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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 injection.
Dosage of Cromorhinol 2% spray
It is recommended that you blow your nose to clear your nostrils before each dose of Cromorhinol 2%
. You should 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 entire 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, you must inform your doctor or pharmacist to avoid overdoses or interactions.
Cromorhinol 2% can be used during pregnancy or breastfeeding, ask your doctor for advice beforehand.
Consult the package leaflet before use or ask your doctor or pharmacist for advice.
Packaging: 15 ml bottle
ANSM - Updated on: 11/21/2024
CROMORHINOL 2%, nasal spray solution
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Sodium cromoglicate ......................................................................................................... 2.00 g
For 100 mL of solution.
Excipient(s) with known effect: polysorbate 80.
This medicine contains 0.0140 mg of polysorbate 80 per spray which is equivalent to 0.10 mg/mL.
For the full list of excipients, see section 6.1.
It is indicated in the treatment of seasonal allergic rhinitis (hay fever) or non-seasonal (animal hair, mold, dust mites, etc.).
4.2. Dosage and method of administration
Adults and children: 1 spray in each nostril 4 to 6 times a day.
The duration of treatment will depend on the duration of exposure to the allergen.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1, in particular to polysorbates.
4.4. Special warnings and precautions for use
This medicine contains polysorbates and may cause allergic reactions.
4.5. Interactions with other medicinal products and other forms of interaction
4.6. Fertility, pregnancy and breastfeeding
Animal studies have not shown any teratogenic effects.
In the absence of a teratogenic effect in animals, a malformative effect in humans is not expected. Indeed, to date, substances responsible for malformations in humans have proven teratogenic in animals during well-conducted studies on two species.
Clinically, analysis of a large number of exposed pregnancies has apparently revealed no particular malformative or fetotoxic effects of cromoglicic acid. However, only epidemiological studies would allow verification of the absence of risk.
Therefore, cromoglicic acid can be prescribed during pregnancy if needed.
Breastfeeding
There are no data on the passage of sodium cromoglicate into breast milk.
However, given the absence of toxicity, breastfeeding is possible during treatment with this medication.
4.7. Effects on ability to drive and use machines
· Possibility of occurrence of hypersensitivity reactions to sodium cromoglicate.
· Brief nasal irritation may occur at the start of treatment after spraying.
Symptoms are usually transient.
Rarely, epistaxis may occur.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after drug authorization is important. It allows for continued monitoring of the drug's benefit/risk balance. Healthcare professionals report any suspected adverse reactions 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/ .
No overdose accidents have been described with sodium cromoglicate.
If an overdose is suspected, symptomatic treatment and medical supervision are required.
5.1. Pharmacodynamic properties
Pharmacotherapeutic group: ANTI-ALLERGICS, ATC code: S01GX01.
Sodium cromoglicate exerts a direct local action on the mucous membranes (bronchial, pituitary, conjunctival, digestive). Its mechanism of action remains poorly understood.
It prevents the release of chemical mediators of anaphylaxis by stabilizing the mast cell membrane.
Sodium cromoglicate has no direct effect at peripheral receptors.
5.2. Pharmacokinetic properties
Sodium cromoglicate is not metabolized. The study of urinary elimination of the 14 C-labeled product shows low absorption by the pituitary mucosa (around 2 to 5%). The majority is swallowed, absorption by the digestive tract being slow and very limited (around 0.5%).
The absorbed part is eliminated, as after intravenous administration, in unchanged form in approximately equal parts via the biliary and urinary routes.
There are no other preclinical data available that are considered relevant to clinical safety other than those presented in other sections of the SPC.
Sodium edetate, polysorbate 80, sorbitol, sodium hydroxide, water for injections.
3 years
6.4. Special storage precautions
This medicine does not require any special storage precautions.
6.5. Nature and contents of outer packaging
15 mL in spray bottle (polyethylene)
6.6. Special precautions for disposal and handling
· Before use, remove the cap by pulling upwards. The sprayer is ready to use.
· When using for the first time, hold the bottle upright and press the sprayer two or three times to prime the pump.
· After blowing your nose and holding the bottle upright, insert the nasal nozzle into one nostril and block the other with your finger. Briefly press the spray and inhale through your nose and exhale slowly through your mouth.
· Repeat the same operation in the other nostril.
· Wipe the nosepiece and then replace the cap to avoid accidental spraying.
7. MARKETING AUTHORISATION HOLDER
416 RUE SAMUEL MORSE - CS99535
34961 MONTPELLIER
8. MARKETING AUTHORISATION NUMBER(S)
· CIP 34009 339 983 0 1: 15 mL in spray bottle (PE).
9. DATE OF FIRST AUTHORIZATION/RENEWAL OF AUTHORIZATION
[to be completed later by the holder]
Date of first authorization: {DD month YYYY}
Last renewal date: {DD month YYYY}
[to be completed later by the holder]
{DD month YYYY}
Not applicable.
12. INSTRUCTIONS FOR THE PREPARATION OF RADIOPHARMACEUTICALS
Drug not subject to medical prescription.
ANSM - Updated on: 11/21/2024
CROMORHINOL 2%, nasal spray solution
Sodium cromoglicate
Please read all of this leaflet carefully before you start using this medicine because it contains important information for you.
