NAUSICALM 15,7 mg syrup in sachet 15sachet/5mL

Syrup (amber yellow in colour, with a caramel odour).
Sachet of 5 ml. Box of 15.

One sachet contains 15,7 mg of dimenhydrinate.

Excipients with known effect : one sachet contains 3,6 g of sucrose, 0,0025 g of methyl parahydroxybenzoate (E218), 0,0015 g of propyl parahydroxybenzoate (E216) and 0,106 g of ethanol (contained in the caramel flavouring).

In children aged 6 to 15 years:

• Prevention and treatment of motion sickness.
• Short-term symptomatic treatment of nausea and vomiting not accompanied by fever.

Oral use.

One sachet contains 15,7 mg of dimenhydrinate.

Children aged 6 to 15 years

• Motion sickness

1 to 2 sachets.

Maximum dosage: 150 mg/24 h, i.e. 10 sachets every 24 hours.

The first dose should be taken half an hour before departure. The dose may be repeated during the journey if necessary.

• Symptomatic treatment of nausea and vomiting not accompanied by fever

1 to 2 sachets every 6 to 8 hours.

Maximum dosage: 150 mg/24 h, i.e. 10 sachets every 24 hours.

The duration of treatment without medical advice must not exceed 2 days.

This medicine is CONTRAINDICATED in the following situations:

• Hypersensitivity to the active substance or to any of the excipients listed in section Composition.
• Hypersensitivity to antihistamines.
• Risk of glaucoma due to angle closure.
• Risk of urinary retention related to urethro-prostatic disorders.
• Children under 6 years

Special warnings

This medicine contains sucrose. Its use is not recommended in patients with fructose intolerance, glucose-galactose malabsorption syndrome or sucrase/isomaltase deficiency.

This medicine contains 3,6 g of sucrose per sachet, which must be taken into account in the daily ration in cases of a low-sugar diet or diabetes.

This medicine contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) and may cause allergic reactions (possibly delayed).

This medicine contains 106 mg of ethanol (alcohol) per sachet. The use of this medicine is dangerous in alcoholic subjects and must be taken into account in pregnant or breast-feeding women, children and high-risk groups such as patients with hepatic insufficiency or epileptics.

Precautions for use

As a precaution, do not use this medicine in cases of bronchial asthma.

Dimenhydrinate should be used with caution in cases of severe hepatic and/or renal insufficiency, because of the risk of accumulation.

Precautions must be taken when combined with certain ototoxic antibiotics, dimenhydrinate possibly masking the symptoms of ototoxicity.

The risk of abuse and drug dependence is low. However, cases of abuse and drug dependence have been reported mainly in adolescents or young adults for recreational purposes and/or in patients suffering from psychotic disorders or having a history of abuse and/or drug dependence.

The occurrence of signs or symptoms suggestive of misuse of dimenhydrinate should be carefully monitored.

Combinations not recommended

+ Alcohol

Alcohol increases the sedative effect of H1 antihistamines. Impaired alertness may make driving vehicles and using machines dangerous.

Avoid taking alcoholic beverages and medicines containing alcohol.

Associations to be taken into account

+ Atropine and other atropine-like substances (imipramine-type antidepressants, anticholinergic antiparkinsonian agents, atropine-type antispasmodics, disopyramide, phenothiazine neuroleptics)

Additive atropinic undesirable effects of the urinary retention, constipation, dry mouth type.

+ Other central nervous system depressants: morphine derivatives (analgesics, antitussives and substitution treatments); benzodiazepines, barbiturates, anxiolytics other than benzodiazepines, hypnotics, neuroleptics, sedative antidepressants, central antihypertensives, baclofen, thalidomide.

Increased central depression. Impaired alertness may make driving a vehicle and operating machinery dangerous.

Pregnancy

Studies in animals have not shown any teratogenic effect. In clinical use, dimenhydrinate during a limited number of pregnancies has apparently not revealed any particular malformative effect to date. However, additional studies are necessary to evaluate the consequences of exposure during pregnancy.

