Package Leaflet: Information for the User

Kivizidiale 40 micrograms/mL + 5 mg/mL eye drops solution

Travoprost/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 or pharmacist.

-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 Kivizidiale is and what it is used for

2.What you need to know before using Kivizidiale

3.How to use Kivizidiale

4.Possible side effects

5.Storage of Kivizidiale

6.Contents of the pack and additional information

Kivizidialeeye drop solution is a combination oftwo active principles (travoprost and timolol). Travoprost is a prostaglandin analogue that acts by increasing the outflow of aqueous fluid from the eye, thereby reducing eye pressure. Timolol is a beta-blocker that acts by reducing the formation of fluid inside the eye. The two substances act in conjunction to reduce eye pressure.

Kivizidiale eye drop solution is used for the treatment of elevated eye pressure in adults, including elderly patients. This elevated pressure may cause a disease called glaucoma.

Kivizidiale eye drop solution is a sterile solution that does not contain preservatives.

Do not use Kivizidiale eye drops in solution:

• If you are allergic to travoprost, prostaglandins, timolol, beta blockers, or any of the other components of this medication (listed in section 6).
• If you have or have had in the past respiratory problems such as asthma, severe chronic obstructive pulmonary disease (a serious lung disease that can cause wheezing, difficulty breathing, and/or persistent cough), or other types of respiratory problems.
• If you have severe allergic rhinitis.
• If you have a slow heart rate, heart failure, or a heart rhythm disorder (irregular heartbeat).
• If the surface of your eye is cloudy.

Consult your doctor if you are in any of these situations.

Warnings and precautions

Consult your doctor before starting to use Kivizidiale if you have or have had in the past:

• Coronary heart disease (symptoms may include chest pain or pressure, difficulty breathing, or a feeling of suffocation), heart failure, low blood pressure.
• Heart rhythm disorders, such as a slow heart rate.
• Respiratory problems, asthma, or chronic obstructive pulmonary disease.
• Circulatory disorders (such as Raynaud's disease or Raynaud's syndrome).
• Diabetes (since timolol can mask the signs and symptoms of low blood sugar).
• Hypothyroidism (since timolol can mask the signs and symptoms of thyroid disease).
• Myasthenia gravis (chronic muscle weakness).
• Cataract surgery.
• Ocular inflammation.

If you need to undergo any type of surgery, inform your doctor that you are using Kivizidiale, as timolol may modify the effects of some medications used during anesthesia.

If you experience any severe allergic reaction (skin rash, eye redness, and itching) while using Kivizidiale, regardless of the cause, adrenaline treatment may not be as effective. Therefore, it is essential to inform your doctor that you are using Kivizidiale when you receive any other treatment.

Kivizidiale may change the color of your iris (colored part of your eye). This change may be permanent.

Kivizidiale may increase the length, thickness, color, and/or number of your eyelashes and may cause unusual hair growth on your eyelids.

Travoprost may be absorbed through the skin and should not be used by pregnant women or those trying to become pregnant. If this medication comes into contact with your skin, wash it immediately.

Children

Kivizidiale should not be used in children and adolescents under 18 years of age.

Other medications and Kivizidiale

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

Kivizidiale may affect or be affected by other medications you are using, including other eye drops for glaucoma treatment. Inform your doctor if you are using or plan to use:

• blood pressure-lowering medications,
• heart medications, including quinidine (used to treat heart conditions and some types of malaria),
• diabetes medications or antidepressants known as fluoxetine and paroxetine.

Pregnancy, breastfeeding, and fertility

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

Do not use Kivizidiale if you are pregnant unless your doctor recommends it. If you can become pregnant, use an appropriate contraceptive method while using this medication.

Do not use Kivizidiale if you are breastfeeding. This medication may pass into breast milk.

Driving and operating machinery

Kivizidiale may cause blurred vision immediately after use. Do not drive or operate machinery until the symptoms have disappeared.

Kivizidiale contains hydroxyestearate of macrogolglycerol 40

This medication contains hydroxyestearate of macrogolglycerol 40, which may cause skin reactions.

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

The recommended dose is

One drop administered once a day, either in the morning or in the evening, in the affected eye or eyes. Use this medication every day at the same time.

Only use Kivizidiale in both eyes if your doctor has instructed you to do so.

Use Kivizidiale for as long as your doctor has told you to.

Kivizidiale should only be used as eye drops..

If you are using other eye drops in addition to Kivizidiale, wait at least 5 minutes between the application of Kivizidiale and the other drops.

