Clatra

Package leaflet: Information for the user

Clatra, 6 mg/mL, eye drops, solution
Bilastinum
Please read the entire leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet for future reference.
• Consult your doctor or pharmacist if you have any further questions.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm other people, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform a doctor or pharmacist immediately. See section 4.

Table of contents:

1. What Clatra is and what it is 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 Clatra is and what it is used for

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

2. Important information before using Clatra

When not to use Clatra

• if the patient is allergic to bilastine or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting treatment with Clatra, consult a doctor or pharmacist. If the patient experiences any adverse reactions during treatment such as eye irritation, pain, redness or worsening of vision, or if the patient's condition worsens, discontinuation of treatment may be necessary.
After instillation into the conjunctival sac of Clatra antiallergic eye drops, visual acuity may be temporarily reduced for a few minutes due to the formation of streaks.
If the patient has signs of inflammation, including allergic conjunctivitis, they should consult their ophthalmologist whether they can continue wearing contact lenses despite these symptoms.
Children and adolescents
Clatra is indicated for use in adults and children aged 2 years and older.
This medicine should not be given to children under 2 years of age, as its safety and efficacy have not been established in this population.
Clatra and other medicines
Inform the doctor or pharmacist about all medicines currently used or recently used, as well as any medicines the patient intends to use.
When treating simultaneously with other locally applied ophthalmic medicines, a 5-minute interval should be maintained between administration of each medicine. Ophthalmic ointments should be administered last.
Pregnancy, breastfeeding and fertility
Clatra may be used during pregnancy and breastfeeding. If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Driving and operating machinery
Transient blurred vision or other visual disturbances affecting the ability to drive and operate machinery may occur after using this medicine. Patients should wait until vision clears before driving or operating machinery.
Contact lenses
This medicine does not alter the properties of contact lenses. Use of contact lenses may be continued after administration of the medicine.
Contact lenses must be removed before applying the medicine and should not be reinserted earlier than 15 minutes after administration.

3. How to use Clatra

This medicine should always be used exactly as instructed by your doctor or pharmacist. If in doubt,
please consult your doctor or pharmacist.
The recommended dose for adults and children aged 2 years and older is one drop in each eye once daily.
This medicine may be used for up to 8 weeks. Your doctor will determine, based on your condition,
how long you should continue using Clatra.
For ophthalmic use only.
Method of administration

1. Before administering this medicine, always wash your hands and dry them with a clean towel.
2. If there is dried discharge on the eyelid, gently clean it by wiping the closed eyelid from the inner to the outer corner using a cotton swab moistened with warm water.
3. Open the bottle and avoid touching the eye or any other surface with the dropper tip.
   • The dropper and solution must be kept clean.
4. Tilt your head backward or lie down and look upward (Figure 1). Gently pull down the lower eyelid with your finger (Figure 2).
5. Look upward and instill one drop into the eye.
6. Release the lower eyelid and keep the eye closed 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.

To avoid contamination during use, do not allow the dropper tip to touch any surfaces (eyelids, eye area, or other surfaces). After use, wipe the dropper tip with a clean tissue to remove any residual liquid.
Use of more Clatra than recommended
Rinse the eyes with warm water.
If you forget to use 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, then continue with your regular dosing schedule.
Stopping Clatra
If possible, treatment with this medicine should be continued regularly until symptoms resolve.
If Clatra is discontinued during exposure to allergen(s), a recurrence of typical allergy symptoms may occur.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicinal product may cause adverse reactions, although not everyone experiences them.
The adverse reactions listed below have been reported.
Not common (occurring in fewer than 1 in 100 people):
Taste disturbances, headache.
Dry eye syndrome, eye discharge, eye irritation, increased lacrimation, ocular discomfort.

If any of the adverse reactions listed above occur, use of this medicine should be discontinued and immediate medical advice should be sought. Adverse reactions are usually mild and resolve quickly in all cases. Therefore, no special precautionary measures are required.

Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed in the package leaflet, inform a doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration 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

Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store the medicine Clatra

Keep this medicine out of the sight and reach of children.
Do not use the medicine after the expiry date stated on the carton and bottle after "EXP".
The expiry date refers to the last day of the stated month.
This medicinal product does not require any special storage conditions.
After first opening the bottle: do not use this medicine more than 2 months after first opening.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the package and other information

What Clatra contains

• The active substance is bilastine 6 mg/mL. One drop contains 0.2 mg of bilastine.
• Other ingredients are: hydroxypropyl betadex, 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, colourless solution for eye drops in a white multidose bottle made of LDPE, containing 5 mL of preservative-free solution, with a dropper made of HDPE and a tamper-evident cap.
Pack size: 1 bottle containing 5 mL
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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
(Under licence from Faes Farma, S.A. (Spain))
This product is authorised in 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: Bysabel 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 further information about this medicine, please contact the representative of the Marketing Authorisation Holder:
Berlin-Chemie/Menarini Polska Sp. z o.o.
Tel: +48 22 566 21 00
Fax: +48 22 566 21 01