Prospecto: information for the user

CUSIMOLOL 5mg/ml eye drops solution

Timolol

Read this prospect carefully before starting to use this medicine, because 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 medicine has been prescribed only for you and should not be given 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 CUSIMOLOL 5mg/ml and for what it is used

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

3.How to use CUSIMOLOL 5mg/ml

4.Possible adverse effects

5.Storage of CUSIMOLOL 5mg/ml

6.Contents of the package and additional information

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 it is associated with glaucoma.

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

Do not use CUSIMOLOL

• If you are allergic to timolol, other beta-blockers, or any of the other components of this medication (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 eye corneal alterations.

Warnings and precautions

Consult your doctor or pharmacist before starting to use CUSIMOLOL.

Only use this medication in your eye(s).

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

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

Inform your doctor that you are using this medication before undergoing surgery, as timolol may alter the effects of some medications used during anesthesia.

If you have angle-closure glaucoma, you must use this medication in combination with other medications that close the pupil. You must regularly monitor your eye pressure, especially at the beginning of treatment.

Do not use contact lenses during the administration of this medication (see the section "CUSIMOLOL contains benzalkonium chloride and phosphates").

Children and adolescents

Generally, timolol eye drops should be used with caution in young patients. This medication should be used with extreme caution in newborns, infants, and small children. Immediately discontinue use of this medication if you notice coughing, wheezing, abnormal breathing, or pauses in breathing (apnea). Consult your doctor as soon as possible. A portable apnea monitor may be helpful.

This medication has been studied in babies and children aged 12 days to 5 years with increased eye pressure or diagnosed with glaucoma. For more information, consult your doctor.

Other medications and CUSIMOLOL

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

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

Consult your doctor if you are being treated for depression, as CUSIMOLOL should not be taken with type IMAO medications 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 medication.

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

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

Driving and operating machinery

You may notice that your vision becomes blurry after applying the eye drop. 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 medication 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 lenses. 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 eyes or other corneal disorders (transparent layer at the front of the eye). Consult your doctor if you feel a strange sensation, burning, or pain in the eye after using this medication.

This medication contains 9.4 mg of phosphates in each ml.

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

Use in athletes

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

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, 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 5mg/ml in the affected eye(s) twice a day (morning and evening).

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

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

In the case of this eye drop replacing a previous treatment for your glaucoma or being used in conjunction with other medications, follow exactly the dosage indicated by your doctor.

Your doctor will indicate the duration of your treatment with this medication. Do not discontinue treatment unless your doctor instructs you to do so.

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

Remember to apply your medication when it is due.

Paediatric population

A detailed medical examination must precede the use of timolol. Your doctor will rigorously evaluate 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. In relation to "use in children", a concentration of 0.1% active ingredient may be sufficient to control intraocular pressure. If this dose is not sufficient to control intraocular pressure, it may be necessary to administer it twice a day with 12-hour intervals. Patients, especially neonates, must be strictly observed for one or two hours after the first dose and closely monitor any side effects that may appear until the operation is performed.

Administration form

This eye drop should only be instilled in one drop per administration.

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

Treatment duration:

For a transient treatment in the paediatric population.

Use recommendations

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1. Wash your hands.
2. Take 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. Incline 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 2).
6. Bring the tip of the bottle close to your eye. It may be helpful to use a mirror.
7. Do not touch your eye or eyelid, surrounding areas or other surfaces with the dropper. The eye drop could become contaminated.
8. Press gently on the base of the bottle with your index finger to allow one drop to fall each time (figure 3).
9. After using this eye drop, press with your finger the edge of your eye next to your nose for 2 minutes (figure 4). This helps to prevent this medication from passing into the rest of your body.
10. If drops are 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.

When using other eye medications, wait at least 5 minutes between administering this eye drop and the other eye medications. Eye ointments should be administered last.

If you use more CUSIMOLOL than you should,you can remove it by rinsing 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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication 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 CUSIMOLOLapply 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.Do notapply a double dose to compensate for the missed doses.

If you interrupt treatment withCUSIMOLOL

Do not discontinue treatment without first consulting your doctor or pharmacist.

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

Like all medications, this medication may cause side effects, although not everyone will experience them.

The following side effects have been observed with this medication:

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

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

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

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

• General effects: depression, reduced cerebral blood flow, dizziness, migraine, infarction, increased blood pressure, tissue swelling, cold extremities, pulmonary obstructive disease (COPD), bronchial constriction 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 side effects have been reported, the frequency of which is unknown:(cannot be estimated from available data):

• Eye effects: retinal detachment with underlying vascular damage that can cause vision disturbances after filtration surgery, upper eyelid drooping (causing the eye to be half-closed).

• General effects:

• Swelling under the skin that can occur on the face and extremities, and may obstruct airways, causing difficulty swallowing or breathing, allergy.
• Low blood sugar levels.
• Hallucinations, insomnia, memory loss, nightmares.
• Fatigue, syncope, unusual sensations such as tingling.
• Cardiac arrest, type of cardiac rhythm alteration, worsening of congestive heart failure (heart disease with difficulty breathing and swelling of the feet and legs due to fluid accumulation), changes in heart rhythm or frequency, palpitations.
• Raynaud's phenomenon (numbness and coldness in fingers and toes).
• Respiratory disorders.
• Vomiting, diarrhea, nausea.
• Urticaria or hives with itching, 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 layer of the front part of the eye (cornea) have experienced cloudy areas in the cornea due to calcium accumulation during treatment.

Like other medications administered in the eyes,timolol is absorbed into the bloodstream. This can cause side effects similar to those observed with intravenous and oral beta-blocker medications. The incidence of side effects after topical administration is lower than with medications administered orally or by injection. The adverse reactions described include reactions observed within the class of beta-blocker eye drops when used to treat eye diseases:

• Generalized allergic reactions, urticaria or hives with itching, localized and generalized rash, itching, severe and sudden allergic reaction that may put your life at risk.
• Memory loss.
• Increased signs and symptoms of myasthenia gravis (muscular 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 medication without consulting your doctor.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaRAM.es.By reporting side 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.

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

To prevent infections, discard the bottle 4 weeks after first opening it.

Note the date of opening the bottle in the reserved box for this purpose.

Medications should not be thrown down the drains or in the trash.Deposit the containers and medications you no longer need at the SIGRE collection point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

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 components are sodium monobasic phosphate monohydrate, disodium dodecahydrogenophosphate, sodium chloride, benzalkonium chloride, and purified water.

Appearance of the product and contents of the packaging

CUSIMOLOL 5 mg/ml eye drops solution is a liquid (transparent and colorless) that is presented in a box containing a plastic bottle of 5 ml with a cap.