Prospect: Information for the User

Travoprost/Timolol Stada40 micrograms/ml+ 5 mg/ml eye drops in solution

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 your doctor or pharmacist.
• This medicine has been prescribed only to you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they do not appear in this prospect. See section 4.

1. What isTravoprost/Timolol Stadaand for what it is used

2. What you need to know before starting to useTravoprost/Timolol Stada

3. How to useTravoprost/Timolol Stada

4. Possible adverse effects

5. Storage ofTravoprost/Timolol Stada

6. Contents of the package and additional information

Travoprost/Timolol Stada eye 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 aqueous 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.

Travoprost/Timolol Stada eye drops are used to treat high eye pressure in adults, including elderly patients. This pressure may lead to a disease called glaucoma.

Do not use Travoprost/Timolol Stada

• 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 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 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 heartbeats).
• If your eye surface is cloudy.

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

Warnings and precautions

Before starting to use this medication, inform your doctor if 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 choking), heart failure, low blood pressure,

• heart rhythm disorders such as 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 may mask the signs and symptoms of low blood sugar)
• hyperthyroidism (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 travoprost/timolol, 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 travoprost/timolol, any cause, the treatment with adrenaline may not be as effective. Therefore, it is very important to inform your doctor that you are using travoprost/timolol when receiving any other treatment.

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

Travoprost/timolol 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 trying to become pregnant should not use it. In case of contact with the medication on the skin, it should be removed by washing immediately.

Children

Travoprost/timolol should not be used in children and adolescents under 18 years of age.

Other medications and Travoprost/Timolol Stada

Inform your doctor or pharmacist if you are using,have usedrecentlyor may need to use anyother medication.

Travoprost/timolol may 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:

• 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 or pharmacist before using this medication.

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

Do not use travoprost/timolol if you are breastfeeding. Travoprost/timolol may pass into breast milk.

Driving and using machines

Immediately after applying travoprost/timolol, you may notice that your vision becomes blurry. Do not drive or use machines until these effects have disappeared.

Travoprost/Timolol Stada contains benzalkonium chloride

This medication contains 150 micrograms of benzalkonium chloride in each ml of eye drop solution. Benzalkonium chloride can be absorbed by soft contact lenses, altering their color. Remove contact lenses before using this medication and wait 15 minutes before reinserting them.

Benzalkonium chloride may cause eye irritation, especially if you have dry eye or other corneal diseases (the transparent layer at the front of the eye). Consult your doctor if you feel a strange sensation, stinging, or pain in the eye after using this medication.

Travoprost/Timolol Stada contains macrogolglycerol hydroxystearate 40

This medicationmay causereactions on the skin because it contains macrogolglycerol hydroxystearate 40.

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

This medication should only be applied to the eyes.

This medication should only be used as eye drops.

Instructions for use

If a drop falls outside the eye, try again.

If you use moreTravoprost/Timolol Stadathan you should

If you use moretravoprost/timololthan you should, rinse your eyes with warm water. Do not apply more drops until you are instructed to do so.

If you forgot to useTravoprost/Timolol Stada

If you forgot to usetravoprost/timolol,continue with the next scheduled dose. 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 withTravoprost/Timolol Stada

If you stop usingtravoprost/timololwithout consulting your doctor, the pressure in your eye will not be controlled, which may cause vision loss.

If you are using another eye drop in addition to Travoprost/Timolol Stada, wait at least 5 minutes between the application oftravoprost/timololand the other drops.

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

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 using this medicine 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 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 side effects(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, eye allergy, eye swelling, 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.

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

Eye effects:

Thinning of the surface of the eye, eyelid gland inflammation, broken blood vessel in the eye, eyelid crusts, 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, thirst, fatigue, strange sensation inside the nose, colored urine, hand and foot pain.

Unknown frequency(cannot be estimated from available data)

Eye effects:

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

Other effects:

Skin rash, heart failure, chest pain, stroke, fainting, depression, asthma, increased heart rate, numbness or tingling, palpitations, leg swelling, bad taste.

Additionally:

Travoprost/Timolol Stada is a combination of 2 active substances, travoprost and timolol. Like other eye medications, travoprost and timolol (a beta-blocker) are absorbed into the bloodstream. This can cause side effects similar to those observed with beta-blocker medications taken by mouth or injection. The incidence of side effects after eye administration is lower than with medications 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 eyelid inflammation, corneal inflammation, retinal detachment, decreased corneal sensitivity, corneal erosion (damage to the anterior layer of the eyeball), double vision, eye discharge, eye swelling, eyelid itching, abnormal eyelid turning outward with redness, irritation, and increased tear production, blurred vision (sign of cataract), eye swelling, eczema of the eyelids, halo vision, decreased eye sensitivity, pigmentation within the eye, dilated pupils, change in eyelash color, change in eyelash texture, altered visual field.

