Kivizidiale 40 micrograms/ml + 5 mg/ml eye drops solution
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Kivizidiale 40 micrograms/ml + 5 mg/ml ophthalmic solution
Travoprost/timolol
Read all of this leaflet carefully before you start using this medicine, because it contains important information for you.
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Keep this leaflet, as you may need to read it again.
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If you have any questions, ask your doctor or pharmacist.
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This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if these are effects not listed in this leaflet. See section 4.
Contents of the leaflet:
- What Kivizidiale is and what it is used for
- What you need to know before using Kivizidiale
- How to use Kivizidiale
- Possible side effects
- How to store Kivizidiale
- Contents of the pack and other information
1. What Kivizidiale is and what it is used for
Kivizidiale eye drops solution is a combination of two active substances (travoprost and timolol). Travoprost is a prostaglandin analogue that works by increasing the outflow of aqueous fluid from the eye, thereby reducing intraocular pressure. Timolol is a beta-blocker that works by reducing the production of fluid within the eye. Together, these two substances act in combination to lower the pressure inside the eye.
Kivizidiale eye drops solution is used to treat elevated intraocular pressure in adults, including elderly patients. This increased pressure can lead to a condition known as glaucoma.
Kivizidiale eye drops solution is a sterile solution that does not contain preservatives.
2. What you need to know before using 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 currently have or have previously had respiratory problems such as asthma, severe chronic obstructive bronchitis (a serious lung disease that may cause wheezing, difficulty breathing, and/or persistent cough), or other types of breathing disorders.
- 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
Talk to your doctor before starting to use Kivizidiale if you have or have previously had:
- Coronary heart disease (symptoms may include chest pain or tightness, difficulty breathing, or a feeling of suffocation), heart failure, or low blood pressure.
- Heart rate disturbances, such as a 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).
- Overactive thyroid gland (since timolol may mask 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 alter the effects of certain medications used during anesthesia.
If you experience any severe allergic reaction (skin rash, eye redness and itching) while using Kivizidiale, regardless of the cause, treatment with adrenaline may be less effective. Therefore, it is important to inform your doctor that you are using Kivizidiale when receiving any other treatment.
Kivizidiale may change the color of the iris (the colored part of the 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 women or women trying to become pregnant. If this medicine comes into contact with the skin, wash it off immediately.
Children
Kivizidiale must not be used in children and adolescents under 18 years of age.
Other medicines and Kivizidiale
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including medicines obtained without a prescription.
Kivizidiale may interact with or be affected by other medicines you are using, including other eye drops for glaucoma treatment. Inform your doctor if you are using or planning to use:
- Medicines to lower blood pressure,
- Medicines for heart conditions, including quinidine (used to treat heart conditions and some types of malaria),
- Medicines for diabetes or antidepressants known as fluoxetine and paroxetine.
Pregnancy, breast-feeding, and fertility
If you are pregnant or breast-feeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine.
Do not use Kivizidiale if you are pregnant unless your doctor specifically recommends it. If you could become pregnant, you should use an appropriate method of contraception while using this medicine.
Do not use Kivizidiale if you are breast-feeding. This medicine may pass into breast milk.
Driving and using machines
Kivizidiale may cause blurred vision shortly after use. Do not drive or operate machinery until these symptoms have resolved.
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 given by your doctor for administering this medicine. If in doubt, consult your doctor or pharmacist again.
Recommended dose
One drop administered once a day, either in the morning or in the evening, in the affected eye or eyes. Use this medicine every day at the same time.
Use Kivizidiale in both eyes only if your doctor has specifically instructed you to do so.
Use Kivizidiale for as long as your doctor has told you to.
Kivizidiale is for ophthalmic use only.
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 while wearing them. Wait 15 minutes after instilling the drops before putting your contact lenses back in.
Instructions for use
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If you use more Kivizidiale than you should
If you use more Kivizidiale than you should, rinse your eyes with lukewarm water. Do not apply any more drops until it is time for your next scheduled dose.
In case of overdose or accidental ingestion, immediately consult your doctor or pharmacist, or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medication 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 missed dose. The dose must 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 about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
In general, unless the effects are severe, you may continue using the eye drops. If you have any doubts, consult your doctor or pharmacist. Do not stop using Kivizidiale without consulting your doctor.
Very common adverse effects (may affect more than 1 in 10 people):
Eye effects
Eye redness.
Common adverse effects (may affect up to 1 in 10 people):
Eye effects
Inflammation of the ocular surface 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).
Uncommon adverse effects (may affect up to 1 in 100 people):
Eye effects
Inflammation of the surface of the eye, eyelid inflammation, conjunctival swelling, increased eyelash growth, iris inflammation, eye inflammation, light sensitivity, reduced vision, tired eyes, ocular allergy, swollen eyes, increased tear production, eyelid redness, change in eyelid color, 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, postnasal drip, skin inflammation and itching, decreased heart rate.
