NATURACTIVE GOUTTES AUX ESSENCES GAE Oral Solution 45ml

ANSM - Updated on : 14/03/2019

IN THIS APPENDIX, THE TERM "MARKETING AUTHORIZATION" IS UNDERSTOOD TO MEAN "TRADITIONAL HERBAL MEDICINE REGISTRATION" AND THE TERM "AUTHORIZATION" IS UNDERSTOOD TO MEAN "REGISTRATION"

1. DRUG NAME

GOUTTES AUX ESSENCES, drinkable solution

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Peppermint (Mentha x piperita L.) (essential oil of flowering aerial part of)...................... 1.50 g

Clove (Syzygium aromaticum L.) Merill et L.M. Perry) (essential oil of the flower bud of)

.50 g

Lavender (Lavandula angustifolia Mill.) (flowering top essential oil of)............................... 0.50 g

Thyme (Thymus zygis Loefl. ex L.)(essential oil of flowering part of)............................ 0.50 g

Per 100 g drinking solution.

Notable excipient: ethanol.

For full list of excipients, see section 6.1

3. PHARMACEUTICAL FORM

Drinkable solution.

4. CLINICAL DATA

4.1. therapeutic indications

Traditional herbal medicine for benign acute bronchial disorders.

Its use is reserved for the specified indication, based exclusively on the length of time it has been used

GOUTTES AUX ESSENCES, solution buvable is indicated for adults and adolescents over 12 years of age

4.2. Dosage and administration

Dosage

Adults and adolescents over 12 years of age:

25 drops diluted in water, 3 to 4 times a day

Pediatric population:

Use in children under 12 years of age is not recommended (see section 4.4)

Method of administration

Oral administration.

To be diluted in water.

Treatment time

7 days

If symptoms persist after 7 days, consult a doctor or pharmacist

4.3. Contraindications

Hypersensitivity to the active ingredients, menthol or any of the excipients listed in section 6.1.

the presence of terpene derivatives, this medicine is contraindicated in cases of history of epilepsy and/or convulsive seizures

presence of peppermint essential oil, this drug is contraindicated:

in cases of

liver disease

in cases of

gallstones, cholangitis or other disorders of the bile du

in

cases ofachlorhydria.

4.4 Special warnings and precautions for use

This drug contains 97% vol. ethanol (alcohol), i.e. up to 500 mg per dose, equivalent to 12 mL beer or 5 mL wine per dose. The use of this drug is dangerous for alcoholics, and must be taken into account by pregnant or breast-feeding women, children and high-risk groups such as liver failure patients or epileptics.

fever, respiratory difficulties or purulent exhalations, a doctor should be consulted

presence of peppermint essential oil, this drug should be used with caution in patients suffering from :

heart

,

hiatal hernia.

This product contains terpene derivatives which, in excessive doses, may cause:

convulsions in infants and children,

- respiratory pauses and collapse in infants.

not

Pediatric population

In the absence of sufficient data in this population, the use of this drug in children under 12 years of age is not recommended

Precautions for use

In case of previous depilepsy, take into account the presence of terpene derivatives

4.5. Interactions with other drugs and other forms of interaction

Associations to be taken into account

anticoagulant, platelet anti-aggregant or thrombolytic

Increased risk of bleeding due to the presence of clove oil.

+ other drugs that lower the epileptogenic threshold

Increased risk of convulsions due to terpene derivatives

4.6. Fertility, pregnancy and lactation

Pregnancy

This medicine contains terpene derivatives. There is little or no data on the use of terpene derivatives in pregnant women. GOUTTES AUX ESSENCES, solution buvable is not recommended during pregnancy or for women of childbearing age not using contraception

Breast-feeding

There are no data on the excretion of the essential oil components contained in GOUTTES AUX ESSENCES, solution buvable and/or their metabolites into breast milk. A risk to newborns/infants cannot be excluded. This medicine must not be used during breast-feeding.

Fertility

No data on fertility are available.

