Clatra

Leaflet accompanying the packaging: patient information

Clatra, 10 mg, orally disintegrating tablets

For children aged 2 to 11 years with a body weight of at least 15 kg

Bilastine

Read the leaflet carefully before giving the medicine to the child, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed specifically for this child. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the child experiences any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. 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 acts as an antihistamine.
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).
Clatra, 10 mg, orally disintegrating tablets are indicated for use in children aged 2 to 11 years with a body weight of at least 15 kg.

2. Important information before taking Clatra

When not to take Clatra

Warnings and precautions

Before starting to take Clatra, discuss it with your doctor or pharmacist if the child has moderate or severe kidney or liver problems, low levels of potassium, magnesium, or calcium in the blood, if the child has or has had heart rhythm problems or very slow heart rate, if the child is taking medicines that may affect the heart rhythm, if the child has or has had an abnormal heart rhythm (known as QTc interval prolongation on an electrocardiogram), which may occur in certain types of heart disease, or if the child is taking other medicines (see "Clatra and other medicines").

Children

Do not give this medicine to children under 2 years of age or with a body weight below 15 kg, as there is not enough data on the use of the medicine.

Clatra and other medicines

Tell your doctor or pharmacist about all medicines the child is taking, including those bought without a prescription, and about any medicines the child may take in the future.
Some medicines should not be taken at the same time, and for others, the dose may need to be changed when taken together.
Always inform your doctor or pharmacist if the child is taking any of the following medicines in addition to Clatra:

• ketokonazole (an antifungal medicine)
• erythromycin (an antibiotic)
• diltiazem (a medicine used for angina - chest pain or discomfort)
• cyclosporin (a medicine that reduces the activity of the immune system, used to prevent transplant rejection or reduce the severity of autoimmune or allergic diseases, such as psoriasis, atopic dermatitis, or rheumatoid arthritis)
• ritonavir (used to treat HIV)
• rifampicin (an antibiotic)

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

because it reduces the effect of Clatra. To avoid reducing the effect of the medicine, you should:

• give the child an orally disintegrating tablet and wait for 1 hour before giving the child a meal or fruit juice or

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

Pregnancy, breastfeeding, and fertility

This medicine is intended for use in children aged 2 to 11 years with a body weight of at least 15 kg. However, consider the following information on the safe use of this medicine. 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, or plans to have a child, they should consult a doctor before taking 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 vehicles in adults. However, the response to treatment may vary from patient to patient.
Therefore, check how this medicine affects the child before allowing them to ride a bike, drive another vehicle, or operate machinery.

Clatra contains ethanol and sodium

This medicine contains 0.0015 mg of alcohol (ethanol) per orally disintegrating tablet, which is equivalent to 1 mg/100 g (0.001% w/w). The amount of alcohol in an orally disintegrating tablet is equivalent to less than 0.00004 ml of beer or 0.00002 ml of wine.
The small amount of alcohol in this medicine will not have noticeable effects.
This medicine contains less than 1 mmol (23 mg) of sodium per orally disintegrating tablet, which means the medicine is considered "sodium-free".

3. How to take Clatra

This medicine should always be taken exactly as advised by your doctor or pharmacist. If you are not sure, ask your doctor or pharmacist.

Use in children

The recommended dose for children aged 2 to 11 years with a body weight of at least 15 kg is 10 mg of bilastine (1 orally disintegrating tablet) once a day to relieve the symptoms of allergic rhinitis and hives.
Do not give this medicine to children under 2 years of age or with a body weight below 15 kg, as there is not enough data on the use of the medicine.
For adults, including the elderly, and adolescents aged 12 years and older, the recommended dose of bilastine is 20 mg once a day. For this population of patients, a more suitable form of the medicine is available - a tablet; consult your doctor or pharmacist.

• The orally disintegrating tablet is intended for oral use.
• Place the orally disintegrating tablet in the child's mouth. It will dissolve quickly in saliva and can then be swallowed easily.
• The orally disintegrating tablet can also be dissolved in a spoonful of water before giving it to the child. This is highly recommended for children under 6 years of age, as they have a higher risk of choking on the tablet. Make sure there are no remaining bits on the spoon.
• To dissolvethe tablet, use only water, do not use grapefruit juice or other fruit juices.
• Give the orally disintegrating tablet to the child 1 hour before or 2 hours after any meal or fruit juice.

The duration of treatment depends on the type of disease in the child. The doctor will decide how long the child should take Clatra.

