CUSIMOLOL 5 mg/ml EYE DROPS SOLUTION

Introduction

Package Leaflet: Information for the User

CUSIMOLOL 5mg/ml eye drops solution

Timolol

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the package leaflet:

1. What is CUSIMOLOL 5 mg/ml and what is it used for
2. What you need to know before you use CUSIMOLOL 5 mg/ml
3. How to use CUSIMOLOL 5 mg/ml
4. Possible side effects
5. Storage of CUSIMOLOL 5 mg/ml
6. Contents of the pack and further information

1. What is CUSIMOLOL 5 mg/ml and what is it used for

CUSIMOLOL is an eye drop that contains an active ingredient (timolol), which acts by decreasing the pressure inside the eye (intraocular pressure), whether or not it is associated with glaucoma.

This medicine is used to reduce high eye pressure in ocular hypertension (increased pressure in the eye) and in chronic open-angle glaucoma (including patients who have undergone cataract surgery).

2. What you need to know before you use CUSIMOLOL 5 mg/ml

Do not use CUSIMOLOL

• If you are allergic to timolol, other beta-blockers, or any of the other ingredients of this medicine (listed in section 6).
• If you have or have had respiratory problems such as asthma, severe chronic obstructive bronchitis (a serious lung disease that can cause wheezing, difficulty breathing, and/or long-term coughing).
• If you have heart failure, slow heart rate, or heart rhythm disorders (irregular heartbeats).
• If you have severe allergic rhinitis.
• If you have corneal disorders.

Warnings and precautions

Consult your doctor or pharmacist before starting to use CUSIMOLOL.

Only use this medicine in your eye(s).

Before starting to use this medicine, tell your doctor if you have or have had:

• coronary heart disease (symptoms may include chest pain or discomfort, shortness of breath, or choking), heart failure, low blood pressure.
• heart rate disorders such as bradycardia (slow heart rate).
• respiratory problems, asthma, or chronic obstructive pulmonary disease.
• diseases due to poor blood circulation (such as Raynaud's disease or Raynaud's syndrome).
• diabetes, as timolol may mask the signs and symptoms of low blood sugar levels.
• hyperthyroidism, as timolol may mask the signs and symptoms.
• If you have myasthenia gravis (a chronic neuromuscular weakness).
• If you suffer from any severe allergic reaction (skin rash, redness, and itching in the eye) while using this medicine, regardless of the cause, treatment with adrenaline may not be as effective. Therefore, when receiving any other treatment, inform your doctor that you are using this medicine.
• If you have corneal disorders, consult your doctor, as this medicine may cause dry eyes.

Tell your doctor that you are using this medicine before undergoing surgery, as timolol may alter the effects of some medicines used during anesthesia.

If you have angle-closure glaucoma, you should use this medicine in combination with other medicines that act by closing the pupil. You should regularly check your eye pressure, especially at the beginning of treatment.

The use of contact lenses is not recommended during the administration of this medicine (see the section "CUSIMOLOL contains benzalkonium chloride and phosphates").

Children and adolescents

Timolol should generally be used with caution in young patients. This medicine should be used with extreme caution in newborns, infants, and small children. Use of this medicine should be stopped immediately if coughing, wheezing, abnormal breathing, or abnormal pauses in breathing (apnea) appear. Consult your doctor as soon as possible. A portable apnea monitor may be helpful.

This medicine has been studied in babies and children from 12 days to 5 years of age who have increased eye pressure or have been diagnosed with glaucoma. For more information, consult your doctor.

Other medicines and CUSIMOLOL

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

This medicine may affect or be affected by other medicines you are using, including other eye drops for the treatment of glaucoma. Consult your doctor if you are using or plan to use medicines to lower blood pressure, heart medicines including quinidine (used to treat heart conditions and some types of malaria), medicines to treat diabetes, or antidepressants known as fluoxetine and paroxetine.

Consult your doctor if you are being treated for depression. CUSIMOLOL should not be taken with MAOI-type medicines used to treat this type of condition.

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 medicine.

Do not use this medicine if you are pregnant unless your doctor considers it necessary.

Do not use this medicine if you are breastfeeding, as timolol may pass into breast milk.

Driving and using machines

You may notice that your vision becomes blurred after applying the eye drops. In some patients, Cusimolol may also cause hallucinations, dizziness, nervousness, or fatigue. Do not drive or use machines until these symptoms have disappeared.

CUSIMOLOL contains benzalkonium chloride and phosphates

This medicine contains 0.1 mg of benzalkonium chloride in each ml.

