Clatra

Leaflet attached to the packaging: patient information

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Clatra (Bilaz), 20 mg, tablets

Bilastine
Clatra and Bilaz are different trade names for the same medicine.

You should read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• You should consult a doctor or pharmacist if you have any further doubts.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

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

1. What Clatra is and what it is used for

Clatra contains the active substance bilastine, which has antihistamine properties.
Clatra is used to relieve the symptoms of hay fever (itching, sneezing, runny nose, and congested nose, as well as red and itchy eyes) and other forms of allergic rhinitis. The medicine may also be used to treat itchy skin rashes (hives or urticaria).

2. Important information before taking Clatra

When not to take 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 taking Clatra, the patient should discuss it with their doctor or pharmacist if they have moderate to severe kidney problems and are taking other medicines (see "Clatra and other medicines").

Children

This medicine should not be given to children under 12 years of age.

Do notexceed the recommended dose. If symptoms persist, the patient should consult their doctor.

Clatra and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, or have recently taken, and about any medicines they plan to take, including those that can be bought without a prescription.
In particular, the patient should inform their doctor about taking any of the following medicines:

• ketokonazole (an antifungal medicine)
• erythromycin (an antibiotic)
• diltiazem (a medicine used for coronary heart disease)
• cyclosporin (an immunosuppressant medicine used in organ transplant patients or for the treatment of autoimmune diseases and allergies, such as psoriasis, atopic dermatitis, or rheumatoid arthritis)
• ritonavir (for the treatment of HIV)
• rifampicin (an antibiotic)

Clatra with food, drink, and alcohol Do not take Clatra with food or grapefruit juice, or other fruit juices

asthey may reduce the effect of Clatra. To avoid reducing the effect of Clatra, the patient should:

• swallow the tablet and wait for one hour before eating or drinking fruit juice or
• wait for two hours after eating or drinking fruit juice before taking the tablet. Bilastine at the recommended dose (20 mg) does not increase the sedative effect of alcohol.

Pregnancy, breastfeeding, and fertility

There are no data or limited data on the use of bilastine in pregnant or breastfeeding women, or on its effects on fertility.
If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor before taking this medicine. Before taking any medicine, the patient should consult their doctor or pharmacist.

Driving and using machines

It has been shown that taking bilastine at a dose of 20 mg does not affect the ability to drive in adults. However, the response to treatment may vary from patient to patient.
Therefore, before driving or operating machinery, the patient should check how the medicine affects them.

Clatra contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3. How to take Clatra

This medicine should always be taken exactly as advised by the doctor or pharmacist. If in doubt, the patient should consult their doctor or pharmacist.
The recommended dose for adults, including the elderly and adolescents from 12 years of age, is one tablet (20 mg) per day.

• The tablet should be taken orally.
• The tablet should be taken one hour before or two hours after any meal or fruit juice (see section 2, "Clatra with food, drink, and alcohol").
• The tablet should be swallowed with a glass of water.
• The break line on the tablet is only to facilitate breaking the tablet to make it easier to swallow.

Regarding the duration of treatment, the doctor will determine the type of disease and decide how long the patient should take Clatra.

Use in children

Other pediatric forms of this medicine - bilastine 10 mg orodispersible tablet or bilastine 2.5 mg/mL oral solution - are more suitable for children from 6 to 11 years of age with a body weight of at least 20 kg - the patient should ask their doctor or pharmacist.

Do not give these forms of bilastine to children under 6 years of age with a body weight below

20 kg, as there is not enough data on their use.

Overdose of Clatra

In case of overdose, the patient should immediatelycontact their doctor or pharmacist or go to the emergency department of the nearest hospital. The patient should take the packaging or leaflet with them.

Missed dose of Clatra

Do nottake a double dose to make up for a missed dose.
If a dose is missed, the patient should take the missed dose as soon as possible and then continue taking the medicine at the usual time.
If in doubt, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Clatra can cause side effects, although not everybody gets them.
If the patient experiences any allergic reactions, including: difficulty breathing, dizziness, fainting, or loss of consciousness, swelling of the face, lips, tongue, or throat, and (or) swelling and redness of the skin, they should stop taking the medicine and consult their doctor immediately.

