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Humex for Hay fever, Anti-inflammatory, Beclometasone, Nasal Spray Solution, 100 doses

This medication is treatment for hay fever (seasonal rhinitis) during pollen season for adults (from 15 years). More Info
Warning: This is a medicine




    

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Humex Rhume Des Foins Suspension Pour Pulverisation Nasale, 100 Doses

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  • Humex Rhume Des Foins Suspension Pour Pulverisation Nasale, 100 Doses
  • Humex Rhume Des Foins Anti-Inflammatoire, Beclometasone, Suspension Pour Pulverisation Nasale, 100 Doses
  • Humex Rhume Des Foins Anti-Inflammatoire, Beclometasone, Suspension Pour Pulverisation Nasale, 100 Doses

Buy Humex for Hay fever, Anti-inflammatory, Beclometasone, Nasal Spray Solution, 100 doses

Warning: This is a medicine. Please ensure you carefully read all literature provided with your product prior to use. In case of doubt, ask your Doctor or Pharmacist for advice before taking this medicine.

1. NAME OF DRUG


HUMEX HAYFEVER WITH BECLOMETASONE 50mg/dose, nasal spray solution

2. COMPOSITION QUALITATIVE ET QUANTITATIVE


Beclometasone dipropionate: 50 mg
Per dose.
To see a complete list of dilutants, see section 6.1.

3. PHARMACEUTICAL FORM


Suspension pour pulvérisation nasale.Nasal spray solution.

4. CLINICAL DATA


4.1. Therapeutic Indications
This medication is treatment for hay fever (seasonal rhinitis) during pollen season for adults (from 15 years).

4.2. Dosage and how to use
Dosage
Suitable for adults (from the age of 15).
1 spray: 50 mg
The recommended daily dose is 400mg per day (1 spray in each nostril 4 times per day).
The length of treatment depends on pollen exposure.
How to use
Nasal.
Lightly shake the bottle well before use.
If it is the first use or if the pump has not been used for several days, you will need to press down on the pump a few times for the spray to come out.

4.3. Contraindications
This drug is not recommended in the following cases:
· allergy to one of its components,

· haemostasis problems,

· pulmonary tuberculosis

· stomach ulcer

· ear-mouth-nose infection and herpes.

4.4. Special warnings and side effects
Special warnings
Side effects can appear during long-term treatment with high doses. The risk of systemic repercussions is nevertheless less important than with the oral corticosteroids and may vary depending on the individual susceptibility and the composition of the corticoid speciality used. Possible systemic effects are Cushing’-s syndrome or cushingoid symptoms, skin thinning, subcutaneous haematoma, adrenal insufficiency, growth retardation in children and adolescents, decreased bone density, cataract and glaucoma and, more rarely, psychological and behavioural disorders Including psycho-motor hyperactivity, sleep disorders, anxiety, depression or aggression (especially in children).
Joint nasal corticosteroid administration by patients taking long-term oral corticosteroids does not provide the necessary precautions when reducing doses of oral corticosteroid. These will slowly decrease and the withdrawal will be under medical supervision (from examining any potential signs of renal insufficiency).
The risk of systemic, adrenal cortex and growth impairment is increased when simultaneous administration of corticosteroids by inhaled or a fortiori systemic route.
The occurrence of a concomitant bacterial, viral or mycotic broncho-pulmonary infection requires the cessation of local corticosteroids and the introduction of adequate treatment.
Local nasal administration of corticosteroids is not recommended for patients who have recently had a nasal septum ulcer or have had nasal surgery or trauma as long as the cure is not complete.

Precautions for use
It is important to check the permeability of the nasal passages to ensure best results from the product. Inform the patients to dry the nose before using the spray.
In case of nasal obstruction, a detailed examination will need to be carried out.
It is also important to inform the patient that this is not a treatment of the cause and there can be a delay in the effects of the product.
It is recommended that the patients seeks medical advice:
- if no improvement or symptoms persist outside of pollen season,

- if other symptoms appear leading to conjunctivitis or asthma.

