Starazolin Alergia

Package Leaflet: Information for the Patient

Starazolin Alergia, 1 mg/ml, Eye Drops, Solution

Olopatadine

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

This medicine should always be used exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.
• If there is no improvement or the patient feels worse after 3 days, they should contact their doctor.

Table of Contents of the Leaflet

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

1. What is Starazolin Alergia and what is it used for

Starazolin Alergia is intended for the treatment of eye symptoms(itching, tearing, redness, swelling of the eyelids and conjunctiva) in patients with diagnosed seasonal allergic conjunctivitis.
The medicine can only be used in adults.
Allergic conjunctivitis.Some substances (allergens), such as plant pollen, house dust, or animal dander, can cause allergic reactions, manifested by itching, redness, tearing, and swelling of the eye surface (without vision disturbances).
These symptoms occur suddenly, have an acute and transient course. They are often accompanied by watery rhinitis and sneezing or itching in the nose and ears.
In the case of co-existing nasal symptoms (rhinitis, sneezing, itching), the administration of Starazolin Alergia eye drops reduces their severity.
Starazolin Alergia is an anti-allergic medicineused in the eyes. Its action is based on reducing the severity of allergic reactions.

2. Important information before using Starazolin Alergia

When not to use Starazolin Alergia

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

Warnings and precautions

In the absence of improvement or worsening of symptoms within three days of starting the medicine, the patient should consult a doctor.
Treatment should be discontinued and the doctor should be contacted immediately if any symptoms of hypersensitivity occur, including breathing problems, throat or face swelling.
In the case of a severe allergic reaction, immediate emergency treatment may be necessary.
Contact lenses should be removed before using Starazolin Alergia and the patient should wait at least 15 minutes before reinserting them.
Children and adolescents
Starazolin Alergia should not be used in children and adolescents under 18 years of age.

Starazolin Alergia 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,they should wait at least 5 minutes between administrations of the next medicines. Eye ointments should be used last.

Pregnancy and breastfeeding

If the patient is pregnant or thinks she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.
Starazolin Alergia should not be used during pregnancy or breastfeeding.

Driving and using machines

For some time after administering the Starazolin Alergia eye drops, vision may be blurred. The patient should not drive or operate machinery until their vision has improved.

3. How to use Starazolin Alergia

This medicine should always be used exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist. If in doubt, the patient should consult a doctor or pharmacist.
The medicine is used locally in the conjunctival sac.
Before using the medicine, the patient should remove their contact lenses and wait at least 15 minutes before reinserting them.

Adults

The recommended dose is:
One drop into the eye or eyes, twice a day - morning and evening. The patient should maintain an interval of at least 8 hours between administrations.
The drops should be used according to the above dosage, unless the doctor recommends otherwise. If there is no improvement or worsening of symptoms within three days of starting the medicine, the patient should consult a doctor. The treatment duration is up to two weeks. If necessary, treatment can be continued for up to four months after consulting a doctor. The medicine should not be used for more than 4 months.
Starazolin Alergia should be administered only to the eyes.

Children and adolescents

Starazolin Alergia should not be used in children and adolescents under 18 years of age.
Starazolin Alergia is a sterile solution that does not contain preservatives. See section 6. What Starazolin Alergia looks like and what the pack contains.

Before administering the eye drops:

• In case of first use, before administering the drops to the eye, the patient should test the use of the bottle with the dropper by slowly squeezing it until one drop is released from the bottle. This should be done away from the eye.
• If the patient is sure they can administer a single drop of the medicine, they should take the most comfortable position for administration (they can sit, lie on their back, or stand in front of a mirror).

Administration instructions:

• 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 form a "pocket" between the eye and the eyelid (Figure 2.). The patient should avoid touching the tip of the dropper with the eye, eyelids, or fingers.
• 6. The patient should administer one drop by slowly squeezing the bottle (Figure 3.). The bottle should be gently squeezed 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 releasing the drop. The bottle should not be squeezed too hard. If the patient has any doubts about using the medicine, they should consult a pharmacist.
• 7. If the doctor recommends using the drops in the other eye, the patient should repeat steps 5 and 6.
• 8. After use and before closing the bottle, the patient should shake the bottle downwards without touching the tip of the dropper to remove any remaining liquid from the tip of the dropper. This is necessary to ensure that the next drops can be administered. Immediately after use, the bottle should be tightly closed (Figure 4.).

If the drop does not get into the eye, the patient should repeat the attempt.

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

Using a higher dose of Starazolin Alergia than recommended

In case of using a higher dose of Starazolin Alergia than recommended, the patient should rinse their eye (eyes) with lukewarm water. The patient should not administer the next drops until the time of the next scheduled dose.

Missing a dose of Starazolin Alergia

In case of missing a dose of Starazolin Alergia, the patient should administer one drop to the eye as soon as possible and then return to the normal, established dosing schedule. If it is almost time for the next dose, the patient should skip the missed dose and continue with the prescribed dosing schedule. The patient should not use a double dose to make up for the missed dose.
In case of any further doubts about using this medicine, the patient should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Treatment should be discontinued and the doctor should be contacted immediatelyor the Emergency Department of the nearest hospital if any symptoms of hypersensitivity occur, including breathing problems, throat or face swelling.
In the case of a severe allergic reaction, immediate emergency treatment may be necessary.
The following side effects have been observed during the use of Starazolin Alergia:
Common(occurring in less than 1 in 10 patients)
Eye-related:eye pain, eye irritation, dry eye, abnormal sensations in the eye.
General:headaches, unpleasant taste in the mouth, dryness of the nasal mucosa, fatigue.
Uncommon(occurring in less than 1 in 100 patients)
Eye-related:corneal disorders, surface eye inflammation with or without damage, eye discharge, sensitivity to light, blurred or impaired vision, eyelid spasms, eye discomfort, eye itching, conjunctival disorders, feeling of a foreign body in the eye, increased tear production, eyelid redness or swelling, eyelid abnormalities, eye redness.
General:nasal mucosa inflammation, dizziness, abnormal or impaired sensation, skin inflammation (contact), burning sensation on the skin, skin dryness.
Frequency not known(cannot be estimated from the available data)
Eye-related:corneal edema, eye swelling, conjunctivitis, change in pupil size, vision disorders, eyelid margin abnormalities.
General:hypersensitivity, face swelling, drowsiness, shortness of breath, sinusitis, nausea, vomiting, skin inflammation and redness, general weakness, malaise.
In patients with significantly damaged anterior, transparent eye layer (cornea), very rare cases of blurred 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 tell their doctor or pharmacist. Side effects can be reported directly to the Department of Post-Marketing Surveillance 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 Starazolin Alergia

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 after EXP.
The expiry date refers to the last day of the month.
Shelf life after first opening the bottle: 90 days.
After this time, the bottle should be discarded and the next bottle of the medicine should be started.
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 Starazolin Alergia contains

• The active substance of the medicine is olopatadine (as 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 (to adjust pH), water for injections.

What Starazolin Alergia looks like and what the pack contains

Clear, colorless or almost colorless solution.
The medicine is available in white 5 ml (LDPE) bottles with a multi-dose 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.
Starazolin Alergia is available in packs containing 1 or 2 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: