Clatra

Patient Information Leaflet

Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
Clatra (Bilaz), 20 mg, tablets
Bilastinum
Clatra and Bilaz are different brand names for the same medicine.
Please read the entire leaflet before using the medicine, as it contains important information for the patient.

• Keep this leaflet for possible future reference.
• Consult your doctor or pharmacist if you have any further questions.
• This medicine has been prescribed for a specific individual. Do not share it with others. The medicine may harm other people, even if their symptoms are identical.
• If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents:

1. What Clatra is and what it is 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 Clatra is and what it is used for

Clatra contains the active substance bilastinum, which has antihistaminic properties.
Clatra is used to relieve symptoms of hay fever (sneezing, itching, runny or blocked nose, red and watery 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 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 starting Clatra, consult your doctor or pharmacist if the patient has moderate to severe kidney function impairment and is taking other medicines (see "Clatra and other medicines").

Children
Do not give this medicine to children under 12 years of age.
Do not exceed the recommended dose. If symptoms persist, consult a doctor.

Clatra and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take, including those obtained without a prescription.

In particular, inform your doctor if the patient is taking any of the following medicines:

• ketoconazole (an antifungal medicine)
• erythromycin (an antibiotic)
• diltiazem (a medicine used for coronary heart disease)
• cyclosporine (an immunosuppressive medicine used in organ transplant patients or in autoimmune and allergic conditions such as psoriasis, atopic dermatitis, rheumatoid arthritis)
• ritonavir (used in the treatment of HIV)
• rifampicin (an antibiotic)

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

• swallow the tablet and wait one hour before eating a meal or drinking fruit juice, or
• wait two hours after eating or drinking fruit juice 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, or on fertility.
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor before using this medicine.
Before taking any medicine, consult a doctor or pharmacist.

Driving and operating machinery
It has been shown that bilastine at a dose of 20 mg does not affect the ability to drive in adults. However, individual response to treatment may vary.
Therefore, before driving or operating machinery, the patient should assess how this medicine affects them.

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

3. How to take Clatra

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

• This is an oral tablet.
• 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").
• Swallow the tablet with a glass of water.
• The break line on the tablet is only intended to facilitate splitting for easier swallowing.

Regarding duration of treatment, your doctor will determine the type of illness and decide how long you should take Clatra.
Use in children
Other paediatric 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 weighing at least 20 kg – consult your doctor or pharmacist.
Bilastine formulations should not be given to children under 6 years of age weighing less than 20 kg, due to insufficient data on use.
Taking more Clatra than recommended
If you take more Clatra than recommended, you should immediately contact your doctor or pharmacist or go to the nearest hospital emergency department. Take the medicine pack or leaflet with you.
Missing a dose of Clatra
Do not take a double dose to make up for a missed dose.
If you miss a dose, take it as soon as possible, then continue taking your regular dose at the usual time.
If you have any further questions, 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 the patient experiences 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, the use of the medicine should be discontinued and immediate medical advice should be sought.

Other adverse effects that may occur in adults and adolescents include:

Common: occurring in fewer than 1 in 10 treated patients

• Headache
• Drowsiness

Uncommon: occurring in fewer than 1 in 100 treated patients

• Abnormal ECG recording
• Blood test abnormalities indicating liver function disorders
• Dizziness
• Stomach pain
• Fatigue
• Increased appetite
• Heart rhythm disturbances
• Weight gain
• Nausea
• Anxiety
• Dryness or discomfort in the nose
• Abdominal pain
• Diarrhoea
• Gastritis
• Dizziness (dizziness or sensation of spinning)
• Weakness
• Increased thirst
• Dyspnoea (difficulty breathing)
• Dry mouth
• Dyspepsia
• Itching
• Facial rash
• Fever
• Tinnitus (ringing in the ears)
• Sleep disturbances
• Blood test abnormalities indicating kidney function disorders
• Increased blood lipid levels

Frequency not known: cannot be estimated from available data

• Palpitations (awareness of heartbeat)
• Tachycardia (rapid heartbeat)
• Vomiting

Adverse effects that may occur in children:

Common: occurring in fewer than 1 in 10 treated patients

• Nasal mucositis (nasal irritation)
• Allergic conjunctivitis (eye irritation)
• Headache
• Stomach pain (abdominal pain, epigastric pain)

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

Reporting of adverse effects
If any adverse effects occur, 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, 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.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Clatra

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
No special storage conditions are required.
Medicines must 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 carboxymethyl starch (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 marked on one side (10 mm in length, 5 mm in width).
The tablets are packed in blisters. Pack sizes: 10, 20, 30, 40 or 50 tablets.
For more detailed information, please contact the Marketing Authorisation Holder or Parallel Importer.

Marketing Authorisation Holder in Greece, country of export:
Menarini International Operations Luxembourg SA
1, Avenue de la Gare
L-1611 Luxembourg
Luxembourg

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

Parallel Importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Poland

Relabeled in:
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
Poland

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland

Marketing Authorisation Number in Greece, country of export: 44881/7-7-2011
Parallel Import Authorisation Number: 239/19

This product is authorised for sale in the European Economic Area (EEA) under the following names:
Austria: Olisir 20 mg Tabletten
Belgium: Bellozal 20 mg Tablet
Bulgaria: Fortecal 20 mg Таблетка
Cyprus: Bilaz 20 mg Δισκίο
Czech Republic: Xados
Denmark: Revitelle, tabletter 20 mg
Estonia: Opexa
Finland: Revitelle 20 mg tabletti
France: Bilaska 20 mg Comprimé
Germany: Bilaxten 20 mg Tabletten
Greece: Bilaz 20 mg Δισκίο
Hungary: Lendin 20 mg tabletta
Iceland: Bilaxten 20 mg töflur
Ireland: Drynol 20 mg tablets
Italy: Bysabel 20 mg Compressa
Latvia: Opexa 20 mg tabletes
Lithuania: Opexa 20 mg tabletès
Luxembourg: Bellozal 20 mg Tablet
Malta: Gosall 20 mg tablets
Norway: Zilas 20 mg tablett
Poland: Clatra
Portugal: Lergonix 20 mg Comprimido
Romania: Borenar 20 mg comprimate
Slovakia: Omarit 20 mg Tableta
Slovenia: Bilador 20 mg tablete
Spain: Ibis 20 mg Comprimido
Sweden: Bilaxten 20 mg tablett
United Kingdom (Northern Ireland): Ilaxten 20 mg tablets