Olopatadine Unimed Pharma

Package Leaflet: Information for the User

Olopatadine UNIMED PHARMA, 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 package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

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

1. What is Olopatadine UNIMED PHARMA and what is it used for

Olopatadine UNIMED PHARMA 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. Olopatadine UNIMED PHARMA is a medicine used to treat allergic eye diseases. Its action is based on reducing the severity of allergic reactions. Olopatadine UNIMED PHARMA is indicated for use in adults, adolescents from 12 to 18 years old, and children from 3 to 12 years old. Olopatadine UNIMED PHARMA is a sterile solution that does not contain preservatives.

2. Important information before using Olopatadine UNIMED PHARMA

When not to use Olopatadine UNIMED PHARMA

Warnings and precautions

Before starting treatment with Olopatadine UNIMED PHARMA, discuss it with your doctor or pharmacist. If, during treatment with Olopatadine UNIMED PHARMA, you experience any side effects related to the eye, such as eye irritation, pain, redness, or vision disturbances, or if the disease worsens, contact your doctor. Do not use this medicine in patients with a history of hypersensitivity to silver, as the eye drops may contain trace amounts of silver from the bottle cap.

People wearing contact lenses

If you wear contact lenses, remove them before using Olopatadine UNIMED PHARMA and wait at least 15 minutes before reinserting the contact lenses.

Children

Do not use Olopatadine UNIMED PHARMA in children under 3 years of age. Do not give this medicine to children under 3 years of age, as there is no data on the safety and efficacy of the medicine in children under 3 years of age.

Olopatadine UNIMED PHARMA and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take. If you are using other eye drops or ointments, wait at least 5 minutes between administrations of the next medicines. Apply eye ointments last.

Using Olopatadine UNIMED PHARMA with food and drink

Since the medicine is an eye solution, food and drink do not affect its use.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor before using this medicine. Do not use Olopatadine UNIMED PHARMA if you are pregnant or breastfeeding; consult your doctor before using this medicine.

Driving and using machines

For some time after administering Olopatadine UNIMED PHARMA, vision may be blurred. Do not drive or operate machinery until this effect has resolved.

Olopatadine UNIMED PHARMA contains phosphates

This medicine contains 2.991 mg of disodium phosphate dodecahydrate in 1 mL of solution (which corresponds to 0.8 mg of phosphates in 1 mL of solution). In patients with severe damage to the transparent front part of the eye (cornea), phosphates may, in very rare cases, cause corneal clouding due to calcium deposition during treatment.

3. How to use Olopatadine UNIMED PHARMA

Always use this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist. The recommended dose is one drop into the eye or eyes, twice a day - in the morning and evening. Use the drops as directed, unless your doctor has recommended a different dosage. Olopatadine UNIMED PHARMA should only be used in both eyes if recommended by your doctor. Use the medicine for as long as your doctor has prescribed. Olopatadine UNIMED PHARMA is for use as eye drops only.

Instructions for use

• 1. Wash your hands and sit or stand in a comfortable position.
• 2. Remove the cap from the bottle. If the protective collar is loose after removing the cap, remove it before using the medicine.

• 3. Hold the inverted bottle between your thumb and other fingers.
• 4. Tilt your head back. Gently pull down the lower eyelid of the affected eye with your finger.

• 5. Bring the dropper tip close to the eye. Do not touch the dropper tip to the eye or surrounding area.
• 6. Gently squeeze the bottle to release a single drop of medicine into the eye, then release the lower eyelid. Remember that there may be a few seconds' delay between squeezing the bottle and the drop coming out. Do not squeeze the bottle too hard.

• 7. Press the inner corner of the affected eye near the nose with your finger. Hold the pressure for 1 minute, keeping the eye closed.

• 8. If your doctor has recommended using drops in the other eye, repeat the steps.
• 9. After use, to remove any remaining liquid from the dropper tip, shake the bottle downwards without touching the dropper tip. This is necessary to ensure the sterility of the eye drops and to facilitate the administration of the next drop during the next use.

• 10. Immediately after use, tighten the bottle cap carefully.

Using more Olopatadine UNIMED PHARMA than recommended

Rinse your eyes with warm water. Do not administer the next drop until the next scheduled dose.

