Olodon Free

Package Leaflet: Information for the Patient

Olodon Free, 1 mg/ml, Eye Drops, Solution

Olopatadine

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Olodon Free and what is it used for
• 2. Important information before using Olodon Free
• 3. How to use Olodon Free
• 4. Possible side effects
• 5. How to store Olodon Free
• 6. Contents of the pack and other information

1. What is Olodon Free and what is it used for

Olodon Free is intended for the treatment of subjective and objective symptoms of seasonal allergic conjunctivitis.

Allergic conjunctivitis.Some substances (allergens), such as plant pollen, house dust, or animal dander, can cause allergic reactions, which manifest as itching, redness, and swelling of the eye surface.
Olodon Free is a medicineused to treat allergic eye diseases. Its action involves reducing the severity of allergic reactions.

2. Important information before using Olodon Free

When not to use Olodon Free

• if the patient is allergic to olopatadine or any of the other ingredients of this medicine (listed in section 6)
• during breastfeeding.

Warnings and precautions

Before starting to use Olodon Free, the patient should discuss it with their doctor or pharmacist.
The patient should remove contact lenses before using Olodon Free and wait at least 15 minutes before putting them back on.
Children
Olodon Free should not be used in children under 3 years of age, as there is no data on the safety and efficacy of the medicine in this age group.

Olodon Free and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
If the patient is using other eye drops or ointments at the same time,they should leave an interval of at least 5 minutes between administrations of the different medicines. Eye ointments should be used last.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
Olodon Free should not be used during breastfeeding.
The patient should consult their doctor before using this medicine during pregnancy.

Driving and using machines

For some time after administering Olodon Free, vision may be blurred. The patient should not drive or operate machines until their vision has improved.

3. How to use Olodon Free

This medicine should always be used exactly as the doctor or pharmacist has advised. If the patient is unsure, they should consult their doctor or pharmacist.

Recommended dose:

One drop into the eye(s) twice a day, in the morning and evening. The patient should leave an interval of at least 8 hours between administrations of the drops.
The drops should be used as directed above unless the doctor has recommended a different dosage. Olodon Free should be used in both eyes only if the doctor has recommended it. The medicine should be used for as long as the doctor has advised.
Olodon Free should be used only as eye drops.
Olodon Free is a sterile solution that does not contain preservatives. See section 6, What Olodon Free looks like and what the pack contains.

Before administering the drops:

• In case of first use, before administering the drops, the patient should practice using the dropper bottle away from the eye, squeezing it slowly so that one drop comes out.
• If the patient is sure they can administer a single drop, they should take the most comfortable position for administration (they can sit, lie on their back, or stand in front of a mirror).

Instructions for use:

• 1. Before administering the medicine, the patient should wash their hands thoroughly.
• 2. If the packaging or bottle is damaged, the medicine should not be used.
• 3. Before using the drops for the first time, the patient should unscrew the cap after making sure the tamper-evident ring on the cap is intact. When unscrewing, a slight resistance will be felt until the ring breaks (Figure 1.).
• 4. If the tamper-evident ring is loose, it should be removed before using the medicine, as it may fall into the eye and cause injury.
• 5. The patient should tilt their head back and gently pull the lower eyelid down with their finger to create a "pocket" between the eye and the eyelid (Figure 2.). The patient should not touch the dropper tip to the eye, eyelids, fingers, or any other surface.

• 6. The patient should administer one drop by slowly squeezing the bottle (Figure 3.). The bottle should be squeezed gently in the middle so that the drop gets into the patient's eye. The patient should remember that there may be a few seconds' delay between squeezing the bottle and the drop coming out. The patient should not squeeze the bottle too hard. If they have any doubts about using the medicine, they should consult their pharmacist.
• 7. If the doctor has recommended using the drops in the other eye, the patient should repeat the actions from points 5 and 6.
• 8. After use and before closing the bottle, the patient should shake the bottle downwards without touching the dropper tip to remove any remaining liquid from the tip. This is necessary to ensure that the next drops can be administered. Immediately after use, the patient should tightly close the bottle (Figure 4.).

