Bausch + Lomb Allergiflash eye drops

Allergiflash is an eye drop containing levocabastine, a substance belonging to the antihistamine family. These drugs block the release of histamine in the body and thus reduce allergic reactions (histamine plays an important role in allergies).

Allergiflash eye drops are indicated for ophthalmic allergies, allergic conjunctivitis, which manifests as swollen eyes and/or eyelids, red, itchy, or watery eyes.

Allergiflash is available in a 5 ml bottle containing 0.05 g of levocabastine per 100 ml of solution. The other ingredients are hydroxypropylbetadex, sodium dihydrogen phosphate dihydrate, disodium phosphate dodecahydrate, sodium chloride, and purified water. Dosage of Allergiflash Eye Drops for Allergies

The dosage is 1 drop in each eye, twice a day, which can be increased, if necessary, to 1 drop 3 to 4 times a day.

Contraindications for Allergiflash Antihistamine Eye Drops

In case of allergy (hypersensitivity) to the active ingredient (levocabastine) or to any of the other ingredients in the eye drops, Allergiflash is contraindicated.

Due to a lack of studies, the use of Allergiflash is not recommended for children under 6 years of age.

Allergiflash 0.05% should also not be used by pregnant or breastfeeding women. Consult your doctor or pharmacist before taking any medication.

In case of vision disturbances, patients should avoid driving vehicles until these effects have subsided.

Packaging: 5 ml bottle

This anti-allergy eye drop is also available in single-dose AllergiFlash.


LEAFLET
ANSM - Updated on: 03/10/2023
Name of the medicinal product
ALLERGIFLASH 0.05%, eye drops, solution
Levocabastine
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 after 5 days.
What is in this leaflet? 1. What is ALLERGIFLASH 0.05% Eye Drops, Solution and what is it used for?
2. What you need to know before using ALLERGIFLASH 0.05% Eye Drops, Solution?
3. How to use ALLERGIFLASH 0.05% Eye Drops, Solution?
4. Possible side effects?
5. How to store ALLERGIFLASH 0.05% Eye Drops, Solution?
6. Contents of the pack and other information.
1. WHAT IS ALLERGIFLASH 0.05% Eye Drops, Solution AND WHAT IS IT USED FOR?
Pharmacotherapeutic group: Decongestant and antiallergic - ATC code: S01GX02
ALLERGIFLASH 0.05% Eye Drops, Solution contains the active ingredient levocabastine. This substance belongs to the family of medications called antihistamines. These medications block the release of histamine in the body and thus reduce allergic reactions (histamine plays an important role in allergies).
This medication is used to treat the symptoms of an eye allergy (allergic conjunctivitis), characterized by swollen, red, itchy, or watery eyes and/or eyelids.
This eye drop does not contain a preservative.
You should consult your doctor if you do not feel better or if you feel worse after 5 days.
2. WHAT YOU NEED TO KNOW BEFORE USING ALLERGIFLASH 0.05%, Eye Drops, Solution?
Never use ALLERGIFLASH 0.05% eye drops, solution:
· if you are allergic to levocabastine or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before using ALLERGIFLASH 0.05% eye drops, solution.
Children
The use of ALLERGIFLASH 0.05% eye drops, solution is not recommended in children under 6 years of age due to limited data.
Other medicines and ALLERGIFLASH 0.05% eye drops, solution
Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.
ALLERGIFLASH 0.05% eye drops, solution with food, drink, and alcohol
Not applicable. Pregnancy, Breastfeeding, and Fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist before taking this medicine.
Pregnancy
Caution should be exercised when using this medicine during pregnancy.
Breastfeeding
Due to a lack of data, the use of levocabastine is not recommended during breastfeeding.
Driving and Using Machinery
Patients experiencing visual disturbances (slight irritation following instillation) should refrain from driving or operating machinery until these symptoms disappear.
ALLERGIFLASH 0.05% eye drops, solution, contain Phosphates
This medicine contains 39.65 mg of phosphates per 5 mL (see section 4 "Possible side effects").
3. HOW TO USE ALLERGIFLASH 0.05% Eye Drops, Solution
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 you are unsure.
Dosage
The recommended dose is one drop in each eye, twice a day. This dose can be increased, if necessary, to one drop 3 to 4 times a day.
Use in children aged 6 years and older and adolescents: the recommended dose remains unchanged.
Use the eye drops at regular intervals.
Never exceed the recommended dose.
Method of administration
This medicine should be administered directly into the eye. Under no circumstances should it be injected.
When using this eye drop, wash your hands thoroughly before opening the bottle and follow these steps:

A. Before first use

1. Remove the safety ring.

2. Remove the protective cap.

3. Hold the bottle upside down.
Press the center of the bottle firmly enough to extract 1 to 2 drops.

B. To instill the eye drops into the eye

1. Looking upward and pulling the lower eyelid downward, position the bottle above the eye and gradually press the center of the bottle until the drop appears.
Avoid touching the eye or eyelid with the tip of the bottle.

