Starazolin allergy

Package leaflet: Information for the user

Starazolin Alergia, 1 mg/ml, eye drops, solution
Olopatadinum
Please read this leaflet carefully before using this medicine because it contains
important information for you.
This medicine should always be used exactly as described in this patient leaflet or as
instructed by your doctor or pharmacist.

• Keep this leaflet so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. See section 4.
• If there is no improvement after 3 days, or if your condition worsens, contact your doctor.

Table of contents

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

Starazolin Alergia is indicated for the treatment of ocular symptoms (itching, tearing,
redness, eyelid and conjunctival swelling) in patients diagnosed with seasonal allergic
conjunctivitis.
This medicine may be used only in adults.
Allergic conjunctivitis. Certain substances (allergens), such as plant pollen, house dust, or
animal fur, may cause allergic reactions, manifesting as itching, redness, tearing, and swelling
of the eye surface (without visual disturbances).
These symptoms appear suddenly and are acute and transient. They are often accompanied by
watery nasal discharge, sneezing, or nasal and ear itching.
In cases of coexisting nasal symptoms (nasal discharge, sneezing, nasal itching),
administration of Starazolin Alergia into the eye reduces their severity.
Starazolin Alergia is an ophthalmic anti-allergic medicine. Its action consists of reducing the
intensity 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
If there is no improvement or if symptoms worsen within three days of starting treatment,
consult a doctor.
Treatment should be discontinued and medical advice should be sought immediately if any
signs of hypersensitivity reactions occur, including breathing difficulties, throat or facial swelling.
In the case of a severe allergic reaction, immediate emergency treatment may be necessary.
Contact lenses must be removed before using Starazolin Alergia, and at least 15 minutes should be waited 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
Tell your doctor or pharmacist about all medicines you are currently using, have recently used, or plan to use.
If you are using other eye drops or eye ointments at the same time, wait at least 5 minutes between applying each medicine. Eye ointments should be used last.
Pregnancy and breastfeeding
If the patient suspects she may be pregnant or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Starazolin Alergia should not be used during pregnancy or while breastfeeding.
Driving and operating machinery
For a short time after instilling Starazolin Alergia, vision may be blurred. Do not drive or operate machinery until vision has cleared.

3. How to use Starazolin Alergia

This medicine should always be used exactly as described in this patient leaflet or as directed by a
doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
The medicine is applied locally into the conjunctival sac.
Before applying the medicine, contact lenses must be removed and at least 15 minutes should be
waited before reinserting them.
Adults
Recommended dose:
One drop into one or both eyes, twice daily – in the morning and evening. There should be at least
an 8-hour interval between doses.
Use the drops according to the dosing instructions above unless otherwise directed by a doctor.
If there is no improvement or if symptoms worsen within three days of starting treatment, consult
a doctor. The treatment duration is up to two weeks. If necessary, treatment may continue for up
to four months following medical consultation. Do not use the medicine for longer than 4 months.
Starazolin Alergia is for ocular use only.
Children and adolescents
Starazolin Alergia must 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 instilling eye drops:

• For first-time use, before administering the drops into the eye, the patient should test the dropper bottle by slowly squeezing it until one drop is dispensed. This should be done away from the eye.
• If the patient is confident in their ability to instill a single drop, they should assume the most comfortable position for doing so (sitting, lying on their back, or standing in front of a mirror).

Instructions for use:

1. Wash hands thoroughly before instilling the drops.
2. Do not use the medicine if the packaging or bottle is damaged.
3. Before first use, unscrew the cap after ensuring that the tamper-evident ring on the cap is intact. There will be slight resistance when unscrewing until the ring breaks ( Figure 1. ).
4. If the tamper-evident ring is loose, remove it before using the medicine, as it may fall into the eye and cause injury.
5. 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. ). Avoid contact between the dropper tip and the eye, eyelids, or fingers.
6. Instill one drop by slowly squeezing the bottle ( Figure 3. ). Gently squeeze the middle of the bottle so that a drop enters the patient's eye. Note that there may be a delay of several seconds between squeezing the bottle and the drop being released. Do not squeeze the bottle too hard. If in doubt about proper use, the patient should consult a pharmacist.
7. If the doctor has recommended using the drops in the other eye, repeat steps 5 and 6.
8. After use and before closing the bottle, shake the bottle downward without touching the tip to remove any residual liquid from the dropper tip. This is necessary to ensure proper function for subsequent doses. Immediately after use, tightly screw the cap back on ( Figure 4. ).

If a drop misses the eye, repeat the instillation attempt.

Figure 1. Figure 2. Figure 3. Figure 4.
Use of more than the recommended dose of Starazolin Alergia
If more than the recommended dose of Starazolin Alergia is used, rinse the eye(s) with lukewarm water.
Do not instill further drops until it is time for the next scheduled dose.
Missed dose of Starazolin Alergia
If a dose of Starazolin Alergia is missed, instill one drop into the eye as soon as possible, then
resume the normal dosing schedule. If it is almost time for the next dose, 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.
If there are any further doubts about the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine may cause adverse reactions, although not everybody will experience them.
Treatment must be discontinued and immediate contact made with a doctor or the Emergency Department
of the nearest hospital if any symptoms of hypersensitivity occur, including breathing difficulties,
throat or facial swelling.
Severe allergic reactions may require immediate emergency treatment.
The following adverse reactions have been observed during use of Starazolin Alergia:
Common (occur in less than 1 in 10 patients)
Eye-related effects: eye pain, eye irritation, dry eyes, unusual sensations inside the eye.
General symptoms: headache, unpleasant taste in the mouth, dryness of the nasal mucosa, fatigue.
Uncommon (occur in less than 1 in 100 patients)
Eye-related effects: corneal disorders, surface eye inflammation with or without surface damage, eye discharge, light sensitivity, blurred or restricted vision, eyelid spasm, eye discomfort, eye itching, conjunctival disorders, foreign body sensation in the eye, increased tear production, redness or swelling of the eyelids, eyelid abnormalities, eye redness.
General symptoms: nasal mucositis, dizziness, altered or impaired sensation, contact dermatitis, skin burning sensation, dry skin.
Frequency not known (cannot be estimated from the available data)
Eye-related effects: corneal edema, eye swelling, conjunctivitis, change in pupil size, visual disturbances, crusts at the eyelid margins.
General symptoms: hypersensitivity, facial swelling, somnolence, dyspnea, sinusitis, nausea, vomiting, skin inflammation and redness, general weakness, malaise.
In patients with significantly damaged anterior transparent layer of the eye (cornea), corneal opacities due to 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, inform a 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 Warszawa
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions may also be reported directly to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Starazolin Alergia

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 after EXP.
The expiry date refers to the last day of the stated month.
Shelf life after first opening the bottle: 90 days.
After this period, the bottle should be discarded and a new bottle of the medicine used.
The date of opening the bottle should be recorded on the carton.
Medicines must not be disposed of via wastewater or household waste. Ask a pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Starazolin Alergia contains

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

What Starazolin Alergia looks like and contents of the pack
A clear, colourless or almost colourless solution.
The medicine is available in 5 ml white bottles (LDPE), with a multi-dose dropper (HDPE)
preventing bacterial contamination of the solution thanks to a system consisting of
a silicone membrane and filtration of the air drawn into the bottle, with a closure cap made of HDPE
with a tamper-evident ring, packed in a cardboard box.
Starazolin Alergia is available in packs containing 1 or 2 bottles.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Zakłady Farmaceutyczne POLPHARMA S.A.
Pelplińska Street 19, 83-200 Starogard Gdański
tel. + 48 22 364 61 01

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