Treatment during colds of adults and adolescents over 15 years

· Sensations of stuffy nose

· Clear nasal discharge

· Headache and / or fever.

Orally.

RESERVED FOR ADULTS AND ADOLESCENTS OF MORE THAN 15 YEARS.

During the day: 1 tablet, white, to be renewed if necessary after 4 hours, minimum, without exceeding 3 tablets per day.
In the evening at bedtime: 1 tablet, blue if necessary.

The tablet should be swallowed with a drink (eg water, milk, fruit juice).

In the absence of improvement after 4 days of treatment, it is necessary to take a medical opinion.


In patients with renal insufficiency, severe (creatinine clearance, less than 10 ml / min), the interval between 2 doses should be at least 8 hours. The dose of paracetamol should not exceed 3 g per day.

Absence of information in the AMM

R01X - OTHER RHEUME MEDICINES IN ASSOCIATION

This medication combines analgesic, antipyretic paracetamol, an antihistamine diphenhydramine and a vasoconstrictor pseudoephedrine.


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


· Hypersensitivity to any of the constituents of the product

· In children under the age of 15.

· In case of a history of stroke, cerebral or risk factors that may favor the occurrence of stroke, due to the alpha sympathomimetic activity of the vasoconstrictor. >

· In case of severe or poorly balanced hypertension, balanced by treatment.

· In case of severe coronary insufficiency

· If there is a risk of glaucoma by closing the angle

· If there is a risk of urinary retention due to urethroprostatic disorders

· If you have a history of seizures.

· In case of hepatocellular insufficiency due to the presence of paracetamol.

· If you are breast-feeding (see section Pregnancy and breast-feeding).

· In association with non-selective MAOIs due to the risk of paroxysmal hypertension and hyperthermia which may be fatal (see section 4.3).

In combination with sympathomimetics with indirect action: vasoconstrictors intended to decongest the nose, whether administered orally or nasally (phenylephrine (alias, neosynephrine), pseudoephedrine, ephedrine] and methylphenidate; Vasoconstriction and / or hypertensive (see Interactions with other medicines and other forms of interactions.)

In combination with alpha sympathomimetics, vasoconstrictors to relieve congestion, nose, whether administered orally or nasally, [etiletrin, naphazoline, oxymetazoline, phenylephrine (aka neosynhephrine), synephrine, tetrazoline, tuaminoheptane, tymazoline] , As well as midodrine, due to the risk of vasoconstriction and / or hypertensive outbreaks (see section 4.4 Interactions with other medicinal products and other forms of interaction).

The combination of two decongestants is contraindicated irrespective of the route of administration (oral and / or nasal): such an association is unnecessary and dangerous and corresponds to misuse.
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This medication MUST NOT BE GENERALLY USED IN PREGNANCY (see Pregnancy and Breastfeeding).

In case of high or persistent fever, signs of superinfection or persistence of symptoms, a reassessment of treatment should be carried out beyond 4 days.

Special warnings

Because of the presence of pseudoephedrine

· It is imperative to strictly observe the dosage, the duration of treatment of 4 days, contraindications (see section Undesirable effects)

Patients should be informed that the occurrence of arterial hypertension, tachycardia, palpitations or heart rhythm disorders, nausea, or any neurological signs (such as the onset or increase of headache ) Requires the cessation of processing.

· Patients are advised to take medical advice in case of high blood pressure, heart ailments, hyperthyroidism, psychosis or diabetes. >
The use of this medication is not recommended because of the risk of vasoconstriction and / or hypertensive outbreaks related to its indirect sympathomimetic activity with the following medications (see section 4.3 Interaction with other medicinal products and other forms of interaction )

· Selective MAO-A

· Dopaminergic ergot alkaloids (bromocriptine, cabergoline, lisuride or pergolide) or vasoconstrictors (dihydroergotamine, ergotamine, methylergometrine or methysergide). >
· In association with linezolid.

· Neurological disorders such as convulsions, hallucinations, behavioral disturbances, restlessness, insomnia have been described more frequently in children following systemic administration of vasoconstrictors, During febrile episodes or during overdoses.

Therefore, it is appropriate, in particular

· Not to prescribe this treatment in combination with drugs capable of lowering the threshold, epileptogenic such as: derivatives, terpenics, clobutinol, atropine substances, local anesthetics ... or in case of convulsive antecedents

· To comply with the recommended dosage in all cases and to inform the patient of the risks of overdose in association with other medicinal products containing vasoconstrictors.

Due to the presence of paracetamol

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

In adults and children over 50 kg, TOTAL DOSE OF PARACETAMOL MUST NOT EXCEED 3 GRAMS PER DAY (see section on Overdose). >
Precautions for use

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 renal insufficiency due to the risk of accumulation

Because of the presence of diphenhydramine, it is not advisable to take alcoholic drinks or medicines containing alcohol or sedatives (barbiturates in particular) during the treatment because they potentiate the sedative effect of antihistamines; (See section Interactions with other medicinal products and other forms of interactions)

The attention of athletes is drawn to the fact that pseudoephedrine may induce a positive reaction of the tests carried out during the anti-doping tests.
Related to the presence of paracetamol

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.

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

Related to the presence of pseudoephedrine

Associations contraindicated

(See section Contraindications, Contraindications)

+ Non-selective MAOI

Paroxysmal hypertension, hyperthermia, potentially fatal. Owing to the duration of action of the MAOI, this interaction is still possible 15 days after, the stop of the MAOI.

