRAINDICATIONS

Passipax is contraindicated:

In patients with a history of hypersensitivity and allergy to the components of the product formulation 

In patients on sedative, hypnotic or antihistamine drugs therapy

During the consumption of alcoholic beverages

In pregnant, lactating women and children under 13 years.

 

 

ADVERSE REACTIONS 

At recommended doses, There is no adverse effects of Passipax. In rare cases, it can have adverse reactions, such as nausea, vomiting, headache, and tachycardia. Hypersensitivity (eg. allergy) may occur. If this occurs, discontinue use.

EXCESSIVE DOSES MAY CAUSE PROLONGED SEDATION AND STATES OF SOMNOLENCE.

People experiencing somnolence after taking Passipax should not drive heavy machinery or a motor vehicle, or undertake activities that require alertness