Overdose of Clatra

If the child takes more Clatra than they should, or if someone else takes the medicine, contact a doctor or go to the emergency department of the nearest hospital immediately.
Take the packaging or leaflet with you.

Missed dose of Clatra

If a dose is missed in a child, give it as soon as possible on the same day. Then, give the next dose the following day at the usual time as advised by the doctor. Never take a double dose to make up for a missed dose.

Stopping Clatra treatment

No effects are expected due to stopping Clatra treatment.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Clatra can cause side effects, although not everybody gets them.
If the child experiences an allergic reaction, 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, stop taking the medicine and consult a doctor immediately.

Other side effects that may occur in children are:

Common: occurring in less than 1 in 10 treated patients

• allergic conjunctivitis (eye irritation)
• headache

Uncommon: occurring in less than 1 in 100 treated patients

• eye irritation
• dizziness
• loss of consciousness
• diarrhea
• nausea
• lip swelling
• rash
• hives
• fatigue
• rhinitis (nasal irritation)
• stomach pain (abdominal pain, epigastric pain)

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
• blood test changes indicating liver problems
• dizziness
• stomach pain
• fatigue
• increased appetite
• heart rhythm problems
• weight gain
• nausea
• anxiety
• feeling of dryness or discomfort in the nose
• abdominal pain
• diarrhea
• gastritis (inflammation of the stomach lining)
• dizziness (dizziness or feeling of spinning)
• weakness
• increased thirst
• shortness of breath (difficulty breathing)
• dry mouth
• indigestion
• itching
• oral thrush
• fever
• tinnitus (ringing in the ears)
• sleep disorders
• blood test changes indicating kidney problems
• increased blood lipid levels

Frequency not known: cannot be estimated from the available data

• palpitations (feeling of heartbeat)
• tachycardia (fast heartbeat)
• vomiting.

Reporting side effects

If the child experiences any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products of the 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
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Clatra

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after "EXP".
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. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Clatra contains

• The active substance is bilastine. Each orally disintegrating tablet contains 10 mg of bilastine. The other ingredients are: mannitol (E 421), croscarmellose sodium, sodium stearyl fumarate, sucralose (E 955), red grape flavor (main components: gum arabic, ethyl acetate, triacetin, methyl anthranilate, ethanol, D-limonene, linalool).

What Clatra looks like and contents of the pack

Clatra, orally disintegrating tablets are round, slightly biconvex, white tablets with a diameter of 8 mm.
The orally disintegrating tablets are packaged in blisters. Pack sizes: 10, 20, 30, or 50 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder
Menarini International Operations Luxembourg S.A.
1, Avenue de la Gare
1611 Luxembourg
Luxembourg
Manufacturer
Faes Farma, S.A.
Màximo Aguirre, 14
48940 Leioa (Vizcaya)
Spain

• A. Menarini Manufacturing Logistics and Services S.r.l. Via Campo di Pile, 67100 L’Aquila Italy

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Austria: Nasitop 10 mg Schmelztabletten
Belgium: Bellozal 10 mg orodispersible tablets
Bulgaria: Фортекал за деца 10 mg диспергиращи се в устата таблетки
Cyprus: Bilaz 10 mg δισκία διασπειρόμενα στο στόμα
Czech Republic: Xados
Denmark: Revitelle, smeltetabletter 10 mg
Estonia: Opexa
Finland: Revitelle
France: Bilaska 10 mg comprimé orodispersible
Germany: Bilaxten 10 mg Schmelztabletten
Greece: Bilaz 10 mg δισκία διασπειρόμενα στο στόμα
Hungary: Lendin
Iceland: Bilaxten 10 mg munndreifitöflur
Ireland: Drynol
Latvia: Opexa 10 mg mutē disperģējamās tabletes
Lithuania: Opexa
Luxembourg: Bellozal 10 mg orodispersible tablets
Malta: Gosall 10 mg orodispersible tablets
Norway: Zilas 10 mg smeltetablett
Poland: Clatra
Portugal: Lergonix 10 mg comprimido orodispersível
Romania: Borenar 10 mg comprimate orodispersabile
Slovakia: Omarit 10 mg orodispergovateľné tablety
Slovenia: Bilador 10 mg orodispersibilne tablete
Spain: Ibis 10 mg comprimidos bucodispersables
Sweden: Bilaxten
United Kingdom (Northern Ireland): Ilaxten
To obtain more detailed information on this medicine, contact the local representative of the marketing authorization holder:
Berlin-Chemie/Menarini Polska Sp. z o.o.
Phone: +48 22 566 21 00
Fax: +48 22 566 21 01
Date of last revision of the leaflet:03/2025