For sport players: be aware of an ingredient that will have a positive response when tested for doping.
One bottle per patient.

4.5. Interactions with other drugs
Not applicable.

4.6. Pregnancy and breast feeding
Studies in animals have shown, as with all corticosteroids, a teratogenic effect that varies according to the species.
In clinical studies, epidemiological studies did not reveal any malformative effect related to the use of beclometasone during the first trimester of pregnancy.
The neonatal problems described with general corticosteroid therapy (intrauterine growth retardation, neonatal adrenal insufficiency) have not been reported, to date, during administration of corticosteroids by this route of administration.
As a result, this medication may be prescribed during pregnancy if needed.

4.7. Effects on the ability to drive and operate machinery
Not applicable.

4.8. Side effects
Local effects

- Possibility of dryness and irritation in the nose and throat, headaches and unpleasant tastes & smells.

- Hypersensitive reactions (itching, spots, angioedema).

- Infections of nasal and pharyngeal Candida albicans during local corticosteroid treatment. It is recommended to stop this treatment and find another one.

Rare cases of ocular hypertonia have been reported.

Systematic effects

The risk of systematic effects from this medication have not been excluded (see section 4.4). This risk is increased if you simultaneously take corticoids by inhalation.
The risk of latent corticotropic insufficiency after prolonged administration should therefore be considered in case of intercurrent infection, accident or surgery.
Very rare: glaucoma, cataract.

4.9. Overdose
It can only lead to hypophyso-adrenal suppression and then clinical signs of hypercorticism. These symptoms disappear after treatment is stopped.

5. PHARMACOLOGICAL PROPERTIES


5.1. Pharmaco-dynamic properties
Corticoids, Code ATC: R01AD01.
After taking beclometasone dipropionate, it has an anti-inflammatory effect on the nasal passage.
Beclometasone dipropionate exerts a local therapeutic effect at an average daily dose of 400 micrograms in the adult, whereas its brake effect on the pituitary-adrenal axis by the nasal route only occurs at a dose of 8,000 or more micrograms (8 mg). The difference between therapeutic and hormonal doses, as well as the metabolic inactivation of this product, explains the absence of undesirable general effects at the recommended dosage.

5.2. Pharmacokinetics properties
The beclometasone dipropionate is absorbed by the nasal mucous and is partly swallowed. It is metabolised in the liver then excreted in the biole and urine.

5.3. Preclinical safety data
Not applicable.

6. PHARMACEUTICAL DATA


6.1. List of dilutants
Microcrystalline cellulose, sodium carmellose, anhydrous glucose, benzalkonium chloride, phenylethylic alcohol, polysorbate 80, purified water.

6.2. Incompatibilities
Not applicable.

6.3. Shelf life
3 years.

6.4. Storage precautions
Store in a place below 25°C.

6.5. Nature and contents of outside packaging
100 doses in a 20ml spray bottle (brown glass) with a measure pump and nose piece. 100 doses = 12ml.

6.6. Precautions for handling and disposal
No specific requirements.

7. THE MARKETING AUTHORISATION HOLDER


Laboratoires URGO Soins & Sante
42, rue de Longvic
BP 157
21304 Chenove Cedex

8. NUMBER OF THE MARKETING AUTHORSATION HOLDER


· 343 213-1: 100 doses in a 20ml spray bottle (brown glass).

9. START/RENEWEL DATE OF AUTHORISATION

[To be completed by holder]

10. DATE OF UPDATE OF TEXT

[To be completed by holder]

11. DOSIMETRY

Not applicable.

12. INSTRUCTIONS FOR RADIOPHARMACEUTICAL PREPARATION

Not applicable.

PRESCRIPTION AND DELIVERY CONDITIONS

Drug not subjected to prescription.


If your symptoms persist, consult your doctor.


Last updated the 27/12/2019 at 16:08
Additional Information
Brand Humex
Symptom Rhinitis, Cold, hay fever
Pour qui A partir de 15 ans
Forme Spray nasal
Femme enceinte Non
Pour diabétique Oui
Homéopathie Non
acl code 3400934321313
EAN 3400934321313

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