Other side effects that may occur in adults and adolescents are:

Common: occurring in less than 1 in 10 treated patients

• headache
• drowsiness

Uncommon: occurring in less than 1 in 100 treated patients

• abnormal ECG
• blood test changes indicating liver problems
• dizziness
• stomach pain
• fatigue
• increased appetite
• heart rhythm disorders
• weight gain
• nausea
• anxiety
• feeling of dryness or discomfort in the nose
• abdominal pain
• diarrhea
• gastritis
• dizziness (feeling of spinning or vertigo)
• weakness
• increased thirst
• shortness of breath (difficulty breathing)
• dry mouth
• indigestion
• itching
• facial herpes
• fever
• tinnitus (ringing in the ears)
• sleep disorders
• blood test changes indicating kidney problems
• increased blood lipid levels

Frequency not known: cannot be estimated from the available data

• palpitations (feeling of heartbeat)
• tachycardia (fast heartbeat)
• vomiting

Side effects that may occur in children are:

Common: occurring in less than 1 in 10 treated patients

• nasal congestion (nasal irritation)
• allergic conjunctivitis (eye irritation)
• headache
• stomach pain (abdominal pain, epigastric pain)

Uncommon: occurring in less than 1 in 100 treated patients

• eye irritation
• dizziness
• loss of consciousness
• diarrhea
• nausea
• lip swelling
• rash
• hives
• fatigue

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Pharmacovigilance of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Aleje Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Clatra

The medicine should be stored out of sight and reach of children.
Do not use the medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
There are no special precautions for storage.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Clatra contains

• The active substance is bilastine. Each tablet contains 20 mg of bilastine.
• The other ingredients are: microcrystalline cellulose, sodium carboxymethylcellulose (type A), colloidal anhydrous silica, magnesium stearate.

What Clatra looks like and contents of the pack

Clatra tablets are white, oval, and biconvex, with a break line on one side (length 10 mm, width 5 mm).
The tablets are packaged in blisters. The pack sizes are: 10, 30 tablets.
For more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Greece, the country of export:

Menarini International Operations Luxembourg SA
1, Avenue de la Gare
L-1611 Luxembourg, Luxembourg

Manufacturer:

Faes Farma, S.A.
Maximo Aguirre, 14
48940 Leioa (Vizcaya)
Spain

• A. Menarini Manufacturing Logistics and Services Srl Campo di Pile L’Aquila Italy

Menarini Von Heyden GmbH
Leipziger Strasse 7-13
01097 Dresden
Germany

Parallel importer:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Marketing authorization number in Greece, the country of export: 44881/7-7-2011

Parallel import authorization number: 313/20

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

Austria:
Olisir 20 mg Tablets
Belgium:
Bellozal 20 mg Tablet
Bulgaria:
Fortecal 20 mg Tablet
Cyprus:
Bilaz 20 mg Δισκίο
Czech Republic:
Xados
Denmark:
Revitelle, tablets 20 mg
Estonia:
Opexa
Finland:
Revitelle 20 mg tablets
France:
Bilaska 20 mg Comprimé
Germany:
Bilaxten 20 mg Tablets
Greece:
Bilaz 20 mg Δισκίο
Hungary:
Lendin 20 mg tablet
Iceland:
Bilaxten 20 mg tablets
Ireland:
Drynol 20 mg tablets
Italy:
Bysabel 20 mg Compressa
Latvia:
Opexa 20 mg tablets
Lithuania:
Opexa 20 mg tabletès
Luxembourg:
Bellozal 20 mg Tablet
Malta:
Gosall 20 mg tablets
Norway:
Zilas 20 mg tablet
Poland:
Clatra
Portugal:
Lergonix 20 mg Comprimido
Romania:
Borenar 20 mg comprimate
Slovakia:
Omarit 20 mg Tablet
Slovenia:
Bilador 20 mg tablets
Spain:
Ibis 20 mg Comprimido
Sweden:
Bilaxten 20 mg tablet
United Kingdom (Northern Ireland):
Ilaxten 20 mg tablets

Date of approval of the leaflet: 25.04.2025

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