Travoprost Stada 40 micrograms/ml eye drops solution

Spain
Brand name Travoprost Stada 40 micrograms/ml eye drops solution
Form solution, ophthalmic
Active substance / Dosage
TRAVOPROST · 0,100 mg
Prescription type Prescription Only Medicine
ATC code
S01E S01EE S01EE04
Registration number 79133
Manufacturer Laboratorio Stada S.L.
Travoprost Stada 40 micrograms/ml eye drops solution solution, ophthalmic

Table of Contents

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Travoprost Stada 40 micrograms/ml eye drops solution

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. Do not give it to other people, even if they have the same symptoms as you, because it could harm them.
  • If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

  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. How to store Travoprost Stada
  6. Contents of the pack and other information

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

Travoprost Stada contains travoprost, which belongs to a group of medicines called prostaglandin analogues. It works by reducing pressure inside the eye. It can be used alone or in combination with other eye drops, for example beta-blockers, which also reduce pressure inside the eye.

Travoprost Stada is used to reduce elevated intraocular pressure in adults, adolescents, and children from the age of 2 months. This pressure can lead to a condition called glaucoma.

2. What you need to know before using Travoprost Stada

DO NOT use Travoprost Stada

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

Consult your doctor if you are in this situation.

Warnings and precautions

  • Travoprost may increase the length, thickness, colour, and/or number of your eyelashes. Changes such as unusual hair growth on the eyelids or surrounding eye tissues have also been observed.

  • Travoprost may change the colour of the iris (the coloured part of the eye). This change may be permanent. It may also cause a change in the skin colour around the eye.

  • If you have had cataract surgery, consult your doctor before starting to use Travoprost Stada.

  • If you currently have or have previously had eye inflammation (iritis or uveitis), consult your doctor before starting to use Travoprost Stada.

  • Travoprost may rarely cause shortness of breath, noisy breathing, or worsen symptoms of asthma. If you are concerned about changes in your breathing while using Travoprost Stada**, consult your doctor as soon as possible.**

  • Travoprost can be absorbed through the skin. If the medicine comes into contact with the skin, it should be removed immediately by washing. This is particularly important for women who are pregnant or 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 reinserting your lenses.

Children and adolescents

Travoprost can be used in children from 2 months of age up to < 18 years of age at the same dose as adults. The use of travoprost is not recommended in children under 2 months of age.

Other medicines and Travoprost Stada

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

Pregnancy, breastfeeding and fertility

Do not use Travoprost Stada if you are pregnant. If you think you may be pregnant, tell your doctor immediately. If you are able to 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 are planning to become pregnant, consult your doctor before using this medicine.

Driving and using machines

You may experience blurred vision immediately after applying travoprost. Do not drive or operate machinery until this effect has passed.

Travoprost Stada contains benzalkonium chloride

This medicine contains 0.15 mg of benzalkonium chloride per ml.

Benzalkonium chloride can be absorbed by soft contact lenses, altering their colour. Remove contact lenses before using this medicine 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 experience a foreign body sensation, stinging, or eye pain after using this medicine.

Travoprost Stada contains macrogolglycerol hydroxystearate 40

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

3. How to use Travoprost Stada

Follow exactly the instructions for administering this medicine given by your doctor or the doctor treating your child. If in doubt, consult your doctor, the doctor treating your child, or the pharmacist again.

Recommended dose:

One drop in the affected eye or eyes, once daily in the evening.

Travoprost should be applied to both eyes only if instructed by your doctor. Continue treatment for the length of time prescribed by your doctor or the doctor treating your child.

Travoprost Stada is for use only as eye drops in your eyes or your child's eyes.

1Technical drawing showing the

  • Immediately before using a bottle for the first time, open the pouch, remove the bottle (Figure 1), and write the date of opening in the space provided on the label.
  • Wash your hands.
  • Unscrew the cap.

2Stylized illustration of an eye with thick lashes and dark eyebrows, with an arrow pointing downward below the lower eyelid

  • Hold the bottle upside down between your fingers.
  • Gently tilt the head or the child's head backward. Gently pull down the lower eyelid with one finger until a small pocket forms between the eyelid and the eye. The drop should fall into this pocket (Figure 2).
  • Bring the tip of the bottle close to the eye. A mirror may be helpful.

3Schematic drawing showing the

  • Do not touch the eye, eyelid, surrounding areas, or any other surface with the dropper tip. The drops could become contaminated.
  • Gently squeeze the bottle so that one drop of travoprost falls at a time (Figure 3).
  • After using travoprost, close your eyes gently and press with one finger on the corner of the eye near the nose (Figure 4) for at least 1 minute. This helps prevent travoprost from passing into the rest of the body.

4Black and white drawing of a face showing a closed eye and a finger gently pressing on the upper eyelid

  • If applying drops to both eyes, repeat the previous steps for the other eye.
  • Closely replace the cap on the bottle immediately after use.
  • Use only one bottle at a time. Do not open the pouch until you need to use the bottle.

