Clatra

PACKAGE LEAFLET: INFORMATION FOR THE USER

Warning! Keep the leaflet. Information on the immediate packaging in a foreign language!
Clatra (Bilaz)
20 mg, tablets
Bilastinum
Clatra and Bilaz are different trade names for the same medicine.
Please read this leaflet carefully before taking the medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• Consult your doctor or pharmacist if you have any further questions.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm others, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform the doctor or pharmacist. See section 4.

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 pack and other information

1. What Clatra is and what it is used for

Clatra contains the active substance bilastine, which has antihistaminic properties.
Clatra is used to relieve symptoms of seasonal 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 any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting to use Clatra, consult a doctor or pharmacist if the patient has moderate to severe kidney function impairment, low blood levels of potassium, magnesium, or calcium, 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, 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, and additionally if the patient is taking other medicines (see "Clatra and other medicines").

Children
This medicine must 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
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take, including those obtained without a prescription.
In particular, inform the doctor if the patient is taking any of the following medicines:

• ketoconazole (an antifungal medicine)
• erythromycin (an antibiotic)
• diltiazem (a medicine used in coronary heart disease)
• cyclosporine (an immunosuppressive medicine used in organ transplant patients or in autoimmune and allergic conditions 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 the medicine together with food, grapefruit juice, or other fruit juices, as this may reduce the effectiveness of Clatra. To avoid reduced effectiveness, do the following:

• swallow the tablet and wait one hour before eating a meal or drinking fruit juice, or
• wait two hours after eating or drinking fruit juice 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 on the use of bilastine in pregnant or breastfeeding women, or on its effect on fertility.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor before using this medicine. Before taking any medicine, consult a 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, individual response to treatment may vary.
Therefore, before driving or operating machinery, the patient should assess how this medicine affects them.

Clatra contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e., this medicine is considered "sodium-free".

3. How to take Clatra

This medicine should always be taken exactly as directed by your doctor or pharmacist.
If in doubt, consult your doctor or pharmacist.
The recommended dose for adults, including elderly people, 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 only intended to facilitate splitting the tablet for easier swallowing.

Regarding duration of treatment, your doctor 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 your 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 you take more Clatra than you should, contact your doctor or pharmacist immediately or go to the nearest hospital emergency department. Take the medicine pack or leaflet with you.

If you forget to take Clatra
Do not take a double dose to make up for a forgotten dose.
If you miss a dose, take it as soon as possible, then return to taking your medicine at the usual time.
If you have any further questions, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences 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 redness and swelling,
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 less than 1 in 10 treated patients

• Headache
• Drowsiness

Uncommon: occurring in less than 1 in 100 treated patients

• Abnormal ECG findings
• Blood test abnormalities indicating liver function disorders
• Dizziness
• Stomach pain
• Fatigue
• Increased appetite
• Heart rhythm disturbances
• Weight gain
• Nausea
• Anxiety
• Nasal dryness or discomfort
• Abdominal pain
• Diarrhea
• Gastritis
• Dizziness (dizziness or sensation of spinning)
• Weakness
• Excessive thirst
• Dyspnea (breathing difficulties)
• 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 not known: 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 less than 1 in 10 treated patients

• Nasal mucositis (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
• Swelling of the lips
• Rash
• Urticaria (hives)
• Fatigue

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet,
they should be reported to a doctor, pharmacist, or nurse. Adverse reactions can also be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products, 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
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Clatra

Keep this medicine out of the sight and reach of children.
Do not use this 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 required. Such measures 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 pack
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. Pack sizes: 10, 20 or 30 tablets.
For further information, please contact the responsible party or the parallel importer.

Marketing Authorisation 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:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Marketing Authorisation Number in Greece, the country of export: 44881/7-7-2011
Parallel Import Licence Number: 333/20

This medicinal product is authorised in the European Economic Area (EEA) Member States under the following 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: 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