Clatra
Poland
Table of Contents
Package leaflet: Information for the patient
Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
Clatra (Bellozal), 20 mg, tablets
Bilastinum
Clatra and Bellozal are different trade 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, as you may need to read it again.
- Consult your doctor or pharmacist if you have any further questions.
- This medicine has been prescribed for a specific individual only. Do not give it to others. It may harm someone else, even if their symptoms are the same.
- If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform the doctor or pharmacist. See section 4.
Table of contents of the leaflet:
- 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 bilastine, which has antihistaminic activity.
Clatra is used to relieve symptoms of allergic rhinitis (hay fever), such as sneezing, itching, runny nose, nasal congestion, and red, watery eyes, as well as 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 treatment with Clatra, consult a doctor or pharmacist if the patient has moderate to severe kidney function impairment and is taking other medicines (see "Clatra and 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 and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, including those obtained without a prescription, as well as any medicines the patient plans to take.
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 patients after organ transplantation 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 or with 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 data are limited regarding the use of bilastine during pregnancy, breastfeeding, or its effect on fertility.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor before using this medicine. Before using any medicine, consult a doctor or pharmacist.
Driving and using machines
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; therefore, this 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 consumption (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 the tablet for easier swallowing.
Regarding duration of treatment, your treating physician will determine the type of illness and decide how long Clatra should be taken.
Use in children
Other pediatric formulations 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 body weight of at least 20 kg – please consult your doctor or pharmacist.
These bilastine formulations must not be given to children under 6 years of age with body weight below 20 kg, due to insufficient data on use.
Taking more Clatra than recommended
If you take more Clatra than recommended, contact your doctor or pharmacist immediately or go to the nearest hospital emergency department. Bring the medicine packaging 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 you miss a dose, take it as soon as possible, then return to taking your regular dose at the usual time.
If you have any further questions, consult your doctor or pharmacist.
4. Possible adverse reactions
Like all medicines, this medicine can cause adverse reactions, although not everyone will experience 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, administration of the medicine should be discontinued immediately and medical advice should be sought without delay.
Other adverse reactions that may occur in adults and adolescents include:
Common: occurring in less than 1 in 10 patients treated
- Headache
- Drowsiness
Uncommon: occurring in less than 1 in 100 patients treated
- Abnormal ECG readings
- Blood test abnormalities indicating liver function disorders
- Dizziness
- Stomach pain
- Fatigue
- Increased appetite
- Heart rhythm disturbances
- Weight gain
- Nausea
- Anxiety
- Sensation of 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 based on available data
- Palpitations (awareness of heart beating)
- Tachycardia (rapid heartbeat)
- Vomiting
Adverse reactions that may occur in children include:
Common: occurring in less than 1 in 10 patients treated
- Nasal mucositis (nasal irritation)
- Allergic conjunctivitis (eye irritation)
- Headache
- Stomach pain (abdominal pain, epigastric pain)
Uncommon: occurring in less than 1 in 100 patients treated
- Eye irritation
- Dizziness
- Loss of consciousness
- Diarrhoea
- Nausea
- Swelling of the lips
- Rash
- Urticaria
- Fatigue
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, patients should inform their 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.
Reporting adverse reactions enables better assessment of the medicine’s safety and helps to provide more information on its safe use.
5. How to store the medicine Clatra
Keep the medicine out of the 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 specified month.
No special storage conditions apply.
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 score line 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 responsible party or the parallel importer.
Marketing Authorisation Holder in Belgium, the country of export:
Menarini International Operations Luxembourg S.A.
1, Avenue de La Gare
L-1611 Luxembourg
Luxembourg
Manufacturers:
Faes Farma, S.A.
Maximo Aguirre, 14
E-48.940 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
Poland
Repackaged by:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland
Marketing Authorisation Number in Belgium, the country of export: BE381211
Parallel Import Authorisation Number: 381/24
This medicinal product is authorised 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