Bausch + Lomb OphtacalmFree 2% preservative-free eye drops

OphtacalmFree 2% preservative-free eye drops are used to relieve seasonal or non-seasonal allergic conjunctivitis (recognizable by swollen eyes and/or eyelids, red, itchy, or watery eyes).

This medication is for adults and adolescents over 15 years of age. For younger children, medical advice is required.

This 10 ml bottle contains sodium cromoglicate (2 g/100 ml), an antihistamine, as the active ingredient.

Dosage of OphtacalmFree 2% eye drops

The recommended dosage should be adjusted according to the severity of symptoms. One drop can be instilled into each affected eye 2 to 6 times a day, at regular intervals.

Be careful not to exceed the recommended dosage.

If you are using another eye drop, you must wait 15 minutes between each instillation.

Before first use, you must first perform 15 pumping movements to activate the pumping mechanism and obtain the required amount of solution. Wash your hands thoroughly before instilling.
You must avoid contact between the tip of the bottle and your eyes or eyelids.
This eye drop solution features a patented pump mechanism and is safe and easy to use.

Do not extend treatment beyond 7 days without medical advice.

Precautions for use of OphtacalmFree 2% anti-allergy preservative-free

You should not use OphtacalmFree 2% eye drops if you have a history of allergy to cromoglicate or any of the eye drop ingredients.

If you are taking or have recently taken any other medication, even if obtained without a prescription, you must inform your doctor or pharmacist.

Pregnant or breastfeeding women should consult their doctor before taking any medication.

When driving a vehicle or operating machinery, caution should be exercised as temporary visual discomfort may be experienced after administering the eye drops. In this case, you should wait until the symptoms subside.

Consult the package leaflet before use.

Condition: 10 ml bottle

Before using these eye drops, it is recommended to rinse the eyes with Ophtaxia single-dose eye drops.


LEAFLET
ANSM - Updated on: 11/30/2022
Name of the medicinal product
OPHTACALMFREE 2%, eye drops, solution
Sodium cromoglicate
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 7 days.
What is in this leaflet? 1. What is OPHTACALMFREE 2%, eye drops, solution and what is it used for?
2. What you need to know before using OPHTACALMFREE 2%, eye drops, solution?
3. How to use OPHTACALMFREE 2%, eye drops, solution?
4. Possible side effects?
5. How to store OPHTACALMFREE 2%, eye drops, solution?
6. Contents of the pack and other information.
1. WHAT IS OPHTACALMFREE 2%, eye drops, solution AND WHAT IS IT USED FOR?
Pharmacotherapeutic group - Local antiallergic, ATC code: S01GX01
OPHTACALMFREE 2%, eye drops, solution contains the active ingredient sodium cromoglicate, which has antiallergic properties. This eye drop is indicated for adults and children over 15 years of age for seasonal or non-seasonal allergic conjunctivitis (recognizable by swollen eyes and/or eyelids, red, itchy, or watery eyes).
You should consult your doctor if you do not feel any improvement or if you feel worse after 7 days of treatment.
2. WHAT YOU NEED TO KNOW BEFORE USING OPHTACALMFREE 2%, eye drops, solution?
Never use OPHTACALMFREE 2%, eye drops, solution:
· if you are allergic to sodium cromoglicate or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Consult your doctor or pharmacist before using OPHTACALMFREE 2%, eye drops, solution. NEVER LEAVE OUT OF REACH OF CHILDREN.
Do not exceed the recommended dosage.
If there is no improvement or if symptoms persist beyond 7 days of treatment, seek medical advice.
If you are taking another eye drop at the same time, wait 15 minutes between each application.
Wash your hands thoroughly before applying the drops.
Close the bottle tightly after use.
Children
For children under 15 years of age, seek medical advice.
Other medicines and OPHTACALMFREE 2%, eye drops, solution
The effectiveness of eye drops may be affected by the simultaneous application of another eye drop. You should leave 15 minutes between applications.
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. OPHTACALMFREE 2% Eye Drops, Solution with Food, Drinks, and Alcohol
Not applicable.
Pregnancy and Breastfeeding
As a precautionary measure, it is preferable not to use OPHTACALMFREE 2% Eye Drops, Solution during pregnancy.
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.
Driving and Using Machinery
Be careful. Temporary visual discomfort may be experienced after administering the eye drops. In this case, you should wait until the symptoms resolve before driving a vehicle or operating machinery.
OPHTACALMFREE 2% Eye Drops, Solution contains {name the excipient(s)}
Not applicable.
3. HOW TO USE OPHTACALMFREE 2% 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 in doubt.
Dosage
Adults and children over 15 years: Depending on the severity of symptoms, instill 1 drop into each affected eye 2 to 6 times a day, at regular intervals.
Use in children
For children under 15 years, prior medical advice is required.
Space out instillations.
If taking another eye drop at the same time, wait 15 minutes between instillations.
Never exceed the recommended dose.
Method of administration
Ophthalmic use
DO NOT INJECT OR SWALLOW.
The eye drops should not be administered by periocular or intraocular injection.
Wash your hands thoroughly before instilling. Avoid contact between the tip of the bottle and your eyes or eyelids.
OPHTACALMFREE 2% Eye Drops, Solution features a patented pump mechanism and is safe and easy to use.
When using this eye drop, follow these steps:

Bottle with side-actuated dispenser sleeve:

1. Wash your hands before using OPHTACALMFREE 2% Eye Drops, Solution and hold the bottle as directed.

2. Remove the protective cap from the tip of the bottle by twisting it before each use. Avoid contact between the tip of the bottle and your fingers or any other surface to avoid the risk of contaminating the solution.

