Leaflet: information for the user

Travoprost Stada 40 micrograms/ml eye drops in solution

Read this 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, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What Travoprost Stada is and what it is used for

2. What you need to know before using Travoprost Stada

3. How to use Travoprost Stada

4. Possible side effects

5. Storage of Travoprost Stada

6. Contents of the pack and additional information

Travoprost Stadacontains travoprost, which is part of a group of medications calledprostaglandin analogs. It works by reducing eye pressure. It can be used alone or with other eye drops, such as beta-blockers, which also reduce eye pressure.

Travoprost Stadais used toreducehigh eye pressurein adults, adolescents, and children aged 2 months and older. This pressure can lead to a disease called glaucoma.

Do not use Travoprost Stada

• If you are allergic to travoprost or any of the other ingredients of this medication (listed in section 6).

Consult your doctor if you are in this situation.

Warnings and precautions

• Travoprostmay increasethe length, thickness, color, and/or number of youreyelashes. It has also been observed that changes such as unusual hair growth on the eyelids or in the tissues around the eye may occur.

• Travoprostmayalter the color of the iris(the colored part of the eye). This change may be permanent. It may also cause a change in the color of the skin around the eye.
• If you have undergonecataract surgery, consult your doctor before starting to use Travoprost Stada.
• If you suffer or have previously suffered fromeye inflammation(iritis and uveitis), consult your doctor before starting to use Travoprost Stada.

• Travoprostmay cause, in rare cases,shortness of breathornoisy breathingor increase the symptoms ofasthma.If you are concerned about changes in your breathing while usingTravoprost Stada, consult your doctor as soon as possible.
• Travoprostmay be absorbed through the skin.In case of contactof the medicationwith the skin,it must be removedby washingimmediately.This is especially important in pregnant women or those trying to become pregnant.
• If you wear soft contact lenses, do not apply the drops while wearing them. After applying the drops, wait 15 minutes before putting them back in.

Children and adolescents

Travoprostcan be used in children from 2 months of age to

Travoprostshould not be used in children under 2 months of age.

Other medications and Travoprost Stada

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Pregnancy, breastfeedingand fertility

Do not use Travoprost Stada if you are pregnant.If you think you may be pregnant, tell your doctor immediately. If you can become pregnant, you should use an appropriate contraceptive method while using travoprost.

Do not use Travoprost Stada if you are breastfeeding.Travoprost may pass into breast milk.

If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your doctor before using this medication.

Driving and operating machinery

You may notice blurred vision immediately after applying travoprost. Do not drive or use machines until this effect has disappeared.

Travoprost Stada contains benzalkonium chloride

This medication contains 0.15 mg of benzalkonium chloride in each ml.

Benzalkonium chloride can be absorbed by soft contact lenses, altering their color. Remove your contact lenses before using this medication and wait 15 minutes before putting them back in.

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, burning, or pain in your eye after using this medication.

Travoprost Stada contains macrogolglycerol hydroxystearate 4040

This medication may cause skin reactions because it contains macrogolglycerol hydroxystearate 40.

Follow exactly the administration instructions of this medication indicated by your doctor or the doctor treating your child. In case of doubt, consult your doctor, the doctor treating your child, or the pharmacist again.or the pharmacist.

The recommended dose is:

Onedrop in the affected eye or eyes, once a day-at night.

This medication should only be applied to the two eyes if your doctor instructs you to do so. Follow the treatment for the indicated period of time by your doctor or the doctor treating your child.

Travoprost Stada should only be used as eye drops for your eyes or your child's eyes.

If a drop falls outside the eye,try again.

If you or your child are using other eye medications, such as eye drops or ointments, wait at least 5 minutes between the application of travoprostand the other eye medications.

If you oryour childreceive moreTravoprost Stada than they should

You can remove it by washing your eye with warm water. Do not apply more drops until the next scheduled dose.

If you forgot to use Travoprost Stada

Continue with the next scheduled dose.Do notapply a double dose to compensate for the missed dose. Never apply more than one drop per day to the affected eye(s).

If you interrupt the treatment with Travoprost Stada

Do not stop using travoprostwithout consulting your doctor or the doctor treating your child first, as the pressure in your eye or your child's eye will not be controlled, which could cause vision loss.

If you have any other questions about the use of this medication, ask your doctor, the doctor treating your child, or the pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

You can continue with the treatment unless the side effects are severe. If these side effects concern you, consult your doctor or pharmacist. Do not stop applying travoprost without consulting your doctor.

