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OphtacalmFree 2% preservative-free eye drops are used to relieve seasonal or non-seasonal allergic conjunctivitis (recognizable by swollen eyes and/or swollen eyelids, red eyes, biting or tearful eyes).
This medicine is for adults and adolescents over 15 years of age. In younger children, medical advice is required.
This 10 ml vial has sodium cromoglicate (2 g/100 ml) as active ingredient.
Dosage of eye drops OphtacalmFree 2%
The recommended dose should be adjusted according to the severity of the symptoms, one drop may be instilled into each sick eye 2 to 6 times a day, at regular intervals.
Care should be taken not to exceed the recommended dose.
If you use another eye drops, you should wait 15 minutes between each drop.
Before first use, 15 pressure movements must first be performed in order to activate the pumping mechanism and obtain the necessary amount of solution. Wash your hands thoroughly before instilting.
You should avoid contact of the vial tip with the eye or eyelids.
This solution eye drops have a patented pump mechanism and is used safely and simply.
Do not extend treatment for more than 7 days without medical advice.
Precautions for use of OphtacalmFree 2% anti-allergic without preservative
You should not use OphtacalmFree 2% eye drops if you have a history of allergy to crooglicate or any of the ingredients of eye drops.
If you are taking or have recently taken any other medicines, even if you have obtained it without a prescription, you should tell your doctor or pharmacist.
Pregnant or breast-feeding women should consult their doctor for any medicine.
To drive a vehicle or use a machine, you should be careful as transient visual discomfort may be experienced after the eye drop is given. In this case, you should wait until the symptoms are over
See the package leaflet before administration.
Pack size: 10 ml vial
ANSM - Updated on: 11/30/2022
OPHTACALMFREE 2%, eye drops solution
Sodium cromoglicate
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 7 days.
What does this leaflet contain?
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. What are the possible side effects?
5. How to store OPHTACALMFREE 2%, eye drops, solution?
6. Package contents and other information.
1. WHAT IS OPHTACALMFREE 2%, eye drops, solution AND WHAT IS IT USED FOR?
Pharmacotherapeutic group - Local anti-allergic, ATC code: S01GX01
OPHTACALMFREE 2%, eye drops in solution contains an active substance, sodium cromoglicate, which has an anti-allergic action.
This eye drop is indicated for adults and children over 15 years of age in cases of seasonal or non-seasonal allergic conjunctivitis (recognizable by swollen eyes and/or eyelids, red, itchy or watery eyes).
You should contact 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
Talk to your doctor or pharmacist before using OPHTACALMFREE 2%, eye drops, solution .
NEVER LEAVE WITHIN 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 instillation.
Wash your hands thoroughly before instilling.
Carefully close the bottle after use.
Children
In children under 15 years of age, medical advice is necessary.
Other medicines and OPHTACALMFREE 2%, eye drops, solution
The effectiveness of one eye drop may be affected by using another eye drop at the same time. You should space the use of these eye drops 15 minutes apart.
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.
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 for advice before taking this medicine.
Driving and operating machinery
Be careful. Temporary visual discomfort may be experienced after administering the eye drops. In this case, you should wait until the symptoms subside 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 your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are unsure.
Dosage
Adults and children over 15 years: Depending on the severity of symptoms, instill 1 drop in each affected eye 2 to 6 times a day, at regular intervals.
Use in children
In children under 15 years of age, prior medical advice is necessary.
Space out the instillations.
If you are taking another eye drop at the same time, wait 15 minutes between each instillation.
Never exceed the recommended dose.
Mode of administration
Ophthalmic route
DO NOT INJECT, DO NOT SWALLOW.
The eye drops should not be administered as a peri- or intra-ocular injection.
Wash your hands thoroughly before instilling.
Avoid contact of the tip of the bottle with the eye or eyelids.
OPHTACALMFREE 2% eye drops solution has a patented pump mechanism and is safe and easy to use.
When using this eye drop, you must follow these steps:
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Bottle with side-actuated dispenser sleeve: |
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1. Wash your hands before using OPHTACALMFREE 2% Eye Drops Solution and hold the bottle as directed. |
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2. Remove the protective cap from the bottle tip by twisting it off before each use. Avoid contact between the bottle tip and your fingers or any other surface to avoid the risk of contaminating the solution. |
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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 at the same time 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 any risk of injury. Close your eye and turn it gently to distribute the solution evenly over the surface of your eye. |
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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 declared filling volume. Due to the design of the bottle, some solution remains in the bottle. |
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Bottle with ergonomic thumb rest sleeve: |
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Before first use , approximately 15 pressure movements are necessary to activate the pumping mechanism and obtain the required quantity of solution (Fig. 1). Hold the bottle upside down as shown in the diagram. This manipulation will then no longer be necessary . |
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Figure 3 describes how to hold the product so that it can be instilled safely and comfortably.
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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 the lower eyelid slightly downward. The space that forms is called the conjunctival sac. Hold the dropper bottle upright whenever possible. Avoid touching the tip of the bottle with your fingers or eyes. |
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To place a drop of OPHTACALMFREE 2% eye drops, solution, into the conjunctival sac, press the bottle briefly but firmly. Thanks to the automatic dosing, 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.
Close 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: in the absence of 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; just 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. WHAT ARE THE 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 components of the eye drops,
· 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 which is stated on the outer packaging after EXP. The expiry date refers to the last day of that month.
After first opening the bottle: keep for a maximum of 3 months.
Once this period has passed, you should no longer use this eye drop.
Write the opening date clearly on the packaging.
No special storage precautions.
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 OPHTACALMFREE 2% Eye Drops Solution Contains
· The active substance is:
Sodium cromoglicate........................................................................................................ 2 g
For 100 mL of solution.
· The other component is:
Water for injections.
What OPHTACALMFREE 2%, eye drops, solution is and contents of the outer packaging
This medicine comes in the form of an eye drop solution; box of 1 bottle of 10 mL with a pump fitted with a filter or bottle fitted with a side-actuated dispenser sleeve.
Not all presentations may be marketed.
Marketing Authorisation Holder
416 RUE SAMUEL MORSE - CS99535
34961 MONTPELLIER
Marketing Authorization Operator
CHAUVIN LABORATORY
416 RUE SAMUEL MORSE - CS99535
34961 MONTPELLIER
RIPOTIER INDUSTRIAL ZONE
50 AVENUE JEAN MONNET
07200 AUBENAS
Or
DR GERHARD MANN CHEM. PHARM. FABRIK GMBH
BRUNSBÜTTELER DAMM, 165/173
13581 BERLIN
GERMANY
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 contact of the 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) In case of acute eye pain, sensation of decreased vision or blurred vision, consult your doctor.
e) Prevention of recurrences
· Removing the allergen (this is known as 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 your 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.
