Mercalm - Mal Des Transports -15 Tablets

1. NAME OF THE MEDICINAL PRODUCT

MERCALM, scored film-coated tablet

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Dimenhydrinate ................................................. .................................................. ........... 50 mg

Caffeine ................................................. .................................................. ....................... 10 mg For a scored film-coated tablet.

Excipient: lactose. For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Divisible coated tablet.

4. CLINICAL PARTICULARS

4.1. Therapeutic indications Prevention and treatment of motion sickness.

4.2. Posology and method of administration

RESERVED FOR ADULTS AND CHILDREN OVER 6 YEARS OLD.

Dosage

The usual dosage is:

· Adult and children over 15 years: 1 to 2 tablets per dose, without exceeding 6 tablets per day.

· Child from 6 to 15 years old: 1/2 to 1 tablet per dose, without exceeding 3 tablets per day.

Method of administration For oral use. Swallow the tablets half an hour before departure with a little water. If the disorders persist, renew the intake at an interval of more than 6 hours. Do not exceed 3 doses per day. In children, in order to facilitate the intake, it is possible to crush the 1/2 or the tablet in a glass of sugar water.

4.3. Contraindications

This drug is CONTRAINDICATED in the following situations:

Hypersensitivity to antihistamines,

Risk of glaucoma by closing the angle,

Risk of urinary retention linked to urethro-prostatic disorders,

· Children under 6 years of age due to the presence of caffeine.

This medication SHOULD NOT GENERALLY BE USED in case of breast-feeding and in combination with enoxacin.

4.4. Special warnings and precautions for use

Special warnings

This medicine contains caffeine (10 mg per tablet) which may cause excitement, insomnia and palpitations, especially in children (see section 4.8). Avoid association with certain foods which also contain caffeine (cola-based drink, coffee, tea, chocolate). The attention of athletes is drawn to the fact that caffeine can induce a positive reaction from the tests carried out during doping controls. This medicine contains lactose. Its use is not recommended in patients with lactose intolerance. Precautions for use As a precaution, do not use this medication in cases of bronchial asthma. Dimenhydrinate should be used with caution: · In elderly patients with: o greater sensitivity to postural hypotension, dizziness and sedation; o chronic constipation (risk of paralytic ileus); o possible prostatic hypertrophy. In severe hepatic and / or renal insufficiency, due to the risk of accumulation. The intake of alcoholic beverages and medicines containing alcohol (see section 4.5) during treatment is strongly discouraged. Due to the possibility of caffeine-related insomnia, it is best to avoid taking this medication after 4 p.m. The risk of abuse and drug dependence is low. However, cases of abuse and drug dependence have been reported primarily in adolescents or young adults for recreational purposes and / or in patients with psychotic disorders or with a history of abuse and / or drug dependence. The occurrence of signs or symptoms suggesting abuse of dimenhydrinate should be carefully monitored.

4.5. Interactions with other drugs and other forms of interactions

Combinations not recommended + Alcohol Increase by alcohol of the sedative effect of H1 antihistamines. Impaired vigilance can make driving and using machines dangerous. Avoid taking alcoholic beverages and drugs containing alcohol. + Enoxacin Significant increase in caffeine levels in the body which can lead to excitement and hallucinations (decrease in the hepatic catabolism of caffeine). Combinations to be taken into account · Linked to the presence of dimenhydrinate. + Other central nervous system depressants: morphine derivatives (analgesics, cough suppressants and substitution treatments); benzodiazepines; barbiturates; anxiolytics other than benzodiazepines; hypnotics; neuroleptics; sedative antidepressants; central antihypertensive drugs; baclofen; thalidomide. Increase in central depression. Impaired vigilance can make driving and using machines dangerous. + Atropine and other atropine substances (imipramine antidepressants, antiparkinsonian anticholinergics, atropine antispasmodics, disopyramide, phenothiazine neuroleptics) Addition of atropine side effects such as urinary retention, constipation, dry mouth. 

4.6. Pregnancy and breast feeding

The action to be taken during pregnancy and lactation is due to the presence of dimenhydrinate.

Pregnancy

· Malformative aspect (1st trimester): o In animals, experimental studies have not demonstrated a teratogenic effect of dimenhydrinate. o In humans, the risk of malformation from H1 antihistamines is unevenly assessed.

