Pilocarpinum Vzf 2%

Package Leaflet: Information for the Patient

PILOCARPINUM WZF 2%, 20 mg/ml, Eye Drops, Solution

Pilocarpine Hydrochloride

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.
• 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 leaflet, they should inform their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Pilocarpinum WZF 2% and what is it used for

Pilocarpinum WZF 2% is an ophthalmic medicine in the form of sterile eye drops, containing pilocarpine hydrochloride as the active substance. Pilocarpine hydrochloride belongs to a group of medicines called cholinomimetics.
Pilocarpinum WZF 2% is used to reduce increased pressure in the eye (eyes) and to treat glaucoma (with open or narrow angle).
The medicine causes constriction of the pupil.

2. Important information before using Pilocarpinum WZF 2%

When not to use Pilocarpinum WZF 2%

• If the patient is allergic to pilocarpine hydrochloride or any of the other ingredients of this medicine (listed in section 6).
• If the patient has conditions where pupil constriction is not recommended, e.g. in certain inflammatory eye conditions (acute and chronic uveitis and iritis, corneal inflammation and anterior segment inflammation) and in certain types of secondary glaucoma.
• If the patient has or has had a retinal detachment or conditions that may lead to retinal detachment.
• If the patient is breastfeeding.

Warnings and precautions

Before starting treatment with Pilocarpinum WZF 2%, the patient should discuss it with their doctor or pharmacist.

When to be particularly cautious when using Pilocarpinum WZF 2%

• if the patient has severe heart disease (acute heart failure), high blood pressure;
• if the patient has asthma;
• if the patient has stomach ulcers;
• if the patient has difficulty urinating;
• if the patient has Parkinson's disease;
• if the patient has corneal damage;
• if the patient wears contact lenses - see section "Pilocarpinum WZF 2% contains benzalkonium chloride". In sensitive patients, especially those with a history of retinal disease, isolated cases of retinal detachment have been reported, therefore the doctor may recommend an eye examination before starting treatment with pilocarpine, and during treatment, intraocular pressure measurements and visual field assessments.

Pilocarpinum WZF 2% 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.
Pilocarpine has an opposite effect to medicines that dilate the pupils (e.g. tropicamide).

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 can be used during pregnancy only if the doctor decides it is necessary.
Using the medicine during breastfeeding is contraindicated.
There is no data on the effect of the medicine on fertility.

Driving and using machines

Pilocarpinum WZF 2% may impair vision, and therefore should be used with caution in patients who drive vehicles or operate machinery.
While using the medicine, the patient should not drive at night, as Pilocarpinum WZF 2% impairs the ability to adapt to darkness.

Pilocarpinum WZF 2% contains benzalkonium chloride

The medicine contains 0.1 mg of benzalkonium chloride per 1 ml of solution.
Benzalkonium chloride may be absorbed by soft contact lenses and change their color. The patient should remove their contact lenses before instilling the drops and wait at least 15 minutes before putting them back on.
Benzalkonium chloride may also cause eye irritation, especially in patients 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 pain after using the medicine, they should consult their doctor.

3. How to use Pilocarpinum WZF 2%

This medicine should always be used as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.
Pilocarpinum WZF 2% is intended for use in the eyes.
The usual dose is one to two drops into the affected eye (eyes) three times a day, e.g. in the morning, at noon, and in the evening.
In emergency situations - an attack of acute glaucoma with a narrow angle: one drop into the affected eye (eyes) every 5 minutes until pupil constriction is achieved.
If the patient is using other eye medicines, they should wait 15 minutes between instilling the different medicines.
The patient should not change the dosing schedule of Pilocarpinum WZF 2% without consulting their doctor.
Children and adolescents
In children and adolescents under 18 years of age, the doctor will recommend starting treatment with the lowest possible dose and strength of pilocarpine. If necessary, the doctor may increase the dose to the maximum dose used in adults (in the form of eye drops containing a 2% solution of pilocarpine).

