Sinetrav 40 micrograms/ml eye drops solution
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Sinetrav 40 micrograms/ml eye drops solution
Travoprost
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, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
Leaflet contents
- What Sinetrav is and what it is used for
- What you need to know before using Sinetrav
- How to use Sinetrav
- Possible side effects
- How to store Sinetrav
- Contents of the pack and other information
1. What Sinetrav is and what it is used for
Sinetrav contains travoprost, a prostaglandin analogue medicine. It works by reducing 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 elevated intraocular pressure in adults, adolescents, and children from 2 months of age. This pressure can lead to a condition called glaucoma.
Sinetrav eye drops solution is a sterile solution without preservatives.
2. What you need to know before using Sinetrav
Do not use Sinetrav
- 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
- Sinetrav may increase the length, thickness, color, and/or number of your eyelashes. Changes such as unusual growth of hair on the eyelids or tissues 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 may also cause a change in the skin color around the eye.
- If you have undergone cataract surgery, consult your doctor before starting to use Sinetrav.
- If you currently have or have previously had eye inflammation (iritis or uveitis), consult your doctor before starting to use Sinetrav.
- Sinetrav may, in rare cases, cause difficulty breathing, wheezing, or worsen asthma symptoms. If you are concerned about changes in your breathing while using this medicine, consult your doctor as soon as possible.
- Sinetrav may be absorbed through the skin. If the medicine comes into contact with the skin, it should be washed off immediately. This is particularly important for pregnant women or women 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 reinserting your contact lenses.
Children and adolescents
Sinetrav may be used in children from 2 months of age up to < 18 years of age at the same dose as in adults. Use of Sinetrav is not recommended in children under 2 months of age.
Other medicines and Sinetrav
Tell 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 Sinetrav if you are pregnant. If you think you may be pregnant, speak to your doctor immediately. If you are able to become pregnant, you should use appropriate 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 may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.
Driving and using machines
You may notice blurred vision for a short time immediately after applying Sinetrav. Do not drive or operate machinery until this effect has passed.
Sinetrav contains macrogol glycerol hydroxystearate 40
This medicine may cause skin reactions because it contains macrogol glycerol hydroxystearate 40.
3. How to use Sinetrav
Follow exactly the administration instructions for this medicine given by your doctor or the doctor treating the child. If in doubt, consult your doctor, the child's doctor, or pharmacist again.
Sinetrav should only be used as eye drops in your eyes or in the eyes of children.
The recommended dose is 1 drop in the affected eye(s) once daily, in the evening.
Use Sinetrav in both eyes only if your doctor has instructed you to do so.
Use this medicine for the length of time indicated by your doctor or the doctor treating the child.
Instructions for use
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If you use more Sinetrav than you should
Remove the medication by washing the eye with lukewarm water. Do not apply further drops until it is time for your next dose.
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number 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 a missed dose. Never apply more than one drop in the affected eye(s) in a single day.
If you stop treatment with Sinetrav
Do not stop using this medicine 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 lead to vision loss.
If you or the child are using other eye medications, such as eye drops or eye ointments
Wait at least 5 minutes between applying Sinetrav and the other eye medications.
If you have any further questions about the use of this medicine, ask your doctor, the child's doctor, or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone experiences 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 Sinetrav without first consulting your doctor.
The following adverse effects have been observed with the use of 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 disorder
- 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
General adverse effects:
- worsening of allergic symptoms
- headache
- irregular heartbeat
- cough
- nasal congestion
- throat irritation
- darkening of the skin around the eye(s)
- skin darkening
- abnormal hair texture
- excessive hair growth
Rare (may affect up to 1 in 1,000 people)
Eye effects:
- iridocyclitis
- perception of flashes of light
- eyelid eczema
- abnormally positioned eyelashes growing toward the eye
- eye swelling
- reduced vision
- halos around lights
- decreased eye sensitivity
- inflammation of the eyelid glands
- pigmentation inside the eye
- increased pupil size
- eyelash thickening
- change in eyelash colour
- tired eyes
General adverse effects:
- viral eye infection
- dizziness
- bad taste in mouth
- irregular or slow heartbeat
- increased or decreased blood pressure
- difficulty breathing
- asthma
- nasal allergy or inflammation
- nasal dryness
- voice changes
- stomach ulcer or gastrointestinal discomfort
- constipation
- dry mouth
- red or itchy skin
- rash
- change in hair colour
- eyelash loss
- joint pain
- musculoskeletal pain
- generalised weakness
Frequency not known (frequency cannot be estimated from available data)
Eye effects:
- inflammation of the back of the eye
- sunken eyelid crease
General adverse effects:
- depression
- anxiety
- insomnia
- false sensation of movement
- ringing in the ears
- chest pain
- heart rhythm disturbances
- increased heartbeats
- worsening of asthma
- diarrhoea
- nosebleeds
- abdominal pain
- nausea
- vomiting
- itching
- abnormal hair growth
- painful or involuntary urination
- increased prostate cancer marker
In children and adolescents, the most commonly observed adverse effects with travoprost are eye redness and eyelash growth. Both of these adverse effects occurred more frequently 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 Medicinal Products: https://www.notificaram.es. By reporting adverse 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 stated on the bottle and the 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 multidose container is broken or damaged before first opening.
Store below 25°C.
After opening, this medicine does not require any special storage conditions.
To prevent infection, the bottle must be discarded 4 weeks after first opening. Record the date of opening in the space provided on the carton and on the bottle.
Medicines must not be disposed of via wastewater or household waste. Unused containers and medicines should be taken to the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. Contents of the container and other information
Composition of Sinetrav
- The active substance is travoprost. Each ml of solution contains 40 micrograms of travoprost.
- The other components are macrogol glycerol hydroxystearate 40, sodium chloride, propylene glycol (E-1520), boric acid (E-284), mannitol (E-421), sodium hydroxide for pH adjustment, and purified water.
Appearance of the product and contents of the container
Sinetrav is a colorless and transparent solution of 2.5 ml, supplied in a cardboard box containing a 5 ml multidose container (PP) 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 vials.
Only certain pack 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
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, 6th floor
08028 Barcelona, Spain
Date of the most recent revision of this leaflet: July 2021
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/