If you use soft contact lenses, do not use the drops with the lenses in place. Wait 15 minutes after applying the drops before putting the contact lenses back in.

Instructions for use

If you use more Kivizidiale than you should

If you use more Kivizidiale than you should, rinse your eyes with warm water. Do not apply more drops until it is time for your regular 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 ingested.

If you forgot to use Kivizidiale

If you forgot to apply Kivizidiale, continue with the next dose as planned. Do not apply a double dose to compensate for the missed dose. The dose should not exceed 1 drop per day in the affected eye(s).

If you interrupt treatment with Kivizidiale

If you stop using Kivizidiale without consulting your doctor, the pressure in your eye will no longer be controlled, which could cause vision loss.

If you have any other questions 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.

Generally, unless the side effects are severe, you can continue using the eye drops. If you have any doubts, consult a doctor or pharmacist. Do not stop using Kivizidiale without consulting your doctor.

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

Eye effects

Redness of the eye.

Common side effects(may affect 1 in 10 people):

Eye effects

Conjunctival inflammation with surface damage, eye pain, blurred vision, abnormal vision, dry eye, eye itching, eye discomfort, signs and symptoms of ocular irritation (e.g., burning, stinging).

Rare side effects(may affect 1 in 100 people):

Eye effects

Conjunctival inflammation, eyelid inflammation, conjunctival edema, increased eyelash growth, iris inflammation, eye inflammation, light sensitivity, reduced vision, tired eyes, ocular allergy, swollen eyes, increased tear production, eyelid redness, eyelid color change, skin darkening (around the eye).

Other effects

Allergic reaction to the active substance, dizziness, headache, increased or decreased blood pressure, shortness of breath, excessive hair growth, posterior throat dripping, skin inflammation and itching, decreased heart rate.

Very rare side effects(may affect 1 in 1,000 people):

Eye effects

Corneal thinning, eyelid gland inflammation, eye blood vessel rupture, eyelid crusts, abnormal eyelash arrangement, abnormal eyelash growth.

Other effects

Nervousness, irregular heart rate, hair loss, voice changes, breathing difficulty, cough, throat irritation, urticaria, abnormal liver function test results, skin discoloration, thirst, fatigue, nasal discomfort, colored urine, hand and foot pain.

Unknown frequency (cannot be estimated from available data):

Eye effects

Lowered eyelid (causing the eye to be half-closed), sunken eyes (eyes appear deeper), iris color changes.

Other effects

Skin rash, heart failure, chest pain, heart attack, fainting, depression, hallucination, asthma, increased heart rate, numbness or tingling, palpitations, leg swelling, bad taste in the mouth.

Furthermore:

Kivizidiale is a combination of 2 active substances, travoprost and timolol. Like other eye medications, travoprost and timolol (a beta-blocker) are absorbed and pass into the bloodstream. This can cause side effects similar to those observed with beta-blockers taken by mouth or injection. The incidence of side effects after eye administration is lower than when the medications are taken by mouth or injected.

The side effects listed below include reactions observed with the class of beta-blockers used to treat eye conditions, or reactions observed with travoprost alone:

Eye effects

Eye inflammation, corneal inflammation, retinal detachment after surgery, decreased corneal sensitivity, corneal erosion (damage to the front surface of the eye), double vision, eye discharge, eyelid swelling, abnormal eyelid turning outward with redness, irritation, and increased tear production, blurred vision (sign of opacity of the lens), uveal edema, eyelid eczema, halos around lights, decreased eye sensitivity, pigmentation within the eye, dilated pupils, eyelash color change, eyelash texture change, abnormal visual field.

Other effects

• Ear and labyrinth disorders: dizziness with vertigo sensation, ringing in the ears.

• Cardiac and circulatory disorders: slow heart rate, palpitations, edema (fluid accumulation), changes in heart rhythm or rate, congestive heart failure (heart disease with difficulty breathing and swelling of the feet and legs due to fluid accumulation), a type of heart rhythm disorder, heart attack, decreased blood pressure, Raynaud's phenomenon, cold hands and feet, reduced cerebral blood flow.

• Respiratory disorders: bronchospasm (constriction of the airways in the lungs, primarily in patients with pre-existing disease), runny or blocked nose, sneezing (due to allergy), difficulty breathing, nosebleeds, dry nose.

• General and nervous system disorders: insomnia (difficulty sleeping), nightmares, memory loss, loss of strength and energy, anxiety (excessive emotional distress).

• Gastrointestinal disorders: altered taste, nausea, indigestion, diarrhea, dry mouth, abdominal pain, vomiting, constipation.

