Prospecto: information for the user

COLIRCUSÍ PILOCARPINA 20mg/ml eye drop solution

pilocarpine hydrochloride

Read this prospect carefully before starting to use this medication, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only to you, and you should not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

1.What is COLIRCUSÍ PILOCARPINA and for what it is used

2.What you need to know before starting to use COLIRCUSÍ PILOCARPINA

3.How to use COLIRCUSÍ PILOCARPINA

4.Possible adverse effects

5.Storage of COLIRCUSÍ PILOCARPINA

1. Contents of the package and additional information

Colircusí Pilocarpina is an eye drop that contains an active substance (pilocarpine hydrochloride) thatbelongs to a group of medications known as miotics, used to constrict the pupil and reduce the pressure inside the eye.

It is used as a miotic: to counteract the pupillary dilation that occurs after a surgical operation or an eye examination.

In cases of accidents or operations where the iris should not prolapse (exit).

As a differential diagnosis of iris diseases, since it produces a constriction of the pupil.

It is also used as an ocular hypotensor: to reduce pressure before a surgical operation and prevent an increase in pressure in the eye during laser surgery.

To treat acute (angle-closure) or chronic (angle-open) glaucoma.

Do not use Colircusí Pilocarpina

• If you are allergic to pilocarpine or any of the other components of this medication (listed in section 6).
• If you have inflammation of the iris or the anterior uvea (one of the superficial layers of the eye).
• If you have angle-closure glaucoma (resistance of the eye fluid flow through the pupil).

Warnings and precautions

Consult your doctor or pharmacist before starting to use Colircusí Pilocarpina.

• Only use this medication in your eye(s).
• If you have had a retinal detachment or are predisposed to it, or other retinal diseases.
• If you are young and have myopia (nearsightedness).

(You may undergo a fundus examination before starting treatment with this medication).

• If you have any damage to the cornea or other parts of the eye.
• Consult your doctor if you have any of the following conditions, as they may worsen:

• Problems with the outflow of aqueous humor (fluid inside the eye)
• Heart problems
• Hypertension or hypotension
• Asthma or other lung diseases
• Urinary incontinence or difficulty urinating
• Peptic ulcers (stomach ulcers)
• Hypothyroidism
• Gastrointestinal spasms (painful digestive contractions)
• Parkinson's disease
• Recent myocardial infarction.

• If you drive at night or perform hazardous tasks in low light, as this medication may cause blurred vision and light sensitivity.
• If you have dark eyes, you may need a higher concentration of this medication or apply it more frequently to achieve the desired effect. Consult your doctor, as there may be a risk of overdose.
• If you use this medication for a long period, you may experience irritation or allergic reactions. In these cases, discontinue treatment.

Children

Do not use in children, as the safety and efficacy have not been established.

Other medications and Colircusí Pilocarpina

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Especially, inform your doctor if you are using:

• Nonsteroidal anti-inflammatory drugs (NSAIDs) for the eyes, such as ibuprofen, as they may reduce the effect of this medication.
• Beta-adrenergic antagonists (used to treat hypertension and heart disease), as they may increase the risk of heart problems.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Do not use this medication during pregnancy or breastfeeding, unless your doctor considers it necessary.

Driving and operating machinery

The influence of this medication on your ability to drive and operate machinery is important.

After application, this medication may cause blurred vision and difficulty adapting to darkness. If these effects occur, do not drive or operate machinery until they have resolved.

Be particularly cautious when driving at night or performing hazardous tasks in low light.

COLIRCUSÍ PILOCARPINA contains benzalkonium chloride

This medication contains 0.1 mg of benzalkonium chloride per ml.

Benzalkonium chloride can be absorbed by soft contact lenses, altering their color. Remove contact lenses before using this medication and wait 15 minutes before reinserting them.

Benzalkonium chloride may cause eye irritation, especially if you have dry eye or other corneal diseases (transparent layer of the front of the eye). Consult your doctor if you experience a strange sensation, burning, or pain in the eye after using this medication.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The following measure is useful to limit the amount of medication that passes into the blood after application of the eye drops:

Keep your eyes closed while gently pressing with a finger on the tear duct for at least 2 minutes.

The recommended dose is:

Adults including elderly patients

- Induction of miosis: 1 or 2 drops spaced 5 minutes in the affected eye(s).

- Prevention of ocular hypertension in case of laser surgery: 1 or 2 drops spaced 5 minutes in the affected eye(s), between 15 to 60 minutes before surgery.

- Acute glaucoma: 1 drop in the affected eye(s), up to 3 times in a 30-minute period (it may be necessary to apply a previous treatment).

- Ocular hypertension and elevated intraocular pressure due to open-angle glaucoma: 1 drop in the affected eye(s), up to 4 times a day.

Your doctor may modify the number of daily applications and will indicate the duration of treatment with this eye drop. Do not stop treatment unless your doctor tells you to.

