Travoprost Abamed 40 micrograms/ml eye drops solution
Spain
Table of Contents
- Package leaflet: Information for the user
- Introduction
- 1. What Travoprost Abamed is and what it is used for
- 2. What you need to know before using Travoprost Abamed
- 3. How to use Travoprost Abamed
- 4. Possible adverse effects
- 5. Storage of Travoprost Abamed
- 6. Contents of the pack and other information
Package leaflet: Information for the user
Introduction
PACKAGE LEAFLET: INFORMATION FOR THE USER
Travoprost Abamed 40 micrograms/ml eye drops solution
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 could harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Leaflet contents
- What Travoprost Abamed is and what it is used for
- What you need to know before using Travoprost Abamed
- How to use Travoprost Abamed
- Possible adverse effects
- How to store Travoprost Abamed
- Contents of the pack and other information
1. What Travoprost Abamed is and what it is used for
Travoprost Abamed contains travoprost, which belongs to a group of medicines called prostaglandin analogues. It works by reducing the pressure inside the eye. It may be used alone or in combination with other eye drops, for example beta-blockers, which also reduce intraocular pressure.
Travoprost Abamed is used to reduce elevated intraocular pressure in adults, adolescents, and children from the age of 2 months. Elevated pressure can lead to a condition called glaucoma.
2. What you need to know before using Travoprost Abamed
Do not use Travoprost Abamed:
- 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
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Travoprost Abamed may increase the length, thickness, colour, and/or number of your eyelashes. Changes such as unusual growth of hair on the eyelids or tissues around the eye may also occur.
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Travoprost Abamed may change the colour of the iris (the coloured part of the eye). This change may be permanent. Changes such as unusual growth of hair on the eyelids or tissues around the eye may also occur.
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If you have undergone cataract surgery, consult your doctor before starting to use Travoprost Abamed.
- If you currently have or have previously had eye inflammation (iritis or uveitis), consult your doctor before starting to use Travoprost Abamed.
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Travoprost Abamed may, in rare cases, cause shortness of breath, noisy breathing, or worsen asthma symptoms. If you are concerned about changes in your breathing while using Travoprost Abamed, consult your doctor as soon as possible.
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Travoprost can be absorbed through the skin. If the medicine comes into contact with the skin, wash the area immediately. This is especially important for pregnant women or women trying to become pregnant.
Children and adolescents
Travoprost Abamed can be used in children from 2 months of age up to under 18 years of age at the same dose as in adults. The use of Travoprost Abamed is not recommended in children under 2 months of age.
Other medicines and Travoprost Abamed
Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Pregnancy
Do not use Travoprost Abamed if you are pregnant. If you think you might be pregnant, consult your doctor immediately. If you could become pregnant, you should use an appropriate method of contraception while using Travoprost Abamed.
Breastfeeding
Do not use Travoprost Abamed if you are breastfeeding, as Travoprost Abamed may pass into breast milk.
Consult your doctor before using any medicine.
Driving and using machines
Immediately after applying Travoprost Abamed, you may experience blurred vision. Do not drive or operate machinery until this effect has disappeared.
Travoprost Abamed contains benzalkonium chloride.
This medicine contains 0.375 mg of benzalkonium chloride per 2.5 ml bottle, equivalent to 0.150 mg/ml.
Benzalkonium chloride may be absorbed by soft contact lenses and may change the colour of contact lenses. Remove contact lenses before using this medicine and wait 15 minutes before reinserting them.
Benzalkonium chloride may cause eye irritation, particularly if you have dry eye or other corneal diseases (the transparent layer at the front of the eye). Consult your doctor if you experience a foreign body sensation, stinging, or eye pain after using this medicine.
3. How to use Travoprost Abamed
Follow exactly the instructions for administering this medicine as given by your doctor or the doctor treating the child. If in doubt, consult your doctor, the child's doctor, or pharmacist again.
The recommended dose is 1 drop in the affected eye or eyes, once daily in the evening.
Travoprost should be applied to both eyes only if your doctor specifically instructs you to do so. Continue treatment for the entire period indicated by your doctor or the child's doctor.
Travoprost should only be used as eye drops for your eyes or for those of children.
Instructions for use
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Before using this medicine for the first time, make sure the security ring is intact.
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Wash your hands and sit or stand comfortably.
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Unscrew the cap.
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Remove the security ring from the container.
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Hold the bottle upside down between your fingers. Gently tilt your head or the child's head backward. Gently pull down the eyelid to create a pouch, into which the drop should fall
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Bring the tip of the bottle close to the eye. A mirror may be helpful.
- Gently squeeze the bottle so that only one drop enters the eye, then release the lower eyelid. Do not touch the eye, eyelid, surrounding areas, or any other surfaces with the dropper tip, as the drops could become contaminated.
If a drop misses the eye, try again.
- Gently squeeze the bottle to release one drop of travoprost at a time.
