Tropicamidum Vzf 1%

Package Leaflet: Information for the Patient

TROPICAMIDUM WZF 1%, 10 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 leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

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

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

• in ophthalmic diagnostics - to paralyze accommodation;
• in preoperative and postoperative conditions requiring the use of a short-acting pupil dilator.

2. Important information before using Tropicamidum WZF 1%

When not to use Tropicamidum WZF 1%

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

Warnings and precautions

Before starting treatment with Tropicamidum WZF 1%, discuss it with your doctor or pharmacist.

• Before using the medicine to dilate the pupil for examination of the fundus, the doctor will diagnose glaucoma with a narrow angle to prevent possible acute glaucoma attack after administration of tropicamide.
• Particular caution should be exercised in people who are hypersensitive to compounds called 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, wash your hands to remove any remaining tropicamide.

Children

When administering the medicine, it is recommended to exercise particular caution in children, as side effects may occur (see section 4 of the 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 in a place inaccessible to children.

Tropicamidum WZF 1% and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.
The action of tropicamide is enhanced by medicines used in Parkinson's disease (e.g., amantadine), some antihistamines belonging to the so-called first-generation antihistamines (e.g., clemastine), medicines used in mental disorders (e.g., chlorpromazine and haloperidol), and tricyclic antidepressants (e.g., imipramine, amitriptyline).

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor before using this medicine.
The medicine may be used in pregnant women only when, in the doctor's opinion, its use is necessary.
A 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 for the mother.
There are no data on the effect of the medicine on fertility.

Driving and using machines

After using the medicine, vision disturbances and photophobia may occur. Do not drive or operate machinery until your vision returns to normal, which usually occurs about 6 hours after administration of the medicine.

Tropicamidum WZF 1% 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. Remove contact lenses before administration and wait at least 15 minutes before reinserting.
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 you experience any abnormal sensations in the eye, stinging, or eye pain after using the medicine, contact your doctor.

3. How to use Tropicamidum WZF 1%

This medicine should always be used exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Usually, the medicine is used as described below.
Adults and elderly patients

• Akomodation paralysis: 1 drop instilled twice at 5-minute intervals. The examination is best performed 25 to 50 minutes after the last instillation of the medicine. Note: In children, to induce accommodation paralysis, atropine should be used.

Adults, elderly patients, and children

• To dilate the pupil: 1 drop of Tropicamidum WZF 1%. If it is not possible to examine the patient within 15-30 minutes after administration, 1 drop can be instilled again to prolong the pupil-dilating effect. Maximum pupil dilation occurs about 15 minutes after administration of the medicine. The effect of the medicine lasts for up to 3 hours. Note: In infants and small children, tropicamide should be used only at a concentration of 0.5%.

Method of administration

Tropicamidum WZF 1% is intended for external use - it should be used locally in the eye (eyes).
Do not touch the tip of the dropper to the eye, eyelids, or any other surface, as this may contaminate the contents of the bottle. Using contaminated drops can lead to dangerous complications, even vision loss.

• 1. Before instillation, wash your hands thoroughly.
• 2. Remove the cap from the bottle.
• 3. Tilt your head back and pull the lower eyelid down to create a pocket between the eyelid and the eye.
• 4. Invert the bottle and gently press the thumb or index finger on the wall until one drop of the medicine is released into the eye. Do not touch the tip of the dropper to the eye or eyelids. If the drop does not get into the eye, instill another one.
• 5. Immediately after instillation of Tropicamidum WZF 1%, gently press the inner corner of the eye for about 1 minute. This will help reduce the risk of systemic side effects.
• 6. If your doctor has instructed you to instill the medicine into the other eye as well, repeat the actions from points 3, 4, and 5.
• 7. The dropper is designed to measure drops accurately, so do not enlarge the opening of the dropper.
• 8. After instillation, replace the cap on the bottle. However, do not tighten it too much.

Using more than the recommended dose of Tropicamidum WZF 1%

In case of excessive absorption of tropicamide into the systemic circulation, systemic toxic effects may occur (especially in children), characterized by: flushing of the face, dryness of the oral mucosa (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), seek medical attention immediately 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, this medicine can cause side effects, although not everybody gets them.
If you experience an allergic reaction, stop using Tropicamidum WZF 1% and contact your doctor immediately.
Local side effects may occur:
Frequency not known (frequency cannot be estimated from the available data):

• increased intraocular pressure;
• 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 oral mucosa;
• flushing, dryness of the 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 such symptoms occur during treatment with the medicine, stop using Tropicamidum WZF 1% and contact your doctor or the Emergency Department of the nearest hospital immediately.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell your 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
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.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Tropicamidum WZF 1%

Store in a temperature below 25°C.
Keep the bottle tightly closed.
Store the medicine in a place out of sight and reach of children.
Shelf life after first opening of the bottle: 4 weeks.
After this time, 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 refers to the last day of the 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. 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 Tropicamidum WZF 1% contains

• The active substance is tropicamide. Each ml of solution contains 10 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 1% looks like and contents of the pack

Tropicamidum WZF 1% is a sterile eye drop solution in the form of a colorless, transparent liquid.
The pack contains 2 polyethylene bottles of 5 ml solution, 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 last revision of the leaflet: