Clatra

LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE PATIENT

Warning! Keep the leaflet, the information on the immediate packaging is 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 to a specific person. 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 or pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

• 1. What is Clatra and what is it 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 pack and other information

1. What is Clatra and what is it used for

Clatra contains the active substance bilastine, which has antihistamine properties.
Clatra is used to relieve the symptoms of hay fever (sneezing, itching, runny nose, and blocked 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 starting to take 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 the medicines they are taking now or have taken recently, as well as any medicines they plan to take, including those that are available without a prescription.
In particular, the patient should inform their doctor if they are 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, rheumatoid arthritis)
• ritonavir (used in the treatment of AIDS)
• rifampicin (an antibiotic)

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

asthis reduces 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
• after eating or drinking fruit juice, wait for 2 hours before taking the tablet.

Bilastine at the recommended dose (20 mg) does not increase the sedation caused by alcohol consumption.

Pregnancy, breastfeeding, and fertility

There are no data or limited data on the use of bilastine in pregnant women, during breastfeeding, and 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 that the medicine is considered "sodium-free".

3. How to take Clatra

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. If the patient is unsure, they 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 is for oral use.
• 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.

Pediatric forms of this medicine should not be given to children under 6 years of age with a body weight below 20 kg, as there are insufficient data on the use of the medicine in this population.

Overdose of Clatra

In case of overdose of Clatra, 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 return to their regular dosing schedule.
If the patient has any questions, they 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
• changes in blood tests 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 (dizziness or feeling of spinning)
• weakness
• increased thirst
• shortness of breath (difficulty breathing)
• dry mouth
• indigestion
• itching
• facial rash
• fever
• tinnitus (ringing in the ears)
• sleep disorders
• changes in blood tests indicating kidney problems
• increased lipid levels in the blood

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 (irritation of the nose)
• allergic conjunctivitis (irritation of the eyes)
• headache
• stomach pain (abdominal pain, pain in the upper abdomen)

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 or pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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, it is possible to gather more information 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 pack 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, 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, 20, or 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.
Màximo Aguirre, 14
48940 Leioa (Vizcaya)
Spain

• A. Menarini Manufacturing Logistics and Services S.r.l. Campo di Pile L’Aquila Italy

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

Parallel importer:

Pharmapoint SA
Zbąszyńska 3 Street
91-342 Łódź

Repackaged by:

CEFEA Sp. z o.o. Sp. komandytowa
Działkowa 56 Street
02-234 Warsaw
Pharma Innovations Sp. z o.o.
Jagiellońska 76 Street
03-301 Warsaw
Synoptis Industrial Sp. z o.o.
Szosa Bydgoska 58 Street
87-100 Toruń
IVA Pharm Sp. z o.o.
Drawska 14/1 Street
02-202 Warsaw
CANPOLAND SPÓŁKA AKCYJNA
Beskidzka 190 Street
91-610 Łódź
Medezin Sp. z o.o.
Zbąszyńska 3 Street
91-342 Łódź
Marketing authorization number in Greece, the country of export: 44881/7-7-2011
Parallel import authorization number: 333/20

This product is authorized 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 Таблетка

Cyprus:

Bilaz 20 mg Δισκίο

Czech Republic:

Xados

Denmark:

Revitelle, tablets 20 mg

Estonia:

Opexa

Finland:

Revitelle 20 mg Tabletti

France:

Bilaska 20 mg Comprimé

Germany:

Bilaxten 20 mg Tabletten

Greece:

Bilaz 20 mg Δισκίο

Hungary:

Lendin 20 mg tabletta

Iceland:

Bilaxten 20 mg töflur

Ireland:

Drynol 20 mg tablets

Italy:

Olisir 20 mg Compressa

Latvia:

Opexa 20 mg tabletes

Lithuania:

Opexa 20 mg Tabletìs

Luxembourg:

Bellozal 20 mg Tablet

Malta:

Gosall 20 mg tablets

Norway:

Zilas 20 mg tablett

Poland:

Clatra

Portugal:

Lergonix 20 mg Comprimido

Romania:

Borenar 20 mg comprimate

Slovakia:

Omarit 20 mg Tableta

Slovenia:

Bilador 20 mg tablete

Spain:

Ibis 20 mg Comprimido

Sweden:

Bilaxten 20 mg Tablett

United Kingdom (Northern Ireland):

Ilaxten 20 mg tablets

Date of leaflet approval: 31.01.2022

[Information about the trademark]