TAVLIANT 40 micrograms/ml eye drops solution

Introduction

Package Leaflet: Information for the User

Tavliant 40 micrograms/ml eye drops, solution

travoprost

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

1. What is Tavliant and what is it used for

Tavliant 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 with beta-blockers, which also reduce the pressure in the eye.

Tavliant is usedtoreducehighpressureintheeyeinadults, adolescents and children from 2 months of age. This pressure can lead to an illness called glaucoma.

2. What you need to know before you use Tavliant

Do not use Tavliant

• 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 cataract surgery, talk to your doctor before you start using this medicine.
• If you have or have had eye inflammation(iritis and uveitis), talk to your doctor before you start using this medicine.

• 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, talk to your doctor as soon as possible.
• Travoprost may be absorbed through the skin. In case of contactof the medicine with the skin, it should be removed by washingimmediately. This is especially important in pregnant or breastfeeding 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 of age to < 18 years with the same dose as in adults. The use of travoprost is not recommended in children under 2 months of age.

Other medicines and Tavliant

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

Pregnancy, breastfeeding and fertility

Do not use Tavliant if you are pregnant. If you think you might be pregnant, tell your doctor. If you can become pregnant, you should use an effective method of birth control while using travoprost.

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

Talk to your doctor before using any medicine.

Driving and using machines

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

Tavliant contains benzalkonium chloride

This medicine contains 0.15 mg of benzalkonium chloride per ml.

Benzalkonium chloride may be absorbed by soft contact lenses and may alter the color of the contact lenses. Remove the 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 (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.

Tavliant contains macrogolglycerol hydroxystearate

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

3. How to use Tavliant

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

The recommended dose is

One drop in the affected eye(s), once a day- at night.

Travoprost should only be applied in both eyes if your doctor tells you to do so. Follow the treatment for the period of time indicated by your doctor or the doctor treating the child.

Travoprost should only be used as eye drops.

If a drop falls outside the eye,try again.

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

If you or the child receive more Tavliant than you should

You can rinse your eye with warm water. Do not apply more drops until it is time for your next dose.

If you forget to use Tavliant

Continue with the next dose as planned. Do notapply a double doseto make up for the forgotten dose. Never apply more than one drop per day in the affected eye(s).

If you stop using Tavliant

Do not stop using travoprost without talking to your doctor or the doctor treating the child first, as the pressure in your eye or the 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, the doctor treating the child or your 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 they are serious, talk to your doctor or pharmacist. Do not stop using travoprost without talking to your doctor.

The following side effects have been seen 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 (the colored part of the eye)
• Pain in the eye
• Discomfort in the eye
• Dry eye
• Itching in the eye
• Irritation in the eye

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

Eye effects:

• Corneal changes
• Eye inflammation
• Iris inflammation
• Inflammation inside the eye
• Inflammation with or without damage to the surface of the eye
• Sensitivity to light
• Eye discharge
• Eyelid inflammation
• Redness of the eyelid
• Swelling around the eye
• Itching of the eyelid
• Blurred vision
• Increased tear production
• Conjunctivitis (inflammation of the conjunctiva)
• Abnormal turning out of the lower eyelid
• Darkening of vision
• Crusts on the eyelid
• Growths of the eyelashes

Other effects:

• Increased allergic symptoms
• Headache
• Irregular heartbeat
• Cough
• Stuffy nose
• Sore throat
• Darkening of the skin around the eyes
• 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
• Eyelid eczema
• Abnormally positioned eyelashes that grow inwards towards the eye
• Swelling of the eye
• Reduced vision
• Halos around lights
• Decreased sensation in the eye
• Inflammation of the eyelid glands
• Pigmentation inside the eye
• Increased pupil size
• Thickening of the eyelashes
• Change in eyelash color
• Tired eyes

Other effects:

• Viral eye infection
• Dizziness
• Bad taste in the mouth
• Irregular or slow heartbeat
• Increased or decreased blood pressure
• Shortness of breath
• Asthma
• Nasal allergy or inflammation
• Nasal dryness
• Changes in voice
• Ulcers or gastrointestinal discomfort
• 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
• Painful or involuntary urination (involuntary urination or pain when urinating)
• Increased prostate cancer marker.

In children and adolescents, the most common side effects seen with travoprost are redness of the eye and growth of the eyelashes. Both side effects were seen more frequently 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 to the Spanish Medicines Agency: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Tavliant

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 shown.

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

This medicine does not require any special storage conditions. Keep the bottle in the bag before opening.

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

To avoid infections, you must discard the bottle 4 weeks after first opening, and use a new bottle. Write the opening date on the space provided on the carton.

Medicines should not be disposed of via wastewater or household waste. Return the containers and any unused medicines to the pharmacy. If you are unsure, ask your pharmacist how to dispose of the containers and any unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Tavliant

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

Appearance and packaging of the product

Tavliant is a clear and transparent solution presented in packs containing bags with a 5 ml bottle of translucent polypropylene with a low-density polyethylene (LDPE) dropper and a high-density polyethylene (HDPE) white cap. Each pack contains a bottle with 2.5 ml of eye drops solution.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Laboratorio Stada, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[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 AG

Stadastrasse 2-18, 61118 Bad Vilbel

Germany

or

JADRAN – GALENSKI LABORATORIJ d.d.

Svilno 20,

Rijeka, 51000

Croatia

Date of last revision of the leaflet: August 2024

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/