Bilaxten 6 mg/ml eye drops solution
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Bilaxten 6 mg/ml eye drops, solution
bilastine
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, consult your doctor or pharmacist.
- This medicine has been prescribed for you only, and you should not give it to others, 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.
Contents of the leaflet
- What Bilaxten is and what it is used for
- What you need to know before using Bilaxten
- How to use Bilaxten
- Possible adverse effects
- How to store Bilaxten
- Contents of the pack and other information
1. What Bilaxten is and what it is used for
This medicine contains bilastine, which belongs to a group of medicines called antihistamines. Antihistamines work by preventing the effects of a substance called histamine, which the body produces as part of an allergic reaction.
This medicine is used to treat the signs and symptoms of ocular disorders associated with seasonal allergic conjunctivitis in adults and children from 2 years of age.
This medicine is also used to treat the signs and symptoms of ocular disorders caused by allergies to substances such as house dust mites or animal hair (perennial allergic conjunctivitis) in adults and children from 2 years of age.
2. What you need to know before using Bilaxten
Do not use Bilaxten
- if you are allergic to bilastine or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Consult your doctor or pharmacist before starting to use Bilaxten if adverse effects occur during treatment, such as eye irritation, pain, redness, or changes in vision, or if your condition worsens. It may be necessary to discontinue treatment.
After administering Bilaxten eye drops into the conjunctival sac of the eye, visual acuity may decrease for a few minutes due to the formation of spots.
In case of inflammation, including allergic conjunctivitis, consult your ophthalmologist about whether you can wear contact lenses despite symptoms.
Children and adolescents
This medicine is indicated for use in adults and children aged 2 years and older.
Do not administer this medicine to children under 2 years of age, as efficacy and safety have not been studied in these groups.
Other medicines and Bilaxten
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
If you are using other eye medications, leave at least 5 minutes between each medication.
Ophthalmic ointments should be administered last.
Pregnancy, breastfeeding and fertility
Bilaxten may be used during pregnancy and breastfeeding. If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.
Driving and using machines
After instillation of this medicine, temporary blurred vision or other visual disturbances may occur, which may affect your ability to drive or operate machinery. Wait until your vision is clear before driving or using machinery.
Contact lenses
The use of this medicine does not affect the properties of contact lenses. You may continue wearing contact lenses during treatment with this medicine.
However, you must remove your contact lenses before applying the eye drops and wait at least 15 minutes after administration before reinserting them.
3. How to use Bilaxten
Follow exactly the instructions for administering this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
The recommended dose for adults and children from 2 years of age is one drop in each affected eye once daily.
This medicine may be used for up to a maximum of 8 weeks. Your doctor will decide and advise you on how long you should use it, depending on your individual condition.
For ocular use only.
Method of administration
- Always wash your hands and dry them with a clean towel before administering this medicine.
- Gently clean the eyelids if there is any discharge by wiping the closed eyelid from the inner to the outer part using cotton moistened with warm water.
- Open the bottle and avoid touching the dropper tip to your eye or any other surface: the drops and dropper must remain clean.
- Tilt your head backwards, or lie down, and look upwards (Figure 1). Using your finger, gently pull down the lower eyelid (Figure 2).
- Look upwards and squeeze the bottle so that one drop falls into the eye.
- Release the lower eyelid and keep the eye closed for a while to spread the drop over the eye surface (Figure 3).
- Repeat the above steps in the other eye if necessary.
To avoid contamination during use of this medicine, do not touch any surface (eyelids, areas around the eye, or other surfaces) with the dropper tip, and dry the dropper tip after use with a clean tissue to remove any residual liquid.
If you use more Bilaxten than you should
You may rinse the eye with warm water. In case of doubt, consult your doctor. In case of overdose or accidental ingestion, contact the Toxicology Information Service at Tel.: 91 562 04 20.
If you forget to use Bilaxten
Do not use a double dose to make up for missed doses.
If you forget to apply the drop on time, apply the missed dose as soon as possible and then continue with your usual dosing schedule.
If you stop using Bilaxten
Treatment with this medicine should, if possible, be continued regularly until symptoms have resolved. If you stop using Bilaxten while still exposed to allergens, typical allergy symptoms may reappear.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine may produce adverse effects, although not everyone experiences them.
The following adverse effects have been reported.
Uncommon adverse effects (may affect up to 1 in 100 people):
Altered taste (dysgeusia), headache.
Dry eye, eye discharge, eye irritation, increased tear production, eye discomfort.
If any of the adverse effects listed above occur, stop using this medicine and consult your doctor immediately. The adverse effects mentioned are usually mild and resolve quickly in all cases. Therefore, no specific measures are required.
Reporting of adverse effects
If you experience any type of adverse effect, consult 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 Bilaxten
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label or container after EXP. The expiry date refers to the last day of the month indicated.
This medicine does not require any special storage conditions.
After first opening the bottle: do not use this medicine if the bottle has been open for more than 2 months.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point in your pharmacy. If in doubt, ask your pharmacist how to properly 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 Bilaxten
- The active substance is bilastine 6 mg/ml.
One drop contains 0.2 mg of bilastine.
- The other components are hydroxypropyl betadex, methylcellulose, sodium hyaluronate, glycerol (E 422), sodium hydroxide 1 N (for pH adjustment), water for injections.
Appearance of the product and contents of the container
Bilaxten is a clear, colourless ophthalmic solution supplied in 1 multidose bottle made of white LDPE containing 5 ml of preservative-free solution, with a white HDPE dropper and a tamper-evident safety seal.
Pack size: 1 bottle of 5 ml.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Faes Farma, S.A.
Autonomia Etorbidea, 10
48940 Leioa (Bizkaia)
Spain
Manufacturer
FAMAR Health Care Services Madrid, S.A.U.
Avenida Leganés, 62
28923 Alcorcón
Madrid
Spain
This medicinal product is authorised in the European Economic Area Member States under the following names:
Germany: Antires 6 mg/ml Augentropfen, Lösung;
Spain: Bilaxten 6 mg/ml colirio en solución;
France: Inorial 6 mg/ml collyre en solution;
Greece: Bilargen;
Italy: Robilas 6 mg/ml collirio, soluzione;
Poland: Bilaxten;
Portugal: Bilaxten 6 mg/ml colírio, solução;
Date of the most recent review of this leaflet: June 2025
Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).