NOTICE
ANSM - Last updated: 11/05/2017
Name of the medicinal product
HUMEX BECLOMETASONE HAY OF HAY 50 micrograms / dose, nasal spray suspension in vial
Beclometasone Dipropionate
framed
Read this leaflet carefully before you start using this medicine. It contains important information for your treatment.
· This medication is a specialty of AUTOMEDIZATION which can be used without consultation or prescription from a doctor.
· The persistence of the symptoms, the aggravation or the appearance of new disorders, require to take a medical opinion.
· Keep this leaflet, you may need to read it again.
· If you need more information and advice, ask your pharmacist or doctor.
Review summary
In this notice :
1. WHAT HUMEX CHEESE HUMEX BECLOMETASONE 50 micrograms / dose, suspension for nasal sprays in a vial AND WHAT CASES IS IT USED FOR?
2. BEFORE YOU USE HUMEX HUMAN HAY OF BECLOMETASONE HAY 50 micrograms / dose, nasal spray suspension in a vial?
3. HOW TO USE HUMEX HUMAN HAY AT BECLOMETASONE 50 micrograms / dose, nasal spray suspension in vial?
4. WHAT ARE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE HUMEX HUMAN HAY AT BECLOMETASONE 50 micrograms / dose, nasal spray suspension in vial?
6. ADDITIONAL INFORMATION
1. WHAT HUMEX CHEESE HUMEX BECLOMETASONE 50 micrograms / dose, suspension for nasal sprays in a vial AND WHAT CASES IS IT USED FOR?
Pharmacotherapeutic group
This medicine contains a corticosteroid. It is an anti-inflammatory treatment that is administered nasally.
Therapeutic indications
This medication is indicated in adults (from 15 years of age) in the treatment of "hay fever" (seasonal allergic rhinitis) during the duration of exposure to the pollen (s) responsible.
How to recognize a hay fever: see Health Education Tips .
2. BEFORE YOU USE HUMEX HUMAN HAY OF BECLOMETASONE HAY 50 micrograms / dose, nasal spray suspension in a vial?
List of information needed before taking the medication
Not applicable.
Cons-indications
Do not use HUMEX HUMAN HAY OF BECLOMETASONE 50 micrograms / dose, nasal spray suspension in vial in the following cases:
· allergy known to any of the constituents,
· blood clotting disorders (including nosebleeds),
· untreated pulmonary tuberculosis,
· untreated digestive ulcer,
· nasal, oral and ocular herpes infection.
IN CASE OF DOUBT, YOU MUST REQUEST THE NOTICE OF YOUR DOCTOR OR PHARMACIST.
Precautions for use; special warnings
Take special care with HUMEX BECLOMETASONE HAY OF HAY 50 micrograms / dose, nasal spray suspension in vial:
Special warnings
· DO NOT LEAVE THIS MEDICINE FOR CHILDREN.
· This medication should only be used in the case of hay fever . In order to recognize a hay fever, read the health education advice carefully.
· CONSULT YOUR DOCTOR
1- in the absence of improvement after one week,
2- in case of fever, sputum, purulent nasal discharge,
3- in the event of other disorders evoking conjunctivitis or asthma (shortness of breath, wheezing, cough ...),
4- if the symptoms of hay fever continue beyond the period of exposure to pollen.
· This product is not recommended in patients who have recently undergone surgery or trauma to the nose as long as the healing is not complete.
· In case of infection, other diseases, surgery, it is imperative to report to your doctor the treatment in progress.
Precautions for use
This medicine contains a corticosteroid: beclometasone . If you are already taking a medication containing corticosteroids (regardless of the route of administration), you should seek the advice of your doctor before taking this medication. |
· The maximum efficacy of this medication is only reached after 2 or 3 days and depends on the rigorous compliance of the dosage.
In case of aggravation or lack of improvement after one week:
o do not increase doses beyond what is recommended
o but take the OPINION OF YOUR DOCTOR
· Any opened bottle should be reserved for one patient only.
Interaction with other medicines
Taking or using other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. Even if it is a non-prescription drug.
Interactions with food and beverages
Not applicable.
Interactions with Herbal Medicines or Alternative Therapies
Not applicable.
Use during pregnancy and lactation
If you are pregnant or breastfeeding
Do not take this medicine without consulting your doctor or pharmacist. |
Pregnancy
This medication will only be used during pregnancy on the advice of your doctor.
Sport
Sports :
Attention , this specialty contains an active principle that can induce a positive reaction of the tests carried out during anti-doping controls.
Effects on ability to drive or use machines
Not applicable.
List of excipients with known effect
Not applicable.
3. HOW TO USE HUMEX HUMAN HAY AT BECLOMETASONE 50 micrograms / dose, nasal spray suspension in vial?
Instructions for proper use
RESERVED FOR THE ADULT (FROM 15 YEARS).
Dosage, Mode and / or route (s) of administration, Frequency of administration and Duration of treatment
Dosage
Take as soon as symptoms appear and during the period of pollen exposure, spray into each nostril 4 times a day, distributing the catch.
Never exceed this dose.
Administration mode
Nasal route.
Frequency of Administration
The efficacy of beclometasone dipropionate is optimal with 1 spray in each nostril, 4 times per day by distributing the catch.