3. Turn the bottle upside down and tilt your head back slightly. Gently pull your lower eyelid down with one finger of your free hand, hold the bottle upright above your eye, and simultaneously press the pump mechanism to apply one drop into your eye. Avoid touching the surface of your eye with the tip of the bottle to avoid the risk of injury. Close your eye and gently rotate it to distribute the solution evenly over the surface of your eye.

4. Immediately after use, shake the bottle to remove any residual drops and replace the protective cap on the dry tip of the bottle.
The bottle can be completely emptied to the stated filling volume. Due to the design of the bottle, some solution remains in the bottle.

Bottle with ergonomic thumb rest:

Before first use, approximately 15 pumping movements are required to activate the pump mechanism and obtain the required amount of solution (Fig. 1). Hold the bottle upside down as shown in the diagram. This manipulation will then no longer be necessary.

Before each use, wash your hands and remove the protective cap from the bottle tip (Fig. 2). Avoid any possible contact with the bottle tip.

Figure 3 describes how to hold the product for safe and comfortable instillation.
Place your thumb on the ergonomic support provided specifically for this purpose and two fingers on the base of the bottle.

To use, tilt your head slightly back and hold the dropper bottle above your eye, as shown in Figure 4.
With the index finger of your free hand, pull your lower eyelid slightly downward. The space that forms is called the conjunctival sac.
Make sure to hold the dropper bottle upright whenever possible. Avoid contact with the bottle tip with your fingers or the eye.

To place a drop of OPHTACALMFREE 2%, eye drops, solution, into the conjunctival sac, briefly but firmly press the bottle. Thanks to the automatic dosing system, exactly one drop is released with each pump. Now close your eye and move it slowly in all directions to optimally distribute the ophthalmic solution over the surface of the eye.
Reclose the bottle tip with the cap immediately after use.
If you feel that the effect of OPHTACALMFREE 2%, eye drops, solution is too strong or too weak, consult your doctor or pharmacist.
Frequency of administration
The recommended dose is 1 drop in each eye, 2 to 6 times a day, at regular intervals.
Duration of treatment
Do not extend treatment beyond 7 days without medical advice: if there is no improvement or if symptoms persist, seek medical advice. If you use more OPHTACALMFREE 2% Eye Drops, Solution than you should
Rinse thoroughly with clean water in case of overdose.
Consult your doctor or pharmacist immediately.
If you forget to use OPHTACALMFREE 2% Eye Drops, Solution
Do not take a double dose to make up for a forgotten dose; simply continue with your treatment.
If you stop using OPHTACALMFREE 2% 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. The following effects may occur:
· allergic reactions to the eye drop components,
· temporary visual discomfort after applying the eye drops.
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 OPHTACALMFREE 2%, 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 outer packaging after EXP. The expiry date refers to the last day of that month.
After first opening the bottle: store for a maximum of 3 months.
After this period, you should no longer use this eye drop.
Write the opening date clearly on the packaging.
No special storage precautions are required.
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 PACK AND OTHER INFORMATION
What OPHTACALMFREE 2%, eye drops, solution, contains
· The active ingredient is:
Sodium cromoglicate............................................................................................................ 2 g
Per 100 mL of solution.
· The other ingredient is:
Water for injections.
What OPHTACALMFREE 2%, eye drops, solution, looks like and contents of the outer packaging
This medicine is presented as an eye drop solution; a box of one 10 mL bottle with a pump equipped with a filter or a bottle with a side-actuated dispenser sleeve.
Not all pack sizes may be marketed. Marketing Authorization Holder
LABORATOIRE CHAUVIN
416 RUE SAMUEL MORSE - CS99535
34961 MONTPELLIER
Marketing Authorization Holder
LABORATOIRE CHAUVIN
416 RUE SAMUEL MORSE - CS99535
34961 MONTPELLIER
Manufacturer
LABORATOIRE CHAUVIN
ZONE INDUSTRIELLE DE RIPOTIER
50 AVENUE JEAN MONNET
07200 AUBENAS

or

DR. GERHARD MANN CHEM. PHARM. FABRIK GMBH
BRUNSBÜTTELER DAMM, 165/173
13581 BERLIN
GERMANY
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 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 excessive reaction of our body to substances it considers harmful, allergens. Allergens are the factors and substances that trigger allergies and the associated disorders.
During repeated contact of the body with 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 body to release substances such as histamine, which are responsible for the symptoms experienced.
As with any allergic illness, it is important to consult a doctor at least once. A doctor 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, rubbing 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 recurrence upon reapplication may help identify the causative 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 during the entire 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 well as 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 bedroom should be ventilated and cleaned regularly.
· On the floor, avoid bed rugs and carpets.
· 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.