Tropicamide wzf 0,5%

Package leaflet: Information for the patient

TROPICAMIDUM WZF 0.5%, 5 mg/ml, eye drops, solution
Tropicamidum
Please read all of this leaflet carefully before using this medicine because it contains
important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

1. What Tropicamidum WZF 0.5% is and what it is 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 pack and other information

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

The medicine contains tropicamide, which, when applied locally to the eye, dilates the pupil and paralyzes accommodation of the eye (the eye's ability to adjust for clear vision of objects at varying distances).
This medicine is used:

• in ophthalmic diagnostics – for fundus examination (ophthalmoscopy);
• in preoperative conditions requiring a short-acting mydriatic agent.

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 to any of the other ingredients of this medicine (listed in section 6);
• if the patient has primary glaucoma with a tendency to angle closure;
• if the patient has narrow-angle glaucoma;
• in patients wearing soft contact lenses due to the presence of benzalkonium chloride in the formulation.

Warnings and precautions
Before starting treatment with Tropicamidum WZF 0.5%, discuss this with your doctor or
pharmacist.

• Before administering the medicine to dilate the pupil for fundus examination, the doctor will perform diagnostic tests to rule out narrow-angle glaucoma to prevent a possible acute glaucoma attack after tropicamide administration.
• Exercise particular caution in patients hypersensitive to substances known as belladonna alkaloids (deadly nightshade).
• In patients with increased sensitivity to anticholinergic drugs, psychotic reactions and behavioral disturbances may occur after instillation of tropicamide.
• Hands should be washed after each instillation to remove any residual tropicamide.

Children
Particular caution is recommended when administering this medicine to children, as adverse reactions may occur (see section 4 of the leaflet). Tropicamide may cause central nervous system disturbances, which may be dangerous in infants and children.
Accidental ingestion of the medicine by a child may lead to toxic effects; therefore, as with all other medicines, this medicine should be stored out of reach of children.

Tropicamidum WZF 0.5% and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient intends to use.
The effect of tropicamide may be enhanced by drugs used in Parkinson's disease (e.g. amantadine), certain antiallergic drugs belonging to first-generation antihistamines (e.g. clemastine), drugs 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, suspects she may be pregnant, or is planning to have a child, she should consult a doctor before using this medicine.
This medicine may be used in pregnant women only if, in the opinion of the doctor, its use is necessary.
A risk to the breastfed infant cannot be excluded.
The decision on whether to continue or discontinue breastfeeding, or to continue or discontinue the use of tropicamide, will be made by the doctor after considering the benefits of breastfeeding for the child and the benefits of using tropicamide for the mother.
There is no data available on the effect of the medicine on fertility.

Driving and operating machinery
After administration of the medicine, disturbances in vision and photophobia may occur. Driving and operating machinery should be avoided until normal vision returns, which usually occurs approximately 6 hours after administration of the medicine.

Tropicamidum WZF 0.5% contains benzalkonium chloride
The medicine contains 0.1 mg of benzalkonium chloride per ml of solution. Benzalkonium chloride may be absorbed by soft contact lenses and may alter their color. Contact lenses should be removed before instillation and at least 15 minutes should elapse before reinsertion.
Benzalkonium chloride may also cause eye irritation, especially in patients with dry eye syndrome or corneal disorders (the transparent layer at the front of the eye). If abnormal sensations, stinging, or pain in the eye occur after administration of the medicine, consult a doctor.

3. How to use Tropicamidum WZF 0.5%

This medicine should always be used exactly as directed by your doctor or pharmacist. If in doubt,
please consult your doctor or pharmacist.
Usually, the medicine is used as described below.
Adults, elderly patients, and children

• Examination of the fundus: Instill 1 to 2 drops into the conjunctival sac 15 to 20 minutes before the examination.
• For pupil dilation: Instill 2 drops into the conjunctival sac (with a 5-minute interval between drops). If the patient could not be examined within 15–30 minutes after administration, one additional drop may be instilled to prolong the pupil-dilating effect. Maximum pupil dilation occurs approximately 15 minutes after administration. The effect of the medicine lasts up to 3 hours.

