Tropicamidum Vzf 0,5%

Package Leaflet: Information for the Patient

TROPICAMIDUM WZF 0.5%, 5 mg/ml, eye drops, solution
Tropicamidum

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

• Keep this package leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including those not listed in this package leaflet, they should inform their doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Tropicamidum WZF 0.5% and what is it used for
• 2. Important information before using Tropicamidum WZF 0.5%
• 3. How to use Tropicamidum WZF 0.5%
• 4. Possible side effects
• 5. How to store Tropicamidum WZF 0.5%
• 6. Contents of the package and other information

1. What is Tropicamidum WZF 0.5% and what is it used for

The medicine contains tropicamide, which, when used locally in the eye, dilates the pupil and paralyzes the eye's accommodation (ability to adapt to sharp vision of objects at different distances).
The medicine is used:

• in ophthalmic diagnostics - to examine the fundus of the eye (ophthalmoscopy);
• in preoperative conditions requiring the use of a short-acting pupil dilator.

2. Important information before using Tropicamidum WZF 0.5%

When not to use Tropicamidum WZF 0.5%

• if the patient is allergic to tropicamide or any other ingredient of this medicine (listed in section 6);
• if the patient has primary glaucoma (increased pressure in the eyes) with a tendency to angle closure;
• if the patient has glaucoma with a narrow angle;
• in the case of soft contact lenses, due to the presence of benzalkonium chloride in the composition.

Warnings and precautions

Before starting to use Tropicamidum WZF 0.5%, the patient should discuss it with their doctor or pharmacist.

• Before using the medicine to dilate the pupil for an eye examination, the doctor will perform a diagnostic test for narrow-angle glaucoma to prevent a possible acute glaucoma attack after administering tropicamide.
• Particular caution should be exercised in people who are hypersensitive to belladonna alkaloids.
• In patients with increased sensitivity to anticholinergic drugs, psychotic reactions and behavioral disorders may occur after tropicamide administration.
• After each administration of the medicine, the patient should wash their hands to remove any remaining tropicamide.

Children

When administering the medicine, particular caution is recommended in children, as side effects may occur (see section 4 of the package leaflet). Tropicamide may cause central nervous system disorders, which can be dangerous for infants and children.
If the medicine is accidentally ingested by a child, it may cause toxic effects, so, like all other medicines, it is recommended to store it out of the reach of children.

Tropicamidum WZF 0.5% and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
The effect of tropicamide is enhanced by medicines used in Parkinson's disease (e.g., amantadine), some antihistamines (e.g., clemastine), medicines used in psychiatric disorders (e.g., chlorpromazine and haloperidol), and tricyclic antidepressants (e.g., imipramine, amitriptyline).

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before using this medicine.
The medicine may be used in pregnant women only when, in the doctor's opinion, its use is necessary.
The risk to the breastfed child cannot be excluded.
The decision to continue or stop breastfeeding, or to continue or stop using tropicamide, will be made by the doctor after weighing the benefits of breastfeeding for the child and the use of tropicamide in the mother.
There is no data on the effect of the medicine on fertility.

Driving and using machines

After using the medicine, vision disturbances and photophobia may occur. The patient should not drive or operate machines until their vision returns to normal, which usually happens about 6 hours after using the medicine.

Tropicamidum WZF 0.5% 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. The patient should remove their contact lenses before administering the medicine 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 on the front of the eye). If the patient experiences any abnormal sensations in the eye, stinging, or eye pain after using the medicine, they should contact their doctor.

3. How to use Tropicamidum WZF 0.5%

This medicine should always be used exactly as directed by the doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist.
Usually, the medicine is used as described below.

Adults, elderly patients, and children

• Eye examination: 1 to 2 drops should be administered into the conjunctival sac 15 to 20 minutes before the examination.
• To dilate the pupil: 2 drops should be administered into the conjunctival sac (at 5-minute intervals). If it is not possible to examine the patient within 15-30 minutes after administration, 1 additional drop may be administered to prolong the pupil-dilating effect. The maximum dilation of the pupil occurs about 15 minutes after administration. The effect of the medicine lasts for up to 3 hours.

Method of administration

Tropicamidum WZF 0.5% is intended for external use - it should be administered locally to the eye (eyes).
The patient should not touch the dropper tip to the eye, eyelids, or any other surfaces, as this may contaminate the contents of the bottle. Using contaminated drops can lead to serious complications, even vision loss.