Given their anticholinergic and sedative properties, digestive signs (abdominal distension, meconium ileus, delayed passage of meconium, difficulty starting feeding), respiratory signs (respiratory distress, tachycardia) and neurological disorders have been described in newborns of mothers treated long-term with high doses of an anticholinergic antihistamine.

Consequently, use of this medicine should be considered during pregnancy only if necessary; limiting it, in the 3^th trimester to occasional use.

If this medication was administered at the end of pregnancy, it seems justified to observe a period of monitoring of the newborn's neurological and digestive functions.

Breast-feeding

Given passage into breast milk and the sedative and anticholinergic properties of dimenhydrinate, use of this medicine is not recommended during breast-feeding.

Attention is drawn, particularly to vehicle drivers and machine operators, to the risks of drowsiness associated with the use of this medication.

This phenomenon is accentuated by taking alcoholic beverages or medicines containing alcohol.

The pharmacological characteristics of dimenhydrinate are responsible for adverse effects of varying intensity, related or not related to the dose (see section Pharmacodynamics) :

• Neurovegetative effects:
  • sedation or drowsiness, more marked at the start of treatment;
  • anticholinergic effects such as dry mucous membranes, constipation, accommodation disorders, mydriasis, heart palpitations, urinary retention, cessation of milk secretion;
  • orthostatic hypotension;
  • balance disorders, dizziness, decreased memory or concentration, more frequent in the elderly;
  • motor incoordination, tremors;
  • mental confusion, hallucinations;
  • more rarely, effects of an excitatory type: agitation, nervousness, insomnia,
  • very rare cases of extrapyramidal symptoms in children.
• Haematological effects:
  • leukopenia, neutropenia;
  • thrombocytopenia;
  • haemolytic anaemia.
• Sensitisation reactions:
  • erythema, eczema, purpura, possibly giant urticaria;
  • edema, more rarely Quincke's edema;
  • anaphylactic shock.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centres - Website: https://signalement.social-sante.gouv.fr

The predominant signs include excitation with agitation, hallucinations, incoordination, and convulsions. Fixed and dilated pupils, flushing of the skin (face), and hyperthermia are frequent signs. The terminal phase is accompanied by coma that worsens with cardiorespiratory collapse; death may occur within 2 to 98 hours.

Pharmacotherapeutic class: ANTINAUSEA AGENTS.

(N: central nervous system)

Dimenhydrinate: H1 antihistamine, with an ethanolamine structure, characterised by:

• a significant sedative effect at usual doses, of histaminergic and central adrenolytic origin;
• an anticholinergic effect causing peripheral adverse effects, utilized in the prevention and treatment of motion sickness;
• a peripheral adrenolytic effect that may have hemodynamic repercussions (risk of orthostatic hypotension).

Antihistamines share the property of opposing, through more or less reversible competitive antagonism, the effects of histamine notably on the skin, bronchi, intestine and blood vessels.

For all antihistamines, general information can be provided:

• Bioavailability is generally moderate.
• Where applicable, metabolism may be intense, with formation of numerous metabolites, which explains the very low percentage of product recovered unchanged in the urine.
• The half-life is variable but often prolonged, allowing a single daily dose.
• The liposolubility of these molecules is responsible for the high value of the volume of distribution.

Pathophysiological variation : risk of accumulation of antihistamines in patients with renal or hepatic insufficiency.

Toxicity from repeated administration

Dimenhydrinate is well tolerated by rats and dogs to which it was administered orally at doses 10 times higher than the therapeutic dose, for 4 and 6 months respectively.

Mutagenic potential

In vitro mutagenesis tests performed on dimenhydrinate gave ambiguous results: positive on bacterial cells but negative on mammalian cells.

Carcinogenesis

No carcinogenesis data exist in animals.

Teratogenic potential

Dimenhydrinate administered orally to rats at doses 20 times higher than the therapeutic dose and to rabbits at doses 25 times higher than the therapeutic dose showed no effect on fertility and no teratogenic effect.

Dimenhydrinate crosses the placental barrier and is excreted in breast milk.

Before opening: 3 years.

This medicine does not require any particular storage precautions.

No special requirements.