Filiop 40 micrograms/ml + 5 mg/ml eye drops solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

FILIOP 40 micrograms/ml + 5 mg/ml eye drops solution

travoprost/timolol

Read the entire 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, 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 or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What FILIOP is and what it is used for
2. What you need to know before using FILIOP
3. How to use FILIOP
4. Possible side effects
5. How to store FILIOP
6. Contents of the pack and other information

1. What FILIOP is and what it is used for

FILIOP 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 fluid from the eye, thereby reducing intraocular pressure. Timolol is a beta-blocker that works by reducing the production of fluid inside the eye. The two substances work together to lower the pressure inside the eye.

FILIOP eye drops solution is used to treat elevated intraocular pressure in adults, including elderly patients. This pressure may lead to a condition called glaucoma.

FILIOP eye drops solution is a sterile, preservative-free solution.

2. What you need to know before using FILIOP

Do not use FILIOP:

• if you are allergic to travoprost, timolol, or any of the other components of this medicine (listed in section 6)
• if you are allergic to prostaglandins or beta-blockers
• if you currently have or have previously had breathing problems such as asthma, severe chronic obstructive bronchitis (a serious lung condition that may cause wheezing, difficulty breathing, and/or persistent cough), or other types of respiratory disorders
• if you have severe allergic rhinitis
• if you have a slow heart rate, heart failure, or heart rhythm disorders (irregular heartbeats)
• 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 or pharmacist before starting to use FILIOP if you currently have or have previously had:

• coronary heart disease (symptoms may include chest tightness or pain, shortness of breath, or suffocation), heart failure, low blood pressure
• heart rhythm disturbances such as slow heartbeat
• respiratory problems, asthma, or chronic obstructive pulmonary disease
• disease due to poor blood circulation (such as Raynaud's disease or Raynaud's syndrome)
• diabetes, as timolol may mask the signs and symptoms of low blood sugar
• overactivity of the thyroid gland, as timolol may mask signs and symptoms of thyroid disease
• myasthenia gravis (chronic muscle weakness)
• if you experience any severe allergic reaction (skin rash, redness and itching in the eye) while using FILIOP, regardless of the cause, treatment with adrenaline may be less effective. Therefore, when receiving any other treatment, inform the doctor that you are using FILIOP
• cataract surgery
• eye inflammation (currently or in the past)

Consult your doctor before undergoing surgery; inform your doctor that you are using FILIOP, as timolol may alter the effects of certain medications used during anesthesia.

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

FILIOP 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; therefore, pregnant women or women attempting to become pregnant should not use it. In case of contact with the skin, wash immediately to remove the medication.

Children

FILIOP must not be used in children and adolescents under 18 years of age.

Other medicines and FILIOP

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

FILIOP may affect or may be affected by other medicines you are using, including other eye drops for the treatment of glaucoma. Consult your doctor if you are using or planning to use:

• medicines to lower blood pressure,
• medicines for the heart, including quinidine (used to treat heart conditions and some types of malaria),
• medicines for 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 become pregnant, consult your doctor or pharmacist before using this medicine.

Do not use FILIOP if you are pregnant unless your doctor considers it necessary. If you are able to become pregnant, you should use an appropriate contraceptive method while using this medicine.

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

Driving and using machines

You may notice blurred vision immediately after applying FILIOP.

FILIOP may also cause hallucinations, dizziness, nervousness, or fatigue in some patients.

Do not drive or operate machinery until these effects have subsided.

FILIOP contains macrogolglycerol hydroxystearate 40 and propylene glycol

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

This medicine contains 7.5 mg of propylene glycol per ml of solution.

3. How to use FILIOP

Follow exactly the administration instructions for this medicine as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Recommended dose:

One drop in the affected eye(s) once daily, in the morning or at night. Use it at the same time each day.

FILIOP should be applied to both eyes only if your doctor has specifically instructed you to do so. Continue treatment for the entire duration indicated by your doctor.

FILIOP is for use only as eye drops.

Instructions for use

If you use more FILIOP than you should

If you use more FILIOP than you should, rinse your eyes with lukewarm water. Do not apply more drops until your next usual dose.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, 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 FILIOP

If you forget to use FILIOP, continue with the next scheduled dose. Do not apply a double dose to make up for the missed dose. The dose should not exceed one drop per day in the affected eye(s).

If you stop using FILIOP

If you stop using FILIOP without consulting your doctor, the pressure in your eye will not be controlled and could lead to vision loss.

If you are using other eye drops, wait at least 5 minutes between applying FILIOP and the other eye drops.

If you wear soft contact lenses, do not apply the drops while wearing them. After applying the drops, wait 15 minutes before reinserting your contact lenses.

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 experiences them.

Unless the effects are severe, continue treatment as usual. If you are concerned about any of these effects, consult your doctor or pharmacist. Do not stop using FILIOP without first consulting your doctor.

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

Eye effects: eye redness.

