Clatra

Leaflet attached to the packaging: patient information

Clatra, 20 mg, tablets

Bilastine

Read the leaflet carefully before taking the medicine, 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 you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those 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 packaging and other information

1. What is Clatra and what is it used for

Clatra contains the active substance bilastine, which has antihistamine properties.
Clatra is used to relieve the symptoms of hay fever (sneezing, itching, runny nose, blocked nose, and red or itchy eyes) and other forms of allergic rhinitis. The medicine may also be used to treat itchy skin rashes (hives or urticaria).

2. Important information before taking Clatra

When not to take Clatra

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

Warnings and precautions

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

Children

Do not give this medicine to children under 12 years of age.

Do notexceed the recommended dose. If symptoms persist, consult your doctor.

Clatra and other medicines

Tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take, including those available without a prescription.
In particular, inform your doctor about taking any of the following medicines:

• ketokonazole (an antifungal medicine)
• erythromycin (an antibiotic)
• diltiazem (a medicine used for coronary heart disease)
• cyclosporin (an immunosuppressive medicine used in organ transplant patients or for autoimmune diseases and allergies, such as psoriasis, atopic dermatitis, rheumatoid arthritis)
• ritonavir (for HIV treatment)
• rifampicin (an antibiotic)

Clatra with food, drink, and alcohol Do not take Clatra with food or grapefruit juice, or other

fruit juices, as this may reduce the effect of Clatra. To avoid reducing the effect of Clatra:

• swallow the tablet and wait one hour before eating or drinking fruit juice (see section 2, "Clatra with food, drink, and alcohol").
• after eating or drinking fruit juice, wait 2 hours before taking the tablet.

Bilastine at the recommended 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 in pregnant women, during breastfeeding, and on fertility.
If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor before taking this medicine. Before taking any medicine, consult your 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 in adults. However, the response to treatment may vary from patient to patient.
Therefore, before driving or operating machinery, check how this medicine affects you.

Clatra contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to take Clatra

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
The recommended dose for adults, including the elderly and adolescents from 12 years of age, is 1 tablet (20 mg) per day.

• Tablet for oral use.
• Take the tablet 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 to facilitate breaking the tablet to make it easier to swallow.

Regarding the duration of treatment, your doctor will determine the type of disease and decide how long you should take Clatra.

Use in children

Other pediatric forms of this medicine - bilastine 10 mg orodispersible tablet or bilastine 2.5 mg/mL oral solution - are more suitable for children from 6 to 11 years of age with a body weight of at least 20 kg - ask your doctor or pharmacist.

Do not give these forms of bilastine to children under 6 years of age with a body weight below 20 kg, as there is insufficient data on the use.

Overdose of Clatra

If you have taken more than the recommended dose of Clatra, immediatelycontact your doctor or pharmacist or go to the emergency department of the nearest hospital. Take the packaging or leaflet with you.

Missed dose of Clatra

Do nottake a double dose to make up for a missed dose.
If you miss a dose, take the missed dose as soon as possible, and then continue with your regular dose at the usual time.
If you have any questions, ask your doctor or pharmacist.

• 4.

Possible side effects

Like all medicines, Clatra can cause side effects, although not everybody gets them.
If you experience 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 your doctor immediately.

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

Frequency not known: cannot be estimated from the available data

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

Side effects that may occur in children are:

Common: occurring in less than 1 in 10 treated patients

• nasal congestion (nasal irritation)
• allergic conjunctivitis (eye irritation)
• headache
• stomach pain (abdominal pain, pain in the upper abdomen)

Uncommon: occurring in less than 1 in 100 treated patients

• eye irritation
• dizziness
• loss of consciousness
• diarrhea
• nausea
• lip swelling
• rash
• hives
• fatigue

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist, or nurse.
Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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 the medicine after the expiry date stated on the carton and blister after "EXP". The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
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 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 starch glycolate type A, colloidal anhydrous silica, magnesium stearate.

What Clatra looks like and contents of the pack

Clatra tablets are white, oval, biconvex, with a break line on one side (length 10 mm, width 5 mm).
The tablets are packaged in blisters. Pack sizes: 10, 20, 30, 40, or 50 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

Menarini International Operations Luxembourg S.A.
1, Avenue de la Gare
L-1611 Luxembourg
Luxembourg

Manufacturer

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

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

or
Menarini – Von Heyden GmbH
Leipziger Strasse 7 – 13
01097 Dresden
Germany

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:
Olisir 20 mg Tablets
Belgium:
Bellozal 20 mg Tablet
Bulgaria:
Fortecal 20 mg Tablet
Cyprus:
Bilaz 20 mg Δισκίο
Czech Republic:
Xados
Denmark:
Revitelle, tablets 20 mg
Estonia:
Opexa
Finland:
Revitelle 20 mg tablets
France:
Bilaska 20 mg Comprimé
Germany:
Bilaxten 20 mg Tablets
Greece:
Bilaz 20 mg Δισκίο
Hungary:
Lendin 20 mg tabletta
Iceland:
Bilaxten 20 mg tablets
Ireland:
Drynol 20 mg tablets
Italy:
Bysabel 20 mg Compressa
Latvia:
Opexa 20 mg tablets
Lithuania:
Opexa 20 mg tabletès
Luxembourg:
Bellozal 20 mg Tablet
Malta:
Gosall 20 mg tablets
Norway:
Zilas 20 mg tablet
Poland:
Clatra
Portugal:
Lergonix 20 mg Comprimido
Romania:
Borenar 20 mg comprimate
Slovakia:
Omarit 20 mg Tablet
Slovenia:
Bilador 20 mg tablets
Spain:
Ibis 20 mg Comprimido
Sweden:
Bilaxten 20 mg tablets
United Kingdom (Northern Ireland): Ilaxten 20 mg tablets
Date of last revision of the leaflet:02/2025