2. Blink once so that the eye drops are distributed over the entire surface of the eye.
With your eye closed, wipe off any excess drops.

3. To avoid systemic effects, it is recommended to compress the inner corner of the eye for 1 minute after each instillation while keeping the eye closed.

4. Replace the protective cap after use.

C. If the drop fails to appear, repeat steps A2 and A3.

If you are taking another eye drop at the same time, leave 15 minutes between instillations.
Duration of treatment
Treatment should not be extended beyond 5 days without medical advice.
If you do not feel any improvement or if your symptoms persist, you should consult your doctor.
If you have used more ALLERGIFLASH 0.05% Eye Drops Solution than you should:
In case of overdose, you may feel drowsy. Rinse thoroughly with saline solution. Simply continue your treatment with the next instillation.
If you forget to use ALLERGIFLASH 0.05% Eye Drops Solution:
Do not take a double dose to make up for the forgotten dose; simply continue your treatment. If you stop using ALLERGIFLASH 0.05% eye drops, 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. Common side effects (may affect up to 1 in 10 people) include:
Eye pain, blurred vision, burning, stinging, and eye irritation
Uncommon side effects (may affect up to 1 in 100 people) include:
Swelling (oedema) of the eyelids
Very rare side effects (may affect up to 1 in 10,000 people) include:
Conjunctivitis, eye swelling and inflammation of the eyelids, eye redness, watery eyes, and itchy eyes;
Rash, skin redness, and a systemic allergic reaction that may be serious and manifest as sudden swelling of the face and neck or sudden malaise with a drop in blood pressure and difficulty breathing. In this case, stop treatment immediately and contact your doctor.
Headache;
Palpitations. If you have severe damage to the cornea (the transparent layer at the front of the eye), phosphates may, in very rare cases, cause vision problems due to calcium accumulation during treatment (clouding) (see section 2 "Warnings and precautions").
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 ALLERGIFLASH 0.05%, eye drops, solution?
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date printed on the bottle after EXP. The expiry date refers to the last day of that month. Write the date of opening clearly on the packaging.
Do not store above 25°C.
Shelf life after opening: 3 months.
Do not use this medicine if you notice any visible signs of deterioration.
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 protect the environment. 6. CONTENTS OF THE PACK AND OTHER INFORMATION
What ALLERGIFLASH 0.05% Eye Drops, Solution Contains
· The active ingredient is:
Levocabastine................................................................................................................. 0.05 g
as levocabastine hydrochloride
Per 100 mL of solution
· The other ingredients are: Hydroxypropylbetadex, monosodium phosphate dihydrate, disodium phosphate dodecahydrate, sodium chloride, purified water.
What ALLERGIFLASH 0.05% Eye Drops, Solution looks like and contents of the outer packaging
This medicine is presented as eye drops, solution. Each carton contains one 5 mL bottle. Marketing Authorization Holder
LABORATOIRE CHAUVIN
416 RUE SAMUEL MORSE – CS 99535
34961 MONTPELLIER
FRANCE
Marketing Authorization Holder
LABORATOIRE CHAUVIN
416 RUE SAMUEL MORSE – CS 99535
34961 MONTPELLIER
FRANCE
Manufacturer
LABORATOIRE CHAUVIN
ZONE INDUSTRIELLE DE RIPOTIER
50 AVENUE JEAN MONNET
07200 AUBENAS
FRANCE
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 medicinal product is available on the ANSM website (France). Health Education Tip:
a) What is an allergy? What is an allergic reaction?
An allergy is an excessive reaction 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 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 release of substances such as histamine into the body, which is responsible for the symptoms experienced.
As with any allergic illness, it is important to consult a doctor at least once. IT WILL DETERMINE THE NEED FOR AN ALLERGY TESTING.
b) How to recognize allergic conjunctivitis?
Redness of the eye and the inside of the eyelids accompanied by itching, swelling, and watering are signs of allergic conjunctivitis.
This condition often accompanies allergic rhinitis (sneezing, runny nose, stuffy nose) because they are triggered by the same allergens (pollen, dust mites, pet dander, etc.).
c) Some practical advice
· Do not rub your eyes, even if they itch, because after temporary relief, this can only make the situation worse.
· Gently rinse your eyes with clean water or a sterile eye wash to remove pollen and thus provide relief.
· Temporarily remove makeup. Healing of conjunctivitis or its recurrence upon reapplication may eventually help identify the responsible substance. The presence of an eye allergy should lead to careful selection of cosmetics.
· If you wear contact lenses, it is best to remove them for the duration of eye drop treatment.
d) In case of acute eye pain, decreased vision, or blurred vision, consult your doctor.
e) Prevention of recurrence
Removing the allergen (elimination) is the best measure 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 covered with a dust mite-proof plastic cover, as must the pillows. The bed base, unless it is made of slats or metal, must be covered with plastic. All bedding should be washed twice a month at 60°C if possible. · The room should be ventilated and cleaned regularly.
· Avoid bed rugs and carpets on the floor.
· Avoid pets.
· During 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.
· Gardening is best done with protective goggles and a mask.