Fetotoxic aspect (2nd and 3rd trimesters): In newborns of mothers treated for long periods of time with high doses of an anticholinergic antihistamine, digestive signs linked to atropine properties have rarely been described (abdominal distension, meconium ileus, delayed the emission of meconium, difficulty in starting the diet, tachycardias, neurological disorders ...). Consequently, the teratogenic risk, if any, appears to be low. It is necessary to carefully reassess the indication during pregnancy, and, if possible, to try to limit the duration of the prescription. If the administration of this drug took place at the end of pregnancy, it seems justified to observe a period of monitoring of the neurological and digestive functions of the newborn. Breast-feeding · The use of this medication is not recommended during breast-feeding (dimenhydrinate passes into breast milk).

4.7. Effects on ability to drive and use machines

Attention is drawn, especially among vehicle drivers and users of machines, to the risks of drowsiness associated with the use of this medication. This phenomenon is accentuated by the intake of alcoholic beverages or drugs containing alcohol.

4.8. Side effects

The pharmacological characteristics of dimenhydrinate are the cause of undesirable effects of unequal intensity and related or not to the dose (see section 5.1):

· Neurovegetative effects: o sedation or somnolence, more marked at the start of treatment; o anticholinergic effects such as dryness of the mucous membranes, constipation, accommodation disorders, mydriasis, heart palpitations, urinary retention, drying up of milk secretion; o orthostatic hypotension; o balance disorders, dizziness, loss of memory or concentration, more frequent in the elderly; o motor incoordination, tremors; o mental confusion, hallucinations; o more rarely, effects are of the type of excitement: agitation, nervousness, insomnia. Very rare cases of extrapyramidal symptoms in children.

· Haematological effects: o leukopenia, neutropenia; o thrombocytopenia; o hemolytic anemia.

Sensitization reactions: o erythema, eczema, purpura, possibly giant urticaria; o edema, more rarely angioedema; o anaphylactic shock.

· Adverse effects linked to the presence of caffeine: Possibility of excitement, insomnia and palpitations. Abuse and drug dependence have been reported in adolescents or young adults for recreational purposes and / or in patients with psychotic disorders or with a history of abuse and / or dependence. Reporting of suspected adverse reactions The reporting of suspected adverse reactions after authorization of the medicinal product is important. It allows continuous monitoring of the benefit / risk ratio of the medicinal product. Health professionals report any suspected adverse reactions via the national reporting system: National Agency for Medicines and Health Products Safety (Ansm) and network of Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr

4.9. Overdose Symptoms of overdose with dimenhydrinate: · convulsions, (especially in infants and children); Disturbance of consciousness, coma. Symptomatic treatment in a specialized environment.

5. PHARMACOLOGICAL PROPERTIES

5.1. Pharmacodynamic properties

ANTINAUPATHIC (N: Central nervous system)

Dimenhydrinate: H1 antihistamine, with an ethanolamine structure, which is characterized by:

A significant sedative effect at the usual doses, of histaminergic and central adrenolytic origin;

An anticholinergic effect causing peripheral adverse effects, used in the prevention and treatment of motion sickness;

A peripheral adrenolytic effect, which may have haemodynamic effects (risk of postural hypotension).

The antihistamines have in common the property of opposing, by more or less reversible competitive antagonism, the effects of histamine in particular on the skin, the bronchi, the intestine, and the vessels.

5.2. Pharmacokinetic properties

Pharmacokinetic data with dimenhydrinate are lacking: For all antihistamines, general elements can be provided:

· Bioavailability is generally moderate.

· If necessary, the metabolism can be intense, with the formation of numerous metabolites, which explains the very low percentage of product found unchanged in the urine.

· The half-life is variable but often prolonged, allowing a single daily intake.

· The liposolubility of these molecules is the cause of the high value of the volume of distribution. Physiopathological variation: risk of accumulation of antihistamines in patients with renal or hepatic insufficiency. Caffeine Pharmacokinetic Data: Caffeine is rapidly and completely absorbed. Maximum plasma concentration is usually reached between a few minutes and 1 hour after ingestion. It is metabolized by the liver. Its elimination is urinary.

5.3. Preclinical safety data Not specified.

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