Benzalkonium chloride can be absorbed by soft contact lenses and may alter the color of the contact lenses. Remove contact lenses before using this medicine and wait 15 minutes before putting them back.

Benzalkonium chloride may cause eye irritation, especially if you have dry eyes or other corneal diseases (diseases of the transparent layer on the front of the eye). Consult your doctor if you feel any unusual sensation, itching, or pain in the eye after using this medicine.

This medicine contains 9.4 mg of phosphates in each ml.

If you have severe damage to the transparent layer on the front of the eye (cornea), treatment with phosphates, in very rare cases, may cause cloudy patches on the cornea due to calcium.

Use in athletes

This medicine contains timolol, which may produce a positive result in doping tests.

3. How to use CUSIMOLOL 5 mg/ml

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

The recommended dose is:

Use in adults (including elderly patients)

It is recommended to start treatment with the lowest available dose of timolol. If the response is not satisfactory, your doctor may change the dose to 1 drop of CUSIMOLOL 5 mg/ml in the affected eye(s) twice a day (morning and evening).

If necessary, your doctor may decide to supplement this treatment with other medicines that reduce eye pressure.

In some patients, the decrease in eye pressure in response to treatment with timolol may require a period to stabilize. Therefore, the doctor may recommend that you check your intraocular pressure approximately 4 weeks later. If your doctor considers it appropriate, they may reduce the dose to one drop per day in the affected eye(s).

In the event that this eye drop replaces previous glaucoma treatment or is used in conjunction with other medicines, the dosage indicated by the doctor will be followed exactly.

Your doctor will indicate the duration of your treatment with this medicine. Do not stop treatment unless your doctor tells you to.

Follow these instructions unless your doctor has given you different ones.

Remember to apply your medicine when it is due.

Pediatric population

A detailed medical examination must precede the use of timolol. Your doctor will carefully weigh the risks and benefits before considering treatment with timolol. If the benefits outweigh the risks, it is recommended to use the lowest available concentration of active ingredient, once a day. Regarding "use in children," a concentration of 0.1% active ingredient may be sufficient to control eye pressure. If this dose is not sufficient to control pressure, it may be necessary to administer it twice a day with 12-hour intervals. Patients, especially neonates, should be closely observed during the first one or two hours after the first dose and closely monitored for any side effects that may appear until the operation is performed.

Method of administration

Only one drop of this eye drop should be instilled in each administration.

After using this eye drop, gently close your eyes for as long as possible (e.g., 3-5 minutes) and press the edge of your eye next to your nose with your finger to prevent this medicine from passing into the rest of your body.

Duration of treatment:

For transient treatment in the pediatric population.

Recommendations for use

1 2 3 4

1. Wash your hands.
2. Pick up the bottle.
3. After opening the bottle for the first time, remove the plastic ring from the seal.
4. Hold the bottle, upside down, between your fingers (figure 1).
5. Tilt your head back. Gently pull your lower eyelid down to form a pocket between your eyelid and your eye, where the drop should fall (figure 2).
6. Bring the tip of the bottle close to your eye. You may find it helpful to look in a mirror.
7. Do not touch your eye or eyelid, or the surrounding areas, or other surfaces with the dropper. The eye drop could become contaminated.
8. Gently squeeze the base of the bottle with your index finger to release one drop at a time (figure 3).
9. After using this eye drop, press the edge of your eye next to your nose with your finger for 2 minutes (figure 4). This helps prevent the medicine from passing into the rest of your body.
10. If you are applying drops in both eyes, repeat all the previous steps with the other eye.
11. Close the bottle tightly immediately after use.

If a drop falls outside the eye, try again.

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

If you use more CUSIMOLOL than you should, you can rinse your eyes with warm water. Do not apply more drops until the next dose.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount used.

The symptoms of overdose may be: slow heart rate, heart failure, decreased blood pressure, and respiratory problems.

If you forget to use CUSIMOLOL, 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 schedule. Do notapply a double dose to make up for missed doses.

If you stop treatment with CUSIMOLOL

Never stop treatment without consulting your doctor or pharmacist first.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects have been observed with this medicine:

Common side effects (may affect more than 1 in 10 people):

• Eye effects: blurred vision, pain, irritation, discomfort, and redness of the eye.