Missing a dose of Olopatadine UNIMED PHARMA

Use one drop in the eye as soon as possible, and then return to your normal dosing schedule. If it is almost time for the next dose, skip the missed dose and continue with the scheduled dosing regimen. Do not use a double dose to make up for the missed dose.

Stopping treatment with Olopatadine UNIMED PHARMA

Do not stop using Olopatadine UNIMED PHARMA without consulting your doctor first. If you have any further questions about using 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 side effects have been observed during treatment with this medicine: Common: may affect up to 1 in 10 peopleEye disorders: eye pain, eye irritation, dry eye, abnormal sensations in the eye, eye discomfort. General disorders: headache, fatigue, dry nose, unpleasant taste in the mouth. Uncommon side effects: may affect up to 1 in 100 peopleEye disorders: blurred, limited, or abnormal vision, corneal disorders, eye surface inflammation with or without damage, conjunctivitis, eye discharge, sensitivity to light, increased tear production, eye itching, eye redness, eyelid abnormalities, itching, redness, swelling, or lumps on the eyelids. General disorders: abnormal or decreased sensation, dizziness, rhinitis, dry skin, skin inflammation. Frequency not known: frequency cannot be estimated from the available dataGeneral disorders: eye swelling, corneal edema, change in pupil size. General disorders: shortness of breath, worsening of allergic symptoms, facial swelling, drowsiness, general weakness, nausea, vomiting, sinusitis, skin redness and itching. In patients with severely damaged transparent front part of the eye (cornea), very rare cases of corneal clouding due to calcium deposition during treatment have been observed.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. You can also report side effects directly to the Department of Adverse Reaction Monitoring 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. You can also report side effects to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Olopatadine UNIMED PHARMA

Keep the medicine out of the sight and reach of children. Do not store above 25°C. Do not refrigerate or freeze. Do not use this medicine after the expiry date stated on the label and carton after "EXP". The expiry date refers to the last day of that month. Do not use the medicine if, before starting to use a new bottle, you notice that the plastic protection around the cap and neck of the bottle has been broken or damaged. In such a case, return the medicine to the pharmacy. Shelf life after first opening the bottle: 8 weeks. Immediately after use, tighten the bottle cap carefully. Medicines should 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 Olopatadine UNIMED PHARMA contains

• The active substance is olopatadine. 1 mL of solution contains 1 mg of olopatadine (which corresponds to 1.11 mg of olopatadine hydrochloride). One drop of solution contains 30 micrograms of olopatadine (which corresponds to 33.3 micrograms of olopatadine hydrochloride).
• The other ingredients are: sodium chloride, disodium phosphate dodecahydrate (E 339), hydrochloric acid or sodium hydroxide (to adjust pH), water for injections.

What Olopatadine UNIMED PHARMA looks like and contents of the pack

Olopatadine UNIMED PHARMA is a clear and colorless solution (solution) without preservatives, supplied in packs containing 1 x 5 mL, 1 x 10 mL, or 3 x 5 mL polyethylene bottles with a Novelia dropper and a threaded, polyethylene cap with a protective ring. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

UNIMED PHARMA spol. s r.o., Oriešková 11, 821 05 Bratislava, Slovak Republic

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Austria: Olopatadin UNIMED PHARMA 1 mg/ml Augentropfen, Lösung; Bulgaria: Олопатадин УНИМЕД ФАРМА 1 mg/ml капки за очи, разтвор; Croatia: Olopatadin UNIMED PHARMA 1 mg/ml kapi za oko, otopina; Estonia: Olopatadine UNIMED PHARMA; Lithuania: Olopatadine UNIMED PHARMA 1 mg/ml akių lašai (tirpalas); Latvia: Olopatadine UNIMED PHARMA 1 mg/ml acu pilieni, šķīdums; Poland: Olopatadine UNIMED PHARMA; Czech Republic: Olopatadine UNIMED PHARMA; Slovakia: Olopatadine UNIMED PHARMA 1 mg/ml očná roztoková instilácia; Romania: Olopatadină UNIMED PHARMA 1 mg/ml picături oftalmice, soluţie; Slovenia: Olopatadin UNIMED PHARMA kapljice za oko, raztopina; Hungary: Olopatadine UNIMED PHARMA 1 mg/ml oldatos szemcsepp; Date of last revision of the leaflet:27.03.2023