TIMABAK 2.5 mg/ml EYE DROPS SOLUTION

Introduction

Package Leaflet: Information for the User

TIMABAK 2.5 mg/ml eye drops, solution

Timolol

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

• Keep this package 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 experience any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the package leaflet

1. What is TIMABAK 2.5 mg/ml and what is it used for
2. What you need to know before you start using TIMABAK 2.5 mg/ml
3. How to use TIMABAK 2.5 mg/ml
4. Possible side effects
5. Storage of TIMABAK 2.5 mg/ml
6. Contents of the pack and further information

1. What is TIMABAK 2.5 mg/ml and what is it used for

Timabak is an eye drop solution for ocular administration.

The active substance, timolol, is a beta-blocker that belongs to the group of medicines called topical anti-glaucoma agents.

This medicine is indicated for the reduction of elevated intraocular pressure in:

• ocular hypertension
• chronic open-angle glaucoma (including aphakic patients).

2. What you need to know before using TIMABAK 2.5 mg/ml

Do not use Timabak:

• If you are allergic to timolol, other beta-blockers, or any of the other components of this medicine (listed in section 6).
• If you have or have had respiratory problems such as asthma or severe chronic obstructive bronchitis (severe lung disease that can cause wheezing, difficulty breathing, and/or persistent cough).

Warnings and precautions

Consult your doctor or pharmacist before starting to use Timabak. Before using this medicine, inform your doctor if you have or have had:

• coronary heart disease (symptoms include chest pain or tightness, shortness of breath or choking), heart failure, hypotension (low blood pressure)
• heart rhythm disorders such as bradycardia (slow pulse)
• respiratory problems, asthma, or chronic obstructive pulmonary disease
• peripheral arterial disease such as Raynaud's disease or Raynaud's syndrome (disorders of blood circulation)
• diabetes, as timolol may mask the signs and symptoms of low blood sugar
• overactive thyroid gland, as timolol may mask its signs and symptoms
• untreated pheochromocytoma (production of a hormone that causes severe low blood pressure)

Before undergoing surgical anesthesia, inform your doctor that you are using Timabak, as timolol may change the effects of the medicines used during anesthesia.

If you use contact lenses, it is not recommended to use Timabak, as it increases the risk of intolerance to them.

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. The use of this medicine should be stopped immediately if coughing, wheezing, abnormal breathing, or abnormal breathing pauses (apnea) occur. Inform your doctor immediately. A portable apnea monitor may be useful.

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

Using Timabak with other medicines

Timabak may affect or be affected by other medicines you are taking, including other eye drops for the treatment of glaucoma.

Tell your doctor if you are using or plan to use medicines to lower blood pressure, heart medicines, or medicines to treat diabetes.

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

Tell your doctor if you are taking quinidine (used to treat heart problems and some types of malaria) or antidepressant medicines such as fluoxetine or paroxetine.

Pregnancy and breastfeeding

Pregnancy

Do not use Timabak if you are pregnant, unless your doctor considers it necessary.

Breastfeeding

Do not use Timabak if you are breastfeeding. Timolol maleate may pass into breast milk.

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.

Driving and using machines

Timabak may cause dizziness, fatigue, or blurred vision, which may affect your ability to drive and use machines.

Timabak contains phosphates

This medicine contains 0.407 mg of phosphates per drop, which is equivalent to 12.7 mg/ml.

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

Athletes

Athletes are informed that Timabak contains a component that may result in a positive analytical result in doping tests.

3. How to use TIMABAK 2.5 mg/ml

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

Remember to use your medication.

The recommended dose is to start treatment with one drop of Timabak 2.5 mg/ml twice a dayin the affected eye(s). If the response is not satisfactory, the dose will be changed to one drop of Timabak 5 mg/ml twice a dayin the affected eye(s). Your doctor will periodically evaluate the response to treatment with Timabak and decide if it is necessary to complement it with other available medicines to reduce intraocular pressure.

If you are using other eye drops at the same time, you should wait at least five minutes between applications to allow the active substances to be eliminated from the eye.

In the case of this eye drop replacing a previous treatment for glaucoma or being used in conjunction with other medicines, your doctor will indicate the process to follow.

Use in children

Dosage:

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

In the case of "use in children", to control the pressure inside the eye, a concentration of 0.1% active substance may be sufficient. 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 during the first one to two hours after the first administration, carefully observing the appearance of side effects until surgery is performed.

Method of administration:

Only one drop of timolol should be instilled at each administration.

