TRAVOPROST STADA 40 micrograms/ml eye drops solution

Introduction

Package Leaflet: Information for the User

Travoprost Stada 40 micrograms/ml eye drops, solution

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

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

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

2. What you need to know before you use Travoprost Stada

Do not use Travoprost Stada

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

Talk to your doctor if you are in this situation.

Warnings and precautions

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

• Travoprost may change 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 had eye surgery (cataract surgery), talk to your doctor before using Travoprost Stada.
• If you have or have had eye inflammation (iritis and uveitis), talk to your doctor before using Travoprost Stada.

• Travoprost may rarely cause shortness of breathor noisy breathingor increase the symptoms of asthma. If you are concerned about changes in your breathing while usingTravoprost Stada, talk to your doctor as soon as possible.
• Travoprost may be absorbed through the skin. If the medicine comes into contact with the skin, it should be removed by washingimmediately. This is especially important in pregnant or breast-feeding women.
• If you wear soft contact lenses, do not apply the drops while wearing them. After applying the drops, wait 15 minutes before putting the lenses back in.

Children and adolescents

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

Other medicines and Travoprost Stada

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Pregnancy, breast-feeding, and 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 must use an effective method of birth control while using travoprost.

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

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine.

Driving and using machines

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

Travoprost Stada contains benzalkonium chloride

This medicine contains 0.15 mg of benzalkonium chloride per ml.

Benzalkonium chloride may be absorbed by soft contact lenses and change their color. Remove contact lenses before using this medicine and wait 15 minutes before putting them back in.

Benzalkonium chloride may cause eye irritation, especially if you have dry eyes or other corneal diseases (diseases of the transparent layer on the front of the eye). Talk to your doctor if you feel any unusual sensation, itching, or pain in the eye 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 given to you by your doctor or your child's doctor for the administration of this medicine. If you are unsure, talk to your doctor or pharmacist again.

The recommended dose is:

One drop into the affected eye(s) once daily, in the evening.

Travoprost should only be applied to both eyes if your doctor has told you to do so. Continue the treatment for the period of time recommended by your doctor or your child's doctor.

Travoprost Stada should only be used as eye drops.

If a drop falls outside the eye, try again.

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

If you or your child receive more Travoprost Stada than you should

Rinse your eye with lukewarm water. Do not apply more drops until the next dose is due.

If you forget to use Travoprost Stada

Continue with the next dose as planned. Do notapply 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 talking to your doctor or your child's doctor first. 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 on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

You can normally continue your treatment as long as the side effects are not serious. If you are worried about side effects, talk to your doctor or pharmacist. Do not stop using travoprost without talking to 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:

• Eye redness

Common side effects: may affect up to 1 in 10 people

Eye effects:

• Changes in iris color (the colored part of the eye)
• Eye pain
• Eye discomfort
• Dry eye
• Eye itching
• Eye irritation

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

Eye effects:

• Corneal disorders
• Eye inflammation
• Iritis
• Uveitis
• Inflammation with or without damage to the surface of the eye
• Sensitivity to light
• Eye discharge
• Eye lid inflammation
• Eye lid redness
• Swelling around the eye
• Eye lid itching
• Blurred vision
• Increased tear production
• Conjunctivitis (inflammation of the conjunctiva)
• Abnormal turning out of the lower eyelid
• Dim vision
• Eye lid crusts
• Increased growth of eyelashes

Other effects:

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

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

Eye effects:

• Flashes of light
• Eye lid eczema
• Abnormally positioned eyelashes growing inwards towards the eye
• Eye swelling
• Reduced vision
• Halos around lights
• Decreased sensation in the eye
• Inflammation of the glands of the eyelids
• Pigmentation inside the eye
• Increased pupil size
• Thickening of the eyelashes
• Change in eyelash color
• Tired eyes

Other effects:

• Viral infection of the eye
• Dizziness
• Bad taste in the mouth
• Irregular or decreased heartbeat
• Increased or decreased blood pressure
• Shortness of breath
• Asthma
• Nasal allergy or inflammation
• Nasal dryness
• Changes in voice
• Ulcers or discomfort in the stomach or intestines
• Constipation
• Dry mouth
• Redness or itching of the skin
• Rash
• Change in hair color
• Loss of eyelashes
• Joint pain
• Musculoskeletal pain
• General weakness

Frequency not known: cannot be estimated from the 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 heartbeat
• Increased heart rate
• Worsening of asthma
• Diarrhea
• Nosebleeds
• 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 eye redness and increased growth of eyelashes. Both side effects were observed with a higher incidence in children and adolescents compared to adults.

Reporting of side effects:

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Agency's website: https://www.notificaram.es. By reporting side 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 which is stated on the bottle and carton after EXP. The expiry date is the last day of the month stated.

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

Keep the bottle in the pouch until you are ready to use it to protect it from moisture.

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

You must throw away the bottle 4 weeks after you first opened it, and use a new bottle. Write the date you opened it on the space provided on the carton.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Travoprost Stada contains

• The active substance is travoprost. This medicine contains 40 micrograms/ml of travoprost.
• The other ingredients are benzalkonium chloride, macrogolglycerol hydroxystearate 40, trometamol, disodium edetate, boric acid, mannitol, sodium hydroxide (for pH adjustment), and water for injections or purified water.

Appearance and packaging

Travoprost Stada is a clear and colorless solution and comes in packs containing pouches with a 5 ml bottle of translucent polypropylene with a low-density polyethylene (LDPE) dropper and a high-density polyethylene (HDPE) white cap. Each bottle contains 2.5 ml of solution.

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

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation 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

Netherlands

or

JADRAN – GALENSKI LABORATORIJ d.d.

Svilno 20,

Rijeka, 51000

Croatia

Date of last revision of the leaflet: September 2019

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

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