Method of administration

Pilocarpinum WZF 2% is intended for external use - it should be used locally in the affected eye (eyes).
The patient should not touch the tip of the dropper bottle to the eye, eyelids, or any other surfaces, as this may contaminate the contents of the bottle. Using contaminated drops may lead to serious complications, even vision loss.

• 1. Before instilling 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 of the bottle until one drop of the medicine falls into the eye. The patient should not touch the tip of the dropper bottle to the eye, eyelids, or any other surfaces. If the drop does not get into the eye, the patient should instill another drop.
• 5. Immediately after instilling 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 instilling the medicine into the second eye, the patient should repeat the actions 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 instilling the medicine, the patient should screw the cap back on the bottle. However, they should not screw it on too tightly.

Using a higher dose of Pilocarpinum WZF 2% than recommended

In case of instilling a higher dose of the medicine into the eye than recommended or accidentally swallowing the contents of the bottle, the patient should immediately consult their doctor.
Symptoms may occur such as: increased tear production, salivation, sweating, gastric juice production, slowed heart rate, decreased blood pressure.
In case of instilling too much medicine, the excess can be rinsed out of the conjunctival sac with boiled water at room temperature.

Missing a dose of Pilocarpinum WZF 2%

It is important to use this medicine as directed by the doctor.
If the patient misses a dose, they should instill the medicine as soon as possible.
However, if it is almost time for the next dose, the patient should skip the missed dose and instill the next dose according to the schedule recommended by the doctor.
The patient should not use a double dose to make up for the missed dose.

Stopping treatment with Pilocarpinum WZF 2%

If the patient needs to stop using the medicine, they should immediately consult their doctor.
In case of any further doubts about using this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If the patient experiences allergic reactions, breathing difficulties, or other severe side effects, they should stop using Pilocarpinum WZF 2% and immediately consult their doctor.
The following side effects may occur after using pilocarpine.
Frequency not known (cannot be estimated from the available data):

• symptoms of corneal irritation (pain, feeling of stinging, burning in the place of administration, photophobia),
• conjunctival hyperemia,
• lacrimation,
• visual disturbances in low light conditions,
• accommodation disorders (the ability of the eye to adapt to sharp vision of objects at different distances),
• blurred vision (especially in patients with myopia),
• appearance of moving spots in the visual field,
• visual acuity disorders (lens clouding) with prolonged use,
• headache (especially in young patients who have started treatment), transient headaches,
• hypotension,
• bradycardia,
• excessive salivation and (or) sweating,
• nausea, vomiting,
• diarrhea,
• breathing difficulties (bronchospasm).

Reporting side effects

If the patient experiences any side effects, including those not listed in the leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Medicinal Product Monitoring, 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. 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 the medicine.

5. How to store Pilocarpinum WZF 2%

Store in a temperature below 25°C.
Keep the bottle tightly closed.
The medicine should be stored out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and bottle after EXP.
The expiry date stated on the carton and bottle after EXP 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.
After opening the bottle, the medicine should not be used for more than 30 days. After this time, the medicine should be discarded, even if it has not been used up.
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 Pilocarpinum WZF 2% contains

• The active substance of the medicine is pilocarpine hydrochloride. Each 1 ml of solution contains 20 mg of pilocarpine hydrochloride.
• The other ingredients are: sodium chloride; benzalkonium chloride, solution; disodium edetate; sodium hydroxide 10% (to adjust pH); polyvinyl alcohol; purified water.

What Pilocarpinum WZF 2% looks like and contents of the pack

Pilocarpinum WZF 2% is a sterile eye drop solution in the form of a colorless, clear liquid.
Pilocarpinum WZF 2% is available in polyethylene bottles containing 5 ml of solution.

Marketing authorization holder

Zakłady Farmaceutyczne POLPHARMA S.A., ul. Pelplińska 19, 83-200 Starogard Gdański, tel. +48 22 364 61 01

Manufacturer

Warszawskie Zakłady Farmaceutyczne Polfa S.A., ul. Karolkowa 22/24, 01-207 Warszawa

Date of last revision of the leaflet: