Cusimolol 5 mg/ml eye drops solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

CUSIMOLOL 5 mg/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 as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet:

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

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

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

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

2. What you need to know before using 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 breathing problems such as asthma, severe chronic obstructive bronchitis (a serious lung disease that may cause wheezing, difficulty breathing, and/or long-term cough).
• If you have heart failure, slow heartbeat, or heart rhythm disorders (irregular heartbeats).
• If you have severe allergic rhinitis.
• If you have corneal eye disorders.

Warnings and precautions

Talk to your doctor or pharmacist before using CUSIMOLOL.

This medicine is for use in the eye(s) only.

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

• Coronary heart disease (symptoms may include chest tightness or pain, shortness of breath, or suffocation), heart failure, low blood pressure.
• Heart rate disorders such as bradycardia (slow heartbeat).
• Breathing problems, asthma, or chronic obstructive pulmonary disease.
• Circulatory disorders (such as Raynaud's disease or Raynaud's syndrome).
• Diabetes, as timolol may mask the signs and symptoms of low blood sugar.
• Overactive thyroid gland, as timolol may mask the signs and symptoms.
• If you have myasthenia gravis (chronic neuromuscular weakness).
• If you experience any severe allergic reaction (skin rash, eye redness and itching) while using this medicine, regardless of the cause, treatment with adrenaline may be less 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.

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

If you have closed-angle glaucoma, you must use this medicine together with other medicines that constrict the pupil. You should have regular eye pressure checks, especially at the beginning of treatment.

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

Children and adolescents

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

This medicine has been studied in infants and children aged 12 days to 5 years who have elevated eye pressure or have been diagnosed with glaucoma. For further information, consult your doctor.

Other medicines and CUSIMOLOL

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

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

Consult your doctor if you are being treated for depression. CUSIMOLOL must not be taken with MAO inhibitors used to treat depression.

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 blurred vision after applying the eye drops. In some patients, Cusimolol may also cause hallucinations, dizziness, nervousness, or fatigue. Do not drive or operate machinery until these symptoms have disappeared.

CUSIMOLOL contains benzalkonium chloride and phosphates

This medicine contains 0.1 mg of benzalkonium chloride per ml.

Benzalkonium chloride may be absorbed by soft contact lenses and may change the color of contact lenses. Remove contact lenses before using this medicine and wait 15 minutes before reinserting them.

Benzalkonium chloride may cause eye irritation, especially if you have dry eye or other corneal diseases (the transparent layer at the front of the eye). Consult your doctor if you experience a foreign body sensation, stinging, or eye pain after using this medicine.

This medicine contains 9.4 mg of phosphates per ml.

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

Use in athletes

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

3. How to use CUSIMOLOL 5 mg/ml

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

Recommended dose:

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 daily (morning and evening).

If necessary, your doctor may decide to complement this treatment with other medications that reduce intraocular pressure.

In some patients, the reduction in eye pressure in response to timolol treatment may require a period to stabilize; therefore, your doctor may recommend monitoring your intraocular pressure approximately 4 weeks after starting treatment. If your doctor considers it appropriate, the dose may be reduced to one drop daily in the affected eye(s).

If this eye drop is replacing a previous glaucoma treatment or is used concomitantly with other medications, the dosing regimen prescribed by your doctor must be strictly followed.

Your doctor will indicate the duration of your treatment with this medicine. Do not stop treatment earlier unless instructed by your doctor.

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

Remember to apply your medication at the scheduled time.

Paediatric population

Before initiating timolol, a thorough medical examination must be performed. Your doctor will carefully assess the risks and benefits before considering treatment with timolol. If benefits outweigh risks, it is recommended to use the lowest available concentration of active ingredient, administered once daily. Regarding "use in children", the 0.1% active ingredient concentration may be sufficient to control eye pressure. If this dose is insufficient, administration twice daily at 12-hour intervals may be required. Patients must be closely observed, especially neonates, for one or two hours after the first dose, and monitored closely for any adverse effects until surgery is performed.

Method of administration

Only one drop of this eye drop should be instilled per administration.

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

Duration of treatment:

For short-term treatment in the paediatric population.

Instructions for use

1 2 3 4

1. Wash your hands.
2. Take the bottle.
3. After opening the bottle for the first time, remove the plastic ring of the seal.
4. Hold the bottle upside down between your fingers (Figure 1).
5. Tilt your head backwards. Gently pull down the eyelid of the eye with one finger to form a pouch between the eyelid and your eye, into which the drop should fall (Figure 2).
6. Bring the tip of the bottle close to the eye. A mirror may be helpful.
7. Do not touch the eye, eyelid, surrounding areas, or any other surfaces with the dropper tip. 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 with your finger on the inner corner of the eye near the nose for 2 minutes (Figure 4). This helps prevent the medicine from passing into the rest of the body.
10. If drops are being applied to both eyes, repeat all the previous steps for the other eye.
11. Close the bottle tightly immediately after using the product.

If a drop falls outside the eye, try again.

If you are using other ophthalmic medications, wait at least 5 minutes between administering this eye drop and other ophthalmic medications. Ophthalmic ointments should be administered last.

If you use more CUSIMOLOL than you should, you can remove it by rinsing the eyes with lukewarm water. Do not instill any more drops until your next scheduled dose.

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

Symptoms of overdose may include: slow heart rate, heart failure, low blood pressure, and breathing difficulties.

If you forget to use CUSIMOLOL, apply a single dose as soon as you remember and continue with the next dose as scheduled. However, if it is almost time for the next dose, do not apply the missed dose and continue with your regular dosing schedule. Do not apply a double dose to make up for a missed dose.

If you stop treatment with CUSIMOLOL

Never stop treatment without first consulting your doctor or pharmacist.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

The following adverse effects have been observed with this medicine:

Frequent adverse effects (may affect more than 1 in 10 people):

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

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

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

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

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

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

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

During post-marketing experience, additional adverse effects have been reported, for which the frequency is unknown (cannot be estimated from the available data):

• Eye effects: detachment of the layer beneath the retina containing blood vessels, which may cause visual disturbances after filtration surgery; drooping of the upper eyelid (causing the eye to be partially closed).

• General effects:

• Swelling under the skin that may occur in the face and extremities, and may obstruct the airways causing difficulty swallowing or breathing, allergy.

• Low blood sugar levels.

• Hallucinations, difficulty sleeping (insomnia), memory loss, nightmares.

• Tiredness, fainting (syncope), unusual sensations such as tingling.

• Cardiac arrest, type of heart rhythm disturbance, worsening of congestive heart failure (heart disease with difficulty breathing and swelling of feet and legs due to fluid accumulation), changes in heart rhythm or heartbeat frequency, palpitations.

• Raynaud's phenomenon (numbness and coldness in fingers and toes).

• Respiratory disorders.

• Vomiting, diarrhea, nausea.

• Urticaria 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 transparent front layer of the eye (the cornea) have experienced cloudy areas in the cornea due to calcium accumulation during treatment.

Like other eye medications, timolol is absorbed into the bloodstream. This may produce adverse effects similar to those observed with intravenous and/or oral beta-blocker drugs. The incidence of adverse effects after ocular administration is lower than with medications taken orally or by injection. The adverse reactions described include those observed within the class of ophthalmic beta-blockers when used for the treatment of eye diseases:

• Generalized allergic reactions, urticaria or itchy rash, localized and generalized rash, itching, severe and sudden allergic reaction that may 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 the airways in the lungs (mainly in patients with pre-existing bronchospastic disease).
• Muscle pain not caused by exercise.
• Decreased libido.

Generally, you may 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 adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaRAM.es. By reporting adverse 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 stated on the bottle and outer packaging following "EXP.". The expiry date refers to 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 prevent infections, the bottle must be discarded 4 weeks after first opening.

Record the date of opening the bottle in the space provided for this purpose on the carton.

Medicines must not be disposed of via wastewater or household waste. Unused medicines and waste materials should be returned to the SIGRE Point at your pharmacy. If in doubt, please consult your pharmacist on how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of CUSIMOLOL 5 mg/ml eye drops solution

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

Nature of the product and contents of the container

CUSIMOLOL 5 mg/ml eye drops solution is a liquid (clear and colourless) supplied in a carton containing one 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 latest review 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/