Label: information for the user

TIMOFTOL 5 mg/ml eye drops in solution

Timolol

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

-Keep this label, as you may need to read it again.

-If you have any questions, consult your doctor or pharmacist.

-This medicine has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.

-If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

Timoftol is an ocular beta-blocker agent that belongs to the group of medications known as topical antiglaucomatous agents.

This medication is indicated to reduce elevated eye pressure in:

-ocular hypertension

-chronic open-angle glaucoma (including aphakic patients)

-some patients with secondary glaucoma.

Do not use TIMOFTOL

• If you are allergic (hypersensitive) to timolol, beta-blockers, or any of the other components of Timoftol (listed in section 6).
• If you have now or have had in the past certain important respiratory problems such as asthma.
• If you have now or have had in the past chronic obstructive pulmonary disease (a serious lung disease that can cause wheezing, difficulty breathing, and/or persistent coughing).
• If you have certain heart diseases (such as slow or irregular heartbeats), sinus bradycardia (heart rate less than 60 beats per minute), second- or third-degree atrioventricular block, manifest heart failure, or cardiogenic shock.
• If you have corneal dystrophy (degenerative alteration of the cornea).
• If you have severe allergic rhinitis and bronchial hyperreactivity.

Warnings and precautions

Consult your doctor before starting to use Timoftol.

Be especially careful with Timoftol.

Before using this medication, inform your doctor if you have or have had in the past:

• heart problems such as coronary disease (symptoms include chest pain or tightness, shortness of breath or choking), heart failure, or low blood pressure
• heart rhythm alterations (such as slow or irregular heartbeats)
• circulation problems (such as Raynaud's disease or Raynaud's syndrome)
• respiratory or lung problems (such as asthma or chronic obstructive pulmonary disease)
• diabetes or other blood sugar problems, as timolol may mask signs and symptoms of low blood sugar
• overactivity or thyroid disease, as timolol may mask its signs and symptoms

Inform your doctor before surgery that you are using Timoftol, as it may change the effects of some anesthetic medications.

Also inform your doctor about any allergies or medications.

Timolol may be absorbed through the eye and reach the bloodstream, producing the same adverse effects as oral beta-blocker medications.

-If you are taking oral beta-blockers or antidepressant monoamine oxidase inhibitors, inform your doctor, as they may increase the effects of Timoftol.

-Do not use two topical beta-blockers at the same time.

-If you have breast disease, Prinzmetal's angina, untreated phaeochromocytoma, metabolic acidosis, severe peripheral circulatory disorders (Raynaud's disease), or low blood pressure.

-If you wear contact lenses, do not use Timoftol, as it increases the risk of intolerance to them.

As with any glaucoma treatment, it is recommended that your doctor regularly monitor eye pressure and corneal status.

Use in athletes

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

Children

As a general rule, timolol-containing eye drops should be used with caution in young patients. In the case of newborns, infants, and young children, timolol should be used with extreme caution. Discontinue use immediately if you experience coughing, wheezing, abnormal breathing, or abnormal pauses in breathing (apnea). Inform your doctor immediately. A portable apnea monitor may be useful.

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

Use of TIMOFTOL with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication, including those purchased without a prescription.

Certain medications may interact with Timoftol, including other glaucoma treatments, and in these cases, the dose may need to be changed or the treatment interrupted. It is essential to inform your doctor if you take any of the following medications:

-Beta-blockers by mouth or medications that lower blood pressure, as they may increase the effects of timolol on intraocular pressure.

-Clonidine, as rebound hypertension may occur when clonidine treatment is discontinued.

-Heart rhythm medications, such as disopyramide, quinidine (also used to treat certain types of malaria), and amiodarone, as timolol may increase their effects.

-Diabetes medications (insulin and oral antidiabetics), as timolol may mask certain signs of hypoglycemia (low blood sugar) such as tachycardia (rapid heart rate).

-Anesthetics.

-Medications for stomach ulcers, such as cimetidine.

-Alcohol.

-Epinephrine, as it may cause pupil dilation (mydriasis) when combined with timolol.

-Depression medications, such as fluoxetine or paroxetine.

