Pilocarpinum wzf 2%

Package leaflet: Information for the patient

PILOCARPINUM WZF 2%, 20 mg/ml, eye drops, solution
Pilocarpini hydrochloridum
Please read carefully the entire leaflet before using the medicine, because it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm others, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform the doctor or pharmacist immediately. 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 adverse 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 elevated intraocular pressure and to treat glaucoma (open-angle or narrow-angle).
The medicine causes constriction of the pupil.

2. Important information before using the medicine 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 pupil constriction is contraindicated in the patient, e.g. in certain inflammatory eye conditions (acute and chronic iritis, cyclitis, keratitis, and anterior uveitis) and in certain forms of secondary glaucoma.
• If the patient has current or previous retinal detachment or conditions predisposing to retinal detachment.
• If the patient is breastfeeding.

Warnings and precautions
Before starting treatment with Pilocarpinum WZF 2%, discuss this with your doctor or pharmacist.

When to exercise special caution when using Pilocarpinum WZF 2%

• if the patient has severe heart disease (acute heart failure) or high blood pressure;
• if the patient has bronchial asthma;
• if the patient has peptic ulcer disease;
• if the patient has difficulty urinating;
• if the patient has Parkinson's disease;
• if the patient has corneal defects;
• if the patient wears contact lenses – see section "Pilocarpinum WZF 2% contains benzalkonium chloride".
  In patients who are particularly sensitive, especially those with a history of retinal disease, isolated cases of retinal detachment have been reported. Therefore, the doctor may recommend an ophthalmoscopic examination before starting treatment with pilocarpine, as well as regular monitoring of intraocular pressure and visual field assessment during treatment.

Pilocarpinum WZF 2% and other medicines
Inform your doctor or pharmacist about all medicines currently used or recently used, as well as any medicines you plan to use.

Pilocarpine has an antagonistic effect to mydriatic drugs (e.g. tropicamide).

Pregnancy, breastfeeding and fertility If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor before using this medicine.
This medicine should only be used during pregnancy if the doctor decides it is necessary.
Use of this medicine during breastfeeding is contraindicated.
There is no data available on the effect of this medicine on fertility.

Driving and operating machinery
Pilocarpinum WZF 2% may impair vision and therefore should be used with caution in people who drive or operate machinery.
Driving at dusk or in the dark should be avoided during treatment, because 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 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 occur in the eye, such as stinging or pain after using the medicine, contact your doctor.

3. How to use Pilocarpinum WZF 2%

This medicine should always be used as directed by the physician. In case of doubt, consult your
doctor or pharmacist.
Pilocarpinum WZF 2% is intended for ophthalmic use.
The usual dose is one to two drops into the affected eye(s) three times daily, e.g. in the morning,
at noon, and in the evening.
In acute conditions – an attack of acute angle-closure glaucoma: one drop into the affected eye(s)
every 5 minutes until pupillary constriction is achieved.
If the patient is using other eye medications simultaneously, an interval of 15 minutes should be
maintained between the administration of each medication.
Do not change the dosing regimen of Pilocarpinum WZF 2% without consulting your 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 gradually
increase the dose up to the maximum adult dose (in the form of eye drops containing a 2% solution of
pilocarpine).

Method of administration
Pilocarpinum WZF 2% is intended for external use – apply locally to the affected eye(s).
Do not allow the dropper tip to 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
even loss of vision.

1. Wash hands thoroughly before instilling the drops.
2. Unscrew the cap from the bottle.
3. Tilt the head backward and gently pull down the lower eyelid to create a pocket between the eyelid and the eyeball.
4. Invert the bottle and gently squeeze with the thumb or index finger until one drop of the medicine is instilled into the eye. Do not allow the dropper tip to touch the eye, eyelids, or any other surface. If the drop missed the eye, instill another one.
5. Immediately after instillation of Pilocarpinum WZF 2%, gently press the inner corner of the eye for about 1 minute. This helps reduce the risk of systemic adverse effects.
6. If the doctor has prescribed instillation into the second eye, repeat steps 3, 4, and 5.
7. The dropper is designed to accurately measure drops; therefore, do not enlarge the dropper orifice.
8. After instillation, replace the cap on the bottle. Do not overtighten.

Use of more than the recommended dose of Pilocarpinum WZF 2%
If more than the recommended dose of the medicine is instilled into the eye or if the contents of the
bottle are accidentally ingested, contact a doctor immediately. Symptoms may include increased
tearing, salivation, sweating, gastric secretion, bradycardia, and hypotension. In case of instilling
excessive amounts of the medicine, the excess can be rinsed out of the conjunctival sac with cooled
boiled water at room temperature.

Missed dose of Pilocarpinum WZF 2%
It is important to use this medicine as directed by the physician.
If a dose is missed, instill the medicine as soon as possible.
However, if it is almost time for the next dose, skip the missed dose and instill the next dose
according to the prescribed schedule.
Do not use a double dose to make up for a missed dose.

Stopping treatment with Pilocarpinum WZF 2%
If it becomes necessary to discontinue the medicine, contact your doctor immediately.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
If the patient experiences allergic reactions, breathing difficulties, or other serious adverse reactions,
treatment with Pilocarpinum WZF 2% should be discontinued and medical advice should be sought
immediately.
The adverse reactions listed below may occur after administration of pilocarpine.
Frequency unknown (cannot be estimated from available data):

• symptoms of corneal irritation (pain, stinging, burning at the site of administration, photophobia),
• conjunctival hyperemia,
• lacrimation,
• impaired vision in dim light,
• accommodation disorders (the ability of the eye to adjust for clear vision of objects at varying distances),
• blurred or hazy vision (especially in patients with myopia),
• appearance of moving spots in the visual field,
• visual acuity disturbances (lens opacification) with long-term use,
• headache (particularly in young patients initiating treatment), transient headaches,
• hypotension,
• bradycardia,
• excessive salivation and/or sweating,
• nausea, vomiting,
• diarrhea,
• breathing difficulties (bronchospasm).

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions at 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 Pilocarpinum WZF 2%

Store below 25°C.
Keep the bottle tightly closed.
Store the medicine in a place inaccessible and out of sight of children.
Do not use this medicine after the expiry date stated on the carton and bottle following EXP.
The expiry date refers to the last day of the stated month.
The labelling on the packaging following the abbreviation EXP indicates the expiry date, and following the abbreviation Lot indicates the batch number.
After first opening the bottle, do not use the medicine for longer than 30 days. After this period, the medicine should be discarded, even if it has not been completely used.
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 Pilocarpinum WZF 2% contains

• The active substance is pilocarpine hydrochloride. Each ml of solution contains 20 mg of pilocarpine hydrochloride.
• The other ingredients are: sodium chloride; benzalkonium chloride, solution; disodium edetate; sodium hydroxide 10% (for pH adjustment); 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 colourless, clear liquid.
Pilocarpinum WZF 2% is available in polyethylene bottles containing 5 ml of solution.
Marketing Authorisation 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