• Allergic reactions: increased allergic symptoms, generalized allergic reactions including skin swelling that can occur in areas such as the face and extremities, and may obstruct the airways and cause difficulty swallowing or breathing, localized and generalized rash, itching, sudden severe allergic reaction that can be life-threatening.

• Skin disorders: skin rash with a silver-white appearance (psoriasiform rash) or worsening of psoriasis, skin peeling, abnormal hair texture, skin inflammation with hives and redness, hair color change, eyelash loss, itching, abnormal hair growth, skin redness.

• Musculoskeletal disorders: increased signs and symptoms of myasthenia gravis (muscular disorder), unusual sensation like needles or pinpricks, muscle weakness/fatigue, non-exercise-related muscle pain, joint pain.

• Renal and urinary disorders: difficulty and pain urinating, involuntary urination.

• Reproductive disorders: sexual dysfunction, decreased libido.

• Metabolic disorders: low blood sugar, elevated prostate cancer marker.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Medicines Vigilance System 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 use this medication after the expiration date that appears on the label of the bottle and on the box after "CAD". The expiration date is the last day of the month indicated.

Do not use this medication if you observe that the safety seal of the bottle is broken before using it for the first time.

Do not store at a temperature above 25°C.

To prevent infections,you must discard the medication bottle 28 days after opening it for the first timeand use a new bottle. Write the opening date of the bottle on the label of the bottle and on the box in the designated space.

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

Composition of Kivizidiale

• The active principles are travoprost and timolol. Each ml of solution contains 40 micrograms of travoprost and 5 mg of timolol (as timolol).
• The other components are mannitol (E421), boric acid, sodium hydroxide (for pH adjustment), macrogolglycerol hydroxystearate (nominal value: 40), propylene glycol (E1520), sodium chloride, and purified water.

Appearance of the product Kivizidiale and contents of the package

Kivizidiale eye drops in solution are presented as a transparent, colorless, and practically particle-free aqueous solution of 2.5 ml, in a white multidose container (PP) of 5 ml with a pumping system (PP, HDPE, LDPE) and a pressure cylinder and cap (HDPE) contained in a cardboard box.

The product is available in the following package sizes:

Boxes containing 1 or 3 bottles.

Not all package sizes may be marketed.

Holder of the marketing authorization and responsible manufacturer

Holder of the Marketing Authorization:

BAUSCH + LOMB IRELAND LIMITED

3013 Lake Drive

Citywest Business Campus

Dublin 24, D24PPT3

Ireland

Responsible Manufacturer:

Pharmathen SA,

6 Dervenakion Str,

153 51 Pallini

Greece

O

JADRAN - GALENSKI LABORATORIJ d.d.

Svilno 20,

51000 Rijeka

Croatia

You can request more information about this medication by contacting the local representative of the Holder of the Marketing Authorization.

Local Representative in Spain

Bausch & Lomb S.A.

Avda. Valdelaparra, 4

28108 – Alcobendas, Madrid

Tel: 91 – 657 63 00

This medication is authorized in the member states of the European Economic Area with the following names:

ATKivizidiale 40 Mikrogramm/ml + 5 mg/ml Augentropfen Lösung

BE Kivizidiale40 microgram/ml + 5 mg/ml oogdruppels, oplossing

BG ??????????40 ??????????/ml + 5 mg/ml ????? ?? ???, ???????

CYKivizidiale

DE Kivizidiale40 Mikrogramm/ml + 5 mg/ml Augentropfen, Lösung

DKKivizidiale

EE Kivizidiale

ES Kivizidiale40μg/ml + 5 mg/ml colirioen solución

FR Kivizidiale40 microgrammes/mL + 5 mg/mL,collyre en solution

EL Kivizidiale

HRKivizidiale 40 mikrograma/ml + 5 mg/ml, kapi za oko, otopina

HU Kivizidiale40 mikrogramm/ml + 5 mg/ml oldatos szemcsepp

NL Kivizidiale40 microgram/ml + 5 mg/ml oogdruppels, oplossing

LT Kivizidiale40 mikrogramu/ 5 mg/ ml akiu lašai (tirpalas)

LU Kivizidiale40 microgrammes/ml + 5 mg/ml collyre en solution

PL Kivizidiale

PT Kivizidiale40μg/ml + 5 mg/ml colírio, solução

RO Kivizidiale40 micrograme/mL + 5 mg/mL picaturi oftalmice, solu?ie

SK Kivizidiale40 mikrogramov/ml + 5 mg/ml

Last review date of this leaflet: March 2022.

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