Clatra

Package leaflet: Information for the user

Clatra, 10 mg, orodispersible tablets
For children aged 2 to 11 years weighing at least 15 kg
Bilastinum
Please read this leaflet carefully before giving this medicine to your child because it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific child only. Do not pass it on to others. It may harm someone else even if their symptoms are the same.
• If your child experiences any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Leaflet contents:

1. What Clatra is and what it is used for
2. Important information before using Clatra
3. How to use 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 has antihistaminic properties.
Clatra is used to relieve symptoms of hay fever (sneezing, itching, runny or blocked nose, and red, watery eyes) and other forms of allergic rhinitis. It may also be used to treat itchy skin rashes (hives or urticaria).
Clatra 10 mg orodispersible tablets are indicated for use in children aged 2 to 11 years weighing at least 15 kg.

2. Important information before using Clatra

When not to use Clatra

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

Warnings and precautions
Before starting to use Clatra, discuss with a 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 disorders or very slow heartbeat, if the child is taking medicines that may affect heart rhythm, if the child has or has had an abnormal heart rhythm pattern (known as QTc prolongation on electrocardiogram), which may occur in certain types of heart disease, or if the child is taking other medicines (see "Clatra and other medicines").

Children
This medicine should not be given to children under 2 years of age or weighing less than 15 kg, as there is insufficient data on its use in this population.

Clatra and other medicines
Tell the doctor or pharmacist about all medicines the child is currently taking, has recently taken, or might take in the future, including those obtained without a prescription.
Some medicines should not be taken together, while for others, a dose adjustment may be necessary when used concomitantly.
Always inform the doctor or pharmacist if the child is taking any of the following medicines in addition to Clatra:

• ketoconazole (an antifungal medicine)
• erythromycin (an antibiotic)
• diltiazem (a medicine used for angina – chest pain or tightness)
• cyclosporine (a medicine that reduces immune system activity, used to prevent transplant rejection or to reduce severity of autoimmune and allergic conditions such as psoriasis, atopic dermatitis, or rheumatoid arthritis)
• ritonavir (used in HIV treatment)
• rifampicin (an antibiotic)

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

• give the child the orodispersible tablet and wait one hour before giving the child food or fruit juice, or
• if the child has eaten food or drunk fruit juice, wait two hours before giving the child the orodispersible tablet.

Bilastine at the recommended adult dose (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 weighing at least 15 kg. However, consider the following information regarding safe use of this medicine. There are no data or limited data available on the use of bilastine in pregnant or breastfeeding women, or on its effect on fertility.
If the patient is pregnant, breastfeeding, or planning to become pregnant, she should consult a doctor before using this medicine. Always consult a doctor or pharmacist before taking any medicine.

Driving and using machines
It has been shown that bilastine at a dose of 20 mg does not affect driving ability in adults. However, individual responses to treatment may vary.
Therefore, assess how this medicine affects the child before allowing the child to ride a bicycle, operate any vehicle, or use machinery.

Clatra contains ethanol and sodium
This medicine contains 0.0015 mg of alcohol (ethanol) per orodispersible tablet, equivalent to 1 mg/100 g (0.001% w/w). The amount of alcohol in the orodispersible 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 cause noticeable effects.
This medicine contains less than 1 mmol (23 mg) of sodium per orodispersible tablet, meaning the medicine is considered "sodium-free".

3. How to take Clatra

This medicine should always be taken as directed by the doctor or pharmacist. If in doubt,
consult the doctor or pharmacist.
Use in children
The recommended dose for children aged 2 to 11 years weighing at least 15 kg is 10 mg of bilastine
(1 orodispersible tablet) once daily to relieve symptoms of allergic rhinitis and conjunctivitis, as well as urticaria.
This medicine should not be given to children under 2 years of age or weighing less than 15 kg,
due to insufficient data on its use.
For adults, including elderly individuals and adolescents aged 12 years and older, the recommended
dose of bilastine is 20 mg once daily. For this patient population, a more suitable dosage form – a tablet – is available; consult the doctor or pharmacist.

• The orodispersible tablet is intended for oral administration.
• Place the orodispersible tablet in the child's mouth. It will rapidly dissolve in saliva and can then be easily swallowed.
• The orodispersible tablet may also be dissolved in a teaspoon of water before administration to the child. This is highly recommended for children under 6 years of age, as they have an increased risk of choking on the tablet. Ensure that no residue remains on the spoon.
• Only water should be used to dissolve the tablet; do not use grapefruit juice or other fruit juices.
• The orodispersible tablet should be administered to the child one hour before or two hours after any meal or consumption of fruit juice.

The duration of treatment depends on the type of illness the child has. The doctor will determine how long the child should continue taking Clatra.
Taking more than the recommended dose of Clatra
If a child or another person takes more than the recommended dose of Clatra, contact a doctor immediately or go to the nearest hospital emergency department.
Bring the medicine packaging or leaflet with you.
Missed dose of Clatra
If a dose is missed for a child, administer it as soon as possible on the same day. Then, continue with the next dose at the usual time the following day, as directed by the doctor. Under no circumstances should a double dose be taken to make up for a missed dose.
Stopping Clatra
No consequences are expected from discontinuing treatment with Clatra.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicinal product may cause adverse effects, although not everyone experiences them.
If a child develops 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, administration of the medicine should be discontinued and immediate medical advice should be sought.

Other adverse effects that may occur in children:

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
• Swelling of the lips
• Rash
• Urticaria
• Fatigue
• Rhinitis (nasal irritation)
• Stomach pain (abdominal pain, epigastric pain)

Adverse effects that may occur in adults and adolescents:

Common: occurring in less than 1 in 10 treated patients

• Headache
• Somnolence

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
• Cardiac arrhythmia
• Weight gain
• Nausea
• Anxiety
• Dryness or discomfort in the nose
• Abdominal pain
• Diarrhea
• Gastritis (inflammation of the gastric mucosa)
• Dizziness (dizziness or sensation of spinning)
• Weakness
• Excessive thirst
• Dyspnea (difficulty breathing)
• Dry mouth
• Dyspepsia
• Itching
• Oral herpes
• 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

Reporting of adverse effects

If any adverse effects occur in a child, including any adverse effects not listed in this leaflet, inform a doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects 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 this medicine after the expiry date stated on the carton and blister pack following "EXP".
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 orodispersible tablet contains 10 mg of bilastine.
  Other ingredients are: mannitol (E 421), sodium croscarmellose, sodium stearyl fumarate, sucralose (E 955), red grape flavour (main components: gum arabic, ethyl butyrate, triacetin, methyl anthranilate, ethanol, D-limonene, linalool).

What Clatra looks like and contents of the pack
Clatra orodispersible tablets are round, slightly biconvex, white tablets with a diameter of 8 mm.
The orodispersible tablets are packed in blisters. Pack sizes: 10, 20, 30, or 50 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Menarini International Operations Luxembourg S.A.
1, Avenue de la Gare
1611 Luxembourg
Luxembourg

Manufacturers
Faes Farma, S.A.
Máximo Aguirre, 14
48940 Leioa (Vizcaya)
Spain

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

Faes Farma, S.A., Parque Cientifico y Tecnologico de Bizkaia
Ibaizabal Bidea, Edificio 901
48160 Derio (Bizkaia)
Spain

This medicinal product is authorised in 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

For more detailed information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Berlin-Chemie/Menarini Polska Sp. z o.o.
Tel: +48 22 566 21 00
Fax: +48 22 566 21 01