Pregnancy and lactation

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

Do not use Timoftol if you are pregnant, unless your doctor considers it necessary. Your doctor will assess the benefit/risk of administering Timoftol due to the possible appearance of adverse effects in the fetus.

Do not use Timoftol if you are breastfeeding. Timolol may pass into breast milk. Due to the possible appearance of adverse effects, your doctor will decide whether to suspend the treatment with Timoftol or suspend breastfeeding.

Driving and operating machinery

Timoftol may cause dizziness, fatigue, or blurred vision, which may affect your ability to drive and operate machinery.

TIMOFTOL contains benzalkonium chloride and phosphates

This medication contains 0.11 mg of benzalkonium chloride in each ml.

Benzalkonium chloride may be absorbed by soft contact lenses and alter 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 part of the eye). Consult your doctor if you experience a strange sensation, stinging, or pain in the eye after using this medication.

This medication contains 30.42 mg of disodium dodecahydrate hydrogen phosphate and 6.10 mg of dihydrogen sodium phosphate dihydrate in each ml. If you have severe damage to the transparent layer of the front part of the eye (cornea), treatment with phosphates, in rare cases, may cause cloudy patches in the cornea due to calcium.

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

Remember to use the medication.

Your doctor will establish the dose and duration of treatment with Timoftol. Do not discontinue treatment prematurely, as it will cease to be effective.

Timoftol is an eye drop for topical ophthalmic administration.

The normal dose is one drop of Timoftol 2.5 mg/ml in the affected eye or eyes twice a day. If the response is not satisfactory, your doctor may increase the dose to one drop of Timoftol 5 mg/ml in the affected eye or eyes twice a day.

Your doctor will periodically evaluate the response to treatment with Timoftol and decide if it is necessary to complement it with other available medications to reduce intraocular pressure.

If you are using other eye drops at the same time, you should wait at least 10 minutes between applications to prevent the active principles from being eliminated from the eye.

In the case of this eye drop replacing another treatment for anterior glaucoma or being used with other medications, your doctor will indicate the schedule you should follow.

If you estimate that the action of Timoftol is too strong or too weak, inform your doctor or pharmacist.

Use in children and adolescents

Before using timolol, a complete medical examination should be performed. Your doctor will carefully evaluate the benefits against the risks before proposing a treatment with timolol. If the benefits are greater than the risks, it is recommended to use once a day the lowest available concentration of active substance.

If the pressure is not sufficiently controlled with this concentration, administration twice a day with a 12-hour interval between them may be necessary. Patients, especially newborns, should be closely monitored for one to two hours after the first administration, watching for the appearance of adverse effects until surgery is performed. In the case of its use in children, controlling the pressure inside the eye may be sufficient with a concentration of 1 mg/ml of active substance, if available.

Treatment duration

In the pediatric population, it will be prescribed as a temporary treatment.

Administration form

Only one drop of Timoftol should be instilled in each administration.

After instillation, keep the eyes closed for as long as possible (for example, 3 to 5 minutes) and press with a finger the angle of the eye closest to the nose to prevent the diffusion of the timolol drop into the body.

Usage instructions

Do not use the container if the plastic safety strip around the neck of the container is not or is broken. When opening the container for the first time, tear off the plastic safety strip.

[for different containers than OCUMETER PLUS:]

Each time you use Timoftol:

[only for OCUMETER PLUS containers:]

1. Before using the medication for the first time, make sure the Safety Strip on the front of the bottle is intact. When the bottle has not been opened yet, it is normal for there to be a space between the bottle and the cap.

Opening Arrows?

Safety Strip?

1. Wash your hands. When opening the bottle for the first time, tear off the Safety Strip to break the seal.

Space?

Area to Press with your

Finger?

1. To open the bottle, unscrew the cap by turning it according to the arrows on the top of the cap. Do not pull the cap directly upwards. Pulling the cap upwards will prevent the dispenser from working correctly.

Area to Press with your

Finger?

1. Incline your head back and slightly lower your lower eyelid, forming a small separation between the eyelid and your eye.