Other effects:

• Ear and labyrinth disorders: dizziness with a sense of movement, 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 leg swelling due to fluid accumulation), type of cardiac arrhythmia, heart attack, decreased blood pressure, Raynaud's phenomenon, cold feet and hands, reduced cerebral blood flow.

• Respiratory disorders: bronchospasm in the lungs (predominantly in patients with pre-existing disease), nasal congestion or mucous, sneezing (due to allergy), difficulty breathing, nasal bleeding, dry nose.

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

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

• Allergic reactions: increased allergic symptoms, generalized allergic reactions including skin swelling that can occur in areas such as the face and extremities and can obstruct airways causing difficulty swallowing or breathing, urticaria, localized and generalized skin rash, itching, sudden and severe allergic reaction that puts life at risk.

• Skin disorders: psoriasis-like rash or worsening of psoriasis, skin peeling, abnormal hair texture, skin inflammation with redness and itching, hair color change, eyelash loss, itching, abnormal hair growth, eyelid redness.

• Musculoskeletal disorders

• 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 of side effects

If you experienceany type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines 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 usethismedication after the expiration date that appears on the packaging, overwrap, and bottle, after “CAD”. The expiration date is the last day of the month indicated.

Before opening,this medication does not require any special storage temperature.Keep the bottle in the overwrap to protect it from light.

After its first opening, this medication does not require special storage conditions.

To prevent infections,you must discard the bottle 4 weeks after opening it for the first timeand use a new bottle. Note the opening date in the reserved spaces on the label of each bottle and box.

Medications should not be thrown away through drains or trash. Deposit the packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.

Composition ofTravoprost/Timolol Stada

• The active principles 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 benzalkonium chloride, macrogolglycerol 40 hydroxystearate, trometamol, disodium edetate, boric acid (E284), mannitol (E421), sodium hydroxide (for pH adjustment) and water for injection or purified water.

Appearance of the product and contents of the package

Travoprost/Timolol Stada is a clear, colorless, practically particle-free aqueous solution available in a 5 ml plastic bottle with an colorless nozzle and a white opaque cap with a tamper-evident seal.

Each bottle is closed in a blister pack. Each bottle contains 2.5 ml of solution.

The product is available in the following package sizes:

Package sizes containing 1, 3 or 6 bottles.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

[email protected]

Manufacturer responsible

Pharmathen S.A.

6, Dervenakion str.,

Pallini, Attiki 15351

Greece

or

Balkanpharma-Razgrad AD

68 Aprilsko vastanie Blvd.

Razgrad, 7200

Bulgaria

or

STADA Arzneimittel AG

Stadastrasse 2 – 18

61118 Bad Vilbel

Germany

or

Centrafarm Services B.V.

Van de Reijstraat 31-E

4814 NE Breda

Netherlands

or

JADRAN - GALENSKI LABORATORIJ d.d.

Svilno 20,

Rijeka, 51000

Croatia

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

BelgiumTravoprost/Timolol EG 40 microgram/ml + 5mg/ml eye drops, solution

LuxembourgTravoprost/Timolol EG 40 microgrammes/ml + 5mg/ml eye drops in solution

EstoniaTravoprost/TimololSTADA 40 mikrogrammi/5 mg/ml eye drops, solution

LithuaniaTravoprost/Timolol STADA 40 mikrogramu/ 5 mg/ml eye drops, solution

GermanyTravoprost/Timolol AL 40 Mikrogramm/ml + 5 mg/ml eye drops, solution

DenmarkTravoprost/Timolol STADA 40 mikrogram/ml + 5 mg/ml eye drops, solution

SpainTravoprost/Timolol STADA 40 microgramos/ml + 5 mg/ml eye drops in solution

FinlandTravoprost/Timolol STADA 40 mikrogram/ml + 5 mg/ml eye drops, solution

FranceTRAVOPROST/TIMOLOL EG 40 microgrammes/ml + 5 mg/ml, eye drops in solution

ItalyTravoprost and Timololo EG

NetherlandsTravoprost/Timolol CF 0,04/5 mg/ml, eye drops, solution

SwedenTravoprost/Timolol STADA 40 mikrogram/ml + 5 mg/ml eye drops, solution

Last review date of this leaflet:June 2022

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