Side effects of Levofree
In rare cases, some side effects may occur such as eye pain, blurred vision, burning, tingling or eye irritation.
Pack size: 5 ml vial.
ANSM - Updated on: 05/10/2023
LEVOFREE 0.05%, eye drops, solution
Levocabastine
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 after 5 days.
What does this leaflet contain?
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. What are the possible side effects?
5. How to store LEVOFREE 0.05% eye drops, solution?
6. Package contents 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 medicine 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 preservative.
You should contact your doctor if you do not feel any improvement or if you feel worse after 5 days.
2. WHAT YOU NEED TO KNOW BEFORE USING LEVOFREE 0.05%, eye drops, solution?
Never 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.
LEVOFREE 0.05% eye drops, solution with food, drinks 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 for advice before taking this medicine.
Pregnancy
The use of this medication should be considered with caution during pregnancy.
Breastfeeding
Due to the lack of data, the use of levocabastine is not recommended during breastfeeding.
Driving and operating machinery
Patients experiencing visual disturbances (mild irritation following instillation) should refrain from driving vehicles 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 “what are the 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 your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are unsure.
Dosage
The recommended dose is one drop in each eye, 2 times a day. This dose can be increased, if necessary, to 1 drop 3 to 4 times a day.
Use in children aged 6 years and over and adolescents: the recommended dose is not changed.
Use the eye drops at regular intervals.
Never exceed the recommended dose.
Mode of administration
This medication should be administered directly into the eye. It should never be injected.
When using this eye drop, you must wash your hands thoroughly before opening the bottle and follow these steps:
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 experience improvement or if your symptoms persist, you should consult your doctor.
If you use more LEVOFREE 0.05% eye drops, solution than you should:
In case of overdose, drowsiness may occur. Rinse thoroughly with saline solution. And 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; just continue with 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. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Commonly seen conditions (may affect up to 1 in 10 people) are:
· Eye pain, blurred vision, burning sensation, stinging, eye irritation
Uncommon conditions (may affect up to 1 in 100 people) include:
· Swelling (edema) of the eyelids
Very rarely seen 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 itchy eyes;
· Rash, skin redness, systemic allergic reaction which may be serious and manifest as sudden swelling of the face and neck or sudden malaise with drop in blood pressure and breathing difficulties. In this case, stop treatment immediately and inform your doctor.
· Headaches;
· Palpitations.
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 disturbances due to calcium build-up 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 shown 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.
Store at a temperature not exceeding 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 to protect the environment.
6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION
What LEVOFREE 0.05% eye drops, solution contains
· The active substance is:
Levocabastine.................................................................................................................. 0.05 g
as levocabastine hydrochloride
For 100 mL of solution
· The other components are:
Hydroxypropylbetadex, monosodium phosphate dihydrate, disodium phosphate dodecahydrate, sodium chloride, purified water.
What is LEVOFREE 0.05%, eye drops, solution and contents of the outer packaging?
This medication comes in the form of eye drops in solution. Each box contains 1 bottle of 5 mL.
Marketing Authorisation Holder
416 RUE SAMUEL MORSE – CS 99535
34961 MONTPELLIER
FRANCE
Marketing Authorization Operator
CHAUVIN LABORATORY
416 RUE SAMUEL MORSE – CS 99535
34961 MONTPELLIER
FRANCE
RIPOTIER INDUSTRIAL ZONE
50 AVENUE JEAN MONNET
07200 AUBENAS
FRANCE
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. He or she 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 of the eye are signs of allergic conjunctivitis.
This condition often accompanies allergic rhinitis (sneezing, runny nose, blocked nose) because they are triggered by the same allergens (pollens, dust mites, animal hair, etc.).
c) Some practical advice
· Do not rub your eyes, even if they itch, because after temporary relief, rubbing can only make the situation worse.
· Gently rinse your eyes with clean water or a sterile washing solution to remove pollen and thus relieve your eyes.
· Temporarily remove makeup. Healing of the conjunctivitis or recurrence upon reapplication may eventually help identify the responsible substance. The presence of an eye allergy should lead to vigilance in the choice of cosmetics.
· If you wear contact lenses, it is best to remove them for the duration of treatment with eye drops.
d) If you experience acute eye pain, a feeling of decreased vision or blurred vision, consult your doctor.
e) Prevention of recurrences
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 the 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.
