Symptomatic treatment of nasal hypersecretion during the affections, acute nasopharyngeal with headache and / or fever.

NB: in the presence of general clinical signs of bacterial infection, general antibiotic therapy should be considered.


Mode of administration

Oral use.

The capsules are to be swallowed as such with a drink (eg water, milk, fruit juice).

Dosage

Symptomatic treatment of nasal hypersecretion in the course of affections, acute nasopharyngeal with headache and / or fever, NB: in the presence of clinical signs, general bacterial infection, general antibiotic therapy should be Considered.

1 capsule contains 240 mg of paracetamol and 3.2 mg of chlorphenamine maleate.

The dosage in paracetamol

· For children over 12 years of age, the recommended daily dose is approximately 60 mg / kg / day, divided into 4 to 6 doses per day, ie 15 mg / kg, every 6 hours or 10 Mg / kg every 4 hours.

· For adults over 15 years of age, the recommended daily dose is 1 g per dose and 3 g per day.
Frequency, Administration

Due to the amount of chlorphenamine maleate per capsule, the dosage is limited to 1 capsule per dose, to be renewed if necessary after 4 hours, without exceeding 5 capsules per day.

In case of renal insufficiency, severe (creatinine clearance, less than 10 ml / min), the interval between two catches will be at least 8 hours. >
In case of persistence of fever, or pain, the treatment course to be taken should be re-evaluated.



ANTIHISTAMINIC INHIBITOR OF RECEPTORS H 1

(N: Central nervous system)

(R: Respiratory system)

Combination of paracetamol, an antihistamine, chlorphenamine maleate and vitamin C.

Chlorphenamine maleate: antihistamine H 1, with propylamine structure, possessing anticholinergic activity, causing undesirable effects

The antihistamines H 1 have the common property of opposing, by antagonism, more or less reversible, the effects of histamine on the skin, bronchi, intestine and vessels.

The passage of the blood-brain barrier is the cause of sedative effects of a histaminergic and adrenolytic nature, the latter being also able to resonate on a hemodynamic plane (risk of hypotension, orthostatic). Br>

Attention is drawn in particular to the risk of drowsiness associated with the use of this medicinal product, in particular in the case of drivers and users of machinery, especially at the beginning of treatment. >

This phenomenon is accentuated by the use of alcoholic beverages or medicines containing alcohol.


· Hypersensitivity to any of the components

· Hepatocellular insufficiency due to the presence of paracetamol

· Due to the presence of chlorphenamine maleate

O risk of glaucoma by closure of the angle

O risk of urinary retention due to urethro-prostatic disorders

Due to the presence of chlorphenamine maleate, this drug NE SHOULD GENERALLY NOT BE USED in case of breast-feeding (see section Pregnancy and breast-feeding).

In case of high or persistent fever, signs of superinfection or persistence of symptoms beyond 5 days, a re-evaluation of the treatment should be made.

Warnings

To avoid a risk of overdose, check the absence of paracetamol or maleate of chlorphenamine in the composition of other medicines

· Recommended maximum dose of paracetamol

O in children from 38 to 50 kg: the total dose of paracetamol should not exceed 3 g per day (see section 4.3) >
O In adults and children over 50 kg, the total dose of paracetamol should not exceed 4 grams per day (see section 4.4), unless medical advice is given. >

· The maximum dose of chlorphenamine maleate is 4 mg per dose and 16 mg per day.
Precautions for use

Related to paracetamol

The excretion of paracetamol and its metabolites takes place mainly in the urine. In cases of severe renal insufficiency, catches must be spaced at least 8 hours apart.
Related to the presence of chlorphenamine maleate

Chlorphenamine maleate should be used with caution

· In the elderly subject presenting

O increased sensitivity to hypotension, orthostatic, vertigo and sedation

O chronic constipation (risk of paralytic ileus)

O prostate hypertrophy

· In case of severe hepatic and / or renal insufficiency due to risk of accumulation

The use of alcoholic beverages or medicines containing alcohol (see section Interactions with other medicines and other forms of interactions)

Related to paracetamol

Interactions with paraclinical examinations

Taking paracetamol may distort the blood glucose test by the glucose oxidase peroxidase method in case of abnormally high concentrations

The use of paracetamol may distort the determination of blood uric acid by the phosphotungstic acid method.

