PASSIFLORINE oral solution 125ml Passion

For warnings, precautions for use and contraindications, please consult the instructions for use.

Description

PASSIFLORINE, oral solution in bottle

PASSIFLORINE, oral solution in 125ml bottle. Medication traditionally used to reduce nervousness , including:

• if you experience an exaggerated heartbeat (palpitations) after all heart disease has been ruled out;
• in case of sleep disturbances .

Reference: 3078818

Insomnia is the reduction in the usual duration of sleep and / or the achievement of quality of sleep with repercussions on the quality of the next day's waking. During the night the amount of sleep is reduced by difficulty falling asleep, night awakenings, too early awakening in the morning. Sleep is experienced as light and not restful. The next day is difficult with complaints of fatigue, drowsiness, irritability, and is often accompanied by mood disorders.

There are various explanations for sleep disorders. Environmental causes (noise, heat, etc.), lifestyle errors (activity too intense in the evening, coffee or alcohol abuse), an inadequate imposed rhythm (night or team work), organic illness associated disturbing sleep (asthma, angina, peptic ulcer, gastroesophageal reflux ...) or even taking exciting drugs (theophylline, salbutamol, cortisone, beta blockers ...) are often with origin of the troubles.

Learn more about psychophysiological insomnia

This type of sleep disorder accounts for 15 to 20% of insomnia. It is insomnia that appears without obvious cause. It generally follows insomnia, the cause of which can be identified: after a surgical intervention, the birth of a child, significant psychological stress, shift work ...
There is a negative conditioning to insomnia which results in a paradoxical activation of the awakening systems as soon as the person goes to bed. It results in fear of not sleeping, tension or anxiety at bedtime, spontaneous falling asleep when sleep is not wanted (in front of the TV ...), the impossibility of taking a nap to recover .

Find out more
NOTICE

ANSM - Updated on: 16/06/2004
Name of the drug
PASSIFLORINE, oral solution in bottle

Box

Read all of this leaflet carefully before taking this medicine. It contains important information for your treatment.
If you have any further questions, if in doubt, ask your doctor or pharmacist for more information.

• Keep this leaflet, you may need to read it again.
• If you need more information and advice, ask your pharmacist.
• If symptoms worsen or persist, see your doctor.
• If you notice any side effects not listed in this leaflet, or if you experience any of the side effects as serious, please tell your doctor or pharmacist.

Summary notice

In this notice :

1. WHAT IS PASSIFLORIN, oral solution in a vial AND WHAT IT IS USED FOR?
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PASSIFLORINE, oral solution in a vial?
3. HOW TO TAKE PASSIFLORINE, oral solution in a bottle?
4. WHAT ARE THE POSSIBLE SIDE EFFECTS ?
5. HOW TO STORE PASSIFLORINE, oral solution in a vial?
6. ADDITIONAL INFORMATION

1. WHAT IS PASSIFLORIN, oral solution in a vial AND WHAT IT IS USED FOR?
Pharmacotherapeutic group
Herbal medicine.
Therapeutic indications
Traditionally used to reduce nervousness, including:
In case of excessive perception of heartbeat (palpitations) after all heart disease has been ruled out;
In case of sleep disturbances.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PASSIFLORINE, oral solution in a vial?
List of information needed before taking the medicine
Not applicable.
Contraindications
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR OR PHARMACIST.
Precautions for use; special warnings
Take special care with PASSIFLORINE, oral solution in a bottle:
Special warnings
If the symptoms do not improve, consult your doctor.CAUTION: THE ALCOHOLIC TITLE OF THIS MEDICINAL PRODUCT IS 11.2 ° OR 445 mg OF ETHYL ALCOHOL PER COFFEE SPOON.
In case of diabetes, take into account the sugar intake (1.7 g per teaspoon).
IF IN DOUBT DO NOT HESITATE TO ASK FOR THE OPINION OF YOUR DOCTOR OR PHARMACIST.
Interaction with other drugs
Taking or using other medications
If you are taking or have recently taken any other medicines, including medicines obtained without a prescription, tell your doctor or pharmacist.
Food and drink interactions
Not applicable.
Interactions with phytotherapy products or alternative therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy and breast feeding
The use of this medication should generally be avoided during pregnancy.
If you discover that you are pregnant during treatment, consult your doctor as only he can judge the need to continue it.
The use of this medication should be avoided while breastfeeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Sportsmen
Not applicable.
Effects on ability to drive or use machines
Driving and using machines
The attention of vehicle drivers and machine users should be drawn to the sedative effect of this drug which can cause drowsiness or changes in reflexes.
List of excipients with known effect
List of excipients with known effect: alcohol, sucrose, glycerol, sodium methyl parahydroxybenzoate, sodium propyl parahydroxybenzoate.

