Prospecto:information for the user

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

travoprost/timolol

Read this prospect carefully before starting to use this medicine,because it contains important information for you.

• Keep this prospect, as you may need to read it again.

- If you have any doubts, consult yourdoctor or pharmacist.

-This medicine has been prescribedonlyto you, and you must not give it to other people althoughtheymay havethe same symptomsas you,as it may harm them.

• If you experience any adverse effects,consult your doctor or pharmacist,eveniftheyare not listed in this prospect. See section 4.

1.What is FILIOP and for what it is used

2.What you need to knowbeforestarting touse FILIOP

3.How to use FILIOP

4.Possible adverse effects

5.Storage of FILIOP

6. Contents of the package and additional information

FILIOPeye drops in solution is an association of two active substances (travoprost and timolol).Travoprost is a prostaglandin analogue that acts by increasing the outflow of fluid from the eye, and therefore reduces the pressure in the eye. Timolol is a beta-blocker that acts by reducing the formation of fluid inside the eye. The two substances act together to reduce the pressure inside the eye.

FILIOP eye dropsare used to treat high eye pressure in adults, including elderly patients. This pressure may lead to a disease called glaucoma.

FILIOP eye drops in solution are a sterile solution without preservatives.

No use FILIOP:

• If you are allergic to travoprost, timolol, or any of the other components of this medication (listed in section 6)
• If you are allergic to prostaglandins or beta-blockers
• If you currently have or have had in the past respiratory problems such as asthma, severe chronic obstructive pulmonary disease (a serious lung condition that can cause wheezing, difficulty breathing, and/or persistent coughing), or other types of respiratory problems
• 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 FILIOPif you currently have or have had in the past:

• Coronary heart disease (symptoms may include chest tightness or pain, shortness of breath, or feeling of suffocation), heart failure, low blood pressure
• Heart rhythm disorders such as slow heart rate
• 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
• Hyperthyroidism, as timolol may mask the 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, adrenaline treatment may not be as effective. Therefore, when receiving any other treatment, inform your doctor that you are usingFILIOP
• Cataract surgery
• Eye inflammation (current or past)

Consult your doctor beforeundergoing surgery, inform your doctor that you are using FILIOP, as timolol may change the effects of some medications used during anesthesia.

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

FILIOPmay 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 trying to become pregnant should not use it. In case of contact with the medication on the skin, it should be washed immediately to remove it.

Children

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

Other medications and FILIOP

Inform your doctor or pharmacist if you aretaking,havetaken recentlyor may have to take any other medication.

FILIOPmay affect or be affected by other medications you are using, including other eye drops for glaucoma treatment. Consult your doctor if you are using or think you will use:

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

Pregnancy, breastfeeding, and fertility

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

Do not use FILIOPif you are pregnant unless your doctor considers it necessary. If you can become pregnant, use an appropriate contraceptive method while using the medication.

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

Driving and operating machinery

Possible blurred vision immediately after applying FILIOP. Do not drive or operate machinery until these effects have disappeared.

FILIOP contains hydroxypropyl beta cyclodextrin and propylene glycol

This medication containshydroxypropyl beta cyclodextrin, which may cause skin reactions.

This medication contains 7.5 mg of propylene glycol per 1 ml of solution.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist.This medication should be used exactly as directed.Consult your doctor or pharmacist again if you are unsure.

The recommended dose isas follows

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

FILIOP should only be applied to both eyes if your doctor has recommended it. Follow the treatment for the entire period of time indicated by your doctor.

FILIOP should only be used as eye drops.

Instructions for use

If you use more FILIOP than you should

If you use more FILIOP than you should, wash your eyes with warm water. Do not apply more drops until the next scheduled 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 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 doses. The dose should not exceed one drop per day in the affected eye(s).

If you interrupt treatment with FILIOP

If you stop using FILIOP without consulting your doctor, the pressure in your eye will not be controlled and you may lose your vision.

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 putting your contact lenses back in.

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.

Unless the side effects are severe, continue with the treatment as normal. If these side effects concern you, consult your doctor or pharmacist. Do not stop applying FILIOP without first consulting your doctor.