Rare adverse effects (may affect up to 1 in 1,000 people):
Eye effects
Thinning of the ocular surface, inflammation of the eyelid glands, broken blood vessels in the eye, eyelid crusts, abnormal eyelash positioning, abnormal eyelash growth.
Other effects
Nervousness, irregular heart rate, hair loss, voice changes, difficulty breathing, cough, throat irritation, hives, abnormal liver blood test results, skin discoloration, thirst, fatigue, nasal discomfort, colored urine, pain in hands and feet.
Frequency not known (cannot be estimated from available data):
Eye effects
Drooping eyelid (causing the eye to be partially closed), sunken eyes (eyes appear deeper), changes in iris color (colored part of the eye).
Other effects
Skin rash, heart failure, chest pain, heart attack, fainting, depression, hallucinations, asthma, increased heart rate, tingling or numbness sensation, palpitations, swelling in the lower limbs, bad taste in the mouth.
Additionally:
Kivizidiale is a combination of two active substances, travoprost and timolol. Like other eye medications, travoprost and timolol (a beta-blocker) are absorbed into the bloodstream after administration. This may cause adverse effects similar to those observed with beta-blockers taken orally or by injection. The incidence of adverse effects following ocular administration is lower than when these medicines are taken orally or injected.
The adverse 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
Eyelid inflammation, corneal inflammation, detachment of the layer beneath the retina containing blood vessels, which may lead to vision disturbances after filtration surgery, decreased corneal sensitivity, corneal erosion (damage to the front surface of the eyeball), double vision, eye discharge, swelling around the eye, eyelid itching, abnormal outward turning of the eyelid with redness, irritation and increased tear production, blurred vision (a sign of lens opacity), swelling of a part of the eye (uvea), eyelid eczema, seeing halos, decreased eye sensitivity, pigmentation within the eye, dilated pupils, change in eyelash color, change in eyelash texture, abnormal visual field.
Other effects
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Ear and labyrinth disorders: dizziness with vertigo sensation, ringing in the ears.
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Heart and circulation: slow heart rate, palpitations, edema (fluid accumulation), changes in heart rhythm or rate, congestive heart failure (heart disease with breathing difficulty and swelling of feet and legs due to fluid accumulation), a type of heart rhythm disorder, heart attack, low blood pressure, Raynaud's phenomenon, cold hands and feet, reduced blood flow to the brain.
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Respiratory: narrowing of the airways in the lungs (mainly in patients with pre-existing disease), runny or blocked nose, sneezing (due to allergy), difficulty breathing, nosebleeds, nasal dryness.
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General and nervous system disorders: difficulty sleeping (insomnia), nightmares, memory loss, loss of strength and energy, anxiety (excessive emotional distress).
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Gastrointestinal disorders: altered taste, nausea, indigestion, diarrhea, dry mouth, abdominal pain, vomiting, constipation.
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Allergy: worsening of allergic symptoms, generalized allergic reactions including swelling under the skin that may occur in areas such as the face and extremities, and may obstruct airways causing difficulty swallowing or breathing, localized and generalized rash, sudden severe allergic reaction that may be life-threatening.
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Skin: skin rash with silvery-white appearance (psoriasiform rash) or worsening of psoriasis, skin peeling, abnormal hair texture, skin inflammation with rash and redness, hair color change, eyelash loss, itching, abnormal hair growth, skin redness.
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Musculoskeletal: increased signs and symptoms of myasthenia gravis (muscle disorder), unusual sensation like needles or pricking, muscle weakness/fatigue, muscle pain not caused by exercise, joint pain.
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Renal and urinary disorders: difficulty and pain when urinating, involuntary urine loss.
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Reproductive system: sexual dysfunction, decreased libido.
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Metabolism: low blood sugar levels, increased prostate cancer marker.
Reporting of adverse effects
If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse 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 stated on the label of the bottle and on the carton, following «EXP». The expiry date refers to the last day of the month indicated.
Do not use this medicine if you notice that the bottle's tamper-evident seal is broken before first use.
Do not store above 25°C.
To prevent infections, the medicine bottle must be discarded 28 days after first opening, and a new bottle should be used. Write the date of first opening on the label of the bottle and on the carton in the space provided for this purpose.
Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE point located at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This way, you will help protect the environment.
6. Contents of the container and other 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 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 Kivizidiale and contents of the container
Kivizidiale eye drops solution is presented as a 2.5 ml aqueous solution, transparent, colourless and practically free from particles, in a white multidose container (PP) of 5 ml with a pump system (PP, HDPE, LDPE) and a pressure cylinder and cap (HDPE), contained in a cardboard box.
The product is available in the following pack sizes:
Cartons containing 1 or 3 bottles.
Not all pack 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
Further information about this medicinal product can be requested from 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 medicinal product 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 most recent review of this leaflet: March 2022
Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.