3. HOW TO TAKE PASSIFLORINE, oral solution in a bottle?
Instructions for proper use
Not applicable.
Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment
Dosage
RESERVED FOR ADULTS AND CHILDREN OVER 30 MONTHS.
In adults:
Nervousness, palpitations: 1 or 2 teaspoons, noon and evening, before meals.
Sleep disturbance: 1 to 4 teaspoons in the evening before bedtime.
In children over 30 months: 1 teaspoon per day.
Administration mode
Oral use. Dilute the solution in a little water.
Duration of the treatment
In case of nervousness or palpitations, the treatment can be followed for 2 or 3 periods of 20 days.
Symptoms and instructions in case of overdose
Not applicable.
Instructions if one or more doses are missed
Not applicable.
Risk of withdrawal syndrome
Not applicable.

4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Description of side effects
Like all medicines, PASSIFLORINE oral solution in vial may cause side effects, although not everybody gets them.
If you notice any side effects not listed in this leaflet, or if some side effects become serious, please tell your doctor or pharmacist.

5. HOW TO STORE PASSIFLORINE, oral solution in a vial?
Keep out of the reach and sight of children.
Expiration date
Do not use PASSIFLORINE, oral solution in a bottle after the expiry date which is stated on the bottle.
Storage conditions
Keep away from light and moisture.
If necessary, warnings against certain visible signs of deterioration
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist what to do with unused medication. These measures will help to protect the environment.

6. ADDITIONAL INFORMATION
Complete list of active substances and excipients
What does PASSIFLORINE, oral solution in vial contain?
The active substances are:
Passionflower (fluid extract) ............................................. .................................................. ......................... 10 g
Hawthorn (tincture) .............................................. .................................................. ................................ 10 g
Per 100 ml of oral solution.
Alcoholic strength (V / V) = 11.2 °.
A 5 ml teaspoon contains 445 mg of ethanol, and 1.7 g of sucrose.
The other components are:
Sucrose, glycerol, sodium methyl parahydroxybenzoate, sodium propyl parahydroxybenzoate, drinking water.
Pharmaceutical form and content
What is PASSIFLORINE, oral solution in vial and contents of the pack?
This medication is in the form of an oral solution. 125 ml bottle.
Name and address of the marketing authorization holder and the manufacturing authorization holder responsible for batch release, if different

Holder

THERATECH Laboratories
20, rue Jean Daudin
75015 Paris

Operator

JOLLY-JATEL Laboratories
28, avenue Carnot
78100 SAINT GERMAIN EN LAYE

Maker

PHARMA DEVELOPPEMENT
Corbigny industrial site
Marcy's Way
58800 CORBIGNY

Names of the drug in the member states of the European Economic Area
Not applicable.
Notice approval date
The last date this notice was approved is {date}.
Marketing authorization under exceptional circumstances
Not applicable.
Internet Information
Detailed information on this medicine is available on the Afssaps website (France).
Information reserved for healthcare professionals
Not applicable.
Other
Not applicable.

Rcp link: http: //agence-prd.ansm.sante.fr/php/ecodex/frames.php? Specid = 66703316 & typedoc = R & ref = R0130228.htm

Drug warnings

Attention, the drug is not a product like the others. Read the package leaflet carefully before ordering. Keep medicines out of the reach of children. If symptoms persist, seek the advice of your doctor or pharmacist. Beware of incompatibilities on your current products.

• Please inform your online pharmacist of the treatments in progress in order to identify any incompatibilities. The order validation form contains a personalized message field provided for this purpose.
• Click here to find the leaflet for this medication on the website of the National Agency for the Safety of Medicines and Health Products.

