Clatra

Patient Information Leaflet

Warning! Please retain this leaflet. The information on the immediate packaging is in a foreign language.
Clatra (Bellozal), 20 mg, tablets
Bilastinum
Clatra and Bellozal are different trade names for the same medicine.
Please read the entire leaflet carefully before taking this 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 the patient experiences any adverse reactions, including any not listed in this leaflet, inform a doctor, pharmacist, or nurse. See section 4.

Table of Contents:

1. What Clatra is and what it is used for
2. What you need to know 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 bilastin, which acts as an antihistamine.
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 (blisters or hives).

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 your 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, 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, especially when the patient is also taking other medicines (see "Clatra with
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 with 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 (used in coronary heart disease)
• cyclosporine (an immunosuppressant used in organ transplant patients 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:

• 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 during pregnancy, breastfeeding, or its
effect on fertility.
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a
child, 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 demonstrated that bilastine at a dose of 20 mg does not affect the ability to drive in
adults. However, individual patient 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. it is considered "sodium-free".

3. How to use 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 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 only intended to facilitate splitting for easier swallowing.

Regarding duration of treatment, your doctor will determine the type of illness and decide how long you should take Clatra.

Use in children
Other pediatric formulations of this medicine—bilastene 10 mg orodispersible tablet or bilastene 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 bilastene 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 recommended, contact your doctor or pharmacist immediately or go to the nearest hospital emergency department. Bring the medicine pack or leaflet with you.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, 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 urgently.

Other adverse effects which may occur in adults and adolescents include:

Common: affecting fewer than 1 in 10 treated patients

• Headache
• Drowsiness

Uncommon: affecting fewer 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
• Sensation of dryness or discomfort in the nose
• Abdominal pain
• Diarrhoea
• Gastritis
• Dizziness (dizziness or sensation of spinning)
• 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 effects which may occur in children include:

Common: affecting fewer than 1 in 10 treated patients

• Rhinitis (nasal irritation)
• Allergic conjunctivitis (eye irritation)
• Headache
• Stomach pain (abdominal pain, epigastric pain)

Uncommon: affecting fewer than 1 in 100 treated patients

• Eye irritation
• Dizziness
• Loss of consciousness
• Diarrhoea
• Nausea
• Lip swelling
• Rash
• Urticaria
• Fatigue

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform a doctor, pharmacist or nurse. Adverse effects can also 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
Reporting adverse effects helps provide more information on the safety of this 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 apply.
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 components 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 break line marked on one side (10 mm in length, 5 mm in width).
The tablets are packed in blisters. Pack sizes: 10, 30 tablets.
For more detailed information, please contact the responsible party or parallel importer.

Marketing Authorisation Holder in Belgium, the country of export:
Menarini International Operations Luxembourg S.A.
1, Avenue de la Gare
L-1611 Luxembourg
Luxembourg

Manufacturers:
Faes Farma S.A.
Maximo Aguirre, 14
E-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
D-01097 Dresden
Germany

Parallel Importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Poland

Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Poland

Marketing Authorisation Number in Belgium, the country of export: BE381211
Parallel Import Licence Number: 256/25

This medicinal product is authorised for sale in the European Economic Area and the United Kingdom (Northern Ireland) 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: 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 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