After instillation, keep your eyes closed for as long as possible (e.g., 3 to 5 minutes) and press the corner of your eye near your nose with your finger to prevent the timolol drop from spreading to the rest of your body.

Duration of treatment:

In children, it will be prescribed as temporary treatment.

Instructions for use

To ensure proper functioning of the system, follow these operations before proceeding to the first instillation:

• Wash your hands carefully before applying and avoid any contact between the dropper and your fingers, the surface of your eye, or any other surface.
• Check that the packaging seal is intact.
• Open the packaging by unscrewing the cap.
• Instill one drop into the eye, looking up and pulling the lower eyelid down.
• The time it takes for the drop to appear is longer than with a classic eye drop packaging.
• After applying Timabak, press the corner of your eye near your nose with your finger for 2 minutes. This will help prevent timolol from spreading to the rest of your body.
• Close the bottle after each use.

If you use more Timabak than you should:

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

The most common symptoms in case of overdose with beta-blockers are dizziness, headache, shortness of breath, decreased heart rate, low blood pressure, heart failure, and/or cardiac arrest.

In case of overdose or accidental ingestion, go immediately to a medical center or call the Toxicology Information Service, phone 91.562.04.20, indicating the medicine and the amount used.

If you forget to use Timabak

Do not use a double dose to make up for forgotten doses.

If you stop using Timabak

Your doctor will indicate the duration of your treatment with Timabak. Do not stop treatment before this, as it would stop its beneficial effect.

If you have any other questions about 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.

If you experience side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this package leaflet.

Normally, you will be able to continue using the drops, unless the effects are severe. If you are concerned, talk to your doctor or pharmacist. Do not stop using Timabak without discussing it with your doctor first.

As with other eye medicines, timolol passes into the bloodstream. This may cause side effects similar to those observed with beta-blockers administered orally or by injection. The occurrence of side effects via topical ocular administration is less frequent than with oral or injectable administration. The list of side effects includes those that have been observed in the class of beta-blockers used to treat eye diseases:

• generalized allergic reactions including angioedema, urticaria, local or generalized eruptions, pruritus, anaphylactic reaction (sudden and severe allergic reaction that can be life-threatening).
• hypoglycemia (low blood sugar).
• insomnia, depression, nightmares, memory loss, hallucinations (frequency not known).
• syncope (loss of consciousness), stroke, cerebral ischemia (decreased blood flow to the brain), worsening of myasthenia gravis (muscle disorder), dizziness, numbness of the limbs, and headache,
• signs and symptoms of ocular irritation (e.g., burning sensation, stinging, itching, conjunctivitis, tearing, redness), blepharitis, keratitis, blurred vision, and choroidal detachment after filtration surgery, decreased corneal sensitivity, dry eyes, corneal erosion (lesions on the outer layer of the eyeball), drooping of the upper eyelid, double vision,

slow heart rate, chest pain, palpitations, edema (fluid accumulation), irregular heartbeat, congestive heart failure (disease characterized by difficulty breathing and swelling of feet and legs due to fluid accumulation), atrioventricular block, cardiac arrest, heart failure,

• hypotension, Raynaud's phenomenon, cooling of hands and feet,
• bronchospasm (preferably in patients with pre-existing bronchospastic disease), difficulty breathing, cough,
• taste disorders, nausea, indigestion, diarrhea, dry mouth, abdominal pain, vomiting,
• hair loss, psoriasiform eruptions or worsening of psoriasis, skin eruptions,
• muscle pain,
• sexual disorders, decreased libido, impotence,
• muscle weakness/fatigue.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of TIMABAK 2.5 mg/ml

Keep this medicine out of the sight and reach of children. Do not store above 25°C.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated. Do not use the packaging after 8 weeks of first opening.

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

6. Contents of the pack and further information

Composition of Timabak

• The active substance is timolol (as maleate). Each milliliter of solution contains 2.5 mg of timolol.

• The other components are sodium hydrogen phosphate dodecahydrate, sodium dihydrogen phosphate dihydrate, and Water for injections.

Appearance of the product and packaging contents

The product is a colorless, transparent, and preservative-free solution.

It is presented in a 5 ml multidose packaging.

The Timabak eye drop packaging incorporates a new technology for the sterile supply of the product, called the ABAK system.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorios Thea S.A.,

C/ Enric Granados, nº 86-88, 2ª planta,

08008 - Barcelona

Manufacturer

Excelvision

07100 Annonay (France)

FARMILA - THEA FARMACEUTICI, S.P.A.

Via Enrico Fermi, 50- Settimo Milanese (Milan) Italy

Date of last revision of this package leaflet:December 2019

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