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

Eye effects: redness of the eye.

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, conjunctival swelling, increased growth of eyelashes, iris inflammation, eye inflammation, light sensitivity, decreased vision, tired eyes, ocular allergy, swelling in the eye, increased tear production, eyelid redness, change in eyelid color.

Other effects:allergic reaction to the medication, dizziness, headache, increased or decreased blood pressure, shortness of breath, excessive hair growth, posterior throat dripping, 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, eyelid gland inflammation,visible blood vessels in the eye, crusts on the eyelid, abnormal growth and positioning of eyelashes.

Other effects: nervousness, irregular heart rate, hair loss, voice disorders, difficulty breathing, cough, throat irritation, urticaria, abnormal liver function test results, skin discoloration, skin darkening, thirst, fatigue, strange sensation inside the nose, colored urine, hand and foot pain.

Unknown frequency(frequency cannot be estimated from available data)

Eye effects: drooping eyelid (causing the eye to be half-closed).

Other effects:skin rash, heart failure, chest pain, cerebral embolism, fainting, depression, asthma, increased heart rate, tingling or numbness, palpitations, lower limb inflammation, bad taste.

Additionally:

FILIOPis an association of 2 active substances. Like other eye medications, travoprost and timolol (a beta-blocker) are absorbed into the bloodstream. This may cause side effects similar to those observed with intravenous and/or oral beta-blockers. The incidence of side effects after topical administration is lower than that of medications administered orally or by injection. The listed side effects, including reactions observed within the class of beta-blockers when used to treat eye conditions, are as follows:

Eye effects: eyelid inflammation, corneal inflammation, retinal detachment after surgery that can cause vision disturbances, decreased corneal sensitivity, corneal erosion (damage to the anterior layer of the eyeball), double vision, changes in iris color.

Other effects:

• Heart and circulation: 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 feet and hands, reduced blood flow to the brain.

• Respiratory: constriction of airways in the lungs (predominantly in patients with pre-existing disease), difficulty breathing, nasal congestion.

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

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

• Allergy: 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, itching, sudden and severe life-threatening allergic reaction.

• Skin: psoriasiform rash or worsening of psoriasis, skin peeling.

• Muscular: increased signs and symptoms of myasthenia gravis (muscular disorder), unusual sensations such as muscle cramps, muscle weakness/ fatigue, non-exercise-related muscle pain.

• Reproduction: sexual dysfunction, decreased libido.

• Metabolism: low blood sugar levels.

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es.By reporting adverse reactions, you can contribute to providing more information on the safety of this medication.

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears onthe box andthebottleafter “EXP”. The expiration date is the last day of the month indicated.

Do not usethis medicationif you observe that the bottle is broken or damaged before opening it for the first time.

Store below 25°C.

You must discard the bottle 28 days after opening it for the first time,to prevent infections, and use a new bottle. Note the opening date in the reserved spaces on the bottle label and the box label.

Medications should not be thrown away through drains or in the trash. Dispose of containers and medications you no longer need at the SIGRE point of your pharmacy.If in doubt, ask your pharmacist how to dispose of containers and medications you no longer need. In this way, you will help protect the environment.

FILIOP Composition

• The active principles are travoprost and timolol.

Each milliliter 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 the pH), macrogolglycerol hydroxystearate (nominal value: 40), propylene glycol (E1520), sodium chloride, and purified water.

Appearance of the product and contents of the packaging

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

The product is available in the following packaging sizes:

Box with 1 or 3 bottles.

Only some packaging sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Horus Pharma

22, Allée Camille MUFFAT

Inedi 5

06200 Nice

France

Responsible manufacturer:

Pharmaten S.A.

6, Dervenakion Str

15351 Pallini Attikis

Greece

O

Jadran Galenski Laboratorij D.D.

Svilno, 20

51000 Rijeka

Croatia

Local representative

HORUS PHARMA IBÉRICA, S.L.U.

Gran Vía Carlos III, 98, 6th

08028 Barcelona – Spain

Last review date of thisleaflet:December 2023

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