Bausch + Lomb Cromorhinol 2% nasal spray

Cromorhinol 2% Nasal Spray is indicated for the treatment of seasonal (hay fever) or non-seasonal (animal dander, mold, dust mites, etc.) allergic rhinitis.

The active ingredient is sodium cromoglycate.

The other ingredients are sodium edetate, polysorbate 80, sorbitol, sodium hydroxide, and water for injections.

Dosage of Cromorhinol 2% Spray

It is recommended that you blow your nose to clear your nostrils before each dose of Cromorhinol 2%. Spray one spray into each nostril 4 to 6 times a day. Doses should be spaced evenly.

Treatment is symptomatic and should be continued for the duration of exposure to the allergen.
If new symptoms appear or if your condition does not improve, you should consult your doctor.

Precautions for use of Cromorhinol 2% nasal spray

Do not use this nasal spray if you are allergic to any of the ingredients in this product.

If you have taken or are currently taking any other medication, inform your doctor or pharmacist to avoid overdose or interactions.

Cromorhinol 2% can be used during pregnancy or breastfeeding; ask your doctor beforehand.

Consult the package leaflet before use or ask your doctor or pharmacist for advice.

Condition: 15 ml bottle

Because seasonal allergies can also affect the eyes, we offer Bloxallergie eye solution.


LEAFLET
ANSM - Updated on: 11/21/2024
Name of the medicinal product
CROMORHINOL 2%, nasal spray solution
Sodium cromoglicate
Box
Please read all of this leaflet carefully before using this medicine because it contains important information for you.
You must always use this medicine exactly as provided in this leaflet or by your doctor or pharmacist.
Keep this leaflet. You may need to read it again.
Ask your pharmacist for advice or information.
If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
You must talk to your doctor if you do not feel better or if you feel worse.
What is in this leaflet? 1. What is CROMORHINOL 2% Nasal Spray Solution and what is it used for?
2. What you need to know before using CROMORHINOL 2% Nasal Spray Solution?
3. How to use CROMORHINOL 2% Nasal Spray Solution?
4. Possible side effects?
5. How to store CROMORHINOL 2% Nasal Spray Solution?
6. Contents of the pack and other information.
1. WHAT IS CROMORHINOL 2% Nasal Spray Solution AND WHAT IS IT USED FOR?
Pharmacotherapeutic group: ANTI-ALLERGICS, ATC code: S01GX01.
It is indicated for the treatment of seasonal (hay fever) or non-seasonal (animal dander, mold, dust mites, etc.) allergic rhinitis.
2. WHAT YOU NEED TO KNOW BEFORE USING CROMORHINOL 2%, Nasal Spray Solution?
Never use CROMORHINOL 2%, Nasal Spray Solution:
· if you are allergic to sodium cromoglicate or any of the other ingredients of this medicine (listed in section 6), particularly polysorbates.
IF IN DOUBT, IT IS ESSENTIAL TO ASK YOUR PHARMACIST OR DOCTOR FOR ADVICE.
Warnings and Precautions
Talk to your doctor or pharmacist before using CROMORHINOL 2%, Nasal Spray Solution.
· Never leave within reach of children.
· Do not exceed the recommended dosage.
· If there is no improvement or if symptoms persist, seek medical advice.
Children
Not applicable. Other medicines and Cromorhinol 2% Nasal Spray
Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.
Cromorhinol 2% Nasal Spray with food and drink
Not applicable.
Pregnancy and breastfeeding
Cromorhinol 2% Nasal Spray can be used during pregnancy and breastfeeding.
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Not applicable.
Cromorhinol 2% Nasal Spray contains polysorbates.
Polysorbates may cause allergic reactions.
3. HOW TO USE Cromorhinol 2% Nasal Spray
Always use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
Dosage
Adults and children:
Before each dose, blow your nose to clear your nostrils.
1 spray in each nostril 4 to 6 times daily.
Since symptoms of seasonal or non-seasonal allergic rhinitis may recur if treatment is not followed regularly, treatment must be continued continuously throughout the duration of exposure to allergens (responsible for the allergy).
If new symptoms appear, or if you have any doubts about the progress of your condition, do not hesitate to ask your pharmacist or consult your doctor.
Method and route of administration
Nasal use.
1) Before use, remove the cap by pulling upwards.
The spray is ready to use. 2) When using for the first time, hold the bottle upright and squeeze the sprayer 2 or 3 times to prime the pump.
3) After blowing your nose and holding the bottle upright, insert the nozzle into one nostril and block the other with your finger. Briefly press the nozzle and inhale through your nose, then exhale slowly through your mouth.
4) Repeat the same operation in the other nostril.
5) Wipe the nozzle and replace the cap to prevent accidental spraying.
Frequency of administration
Doses should be spaced at regular intervals.
Duration of treatment
Continuously throughout the entire period of allergen exposure.
However, if exposure to allergens can be avoided, this solution is preferable to the use of any medication (see Health Education Advice).
If you use more Cromorhinol 2% Nasal Spray Solution than you should:
Consult your doctor or pharmacist immediately.
If you forget to use Cromorhinol 2% Nasal Spray Solution:
Do not take a double dose to make up for a forgotten dose; simply continue with your treatment.
If you stop using Cromorhinol 2% Nasal Spray Solution:
Not applicable.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine can cause side effects, although not everybody gets them. · Possible allergic reaction to cromoglicate or one of the product's components.
· Brief nasal irritation with sneezing may occur at the beginning of treatment within minutes of spraying. These symptoms are usually transient.
· Rarely, nosebleeds may occur.
Reporting of side effects
If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centers - Website: https://signalement.social-sante.gouv.fr/
By reporting side effects, you help provide more information on the safety of this medicine.
5. HOW TO STORE CROMORHINOL 2%, Nasal Spray Solution?
Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date shown on the packaging. The expiry date refers to the last day of that month. This medicine does not require any special storage conditions. Do not dispose of any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer used. These measures will help to protect the environment. 6. CONTENTS OF THE PACK AND OTHER INFORMATION What Cromorhinol 2%, nasal spray solution, contains: The active ingredient is: Sodium cromoglicate 2.00 g Per 100 mL of solution: Other ingredients: Sodium edetate, polysorbate 80, sorbitol, sodium hydroxide, water for injections. What is CROMORHINOL 2%, nasal spray solution and contents of the outer packaging?
This medicinal product is presented as a nasal spray solution in a 15 mL spray bottle.
Marketing Authorisation Holder
LABORATOIRE CHAUVIN
416 RUE SAMUEL MORSE - CS99535
34961 MONTPELLIER
Marketing Authorisation Holder
LABORATOIRE CHAUVIN
416 RUE SAMUEL MORSE - CS99535
34961 MONTPELLIER
Manufacturer
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. This leaflet was last revised:
[to be completed later by the holder]
{month YYYY}.
Other
Detailed information on this medicine is available on the ANSM (France) website.
Health Education Council:
a) What is an allergy? What is an allergic reaction?
An allergy is an excessive reaction of our body to substances it considers harmful, allergens. Allergens are the factors and substances that trigger allergies and the associated disorders.
During repeated and intensive contact between our body and the allergen, an allergic reaction is triggered.
An allergic reaction refers to the set of symptoms that appear a few minutes or hours after exposure to allergens. These allergens come from plants, animal hair, food, dust mites, mold, or are substances of occupational origin. This allergic reaction causes the body to release substances such as histamine, which are responsible for the symptoms experienced.

