KIVIZIDIALE 40 micrograms/ml + 5 mg/ml EYE DROPS SOLUTION

2. What you need to know before you use Kivizidiale

Do not use Kivizidiale eye drops, solution:

• If you are allergic to travoprost, prostaglandins, timolol, beta-blockers or any of the other ingredients of this medicine (listed in section 6).
• If you have or have had respiratory problems such as asthma, severe chronic obstructive pulmonary disease (severe 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.

Talk to your doctor if you are in any of these situations.

Warnings and precautions

Talk to your doctor before you start using Kivizidiale if you have or have had:

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

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

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

Kivizidiale may change the color of your iris (the 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 therefore should not be used in pregnant or breastfeeding women. If this medicine comes into contact with the skin, it should be washed off immediately.

Children

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

Other medicines and Kivizidiale

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines, including medicines obtained without a prescription.

Kivizidiale may affect or be affected by other medicines you are using, 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, including quinidine (used to treat heart conditions and some types of malaria),
• medicines for the treatment of diabetes or antidepressants known as fluoxetine and paroxetine.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine.

Do not use Kivizidiale if you are pregnant unless your doctor recommends it. If you can become pregnant, you should use an effective method of birth control while using this medicine.

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

Driving and using machines

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

Kivizidiale contains macrogolglycerol hydroxystearate 40

This medicine contains macrogolglycerol hydroxystearate 40, which may cause skin reactions.

3. How to use Kivizidiale

Follow exactly the instructions of administration of this medicine 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(s). Use this medicine every day at the same time.

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

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

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 wear soft contact lenses, do not use the drops with the lenses in place. Wait 15 minutes after applying the drops before putting your 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 next dose.

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 medicine and the amount ingested.

If you forget to use Kivizidiale

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

If you stop using Kivizidiale

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

If you have any further questions on 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.

In general, unless the effects are severe, you can continue using the eye drops. If you are unsure, talk to your doctor or pharmacist. Do not stop using Kivizidiale without talking to 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 up to 1 in 10 people):

Eye effects

Inflammation of the eye surface with damage to the surface, eye pain, blurred vision, abnormal vision, dry eye, itching in the eye, eye discomfort, signs and symptoms of eye irritation (e.g. burning, stinging).

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

Eye effects

Inflammation of the eye surface, inflammation of the eyelid, swelling of the conjunctiva, increased growth of eyelashes, inflammation of the iris, inflammation of the eye, sensitivity to light, reduced vision, tired eyes, eye allergy, swollen eyes, increased tear production, redness of the eyelid, change in eyelid color, darkening of the skin (around the eye).

Other effects

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

Rare side effects(may affect up to 1 in 1,000 people):

Eye effects

Thinning of the eye surface, inflammation of the eyelid glands, rupture of blood vessels in the eye, crusts on the eyelids, abnormal positioning of the eyelashes, abnormal growth of eyelashes.

Other effects

Nervousness, irregular heart rate, hair loss, voice changes, difficulty breathing, cough, throat irritation, hives, abnormal liver blood test values, skin discoloration, thirst, fatigue, discomfort inside the nose, colored urine, pain in hands and feet.

Frequency not known (cannot be estimated from the available data):

Eye effects

Drooping eyelid (causing the eye to be half-closed), sunken eyes (the eyes appear more deep-set), changes in iris color (the colored part of the eye).

Other effects

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

Also:

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

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

Eye effects

Inflammation of the eyelid, inflammation of the cornea, detachment of the layer under the retina that contains blood vessels which can cause vision changes after filtration surgery, decreased corneal sensitivity, corneal erosion (damage to the front of the eyeball), double vision, eye discharge, swelling around the eye, itching of the eyelid, abnormal turning out of the eyelid with redness, irritation and increased tear production, blurred vision (sign of cataract), swelling of a part of the eye (uvea), eczema of the eyelids, seeing halos, decreased sensitivity in the eye, pigmentation inside the eye, dilated pupils, change in eyelash color, change in eyelash texture.

