Package Leaflet: Information for the User

TIMABAK 2.5 mg/ml eye drops solution

Timolol

Read 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, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor, pharmacist, or nurse. See section 4.

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

2. What you need to know before 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 additional information

Timabak is an eye drop solution for ocular administration.

The active ingredient, timolol, is a beta-blocker drug that belongs to the group of medications called topical antiglaucomatous agents.

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

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

Do not use Timabak:

• 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 or severe chronic obstructive pulmonary disease (a serious lung disease that can cause wheezing, difficulty breathing, and/or persistent coughing).

Warnings and precautions

Consult your doctor or pharmacist before starting to use Timabak. Before using this medication, 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, or low blood pressure.
• Cardiac rhythm disorders such as bradycardia (slow pulse).
• Respiratory problems, asthma, or chronic obstructive pulmonary disease.
• Peripheral artery disease such as Raynaud's disease or Raynaud's syndrome (circulatory disorders).
• Diabetes, as timolol may mask the signs and symptoms of low blood sugar.
• Hyperthyroidism, as timolol may mask its signs and symptoms.
• Untreated phaeochromocytoma (production of a hormone that causes severe low blood pressure).

Inform your doctor before undergoing surgical anesthesia, as timolol may change the effects of the medications used during anesthesia.

If you wear contact lenses, do not use Timabak, as it may increase the risk of intolerance to them.

Children

Timabak 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 symptoms such as coughing, wheezing, abnormal breathing, or abnormal pauses in breathing (apnea) appear. 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 intraocular pressure or diagnosed glaucoma. For more information, consult your doctor.

Use of Timabak with other medications

Timabak may affect or be affected by other medications you are taking, including other glaucoma treatments.

Inform your doctor if you are using or plan to use medications to lower blood pressure, heart medications, or diabetes medications.

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

Inform your doctor if you are taking quinidine (used to treat heart problems and some types of malaria) or antidepressants 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, breastfeeding, or think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machinery

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

Timabak contains phosphates

This medication contains 0.407 mg of phosphates in each drop, equivalent to 12.7 mg/ml.

If you have severe corneal damage, treatment with phosphates, in rare cases, may cause blurred vision due to calcium accumulation.

Athletes

Timabak contains a component that may cause a positive analytical result in doping control tests.

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

Remember to use your medication.

The recommended dose is to start treatment withone drop of Timabak 2.5 mg/ml twice a dayin the affected eye(s). In the case of unsatisfactory response, it will be changed toone drop of Timabak 5 mg/ml twice a dayin the affected eye(s). Your doctor will periodically evaluate the response to Timabak treatment 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 five minutes between applications for the active principles to be eliminated from the eye.

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

Use in children

Dosage:

Before using timolol, a complete medical examination must be performed. Your doctor will carefully evaluate the benefits versus the risks before planning 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.

In the case of “use in children”, to control the pressure inside the eye, it may be sufficient to use the 0.1% concentration of active substance. If the pressure is not sufficiently controlled with this concentration, it may be necessary to administer twice a day with 12 hours of interval between them. 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.

Administration form:

With each administration, only one drop of timolol should be instilled.

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 spread of timolol to the body.

Treatment duration:

In children, it will be prescribed as a temporary treatment.

Usage instructions

To ensure proper functioning, follow the operations below before proceeding to the first instillation:

• Wash your hands carefully before proceeding with the application and avoid any contact of the dropper with your fingers and the surface of the eye or any other.
• Verify that the seal on the container is intact.
• Open the container by unscrewing the cap.
• Instill one drop in the eye looking up and pulling the eyelid down.
• The time of appearance of the drop is superior to that of a classic eye drop container.
• After applying Timabak, press with a finger the end of the eye next to the nose for 2 minutes. This will help prevent timolol from spreading to the rest of the body.
• Close the container again 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 Toxicological Information Service, phone 91.562.04.20, indicating the medication and the amount used.

If you forgot to use Timabak

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

If you interrupt the treatment with Timabak

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

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

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

If you experience side effects, consult your doctor or pharmacist, even if they are side effects that do not appear in this leaflet.

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

Like other medicines applied to the eyes, timolol passes into the blood. This can cause side effects similar to those observed with oral or injectable beta-blockers. The appearance of side effects from topical ocular administration is less frequent than with oral or injectable administration. The list of side effects are 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 rashes, pruritus, anaphylactic reaction (a sudden and severe allergic reaction that can be life-threatening).
• Hypoglycemia (decreased blood sugar).
• Insomnia, depression, nocturnal nightmares, memory loss, hallucinations (unknown frequency).
• Syncope (loss of consciousness), stroke, cerebral ischemia (decreased cerebral blood flow), increased signs and symptoms of myasthenia gravis (muscular disorder), vertigo, numbness of the extremities, and headache,
• Signs and symptoms of ocular irritation (e.g., burning sensation, stinging, itching, conjunctivitis, lacrimation, redness), blepharitis, keratitis, blurred vision, and corneal detachment after surgery, decreased corneal sensitivity, dry eyes, corneal erosion (lesions on the upper layer of the eyeball), upper eyelid drooping, double vision,

Corneal detachment after surgery, decreased corneal sensitivity, dry eyes, corneal erosion (lesions on the upper layer of the eyeball), upper eyelid drooping, double vision,

Double vision,

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

Heart failure,

• Hypotension, Raynaud's phenomenon, cold hands and feet,
• Bronchospasm (preferably in patients with pre-existing bronchospastic disease), respiratory difficulty, cough,
• Disturbances of taste, nausea, indigestion, diarrhea, dry mouth, abdominal pain, vomiting,
• Hair loss, psoriasis-like 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 type of side effect, consult your doctor, pharmacist, or nurse, 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 of Pharmacovigilance of Medicines for Human Use: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.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated. Do not use the packaging after 8 weeks of the first opening.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and themedications that you do not need at the SIGREcollection point of the pharmacy. If in doubt, ask yourpharmacist how to dispose of the packaging and the medications that you do not need.This will help protect the environment.

Composition of Timabak

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

• The other components are sodium dodecahydrogenephosphate, dihydrogen sodium phosphate, andWater for injection preparations.

Appearance of the product and contents of the packaging

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

It is presented in a multidose container of 5 ml.

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

Holder of the marketing authorization and responsible for manufacturing

Holderof the marketing authorization

Thea Laboratories S.A.,

Enric Granados Street, nº 86-88, 2nd floor,

08008 - Barcelona

Responsible for manufacturing

Excelvision

07100 Annonay (France)

FARMILA - THEA FARMACEUTICI, S.P.A.

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

Last review date of this prospectus:December 2019

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.es/