1. Invert the bottle and gently press with your thumb or index finger on the “Area to Press with your Finger” (as shown in the following figure) until one drop is dispensed into your eye according to your doctor's instructions.

Area to Press

with your Finger

DO NOT TOUCH YOUR EYE OR EYELID WITH THE TIP OF THE DROPPER TIP.

1. After using Timoftol, press with your finger the corner of your eye next to your nose (as shown in the following figure) for 2 minutes. This helps keep Timoftol in your eye and prevents timolol from entering your body.

1. If after opening for the first time, dispensing the drop is difficult, replace the cap and tighten (DO NOT TIGHTEN TOO MUCH) and then remove the cap by turning it in the opposite direction, as indicated by the arrows on the top of the cap.

1. Repeat steps 4 and 5 in the other eye if your doctor has instructed you to do so.

1. Close the cap by turning it until it touches the edge of the bottle. For a proper closure, the arrow on the left side of the cap should be aligned with the arrow on the left side of the label on the bottle. Do not tighten it too much or it may damage the bottle and cap.

1. The tip of the dispenser is designed to provide a single drop; therefore, DO NOT enlarge the hole at the tip of the dispenser.

1. After you have used all the doses, there will be some Timoftol left in the bottle. Do not worry, as an extra amount of Timoftol has been added, and you will receive the total amount of Timoftol prescribed by your doctor. Do not attempt to extract the excess medication from the bottle.

Eye drops, if used improperly, can become contaminated with common bacteria known to cause eye infections. The use of contaminated eye drops can lead to serious eye disorders and subsequent vision loss. If you think your medication may be contaminated, or if you develop an eye infection, contact your doctor immediately about continued use of that bottle.

If you use more TIMOFTOL than you should

If you have used more Timoftol than you should, consult your doctor or pharmacist immediately.

The most common symptoms in case of overdosewith timolol are: dizziness, headache, shortness of breath, decreased heart rate, decreased blood pressure, heart failure, and/or cardiac arrest.

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 medication and the amount used.

If you forgot to use TIMOFTOL

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

Use Timoftol according to the schedule indicated by your doctor. If you forget a dose, administer it as soon as possible. However, if it is almost time for the next dose, ignore the missed dose and return to your regular administration schedule.

Like all medicines, Timoftol may cause side effects, although not everyone will experience them.

You can usually continue using the drops unless the side effects are severe. If you are concerned, consult your doctor or pharmacist. Do not stop using Timoftol without first discussing it with your doctor.

With the administration of timolol by ocular route, the following side effects have been observed:

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

• Headache
• Signs and symptoms of eye irritation (e.g., burning, stinging, itching, conjunctivitis, tearing, redness), eyelid inflammation, corneal inflammation, decreased corneal sensitivity, and dry eyes

Poorly frequent (may affect up to 1 in 100 patients):

• Depression
• Dizziness, fainting
• Visual disturbances such as refractive changes
• Slow heart rate (bradycardia)
• Difficulty breathing (dyspnea)
• Nausea, heavy digestion(dyspepsia)
• Fatigue/weakness

Rare (may affect up to 1 in 1,000 patients):

• Signs and symptoms of allergic reactions including angioedema (swelling under the skin in areas such as the face and limbs, and which may obstruct airways and cause difficulty swallowing or breathing), urticaria or hives with itching, localized and generalized rash, anaphylaxis (severe allergic reaction that may put life at risk)
• Insomnia (difficulty sleeping), nightmares, memory loss
• Feeling of tingling or pins and needles, increased signs and symptoms of myasthenia gravis (muscular disorder), decreased libido, stroke (ictus), cerebral ischemia (reduced blood supply to the brain)
• Upper eyelid drooping (leaving the eye half-closed), double vision (diplopia), corneal detachment (detachment of the vascular layer under the retina after surgery that may cause vision disturbances)
• Ear noises (tinnitus)
• Chest pain, palpitations, swelling, irregular heart rhythm, congestive heart failure (disease characterized by difficulty breathing and swelling of feet and legs due to fluid accumulation), cardiac block, cardiac arrest
• Low blood pressure, Raynaud's phenomenon (vascular disorder that affects the fingers and toes), pain or discomfort in a limb when starting to walk, cold hands and feet
• Difficulty breathing and constriction of airways (predominant in patients with pre-existing bronchospastic disease), cough
• Diarrhea, dry mouth
• Hair loss, psoriasiform skin rash or exacerbation of psoriasis
• Inflammatory disease with fever, weakness, joint pain, and skin lesions (systemic lupus erythematosus)
• Peyronie's disease (which may cause a marked curvature of the penis)

