Clatra Allergi Fast

Leaflet attached to the packaging: patient information

Clatra Allergy Fast, 20 mg, orally disintegrating tablets

Bilastine

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any side effects, including any possible side effects not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

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

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

Clatra Allergy Fast contains the active substance bilastine, which has antihistamine properties.
Clatra Allergy Fast is used to relieve 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 Allergy Fast

When not to take Clatra Allergy Fast

Warnings and precautions

Before taking Clatra Allergy Fast, discuss it with your doctor or pharmacist if you have moderate or severe kidney problems, low potassium, magnesium, or calcium levels in your blood, if you have or have had heart rhythm problems or a very slow heart rate, if you are taking medicines that may affect your heart rhythm, if you 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 you are taking other medicines (see "Clatra Allergy Fast 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 Allergy Fast and other medicines

Tell your doctor or pharmacist about all medicines you are taking, including those that are available without a prescription, and about medicines you plan to take.
In particular, always inform your doctor or pharmacist if you are taking any of the following medicines:

• ketokonazole (an antifungal medicine)
• erythromycin (an antibiotic)
• diltiazem (a medicine used for angina - chest pain or discomfort)
• cyclosporine (a medicine that reduces the activity of the immune system, used to prevent transplant rejection or reduce the severity of autoimmune diseases and allergies, such as psoriasis, atopic dermatitis, or rheumatoid arthritis)
• ritonavir (a medicine used to treat AIDS)
• rifampicin (an antibiotic)

Clatra Allergy Fast with food, drink, and alcohol Do not take the medicine with food or with grapefruit juice or other fruit juices

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

• swallow the orally disintegrating tablet and wait for 1 hour before eating or drinking fruit juice or
• after eating or drinking fruit juice, wait for 2 hours before taking the orally disintegrating tablet.

Bilastine at the recommended dose for adults (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 you are pregnant or breastfeeding, or if you plan to have a baby, ask your doctor for advice before taking this medicine. Before taking any medicine, consult your 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 person to person.
Therefore, before driving or operating machinery, check how the medicine affects you.

Clatra Allergy Fast contains ethanol and sodium

This medicine contains less than 1 mmol (23 mg) of sodium per orally disintegrating tablet, which means the medicine is considered "sodium-free".
This medicine contains 0.0030 mg of ethanol (alcohol) per orally disintegrating tablet, which is equivalent to 1.6 mg/100 g (0.0016% w/w). The amount of alcohol in a 185 mg orally disintegrating tablet is equivalent to less than 1 ml of beer or 1 ml of wine.
The small amount of alcohol in this medicine will not cause noticeable effects.

3. How to take Clatra Allergy Fast

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
The recommended dose for adults, including the elderly, and adolescents over 12 years of age is 1 orally disintegrating tablet (20 mg) once a day.

• The orally disintegrating tablet is intended for oral use.
• Place the tablet in your mouth. It will dissolve quickly in your saliva, and you can then swallow it easily.
• The orally disintegrating tablet can also be dissolved in water before administration.
• To dissolvethe tablet, use only water, do not use grapefruit juice or other fruit juices.
• Take the orally disintegrating tablet 1 hour before or 2 hours after any meal or fruit juice (see section 2 "Clatra Allergy Fast with food, drink, and alcohol").

The duration of treatment depends on the type of disease. Your doctor will decide how long you should take Clatra Allergy Fast.

Use in children

Other forms of this medicine - bilastine 10 mg orally disintegrating tablets or bilastine 2.5 mg/ml oral solution - may be more suitable for children aged 6 to 11 years with a body weight of at least 20 kg - consult your doctor or pharmacist.

Do not give this medicine to children under 6 years of age with a body weight below 20 kg, as there are insufficient data on the use of the medicine.

Overdose of Clatra Allergy Fast

If you or someone else has taken more than the recommended dose of Clatra Allergy Fast, contact a doctor or go to the emergency department of the nearest hospital immediately. Take the medicine packaging or leaflet with you.

Missed dose of Clatra Allergy Fast

Do not take a double dose to make up for a missed dose.
If you miss a dose, take it as soon as possible on the same day.
Then, take the next dose the following day at the usual time, as recommended by your doctor. If you have any further questions about taking this medicine, ask your doctor or pharmacist.

Stopping treatment with Clatra Allergy Fast

You should not expect any effects from stopping treatment with Clatra Allergy Fast.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Clatra Allergy Fast can cause side effects, although not everybody gets them.
Stop taking the medicine and consult a doctor immediately if you experience an allergic reaction, the symptoms of which may include: difficulty breathing, dizziness, fainting or loss of consciousness, swelling of the face, lips, tongue, or throat, and (or) swelling and redness of the skin.

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 problems
• dizziness
• stomach pain
• fatigue
• increased appetite
• heart rhythm disorders
• weight gain
• nausea (feeling sick)
• anxiety
• feeling of dryness or discomfort in the nose
• abdominal pain
• diarrhea
• gastritis (inflammation of the stomach lining)
• dizziness (feeling dizzy or spinning)
• feeling weak
• increased thirst
• shortness of breath (difficulty breathing)
• dry mouth
• indigestion
• itching
• oral thrush
• fever
• tinnitus (ringing in the ears)
• sleep disorders
• blood test abnormalities indicating kidney problems
• elevated 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 are:

Common: occurring in less than 1 in 10 treated patients

• rhinitis (irritation of the nose)
• allergic conjunctivitis (eye inflammation caused by an allergic reaction)
• 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 (feeling sick)
• lip swelling
• rash
• hives
• fatigue

Reporting side effects

If you experience any side effects, including any possible side effects not listed in this leaflet, tell your 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Clatra Allergy Fast

Keep the medicine out of the sight and reach of children.
Do not use this 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 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 Allergy Fast contains

• The active substance is bilastine. Each orally disintegrating tablet contains 20 mg of bilastine.
• The other ingredients are: mannitol (E 421), croscarmellose sodium, sodium stearyl fumarate, sucralose (E 955), red grape flavor (main components: gum arabic, ethyl acetate, triacetin, methyl anthranilate, ethanol, D-limonene, linalool).

What Clatra Allergy Fast looks like and contents of the pack

Clatra Allergy Fast, orally disintegrating tablets are round, flat, white tablets with a diameter of 8 mm, marked with "20" on one side.
The orally disintegrating tablets are packaged in blisters. Pack sizes: 10 x 1, 20 x 1, 30 x 1, 40 x 1, or 50 x 1 orally disintegrating tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder
Menarini International Operations Luxembourg S.A.
1, Avenue de la Gare
1611 Luxembourg
Luxembourg
Manufacturer
Faes Farma, S.A.
Màximo Aguirre, 14
48940 Leioa (Vizcaya)
Spain

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 Schmeltztabletten
France: Inorial 20 mg comprimé orodispersible
Greece: Bilargen 20 mg δισκία διασπειρόμενα στο στόμα
Italy: Robilas 20 mg compressa orodispersibile
Poland: Clatra Allergy Fast
Portugal: Bilaxten 20 mg comprimido orodispersível
Spain: Bilaxten Flas 20 mg comprimidos bucodispersables
To obtain more detailed information, contact 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