Clatra

Patient Information Leaflet

Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
Clatra (Bilaska 20 mg), 20 mg, tablets
Bilastinum
Clatra and Bilaska 20 mg are different brand names for the same medicine.
Please read the entire leaflet 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 similar.
• If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of Contents:

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 package and other information

1. What Clatra is and what it is used for

Clatra contains the active substance bilastin, which acts as an antihistamine.
Clatra is used to relieve symptoms of allergic rhinitis (sneezing, itching, runny nose, nasal congestion, and red, watery 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 using Clatra

When not to use Clatra

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

Warnings and precautions
Before starting to take Clatra, consult your doctor or pharmacist if the patient has moderate to severe kidney impairment, low levels of potassium, magnesium or calcium in the blood, if the patient has or has had heart rhythm disorders or very slow heartbeat, if the patient is taking medicines that may affect heart rhythm, or if the patient has or has had an abnormal heart rhythm pattern (known as QTc prolongation on electrocardiogram), which may occur in certain types of heart disease; additionally, if the patient is taking other medicines (see "Clatra and other medicines").
Children
This medicine should not be given to children under 12 years of age.
Do not exceed the recommended dose. If symptoms persist, consult a doctor.
Clatra and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, including those obtained without a prescription, as well as any medicines the patient plans to take.
In particular, inform your doctor if the patient is taking any of the following medicines:

• ketoconazole (an antifungal medicine)
• erythromycin (an antibiotic)
• diltiazem (a medicine used for coronary heart disease)
• cyclosporine (an immunosuppressive medicine used in patients after organ transplantation or in autoimmune and allergic conditions such as psoriasis, atopic dermatitis, rheumatoid arthritis)
• ritonavir (used in the treatment of HIV)
• rifampicin (an antibiotic)

Clatra with food, drink and alcohol
Do not take the medicine together with food or grapefruit juice or other fruit juices, as this may reduce the effectiveness of Clatra. To avoid reduced effectiveness of the medicine, the following should be observed:

• swallow the tablet and wait one hour before eating a meal or drinking fruit juice, or
• after eating or drinking fruit juice, wait two hours before taking the tablet.

Bilastine at the recommended dose (20 mg) does not increase drowsiness caused by alcohol consumption.
Pregnancy, breastfeeding and fertility
There are no data or limited data available on the use of bilastine during pregnancy, breastfeeding, or its effect on fertility.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor before using this medicine. Before taking any medicine, consult a doctor or pharmacist.
Driving and operating machinery
It has been demonstrated that bilastine at a dose of 20 mg does not affect the ability to drive in adults. However, individual response to treatment may vary.
Therefore, before driving or operating machinery, patients should assess how this medicine affects them.
Clatra contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to take Clatra

This medicine should always be taken exactly as directed by the doctor or pharmacist.
If in doubt, consult the doctor or pharmacist.
The recommended dose for adults, including elderly patients, and adolescents aged 12 years and older, is 1 tablet (20 mg) once daily.

• This is an oral tablet.
• 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").
• Swallow the tablet with a glass of water.
• The break line on the tablet is intended only to facilitate splitting for easier swallowing.

Regarding duration of treatment, the treating physician will determine the type of illness and decide how long Clatra should be taken.

Use in children
Other pediatric formulations of this medicine – bilastine 10 mg orodispersible tablet or bilastine 2.5 mg/mL oral solution – are more suitable for children aged 6 to 11 years weighing at least 20 kg. Please consult the doctor or pharmacist.
These bilastine formulations should not be given to children under 6 years of age weighing less than 20 kg, due to insufficient data on use.

Taking more Clatra than recommended
If more Clatra has been taken than recommended, contact a doctor or pharmacist immediately or go to the nearest hospital emergency department. Bring the medicine pack or leaflet with you.

If you forget to take Clatra
Do not take a double dose to make up for a missed dose.
If a dose is missed, take it as soon as possible, then resume taking the medicine at the regular time.
If in doubt, consult the doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If the patient experiences hypersensitivity reactions, including: difficulty breathing, dizziness,
collapse or loss of consciousness, swelling of the face, lips, tongue or throat, and (or) skin swelling and redness,
the medicine should be discontinued immediately and medical advice should be sought without delay.

Other adverse reactions that may occur in adults and adolescents include:

Common: occurring in fewer than 1 in 10 patients treated

• headache
• somnolence

Uncommon: occurring in fewer than 1 in 100 patients treated

• abnormal ECG findings
• blood test abnormalities indicating liver function disorders
• dizziness
• stomach pain
• fatigue
• increased appetite
• cardiac arrhythmia
• weight gain
• nausea
• anxiety
• dryness or discomfort in the nose
• abdominal pain
• diarrhoea
• gastritis
• vertigo (dizziness or spinning sensation)
• weakness
• excessive thirst
• dyspnoea (difficulty breathing)
• dry mouth
• indigestion
• itching
• facial rash
• fever
• tinnitus (ringing in the ears)
• sleep disturbances
• blood test abnormalities indicating kidney function disorders
• increased blood lipid levels

Frequency unknown: cannot be estimated from available data

• palpitations (awareness of heartbeat)
• tachycardia (rapid heartbeat)
• vomiting

Adverse reactions that may occur in children include:

Common: occurring in fewer than 1 in 10 patients treated

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

Uncommon: occurring in fewer than 1 in 100 patients treated

• eye irritation
• dizziness
• loss of consciousness
• diarrhoea
• nausea
• lip swelling
• rash
• urticaria
• fatigue

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet,
the patient should inform a doctor or pharmacist.
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, Tel.: +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 authorisation holder or a parallel importer.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store the medicine Clatra

Keep the medicine out of the 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 stated month.
No special storage conditions are required.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. 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 carboxymethyl starch (type A), colloidal anhydrous silica, magnesium stearate.

What Clatra looks like and contents of the packaging
Clatra tablets are white, oval, biconvex, with a score line on one side (10 mm in length, 5 mm in width).
The tablets are packed in blisters. Package sizes: 10, 20, 30, 40 or 50 tablets.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.

Marketing Authorisation Holder in France, the country of export:
Menarini International Operations Luxembourg S.A.
1, avenue de la Gare
1611 Luxembourg
Luxembourg

Manufacturer
Faes Farma S.A.
Maximo Aguirre, 14
48 940 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:
Allpharm Sp. z o.o. sp.k.
ul. M. Zdziechowskiego 11/4
02-659 Warsaw

Repackaged in:
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warsaw
Synoptis Industrial Sp. z o.o.
ul. Forteczna 35-37
87-100 Toruń
Shiraz Productions Sp. z o.o.
ul. Tymiankowa 24/28
95-054 Ksawerów

Marketing Authorisation Numbers in France, the country of export:
34009 499 137 0 1
34009 499 135 8 9
34009 499 136 4 0
34009 578 988 3 0
34009 578 990 8 0

Parallel Import Authorisation Number: 238/25

This medicinal product is authorised in the European Economic Area (EEA) countries and in the United Kingdom (Northern Ireland) under the following trade names:
Austria: Olisir 20 mg Tabletten
Belgium: Bellozal 20 mg Tablet
Bulgaria: Fortecal 20 mg Таблетка
Cyprus: Bilaz 20 mg Δισκίο
Czech Republic: Xados
Denmark: Revitelle, tabletter 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: Bysabel 20 mg Compressa
Latvia: Opexa 20 mg tabletes
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 Tableta
Slovenia: Bilador 20 mg tablete
Spain: Ibis 20 mg Comprimido
Sweden: Bilaxten 20 mg tablett
United Kingdom (Northern Ireland): Ilaxten 20 mg tablets