Usage recommendations

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- Wash your hands.

- Take the bottle (dropper).

- After opening the bottle for the first time, remove the plastic ring from the seal if it is loose.

- Hold the bottle, upside down, between your fingers.

- Tilt your head back. Gently separate your eyelid from your eye with a finger until a pouch forms between your eyelid and your eye, where the drop should fall (figure 1).

- Bring the tip of the bottle close to your eye. It may be helpful to use a mirror.

- Do not touch your eye or eyelid, nearby areas or other surfaces with the dropper. The drops could become contaminated.

- Press gently on the base of the bottle with your index finger to release one drop at a time (figure 2).

- After using this eye drop, close your eye and gently press with your finger on the edge of your eye near your nose for about 2 minutes. This helps to prevent the eye drop from passing into the rest of your body (figure 3).

- If drops are applied to both eyes, repeat all previous steps for the other eye.

- Close the bottle tightly immediately after using the medication.

If a drop falls outside the eye, try again.

Use in case of liver and/or kidney insufficiency

No safety and efficacy have been established in patients with severe liver or kidney insufficiency.

If you are using other eye medications, wait at least 5 minutes between the administration of this medication and the other eye medications. Eye ointments should be administered last.

If you use more Colircusí Pilocarpina than you should,you can remove it by washing your eyes with warm water. Do not apply more drops until you are told to.

The symptoms of overdose or accidental ingestion may include: headache, salivation, sweating, dizziness, slow heart rate, hypotension, abdominal cramps, vomiting, asthma, and diarrhea.

The treatment of overdose is supportive. In case of severe systemic toxicity, treatment with anticholinergics may be necessary.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service. Phone 91 562 04 20, indicating the medication and the amount used.

If you forgot to use Colircusí Pilocarpina

Do not apply a double dose to compensate for the missed doses.

Apply a single dose as soon as you remember and continue with the next dose that was scheduled. However, if it is almost time for the next dose, do not apply the missed dose and continue with the next dose of your regular regimen.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people may experience them.

The following adverse effects have been observed with this medication:

Very frequent (may affect more than 1 in 10 people):

• Eye effects: blurred vision.
• General effects: headache.

Frequent (may affect up to 1 in 10 people):

• Eye effects: floaters in the fluid inside the eye (appearance of spots in vision), reduced vision (especially in elderly patients or those with opacities), eye pain, abnormal light perception, eye irritation, and eye redness.
• General effects: dizziness and nausea.

Rare (may affect up to 1 in 100 people):

• Eye effects: retinal tear, bleeding inside the eye, detachment of the fluid inside the eye, eyelid swelling, pupil constriction, dazzling, and abnormal eye sensation.

Unknown frequency (cannot be estimated from available data):

• Eye effects:increased eye pressure and corneal edema.
• General effects: vomiting.

Other adverse effects that may be produced by this type of medication

Prolonged administration of miotics may lead to an increased risk of cataracts, iris cyst, or retinal detachment in patients with pre-existing retinal pathology.

A paradoxical increase in eye pressure may occur in patients with altered outflow.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaRAM.es.By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the bottle and on the box after “CAD”. The expiration date is the last day of the month indicated.

Do not store at a temperature above 25°C.

To prevent infections, discard the bottle 4 weeks after it has been opened for the first time.

Record the date of opening the bottle in the reserved box on the box.

Medications should not be thrown down the drains or in the trash.Deposit the containers and medications that you do not need in the SIGRE collection pointof the pharmacy. In case of doubt please ask your pharmacist how to dispose of the containers and medications that you do not need. By doing so, you will help protect the environment.

Composition of COLIRCUSÍ PILOCARPINA

• The active ingredient is pilocarpine hydrochloride. One ml of solution contains 20 mg of pilocarpine hydrochloride (2%).
• The other components are benzalkonium chloride, povidone, sodium chloride, borax, and purified water.

Appearance of the product and content of the container

Colircusí Pilocarpina is an eye drop solution (clear and colorless or slightly yellowish liquid).

It is presented in a dropper bottle (plastic bottle with a stopper) in a box.

Each container contains 10 ml of eye drops.

MARKETING AUTHORIZATION HOLDER:

.Mizar Farmacéutica, S.L.

Gran Via de les Corts Catalanes, 764

08013 – Barcelona, Spain

RESPONSIBLE FOR MANUFACTURING

Siegfried El Masnou, S.A.

C/ Camil Fabra, 58

08320 El Masnou - Barcelona, Spain

or

Novartis Farmacéutica, S.A.

Gran Via de les Corts Catalanes, 764

08013 Barcelona, Spain

or

Novartis Pharma GmbH

Roonstrasse 25

90429 Nuremberg, Germany

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Novartis Farmacéutica, S.A.

Gran Via de les Corts Catalanes, 764

08013 – Barcelona, Spain

Last review date of this leaflet: February 2022.

The detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es