CROMORHINOL 2 PERCENT NASAL SPRAY 15ML: The drug Cromorhinol 2% is indicated for the treatment of seasonal and non-seasonal allergic rhinitis.
How is it manifested ?
Whatever the type of allergic rhinitis, it manifests itself in the same way when allergens are present in particular:
Catches should be distributed at regular intervals.
Sodium edetate, polysorbate 80, sorbitol, sodium hydroxide, water for injection.
Cromorhinol 2% solution for nasal spray is in the form of solution for nasal spray in 15 ml spray bottle.
Pharmacovigilance Report an adverse drug reaction(s)
ANSM - Last updated: 23/02/2016
CROMORHINOL 2%, solution for nasal spray
· Keep this leaflet. You might need to read it again.
· If you have any further questions, ask your doctor or pharmacist.
· This medicine has been prescribed for you. Do not give this to anyone else. It could be harmful to them, even if the signs of their illness are the same as yours.
If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. See section 4.
In this notice :
1. WHAT IS CROMORHINOL 2%, solution for nasal spray AND WHAT IT IS USED FOR?
2. BEFORE YOU USE CROMORHINOL 2%, nasal spray solution?
3. HOW TO USE CROMORHINOL 2%, solution for nasal spray?
4. WHAT ARE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE CROMORHINOL 2%, solution for nasal spray?
6. ADDITIONAL INFORMATION
1. WHAT IS CROMORHINOL 2%, solution for nasal spray AND WHAT IT IS USED FOR?
Not applicable.
It is indicated in the treatment of seasonal allergic rhinitis (hay fever) or non-seasonal (animal hair, mold, mites ...).
2. BEFORE YOU USE CROMORHINOL 2%, nasal spray solution?
List of information needed before taking the medication
Not applicable.
Never use CROMORHINOL 2%, nasal spray solution in the following cases:
· previous history of allergy to sodium cromoglicate or any of the excipients.
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR PHARMACIST OR YOUR DOCTOR
Precautions for use; special warnings
Take special care with CROMORHINOL 2%, solution for nasal spray:
· never leave it within the reach of children.
· do not exceed recommended dosage.
· in the absence of improvement as in the case of persisting symptoms, take a medical opinion.
IN CASE OF DOUBT, DO NOT HESITATE TO REQUEST THE NOTICE OF YOUR PHARMACIST OR YOUR DOCTOR
Interaction with other medicines
Taking or using other medicines
If you are taking or have recently taken any other medicines, including medicines obtained without a prescription, talk to your doctor or pharmacist.
Interactions with food and beverages
Not applicable.
Interactions with Herbal Medicines or Alternative Therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy and breast feeding
CROMORHINOL 2%, nasal spray solution can be used during pregnancy and lactation.
Ask your doctor or pharmacist for advice before taking any medicine.
Not applicable.
Effects on ability to drive or use machines
Not applicable.
List of excipients with known effect
Not applicable.
3. HOW TO USE CROMORHINOL 2%, solution for nasal spray?
Not applicable.
Dosage
Adults and children:
Before each take, blow your nose to clear the nostrils.
1 spray into each nostril 4 to 6 times a day.
Symptoms of seasonal or non-seasonal allergic rhinitis may recur if the treatment is not followed regularly, treatment should be continuously monitored throughout the duration of exposure to allergens.
If you have any new symptoms, or if you have any concerns about your condition, please ask your pharmacist or consult your doctor.
Method and route of administration
Nasal route.
1) Before use, remove cap by pulling upwards.
The sprayer is ready to use.
2) When first used, hold the bottle vertically and press the sprayer 2 or 3 times to prime the pump
3) After blowing and holding the bottle vertically, insert the nosepiece into one of the nostrils and plug the other with your finger. Briefly press the sprayer and inhale through the nose then exhale slowly through the mouth.
4) Renew the same operation in the other nostril.
5) Wipe the nosepiece and replace the cap to avoid accidental spraying.
Frequency of Administration
The catch must be distributed at regular intervals.
Duration of treatment
Continuously throughout the period of exposure to allergens.
However, if exposure to allergens can be avoided, this solution is preferable to the use of any drug ( see Health Education Council )
Symptoms and Instructions for Overdose
If you have used more CROMORHINOL 2%, nasal spray solution than you should: immediately consult your doctor or pharmacist.
