STARAZOLIN FREE

Package leaflet: Information for the patient

Starazolin Free, 0,5 mg/ml, eye drops, solution
Tetryzolini hydrochloridum
Please read the entire leaflet carefully before using this medicine, as it contains important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by a physician or pharmacist.

• Keep this leaflet for future reference.
• 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 or pharmacist. See section 4.
• If there is no improvement after 2 days, or if you feel worse, consult your doctor.

Table of contents

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

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

Starazolin Free is a sterile, preservative-free solution for eye drops. Starazolin Free contains tetryzoline hydrochloride as the active substance, which belongs to a group of medicines known as ocular vasoconstrictors.
This medicine is indicated for non-infectious irritation (or) redness of the eye caused by smoke, wind, chlorinated water, or light, as well as for allergic conjunctivitis (e.g. hay fever, pollen allergy).
Local application of this medicine to the conjunctiva leads within minutes to constriction of the capillary vessels (vasoconstriction), lasting from 4 to 8 hours.
This medicine should only be used for mild eye irritation.
Eye irritation or redness is often a symptom of a serious eye condition (see section 2. Important information before using Starazolin Free). If in doubt, consult your doctor before using this medicine.
If there is no improvement after 2 days, or if you feel worse, consult your doctor.

2. Important information before using Starazolin Free

When not to use Starazolin Free

• if the patient is allergic to tetryzoline hydrochloride or any of the other ingredients of this medicine (listed in section 6);
• if the patient has narrow-angle glaucoma;
• if the patient has severe heart or blood vessel disease (e.g. coronary artery disease or hypertension);
• if the patient has a pheochromocytoma;
• if the patient has metabolic disorders: hyperthyroidism, porphyria, or diabetes;
• if the patient is taking monoamine oxidase inhibitors (MAOIs), tricyclic antidepressants, or other medicines that may increase blood pressure (see section "Starazolin Free and other medicines");
• if the patient has benign prostatic hyperplasia;
• in children under 2 years of age.

Warnings and precautions
Before using Starazolin Free, consult a doctor or pharmacist:

• if the patient has dry nasal mucositis, keratoconjunctivitis;
• if the patient has increased intraocular pressure (glaucoma).

This medicine is contraindicated in cases of contact hypersensitivity to silver.
In case of severe eye pain, headache, loss of vision, appearance of "floating" spots in the visual field,
severe, acute, or unilateral eye redness, photophobia, or double vision, consult a doctor immediately.
If eye irritation or redness is due to a serious eye condition, such as infection, presence of a foreign body,
or chemical injury to the cornea, consult a doctor immediately.
Prolonged and inappropriate use of this medicine, especially in doses higher than recommended,
may reduce its effectiveness and lead to rebound conjunctival redness and persistent nasal mucosal hyperemia.
Avoid prolonged use, especially in children.
Children
Starazolin Free is contraindicated in infants and children under 2 years of age.
Always consult a doctor before using this medicine in children.
Starazolin Free and other medicines
Concomitant use of the following medicines may enhance vasoconstrictive effects and increase blood pressure (see also "When not to use Starazolin Free"):

• MAO inhibitors used in the treatment of Parkinson's disease or depression, e.g. selegiline, rasagiline, moclobemide, tranylcypromine;
• tricyclic antidepressants, e.g. amitriptyline and maprotiline;
• other medicines that may increase blood pressure.

Tell your doctor or pharmacist about all medicines you are currently using, have recently used, or plan to use, including over-the-counter medicines.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant,
she should consult a doctor or pharmacist before using this medicine.
There are no available data on the ability of tetryzoline hydrochloride to cross the placenta or pass into breast milk.
Starazolin Free should not be used in pregnant or breastfeeding women.
Driving and operating machinery
After instillation of this medicine, dilatation of the pupils, photophobia, or blurred vision may occur,
which may impair the ability to drive or operate machinery.
The patient should assess how he or she reacts to the medicine before driving or operating machinery.

3. How to use Starazolin Free

This medicine should always be used exactly as described in this patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.

Dosage

Adults and adolescents aged above 12 years
Unless otherwise prescribed, instill one drop into each affected eye 2 to 3 times daily.

Children aged 2 to 12 years
Use of this medicine is not recommended in children aged 2 to 12 years without prior consultation with a doctor.

