Starazolin Free

Package Leaflet: Information for the Patient

Starazolin Free, 0.5 mg/ml, eye drops, solution
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 the package leaflet for the patient or as advised by a doctor or pharmacist.

• This leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse after 2 days, they should contact their doctor.

Table of Contents of the Leaflet

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

Starazolin Free is a sterile solution of eye drops, without a preservative. Starazolin Free contains as an active substance tetryzoline hydrochloride, which belongs to a group of medicines that narrow the blood vessels of the eye.
This medicine is used in the case of non-infectious irritation (or) redness of the eye, caused by smoke, wind, chlorinated water, or light, as well as in the case of allergic conjunctivitis (e.g., hay fever, pollen allergy).
Local application of this medicine to the conjunctiva of the eye leads to constriction of the capillaries (narrowing of the blood vessels) within a few minutes, lasting for 4 to 8 hours.
This medicine can only be used in the case of mild eye irritation.
Irritation or redness of the eye is often a symptom of a serious eye condition (see section 2. Important information before using Starazolin Free). In case of doubt, the patient should consult a doctor before taking this medicine.
If there is no improvement or the patient feels worse after 2 days, they should consult a 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 heart 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 also "When not to use Starazolin Free");
• if the patient has benign prostatic hyperplasia (enlargement of the prostate gland);
• in children under 2 years of age.

Warnings and precautions

Before starting to use Starazolin Free, the patient should discuss it with their doctor or pharmacist:

• if the patient has dry conjunctivitis, keratitis, or conjunctivitis;
• if the patient has increased intraocular pressure (glaucoma).

This medicine is contraindicated in case of contact hypersensitivity to silver.
In case of severe eye pain, headache, vision loss, appearance of "floating" spots in the visual field, severe, sharp, or one-sided redness of the eye, pain when exposed to light, or double vision, the patient should immediately consult a doctor.
If the irritation or redness of the eye is due to a serious eye condition, such as an infection, the presence of a foreign body, or chemical damage to the cornea, the patient should immediately consult a doctor.
Prolonged and improper use of this medicine, especially in doses higher than recommended, may reduce its effectiveness and lead to conjunctival redness and persistent nasal congestion.
Long-term use should be avoided, especially in children.

Children

Starazolin Free is contraindicated for use in infants and children under 2 years of age.
The patient should always consult a doctor before using this medicine in children.

Starazolin Free and other medicines

Concomitant use of the following medicines may enhance the vasoconstrictive effect and increase blood pressure (see also "When not to use Starazolin Free"):

• MAOIs 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.

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, including those available without a prescription.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
There are no available data on the possibility of tetryzoline hydrochloride passing through the placenta and into breast milk.
This medicine should not be used in pregnant or breastfeeding women.

Driving and using machines

After instillation of this medicine, there may be pupil dilation, photophobia, or blurred vision, which may limit the ability to drive vehicles and operate machines.
Before driving vehicles or operating machines, the patient should check how they react to the medicine.

3. How to use Starazolin Free

This medicine should always be used exactly as described in this package leaflet for the patient or as advised by a doctor or pharmacist. In case of doubt, the patient should consult a doctor or pharmacist.
Dosage

Adults and adolescents over 12 years of age

Unless otherwise prescribed, instill one drop into each irritated eye 2 to 3 times a day.

Children from 2 to 12 years of age

The use of this medicine is not recommended in children from 2 to 12 years of age without prior consultation with a doctor.

Children under 2 years of age

Starazolin Free is contraindicated for use in infants and children under 2 years of age.
The patient should always consult a doctor before using this medicine in children.
Duration of use
If there is no improvement or the irritation and redness of the eye persist or worsen after 2 days of treatment, the patient should immediately stop using the medicine and consult a doctor. It is possible that the patient has an eye disease that requires different treatment.
The use of this medicine for more than 3 days is allowed only under medical supervision.
Method of administration
For ophthalmic use only.
Do not swallow.
Information for contact lens wearers
Contact lenses should not be worn in case of eye disease. In special cases, when it is allowed to wear contact lenses, they should be removed before using this medicine. After instillation of the medicine, the patient should wait 15 minutes before reinserting the 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 5 first drops before instilling the medicine into the eye for the first time. Before instilling 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 to the eye.

If the patient misses a dose of Starazolin Free

The patient should not take a double dose to make up for a 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.
Common(occurring in less than 1 in 10 patients)

• increased swelling of the conjunctiva (reactive hyperemia), burning or dryness of the conjunctiva, palpitations, headache, tremor, weakness, sweating, increased blood pressure, rapid heart rate.

Uncommon(occurring in less than 1 in 100 patients)

• pupil dilation.

Rare(occurring in less than 1 in 10,000 patients)

• keratinization (cornification) of the conjunctival surface, leading to closure of the tear ducts and tearing due to disorders of tear outflow after prolonged use of this medicine.

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

• stinging in the eye or its surroundings, redness, swelling, pain, itching, blurred vision, conjunctival irritation.

Reporting side effects

If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should inform their 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
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.
By reporting side effects, it is possible to gather more information on the safety of this medicine.

5. How to store Starazolin Free

The medicine should be stored out of sight and reach of children.
Store in a temperature below 30°C.
After first opening the bottle, the shelf life is 28 days. Store after first opening in 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 given month.
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 Free contains

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

What Starazolin Free looks like and contents of the pack

Clear, colorless 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 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: