Clatra

Package leaflet: Information for the user

Clatra, 20 mg, orodispersible tablets
Bilastinum
Please read all of this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you personally. Do not pass it on to others. It may harm them even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet:

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 is an antihistamine.
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 can 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 to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before taking Clatra, consult your doctor or pharmacist if the patient has moderate or severe kidney function impairment, low blood potassium, magnesium, or calcium levels, 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, 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, including those obtained without a prescription, currently used or recently taken, as well as any medicines the patient plans to take.
In particular, always inform your doctor or pharmacist if the patient is taking any of the following medicines:

• ketoconazole (an antifungal medicine)
• erythromycin (an antibiotic)
• diltiazem (a medicine used for angina pectoris – chest pain or tightness in the chest area)
• 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 (a medicine used in the treatment of AIDS)
• 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, the following should be observed:

• swallow the orodispersible 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 orodispersible tablet.

Bilastine at the recommended adult 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, 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 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 patient response to treatment may vary.
Therefore, before driving or operating machinery, patients should assess how this medicine affects them.
Clatra contains ethanol and sodium
This medicine contains less than 1 mmol (23 mg) of sodium per orodispersible tablet, meaning the medicine is considered "sodium-free".
This medicine contains 0.0030 mg of alcohol (ethanol) per orodispersible tablet, equivalent to 1.6 mg / 100 g (0.0016% w/w). The amount of alcohol in a 185 mg orodispersible tablet is equivalent to less than 1 ml of beer or 1 ml of wine.
The small amount of alcohol in this medicine will not cause noticeable effects.

3. How to take Clatra

This medicine should always be taken exactly as directed by the doctor or pharmacist.
If in doubt, consult the doctor or pharmacist.
The recommended dose for adults, including elderly patients, and adolescents aged 12 years and older, is 1 orally disintegrating tablet (20 mg) once daily.

• The orally disintegrating tablet is intended for oral administration.
• Place the tablet in the mouth. It will rapidly dissolve in saliva and can then be easily swallowed.
• The orally disintegrating tablet may also be dissolved in water before administration.
• Only water should be used to dissolve the tablet; do not use grapefruit juice or other fruit juices.
• The orally disintegrating tablet should be taken one hour before or two hours after any meal or fruit juice intake (see section 2, "Clatra with food, drink and alcohol").

The duration of treatment depends on the type of illness. The doctor will decide how long you should continue taking Clatra.

Use in children
Other formulations of this medicine – bilastin 10 mg orally disintegrating tablets or bilastin 2.5 mg/mL oral solution – may be more suitable for children aged 6 to 11 years weighing at least 20 kg. Consult the doctor or pharmacist.
This medicine must not be given to children under 6 years of age weighing less than 20 kg,
as there is insufficient data on its use in this population.

Taking more Clatra than recommended
If more Clatra has been taken than recommended, either by the patient or another person, contact a doctor or go immediately 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 a dose is missed, take it as soon as possible on the same day.
Then take the next dose at the usual time the following day, according to the doctor's instructions.
If in doubt about any aspect of use, consult the doctor or pharmacist.

Stopping Clatra
No consequences due to stopping treatment with Clatra are expected.
If in doubt about any aspect of use, consult the doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Treatment should be discontinued and immediate medical advice sought if the patient experiences
hypersensitivity reactions, the symptoms of which may include: difficulty breathing, dizziness, collapse or loss of consciousness, swelling of the face, lips, tongue or throat, and (or) skin redness and swelling.

Adverse reactions 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 trace
• blood test abnormalities indicating liver function disorders
• dizziness
• stomach pain
• fatigue
• increased appetite
• cardiac rhythm disturbances
• weight gain
• nausea (feeling sick)
• anxiety
• sensation of dryness or discomfort in the nose
• abdominal pain
• diarrhoea
• gastritis (inflammation of the stomach mucosa)
• vertigo (dizziness or sensation of spinning)
• feeling of weakness
• increased thirst
• dyspnoea (difficulty breathing)
• dry mouth
• dyspepsia
• itching
• oral mucosal lesions
• fever
• tinnitus (ringing in the ears)
• sleep disorders
• blood test abnormalities indicating kidney function disorders
• elevated blood lipid levels

Frequency not known: cannot be estimated from available data

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

Adverse reactions that may occur in children:

Common: occurring in less than 1 in 10 treated patients

• rhinitis (nasal mucosa inflammation, nasal irritation)
• allergic conjunctivitis (eye inflammation due to allergic reaction)
• headache
• stomach ache (abdominal pain, epigastric pain)

Uncommon: occurring in less than 1 in 100 treated patients

• eye irritation
• dizziness
• loss of consciousness
• diarrhoea
• nausea (feeling sick)
• lip swelling
• rash
• urticaria
• fatigue

Reporting of adverse reactions
If any adverse reactions occur, 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 of 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
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store the medicine Clatra

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack after "EXP".
The expiry date refers to the last day of the stated month.
There are no special storage instructions for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. Such measures help protect
the environment.

6. Contents of the pack and other information

What Clatra contains

• The active substance is bilastine. Each orodispersible tablet contains 20 mg of bilastine.
• The 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, flat, white tablets with a diameter of 8 mm, marked with "20" on one side.
The orodispersible tablets are packed in blisters. Pack sizes: 10 x 1, 20 x 1, 30 x 1, 40 x 1 or 50 x 1 orodispersible 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

Manufacturer
Faes Farma, S.A.
Máximo Aguirre, 14
48940 Leioa (Vizcaya)
Spain
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 Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
Austria: Olisir 20 mg Schmelztabletten
Belgium: Bellozal 20 mg orodispersible tablets
Bulgaria: Фортекал за деца 20 mg диспергиращи се в устата таблетки
Croatia: Nixar Alergija 20 mg raspadljive tablete za usta
Cyprus: Bilaz 20 mg δισκία διασπειρόμενα στο στόμα
Czech Republic: Xados
Estonia: Opexa
Finland: Revitelle 20 mg tabletti, suussa hajoava
France: Bilaska 20 mg comprimé orodispersible
Germany: Bilaxten 20 mg Schmelztabletten
Greece: Bilaz 20 mg δισκία διασπειρόμενα στο στόμα
Hungary: Lendin NEO 20 mg szájban diszpergálódó tabletta
Ireland: Drynol 20 mg orodispersible tablets
Italy: Bysabel 20 mg compressa orodispersibile
Latvia: Opexa 20 mg mutē disperģējamās tabletes
Lithuania: Opexa 20 mg burnoje disperguojamos tabletės
Luxembourg: Bellozal 20 mg orodispersible tablets
Malta: Gosall 20 mg orodispersible tablets
Poland: Clatra
Portugal: Lergonix 20 mg comprimido orodispersível
Romania: Borenar 20 mg comprimate orodispersabile
Slovakia: Omarit 20 mg orodispergovateľné tablety
Slovenia: Bilador 20 mg orodisperzibilne tablete
Spain: Ibis 20 mg comprimidos bucodispersables

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