• 1. Before administering the medicine, the patient should wash their hands thoroughly.
• 2. The patient should unscrew the cap on the bottle.
• 3. The patient should tilt their head back and pull the lower eyelid down to create a pocket between the eyelid and the eye.
• 4. The patient should turn the bottle upside down and gently press the thumb or index finger on the wall until one drop of the medicine falls into the eye. The patient should not touch the dropper tip to the eye or eyelids. If the drop does not get into the eye, the patient should administer the next drop.
• 5. Immediately after administering the medicine, the patient should gently press the inner corner of the eye for about 1 minute. This will help reduce the risk of systemic side effects.
• 6. If the doctor has recommended administering the medicine to the other eye as well, the patient should repeat the steps from points 3, 4, and 5.
• 7. The dropper is designed to accurately measure the drops, so the patient should not enlarge the opening of the dropper.
• 8. After administering the medicine, the patient should screw the cap back on the bottle, but not too tightly.

Using a higher dose of Tropicamidum WZF 0.5% than recommended

In case of excessive absorption of tropicamide into the systemic circulation, systemic toxic effects may occur (especially in children), characterized by: facial flushing, dryness of the mucous membranes of the mouth (in children, a rash may occur), vision disturbances, rapid and irregular heartbeat, fever, abdominal distension in infants, convulsions, hallucinations, and loss of neuromuscular coordination. If these symptoms occur or the medicine has been used incorrectly (e.g., ingested), the patient should immediately consult their doctor or go to the hospital. In infants and small children, it is recommended to maintain a moist body surface. If the medicine has been ingested, vomiting can be induced.

4. Possible side effects

Like all medicines, Tropicamidum WZF 0.5% can cause side effects, although not everybody gets them.
If the patient experiences any allergic reactions, they should stop using Tropicamidum WZF 0.5% and immediately consult their doctor.
Local side effects may occur:
Frequency not known (frequency cannot be estimated from the available data):

• increased pressure in the eyes;
• transient stinging in the eye;
• photophobia, resulting from pupil dilation. Prolonged use of the medicine may cause local irritation, hyperemia, edema, and conjunctivitis.

Systemic side effects may occur:
Frequency not known (frequency cannot be estimated from the available data):

• dryness of the mucous membranes of the mouth;
• facial flushing, dry skin;
• irregular heartbeat;
• sudden need to urinate;
• slowing of gastrointestinal peristalsis leading to constipation;
• vomiting;
• dizziness;
• unsteady gait.

Additional side effects in children

Frequency not known (frequency cannot be estimated from the available data): rash, psychotic reactions (e.g., seeing or hearing things that do not exist, delusions), behavioral disorders, respiratory and cardiovascular failure, and abdominal distension in infants.
Tropicamide may cause central nervous system disorders, which can be dangerous in infants and children.
If the patient experiences any of these symptoms while using the medicine, they should stop using Tropicamidum WZF 0.5% and immediately consult their doctor or the Emergency Department of the nearest hospital.

Reporting side effects

If the patient experiences any side effects, including those not listed in the package leaflet, they should inform their doctor or pharmacist.
Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie Avenue 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 Tropicamidum WZF 0.5%

Store in a temperature below 25°C.
Keep the bottle tightly closed.
The medicine should be stored out of sight and reach of children.
Shelf life after first opening the bottle: 4 weeks.
After this period, the bottle with the remaining medicine should be discarded.
Do not use this medicine after the expiry date stated on the carton and bottle.
The expiry date stated on the packaging refers to the last day of the specified month.
The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot means the batch number.
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 package and other information

What does Tropicamidum WZF 0.5% contain

• The active substance of the medicine is tropicamide. Each ml of solution contains 5 mg of tropicamide.
• The other ingredients are: sodium chloride; disodium edetate; benzalkonium chloride solution; hydrochloric acid diluted (to adjust pH); purified water.

What Tropicamidum WZF 0.5% looks like and what the package contains

Tropicamidum WZF 0.5% is a sterile eye drop solution in the form of a colorless, transparent liquid.
The package contains 2 polyethylene bottles of 5 ml solution each, in a cardboard box.

Marketing authorization holder

Polpharma S.A.
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 the last revision of the package leaflet