If a drop falls outside the eye, try again.

If you or your child are using other eye medications, such as eye drops or eye ointments, wait at least 5 minutes between applying travoprost and the other eye medications.

If you or your child have used more Travoprost Stada than you should have

Wash the eye with lukewarm water to remove it. Do not apply any more drops until it is time for your next dose.

If you forget to use Travoprost Stada

Continue with the next scheduled dose. Do not apply a double dose to make up for the missed dose. Never apply more than one drop per day to the affected eye(s).

If you stop using Travoprost Stada

Do not stop using travoprost without first consulting your doctor or your child's doctor, as the pressure in your eye or your child's eye will not be controlled, which could lead to loss of vision.

If you have any further questions about the use of this medicine, ask your doctor, your child's doctor, or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everybody gets them.

You can usually continue treatment unless the adverse effects are severe. If you are concerned about any of these effects, consult your doctor or pharmacist. Do not stop using travoprost without first consulting your doctor.

The following adverse effects have been observed with travoprost:

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:

  • changes in iris colour (the coloured part of the eye)
  • eye pain
  • eye discomfort
  • dry eye
  • itchy eye
  • eye irritation

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

Eye effects:

  • corneal alteration
  • eye inflammation
  • iris inflammation
  • intraocular inflammation
  • inflammation with or without damage to the eye surface
  • light sensitivity
  • eye discharge
  • eyelid inflammation
  • eyelid redness
  • swelling around the eye
  • itchy eyelid
  • blurred vision
  • increased tear production
  • infection or inflammation of the conjunctiva (conjunctivitis)
  • abnormal outward turning of the lower eyelid
  • darkened vision
  • eyelid crusting
  • eyelash growth

Other effects:

  • worsening of allergic symptoms
  • headache
  • irregular heartbeat
  • cough
  • stuffy nose
  • throat irritation
  • darkening of the skin around the eye(s)
  • skin darkening
  • abnormal hair texture
  • excessive growth of body hair

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

Eye effects:

  • perception of flashes of light
  • eyelid eczema
  • abnormally positioned eyelashes growing inward toward the eye
  • eye swelling
  • reduced vision
  • visual halos
  • decreased sensation in the eye
  • inflammation of the eyelid glands
  • pigmentation inside the eye
  • increased pupil size
  • eyelash thickening
  • change in eyelash colour
  • tired eyes

Other effects:

  • viral eye infection
  • dizziness
  • bad taste in mouth
  • irregular or decreased heart rate
  • increased or decreased blood pressure
  • shortness of breath
  • asthma
  • nasal allergy or inflammation
  • dry nose
  • voice changes
  • gastrointestinal ulcer or discomfort
  • constipation
  • dry mouth
  • skin redness or itching
  • rash
  • change in hair colour
  • eyelash loss
  • joint pain
  • musculoskeletal pain
  • generalized weakness

Frequency not known: cannot be estimated from available data

Eye effects:

  • inflammation of the back of the eye
  • sunken eyes

Other effects:

  • depression
  • anxiety
  • insomnia
  • false sensation of movement
  • ringing in the ears
  • chest pain
  • abnormal heart rhythm
  • increased heart rate
  • worsening of asthma
  • diarrhoea
  • 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 adverse effects observed with travoprost are eye redness and eyelash growth. Both of these adverse effects occurred at a higher incidence in children and adolescents compared to adults.

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 Travoprost Stada

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

Do not use this medicine after the expiry date stated on the bottle and 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 seal is broken or damaged before first opening.

Keep the bottle in the pouch before opening to protect it from moisture.

This medicine does not require special storage conditions after first opening.

To prevent infection, the bottle must be discarded 4 weeks after first opening, and a new bottle should be used. Record the date of first opening in the space provided on the 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 in doubt, please ask your pharmacist how to dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the container and other information

Composition of Travoprost Stada

  • The active substance is travoprost. This medicine contains 40 micrograms/ml of travoprost.
  • The other components are benzalkonium chloride, macrogol glycerol hydroxystearate, tromethamine, disodium edetate, boric acid, mannitol, sodium hydroxide for pH adjustment, and water for injection or purified water.

Appearance of the product and contents of the container

Travoprost Stada is a clear, colourless solution supplied in containers consisting of pouches containing vial(s) made of translucent polypropylene with a low-density transparent polyethylene (LDPE) dropper and a white high-density polyethylene (HDPE) screw cap. Each vial contains 2.5 ml of solution.

Pack sizes contain 1, 3, 6, 9, 10 or 12 vials.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

[email protected]

Manufacturer

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

The Netherlands

or

JADRAN – GALENSKI LABORATORIJ d.d.

Svilno 20,

Rijeka, 51000

Croatia

Date of the most recent revision of the leaflet: September 2019

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/