Common (may affect up to 1 in 10 people)

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

Uncommon (may affect up to 1 in 100 people)

Eye effects: inflammation of the surface of the eye, eyelid inflammation, swelling of the conjunctiva, increased eyelash growth, iris inflammation, eye inflammation, light sensitivity, decreased vision, eye strain, eye allergy, swelling in the eye, increased tear production, eyelid redness, change in eyelid colour, 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, postnasal drip, skin inflammation and itching, decreased heart rate.

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

Eye effects: thinning of the surface of the eye, inflammation of eyelid glands, broken blood vessel in the eye, eyelid crusting, abnormal eyelash growth and positioning.

Other effects: nervousness, irregular heart rate, hair loss, voice disorders, difficulty breathing, cough, throat irritation, hives, abnormal liver blood test results, skin discolouration, thirst, fatigue, unusual sensation inside the nose, coloured urine, pain in hands and feet.

Frequency not known (frequency cannot be estimated from available data)

Eye effects: drooping eyelid (causing the eye to appear partially closed), sunken eyes (eyes appear more deeply set), changes in iris colour (coloured part of the eye).

Other effects: skin rash, heart failure, chest pain, stroke, fainting, depression, asthma, increased heart rate, tingling or numbness sensation, palpitations, swelling in the lower limbs, bad taste.

Additionally:

FILIOP is a combination of two active substances.

Like other medicines administered into the eyes, travoprost and timolol (a beta-blocker) are absorbed into the bloodstream. This may cause adverse effects similar to those observed with intravenous and/or oral beta-blocker medicines. The incidence of adverse effects after ophthalmic administration is lower than with medicines taken orally or by injection. The adverse effects listed below include reactions observed within the class of beta-blockers when used to treat eye conditions, and are as follows:

Eye effects: eyelid inflammation, corneal inflammation, detachment of the layer beneath the retina containing blood vessels which may cause visual disturbances after filtration surgery, reduced corneal sensitivity, corneal erosion (damage to the front layer of the eyeball), double vision, eye discharge, swelling around the eye, eyelid itching, abnormal outward turning of the lower 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, visual halos, decreased eye sensitivity, pigmentation within the eye, dilated pupils, change in eyelash colour, change in eyelash texture, abnormal visual field.

Other effects:

• Ear and labyrinth disorders: dizziness with sensation of movement, tinnitus (ringing in the ears).

• Heart and circulation: slow heart rate, palpitations, oedema (fluid accumulation), changes in heart rhythm or rate, congestive heart failure (heart disease causing difficulty breathing 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.

• Respiratory: narrowing of airways in the lungs (predominantly in patients with pre-existing disease), mucus or nasal congestion, sneezing (due to allergy), difficulty breathing, nosebleeds, dry nose.

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

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

• Allergy: generalized allergic reactions including swelling under the skin which may occur in areas such as the face and limbs, and may obstruct airways causing difficulty swallowing or breathing, localized and generalized rash, sudden and severe life-threatening allergic reaction.

• Skin: scaly skin rash with silvery appearance (psoriasiform rash) or worsening of psoriasis, skin peeling, abnormal hair texture, skin inflammation with redness and itching, change in hair colour, eyelash loss, itching, abnormal hair growth, skin redness.

• Muscular: increased signs and symptoms of myasthenia gravis (muscle disorder), unusual sensations such as tingling, muscle weakness/fatigue, muscle pain not caused by exercise, joint pain.

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

• Reproductive: sexual dysfunction, decreased libido.

• 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 can also report them directly via 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 FILIOP

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

Do not use this medicine after the expiry date stated on the carton and vial after "EXP". The expiry date refers to the last day of the month indicated.

Do not use this medicine if you notice that the vial is broken or damaged before first opening.

Store below 25°C.

The vial must be discarded 28 days after first opening to prevent infections, and a new vial should be used. Record the date of opening in the spaces provided on the label of the vial and carton.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, 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 FILIOP

• The active substances are travoprost and timolol.

Each ml of solution contains 40 micrograms of travoprost and 5 mg of timolol (as timolol maleate).

• The other components are mannitol (E421), boric acid, sodium hydroxide (to adjust pH), macrogol glycerol hydroxystearate (nominal value: 40), propylene glycol (E1520), sodium chloride, and purified water.

Appearance of the product and contents of the container

FILIOP eye drops solution is presented as 2.5 ml of aqueous solution, transparent and colorless, practically free from particles, in a cardboard box containing a 5 ml container (PP), white, multidose, with a pump (PP, HDPE, LDPE) and a pressure cylinder and a cap (HDPE).

The product is available in the following pack sizes:

Box containing 1 or 3 bottles.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Horus Pharma

22, Allée Camille MUFFAT

Inedi 5

06200 Nice

France

Manufacturer:

Pharmaten S.A.

6, Dervenakion Str

15351 Pallini Attikis

Greece

Or

Jadran Galenski Laboratorij D.D.

Svilno, 20

51000 Rijeka

Croatia

Local representative

HORUS PHARMA IBÉRICA, S.L.U.

Gran Vía Carlos III, 98, 6th floor

08028 Barcelona – Spain

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

Date of the most recent review of this leaflet: March 2025

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