humoxal solution nasale Uses, Dosage, Side Effects, Precautions & Warnings
Generic drug of the Therapeutic class: Dermatology
Active ingredients: Phenylephrine, Benzalkonium chloride
Medicinal product withdrawn from the market on 02/20/2018
Table of Contents
what is humoxal medication used for and indication?
It is indicated as a short-term local adjunct treatment, antibacterial and decongestant, in rhinitis, sinusitis and nasopharyngitis in adults and adolescents over 15 years.
PRESENTATION (S) AVAILABLE FOR HUMOXAL
2 presentations are available for this medication:
- 1 glass spray bottle (s) of 10 ml with polypropylene dosing pump (s)
- 1 glass spray bottle (s) of 15 ml with dosing pump
FEATURE | DESCRIPTION |
Pharmaceutical class | nasal preparations |
Active substance (s) | per 100 ml: phenylephrine (hydrochloride) (0.250 g), benzalkonium (chloride) (0.040 g) |
General medicine | no |
Pharmaceutical form | solution |
Route (s) of administration | nasal |
Selling price | unregulated price |
Social security reimbursement rate | 0% |
Laboratory (s) | Laboratory (s) manufacturer Humoxal |
Conditions of issue | available by simple prescription |
humoxal Dosage
- RESERVED FOR ADULTS and ADOLESCENTS OVER 15 YEARS OLD.
- Adults and adolescents over 15 years: 1 spray in each nostril, 3 to 5 times a day.
- IN ALL CASES, FOLLOW YOUR DOCTOR’S ORDER.
- If you have the impression that the effect of ANACORYL nasal solution is too strong or too weak, talk to your doctor or pharmacist.
humoxal Contraindications
Never use HUMOXAL, nasal solution in the following cases:
- In case of known allergy to any of the constituents of this medication.
- Child under 15 years old.
- If you have had a stroke.
- In case of severe arterial hypertension or not well balanced by the treatment.
- In case of severe heart disease (coronary insufficiency).
- If you have certain forms of glaucoma (increased pressure in the eye).
- In case of difficulty urinating of prostatic or other origin.
- In case of old or recent convulsions.
- If you are breast-feeding.
- In combination with non-selective MAOIs due to the risk of paroxysmal hypertension and hyperthermia which can be fatal.
- In combination with other sympathomimetics with indirect action, vasoconstrictors intended to decongest the nose whether they are administered orally or nasally [phenylephrine (aka neosynephrine), pseudoephedrine, ephedrine, etc.] and methylphenidate because of the risk of vasoconstriction and / or flare-ups hypertensive.
- In combination with alpha-type sympathomimetics, vasoconstrictors intended to decongest the nose whether administered orally or nasally [etilefrin, midodrine, naphazoline, oxymetazoline, phenylephrine, synephrine, tetryzoline, tuaminoheptane, tymazoline] because of the risk of vasoconstriction and / or hypertensive outbreaks.
The combination of two decongestants is contraindicated, whatever the route of administration (oral and / or nasal): such a combination is unnecessary and dangerous and corresponds to misuse.
You should generally not use this medicine, unless your doctor tells you otherwise, during pregnancy.
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.
How To Take humoxal ?
Method and route of administration
- Nasal sprays are done with the bottle in an upright position, with the head tilted slightly forward, to avoid swallowing the product.
- Before first use, prime the dosing pump by pressing several times sharply outside the nostril.
- Insert the end of the nasal nozzle into the nostril after removing its protective cap and press as shown in the diagram below.
Duration of treatment
- The maximum duration is 3 to 5 days.
how does humoxal work?
- SYMPATHOMIMETICS IN ASSOCIATION EXCEPT CORTICOIDS, ATC Code: R01AB01
- This medication is a combination of an indirect sympathomimetic, vasoconstrictor, decongestant by the nasal route and an antiseptic, benzalkonium chloride.
How To Store humoxal ?
Keep out of the reach and sight of children.
Expiration date
- Do not use HUMOXAL, nasal solution after the expiry date stated on the bottle. The expiration date refers to the last day of the month.
Storage conditions
- No special storage conditions.
humoxal Side Effects
Like all medicines, HUMOXAL nasal solution can cause side effects, although not everybody gets them.
This medicine can cause:
Linked to the presence of phenylephrine
Local effects:
- phenomena of nasal dryness may occur in some patients and exceptionally, local allergic manifestations.
General effects such as:
- headaches, strokes,
- palpitations, high blood pressure, myocardial infarction, sweating, behavioral disturbances, nausea, vomiting,
- the onset of an acute glaucoma attack in susceptible subjects, which can result in a red and painful eye.
IN THESE CASES, STOP THE TREATMENT AND CONTACT YOUR DOCTOR IMMEDIATELY.
Can also occur:
- urinary disorders (significant decrease in urine, difficulty in urinating),
- dry mouth
- convulsions, hallucinations, agitation, behavioral disturbances and insomnia have been described,
- exceptionally, hemorrhagic cerebrovascular accidents have been reported in patients treated with medicinal products containing a vasoconstrictor, in particular in the event of overdose, non-compliance with contraindications or warnings, or in patients presenting vascular risk factors.
