Clatra Allergi

Leaflet attached to the packaging: patient information

Clatra Allergy, 20 mg, tablets

Bilastine

Read the 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 a doctor or pharmacist.

• Keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse after 3 days, they should contact their doctor.

Table of contents of the leaflet:

• 1. What is Clatra Allergy and what is it used for
• 2. Important information before taking Clatra Allergy
• 3. How to take Clatra Allergy
• 4. Possible side effects
• 5. How to store Clatra Allergy
• 6. Contents of the packaging and other information

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

Clatra Allergy contains the active substance bilastine, which has antihistamine properties.
Clatra Allergy 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).
Clatra Allergy is indicated for use in adults and adolescents 12 years of age and older.

2. Important information before taking Clatra Allergy

When not to take Clatra Allergy

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

Warnings and precautions

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

Children

This medicine should not be given to children under 12 years of age.

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

Clatra Allergy and other medicines

Tell the doctor or pharmacist about all medicines the patient is taking, has recently taken, or might take, including those obtained without a prescription.
In particular, inform the doctor about taking any of the following medicines:

• ketokonazole (an antifungal medicine)
• erythromycin (an antibiotic)
• diltiazem (a medicine used for angina)
• cyclosporin (a medicine used to reduce the activity of the immune system, which helps prevent transplant rejection or reduces the severity of symptoms in autoimmune or allergic diseases, such as psoriasis, atopic dermatitis, or rheumatoid arthritis)
• ritonavir (used to treat HIV)
• rifampicin (an antibiotic)

Clatra Allergy with food, drink, and alcohol

Do nottake this medicine with food, grapefruit juice, or other fruit juices, as this may reduce the effectiveness of Clatra Allergy.
To avoid reducing the effectiveness of the medicine, the patient should:

• swallow the tablet and wait for 1 hour before eating or drinking fruit juice, or
• wait for 2 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 or limited data on the use of bilastine in pregnant or breastfeeding women, or on its effects on fertility.
If the patient is pregnant, breastfeeding, thinks they may be pregnant, or plans to have a baby, 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, the patient should check how the medicine affects them.

Clatra Allergy contains sodium

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

3. How to take Clatra Allergy

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist.
In case of doubt, consult a doctor or pharmacist.
The recommended dose for adults, including the elderly, and adolescents 12 years of age and older is 1 tablet (20 mg) per day.

• The tablet is for oral use.
• The tablet should be taken 1 hour before or 2 hours after any meal or fruit juice (see section 2, "Clatra Allergy 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 if the patient has difficulty swallowing it whole.

The duration of treatment depends on the type, duration, and course of the disease.
Clatra Allergy should not be taken for more than 10 days without consulting a doctor.
If there is no improvement or the patient feels worse after 3 days, they should contact their doctor.

Use in children

This medicine should not be given to children under 12 years of age.

Other doses and forms 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 with a body weight of at least 20 kg – consult a doctor or pharmacist.

This form of bilastine should not be given 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 Allergy

In case of overdose, the patient should immediatelyconsult a doctor or pharmacist or go to the emergency department of the nearest hospital.
The patient should take the packaging or leaflet with them.

Missed dose of Clatra Allergy

Do nottake a double dose to make up for a missed dose.
If a dose is missed, the patient should take the missed dose as soon as possible and then continue with their regular dose at the usual time.
In case of further doubts about taking this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Clatra Allergy can cause side effects, although not everybody gets them.
If the patient experiences symptoms of an allergic reaction, including difficulty breathing, dizziness, fainting, or loss of consciousness, swelling of the face, lips, tongue, or throat, and (or) redness and swelling of the skin, they should stop taking the medicine and consult a doctor immediately.

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

Common: occurring in less than 1 in 10 people

• nasal congestion (nasal irritation)
• allergic conjunctivitis (eye irritation)
• headache
• stomach pain (abdominal pain, epigastric pain)

Uncommon: occurring in less than 1 in 100 people

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

Reporting side effects

If the patient experiences any side effects, including those not listed in the leaflet, they should inform their doctor or pharmacist.
Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Aleje 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.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Clatra Allergy

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 the month.
There are no special precautions for storage.
Medicines should not be disposed of via wastewater or household waste.
Ask a 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 Allergy 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 Allergy looks like and contents of the pack

Clatra Allergy tablets are white, oval, biconvex, with a score line on one side (length 10 mm, width 5 mm).
The tablets are packaged in blisters. The pack size is 10 tablets.

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

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:

Germany:
Antires 20 mg tablets
France:
Inorial 20 mg tablets
Greece:
Bilargen 20 mg tablets
Italy:
Robilas 20 mg tablets
Poland:
Clatra Allergy
Portugal:
Bilaxten 20 mg tablets
Spain:
Bilaxten 20 mg tablets
To obtain more detailed information, consult the local representative of the marketing authorization holder:
Berlin-Chemie/Menarini Polska Sp. z o.o.
Phone: (22) 566 21 00
Fax: (22) 566 21 01
Date of last revision of the leaflet:02/2025