Bausch + Lomb Levophta 0.05% eye drops

LEAFLET
ANSM - Updated on: 02/17/2023
Name of the medicinal product
LEVOPHTA 0.05%, eye drops
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 LEVOPHTA 0.05% eye drops and what is it used for?
2. What you need to know before using LEVOPHTA 0.05% eye drops?
3. How to use LEVOPHTA 0.05% eye drops?
4. Possible side effects?
5. How to store LEVOPHTA 0.05% eye drops?
6. Contents of the pack and other information
1. WHAT IS LEVOPHTA 0.05% eye drops AND WHAT IS IT USED FOR?
Pharmacotherapeutic group: Selective H1 antihistamine - ATC code: S01GX02.
LEVOPHTA 0.05% eye drops contain 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.
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 LEVOPHTA 0.05%, Eye Drops?
Never use LEVOPHTA 0.05% eye drops:
· 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 LEVOPHTA 0.05% eye drops.
Avoid wearing contact lenses during treatment.
Children
The use of LEVOPHTA 0.05% eye drops is not recommended in children under 6 years of age due to limited data.
Other medicines and LEVOPHTA 0.05% eye drops
Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.
Take LEVOPHTA 0.05% eye drops with food
Not applicable. 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 before taking this medicine.
Pregnancy
This medicine should be used with caution during pregnancy.
Breastfeeding
Due to the 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.
LEVOPHTA 0.05% eye drops contain propylene glycol, phosphates, and benzalkonium chloride.
This medicine contains propylene glycol equivalent to 50.00 mg/mL. Propylene glycol may cause skin irritation.
This medicine contains phosphates equivalent to 14.05 mg/mL.
If you have severe damage to the cornea (the clear layer at the front of the eye), phosphates may, in very rare cases, cause vision problems due to calcium accumulation during treatment (cloud-like inclusions).
This medicine contains benzalkonium chloride equivalent to 0.15 mg/mL.
Benzalkonium chloride may be absorbed by soft contact lenses and change their color. Remove contact lenses before use and wait at least 15 minutes before reinserting them.
Benzalkonium chloride may also cause eye irritation, especially if you have dry eye syndrome or corneal disorders (the clear layer at the front of the eye). If you experience any abnormal sensation, stinging, or pain in your eyes after using this medicine, contact your doctor. Benzalkonium chloride can irritate the skin.
3. HOW TO USE LEVOPHTA 0.05%, Eye Drops?
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 the eye drops at regular intervals.
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
For ocular use.

LEVOPHTA 0.05%, eye drops must be shaken well before use.

This medicine must be administered directly into the eye. It must never be injected. When using this eye drop, you must follow these steps:
1. Wash your hands thoroughly before opening the bottle.
2. Unscrew the cap.
3. To reduce the risk of infection, avoid contact between the dropper and your eye or eyelids.
4. Tilt your head back and look at the ceiling.
5. Gently lower your lower eyelid to form a small pocket.
6. Tilt the bottle over your eye and squeeze to release one drop into each affected eye.
7. Blink once to distribute the drop over the entire surface of your eye.
8. With your eye closed, carefully wipe off any excess solution, especially on your cheek. 9. To avoid systemic effects, it is recommended to compress the inner corner of the eye for 1 minute after each instillation.
10. Recap the bottle after use.
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 LEVOPHTA 0.05% eye drops than you should
In case of overdose, drowsiness may occur. Rinse thoroughly with sterile saline. Simply continue your treatment with the next instillation.
If you forget to use LEVOPHTA 0.05% eye drops
Do not take a double dose to make up for a forgotten dose; simply continue your treatment. If you stop using LEVOPHTA 0.05% eye drops
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 conditions (may affect up to 1 in 10 people) are:
Eye pain, blurred vision, burning, stinging, eye irritation;
Uncommon conditions (may affect up to 1 in 100 people) are:
Swelling (oedema) of the eyelids;
Very rare conditions (may affect up to 1 in 10,000 people) include:
Conjunctivitis, swelling of the eyes and inflammation of the eyelids, redness of the eye, watering of the eyes, and itching of the eyes;
Rash, reddening of the skin, and a general 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 inform your doctor.
Headaches;
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 the accumulation of calcium during treatment (appearance of cloud-like inclusions) (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 LEVOPHTA 0.05%, eye drops?
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after EXP. The expiry date refers to the last day of that month.
This medicine should not be stored above 25°C. After first opening the bottle, the medication should be stored for a maximum of 30 days. Write the opening date clearly on the packaging.
Do not use this medication if you notice any visible signs of deterioration.
Do not dispose of any medication via wastewater or household waste. Ask your pharmacist how to dispose of medications you no longer use. These measures will help protect the environment. 6. CONTENTS OF THE PACK AND OTHER INFORMATION
What LEVOPHTA 0.05% Eye Drops contains
· The active ingredient is:
Levocabastine hydrochloride...................................................................................... 0.054 g
Amount corresponding to levocabastine base.................................................................. 0.050 g
Per 100 mL
· The other ingredients are:
Propylene glycol, anhydrous disodium phosphate, monosodium phosphate monohydrate, hypromellose, polysorbate 80, benzalkonium chloride (50% solution), sodium edetate, purified water.
What LEVOPHTA 0.05% Eye Drops looks like and contents of the pack
This medicine is presented as eye drops in 3 mL or 5 mL bottles.
Not all pack sizes may be marketed. Marketing Authorization Holder
LABORATOIRE CHAUVIN
416 RUE SAMUEL MORSE – CS 99535
34961 MONTPELLIER
Marketing Authorization Holder
LABORATOIRE CHAUVIN
416 RUE SAMUEL MORSE – CS 99535
34961 MONTPELLIER
Manufacturer
LABORATOIRE CHAUVIN
ZONE INDUSTRIELLE DE RIPOTIER
50 AVENUE JEAN MONNET
07200 AUBENAS
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 ASSESSMENT.
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 rubbing can only worsen the situation.
· 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 (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 allergens:
· 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 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.