Package Insert: Information for the User

Sinetrav 40 micrograms/mL Eye Drops Solution

Travoprost

Read this entire package insert carefully before starting to use this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
  If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only 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 adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

1. What Sinetrav is and for what it is used

2. What you need to know before starting to use Sinetrav

3. How to use Sinetrav

4. Possible adverse effects

5. Storage of Sinetrav

6. Contents of the package and additional information

Sinetravcontains travoprost, an analog of prostaglandinsprostaglandins. It acts by reducing eye pressure. It may be used alone or in combination with other eye drops, such as beta-blockers, which also reduce pressure.

Sinetravis used to reduce elevated intraocular pressure in adults, adolescents, and children aged 2 months and older.This pressure may cause a disease calledglaucoma.

Sinetrav eye drops in solution are a sterile solution that does not contain preservatives.

No use Sinetrav

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

Consult your doctor if you are in this situation.

Warnings and precautions

• Sinetrav may increase the length, thickness, color, and/or number of your eyelashes. It has also been observed that unusual hair growth in the eyelids or around the eye may occur.
• Sinetrav may alter the color of your iris (the colored part of your eye). This change may be permanent. It may also cause a change in the color of the skin around your eye.
• If you have undergone cataract surgery, consult your doctor before starting to use Sinetrav.
• If you suffer or have previously suffered from eye inflammation (iritis or uveitis), consult 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 medication, consult your doctor as soon as possible.
• Sinetrav may be absorbed through the skin. In the event of contact with the medication on the skin, it must be removed by washing immediately. This is particularly important in pregnant women or those trying to become pregnant.
• If you wear contact lenses, do not apply the drops while wearing them. After applying the drops, wait 15 minutes before putting your contact lenses back in.

Children and adolescents

Sinetrav may be used in children from 2 months of age to <18 years old.

Other medications and Sinetrav

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

Pregnancy,breastfeeding, and fertility

Do not use Sinetrav if you are pregnant.If you think you may be pregnant, speak with your doctor as soon as possible. If you can become pregnant, use suitable contraceptive measures while using this medication.

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

If you are pregnant, 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 that your vision becomes blurry for a short time immediately after applying Sinetrav. Do not drive or operate machinery until these effects have disappeared.

Sinetrav contains macrogolglycerol hydroxystearate 40

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 the child. In case of doubt, consult your doctor, the child's doctor, or the pharmacist again.

Sinetrav should only be used as eye drops for your eyes or the child's eyes.

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

Only use Sinetrav in both eyes if your doctor has instructed you to do so.

Use this medication for the time indicated by your doctor or the child's doctor.

Instructions for use

If you use more Sinetrav than you should

Flush the medication out of your eye with warm water. Do not apply more drops until your next scheduled dose.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication 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 missed doses. Never apply more than one drop in the affected eye(s) in a single day.

If you interrupt the treatment with Sinetrav

Do not stop using this medication without consulting your doctor or the child's doctor. This is because the pressure in your eye or the child's eye will not be controlled, which could cause vision loss.

If you or the child are using other eye medications, such as eye drops or ointments

Wait at least 5 minutes between applying Sinetrav and the other eye medications.

If you have any other questions about using this medication, ask your doctor, the child's doctor, or 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 Sinetrav without consulting your doctor.

The following side effects have been observed with the use of travoprost.

Very common side effects(can affect more than 1 in 10 people)

Eye effects:

• eye redness.

Common side effects(can 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(can 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
• eyelid inflammation
• eyelid redness
• swelling around the eye
• eyelid itching
• blurred vision
• increased tear production
• conjunctivitis (infection or inflammation of the conjunctiva)
• abnormal outward turning of the lower eyelid
• shadowed vision
• crusts on the eyelid
• abnormal eyelash growth

General side effects:

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

Rare(can affect up to 1 in 1,000 people)

Eye effects:

• iridocyclitis

• perception of flashes of light
• eyelid eczema
• eyelashes with abnormal position that grow towards the eye
• eye swelling
• reduced vision
• halos vision
• reduced sensitivity in the eye
• inflammation of the eyelid glands
• pigmentation within the eye
• enlarged pupil
• thickening of eyelashes
• change in eyelash color
• tired eyes

General side effects:

• ocular viral infection
• dizziness
• bad taste in the mouth
• irregular or decreased heart rate
• increased or decreased blood pressure
• difficult breathing
• asthma
• nasal allergy or inflammation
• nasal dryness
• voice changes
• gastrointestinal ulcer or discomfort
• constipation
• dry mouth
• skin redness or itching
• eruption
• change in hair color
• hair loss
• joint pain
• musculoskeletal pain
• generalized weakness

Unknown frequency(frequency cannot be estimated from available data)

Eye effects:

• posterior eye inflammation
• sunken eyelid fold

General side effects:

• depression
• anxiety
• insomnia
• false sensation of movement
• tinnitus in the ears
• chest pain
• alteration of heart rhythm
• increased heartbeats
• asthma worsening
• diarrhea
• nasal bleeding
• abdominal pain
• nausea
• vomiting
• itching
• abnormal hair growth
• painful urination or involuntary urination.
• increased 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 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 multidose container is broken or damaged before opening it for the first time.

Store below 25°C.

After opening, this medication does not require special storage conditions.

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

Medications should not be thrown away through the drains or in the trash. Deposit the containers and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. In this way, you will help protect the environment.

Composition of Sinetrav

• The active principle is travoprost. Each ml of solution contains 40 micrograms of travoprost.
• The other components 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 packaging

Sinetrav is a colourless and transparent 2.5 ml solution, presented in a cardboard box that includes a 5 ml multidose container (PP) with a pumping system (PP, HDPE, LDPE), a green pressure cylinder, and a cap (HDPE).

The product is available in the following packaging 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.

Only some packaging sizes may be commercially available.

Marketing authorization holder and manufacturer

Marketing authorization holder

Horus Pharma

22 Allée Camille Muffat

INEDI 5

06200 Nice, France

Manufacturer

JADRAN GALENSKI LABORATORIJ D.D

Svilno, 20

51000 Rijeka

Croatia

O

Pharmathen S.A.

6, Dervenakion Str

GR-15351, Pallini Attikis

Greece

Local representative

HORUS PHARMA IBÉRICA, S.L.U

Gran Vía Carlos III, 98, 6th floor

08028 Barcelona –

Last review date of this leaflet:July 2021

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/