SUMMARY OF PRODUCT FEATURES
ANSM - Updated on: 02/17/2023
1. NAME OF THE MEDICINE
LEVOPHTA 0.05%, eye drops
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Levocabastine hydrochloride...................................................................................... 0.054 g
Quantity corresponding to levocabastine base................................................................................ 0.050 g
For 100 mL.
Excipient with known effect:
This medicine contains propylene glycol equivalent to 50.00 mg/mL.
This medicine contains phosphates equivalent to 14.05 mg/mL.
This medicine contains benzalkonium chloride equivalent to 0.15 mg/mL.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Eye drops.
4. CLINICAL DATA
4.1. Therapeutic indications
Allergic conjunctivitis.
4.2. Dosage and method of administration
Presented in the form of a micro-suspension, LEVOPHTA 0.05% eye drops must be shaken before use.
Dosage
Pediatric population
The safety and efficacy of LEVOPHTA 0.05% eye drops in children aged less than 6 years have not yet been established. These data are limited (see section 5.1).
Adult and child aged at least 6 years
The usual recommended dose is 1 drop in each eye, 2 times a day.
This dose can be increased, if necessary, to 1 drop 3 to 4 times a day.
The eye drops should be used at regular intervals.
Treatment should not be extended beyond 5 days without medical advice.
Mode of administration
As with all eye drops, carry out the following operations in order:
· Wash your hands thoroughly before instillation.
· Avoid touching the eye or eyelids with the tip of the bottle.
· Instill a drop of eye drops into the conjunctival sac of the eye while looking upwards and pulling the lower eyelid slightly downwards,
· With your eye closed, wipe off any excess, especially on your cheek.
· To avoid systemic effects, it is recommended to compress the inner angle of the eye for 1 minute after each instillation.
In case of concomitant treatment with another eye drop, space the instillations 15 minutes apart.
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
4.4. Special warnings and precautions for use
LEVOPHTA 0.05% eye drops should not be used as an injection.
Wearing contact lenses is not recommended during treatment (risk of adsorption of the preservative and active ingredients).
This medicine contains propylene glycol and may cause skin irritation.
This medicinal product contains phosphate (see section 4.8).
This medicine contains benzalkonium chloride equivalent to 0.15 mg/mL.
Benzalkonium chloride can be absorbed by soft contact lenses and change their color. Remove contact lenses before application and wait at least 15 minutes before reinserting them.
Benzalkonium chloride is known to cause eye irritation, symptoms of dry eye syndrome, and may affect the tear film and corneal surface. Should be used with caution in patients with dry eye and those at risk of corneal damage. Patients should be monitored during prolonged use.
Benzalkonium chloride may irritate skin.
4.5. Interactions with other medicinal products and other forms of interaction
Not applicable.
4.6. Fertility, pregnancy and breastfeeding
Pregnancy
No data are available for humans. Given the negligible systemic passage and the fact that no embryotoxic or teratogenic effects have been reported in animal experiments, the use of LEVOPHTA 0.05% eye drops can be considered with caution during pregnancy.
Breastfeeding
Due to the lack of data, the use of levocabastine is not recommended during breastfeeding.
4.7. Effects on ability to drive and use machines
The patient may experience temporary visual discomfort due to slight irritation when instilling the eye drops. In this case, it is recommended to wait until vision returns to normal before driving a vehicle or operating machinery.
4.8. Adverse effects
Adverse reactions from clinical trials, epidemiological studies and post-marketing data are classified according to their frequency of occurrence as follows: very common (≥ 1/10), common (≥ 1/100, < 1/10), uncommon (≥ 1/1000, < 1/100), rare (≥ 1/10000, < 1/1000) and very rare (< 1/10000). The frequencies of reactions reported from post-marketing experience are not known.
Eye conditions
Common : Eye pain, blurred vision
Uncommon : Eyelid edema
Very rare : Conjunctivitis, eye swelling, blepharitis, ocular hyperemia, watery eyes
A few very rare cases of corneal calcification have been reported in association with the use of phosphate-containing drops in some patients with severely damaged corneas.
Heart conditions
Very rare : palpitations
General disorders and administration site conditions
Common : Administration site reaction including burning/stinging, eye irritation
Very rare : Administration site reaction including eye redness, ocular pruritus
Immune system disorders
Very rare : Quincke's edema, hypersensitivity , anaphylactic reaction
Skin and subcutaneous tissue disorders
Very rare : Contact dermatitis, urticaria
Nervous system disorders
Very rare : Headaches
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/.
4.9. Overdose
Sedation after accidental overdose cannot be excluded.
In case of overdose, rinse thoroughly with sterile physiological serum.
5. PHARMACOLOGICAL PROPERTIES
5.1. Pharmacodynamic properties
Pharmacotherapeutic group: selective H1 antihistamine , ATC code: S01GX02 .
Levocabastine is a selective, potent, and fast-acting, long-acting H1-antihistamine.
After ocular instillation, it quickly relieves the symptoms of allergic conjunctivitis (pruritus, erythema, tearing, eyelid edema, chemosis) for several hours.
Pediatric population
Pediatric studies conducted in children aged 6 to 18 years have confirmed the efficacy of levocabastine in ocular instillations. Data on use in children aged 4 to 6 years have been published. Due to their limited nature, the benefit-risk balance should be considered when using ocular levocabastine in children aged at least 4 years and less than 6 years.
5.2. Pharmacokinetic properties
After ocular instillation, levocabastine is gradually and partially reabsorbed by the mucosa.
Plasma concentrations are too low to produce systemic effects.