Related to chlorphenamine maleate

+ Medication, sedatives

It must be taken into account that many drugs or substances can add up to their depressant effects of the central nervous system and contribute to diminish vigilance. These include morphine derivatives (analgesics, antitussives and substitution treatments), neuroleptics, barbiturates, benzodiazepines, anxiolytics, other than benzodiazepines (eg, meprobamate), hypnotics, antidepressants, sedatives (Amitriptyline, doxepin, mianserin, mirtazapine, trimipramine), sedative antihistamines, central antihypertensives, baclofen and thalidomide.
Associations, deprecated

+ Consumption of alcohol

Increase by alcohol of the sedative effect of these substances. The alteration of vigilance can make driving dangerous and the use of machinery.

Avoid drinking alcoholic beverages and medicines containing alcohol

Associations subject to precautions for use

+ Oral anticoagulants

Risk of increased effect of oral anticoagulant and hemorrhagic risk if paracetamol is taken at maximum doses (4 g / d) for at least 4 days.

More frequent control of INR. Possible adaptation of the dosage of oral anticoagulant during treatment with paracetamol and after discontinuation

+ Deferoxamine

With ascorbic acid at high doses and IV: cardiac function abnormalities, even acute heart failure (in general, reversible on withdrawal of vitamin C).
< Br>

In case of hemochromatosis, give vitamin C only after starting treatment with deferoxamine. Monitor cardiac function in case of association.

Not applicable.

Intoxication is to be feared in elderly and especially in young children (therapeutic overdose or accidental and frequent poisoning) in which it can be fatal.



Symptoms

· Chlorphenamine maleate overdose, risk of convulsions, unconsciousness, coma

· An overdose of paracetamol: nausea, vomiting, anorexia, pallor, abdominal pain usually occur within 24 hours
· Overdosage from 10 g of paracetamol in one single dose in adults and 150 mg / kg of body weight in one child only causes

Hepatic cytolysis which may lead to complete and irreversible necrosis resulting in hepatocellular insufficiency, metabolic acidosis, encephalopathy which may lead to coma and death
< Br>

O At the same time, there is an increase in liver transaminases, lactic dehydrogenase, bilirubin and decreased prothrombin levels that may occur 12 to 48 hours after ingestion.
< Br>

Driving emergency

· Immediate transfer to hospitals

· Collect a blood tube to do the initial plasma paracetamol assay

· Rapid evacuation of the product ingested, by washing, gastric

Treatment of overdosage with paracetamol conventionally includes the administration as early as possible of the antidote N-acetylcysteine ​​IV or orally if possible before the tenth hour. Br> -
· Symptomatic treatment.

Pregnancy

Malformative aspect

Studies in animals have not demonstrated teratogenic effects of chlorphenamine.

In clinical studies, the results of epidemiological studies seem to exclude a particular malformative effect of chlorphenamine and paracetamol.


In newborns of mothers treated with long doses of drugs, anticholinergics have rarely been described

· Digestive signs related to the properties, atropinic phenothiazines (distension, abdominal ...)

· Extrapyramidal syndromes.

Given these data

· This medicinal product, under normal conditions of use, may be prescribed during the first 2 trimesters of pregnancy

And its use should be considered during the 3 rd quarter only if necessary, but only for one-time use.

If the administration of this medicinal product took place at the end of pregnancy, it seems justified to observe a period of surveillance of the neurological and digestive functions of the newborn.

Breastfeeding

There is a small but real passage of chlorphenamine in breast milk.Taking account of the sedative properties, the intake of this drug during breast-feeding is not recommended.

Related to paracetamol

A few cases of reactions, hypersensitivity to the type of anaphylactic shock, angioedema, erythema, urticaria, rash, cutaneous have been reported. Their occurrence requires the definitive discontinuation of this medicinal product and related medicinal products.
Related to the presence of chlorphenamine maleate

The pharmacological characteristics of the molecule are at the origin of adverse effects of unequal intensity and whether or not related to the dose (see section "Properties, Pharmacodynamics").

Neurovegetative effects

· Sedation or somnolence, more marked at the beginning, treatment

· Anticholinergic effects such as dryness of the mucous membranes, constipation, arrhythmias, mydriasis, heart palpitations, risk of urinary retention

· Orthostatic hypotension

· Disorders of balance, dizziness, decreased memory or concentration, more common in the elderly

· Motor incoordination, tremor

· Mental confusion, hallucinations.

Awareness reactions

· Erythema, eczema, pruritus, purpura, urticaria, possibly giant.
· Edema, more rarely edema of Quincke.

· Anaphylactic shock.

Hematological effects

· Leucopenia, neutropenia.

· Thrombocytopenia.

· Haemolytic anemia.