Duration of treatment
The presence of a pollen varies from 2 to 6 weeks and determines the duration of your treatment. Your pharmacist will inform you about the pollen schedule.
The maximum duration of treatment is 6 weeks. |
Symptoms and Instructions for Overdose
If you used more HUMEX HUMAN HAYS TO BECLOMETASONE 50 micrograms / dose, nasal spray suspension in a vial you should:
Contact your doctor or pharmacist immediately.
In all cases, comply with your doctor's prescription. Do not increase or decrease the dose without the advice of your doctor or pharmacist.
Instructions for omission of one or more doses
If you forget to take HUMEX HUMAN HAY TO BECLOMETASONE 50 micrograms / dose, nasal spray suspension in vial :
Take the next dose at the usual time regardless of the forgotten spray.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Description of adverse reactions
Like all medicines, HUMEX HAIR CREAM TO BECLOMETASONE 50 micrograms / dose, nasal spray suspension in a vial is likely to have side effects, although not everyone is subject to it.
In some people, this medication may cause irritation (sneezing, runny nose, itching).
They generally cease spontaneously.
Very rarely, a nasal discharge tinged with blood can occur: this phenomenon is also early and transient.
Allergic reactions may occur: rash, hives, itching, unusually swollen face or throat. They require immediate consultation with your doctor.
Nasal mycosis (a condition due to the development of certain microscopic fungi) may sometimes appear, and treatment should be discontinued and appropriate treatment should be considered. Consult your doctor.
Very rare: possibility of glaucoma (increased pressure inside the eye), cataract (opacification of the lens of the eye).
If you notice any side effects not listed in this leaflet, or if any of the side effects gets serious, contact your doctor or pharmacist.
5. HOW TO STORE HUMEX HUMAN HAY AT BECLOMETASONE 50 micrograms / dose, nasal spray suspension in vial?
Keep out of the reach and sight of children.
Expiration date
Do not use HUMEX HUMAN HAY OF BECLOMETASONE 50 micrograms / dose, nasal spray suspension in a vial after the expiry date stated on the carton.
Storage conditions
Store at a temperature not exceeding 25ºC.
If necessary, warnings against visible signs of deterioration
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist what to do with unused medications. These measures will help protect the environment.
6. ADDITIONAL INFORMATION
Full list of active substances and excipients
What does HUMEX HUME HUMAN HAIR TO BECLOMETASONE contain 50 micrograms / dose, suspension for nasal sprays in vial?
The active substance is:
Dipterionate of beclometasone ............................................... ........................................... 50 micrograms
For a dose.
The other components are:
Anhydrous glucose, microcrystalline cellulose, sodium carboxymethylcellulose, phenylethyl alcohol, polysorbate 80, benzalkonium chloride, purified water.
Pharmaceutical form and content
What is HUMEX HUMAN HAYS TO BECLOMETASONE 50 micrograms / dose, suspension for nasal spray in bottle and contents of the pack?
This medication is in the form of a nasal spray suspension with a dosing pump providing 100 sprays of 50 micrograms of beclometasone dipropionate.
Name and address of the marketing authorization holder and the holder of the manufacturing authorization responsible for the release of the lots, if different
Holder
URGO HEALTHCARE LABORATORIES
42 RUE DE LONGVIC
21300 CHENOVE
exploiting
URGO HEALTHCARE LABORATORIES
42 RUE DE LONGVIC
21300 CHENOVE
Maker
URGO LABORATORIES
AVENUE OF STRASBOURG
ZONE EXCELLENCE 2000
21800 chevigny saint sauveur
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
Date of approval of the notice
The last date on which this leaflet was approved is {date}.
AMM under exceptional circumstances
Not applicable.
Internet Information
Detailed information on this medicine is available on the Ansm website (France).
Information for health professionals only
Not applicable.
Other
SANITARY EDUCATION COUNCILS |
a / What is hay fever?
Seasonal allergic rhinitis, the best known of which is hay fever, corresponds to an allergic manifestation due to the pollen (s).
Allergies due to pollen are very common. They usually manifest for the first time during adolescence. They are repeated every year at the same time, depending on the presence of the responsible pollen (s). However, you are not allergic to all pollens, but to one or more of them only.
As with any disease of an allergic nature, it is important to consult a doctor at least once In particular, it will determine the need for an allergy assessment. It will help you to define the pollen (s) to which you are allergic. You can also obtain a "pollen calendar" from your pharmacist. |
b / How to recognize a hay fever?
Hay fever is characterized by the following symptoms:
· nasal obstruction (blocked nose),
· colorless nasal discharge,
· sneezing successively,
· itching and nasal tingling, It may be accompanied by irritation of the eyes (tearing, redness), throat and nose.
c / Some practical tips
During the pollen season it is possible to reduce the exposure to pollen:
· In your garden, diversify the plantations avoiding the most allergenic species (cypress, thuja, birch ...).
· Avoid mowing the lawn yourself during the pollen season.
· Garde preferably with glasses and a protective mask.
Avoid as much as possible some irritating factors that can increase the symptoms of allergic rhinitis such as tobacco and pollution.
DO NOT HESITATE TO ASK YOUR PHARMACIST FOR ADVICE.