Pharmacovigilance Report an adverse drug reaction(s)

Download PDF leaflet

Phytotherapy

passionflower, hawthorn

. Presentations . Composition . Indications . Attention . Drug interactions . Pregnancy and breastfeeding . Instructions for use and dosage . Tips . Lexicon

PRESENTATIONS ^(summary)

PASSIFLORIN: oral solution; bottle of 125 ml.
Not refunded - Free price -

Jolly-Jatel Laboratory

COMPOSITION ^(summary)

	pc to c
Passionflower, fluid extract	500 mg
Hawthorn, dyeing	500 mg
Sucrose	1.7 g
Alcohol	445 mg

INDICATIONS ^(summary)

This medicine contains sedative plants.
It is traditionally used in the symptomatic treatment of nervousness, especially in cases of mild sleep disorders in adults and children, and in the treatment of palpitations in adults.

ATTENTION ^(summary)

Palpitations can be a symptom of heart disease: Do not use this medicine for prolonged periods without the advice of your doctor.
The oral solution contains sugar (sucrose) and alcohol in significant amounts.
If you must drive or use a dangerous machine, first make sure that this medicine does not affect your alertness.

DRUG INTERACTIONS ^(summary)

Given the presence of alcohol, the oral solution may interact with drugs that have an antabuse effect ( ESPÉRAL ...).

PREGNANCY and BREASTFEEDING ^(summary)

This medicine contains presumed plants that are safe to use during pregnancy or while breastfeeding. However, as a precautionary measure, do not use it without consulting your pharmacist or doctor.

DIRECTIONS AND DOSAGE ^(summary)

The oral solution should be diluted in a little water, sweetened or not, or in a hot infusion .

Usual dosage:

• Adult :
  In palpitations and nervousness: 1 to 2 teaspoons, noon and night, before meals.
  In sleep disorders: 1 to 4 teaspoons, at bedtime.
  
• Child over 30 months: 1 teaspoon of oral solution per day.
  

TIPS ^(summary)

Medications are not the only answer to stress: a better lifestyle, a moderate consumption of excitants (coffee, tea, alcoholic beverages ...) can also fight against excessive nervousness and its manifestations ( palpitations , sleeping troubles).

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LEXICON ^(summary)

alcohol
General name for a family of substances that have the property of being able to be mixed with water and fat. The most common alcohol is ethyl alcohol (ethanol), but there are many other alcohols: methanol, butanol, etc. The degree of an alcoholic solution corresponds to the volume of pure alcohol present in 100 ml of solution, knowing that 1 glass of wine flask or 1 half of beer (25 cl) contain about 8 g of alcohol.
When alcohol is used as an antiseptic, a denaturant with an unpleasant smell is often added to prevent it from being drunk. Contrary to popular belief, alcohol at 70o (or even at 60o) is a better antiseptic than alcohol at 90o.


antabuse effect
A set of uncomfortable symptoms caused by certain medications when taken with alcoholic beverages: flushing, flushing, headache, nausea, vomiting.


infusion
Method of preparation of most herbal teas; this process makes it possible to extract the substances contained in the plants by pouring boiling water on them. This technique is different from maceration and decoction.


palpitations
Abnormal perception of irregular heartbeat.


sedative

• Soothing, calm.
  
• Medicines belonging to different families: anxiolytics, hypnotics, analgesics, antitussives, antiepileptics, neuroleptics, etc. but also antidepressants, antihistamines H1, antihypertensives. A sedative may be responsible for drowsiness and increase the effects of alcohol.
  

sugar
A general term for various substances, the most common of which is sucrose. Other sugars may be contained in the drugs: glucose, fructose, lactose, etc. Glucose is the sugar used by the body; it is the only one to circulate in a notable quantity in the blood.
Sweeteners (fake sugar) are allowed in diabetics or people on a diet, and are very low calorie.


symptom
Disorder felt by a person with an illness. The same symptom can translate different diseases and the same disease does not necessarily give the same symptoms in all patients.


symptomatic treatment
Treatment that suppresses or alleviates the symptoms of a disease without attacking its cause.