Frequency unknown (cannot be estimated from available data):

• Hallucinations

Like other eye medications, timolol passes into the bloodstream. This may cause side effects similar to those observed with oral or injectable beta-blockers. The appearance of side effects by topical ocular route is less frequent than with oral or injectable administration. The listed side effects include those observed in the class of beta-blockers used to treat eye diseases:

• Generalized allergic reactions including swelling under the skin in areas such as the face and limbs, and which may obstruct airways and cause difficulty swallowing or breathing, urticaria or hives with itching, localized and generalized rash, anaphylaxis (severe allergic reaction that may put life at risk)
• Low blood sugar.
• Difficulty sleeping (insomnia), depression, nightmares, memory loss.
• Fainting, stroke (ictus), reduced blood supply to the brain, worsening of signs and symptoms of myasthenia gravis (muscular disorder), dizziness, strange sensations such as tingling and headache.
• Signs and symptoms of eye irritation (e.g., burning, stinging, itching, conjunctivitis, tearing, redness), eyelid inflammation, corneal inflammation, blurred vision, and detachment of the vascular layer under the retina after surgery that may cause vision disturbances, decreased corneal sensitivity, dry eyes, corneal erosion (damage to the front layer of the eyeball), upper eyelid drooping (leaving the eye half-closed), double vision.
• Slow heart rate, palpitations, chest pain, edema (fluid accumulation), changes in heart rate or rhythm, congestive heart failure (disease characterized by difficulty breathing and swelling of feet and legs due to fluid accumulation), cardiac block, cardiac arrest
• Low blood pressure, Raynaud's phenomenon, cold hands and feet.
• Constriction of airways (predominant in patients with pre-existing disease), difficulty breathing, cough.
• Alteration of taste, nausea, indigestion, diarrhea, dry mouth, abdominal pain, vomiting.
• Hair loss, psoriasiform skin rash or exacerbation of psoriasis, skin rash.
• Muscle pain not caused by exercise.
• Sexual dysfunction, decreased libido.
• Muscle weakness/weakness.

Reporting of 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 the 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 medicine.

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

Do not store at a temperature above 25 °C.

Store in the original packaging to protect it from light.

Do not use this medication after the expiration date that appears on the packaging after the abbreviation CAD.

The expiration date is the last day of the month indicated.

Dispose of within four weeks after opening the packaging.

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 at the pharmacy. If in 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 TIMOFTOL

• The active principle is timolol. Each ml of Timoftol contains 6.8 mg of timolol maleate, equivalent to 5 mg of timolol
• The other components are sodium dihydrogen phosphate dihydrate, disodium dodecahydrate hydrogen phosphate, sodium hydroxide, benzalkonium chloride, and water for injection preparations.

Appearance of the product and contents of the packaging

Timoftol is presented in the form of a clear, colorless, or light yellow solution eye drop.

It is presented in two alternative packaging:

• Container with a dropper cap containing 5 ml of solution.
• Ocumeter Plus eye drop dispenser containing 3 ml of solution.

Only some sizes of packaging may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Santen OyOy

Niittyhaankatu20

33720Tampere

Finland

Responsible for manufacturing

Laboratoires Merck Sharp & Dohme

Chibret (“MIRABEL PLANT”)

Route de Marsat, RIOM

63963 Clermont – Ferrand, Cedex 9, France

Ó

Santen Oy

Kelloportinkatu 1

33100 Tampere

Finland

Local representative

Santen Pharmaceutical Spain S.L.

Acanto, 22, 7º

28045 – Madrid

Spain

Last review date of this leaflet: April 2020

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