Instructions for omission of one or more doses
If you forget to take CROMORHINOL 2%, nasal spray solution: do not take a double dose to compensate for the single dose you have forgotten to take but simply continue your treatment
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Description of adverse reactions
· Possibility of an allergic reaction to the cromoglicate or one of the components of the product.
· A brief nasal irritation with sneezing may occur at the start of treatment within minutes of spraying. These symptoms are usually transient.
· Rarely may a nose bleed occur.
Declaration of side effects
If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and network of Regional Centers of Pharmacovigilance - Website: www.ansm.sante.fr
By reporting adverse reactions, you are helping to provide more information about drug safety
5. HOW TO STORE CROMORHINOL 2%, solution for nasal spray?
Keep out of the reach and sight of children.
Do not use CROMORHINOL 2%, nasal spray solution after the expiry date which is stated on the carton.
No special storage conditions.
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.
Full list of active substances and excipients
What does CROMORHINOL 2%, solution for nasal spray?
The active substance is:
Sodium Cromoglicate ............................................... .................................................. .................... 2.00 g
For 100 ml of solution.
The other components are:
Sodium hydroxide, polysorbate 80, sorbitol, sodium hydroxide, water for injection
Pharmaceutical form and content
What is CROMORHINOL 2%, solution for nasal sprays and contents of the outer packaging?
This medication is in the form of a nasal spray solution in a 15 ml spray bottle.
416, RUE SAMUEL MORSE
MILLENNIUM PARK II - CS99535
34961 MONTPELLIER CEDEX 2
MILLENNIUM PARK II
416, RUE SAMUEL MORSE
34961 MONTPELLIER CEDEX 2
INDUSTRIAL ZONE RIPOTIER HIGH
07200 AUBENAS
OR
DR GERHARD MANN CHEM. PHARM. FABRIK GMBH
BRUNSBÜTTELER DAMM, 165/173
13581 BERLIN
GERMANY
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.
Detailed information on this medicine is available on the Afssaps website (France).
Information for health professionals only
Not applicable.
a) What is an allergy, what is an allergic reaction?
Allergy is an overreaction of our body to substances it considers harmful, allergens. Allergens are the factors and substances triggering allergy and associated disorders.
During repeated and intensive contacts of our body with the allergen, an allergic reaction is triggered.
The allergic reaction refers to all symptoms appearing a few minutes or hours after exposure to allergens. These allergens come from plants, animal hair, food, dust mites, molds or are substances of occupational origin.
This allergic reaction causes the release in the body of substances such as the histamine responsible for the disorders felt.
As with any disease of an allergic nature, it is important to consult a doctor at least once. IT SHALL DETERMINE IN PARTICULAR THE NEED TO CARRY OUT AN ALLERGOLOGICAL BALANCE SHEET. |
b) How to recognize allergic rhinitis, seasonal or non-seasonal allergic conjunctivitis?
Allergic rhinitis results in the following symptoms: nasal congestion, successive sneezing, colorless nasal discharge, nasal obstruction (stuffy nose), itching and tingling of the nose. It may be accompanied by irritations of both eyes (tearing, redness), throat and nose.
We distinguish:
Seasonal allergic rhinitis or hay fever: frequent, they occur every year in the same season, when pollen concentration increases in the air, and usually occur for the first time during adolescence. However, you may not be allergic to all pollens, but to one or more of them only.
Perennial allergic rhinitis occurs throughout the year and most often depends on domestic allergens such as dust mites, molds and domestic animals.
c) Some practical tips
Removing the allergen (foreclosure) is the measure of choice to suppress or reduce the symptoms of allergy.
For household allergens: measures to reduce the presence of allergens are essential:
· The mattress should be completely surrounded by a plastic dust mite cover as well as the pillows. The bed base, unless it is in slats or metal, shall be surrounded by a plastic. All bedding should be washed twice a month at 60 ° C if possible.
· The room should be ventilated and cleaned regularly.
· On the floor, you will avoid bed runs and carpets.
· Avoid pets.
· 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.
Nasal anti-allergic preparation
cromoglicic acid
. Presentations . Composition . Indications . Contraindications . Warning . Pregnancy and breastfeeding . Directions for use and dosage . Advice . Undesirable effects . Lexicon
CROMORHINOL 2%: nasal solution; 15 ml spray bottle.
-
Laboratory Chauvin Bausch & Lomb
| p 100 ml | |
| Sodium salt cromoglicic acid | 2 g |
| Benzalkonium chloride | + |
Usual dosage:
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