Package leaflet: Information for the patient

Clatra Allergy Fast, 20 mg, orodispersible tablets
Bilastinum
Please read the entire leaflet carefully before taking the medicine, as it contains
important information for the patient.
This medicine should always be used 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, consult your pharmacist.
If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
If there is no improvement after 3 days, or if you feel worse, consult your doctor.

Contents of the leaflet:

What Clatra Allergy Fast is and what it is used for
Important information before taking Clatra Allergy Fast
How to take Clatra Allergy Fast
Possible side effects
How to store Clatra Allergy Fast
Contents of the pack and other information

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

Clatra Allergy Fast contains the active substance bilastin, which has antihistamine properties.
Clatra Allergy Fast is used to relieve symptoms of allergic rhinitis (sneezing, itching, runny nose,
nasal congestion, and red, 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 Allergy Fast

When not to use Clatra Allergy Fast

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 Allergy Fast, consult a doctor or pharmacist if the patient has
moderate or severe kidney function impairment, low blood levels of potassium, magnesium or calcium,
if the patient has or has had heart rhythm disorders or very slow heart rate, if the patient is taking
medicines that may affect heart rhythm, or if the patient has or has had an abnormal heart rhythm
pattern (known as QTc prolongation on electrocardiogram), which may occur in certain types of
heart disease. This is particularly important if the patient is taking other medicines (see "Clatra Allergy
Fast 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 a doctor.
Clatra Allergy Fast with other medicines
Inform your doctor or pharmacist about all medicines, including those obtained without a prescription,
currently taken or recently used, as well as any medicines the patient plans to take.
In particular, always inform the doctor if the patient is taking any of the following medicines:

ketoconazole (an antifungal medicine)
erythromycin (an antibiotic)
diltiazem (a medicine used for angina pectoris – chest pain or tightness)
cyclosporine (a medicine that reduces immune system activity, used to prevent transplant rejection or to reduce severity of autoimmune and allergic diseases such as psoriasis, atopic dermatitis or rheumatoid arthritis)
ritonavir (a medicine used in the treatment of AIDS)
rifampicin (an antibiotic)

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

swallow the orodispersible 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 orodispersible tablet.

Bilastine at the recommended adult 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 during pregnancy, breastfeeding, or its effect on fertility.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child,
she should consult a doctor before using this medicine. Always consult a doctor or pharmacist before
taking any medicine.
Driving and using machines
It has been demonstrated that bilastine 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,
the patient should assess how this medicine affects them.
Clatra Allergy Fast contains ethanol and sodium
This medicine contains less than 1 mmol (23 mg) of sodium per orodispersible tablet, meaning the
medicine is considered "sodium-free".
This medicine contains 0.0030 mg of alcohol (ethanol) per orodispersible tablet, equivalent to
1.6 mg / 100 g (0.0016% w/w). The amount of alcohol in a 185 mg orodispersible 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

This medicine should always be taken exactly as described in this patient leaflet or as advised by your
doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The recommended dose for adults, including elderly patients, and adolescents aged 12 years and older,
is one orodispersible tablet (20 mg) once daily.

The orodispersible tablet is intended for oral administration.
Place the tablet in the mouth. It will rapidly dissolve in saliva and can then be easily swallowed.
The orodispersible tablet may also be dissolved in water before administration.
Only water should be used to dissolve the tablet ; do not use grapefruit juice or other fruit juices.
The orodispersible tablet should be taken one hour before or two hours after any meal or fruit juice consumption (see section 2 “Clatra Allergy Fast with food, drink and alcohol”).

Do not use Clatra Allergy Fast for longer than 10 days without consulting a doctor.
Use in children
Do not give this medicine to children under 12 years of age.
Other formulations and doses of this medicine – bilastine 10 mg orodispersible tablets or
bilastine 2.5 mg/ml oral solution – are intended for 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,
as there is insufficient data on safety and efficacy in this group.
Taking more Clatra Allergy Fast than recommended
If you or someone else has taken more Clatra Allergy Fast than recommended, contact a doctor
immediately or go to the nearest hospital emergency department. Bring the medicine pack or leaflet with you.
If you forget to take Clatra Allergy Fast
Do not take a double dose to make up for a forgotten dose.
If you miss a dose, take it as soon as possible on the same day.
Then take the next dose at the usual time the following day.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.
Stopping Clatra Allergy Fast
You should not expect any consequences resulting from stopping treatment with Clatra Allergy Fast.
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 will experience them.
The medicine should be discontinued and medical advice should be sought immediately if the patient
experiences hypersensitivity reactions, which may include: difficulty breathing, dizziness, collapse or
loss of consciousness, swelling of the face, lips, tongue or throat, and (or) skin rash and redness.

Adverse reactions that may occur in adults and adolescents:

Common: occurring in less than 1 in 10 people

headache
drowsiness

Uncommon: occurring in less than 1 in 100 people

abnormal ECG findings
changes in blood tests indicating liver function abnormalities
dizziness
stomach pain
fatigue
increased appetite
heart rhythm disturbances
weight gain
nausea (feeling sick)
anxiety
dryness or discomfort in the nose
abdominal pain
diarrhoea
gastritis (inflammation of the stomach lining)
vertigo (dizziness or spinning sensation)
feeling weak
increased thirst
dyspnoea (difficulty breathing)
dry mouth
indigestion
itching
oral mucosal lesions
fever
tinnitus (ringing in the ears)
sleep disturbances
changes in blood tests indicating kidney function abnormalities
elevated blood lipid levels

Frequency unknown: cannot be estimated from available data

palpitations (awareness of heart beating)
tachycardia (rapid heartbeat)
vomiting

Adverse reactions that may occur in children:

Common: occurring in less than 1 in 10 people

rhinitis (nasal mucosal inflammation, nasal irritation)
allergic conjunctivitis (eye inflammation due to allergic reaction)
headache
stomach pain (abdominal pain, epigastric pain)

Uncommon: occurring in less than 1 in 100 people

eye irritation
dizziness
loss of consciousness
diarrhoea
nausea (feeling sick)
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 of Adverse Drug Reactions of the 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Clatra Allergy Fast

Keep this medicine out of 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 stated month.
No special storage conditions apply for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Clatra Allergy Fast contains

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

What Clatra Allergy Fast looks like and contents of the pack
Clatra Allergy Fast orodispersible tablets are round, flat, white tablets with a diameter of 8 mm, marked with "20" on one side.
The orodispersible tablets are packed in blisters. Pack sizes: 10 x 1 orodispersible tablet.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Menarini International Operations Luxembourg S.A.
1, Avenue de la Gare
1611 Luxembourg
Luxembourg

Manufacturer
Faes Farma, S.A.
Máximo Aguirre, 14
48940 Leioa (Vizcaya)
Spain
Faes Farma, S.A., Parque Cientifico y Tecnologico de Bizkaia
Ibaizabal Bidea, Edificio 901
48160 Derio (Bizkaia)
Spain

This medicinal product is authorised in the Member States of the European Economic Area 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

For further information, please contact the local representative of the Marketing Authorisation Holder:
Berlin-Chemie/Menarini Polska Sp. z o.o.
Tel.: (22) 566 21 00
Fax: (22) 566 21 01