Clatra allergy
Poland
Table of Contents
Package leaflet: Information for the patient
Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Clatra Allergy (Bellozal), 20 mg, tablets
Bilastinum
Clatra Allergy and Bellozal are different trade names for the same medicine.
Please read this leaflet carefully before taking the medicine, as it contains
important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as directed by
the doctor or pharmacist.
- Keep this leaflet, as you may need to read it again.
- If you need advice or further information, please contact your pharmacist.
- If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.
- If there is no improvement after 3 days, or if you feel worse, contact your doctor.
Table of contents of the leaflet:
- What Clatra Allergy is and what it is used for
- Important information before taking Clatra Allergy
- How to take Clatra Allergy
- Possible side effects
- How to store Clatra Allergy
- Contents of the pack and other information
1. What Clatra Allergy is and what it is used for
Clatra Allergy contains the active substance bilastin, which has antihistamine properties.
Clatra Allergy 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 (urticaria).
Clatra Allergy is indicated for use in adults and adolescents aged 12 years and older.
2. Important information before taking Clatra Allergy
When not to take Clatra Allergy
- if you are allergic to bilastin or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Before starting Clatra Allergy, consult your doctor or pharmacist if you have moderate to severe kidney impairment, low levels of potassium, magnesium, or calcium in the blood, if you have or have had heart rhythm disorders or very slow heart rate, if you are taking medicines that may affect heart rhythm, if you have or have had an abnormal heart rhythm pattern (known as QTc prolongation on electrocardiogram), which may occur in certain types of heart disease, and additionally if you are taking other medicines (see “Clatra Allergy 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 your doctor.
Clatra Allergy with other medicines
Tell your doctor or pharmacist about any medicines you are currently taking, have recently taken, or plan to take, including those obtained without a prescription.
In particular, inform your doctor if you are taking any of the following medicines:
- ketoconazole (an antifungal medicine)
- erythromycin (an antibiotic)
- diltiazem (used to treat angina)
- cyclosporine (a medicine used to reduce immune system activity, helping to prevent transplant rejection or reduce severity of symptoms in autoimmune and allergic conditions such as psoriasis, atopic dermatitis, or rheumatoid arthritis)
- ritonavir (used in the treatment of HIV)
- rifampicin (an antibiotic)
Clatra Allergy 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 Allergy. To avoid reduced effectiveness, you should:
- 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.
Bilastin 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 bilastin in pregnant women, during breastfeeding, or on fertility.
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, you should consult your doctor before using this medicine.
Before taking any medicine, consult your doctor or pharmacist.
Driving and using machines
It has been shown that bilastin at a dose of 20 mg does not affect the ability to drive in adults. However, individual responses to treatment may vary.
Therefore, before driving or operating machinery, you should assess how this medicine affects you.
Clatra Allergy contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet; therefore, it is considered "sodium-free".
3. How to take Clatra Allergy
This medicine should always be taken exactly as described in this patient information leaflet or 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.
- Tablet for oral administration.
- The tablet should be taken one hour before or two hours after any meal or fruit juice (see section 2, "Clatra Allergy with food, drink and alcohol").
- Swallow the tablet with a glass of water.
- The break line on the tablet is intended only to facilitate breaking the tablet if the patient has difficulty swallowing it whole.
The duration of treatment depends on the type, duration and course of symptoms.
Do not use Clatra Allergy for longer than 10 days without consulting a doctor.
If there is no improvement after 3 days, or if symptoms worsen, contact your doctor.
Use in children
Do not give this medicine to children under 12 years of age.
Other strengths and formulations of this medicine – bilastine 10 mg orodispersible tablet or bilastine 2.5 mg/mL oral solution – are available and intended for use in children aged 6 to 11 years weighing at least 20 kg. Consult your doctor or pharmacist.
Do not give these bilastine formulations to children under 6 years of age weighing less than 20 kg, due to insufficient data on use.
Taking more Clatra Allergy than recommended
If you take more Clatra Allergy than recommended, contact your doctor or pharmacist immediately or go to the nearest hospital emergency department. Take the medicine packaging or leaflet with you.
If you forget to take Clatra Allergy
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 medicine at your usual time.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.
4. Possible adverse reactions
Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
If the patient develops symptoms of an allergic reaction, including: difficulty breathing,
dizziness, collapse or loss of consciousness, swelling of the face, lips, tongue or throat and (or) swelling
and redness of the skin, administration of the medicine should be discontinued and immediate medical advice
should be sought.
Other adverse reactions that may occur in adults and adolescents include:
Common: occurring in less than 1 in 10 people
- headache
- drowsiness
Uncommon: occurring in less than 1 in 100 people
- abnormal ECG findings
- 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
- vertigo (dizziness or spinning sensation)
- weakness
- increased thirst
- dyspnoea (difficulty breathing)
- dry mouth
- indigestion
- itching
- facial rash
- fever
- tinnitus (ringing in the ears)
- sleep disturbances
- blood test abnormalities indicating kidney function disorders
- increased blood lipid levels
Frequency unknown: cannot be estimated from available data
- palpitations (awareness of heart beat)
- tachycardia (rapid heartbeat)
- vomiting
Adverse reactions that may occur in children include:
Common: occurring in less than 1 in 10 people
- rhinitis (nasal irritation)
- allergic conjunctivitis (eye irritation)
- headache
- stomach ache (abdominal pain, epigastric pain)
Uncommon: occurring in less than 1 in 100 people
- eye irritation
- dizziness
- loss of consciousness
- diarrhoea
- nausea
- 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 Adverse Drug Reactions
of the Office for Registration 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.
Reporting adverse reactions helps to provide more information on the safety of the medicine.
5. How to store Clatra Allergy
Keep this medicine out of 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 should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Doing so helps protect the environment.
6. Contents of the pack and other information
What Clatra Allergy 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 Allergy looks like and contents of the pack
Clatra Allergy tablets are white, oval-shaped, biconvex, with a score line on one side (10 mm in length, 5 mm in width).
The tablets are packed in blisters. Pack size: 10 tablets.
For more detailed information, please contact the responsible entity or the parallel importer.
Marketing Authorisation Holder in Belgium, 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-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, country of export: BE381211
Parallel Import Authorisation Number: 348/25
This medicinal product is authorised for sale in the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
Germany: Antires 20 mg Tabletten
France: Inorial 20 mg Comprimé
Greece: Bilargen 20 mg Δισκίο
Italy: Robilas 20 mg Compressa
Poland: Clatra Allergy
Portugal: Bilaxten 20 mg comprimido
Spain: Bilaxten 20 mg comprimidos