Olopatadine Farto

Package leaflet: Information for the patient

OLOPATADINE FARTO 1 mg/mL eye drops, solution

olopatadine
Generic medicine
Read this entire leaflet carefully before using this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Contact your doctor if you do not notice any improvement, or if your symptoms worsen after several days of treatment.

Contents of this leaflet

1. What OLOPATADINE FARTO is and what it is used for
2. What you need to know before using OLOPATADINE FARTO
3. How to use OLOPATADINE FARTO
4. Possible side effects
5. How to store OLOPATADINE FARTO
6. Contents of the pack and other information

1. What OLOPATADINE FARTO is and what it is used for

OLOPATADINE FARTO is indicated for the treatment of signs and symptoms of seasonal allergic conjunctivitis.
Allergic conjunctivitis. Certain foreign substances to the body (allergens), such as pollen, house dust, or animal dander, can cause allergic reactions, resulting in itching, redness, and sometimes swelling of the eye surface.
OLOPATADINE FARTO is a medicine used to treat allergic conditions of the eye. It works by reducing the intensity of the allergic reaction.

2. What you need to know before using OLOPATADINE FARTO

Do not use OLOPATADINE FARTO

• If you are allergic (hypersensitive) to olopatadine or to any of the other ingredients of this medicine (listed in section 6);
• Do not use OLOPATADINE FARTO if you are breastfeeding.

Warnings and precautions
Talk to your doctor or pharmacist before using OLOPATADINE FARTO.
If you wear contact lenses, you must remove them before using OLOPATADINE FARTO.
Children
Do not use OLOPATADINE FARTO in children under 3 years of age. Do not give this medicine to children under 3 years of age, as there are no data confirming that it is safe and effective in children below 3 years of age.
Other medicines and OLOPATADINE FARTO
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
If you are using other eye drops or ophthalmic ointments, wait at least 5 minutes between the use of each medicine. Ointments should be used last.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor before taking this medicine.
Driving and using machines
You may experience blurred vision for a period of time after using OLOPATADINE FARTO. Do not drive or operate machinery until this effect has passed.
OLOPATADINE FARTO contains Benzalkonium chloride
This medicine contains 0.5 mg of benzalkonium chloride per 5 mL, which is equivalent to 0.1 mg/mL.
The preservative contained in OLOPATADINE FARTO, benzalkonium chloride, may be absorbed by soft contact lenses and may cause discoloration. Remove contact lenses before using this medicine and wait 15 minutes before reinserting them. Benzalkonium chloride may also cause eye irritation, particularly if you have dry eye or corneal disorders (the transparent outer layer of the eye).
If you experience any unusual eye sensation, burning, or pain after using this medicine, speak with your doctor.
OLOPATADINE FARTO contains Disodium phosphate dihydrate
This medicine contains 16.75 mg of phosphate buffer (in 31.35 mg of disodium phosphate dihydrate) per 5 mL bottle, which is equivalent to 3.35 mg/mL.
If you have severe damage to the outer transparent layer of the eye (cornea), phosphates may, in very rare cases, cause cloudy corneal deposits due to calcium accumulation during treatment.

3. How to use OLOPATADINE FARTO

Use this medicine exactly as directed by your doctor or pharmacist. If you have any doubts,
consult your doctor or pharmacist.
The recommended dose is one drop in the eye/both eyes, twice daily—morning and evening.
Follow this dosage unless your doctor has given you different instructions. Instill OLOPATADINE FARTO
in both eyes only if specifically prescribed by your doctor. Use the product for the length of time
specified by your doctor.
OLOPATADINE FARTO is intended for ophthalmic use only.

• Take the OLOPATADINE FARTO bottle and a mirror.
• Wash your hands.
• Take the bottle and unscrew the cap.
• After removing the cap, if the safety ring has loosened, remove it before using the product.
• Hold the bottle upside down between your thumb and middle finger.
• Tilt your head backward. Gently pull down the lower eyelid with a clean finger to form a pouch between the eyelid and the eye. The drop should be instilled into this pouch (Figure 1).
• Bring the tip of the bottle close to the eye. Use the mirror if it helps.
• Do not touch the eye, eyelid, surrounding areas, or any other surface with the dropper tip to avoid contaminating the remaining drops in the bottle.
• Gently press the base of the bottle to release one drop of OLOPATADINE FARTO at a time.
• Do not squeeze the bottle hard—it is designed so that only gentle pressure on the bottom is needed (Figure 2).
• If instilling drops in both eyes, repeat the same procedure for the other eye.
• Immediately replace and securely tighten the cap after use. If a drop misses the eye, try again.

If you use more OLOPATADINE FARTO than you should
Rinse the eye thoroughly with lukewarm water. Do not instill further eye drops until it is time for your next scheduled dose.
If you forget to use OLOPATADINE FARTO
Instill one drop as soon as possible, then return to your regular dosing schedule. However, if it is almost time for your next dose, skip the missed dose and resume your normal dosing schedule. Do not use a double dose to make up for the missed one.
If you stop using OLOPATADINE FARTO
Do not stop treatment with this medicine without first talking to your doctor.
If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Common (may affect up to 1 in 10 people)
Eye-related effects
Eye pain, eye irritation, dry eyes, abnormal sensation in the eyes, eye discomfort.
General side effects
Headache, fatigue, dry nose, bad taste.

Uncommon (may affect up to 1 in 100 people)
Eye-related effects
Blurred, reduced or abnormal vision, corneal disorder, inflammation with or without damage of the eye surface, conjunctival inflammation or infection, eye discharge, light sensitivity, increased tear production, eye itching, eye redness, eyelid abnormalities, itching, redness, swelling, or crusting of the eyelid.
General side effects
Abnormal or reduced sensitivity, dizziness, runny nose, dry skin, skin inflammation.

Not known (frequency cannot be determined from available data)
Eye-related effects
Eye swelling, corneal swelling, changes in pupil size.
General side effects
Shortness of breath, worsening allergy symptoms, facial swelling, drowsiness, generalized weakness, nausea, vomiting, sinusitis, skin redness and itching.

In very rare cases, some patients with severe damage to the transparent layer in front of the eye (cornea) have developed opaque spots on the cornea due to calcium deposits during treatment.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store OLOPATADINE FARTO

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the bottle and carton after "Exp.". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
The bottle must be discarded 4 weeks after first opening, to prevent possible infections, and a new bottle must be used.
Please record the date of opening in the designated space (i) on the label of the bottle and on the carton.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

The active substance is olopatadine. Each mL of solution contains 1 mg of olopatadine (as hydrochloride).
The other components are benzalkonium chloride, sodium chloride, disodium phosphate dihydrate, hydrochloric acid and/or
sodium hydroxide, water for injections.
Description of the appearance of OLOPATADINA FARTO and package contents
OLOPATADINA FARTO is a clear, colourless liquid (solution) supplied in a pack containing a 5 mL low-density polyethylene dropper bottle with screw cap.
Marketing Authorization Holder
Farto S.r.l. – Via dei Caboto 49 - 50127 Florence
Manufacturer
BALKANPHARMA-RAZGRAD AD
68, Aprilsko Vastanie Blvd.,
7200 Razgrad
Bulgaria