SINETRAV 40 MICROGRAMS/ML EYE DROPS SOLUTION

Introduction

Package Leaflet: Information for the User

Sinetrav 40 micrograms/ml eye drops, solution

Travoprost

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

• Keep this package 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 package leaflet

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

1. What is Sinetrav and what is it used for

Sinetrav contains travoprost, a prostaglandin analogue. It works by reducing the pressure in the eye. It can be used alone or together with other eye drops, such as beta-blockers, which also reduce pressure.

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

Sinetrav eye drops, solution is a sterile solution that does not contain preservatives.

2. What you need to know before you use Sinetrav

Do not use Sinetrav

• 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

• Sinetrav may increase the 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.
• Sinetrav may change the color of your iris (the colored part of the eye). This change may be permanent. It can also cause a change in the color of the skin around the eye.
• If you have had cataract surgery, talk to your doctor before starting to use Sinetrav.
• If you have or have had eye inflammation (iritis or uveitis), talk to your doctor before starting to use Sinetrav.
• Sinetrav may, in rare cases, cause difficulty breathing or wheezing or increase asthma symptoms. If you are concerned about changes in your breathing while using this medicine, talk to your doctor as soon as possible.
• Sinetrav may be absorbed through the skin. In case of contact of the medicine with the skin, it should be removed by washing immediately. This is especially important in pregnant or breastfeeding women.
• If you wear contact lenses, do not apply the drops while wearing them. After applying the drops, wait 15 minutes before putting the contact lenses back in.

Children and adolescents

Sinetrav can be used in children from 2 months of age to <18 years with the same dose as in adults. use of sinetrav is not recommended children under 2 months age.< p>

Other medicines and Sinetrav

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 Sinetrav if you are pregnant.If you think you might be pregnant, talk to your doctor as soon as possible. If you can become pregnant, you must use adequate contraceptive measures while using this medicine.

Do not use Sinetrav if you are breastfeeding.This medicine may pass into breast milk.

If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, talk to your doctor before using this medicine.

Driving and using machines

You may notice that your vision becomes blurry for a while immediately after applying Sinetrav. Do not drive or use machines until these effects have disappeared.

Sinetrav contains macrogolglycerol hydroxystearate 40

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

3. How to use Sinetrav

Follow the instructions for administration of this medicine exactly as indicated by your doctor or the doctor treating the child. If in doubt, consult your doctor, the doctor treating the child, or the pharmacist again.

Sinetrav should only be used as eye drops.

The recommended dose is 1 drop in the affected eye(s) once a day, at night.

Use Sinetrav in both eyes only if your doctor has told you to do so.

Use this medicine for the time indicated by your doctor or the doctor treating the child.

Instructions for use

If you use more Sinetrav than you should

Remove the medicine by washing the eye with lukewarm water. Do not apply more drops until it is time for your next dose.

In case of overdose or accidental ingestion, talk to your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to use Sinetrav

Continue with the next scheduled dose. Do not apply a double dose to make up for forgotten doses. Never apply more than one drop in the affected eye(s) on the same day.

If you stop using Sinetrav

Do not stop using this medicine without talking to your doctor or the doctor treating the child. This is because the pressure in your eye or your child's eye will not be controlled, which could lead to loss of vision.

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 Sinetrav and other eye medicines.

If you have any other questions about the use of this medicine, ask your doctor, the doctor treating the child, or the 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 these effects worry you, talk to your doctor or pharmacist. Do not stop using Sinetrav without talking to your doctor.

The following side effects have been observed with the use of 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 (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 disorder
• eye inflammation
• iris inflammation
• inflammation inside the eye
• inflammation with or without damage to the eye surface
• sensitivity to light
• eye discharge
• eyelid inflammation
• eyelid redness
• swelling around the eye
• eyelid itching
• blurred vision
• increased tear production
• conjunctivitis (inflammation or infection of the conjunctiva)
• abnormal turning out of the lower eyelid
• shadowy vision
• eyelid crusts
• eyelash growth

General side effects:

• increased allergic symptoms
• headache
• irregular heartbeat
• cough
• stuffy nose
• throat irritation
• 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:

• iridocyclitis
• perception of flashes of light
• eyelid eczema
• abnormally positioned eyelashes that grow towards the eye
• eye swelling
• reduced vision
• vision of halos
• decreased sensitivity in the eye
• inflammation of the eyelid glands
• pigmentation inside the eye
• increased pupil size
• thickening of eyelashes
• change in eyelash color
• tired eyes

General side effects:

• eye viral infection
• dizziness
• bad taste in the mouth
• irregular or decreased heartbeat
• increased or decreased blood pressure
• difficult breathing
• asthma
• nasal allergy or inflammation
• nasal dryness
• voice changes
• stomach ulcers or discomfort
• constipation
• dry mouth
• skin redness or itching
• rash
• change in hair color
• loss of eyelashes
• joint pain
• musculoskeletal pain
• general weakness

Frequency not known(frequency cannot be estimated from the available data)

Eye effects:

• inflammation of the back of the eye
• sunken eyelid fold

General side effects:

• depression
• anxiety
• insomnia
• false sense of movement
• ringing in the ears
• chest pain
• heart rhythm disorder
• increased heart rate
• worsening of asthma
• diarrhea
• nosebleeds
• abdominal pain
• nausea
• vomiting
• itching
• abnormal hair growth
• painful or involuntary urination
• increase in prostate cancer marker

In children and adolescents, the most common side effects observed with travoprost are eye redness and eyelash growth. 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 through the Spanish Medicines Monitoring System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Sinetrav

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 multidose container is broken or damaged before you first open it.

Store below 25°C.

After opening, this medicine does not require any special storage conditions.

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

Medicines should not be disposed of via wastewater or household waste. Return the containers and medicines you no longer need to the pharmacy's SIGRE Point. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Sinetrav

• The active substance is travoprost. Each ml of solution contains 40 micrograms of travoprost.
• The other ingredients are macrogolglycerol hydroxystearate 40, sodium chloride, propylene glycol (E-1520), boric acid (E-284), mannitol (E-421), sodium hydroxide to adjust pH, and purified water.

Appearance of the product and contents of the pack

Sinetrav is a clear and transparent solution of 2.5 ml, presented in a cardboard box containing a multidose container (PP) white 5 ml with a pump system (PP, HDPE, LDPE), a green pressure cylinder, and a cap (HDPE).

The product is available in the following pack sizes:

1 x 2.5 ml (one 2.5 ml multidose container)

3 x 2.5 ml (three 2.5 ml multidose containers)

The boxes contain 1 or 3 bottles.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Horus Pharma

22 Allée Camille Muffat

INEDI 5

06200 Nice, France

Manufacturer

JADRAN GALENSKI LABORATORIJ D.D

Svilno, 20

51000 Rijeka, Croatia

Or

Pharmathen S.A.

6, Dervenakion Str

GR-15351, Pallini Attikis, Greece

Local representative

HORUS PHARMA IBÉRICA, S.L.U

Gran Vía Carlos III, 98, 6º

08028 Barcelona –

Date of last revision of this leaflet:July 2021

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