Uncommon side effects (may affect up to 1 in 100 people):

• Eye effects: corneal erosion (damage to the outer layer of the eyeball), superficial inflammation of the eye with or without damage to the surface, inflammation of the iris, inflammation of the conjunctiva, inflammation of the eyelid, reduced vision, sensitivity to light, dry eye, increased tear production, eye discharge, itching in the eye, crust on the eyelid, eye inflammation, eyelid swelling.

• General effects: asthma, bronchitis, shortness of breath, headache, bad taste, reduced heart rate, fatigue, decreased blood pressure.

Rare side effects (may affect up to 1 in 1,000 people):

• Eye effects: double vision, tired eyes, eczema on the eyelids, redness of the eyelid, itching of the eyelid, eye swelling, change in corneal color.

• General effects: depression, reduced blood flow to the brain, dizziness, migraine, heart attack, increased blood pressure, swelling of tissues, coldness of extremities, chronic obstructive pulmonary disease (COPD), constriction of airways in the lungs, difficulty breathing, coughing, wheezing, nasal congestion, stomach upset, abdominal discomfort, dry mouth, facial swelling, skin redness, body weakness, chest discomfort.

Additional side effects have been reported during post-marketing experience, the frequency of which is not known (cannot be estimated from the available data):

• Eye effects: detachment of the layer under the retina that contains blood vessels, which can cause vision disturbances after filtration surgery, drooping of the upper eyelid (causing the eye to be half-closed).

• General effects:

• Swelling under the skin that can occur in the face and extremities and can obstruct the airways, causing difficulty swallowing or breathing, allergy.
• Low blood sugar levels.
• Hallucinations, difficulty sleeping (insomnia), memory loss, nightmares.
• Fatigue, fainting, unusual sensations such as tingling.
• Cardiac arrest, type of heart rhythm disorder, worsening of congestive heart failure (heart disease with difficulty breathing and swelling of the feet and legs due to fluid accumulation), changes in heart rate or rhythm, palpitations.
• Raynaud's phenomenon (numbness and coldness in fingers and toes).
• Respiratory disorders.
• Vomiting, diarrhea, nausea.
• Hives or itchy rash, worsening of psoriasis, rash, hair loss.
• Joint disease or arthropathy (damage and/or discomfort in the joint).
• Lupus.
• Sexual dysfunction and Peyronie's disease (a type of male sexual dysfunction).

Additionally:

In very rare cases, some patients with severely damaged cornea have experienced cloudy patches on the cornea due to calcium during treatment with phosphates.

Like other eye medicines, timolol is absorbed into the bloodstream. This may cause side effects similar to those seen with beta-blocker medicines given by injection or orally. The incidence of side effects after eye administration is lower than with medicines given, for example, by mouth or injection. The adverse reactions described include reactions observed within the class of beta-blocker eye medicines when used for the treatment of eye diseases:

• Generalized allergic reactions, hives or itchy rash, localized and generalized rash, itching, severe and sudden allergic reaction that can be life-threatening.
• Memory loss.
• Increased signs and symptoms of myasthenia gravis (muscle disorder).
• Decreased corneal sensitivity, dry eyes, double vision.
• Chest pain, edema (fluid accumulation), heart failure.
• Constriction of airways in the lungs (mainly in patients with pre-existing bronchospastic disease).
• Muscle pain not caused by exercise.
• Decreased libido.

Generally, you can continue using the drops unless the effects are severe. If you are concerned, consult your doctor or pharmacist. Do not stop using this medicine without consulting your doctor.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaRAM.es.By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of CUSIMOLOL 5 mg/ml

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

Do not use this medicine after the expiry date which is stated on the bottle and carton after "CAD.". The expiry date is the last day of the month indicated.

Store the bottle in the outer packaging to protect it from light. Do not store above 25°C.

To avoid infections, you must discard the bottle 4 weeks after first opening it.

Write the date of opening of the bottle in the space provided on the carton.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the pharmacy's SIGRE collection point. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package contents and additional information

Composition of CUSIMOLOL 5 mg/ml eye drops solution

• The active ingredient is timolol (as maleate). Each ml of solution contains 5 mg of timolol (as maleate).
• The other ingredients are sodium phosphate monobasic monohydrate, disodium hydrogen phosphate dodecahydrate, sodium chloride, benzalkonium chloride, and purified water.

Appearance of the product and package contents

CUSIMOLOL 5 mg/ml eye drops solution is a liquid (clear and colorless) presented in a carton containing a 5 ml plastic bottle with a cap.

Marketing authorization holder

Immedica Pharma AB

SE-113 63 Stockholm

Sweden

Manufacturer

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

Date of last revision of this leaflet: November 2020.

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/