This medication is indicated for the treatment of colds, rhinitis, nasopharyngitis, and influenza-like conditions in adults and children over the age of 15


· Clear nasal discharge and tears

· Sneezing

· Headache and / or fever.

RESERVED FOR ADULTS AND CHILDREN OVER 15 YEARS

Mode of administration

Oral use.

This medication is indicated for the treatment of colds, rhinitis, nasopharyngitis, and influenza conditions in adults and children over 15 years of age, · clear nasal discharge and watery eyes Sneezing · headache and / or fever

Pour the contents of the sachet into a large glass of water.

Take the sachet preferably 1/4 hour before meals.

Due to the sedative effect of chlorphenamine maleate, preference should be given to the evening meal.


The usual dosage is 1 sachet, to be renewed if necessary after 4 hours minimum, without exceeding 4 sachets per day

1 sachet contains 500 mg of paracetamol.

For adults and children over 15 years of age, the dose of paracetamol is 1 g per dose and 3 g 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. >
The maximum duration of the treatment is 5 days.

In case of persistence of fever, or pain, the treatment course to be taken should be re-evaluated.


ANTIHISTAMINIC H1

(R: Respiratory System)

(N: central nervous system)

This medication is a combination of 3 active ingredients

· An analgesic: paracetamol

· An antihistamine: chlorphenamine maleate

· Vitamin C.

Chlorphenamine maleate, antihistamine H1, propylamine structure, with anticholinergic activity, causing undesirable effects

H1 antihistamines have the common property of opposing, by more or less reversible competitive antagonism, the effects of histamine, especially on the skin, bronchi, intestine and vessels. Br>

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 alcohol-containing medicines.
· This medication is contraindicated in the following situations

O Hypersensitivity to one of the constituents of the sachet-dose

O Hepatocellular insufficiency due to the presence of paracetamol

O Due to the presence of chlorphenamine maleate

Risk of glaucoma by closure of the angle

Risk of urinary retention due to urethro-prostatic disorders

Due to the presence of chlorphenamine maleate, this medication should not be used for breast-feeding (see section Pregnancy and lactation).
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In case of high fever, signs of superinfection or persistence of symptoms beyond 5 days, a re-evaluation of the treatment should be made.
Special 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 in adults and children over 50 kg: the total dose of paracetamol should not exceed 4 grams per day (see section 4.4).

· The maximum dose of chlorphenamine maleate is 4 mg per dose and 16 mg per day.
This medicinal product contains sucrose. Its use is discouraged in patients with fructose intolerance, glucose-galactose malabsorption syndrome or sucrase / isomaltase deficiency

Precautions for use

This medicinal product contains 1.19 g of sucrose per dose to be taken into account in the diet in the case of a diet low in sugar or diabetes. Code>
Related to paracetamol

The excretion of paracetamol and its metabolites is mainly in the urine.

In the case of severe renal insufficiency, the catch must be spaced at least 8 hours apart.
Related to chlorphenamine maleate

Monitoring of treatment should be strengthened in the following cases

· 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 liver and / or renal insufficiency, severe, due to the risk of accumulation

The use of alcoholic beverages or medicines containing alcohol (see Interactions with other medicinal products and other forms of interactions) during treatment is not recommended.

Interactions related to the presence of paracetamol

Interactions with paraclinical examinations

Taking paracetamol may distort the blood glucose dosage 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.

Interactions related to the presence of 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 (Amitryptline, doxepin, mianserin, mirtazapine, timipramine), antihistamines H1, sedatives, central antihypertensives, baclofen and thalidomide
Associations, deprecated

+ Consumption of alcohol

Alcohol enhancement of the sedative effect of chlorphenamine maleate Altering alertness can make driving and use of machinery dangerous. Avoid alcoholic beverages and other medicines containing alcohol

Associations subject to precautions for use

+ Oral anticoagulants

Risk of increase in the effect of oral anticoagulant and hemorrhagic risk if paracetamol is taken at maximum doses (4 g / d) for at least 4 days. Regular monitoring of INR. Possible adaptation of the dosage of the oral anticoagulant during treatment with paracetamol and after its 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).
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In case of hemocromatosis, 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 of Chlorphenamine Maleate Overdose: Risk of Convulsions, Conscience Disorders, Coma

Symptoms of an overdose in paracetamol: nausea, vomiting, anorexia, pallor, abdominal pain appear, usually within the first 24 hours.
Overdosage with 10 g of single-dose paracetamol in adults and 150 mg / kg of body weight in a single dose in children results in liver cytolysis that may result in necrosis Complete and irreversible, resulting in hepatocellular insufficiency, metabolic acidosis, encephalopathy which can lead to coma and death.

At the same time, there is an increase in hepatic transaminases, lactic dehydrogenase, bilirubin and decreased prothrombin levels which may occur 12 to 48 hours after ingestion.

Driving emergency

· Immediate transfer to hospitals

· Take a tube of blood to do the plasma dosage of paracetamol initial

· 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

The presence of chlorphenamine maleate conditions the course to be taken in case of pregnancy or lactation

Pregnancy

There is no reliable evidence of teratogenesis in animals.

In clinical studies, epidemiological studies have not revealed any malformative or fetotoxic effect related to the use of chlorphenamine and paracetamol.
Accordingly, chlorphenamine can be prescribed during pregnancy if necessary. In the case of administration at the end of pregnancy, take into account the possible repercussions for the newborn of the atropine and sedative properties of this molecule.
Breastfeeding

The passage of chlorphenamine in breast milk is not known. Considering the possibilities of sedation or paradoxical excitation of the newborn, this medication is not recommended for breastfeeding

Related to the presence of paracetamol

A few cases of reaction: hypersensitivity to anaphylactic shock, angioedema, erythema, urticaria, rash, skin have been reported. Their occurrence requires the permanent cessation of this drug and related medicines. Very exceptional cases of thrombocytopenia, leukopenia and neutropenia have been reported.
Related to the presence of chlorphenamine maleate

The pharmacological characteristics of chlorphenamine are the cause of adverse effects of unequal, intensity and dose-related (see section 5.2).

Neurovegetative effects

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

· Orthostatic hypotension

· Anticholinergic effect on the type of dryness of the mucous membranes, constipation, disorders of accommodation, mydriasis, heart palpitations, urinary disorders (dysuria, retention)
· Disorders of balance, dizziness, decreased memory or concentration, more common in the elderly

· Motor incoordination, tremor

· Mental confusion, hallucinations

Hypersensitivity reactions

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

· Anaphylactic shock.

Hematological effects

· Leucopenia, neutropenia

· Thrombocytopenia

· Haemolytic anemia.