Package leaflet: Information for the patient

Olodon Free, 1 mg/ml, eye drops, solution
Olopatadinum
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

Keep this leaflet, so that you can read it again if necessary.
If you have any questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

What Olodon Free is and what it is used for
Important information before using Olodon Free
How to use Olodon Free
Possible side effects
How to store Olodon Free
Contents of the package and other information

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

Olodon Free is indicated for the treatment of objective and subjective symptoms of seasonal allergic conjunctivitis.
Allergic conjunctivitis. Certain substances (allergens), such as pollen, house dust mites, or animal fur, may cause allergic reactions, manifesting as itching, redness, and swelling of the eye surface.
Olodon Free is a medicine used in the treatment of allergic eye diseases. Its action consists in 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, discuss this with a doctor or pharmacist.
Contact lenses must be removed before using Olodon Free and at least 15 minutes should be waited before reinserting them.
Children
Olodon Free should not be used in children under 3 years of age, as there is no data on safety and efficacy of use in this age group.
Olodon Free and other medicines
Tell the doctor or pharmacist about all medicines currently or recently used, as well as any medicines planned for use.
If the patient is using other eye drops or eye ointments simultaneously, an interval of at least 5 minutes should be maintained between administrations of each medicine. Eye ointments should be applied last.
Pregnancy, breastfeeding and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.
Olodon Free should not be used during breastfeeding.
Consult a doctor before using this medicine during pregnancy.
Driving and operating machinery
For a short period after instillation of Olodon Free, vision may become blurred. Do not drive or operate machinery until vision has cleared.

3. How to use Olodon Free

This medicine should always be used as directed by the physician or pharmacist. If in doubt,
consult a physician or pharmacist.
Recommended dose:
One drop into one or both eyes, twice daily – in the morning and in the evening. There should be at least
an 8-hour interval between doses.
Use the drops as described above unless the physician has advised otherwise.
Olodon Free should be used in both eyes only if so directed by a physician. The medicine should be used for as long as the physician has recommended.
Olodon Free is for ophthalmic use only.
Olodon Free is a sterile solution that does not contain preservatives. See section 6. What Olodon Free looks like and what the package contains.
Before instilling eye drops:

For first-time use, before administering drops into the eye, the patient should practice using the dropper bottle away from the eye by slowly squeezing it until one drop comes out.
If the patient feels confident about being able to instill a single drop, they should assume the most comfortable position for doing so (sitting, lying on the back, or standing in front of a mirror).

Instructions for use:

Wash hands thoroughly before instilling the medicine.
Do not use the medicine if the packaging or bottle is damaged.
Before first use, unscrew the cap after ensuring that the tamper-evident ring on the cap is intact. A slight resistance will be felt when unscrewing until the ring breaks (Figure 1).
If the tamper-evident ring is loose, remove it before using the medicine, as it may fall into the eye and cause injury.
Tilt the head backward and gently pull down the lower eyelid with a finger to create a "pocket" between the eyeball and the eyelid (Figure 2). Do not touch the eye, eyelids, fingers, or any other surface with the tip of the dropper.
Instill one drop by slowly squeezing the bottle (Figure 3). Gently squeeze the middle part of the bottle so that the drop enters the patient's eye. Note that there may be a delay of several seconds between squeezing the bottle and the release of the drop. Do not squeeze the bottle too hard. In case of any doubts regarding the use of the medicine, the patient should consult a pharmacist.
If the physician has advised using drops in the other eye, repeat steps 5 and 6.
After use and before closing the bottle, shake the bottle downward without touching the tip of the dropper to remove any residual liquid from the dropper tip. This is necessary to ensure the ability to instill subsequent drops. Immediately after use, tightly screw the cap back onto the bottle (Figure 4).

If a drop does not enter the eye, repeat the instillation attempt.

Two hands holding two parts of a packaging being connected by screwing a cap onto a bottle

Three illustrations showing the application of eye drops, opening a small medicine bottle, and a finger gently pulling down the lower eyelid

Figure 1. Figure 2. Figure 3. Figure 4.
Use of a higher than recommended dose of Olodon Free
If a higher than recommended dose of Olodon Free is used, rinse the eyes with lukewarm water. Do not instill further drops until it is time for the next scheduled dose.
Missed dose of Olodon Free
If a dose of Olodon Free is missed, instill one drop into the eye as soon as possible, then return to the regular dosing schedule. If there is only a short time remaining before the next dose is due, skip the missed dose and continue treatment according to the prescribed schedule. Do not use a double dose to make up for a missed dose.
Stopping Olodon Free treatment
Do not stop using Olodon Free without first consulting a physician.
If there are any further doubts about the use of this medicine, consult a physician or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience 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 adverse reactions occur,
treatment with this medicine must be discontinued immediately and the patient should contact a
doctor or the nearest hospital Emergency Department without delay.
The following adverse reactions have been observed during the use of Olodon Free:

Common (occur in less than 1 in 10 patients)
Eye disorders: eye pain, eye irritation, dry eye, unusual sensations inside the eye.
General disorders: headache, fatigue, dryness of the nasal mucosa, taste disturbances in the mouth.

Uncommon (occur in less than 1 in 100 patients)
Eye disorders: corneal erosion, corneal epithelial abnormalities, corneal epithelial disorders, punctate keratitis, keratitis, corneal spots, eye discharge, photophobia, blurred vision, decreased visual acuity, eyelid spasm, eye discomfort, eye itching, granules on the conjunctiva, conjunctival disorders, sensation of a foreign body in the eyes, increased lacrimation, eyelid redness, eyelid swelling, eyelid disorders, conjunctival hyperaemia.
General disorders: impaired or altered sensation, dizziness, nasal inflammation, dry skin, skin inflammation (contact), skin burning sensation.

Frequency not known (cannot be estimated from available data)
Eye disorders: eye swelling, corneal oedema, conjunctivitis, change in pupil size, visual disturbances, crusts on eyelid margins.
General disorders: dyspnoea, hypersensitivity (allergy), facial swelling, somnolence, general malaise, nausea, vomiting, sinusitis, skin inflammation and redness.

In patients with significantly damaged anterior transparent layer of the eye (cornea), corneal opacities caused by calcium deposition have very rarely been observed during treatment.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, patients should inform their doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions contributes to further information on the safety of this medicine.

5. How to store Olodon Free

Store below 30°C.
Keep the medicine out of the 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 stated month.
The label on the packaging shows EXP followed by the expiry date, and Lot followed by the batch number.
Discard the bottle 90 days after first opening, and then use a new bottle of medicine. The date of opening should be recorded on the carton.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Olodon Free contains

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

What Olodon Free looks like and contents of the pack
A clear, colourless or almost colourless solution.
The medicine is available in white 5 ml bottles (LDPE), with a multidose dropper (HDPE)
preventing bacterial contamination of the solution, thanks to a system consisting of
a silicone membrane and filtration of air drawn into the bottle, with a closure cap made of HDPE
and a tamper-evident ring, packed in a cardboard box.
Olodon Free is available in packs containing 1 or 3 bottles.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. + 48 22 364 61 01
Manufacturer
Rafarm S.A.
Thesi Pousi Xatzi Agiou Louka
Paiania, 190 02
Greece