Other effects

• Ear and labyrinth disorders: dizziness with a feeling of vertigo, ringing in the ears.

• Heart and circulation: slow heart rate, palpitations, edema (fluid accumulation), changes in heart rate or rhythm, 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 blood flow to the brain.

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

• General and nervous system disorders: difficulty sleeping (insomnia), 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 swelling under the skin that can occur in areas such as the face and limbs, and can obstruct the airways and cause difficulty swallowing or breathing, localized and generalized rash, itching, severe allergic reaction that can be life-threatening.

• Skin: skin rash with a white, scaly appearance (psoriasiform rash) or worsening of psoriasis, skin peeling, abnormal hair texture, skin inflammation with rash and redness, change in hair color, loss of eyelashes, itching, abnormal hair growth, redness of the skin.

• Muscle: increased signs and symptoms of myasthenia gravis (muscle disorder), unusual sensation like pins and needles, muscle weakness/fatigue, muscle pain not caused by exercise, joint pain.

• Kidney and urinary disorders: difficulty and pain when urinating, involuntary loss of urine.

• Reproduction: sexual dysfunction, decreased libido.

• Metabolism: low blood sugar levels, increased prostate cancer marker.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Kivizidiale

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

Do not use this medicine after the expiry date which is stated on the label and carton after 'EXP'. The expiry date is the last day of the month stated.

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

Do not store above 25°C.

To avoid infections, you must discard the medicine bottle 28 days after first openingand use a new bottle. Write the date of opening on the label and on the carton in the space provided.

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

6. Package Contents and Additional Information

Composition of Kivizidiale

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

Appearance of Kivizidiale and Package Contents

Kivizidiale eye drops in solution are presented as a 2.5 ml aqueous solution, transparent, colorless, and practically particle-free, in a 5 ml multidose container (PP) 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.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

BAUSCH + LOMB IRELAND LIMITED

3013 Lake Drive

Citywest Business Campus

Dublin 24, D24PPT3

Ireland

Manufacturer:

Pharmathen SA,

6 Dervenakion Str,

153 51 Pallini

Greece

Or

JADRAN - GALENSKI LABORATORIJ d.d.

Svilno 20,

51000 Rijeka

Croatia

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

Local Representative in Spain

Bausch & Lomb S.A.

Avda. Valdelaparra, 4

28108 – Alcobendas, Madrid

Tel: 91 – 657 63 00

This medicine is authorized in the Member States of the European Economic Area under the following names:

AT Kivizidiale 40 Mikrogramm/ml + 5 mg/ml Augentropfen Lösung

BE Kivizidiale 40 microgram/ml + 5 mg/ml oogdruppels, oplossing

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

CY Kivizidiale

DE Kivizidiale 40 Mikrogramm/ml + 5 mg/ml Augentropfen, Lösung

DK Kivizidiale

EE Kivizidiale

ES Kivizidiale 40 μg/ml + 5 mg/ml colirio en solución

FR Kivizidiale 40 microgrammes/mL + 5 mg/mL, collyre en solution

EL Kivizidiale

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

HU Kivizidiale 40 mikrogramm/ml + 5 mg/ml oldatos szemcsepp

NL Kivizidiale 40 microgram/ml + 5 mg/ml oogdruppels, oplossing

LT Kivizidiale 40 mikrogramu/ 5 mg/ ml akiu lašai (tirpalas)

LU Kivizidiale 40 microgrammes/ml + 5 mg/ml collyre en solution

PL Kivizidiale

PT Kivizidiale 40 μg/ml + 5 mg/ml colírio, solução

RO Kivizidiale 40 micrograme/mL + 5 mg/mL picaturi oftalmice, solu?ie

SK Kivizidiale 40 mikrogramov/ml + 5 mg/ml

Date of the last revision of this leaflet: March 2022.

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