5.3. Preclinical safety data
Non-clinical data on levocabastine from conventional repeated dose toxicology studies conducted by oral, intravenous, dermal and ocular routes in different animal species (rat, dog, rabbit) have not revealed any particular risk for humans.
Reproduction studies in mice and rats by the oral route have shown that levocabastine is devoid of adverse effects on reproduction up to 20 mg/kg/day in rats and up to 40 mg/kg/day in mice.
Levocabastine has not shown mutagenic or carcinogenic potential.
6. PHARMACEUTICAL DATA
6.1. List of excipients
Propylene glycol, anhydrous disodium phosphate, monosodium phosphate monohydrate, hypromellose, polysorbate 80, benzalkonium chloride (50% solution), sodium edetate, purified water.
6.2. Incompatibilities
Not applicable.
6.3. Retention period
2 years.
After first opening the bottle, the medicine should be stored for a maximum of 30 days.
6.4. Special storage precautions
Store at a temperature not exceeding 25°C.
For storage conditions of the medicinal product after first opening, see section 6.3.
6.5. Nature and contents of outer packaging
3 mL in bottle (polyethylene) with dropper (polyethylene).
5 mL in dropper bottle (polyethylene).
Not all presentations may be marketed.
6.6. Special precautions for disposal and handling
No special requirements.
Any unused medicine or waste material should be disposed of in accordance with local regulations.
7. MARKETING AUTHORISATION HOLDER
CHAUVIN LABORATORY
416 RUE SAMUEL MORSE – CS 99535
34961 MONTPELLIER
[Tel, fax, e-mail: to be completed later by the holder]
8. MARKETING AUTHORISATION NUMBER(S)
· 34009 336 075 6 2: 3 mL in bottle (polyethylene) with dropper (polyethylene).
· 34009 347 398 6 6: 5 mL in dropper bottle (polyethylene).
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}
10. DATE OF TEXT UPDATE
[to be completed later by the holder]
{DD month YYYY}
11. DOSIMETRY
Not applicable.
12. INSTRUCTIONS FOR THE PREPARATION OF RADIOPHARMACEUTICALS
Not applicable.
NOTICE
ANSM - Updated on: 02/17/2023
Name of the drug
LEVOPHTA 0.05%, eye drops
Levocabastine
Boxed
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 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. What are the possible side effects?
5. How to store LEVOPHTA 0.05% eye drops?
6. Contents of the package and other information
1. WHAT IS LEVOPHTA 0.05%, EYE DROP 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 medicine 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 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 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.
Wearing contact lenses should be avoided 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.
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 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.
LEVOPHTA 0.05%, eye drops contains 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 transparent layer at the front of the eye), phosphates can, in very rare cases, cause vision problems due to the accumulation of calcium during treatment ( appearance of cloud-like inclusions ).
This medicine contains benzalkonium chloride equivalent to 0.15 mg/mL.
Benzalkonium chloride can be absorbed by soft contact lenses and change their color. Remove contact lenses before application and wait at least 15 minutes before reinserting them.
Benzalkonium chloride may also cause eye irritation, especially if you have dry eye syndrome or problems with the cornea (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 may irritate skin.
3. HOW TO USE LEVOPHTA 0.05%, eye drops?
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 the eye drops at regular intervals.
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
Ocular route.
LEVOPHTA 0.05% eye drops must be shaken well before use.
This medication should be administered directly into the eye. It should 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 limit the risk of infection, avoid contact of the dropper with the eye or eyelids.
4. Tilt your head back and look at the ceiling.
5. Gently lower the lower eyelid to form a small pocket.
6. Tilt the bottle over the eye and squeeze the bottle to release one drop into each affected eye.
7. Blink once so that the eye drops are distributed over the entire surface of the eye.
8. With your eye closed, wipe off any excess, especially on your cheek.
9. To avoid systemic effects, it is recommended to compress the inner angle 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 experience improvement or if your symptoms persist, you should consult your doctor.
If you use more LEVOPHTA 0.05% eye drops than you should
In case of overdose, drowsiness may occur. Rinse thoroughly with sterile saline solution. And 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, but simply continue with 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. 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 ( affecting up to 1 in 100 people ) include:
· Swelling (edema) of the eyelids;
Very rarely observed conditions ( affecting up to 1 in 10,000 people ) are:
· Conjunctivitis, swelling of the eyes and inflammation of the eyelids, redness of the eye, watery eyes and itchy eyes;
· Rash, redness of the skin, general 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 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 be stored at a temperature not exceeding 25°C.
After first opening the bottle, the medicine should be stored for a maximum of 30 days. Write the opening date clearly on the packaging.
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 LEVOPHTA 0.05% eye drops contain
· The active substance is:
Levocabastine hydrochloride...................................................................................... 0.054 g
Quantity corresponding to levocabastine base.................................................................. 0.050 g
Per 100 mL
· The other components 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 and contents of the outer packaging
This medication comes in the form of eye drops in 3 mL or 5 mL bottles.
Not all presentations may be marketed.
Marketing Authorisation Holder
CHAUVIN LABORATORY
416 RUE SAMUEL MORSE – CS 99535
34961 MONTPELLIER
Marketing Authorization Operator
CHAUVIN LABORATORY
416 RUE SAMUEL MORSE – CS 99535
34961 MONTPELLIER
Manufacturer
CHAUVIN LABORATORY
RIPOTIER INDUSTRIAL ZONE
50 AVENUE JEAN MONNET
07200 AUBENAS
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}.
Others
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 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.