+ Other indirect sympathomimetics (ephedrine, methylphenidate, phenylephrine (alias neosynephrine), pseudoephedrine)
Risk of vasoconstriction and / or seizures, hypertensive.

Sympathomimetics alpha (oral and / or nasal route) (etiletrin, midodrine, naphazoline, oxymetazoline, phenylephrine, synephrine, tetrazoline, tuaminoheptane, tymazoline)
Risk of vasoconstriction and / or hypertensive outbreaks

Associations, deprecated

(See Warnings and Precautions for Warnings and Special Precautions)

+ Dopaminergic ergot alkaloids (bromocriptine, cabergoline, lisuride, pergolide)
Risk of vasoconstriction and / or hypertensive outbreaks

Vasoconstrictive rye ergot alkaloids (dihydroergotamine, ergotamine, methylergometrine, methysergide)
Risk of vasoconstriction and / or hypertensive outbreaks

+; Selective MAOI-A (moclobemide, toloxatone)

Risk of vasoconstriction and / or hypertensive outbreaks

+; Linézolide

Risk of vasoconstriction and / or hypertensive outbreaks

Association which is the subject of precautions for use

Halogenated volatile anesthetics

Intraoperative hypertensive outbreak.

In the event of a scheduled intervention, it is preferable to interrupt the treatment a few days before the procedure.
Related to the presence of diphenhydramine

+ Drugs, atropine drugs

It is necessary to take into account the fact that atropine substances can add up to their undesirable effects and lead more easily to urinary retention, acute glaucoma, constipation, dry mouth etc.

The various atropinic drugs are represented by antidepressants, imipraminic, most antihypertensive H1 antihistamines, antiparkinsonian anticholinergic, antispasmodic, atropinic, disopyramide, neuroleptic, phenothiazinic as well as clozapine.

+ 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), antihistamines H1, sedatives, central antihypertensives, baclofen and thalidomide
Associations, deprecated

(See Warnings and Precautions for Warnings and Special Precautions)

+ 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

Not applicable.

Related to pseudoephedrine

Pseudoephedrine overdose may result in: hypertensive, rhythm disorders, convulsions, delirium, hallucinations, restlessness, behavioral problems, insomnia, mydriasis, stroke. >
Related to diphenhydramine

Overdosage of diphenhydramine may result in convulsions (especially in children), unconsciousness, coma.


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

Nausea, vomiting, anorexia, pallor, abdominal pain appear, usually in 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 liver transaminases, lactic dehydrogenase, bilirubin and decreased prothrombin levels which may occur 12 to 48 hours after ingestion.

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

· Acidify the urine by giving ammonium chloride (to increase the elimination of pseudoephedrine)

· Treatment of overdose typically involves administration as early as possible of the antidote, N-acetylcysteine ​​IV or oral if possible before the tenth hour.

· Symptomatic treatment.

The presence of pseudoephedrine among the constituents conditions the course to be taken during pregnancy and lactation.


There are no reliable data for teratogenesis in animals.

In clinical studies, epidemiological studies have not revealed any malformative effect related to the use of pseudoephedrine.
Breastfeeding

Pseudoephedrine passes into breast milk. In view of the possible cardiovascular and neurological effects of vasoconstrictors, the use of this medication is contraindicated during breastfeeding.
Hypersensitivity reactions related to any of the components of this medicinal product

Related to the presence of pseudoephedrine

Cardiac disorders

· Palpitations.

· Tachycardia.

· Myocardial infarction.

Visual Disorders

· Glaucoma crisis by closing the angle.

Gastrointestinal Disorders

· Dry mouth.

· Nausea.

· Vomiting.

Nervous system disorders

· Hemorrhagic stroke, especially in patients who have used pseudoephedrine hydrochloride specialties: These vascular and cerebral accidents have occurred during overdosage or misuse in patients with vascular risk factors. Code>
· Ischemic vascular accidents.

· Headache.

· Convulsions.

Psychiatric disorders

· Anxiety.

· Agitation.

· Behavior disorders.

· Hallucinations.

· Insomnia.

Fever, overdose, drug combination, which may decrease the epileptogenic threshold or promote overdosage, have often been found and appear to predispose to the occurrence of such effects (see section 4.3). And precautions for use.).

Urinary system disorders

· Dysuria (especially in case of disorders, urethroprostatic).

· Urinary retention (especially in case of disorders, urethroprostatic).

Skin disorders

· Sweats.

· Exanthema.

· Pruritus

· Urticaria.

Vascular disorders

· Hypertension (hypertensive outbreak).

Related to the presence of paracetamol

A few cases of hypersensitivity reactions such as anaphylactic shock, angioedema, erythema, urticaria, skin rash have been reported. Their occurrence requires the definitive discontinuation of this medicinal product and related medicinal products.


Related to the presence of diphenhydramine

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

Neurovegetative effects

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

· Orthostatic hypotension

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

· Motor incoordination, tremor

· Mental confusion, hallucinations

· More rarely, effects are to type of excitation, agitation, nervousness, insomnia.

Hypersensitivity reactions (rare)

· Erythema, pruritus, eczema, purpura, urticaria

· Edema, more rarely Quincke edema

· Anaphylactic shock.

Hematological effects

· Leucopenia, neutropenia

· Thrombocytopenia

· Haemolytic anemia.

Treatment during colds of adults and adolescents over 15 years of age · stuffy nose sensations · clear nasal discharge · headache and / or fever. Code>