Clatra

Package Leaflet: Information for the Patient

Clatra, 6 mg/mL, Eye Drops, Solution

Bilastine

Read the Leaflet Carefully Before Using the Medication, as it Contains Important Information for the Patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medication has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

• 1. What is Clatra and what is it used for
• 2. Important information before using Clatra
• 3. How to use Clatra
• 4. Possible side effects
• 5. How to store Clatra
• 6. Contents of the pack and other information

1. What is Clatra and what is it used for

Clatra contains the active substance bilastine, which belongs to a group of medicines called antihistamines.
Antihistamines work by preventing the effects caused by a substance called histamine, which the body produces during an allergic reaction.
This medication is used to treat symptomatic eye disorders associated with seasonal conjunctivitis
in adults and children aged 2 years and older.
This medication is also used to treat symptomatic eye disorders caused by allergy to substances such as house dust mites or animal hair (perennial conjunctivitis)in adults and children aged 2 years and older.

2. Important information before using Clatra

When not to use Clatra

• if you are allergic to bilastine or any of the other ingredients of this medication (listed in section 6).

Warnings and precautions

Before using Clatra, discuss it with your doctor or pharmacist. If you experience side effects such as eye irritation, pain, redness, or blurred vision, or if your condition worsens, it may be necessary to discontinue treatment.
After instilling Clatra eye drops into the conjunctival sac, vision may be blurred for a few minutes due to the formation of streaks.
If you experience symptoms of inflammation, including allergic conjunctivitis, you should ask your treating ophthalmologist if you can wear contact lenses despite these symptoms.

Children and adolescents

Clatra is indicated for use in adults and children aged 2 years and older.
Do not give this medication to children under 2 years of age, as its safety and efficacy have not been established in this population.

Clatra and other medications

Tell your doctor or pharmacist about all medications you are taking, have recently taken, or plan to take.
If you are using other eye drops, wait 5 minutes between instillations. Apply eye ointments last.

Pregnancy, breastfeeding, and fertility

Clatra can be used during pregnancy and breastfeeding. If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before using this medication.

Driving and using machines

Temporary blurred vision or other visual disturbances that affect the ability to drive or operate machinery may occur after using this medication. Wait until your vision returns before driving or operating machinery.

Contact lenses

Using this medication does not change the properties of contact lenses. You can continue to wear contact lenses after using the medication.
Remove contact lenses before using the medication and wait at least 15 minutes after using the medication before putting them back in.

3. How to use Clatra

Always use this medication exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
The recommended dose for adults and children aged 2 years and older is one drop into each eye once daily.
This medication can be used for up to 8 weeks. Your doctor will determine how long you should use Clatra based on your condition.
For ophthalmic use only.
Method of administration

• 1. Before using this medication, always wash your hands and dry them with a clean towel.
• 2. If there is dried secretions on the eyelid, gently clean it by wiping the eyelid with a cotton swab moistened with warm water, from the inner to the outer corner of the eye, with the eye closed.
• 3. Open the bottle and avoid touching the dropper tip to the eye or anything else.
• drops and dropper must be kept clean.

• 4. Tilt your head back or lie down and look up (Figure 1). Gently pull the lower eyelid down (Figure 2).
• 5. Look up and instill one drop into the eye.
• 6. Release the lower eyelid and do not open your eye for a few moments to spread the drop over the eye surface (Figure 3).
• 7. If necessary, repeat the above steps for the other eye.

Figure 1
Figure 2
Figure 3
To avoid contamination when using this medication, do not touch the dropper tip to any surfaces (eyelids, eye area, or other surfaces) and clean the dropper tip with a clean cloth after use to remove any residual liquid.

Overdose of Clatra

You can rinse your eyes with warm water.

Missed dose of Clatra

Do not use a double dose to make up for a missed dose.
If you miss a dose, use it as soon as possible, and then return to your regular dosing schedule.

Stopping Clatra treatment

If possible, treatment with this medication should be continued regularly until symptoms resolve. If you stop using Clatra during exposure to the allergen(s), you can expect a recurrence of typical allergy symptoms.
If you have any further questions about using this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, Clatra can cause side effects, although not everybody gets them.
The following side effects have been reported.
Uncommon (affects less than 1 in 100 people)
Taste disorders, headache.
Dry eye syndrome, eye discharge, eye irritation, increased tearing, eye discomfort.
If you experience any of the above side effects, stop using this medication and consult your doctor. Side effects are usually mild and resolve quickly in all cases. Therefore, no special precautions are required.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. You can also report side effects directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
You can also report side effects to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medication.

5. How to store Clatra

Keep this medication out of the sight and reach of children.
Do not use this medication after the expiry date stated on the carton and bottle after “EXP”.
The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
After first opening the bottle: do not use this medication after 2 months of first opening.
Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Clatra contains

• The active substance is bilastine 6 mg/mL. One drop contains 0.2 mg of bilastine.
• The other ingredients are: hydroxypropylbetadex, methylcellulose, sodium hyaluronate, glycerol (E 422), sodium hydroxide 1N (for pH adjustment), water for injections.

What Clatra looks like and contents of the pack

Clatra is a clear, colorless solution, in a white LDPE bottle with a 5 mL solution, with an HDPE dropper and a tamper-evident cap.
Pack size: 1 bottle of 5 mL

Marketing authorization holder and manufacturer

Marketing authorization holder

Menarini International Operations Luxembourg S.A.
1, Avenue de la Gare
L-1611 Luxembourg
Luxembourg

Manufacturer

FAMAR Health Care Services Madrid S.A.U.

Avenida de Leganés 62
28923 Alcorcón
Spain
(On behalf of Faes Farma, S.A. (Spain))

This product is authorized in the Member States of the European Economic Area (EEA) under the following names:

Austria: Olisir 6 mg/ml Augentropfen, Lösung
Belgium: Bellozal 6 mg/ml eye drops, solution
Croatia: Nixar 6 mg/ml kapi za oko, otopina
Cyprus: Bilaz 6mg/ml οφθαλμικές σταγόνες
Czech Republic: Xados
Estonia: Opexa
France: Bilaska 6 mg/ml collyre en solution
Germany: Bilaxten 6 mg/ml Augentropfen, Lösung
Greece: Bilaz
Hungary: Lendin 6 mg/ml szemcsepp
Ireland: Drynol 6 mg/ml eye drops, solution
Italy: Olisir 6 mg/ml collirio, soluzione
Latvia: Opexa 6 mg/ml acu pilieni, šķīdums
Lithuania: Opexa 6 mg/ml akių lašai, tirpalas
Luxembourg: Bellozal 6 mg/ml eye drops, solution
Malta: Gosall 6 mg/ml eye drops, solution
Poland: Clatra
Portugal: Lergonix 6 mg/ml colírio, solução
Romania: Borenar 6 mg/ml picături oftalmice, soluţie
Slovakia: Omarit 6 mg/ml očné roztokové kvapky
Slovenia: Bilador 6 mg/ml kapljice za oko, raztopina
Spain: Ibis 6 mg/ml colirio en solución
For more information about this medication, contact the representative of the marketing authorization holder:
Berlin-Chemie/Menarini Polska Sp. z o.o.
Phone: +48 22 566 21 00
Fax: +48 22 566 21 01
Date of last revision of the leaflet:05/2025