As with any allergic illness, it is important to consult a doctor at least once.
HE or she will, in particular, determine the need for an allergy assessment.

b) How to recognize allergic rhinitis, seasonal or non-seasonal allergic conjunctivitis?
Allergic rhinitis presents with the following symptoms: nasal congestion, repeated sneezing, colorless nasal discharge, nasal obstruction (blocked nose), itchy, and stinging nose. It may be accompanied by irritation of both eyes (watering, redness), throat, and nose.
There are:
Seasonal allergic rhinitis or hay fever: This is common and occurs every year during the same season, when pollen concentrations increase in the air. It generally first appears during adolescence. However, you may not be allergic to all pollens, but only to one or more of them.
Perennial allergic rhinitis occurs throughout the year and most often depends on household allergens such as dust mites, mold, and pets.
c) Some practical advice
Removing the allergen (avoidance) is the best measure to eliminate or reduce allergy symptoms.
For household allergens: it is essential to take measures to reduce the presence of the allergen:
· The mattress should be completely covered with a dust mite-proof plastic cover, as should the pillows. The bed base, unless it is made of slats or metal, should be covered with plastic. All bedding should be washed twice a month at 60°C if possible.
· The bedroom should be ventilated and cleaned regularly.
· On the floor, bedside rugs and carpets should be avoided. · Avoid pets.
· During pollen season, you can reduce exposure to pollen:
· In your garden, diversify your plantings by avoiding the most allergenic species (cypress, thuja, birch, etc.).
· Avoid mowing the lawn yourself during pollen season.
· Gardening is best done with protective goggles and a mask.