4.7. Effects on ability to drive and use machines

The effects on the ability to drive vehicles and use machines have not been studied.

4.8. Undesirable effects

Adverse reactions have been classified according to the following convention: very common (≥1/10), common (≥1 /100, <1/10), uncommon (≥1/1000, <1/100), rare (≥1/10,000, <1/1000), very rare (<1/ 10,000), undetermined frequency (cannot be estimated on the basis of available data) :

Gastrointestinal disorders:

Undetermined frequency: digestive disorders: heartburn, perianal burning, nausea and vomiting, local irritation, menthol odour of stools.

Immune system disorders:

Undetermined frequency: hypersensitivity reactions: erythematous skin rash, anaphylactic shock, muscle tremors, ataxia, bradycardia and headache

Eye disorders:

Undetermined frequency: blurred vision.

Kidney and urinary tract disorders:

Undetermined frequency: menthol odour in urine.

Undetermined frequency: dysuria.

Reproductive organs and breast disorders:

Undetermined frequency: balanitis.

the presence of terpene derivatives and in case of non-compliance with recommended doses:

possibility of agitation and confusion in elderly subjects

Reporting suspected adverse reactions

It is important to report suspected adverse reactions once the drug has been registered. It enables ongoing monitoring of the drug's risk/benefit ratio. Healthcare professionals report any suspected adverse reaction via the national reporting system: Agence nationale de sécurité du médicament et des produits de santé (ANSM) and the network of Regional Pharmacovigilance Centers - Website: www.signalement-sante.gouv.fr.

4.9. Overdose

Overdose may cause central nervous system disorders (e.g. convulsions, ataxia, loss of consciousness, coma), urinary disorders, gastrointestinal disorders (e.g. diarrhoea, nausea, rectal ulceration), heart rhythm disorders, acidosis with anion gap, deterioration of liver function, apnoea and/or hypoglycaemia.

In the event of rapidly detected massive overdosage in a single dose, treatment consists of stomach lavage and symptomatic therapy.

literature, N-acetylcysteine has been successfully used as an antidote to clove oil overdose

5. PHARMACOLOGICAL PROPERTIES

5.1. Pharmacodynamic properties

Not applicable.

5.2. Pharmacokinetic properties

Not applicable.

5.3. Preclinical safety data

Genotoxicity studies conducted in vitro on each of the essential oils contained in GOUTTES AUX ESSENCES, solution buvable show no mutagenic effect in the Ames test.

No carcinogenicity or reproductive and developmental toxicity studies have been performed

6. PHARMACEUTICAL DATA

6.1. List of excipients

Ethanol.

6.2. incompatibilities

Not applicable.

6.3. Shelf life

36 months before opening.

24 months after opening.

6.4. Special storage precautions

No special precautions.

6.5. Nature and contents of outer packaging

45 mL or 90 mL brown glass (type III) bottle closed with low-density polyethylene dropper cap (VISTOP).

6.6. Special precautions for use and handling

No special requirements.

7. MARKETING AUTHORIZATION HOLDER

PIERRE FABRE MEDICAMENT

45 PLACE ABEL GANCE

92100 BOULOGNE

[Tel, fax, e-Mail: to be completed later by the holder]

8. MARKETING AUTHORIZATION NUMBER(S)

- 34009 303 751 2 9 : 45 mL brown glass bottle with dropper.

34009 303 750 6 8 : 90 mL brown glass bottle with dropper

9. DATE OF FIRST AUTHORIZATION/AUTHORIZATION RENEWAL

to be completed later by the holder] [to be completed later by the holder] [to be completed later by the holder] [to be completed later by the holder

10. TEXT UPDATE DATE

[to be completed later by the holder]

<{JJ Month YYYY}>

11. DOSIMETRY

Not applicable.

12. INSTRUCTIONS FOR THE PREPARATION OF RADIOPHARMACEUTICALS

Not applicable.

Not subject to medical prescription.