The following side effects have been observed with travoprost:

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:

• Changes in iris color (colored part of the eye)
• Pain in the eye
• Eye discomfort
• Dry eye
• Itching in the eye
• Irritation in the eye

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

Eye effects:

• Corneal alteration
• Eye inflammation
• Iris inflammation
• Inflammation within the eye
• Inflammation with or without damage to the eye surface
• Light sensitivity
• Eye secretion
• Palpebral inflammation
• Redness of the palpebra
• Swelling around the eye
• Itching in the palpebra
• Blurred vision
• Increased tear production
• Conjunctivitis (infection or inflammation of the conjunctiva)
• Abnormal outward turning of the lower eyelid
• Shaded vision
• Crusts on the palpebra
• Abnormal hair growth

Other effects:

• Increased allergic symptoms
• Headache
• Irregular heart rate
• Cough
• Stuffy nose
• Irritation of the throat
• Darkening of the skin around the eye(s)
• Darkening of the skin
• Abnormal texture of the hair
• Excessive hair growth

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

Eye effects:

• Perception of flashes of light
• Eczema of the eyelids
• Abnormally positioned eyelashes that grow towards the eye
• Swelling of the eye
• Reduced vision
• Halo vision
• Decreased sensation in the eye
• Inflammation of the eyelid glands
• Pigmentation within the eye
• Enlargement of the pupil
• Thickening of the eyelashes
• Change in color of the eyelashes
• Tired eyes

Other effects:

• Eye infection or inflammation
• Dizziness
• Bad taste in the mouth
• Irregular or decreased heart rate
• Increased or decreased blood pressure
• Shortness of breath
• Asthma
• Nasal allergy or inflammation
• Nasal dryness
• Changes in voice
• Gastrointestinal ulcer or discomfort
• Constipation
• Dry mouth
• Redness or itching of the skin
• Rash
• Change in hair color
• Loss of eyelashes
• Joint pain
• Musculoskeletal pain
• Generalized weakness.

Unknown frequency: cannot be estimated from available data

Eye effects:

• Inflammation of the posterior part of the eye,
• Sunken eyes

Other effects:

• Depression
• Anxiety
• Insomnia
• Fake sense of movement
• Tinnitus in the ears
• Chest pain
• Abnormal heart rhythm
• Increased heart rate
• Worsening of asthma
• Diarrhea
• Nosebleed
• Abdominal pain
• Nausea
• Vomiting
• Itching
• Abnormal hair growth
• Involuntary urination or painful urination
• Increased prostate cancer marker.

In children and adolescents, the most common side effects observed with travoprost are redness of the eye and eyelash growth. Both side effects were observed at a higher incidence in children and adolescents compared to adults.

Reporting of side effects:

If you experience any 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 use this medication after the expiration date that appears on the bottle and on the box after CAD. The expiration date is the last day of the month indicated.

Do not use this medication if you observe that the seal is broken or damaged before the first opening.

Keep the bottle inside the bag before opening to protect it from moisture.

This medication does not require special storage conditions after the first opening.

To prevent infections,you must discard the bottle 4 weeks after opening it for the first time, and use a new bottle.Record the opening date in the reserved space on the box.

Medications should not be disposed of through drains or trash. Deposit the containers and medications you do not need at the SIGRE collection pointof the pharmacy. In case of doubt, ask your pharmacist how to dispose of the containers and medications you do not need. In this way, you will help protect the environment.

Composition of Travoprost Stada

• The active ingredient is travoprost. This medication contains 40 micrograms/ml of travoprost.
• The other components are benzalkonium chloride, macrogolglycerol hydroxystearate, trometamol, disodium edetate, boric acid, mannitol, sodium hydroxide to adjust the pH, and water for injection or purified water.

Appearance of the product and contents of the container

Travoprost Stada is an colorless and transparent solution that is presented in containers that contain bags with 5 ml polypropylene translucent bottles with low-density polyethylene (LDPE) transparent dropper tips and high-density polyethylene (HDPE) white stoppers. Each bottle contains 2.5 ml of solution.

The containers contain 1, 3, 6, 9, 10 or 12 bottles.

Only some sizes of containers may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

[email protected]

Responsible for manufacturing

Pharmathen S.A.

6, Dervenakion str., 15351 Pallini, Athens

Greece

or

BALKANPHARMA-RAZGRAD AD

68 Aprilsko vastanie Blvd., Razgrad 7200

Bulgaria

or

STADA Arzneimittel GmbH

Muthgasse 36, 1190 Vienna

Austria

or

STADA Arzneimittel AG

Stadastrasse 2-18, 61118 Bad Vilbel

Germany

or

Centrafarm Services B.V.

Van de Reijtstraat 31-E, 4814 NE Breda

Netherlands

or

JADRAN – GALENSKI LABORATORIJ d.d.

Svilno 20,

Rijeka, 51000

Croatia

Last review date of the leaflet: September 2019

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

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