Children under 2 years of age
Starazolin Free is contraindicated in infants and children under 2 years of age. Always consult a doctor before using this medicine in children.

Duration of treatment
If there is no improvement after 2 days of treatment, or if eye irritation and redness persist or worsen, discontinue use immediately and contact a doctor. The patient may have an eye condition requiring different treatment.

Use of this medicine for longer than 3 days is permitted only under medical supervision.

Method of administration
For ocular use only.
Do not swallow.

Information for contact lens wearers
Do not wear contact lenses during eye illness. In special cases where wearing contact lenses is permitted, remove them before using this medicine. After instillation, wait 15 minutes before reinserting contact lenses.

Instructions for use:

1. Wash your hands.
2. Remove the protective cap from the bottle (Figure 1).
3. Hold the bottle in your hand (Figure 2).
4. Turn the bottle upside down and press the pump until the first drop appears (Figure 3). Then discard at least the first 5 drops before using the medicine in the eye for the first time. Before administering each subsequent drop, discard at least 2 drops. If the medicine has not been used for 15 days or longer, discard 5 drops before administering the medicine into the eye.
5. Tilt your head backward and gently pull down the lower eyelid to form a pouch between it and the eye. Holding the bottle upside down, press the pump to instill one drop into the eye (Figure 4). Do not let the tip of the dispenser touch any surface to avoid contamination of the solution.
6. Immediately after instilling the drop, press with a finger on the inner corner of the eye near the nose or close the eyelids for 1–2 minutes. This helps prevent the medicine from entering other parts of the body.
7. If the medicine is to be used in the other eye, repeat steps 5 and 6.
8. Immediately after use, close the bottle with the protective cap.

Overdose of Starazolin Free
In case of overdose or accidental ingestion, seek immediate medical advice from a doctor, pharmacist, or nearest hospital, and take the medicine or this package leaflet with you.
Symptoms of local or systemic overdose may include: pupil dilation, cyanosis (bluish discoloration of skin and mucous membranes), fever, convulsions, tachycardia (rapid heartbeat), cardiac arrhythmias, cardiac arrest, hypertension (high blood pressure), pulmonary edema (fluid accumulation in the lungs), respiratory disturbances, and psychiatric disorders.
The risk of overdose symptoms is particularly high in infants and young children due to systemic absorption following ingestion. This may lead to central nervous system disorders, circulatory failure, and respiratory failure.

Missed dose of Starazolin Free
Do not use a double dose to make up for a missed dose.

If you have any further questions about 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.

Common (occur in less than 1 in 10 patients):

• Increased ocular mucous membrane swelling (reactive hyperemia), burning or dryness of the ocular mucous membrane, palpitations, headache, tremor, weakness, sweating, elevated arterial pressure, rapid heartbeat.

Uncommon (occur in less than 1 in 1,000 patients):

• Pupil dilation.

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

• Keratinization of the conjunctival surface, leading to closure of the lacrimal ducts and epiphora (excessive tearing) caused by impaired tear drainage following prolonged use of this medicine.

Frequency not known (frequency cannot be estimated from available data):

• Stinging in the eye or surrounding area, redness, swelling, pain, itching, blurred vision, conjunctival irritation.

Reporting of adverse reactions
If any adverse reactions occur in a patient, including any possible 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 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 the medicine.

5. How to store Starazolin Free

Keep the medicine out of the sight and reach of children.
Store below 30°C.
After first opening the bottle, the shelf life is 28 days. Store after first opening
at a temperature below 30°C.
Do not use this medicine after the expiry date stated on the packaging after "EXP".
The expiry date refers to the last day of the stated month.
Medicines must 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 Free contains

• The active substance is tetrahydrozoline hydrochloride. One ml of eye drops contains 0.5 mg of tetrahydrozoline hydrochloride.
• Other ingredients are: sodium chloride, boric acid, borax, purified water.

What Starazolin Free looks like and contents of the pack
A clear, colourless solution. Does not contain preservatives.
10 ml solution in a white plastic bottle with a dosing pump, protective cap and red applicator, in a cardboard box.
Marketing Authorisation Holder
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19
83-200 Starogard Gdański
tel. + 48 22 364 61 01
Manufacturer
JADRAN-GALENSKI LABORATORIJ d.d.
Svilno 20, 51000 Rijeka, Croatia