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After using travoprost, close your eyes gently and, with light pressure, press your finger against the inner corner of the eye, near the nose, for at least 1 minute. This helps prevent travoprost from passing into the rest of the body.
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Repeat in the other eye if instructed by your doctor.
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Immediately close the bottle tightly after using the product.
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Use one bottle at a time. Do not open the pouch until you need to use the bottle.
If a drop misses the eye, try again.
If you or the child are using other ophthalmic medicines, such as eye drops or eye ointments, wait at least 5 minutes between applying travoprost and the other ophthalmic medicines.
If you or the child use more Travoprost Abamed than you should
You can remove it by rinsing the eyes with lukewarm water. Do not apply any more drops until it is time for your next dose.
If you forget to use travoprost, continue with your next scheduled dose. Do not apply a double dose to make up for the missed dose. Never apply more than 1 drop in the affected eye(s) in a single day.
If you stop treatment with travoprost without first consulting your doctor or the child's doctor, the pressure in your eye or the child's eye will not be controlled, which could lead to vision loss.
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 may cause adverse effects, although not everyone experiences them.
You may continue treatment as usual unless the adverse effects are severe. If you are concerned about any of these effects, consult your doctor or pharmacist. Do not stop using Travoprost Abamed without first consulting your doctor.
The following adverse effects have been observed with Travoprost Abamed:
Very common adverse effects
(May affect more than 1 in 10 patients)
Eye effects: eye redness
Common adverse effects
(May affect up to 1 in 10 patients)
Eye effects: change in iris colour (the coloured part of the eye), eye pain, eye discomfort, dry eye, eye itching, eye irritation
Uncommon adverse effects
(May affect up to 1 in 100 patients)
Eye effects: corneal disorder, eye inflammation, iris inflammation, intraocular inflammation, eye inflammation with or without damage to the eye surface, light sensitivity, eye discharge, eyelid inflammation, eyelid redness, swelling around the eye, eyelid itching, blurred vision, increased tear production, conjunctival infection or inflammation (conjunctivitis), abnormally turned outward lower eyelid, darkened vision, eyelid crusting, eyelash growth.
Other effects: increased allergic symptoms, headache, irregular heartbeat, cough, nasal congestion, throat irritation, darkening of the skin around the eyes, skin darkening, abnormal hair texture, excessive hair growth.
Rare: may affect up to 1 in 1,000 people
Eye effects: perception of flashes of light, eyelid eczema, abnormally positioned eyelashes growing into the eye, eye swelling, reduced vision, visual halos, decreased sensation in the eye, inflammation of the eyelid glands, pigmentation inside the eye, increased pupil size, eyelash thickening, change in eyelash colour, tired eyes.
Other effects: viral eye infection, dizziness, bad taste in mouth, irregular or slow heartbeat, increased or decreased blood pressure, shortness of breath, asthma, nasal inflammation or allergy, nasal dryness, voice changes, gastrointestinal ulcer or discomfort, constipation, dry mouth, skin redness or itching, rash, change in hair colour, eyelash loss, joint pain, musculoskeletal pain, generalized 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, tinnitus (ringing in the ears), chest pain, abnormal heart rhythm, increased heart rate, worsening of asthma, diarrhoea, 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 frequently observed adverse effects with Travoprost Abamed are eye redness and eyelash growth. Both of these adverse effects occurred at a higher incidence in children and adolescents compared to adults.
Reporting of adverse effects
If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Travoprost Abamed
Keep this medicine out of the reach and sight of children.
Do not use this medicine after the expiry date stated on the bottle and the carton, indicated after "EXP". The expiry date refers to the last day of the month shown.
This medicine does not require any special storage conditions.
To prevent infections, the bottle must be discarded 4 weeks after first opening, and a new bottle should be used. Please write the date of opening in the spaces provided on the label of each bottle and on the carton.
Medicines must not be disposed of via wastewater or household waste. Unused medicines and waste materials should be returned to the SIGRE point at your pharmacy. If you have any doubts, please ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Travoprost Abamed
- The active substance is travoprost 40 micrograms/ml.
- The other components are: benzalkonium chloride, macrogol-15-hydroxystearate, tromethamine, boric acid, disodium EDTA, mannitol, and water for injections. Very small amounts of hydrochloric acid or sodium hydroxide are added to adjust the pH.
Appearance of the product and contents of the container
Travoprost Abamed is a liquid (a clear, colourless solution) in a 5 ml plastic dropper bottle with a white screw cap and a safety seal. Each bottle contains 2.5 ml of solution. Travoprost Abamed is available in packs containing 1 or 3 bottles. Only certain pack sizes may be marketed.
Marketing Authorisation Holder
Qualix Pharma, S.L.
C/Botánica 137-139
08908 L’Hospitalet de Llobregat
(Barcelona),
Spain
Manufacturer
Rafarm S.A. Thesi Pousi-Hatzi Agiou Louka, Paiania-Attiki, TK 19002, P.O. 37, Greece
Date of the most recent revision of this leaflet: March 2023
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/