Method of administration
Tropicamidum WZF 0.5% is intended for external use – apply locally to the eye(s).
Do not let the dropper tip touch the eye, eyelids, or any other surface, as this may contaminate the contents of the bottle. Using contaminated drops may lead to dangerous complications, including loss of vision.

1. Wash hands thoroughly before instilling the medicine.
2. Unscrew the cap on the bottle.
3. Tilt the head backward and gently pull down the lower eyelid to create a pouch between the eyelid and the eyeball.
4. Turn the bottle upside down and gently press with the thumb or index finger on the side of the bottle until one drop of the medicine is dispensed into the eye. Do not let the dropper tip touch the eye or eyelids. If the drop missed the eye, instill another drop.
5. Immediately after instillation of Tropicamidum WZF 0.5%, gently press on the inner corner of the eye for about 1 minute. This helps reduce the risk of systemic adverse effects.
6. If your doctor has instructed you to instill the medicine into the other eye, repeat steps 3, 4, and 5.
7. The dropper is designed to dispense drops accurately; do not enlarge the opening of the dropper.
8. After instillation, replace the cap on the bottle. Do not overtighten.

Use of a higher than recommended dose of Tropicamidum WZF 0.5%
If an excessive amount of tropicamide is absorbed into the systemic circulation, systemic toxic effects may occur (especially in children), characterized by: facial flushing, dryness of the oral mucosa (in children, rash may occur), visual disturbances, rapid and irregular heartbeat, fever, abdominal distension in infants, convulsions, hallucinations, and loss of neuromuscular coordination. If any of these symptoms occur or if the medicine has been used incorrectly (e.g. swallowed), seek immediate medical attention or go to a hospital. In infants and young children, it is recommended to maintain moist body surfaces. If the medicine has been ingested, vomiting may be induced.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
If the patient develops allergic reactions, treatment with Tropicamidum WZF 0.5% should be discontinued immediately and medical advice should be sought without delay.

Local adverse reactions may occur:
Frequency unknown (frequency cannot be estimated from available data):

• increased intraocular pressure;
• transient eye pricking;
• photophobia due to pupillary dilation.
  Prolonged use of the medicine may cause local irritation, conjunctival hyperaemia, swelling and inflammation of the conjunctiva.

Systemic adverse reactions may occur:
Frequency unknown (frequency cannot be estimated from available data):

• dryness of the oral mucosa;
• skin redness and dryness;
• irregular heartbeat;
• sudden urge to urinate;
• reduced gastrointestinal motility leading to constipation;
• vomiting;
• dizziness;
• unsteady gait.

Additional adverse reactions in children
Frequency unknown (frequency cannot be estimated from available data): rash,
psychotic reactions (e.g. seeing or hearing things that do not exist, delusions), behavioural disturbances, respiratory and circulatory failure, and abdominal distension in infants.
Tropicamide may cause central nervous system disturbances, which can be dangerous in infants and children. If such symptoms occur during treatment, administration of Tropicamidum WZF 0.5% should be stopped immediately and a doctor or the nearest hospital Emergency Department should be contacted without delay.

Reporting of adverse reactions
If any adverse reactions occur, including those 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
Tel.: +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 Tropicamidum WZF 0,5%

Store below 25 °C.
Keep the bottle tightly closed.
Store the medicine in a place inaccessible and out of sight of children.
Shelf life after first opening the bottle: 4 weeks.
After this time, the bottle with any 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 stated month.
The labelling on the packaging: EXP refers to the expiry date, and Lot refers to the batch number.
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 Tropicamidum WZF 0.5% contains

• The active substance 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 (for pH adjustment); purified water.

What Tropicamidum WZF 0.5% looks like and contents of the pack
Tropicamidum WZF 0.5% is a sterile eye drop solution in the form of a colourless, transparent liquid.
The pack contains 2 polyethylene bottles with a capacity of 5 ml of solution, 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