Starazolin

Package Leaflet: Information for the Patient

Starazolin, 0.5 mg/ml, Eye Drops

Tetryzoline Hydrochloride

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 or as directed by your doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or further information, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.
• If after 2 days there is no improvement or you feel worse, contact your doctor.

Table of Contents of the Leaflet

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

1. What is Starazolin and what is it used for

Starazolin contains the active substance tetryzoline, which is a sympathomimetic amine, an imidazoline derivative.
After local application to the eye, the small blood vessels constrict, which reduces conjunctival hyperemia and edema.

Indications for Use

For the symptomatic treatment of conditions accompanied by conjunctival hyperemia and edema, caused by irritants such as: dust, smoke, contact lenses, wind, bright sunlight, chlorinated water, cosmetics, as well as in allergic inflammatory conditions, such as: hay fever and pollen allergy.
Starazolin alleviates accompanying symptoms: burning, itching, pain, excessive tearing, and irritation.
The medicine is not effective in treating late-type allergic reactions, such as contact conjunctivitis and eyelid skin.

2. Important Information Before Using Starazolin

When Not to Use Starazolin

• if you are allergic to tetryzoline hydrochloride or any of the other ingredients of this medicine (listed in section 6);
• in children under 2 years of age;
• if you have glaucoma, especially with a narrow angle of filtration or other severe eye diseases;
• if you are pregnant or breastfeeding.

Warnings and Precautions

Before starting treatment with Starazolin, discuss it with your doctor or pharmacist.

• Treatment should be discontinued if the symptoms of the inflammatory condition worsen during treatment. The medicine is intended for the treatment of conjunctival irritations of moderate severity only.
• It is not recommended to use the medicine during infection, corneal damage, or severe pain.
• You should stop using the medicine and contact your doctor if, after two days of using the medicine, there is no significant improvement.
• Prolonged use of the medicine may cause secondary irritation and hyperemia, burning and stinging symptoms, as well as atrophic changes caused by chronic hypoxia of the eye mucosa.
• Caution should be exercised in patients with severe cardiovascular diseases (e.g., coronary artery disease) and hypertension, pheochromocytoma, patients with diabetes and hyperthyroidism, treated with monoamine oxidase inhibitors and other medicines that may increase blood pressure.
• During treatment with the medicine, you should stop wearing soft contact lenses (see section "Starazolin contains benzalkonium chloride").
• The medicine, at the recommended dosage, does not cause pupil dilation; however, with excessive use, there is a risk of pupil dilation, especially in patients with light (blue) irises.
• In case of severe eye pain, headache, vision loss, sudden appearance of moving spots in the field of vision, sudden eye redness, pain caused by light, or double vision, you should immediately contact your doctor.
• The medicine is not effective in treating late-type allergic reactions, such as contact conjunctivitis and eyelid skin.

Children

Long-term use of the medicine should be avoided, especially in children.
Using the medicine in children under 2 years of age is contraindicated.

Starazolin and Other Medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take.

• Using the medicine with MAO inhibitors or tricyclic antidepressants, guanethidine, or reserpine may increase blood pressure. When using these medicines, Starazolin can only be used after consulting a doctor.
• Concomitant use of anesthetics, insulin, atropine sulfate, or propranolol with tetryzoline may enhance the effect of these medicines on the circulatory system.
• When using other eye drops, a 15-minute interval should be maintained between instillations.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this medicine.
Pregnancy
The safety of using tetryzoline during pregnancy has not been established.
Starazolin can be used during pregnancy only if, in the doctor's opinion, it is absolutely necessary.
Breastfeeding
There is no data on the penetration of tetryzoline into breast milk. Breastfeeding women should use the medicine with caution and after the doctor has weighed the risks and benefits of treatment.

Driving and Using Machines

There is no data on the effect of Starazolin on the ability to drive and use machines; however, you should take into account the inflammatory condition of the conjunctiva, pupil dilation, and blurred vision, which may impair psychophysical fitness. In such cases, do not drive or operate machines.

