Clatra

Package Leaflet: Information for the Patient

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Clatra(Bellozal), 20 mg, tablets
Bilastine
Clatra and Bellozal are different trade names for the same drug.

You should read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so you can read it again if you need to.
• You should consult a doctor or pharmacist if you have any further doubts.
• This medicine has been prescribed to a specific person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their 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 has antihistamine properties.
Clatra is used to relieve the symptoms of hay fever (sneezing, itching, runny nose, and stuffy 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).

2. Important information before taking Clatra

When not to take Clatra

Warnings and precautions

Before taking Clatra, the patient should discuss it with their doctor or pharmacist if they have moderate to severe kidney problems and 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 a 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 that are available without a prescription.
In particular, inform your doctor if you are taking any of the following medicines:

• ketokonazole (an antifungal medicine)
• erythromycin (an antibiotic)
• diltiazem (a medicine used for coronary heart disease)
• cyclosporine (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 the medicine with food or grapefruit juice, or other fruit juices

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

• swallow the tablet and wait one hour before eating or drinking fruit juice or
• after eating or drinking fruit juice, wait two 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 the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their 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 in adults. However, the response to treatment may vary from patient to patient.
Therefore, before driving or operating machinery, check how the 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

This medicine should always be taken exactly as prescribed by your doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
The recommended dose for adults, including the elderly and adolescents 12 years and older, is 1 tablet (20 mg) per day.

• Tablet for oral use.
• The tablet should be taken one hour before or two hours after any meal or fruit juice (see section 2, "Clatra with food, drink, and alcohol").
• The tablet should be swallowed with a glass of water.
• The score line on the tablet is only to facilitate breaking the tablet to make it easier to swallow.

Regarding the duration of treatment, the treating doctor will determine the type of disease and decide how long to 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 aged 6 to 11 years with a body weight of at least 20 kg - consult a 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 are insufficient data on its use.

Overdose of Clatra

In case of overdose, immediatelycontact a doctor or pharmacist or go to the emergency department of the nearest hospital. Bring the packaging or leaflet with you.

Missed dose of Clatra

Do nottake a double dose to make up for a missed dose.
If a dose is missed, take the missed dose as soon as possible, and then return to the regular dose schedule at the usual time.
If in doubt, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Clatra can cause side effects, although not everybody gets them.
If the patient 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, they should stop taking the medicine and consult a 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
• blood test abnormalities indicating liver function disorders
• dizziness
• stomach pain
• fatigue
• increased appetite
• heart rhythm disorders
• weight gain
• nausea
• anxiety
• feeling of 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
• blood test abnormalities indicating kidney function disorders
• increased blood lipid levels

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 any side effects not listed in the leaflet, you should tell your doctor or pharmacist. 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, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
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 sight and reach of children.
Do not use the medicine after the expiry date stated on the packaging. 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 tablet contains 20 mg of bilastine.
• The other ingredients are: microcrystalline cellulose, sodium carboxymethylcellulose (type A), colloidal anhydrous silica, magnesium stearate.

What Clatra looks like and contents of the pack

Clatra tablets are white, oval, biconvex, with a score 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.
For more detailed information, consult the marketing authorization holder or parallel importer.

Marketing authorization holder in Belgium, the country of export:

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

Manufacturer:

Faes Farma, S.A.
Maximo Aguirre, 14
E-48940 Leioa (Vizcaya)
Spain
A.Menarini Manufacturing Logistics and Services S.r.l.
Campo di Pile, L’Aquila
Italy
Menarini - Von Heyden GmbH
Leipziger Strasse 7-13
D-01097 Dresden
Germany

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in Belgium, the country of export:BE381211

Parallel import authorization number: 381/24

This medicine is authorized in the Member States of the European Economic Area (EEA) under the following names:

Austria:
Olisir 20 mg Tablets
Belgium:
Bellozal 20 mg Tablet
Bulgaria:
Fortecal 20 mg Tablet
Cyprus:
Bilaz 20 mg Tablet
Czech Republic:
Xados
Denmark:
Revitelle, 20 mg tablets
Estonia:
Opexa
Finland:
Revitelle 20 mg tablets
France:
Bilaska 20 mg Comprimé
Germany:
Bilaxten 20 mg Tablets
Greece:
Bilaz 20 mg Tablet
Hungary:
Lendin 20 mg tablet
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 tablet
United Kingdom (Northern Ireland):
Ilaxten 20 mg tablets

Date of approval of the leaflet: 30.10.2024

[Information about the trademark]