If the drop does not get into the eye, the patient should try again.

Figure 1.
Figure 2.
Figure 3.
Figure 4.

Using more than the recommended dose of Olodon Free

In case of using more than the recommended dose of Olodon Free, the patient should rinse their eyes with lukewarm water. They should not administer the next drops until it is time for the next dose.

Missing a dose of Olodon Free

In case of missing a dose of Olodon Free, the patient should administer one drop into the eye as soon as possible and then return to their normal dosing schedule. If it is almost time for the next dose, they should skip the missed dose and continue with their regular dosing schedule. They should not use a double dose to make up for the missed dose.

Stopping the use of Olodon Free

The patient should not stop using Olodon Free without consulting their doctor first.
If they have any further doubts about using this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Olodon Free can cause side effects, although not everybody gets them.
If the patient experiences allergic reactions, including rash, swelling of the face, lips, tongue, and/or
throat, which may cause difficulty in breathing or swallowing, or other serious side effects, they should stop using the medicine and contact their doctor or the Emergency Department of the nearest hospital immediately.
The following side effects have been observed during the use of Olodon Free:
Common(occurring in less than 1 in 10 patients)
Eye disorders: eye pain, eye irritation, dry eye, abnormal sensations in the eye.
General disorders: headache, fatigue, dryness of the nasal mucosa, taste disturbances in the mouth.
Uncommon(occurring in less than 1 in 100 patients)
Eye disorders: corneal ulcers, corneal abnormalities, corneal disease, punctate keratitis, keratitis, spots on the cornea, eye discharge, photophobia, blurred vision, reduced visual acuity, blepharospasm, eye discomfort, eye itching, papillae on the conjunctiva, conjunctival diseases, feeling of a foreign body in the eye, increased lacrimation, redness of the eyelids, eyelid edema, eyelid diseases, conjunctival hyperemia.
General disorders: abnormal or impaired sensation, dizziness, rhinitis, dry skin, contact dermatitis, burning sensation of the skin.
Frequency not known(cannot be estimated from the available data)
Eye disorders: eye edema, corneal edema, conjunctivitis, change in pupil size, vision disturbances, crusts on the eyelid margins.
General disorders: dyspnea, hypersensitivity (allergy), facial edema, somnolence, general weakness, malaise, nausea, vomiting, sinusitis, skin rash and redness.
In patients with significantly damaged anterior, transparent layer of the eye (cornea), very rare cases of cloudy spots on the cornea caused by calcium deposits during treatment have been observed.

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Pharmacovigilance of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Olodon Free

Store in a temperature below 30°C.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and bottle. The expiry date refers to the last day of the month.
The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot means the batch number.
The bottle should be discarded 90 days after first opening,and then the next bottle of the medicine should be used. The date of opening the bottle should be written on the carton.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Olodon Free contains

• The active substance of the medicine is olopatadine (in the form of olopatadine hydrochloride). Each ml of the solution contains 1 mg of olopatadine (in the form of olopatadine hydrochloride).
• The other ingredients are: sodium chloride, disodium phosphate dodecahydrate, polysorbate 80, hydrochloric acid (to adjust pH), water for injections.

What Olodon Free looks like and what the pack contains

Clear, colorless or almost colorless solution.
Olodon Free is available in white 5 ml (LDPE) bottles with a multidose dropper (HDPE) that prevents contamination of the solution with bacteria thanks to a system consisting of a silicone membrane and air filtration entering the bottle, with an HDPE cap with a tamper-evident ring in a cardboard box.
Olodon Free is available in packs containing 1 or 3 bottles.
Not all pack sizes may be marketed.

Marketing authorization holder

Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
phone: +48 22 364 61 01

Manufacturer

Rafarm S.A.
Thesi Pousi Xatzi Agiou Louka
Paiania, 190 02
Greece

Date of last revision of the leaflet: