Patient Information Leaflet: Instructions for Use

Clatra, 2.5 mg/mL, oral solution
For children aged 2 to 11 years weighing at least 15 kg
Bilastinum
Please read this leaflet carefully before administering the medicine to your child, as it
contains important information for the patient.

Keep this leaflet for future reference.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed specifically for your child. Do not give it to others. It may harm someone else, even if their symptoms are similar.
If your child experiences any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents:

What Clatra is and what it is used for
Important information before taking Clatra
How to take Clatra
Possible side effects
How to store Clatra
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 seasonal allergic rhinitis (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 2.5 mg/mL oral solution is 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 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
impairment of kidney or liver function, 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 or has recently taken,
including those obtained without a prescription, as well as any medicines the child may take in the
future.
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 pectoris – 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 diseases such as psoriasis, atopic dermatitis or rheumatoid arthritis)
ritonavir (used in the treatment of HIV)
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:

administer the oral solution and wait one hour before giving the child food or fruit juice, or
if the child has eaten a meal or drunk fruit juice, wait two hours before administering the oral solution.

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,
please consider the following information regarding safe use of this medicine. There are no data or
limited data on the use of bilastine in pregnant women, during breastfeeding, or its effect on
fertility.
If a patient is pregnant, breastfeeding, or planning to become pregnant, she should consult a doctor
before using this medicine.
Before using any medicine, consult a doctor or pharmacist.
Driving and operating machinery
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, assess how this medicine affects the child before allowing the child to ride a bicycle,
drive another vehicle or operate machinery.
Clatra contains methyl parahydroxybenzoate (E 218) and propyl parahydroxybenzoate (E 216),
which may cause allergic reactions (including delayed-type reactions).
Clatra contains ethanol and sodium
This medicine contains 0.44 mg of alcohol (ethanol) per dose (4 mL), equivalent to 11 mg/100 mL
(0.011% w/v). The amount of alcohol in 4 mL of this medicine is equivalent to less than 0.02 mL of
beer or 0.005 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 4 mL, meaning the medicine is
considered "sodium-free".

3. How to use Clatra

This medicine should always be used as directed by a doctor or pharmacist. If in doubt,
consult a 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
(4 mL of oral solution) 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. A more suitable dosage form for this patient population is a tablet; please consult a doctor or pharmacist.

The oral solution is intended for oral administration.
The bottle with child-resistant cap must be opened by pressing down on the plastic cap while turning it counterclockwise.
An oral dosing device (measuring spoon) is provided with the package, marked with a 4 mL indication (=10 mg bilastine per dose), to accurately measure the correct amount of oral solution.
Fill the dosing spoon with 4 mL of oral solution.
Administer the oral solution directly using the dosing spoon.
After use, wash the dosing spoon.
The oral solution should be given to the child one hour before or two hours after any meal or fruit juice consumption.

The duration of treatment depends on the child's condition. 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, 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 treatment
No adverse consequences are expected from stopping treatment with Clatra.
If you have any further questions about the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, 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 immediately and medical advice should be sought without delay.

Other adverse reactions that may occur in children include:
Common: occurring in fewer than 1 in 10 treated patients

allergic conjunctivitis (eye irritation)
headache

Uncommon: occurring in fewer than 1 in 100 treated patients

eye irritation
dizziness
loss of consciousness
diarrhoea
nausea
swelling of the lips
rash
urticaria
fatigue
rhinitis (nasal irritation)
stomach pain (abdominal pain, epigastric pain)

Adverse reactions that may occur in adults and adolescents include:
Common: occurring in fewer than 1 in 10 treated patients

headache
somnolence

Uncommon: occurring in fewer than 1 in 100 treated patients

abnormal ECG reading
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
diarrhoea
gastritis (inflammation of the gastric mucosa)
dizziness (dizziness or sensation of spinning)
weakness
excessive thirst
dyspnoea (difficulty breathing)
dry mouth
dyspepsia
pruritus
oral herpes
fever
tinnitus (ringing in the ears)
sleep disturbances
blood test abnormalities indicating kidney function disorders
elevated blood lipid levels

Frequency unknown: cannot be estimated from available data

palpitations (awareness of heart beating)
tachycardia (rapid heartbeat)
vomiting

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

5. How to store the Clatra medicine

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 bottle after "EXP".
The expiry date refers to the last day of the stated month.
Do not store above 30°C.
The shelf life after first opening is 6 months.
Do not use this medicine if the patient notices any visible particles.
Medicines must not be disposed of via wastewater or household waste. Ask a pharmacist how to properly dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Clatra contains

The active substance in Clatra is bilastine. One millilitre of oral solution contains 2.5 mg of bilastine.
Other ingredients are: betadex (E 459), hydroxyethylcellulose, methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), sucralose (E 955), raspberry flavour (main components: ethanol, triacetin, water, ethyl butyrate, linalyl acetate), hydrochloric acid 37% or 10% (to adjust to the appropriate pH), sodium hydroxide (to adjust to the appropriate pH), purified water.

What Clatra looks like and contents of the pack
Clatra is a clear, colourless, slightly viscous aqueous solution with a pH of 3.0–4.0, free from sediment.

Clatra oral solution 2.5 mg/mL is available in an amber glass bottle closed with an aluminium cap or a child-resistant polypropylene cap, together with a dosing syringe of 15 mL or 25 mL capacity, marked with a 4 mL dose indication. Each bottle contains 120 mL of oral solution.

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

Manufacturers
Berlin-Chemie AG
Glienicker Weg 125
12489 Berlin
Germany

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

This medicinal product is authorised in the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
Austria: Nasitop 2.5 mg/ml Lösung zum Einnehmen
Belgium: Bellozal 2.5 mg oral solution
Bulgaria: Фортекал за деца, 2.5 mg/ml перорален разтвор
Cyprus: Bilaz 2.5 mg/mL πόσιμο διάλυμα
Czech Republic: Xados
Denmark: Revitelle, oral opløsning 2.5 mg/ml
Estonia: Opexa
Finland: Revitelle
France: Bilaska 2.5 mg/ml solution buvable
Germany: Bilaxten 2.5 mg/ml Lösung zum Einnehmen
Greece: Bilaz 2.5 mg/mL πόσιμο διάλυμα
Hungary: Lendin
Iceland: Bilaxten 2.5 mg/ml mixtúra, lausn
Ireland: Drynol
Latvia: Opexa 2.5 mg/ml šķīdums iekšķīgai lietošanai
Lithuania: Opexa
Luxembourg: Bellozal 2.5 mg oral solution
Malta: Gosall 2.5 mg/ml oral solution
Norway: Zilas 2.5 mg/ml mikstur, oppløsning
Poland: Clatra
Portugal: Lergonix 2.5 mg/ml solução oral
Romania: Borenar 2.5 mg/ml soluţie orală
Slovakia: Omarit 2.5 mg/ml perorálny roztok
Slovenia: Bilador 2.5 mg peroralna raztopina
Spain: Ibis 2.5 mg/ml solución oral
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