Olopatadine unimed pharma

Patient Information Leaflet

Olopatadine UNIMED PHARMA, 1 mg/mL, eye drops, solution
Olopatadinum
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• 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. It may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of Contents

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

Olopatadine UNIMED PHARMA is indicated for the treatment of subjective and objective symptoms of seasonal allergic conjunctivitis.
Allergic conjunctivitis. Certain substances (allergens), such as pollen, house dust mites, or animal dander, may cause allergic reactions, manifesting as itching, redness, and swelling of the eye surface.
Olopatadine UNIMED PHARMA is a medicine used in the treatment of allergic eye diseases. It works by reducing the severity of allergic reactions.
Olopatadine UNIMED PHARMA is indicated for use in adults, adolescents aged 12 to 18 years, and children aged 3 to 12 years.
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

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

Warnings and precautions
Before starting treatment with Olopatadine UNIMED PHARMA, discuss this with your doctor or pharmacist.
If during treatment with Olopatadine UNIMED PHARMA the patient experiences eye-related adverse reactions such as eye irritation, pain, redness or vision disturbances, or if their condition worsens, they should contact their doctor.
This medicine should not be used in patients with a history of silver sensitivity, as the eye drops may contain trace amounts of silver originating from the bottle closure.

Contact lens wearers
If the patient wears contact lenses, they should be removed before using Olopatadine UNIMED PHARMA. Wait at least 15 minutes before reinserting contact lenses.

Children
Do not use Olopatadine UNIMED PHARMA in children under 3 years of age. This medicine should not be given to children under 3 years of age, as there is insufficient data on safety and efficacy in children under 3 years of age.

Olopatadine UNIMED PHARMA and other medicines
Tell your doctor or pharmacist if the patient is taking, has recently taken or might take any other medicines.
If the patient is using other eye drops or eye ointments at the same time, at least 5 minutes should be left between applying each medicine. Eye ointments should be used last.

Taking Olopatadine UNIMED PHARMA with food and drink
Since this medicine is an eye drop solution, food and drink do not affect its use.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant or is planning to become pregnant, she should consult her doctor before using this medicine.
Do not use Olopatadine UNIMED PHARMA if the patient is pregnant or breastfeeding. Consult a doctor before using this medicine.

Driving and using machines
For a short time after instillation of Olopatadine UNIMED PHARMA, vision may be blurred. Do not drive or operate machinery until this effect has passed.

Olopatadine UNIMED PHARMA contains phosphate buffers
This medicine contains 2.991 mg of disodium phosphate dodecahydrate per 1 mL of solution (equivalent to 0.8 mg of phosphates per 1 mL of solution).
In patients with severe damage to the clear front part of the eye (cornea), phosphates may very rarely cause corneal opacities due to calcium accumulation during treatment.

3. How to use Olopatadine UNIMED PHARMA

This medicine should always be used as directed by the physician. In case of doubt, consult
your doctor or pharmacist.
The recommended dose is one drop into one or both eyes, twice daily – in the morning and evening.
Use the drops as indicated above unless your doctor has advised a different dosage.
Olopatadine UNIMED PHARMA should be used in both eyes only if so recommended by your doctor.
Continue using the medicine for as long as your doctor has instructed.
Olopatadine UNIMED PHARMA should be used only as eye drops.
Instructions for use

1. Wash your hands and assume a comfortable sitting or standing position.
2. Unscrew the cap from the bottle. If the safety collar is loose after removing the cap, remove it before using the medicine.

3. Hold the inverted bottle between your thumb and remaining fingers.
4. Tilt your head backward. 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 eye or the area around the eye with the dropper tip.
6. Gently squeeze the bottle to release a single drop of medicine into the eye, then release the lower eyelid. 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.

7. Press with your finger on the inner corner of the affected eye near the nose. Maintain pressure for 1 minute with the eye closed.

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

10. Immediately after use, tightly replace the cap on the bottle.

Use of more than the recommended dose of Olopatadine UNIMED PHARMA
Rinse the eyes with lukewarm water. Do not administer further drops until it is time for the next dose.
Missed dose of Olopatadine UNIMED PHARMA
As soon as possible, instill one drop into the eye, then return to your regular dosing schedule. If only a short time remains 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 Olopatadine UNIMED PHARMA
Do not stop using Olopatadine UNIMED PHARMA without first consulting your doctor.
If you have any further doubts concerning the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The following adverse reactions have been observed during treatment with this medicine:
Common: may affect up to 1 in 10 people
Eye-related reactions: eye pain, eye irritation, dry eye, unusual sensations inside the eye, eye discomfort.
General symptoms: headache, fatigue, dry nose, unpleasant taste in the mouth.

Uncommon adverse reactions: may affect up to 1 in 100 people
Eye-related reactions: blurred, limited, or abnormal vision, corneal disorders, inflammation of the eye surface with or without surface damage, conjunctivitis (inflammation or infection of the conjunctiva), eye discharge, light sensitivity, increased tear production, eye itching, eye redness, eyelid abnormalities, itching, redness, swelling, or bumps on the eyelids.
General symptoms: abnormal or reduced sensation, dizziness, rhinitis, dry skin, skin inflammation.

Frequency not known: frequency cannot be estimated from the available data
General symptoms: eye swelling, corneal swelling, change in pupil size.
General symptoms: shortness of breath, worsening of allergic symptoms, facial swelling, drowsiness, general weakness, nausea, vomiting, sinus infection, skin redness and itching.

In patients with significantly damaged anterior transparent layer of the eye (cornea), cloudy corneal spots caused by calcium deposits 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, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions at 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to 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 store in a refrigerator or freeze.
Do not use this medicine after the expiry date stated on the bottle and carton after "Expiry date (EXP)". The expiry date refers to the last day of the stated month.
Do not use the medicine if, before starting treatment with a new bottle, the patient notices that the plastic seal around the cap and neck of the bottle has been broken or damaged. In such a case, return the medicine to the pharmacy.
Period of validity after first opening the bottle: 8 weeks. Close the bottle tightly immediately after use.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging and other information

What Olopatadine UNIMED PHARMA contains

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

What Olopatadine UNIMED PHARMA looks like and contents of the pack
Olopatadine UNIMED PHARMA is a clear, colourless liquid (solution) without preservatives, supplied in containers containing 1 x 5 mL, 1 x 10 mL or 3 x 5 mL polyethylene bottles with a Novelia-type dropper and a screw-on polyethylene cap with a tamper-evident ring.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
UNIMED PHARMA spol. s r.o.
Oriešková 11, 821 05, Bratislava
Slovak Republic
This medicinal product is authorised 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
Slovak Republic 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