Starazolin Contains Benzalkonium Chloride

The medicine contains 0.1 mg of benzalkonium chloride in each ml of solution. Benzalkonium chloride may be absorbed by soft contact lenses and change their color. You should remove contact lenses before instillation and wait at least 15 minutes before putting them back on. Benzalkonium chloride may also cause eye irritation, especially in people with dry eye syndrome or corneal disorders (the transparent layer at the front of the eye). If you experience any abnormal sensations in the eye, stinging, or pain after using the medicine, contact your doctor.

3. How to Use Starazolin

This medicine should always be used exactly as described in the package leaflet or as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.

Adults and Children Over 2 Years

Usually, 1 to 2 drops of the medicine are instilled, 2 to 3 times a day.
Long-term use of the medicine should be avoided, especially in children.
Using the medicine in children under 2 years of age is contraindicated.
Method of administration
Instillation into the eye.

Caution

Starazolin is a sterile solution.
Do not touch the tip of the dropper, and after instillation, immediately tighten the bottle cap.
Before using the medicine, remove contact lenses and put them back on after about 15 minutes from instillation.

Using More Than the Recommended Dose of Starazolin

If you have taken more than the recommended dose of the medicine, contact your doctor or pharmacist immediately.
Overdose of the medicine may cause:

• inhibition of the central nervous system,
• drowsiness, decreased body temperature,
• bradycardia (slow heart rate), decreased blood pressure,
• apnea, coma.

After accidental ingestion of the medicine, common symptoms of overdose are:

• pupil dilation, nausea, cyanosis;
• increased body temperature, muscle cramps, tachycardia (rapid heart rate);
• arrhythmias, cardiac arrest, increased blood pressure;
• pulmonary edema, respiratory disorders, mental disorders.

Missing a Dose of Starazolin

If you miss a dose, take it as soon as possible. Do not take a double dose to make up for the missed dose.
If you have any further questions about using this medicine, consult your doctor or pharmacist.

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Excessive use of the medicine (for too long or too often) may lead to eye pain or burning, reactive hyperemia, blurred vision, conjunctival irritation, or - rarely - pupil dilation. In individual cases, the medicine may cause systemic sympathomimetic effects (increased blood pressure, rapid heart rate, rapid breathing).
Common side effects (in less than 1 in 10 patients):

• reactive hyperemia, burning of the mucous membranes, dryness of the mucous membranes, systemic effects (e.g., palpitations, headaches, tremors, weakness, excessive sweating, increased blood pressure).

Rare side effects (in less than 1 in 10,000 patients):

• excessive conjunctival keratinization with closure of the lacrimal puncta and excessive tearing.

Blurred vision, conjunctival irritation, or rarely, pupil dilation may occur.
There is a risk, especially in newborns and children under 2 years of age, of symptoms related to the absorption of the medicine, including after its ingestion. The most important adverse reactions are: disorders of the central nervous system, such as increased blood pressure, arrhythmias, tachycardia (rapid heart rate), tachyarrhythmia (irregular heart rhythm), reactive bradycardia (slow heart rate).

Reporting Side Effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Aleje 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to Store Starazolin

Do not store above 25°C.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
The medicine is suitable for use for 28 days after first opening the bottle.
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 Starazolin Contains

• The active substance is tetryzoline. Each ml of eye drops contains 0.5 mg of tetryzoline hydrochloride.
• The other ingredients are: sodium chloride, disodium edetate, benzalkonium chloride, sodium tetraborate, boric acid, purified water.

What Starazolin Looks Like and Contents of the Pack

A polyethylene bottle containing 5 ml of eye drops, packaged in a cardboard box with 2 pieces.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
phone: +48 22 364 61 01
Manufacturer
JADRAN-GALENSKI LABORATORIJ d.d.
Svilno 20, 51000 Rijeka
Croatia

Date of Last Revision of the Leaflet: