Clatra

Patient Information Leaflet

Warning! Keep the leaflet, information on the immediate packaging 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 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 the same.
• If the patient experiences any adverse effects, including any not listed in this leaflet, inform the doctor or pharmacist. 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 bilastinum, which has antihistamine properties.
Clatra is used to relieve symptoms of seasonal allergic rhinitis (hay fever) such as sneezing, itching, runny nose, nasal congestion, and red, watery eyes, as well as other forms of allergic rhinitis. The medicine may also be used to treat itchy skin rashes (blisters 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 treatment with 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
heart rate, 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. This is especially important if the patient is also taking other medicines (see "Clatra and other medicines").

Children
Do not administer this medicine 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 the doctor if the patient is taking any of the following medicines:

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

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

• 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 effects on fertility
There are no data or limited data on the use of bilastine in pregnant women, during breastfeeding, or 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. Always consult a doctor or pharmacist before using any medicine.

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 responses to the medicine 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, meaning the medicine 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 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 you should take Clatra.
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 miss a dose of Clatra
Do not take a double dose to make up for a missed dose.
If you miss a dose, take the missed dose as soon as possible, then return to taking your medicine at your 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) swelling and redness
of the skin, the medicine should be discontinued and immediate medical advice sought.

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 readings
• Blood test changes indicating liver function abnormalities
• Dizziness
• Stomach pain
• Fatigue
• Increased appetite
• Heart rhythm disturbances
• Weight gain
• Nausea
• Anxiety
• Nasal dryness or discomfort
• Abdominal pain
• Diarrhea
• Gastritis
• Dizziness (vertigo or sensation of spinning)
• Weakness
• Increased thirst
• Dyspnea (difficulty breathing)
• Dry mouth
• Indigestion
• Itching
• Facial rash
• Fever
• Tinnitus (ringing in the ears)
• Sleep disturbances
• Blood test changes indicating kidney function abnormalities
• 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 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
• Fatigue

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

5. How to store the medicine Clatra

Keep the medicine 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 stated month.
No special storage instructions 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 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-shaped, biconvex tablets with a score line on one side (length 10 mm, width 5 mm).
The tablets are packed in blisters. Pack sizes: 10, 20 or 30 tablets.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.

Marketing authorisation holder in Belgium, the country of export:
Menarini International Operations Luxembourg SA
1, Avenue de la Gare
L-1611 Luxembourg
Luxembourg

Manufacturer:
Faes Farma S.A
Máximo 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:
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 Belgium, the country of export: BE381211
Parallel import authorisation number: 264/25

This medicinal product is authorised 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