You should always use this medicine exactly as directed in this leaflet or by your doctor or pharmacist.
· Keep this leaflet. You may need to read it again.
· Contact your pharmacist for any 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 should contact your doctor if you do not feel any improvement or if you feel worse.
What does this leaflet contain?
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. What are the possible side effects?
5. How to store CROMORHINOL 2%, nasal spray solution?
6. Package contents 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 in the treatment of seasonal allergic rhinitis (hay fever) or non-seasonal (animal hair, mold, dust mites, etc.).
2. WHAT YOU NEED TO KNOW BEFORE YOU USE 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, including 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 solution
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
CROMORHINOL 2%, nasal spray solution with food and drink
Not applicable.
CROMORHINOL 2%, nasal spray solution 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 operating machinery
Not applicable.
CROMORHINOL 2%, nasal spray solution contains polysorbates.
Polysorbates can cause allergic reactions.
3. HOW TO USE CROMORHINOL 2%, nasal spray solution?
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are unsure.
Dosage
Adults and children:
Before each dose, blow your nose to clear your nostrils.
1 spray in each nostril 4 to 6 times a day.
Since symptoms of seasonal or non-seasonal allergic rhinitis may recur when treatment is not followed regularly, treatment must be followed continuously for the entire duration of exposure to allergens (responsible for the allergy).
If new symptoms appear, 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 route.
1) Before use, remove the cap by pulling upwards.
The sprayer is ready to use.
2) When using for the first time, hold the bottle upright and press the sprayer 2 or 3 times to prime the pump
3) After blowing your nose and holding the bottle upright, insert the nasal nozzle into one nostril and block the other with your finger. Briefly press the sprayer and inhale through your nose and exhale slowly through your mouth.
4) Repeat the same operation in the other nostril.
5) Wipe the nosepiece and then replace the cap to avoid accidental spraying.
Frequency of administration
The shots should be distributed at regular intervals.
Duration of treatment
Continuously throughout the entire period of exposure to allergens.
However, if exposure to allergens can be avoided, this solution is preferable to the use of any medication ( see Health Education Council )
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, but simply continue 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. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine can cause side effects, although not everybody gets them.
· Possibility of an allergic reaction to cromoglicate or to one of the components of the product.
· Brief nasal irritation with sneezing may occur at the beginning of treatment within minutes of spraying. These symptoms are usually transient.
· Rarely, a nosebleed 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 can 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 precautions.
Do not dispose of any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.
6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION
What CROMORHINOL 2%, Nasal Spray Solution contains
· The active substance is:
Sodium cromoglicate .................................................................................................. 2.00 g
For 100 mL of solution.
· The other components are:
Sodium edetate, polysorbate 80, sorbitol, sodium hydroxide, water for injections.
What is CROMORHINOL 2%, nasal spray solution and contents of the outer packaging?
This medicine comes as a nasal spray solution in a 15 mL spray bottle.
Marketing Authorisation Holder
416 RUE SAMUEL MORSE - CS99535
34961 MONTPELLIER
Marketing Authorization Operator
CHAUVIN LABORATORY
416 RUE SAMUEL MORSE - CS99535
34961 MONTPELLIER
DR GERHARD MANN CHEM. PHARM. FABRIK GMBH
BRUNSBÜTTELER DAMM, 165/173
13581 BERLIN
GERMANY
Names of the medicine in the member states of the European Economic Area
Not applicable.
The last date this notice was revised is:
[to be completed later by the holder]
{month YYYY}.
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 overreaction of our body to substances it considers harmful, called allergens. Allergens are the factors and substances that trigger allergies and the associated disorders.
During repeated and intensive contact of our body with the allergen, an allergic reaction is triggered.
An allergic reaction refers to the set of symptoms that appear within minutes or hours of 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 release of substances such as histamine into the body, which are responsible for the symptoms experienced.
|
As with any allergic disease, it is important to consult a doctor at least once. IT WILL IN PARTICULAR DETERMINE THE NEED TO CARRY OUT AN ALLERGY ASSESSMENT. |
b) How to recognize allergic rhinitis, seasonal or non-seasonal allergic conjunctivitis?
Allergic rhinitis is characterized by the following symptoms: nasal congestion, repeated sneezing, colorless nasal discharge, nasal obstruction (blocked nose), itching and stinging of the nose. It may be accompanied by irritation of both eyes (watering, redness), throat and nose.
We distinguish:
Seasonal allergic rhinitis or hay fever: This is common and occurs every year at the same time of year, when pollen concentrations in the air increase. It usually 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 is most often caused by household allergens such as dust mites, mold, and pets.
c) Some practical advice
Removing the allergen (avoidance) is the measure of choice to eliminate or reduce allergy symptoms.
For household allergens: it is essential to take measures to reduce the presence of allergens:
· The mattress must be completely surrounded by a dust mite-proof plastic cover, as must the pillows. The bed base, unless it is made of slats or metal, must be surrounded by plastic. All bedding must be washed twice a month at 60°C if possible.
· The room must be ventilated and cleaned regularly.
· On the floor, avoid bed runners and carpets.
· Avoid pets.
· During the pollen season, it is possible to 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.
· Garden preferably with protective glasses and a mask.
