Bausch + Lomb Levofree 0.05% eye drops

Levofree 0.05% eye drops are a decongestant and anti-allergy medication.

Levofree bottle indications

This medication is used to treat the symptoms of allergic conjunctivitis, an allergy affecting the eyes and characterized by red, watery, itchy eyes and swollen eyes and/or eyelids. It is formulated with levocabastine, an antihistamine. Antihistamine medications stop the release of histamine in the body, reducing allergic reactions. Histamine is a molecule involved in allergies.

Composition of Levofree, levocabastine

This medication contains 0.05 g of levocabastine per 100 ml of solution. Its other ingredients are hydroxypropylbetadex, sodium dihydrogen phosphate dihydrate, disodium phosphate dodecahydrate, sodium chloride, and purified water. It is formulated without preservatives.

Levofree Eye Drop Dosage

Always follow the instructions in the package leaflet or as directed by your pharmacist or doctor.
The recommended dosage is: 1 drop per eye, twice a day. It is possible to increase the dose to 1 drop 3 to 4 times a day if needed. The eye drops should be used at regular intervals.

If you take too high a dose of eye drops, you may feel drowsy. Rinse thoroughly with saline solution and simply resume treatment with the next instillation.

Levofree Antihistamine for What Age Group?

This medication is suitable for people over 6 years old.

How to use Levofree 0.05%?

Before first use, remove the safety ring.

Remove the protective cap, hold the bottle upside down, and squeeze the center of the bottle to release 1 to 2 drops. Look upward and pull down the lower eyelid. The tip of the bottle should not touch the eye or eyelid. Blink once to distribute the eye drops over the surface of the eye. Close your eye and wipe off any excess eye drops. Compress the inner corner of the eye for one minute, with the eye closed, after each application to prevent systemic effects.

If you are taking another eye drop, leave 15 minutes between applications.

Levofree: how long should you take the treatment?

Treatment should not exceed 5 days without medical advice. If symptoms do not improve or persist, or if you feel worse, consult a doctor.

What is the shelf life of Levofree?

The shelf life of a bottle of Levofree is 3 months after opening.

Precautions for using Levofree drops for allergies

This medicine should never be used if you are allergic to its active ingredient or any of its other ingredients.

Levofree 0.05% drops should not be used in children under 6 years of age.

Inform your doctor or pharmacist if you are using, have recently used, or might use any other medication.

Ask your doctor or pharmacist before taking this eye drop if you are pregnant or breastfeeding. Its use may be considered with caution during pregnancy. It is not recommended during breastfeeding.

If vision disturbances occur after instillation, avoid driving or operating machinery until the disturbances resolve.

Levofree 0.05% drops contain 39.65 mg of phosphates per 5 ml of solution. Phosphates are excipients with known effects.

Levofree Side Effects

In rare cases, some side effects may occur, such as eye pain, blurred vision, a burning sensation, stinging, or eye irritation.

Condition: 5 ml bottle.

Levofree is a Bauch+Lomb product, which offers a wide range of medications for the treatment of eye problems. For dry eyes, they offer Artelac eye drops.


LEAFLET
ANSM - Updated on: 05/10/2023
Name of the medicinal product
LEVOFREE 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 LEVOFREE 0.05% Eye Drops, Solution and what is it used for?
2. What you need to know before using LEVOFREE 0.05% Eye Drops, Solution?
3. How to use LEVOFREE 0.05% Eye Drops, Solution?
4. Possible side effects?
5. How to store LEVOFREE 0.05% Eye Drops, Solution?
6. Contents of the pack and other information.
1. WHAT IS LEVOFREE 0.05% Eye Drops, Solution AND WHAT IS IT USED FOR?
Pharmacotherapeutic group: Decongestant and antiallergic - ATC code: S01GX02
LEVOFREE 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 YOU USE LEVOFREE 0.05%, Eye Drops, Solution?
Do not use LEVOFREE 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 LEVOFREE 0.05% eye drops, solution.
Children
The use of LEVOFREE 0.05% eye drops, solution is not recommended in children under 6 years of age due to limited data.
Other medicines and LEVOFREE 0.05% eye drops, solution
Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.
Consuming LEVOFREE 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.
LEVOFREE 0.05% Eye Drops, Solution Contains Phosphates
This medicine contains 39.65 mg of phosphates per 5 mL (see section 4, "Possible side effects").
3. HOW TO USE LEVOFREE 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.
For 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.
How to administer
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.

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 LEVOFREE 0.05% eye drops, solution than you should:
In case of overdose, drowsiness may occur. Rinse thoroughly with saline solution. Simply continue your treatment with the next instillation.
If you forget to use LEVOFREE 0.05% eye drops, solution:
Do not take a double dose to make up for a forgotten dose; simply continue your treatment. If you stop using LEVOFREE 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: www.signalement-sante.gouv.fr
By reporting side effects, you can help provide more information on the safety of this medicine.
5. HOW TO STORE LEVOFREE 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 LEVOFREE 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, sodium dihydrogen phosphate dihydrate, disodium phosphate dodecahydrate, sodium chloride, purified water.
What LEVOFREE 0.05%, Eye Drops, Solution, Contains and Contents of the Pack
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.