If you notice any side effects not mentioned in this leaflet, please tell your doctor or pharmacist.
Keep out of the reach and sight of children.
humoxal Interactions
If you are taking or have recently taken any other medicines, including medicines obtained without a prescription, talk to your doctor or pharmacist.
This medication contains a vasoconstrictor: phenylephrine.
This medicine must not be administered in combination with:
- other vasoconstrictors, whether administered orally or nasally (phenylephrine (alias neosynephrine), pseudoephedrine, ephedrine, methylphenidate, etilefrin, midodrine, naphazoline, oxymetazoline, phenylephrine, synephrine, tetryzoline, tuaminoheptane),
- a non-selective MAOI (iproniazid).
It is not recommended to use this medicine if you are already being treated:
- by a selective MAO-A drug, a drug prescribed in certain depressive states;
- and / or by other dopaminergic or vasoconstrictor drugs such as bromocriptine, cabergoline, lisuride, pergolide or dihydroergotamine, ergotamine, methylergometrine, methysergide, drugs prescribed to treat certain neurological or endocrine disorders or migraines ;
- with linezolid
Effects on ability to Drive and use machines
- Not applicable.
- Not applicable.
- Not applicable.
- Not applicable.
Warnings and Precautions
Special warnings
Follow the instructions for use and the doses recommended in this leaflet.
Do not swallow.
From the opening of the packaging, and a fortiori from the first use of a preparation for nasal use, microbial contamination is possible. Do not keep an opened preparation for nasal use for too long, in particular do not reuse it for another treatment.
DO NOT LEAVE THIS MEDICINAL PRODUCT IN THE REACH OR SIGHT OF CHILDREN.
It is imperative to strictly observe the dosage, the maximum duration of treatment of 3 to 5 days and the contraindications.
During the treatment, in case of sensation of acceleration of the heartbeat, palpitations, appearance or increase of headaches, appearance of nausea, behavioral disturbances,
STOP TREATMENT AND CONTACT YOUR DOCTOR IMMEDIATELY.
TELL YOUR DOCTOR if you suffer from:
- high blood pressure,
- heart disease, hyperthyroidism (hyperfunction of the thyroid gland),
- personality disorders,
- of diabetes.
TELL YOUR DOCTOR if you are taking:
- a selective MAO-A (moclobemide, toloxatone)
- a treatment containing a rye ergot alkaloid:
- dopaminergic, such as bromocriptine, cabergoline, lisuride or pergolide, (eg an antiparkinsonian);
- vasoconstrictor, such as dihydroergotamine, ergotamine, methylergometrine, methysergide), (eg an anti-migraine medication);
- linezolid.
In case of purulent nasal discharge, persistent fever, no improvement after 3 to 5 days of treatment, CONSULT YOUR DOCTOR.
Related to the presence of benzalkonium chloride
Due to the presence of benzalkonium chloride, this medication may cause breathing difficulties.
IF IN DOUBT, DO NOT HESITATE TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.
PREGNANCY & BREAST-FEEDING & FERTILITY
Pregnancy
- Clinically, epidemiological studies have not revealed any malformative effect linked to the use of phenylephrine. However, as a precaution and given the potent vasoconstrictor properties of this drug, it is best not to use it during pregnancy. However, in the event of administration, the prescription will be made in accordance with the recommended dosage and duration of administration.
Feeding with milk
- There are no data concerning the passage of phenylephrine in breast milk. In view of the vasoconstrictor properties of phenylephrine and the possible occurrence of cardiovascular and neurological effects in infants, the intake of this drug is contraindicated during breast-feeding.
What happens if I overdose from humoxal ?
In case of repeated or abusive administration, phenylephrine can cause, by systemic passage: hypothermia, sedation, loss of consciousness, coma or respiratory depression.
What should I do if I miss a dose?
If you forget to take HUMOXAL, nasal solution:
- Do not use a double dose to make up for the dose you forgot to use. Continue your treatment as prescribed.
What happens if you stop taking humoxal ?
- Not applicable.
- Not applicable.
- Not applicable.
- Not applicable.
What is Forms and Composition ?
Appearance and shape
- Lack of information in the MA.
- 15 ml in spray bottle (glass) with dosing pump (polypropylene).
Composition
Nasal solution Active ingredient
0.04 g *
Phenylephrine
0.25 g * * per unit dose
Active ingredients: Benzalkonium chloride , Phenylephrine
NOT’s
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general information:
- Includes a general description of the drug, its use, brand names, FAQs, and relevant news and articles
Additional information:
- General explanation about dealing with the medicine: how to take the medicine, the doses and times of it, the start and duration of its effectiveness, the recommended diet during the period of taking the medicine, the method of storage and storage, recommendations in cases for forgetting the dose and instructions to stop taking the drug and take additional doses.
Special warnings:
- For pregnant and breastfeeding women, the elderly, boys and drivers, and use before surgery.
Side effects:
- It treats possible side effects and drug interactions that require attention and its effect on continuous use.
- The information contained in this medicine is based on medical literature, but it is not a substitute for consulting a doctor.