Short-term local treatment of acute congestive conditions during rhinitis and sinusitis in adults and adolescents over 15 years

RESERVED FOR ADULTS AND ADOLESCENTS OVER 15 YEARS

Adult and adolescents over 15 years of age, 1 spray in each nostril, 2 to 3 times a day,

The maximum duration of treatment is from 3 to 5 days.

Mode of administration

The nasal sprays are done with the bottle in a vertical position with the head slightly leaning forward to avoid swallowing the product

Class: Pharmacotherapeutic: SYMPATHOMIMETICS NOT ASSOCIATED ATC code: R01AA05.
This medication is an alpha sympathomimetic, vasoconstrictor and nasal decongestant.
Not applicable.

This medication is contraindicated in the following cases

· Hypersensitivity to any of the constituents of the product

· Child under 15 years old

· History of stroke, cerebral or risk factors that may favor the occurrence of stroke, due to the alpha sympathomimetic activity of the vasoconstrictor.

· Hypertension severe or poorly balanced by treatment

· Severe coronary insufficiency

· Risk of glaucoma by closing the angle

· Risk of urinary retention due to urethro-prostatic disorders

· History of convulsions.

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, The risk of vasoconstriction and / or hypertensive outbreaks (see section Interactions with other medicinal products and other forms of interaction)

The combination of two decongestants is contraindicated, regardless of the route of administration (oral and / or nasal): one such combination is unnecessary and dangerous and corresponds to misuse.

Special warnings

Due to the presence of oxymetazoline

Do not swallow.

Do not use prolonged, because of a risk of rebound and rhinitis, iatrogenic

As soon as the packaging is opened, and a fortiori from the first use, a preparation for nasal use, microbial contamination is possible.
Repeated and / or prolonged instillations may lead to a significant systemic passage of active ingredients

It is imperative to strictly observe the dosage, the duration of treatment from 3 to 5 days, contraindications (see section Contraindications)
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Patients should be informed that the occurrence of arterial hypertension, tachycardia, palpitations or disorders, heart rhythm, nausea or any neurological signs (such as the onset or increase of headache) Imposes the cessation of processing.

Similarly, treatment monitoring should be enhanced in cases of hypertension, arterial disease, heart disease, hyperthyroidism, psychosis or diabetes.

The use of this medication is discouraged due to the risk of vasoconstriction and / or hypertensive outbreaks related to its sympathomimetic activity, alpha, with the following medications (see section 4.3): Interactions with other medicinal products and other forms of d 'Interactions)

· Non-selective MAOIs (iproniazide).

Dopamine ergot alkaloids (bromocriptine, cabergoline, lisuride or pergolide) or vasoconstrictors (dihydroergotamine, ergotamine, methylergometrine or methysergide). >
Neurological disorders such as seizures, convulsions, hallucinations, behavioral disturbances, agitation, 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 medicines that may lower the threshold, epileptogens such as: derivatives, terpenes, clobutinol, atropine substances, local anesthetics ... or in case of convulsive antecedents

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

Related to the presence of excipient

Due to the presence of benzalkonium chloride, this drug may cause edema of the nasal mucosa, especially in the case of long-term use, and respiratory discomfort.

Precautions for use

The attention of athletes is drawn to the fact that oxymetazoline may induce a positive reaction of tests carried out during doping controls.
Related to the presence of oxymetazoline

Associations, contraindicated

+ Indirect Sympathomimetics

[Phenylephrine (aka neosynhephrine), pseudoephedrine, ephedrine) and methylphenidate]

Risk of vasoconstriction and / or hypertensive outbreaks

Associations, deprecated

+ Non-selective MAOIs (iproniazide)

Hypertensive crises (inhibition of the metabolism of pressing amines). Due to the long action of MAOIs, this interaction is still possible 15 days after the end of MAOI.

+ 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

Not applicable.

In the event of repeated or abusive administration, oxymetazoline may cause systemic hypothermia, sedation, loss of consciousness, coma or respiratory depression.
Pregnancy

There is no reliable evidence of teratogenesis in animals.

In clinical use, the use of oxymetazoline in a limited number of pregnancies has apparently shown no particular malformative or fetotoxic effects to date, but additional studies are needed to assess the consequences; Of an exposure during pregnancy.

Therefore, because of the long duration of action of this drug and possible neonatal effects related to the powerful vaso-constrictive properties of this drug, the use of oxymetazoline is not recommended during pregnancy. >

Breastfeeding

There are no data concerning the passage of oxymetazoline into breast milk. Therefore, it is not recommended to administer oxymetazoline during the breastfeeding period

Related to the presence of oxymetazoline

Cardiac disorders

· Palpitations.

· Tachycardia.

· Myocardial infarction.

Visual Disorders

· Glaucoma crisis by closing the angle.

Gastrointestinal Disorders

· Dry mouth.

· Nausea.

· Vomiting.

Nervous system disorders

· Cerebral hemorrhagic strokes, especially in patients who have used pseudoephedrine hydrochloride specialties, these vascular accidents have occurred during overdosage or misuse in patients with vascular risk factors

· Ischemic vascular accidents.

· Headache.

· Convulsions.

Psychiatric disorders

· Anxiety.

· Agitation.

· Behavior disorders.

· Hallucinations.

· Insomnia.

A fever, overdose, drug combination that may lower the threshold, epileptogenic or promote overdosage, have often been found and appear to predispose to the occurrence of such effects (see Contraindications and Warnings 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).

Local effects

· Sensation of nasal dryness. Exceptionally, allergic local manifestations.

Short-term local treatment of acute congestive conditions during rhinitis and sinusitis in adults and adolescents over 15 years