Bilastina Hitaxa

Package Leaflet: Information for the Patient

Bilastyna Hitaxa, 20 mg, Tablets

Bilastinum

Read the package 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 package leaflet for the patient or as directed by a doctor or pharmacist.

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

Table of Contents of the Leaflet:

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

1. What is Bilastyna Hitaxa and what is it used for

Bilastyna Hitaxa contains the active substance bilastine, which has antihistamine properties.
Bilastyna Hitaxa is used in adults and in adolescents 12 years of age and older to relieve symptoms of hay fever (sneezing, itching, runny nose, and nasal congestion, 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).
If there is no improvement after 3 days or the patient feels worse, they should consult their doctor.

2. Important information before taking Bilastyna Hitaxa

When not to take Bilastyna Hitaxa

• 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 Bilastyna Hitaxa, 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 heart rhythm, if they have or have had an abnormal heart rhythm (known as a prolonged QTc interval on an electrocardiogram), which can occur in certain types of heart disease, and also if the patient is taking other medicines (see "Bilastyna Hitaxa and other medicines").

Children

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

Do notexceed the recommended dose.

Bilastyna Hitaxa and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or might take, including those obtained without a prescription.
In particular, the patient should inform their doctor or pharmacist if they are taking any of the following medicines:

• ketokonazole (an antifungal medicine)
• erythromycin (an antibiotic)
• diltiazem (a medicine used for coronary heart disease)
• cyclosporine (a medicine used to reduce the activity of the immune system, which helps prevent transplant rejection or reduces the severity of symptoms in autoimmune and allergic diseases, such as psoriasis, atopic dermatitis, and rheumatoid arthritis)
• ritonavir (used in the treatment of AIDS)
• rifampicin (an antibiotic).

Bilastyna Hitaxa with food, drink, and alcohol

Do nottake this medicine with food or with grapefruit juice or other fruit juices, as this reduces the effect of Bilastyna Hitaxa. To avoid reducing the effect of the medicine, the patient should:

• swallow the tablet and wait for 1 hour before eating or drinking fruit juice (see section 2, "Bilastyna Hitaxa with food, drink, and alcohol").
• after eating or drinking fruit juice, wait for 2 hours 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 limited data on the use of bilastine in pregnant women, during breastfeeding, and on fertility.
If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor before taking this medicine.
The doctor will decide whether Bilastyna Hitaxa can be taken during pregnancy and breastfeeding.

Driving and using machines

It has been shown that taking bilastine at a dose of 20 mg does not affect the ability to drive vehicles in adults. However, the response to treatment may vary from patient to patient.
Therefore, before driving or operating machinery, the patient should check their reaction to the medicine.

3. How to take Bilastyna Hitaxa

This medicine should always be taken exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist. If the patient has any doubts, they should consult their 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, "Bilastyna Hitaxa 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.

Do not take Bilastyna Hitaxa for more than 10 days without consulting a doctor.

Consult a doctorif there is no improvement after 3 days or if the patient feels worse.
The duration of treatment depends on the type of disease and is determined by the doctor.

Use in children

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

Overdose of Bilastyna Hitaxa

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

Missed dose of Bilastyna Hitaxa

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 taking the medicine at the usual time.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

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

Side effects that may occur in adults and adolescents are:

Common: occurring more frequently than 1 in 100, but less frequently than 1 in 10 treated patients

• headache
• drowsiness.

Uncommon: occurring more frequently than 1 in 1000, but less frequently than 1 in 100 treated patients

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

Common: occurring less frequently than 1 in 10 treated patients

• rhinitis (irritation of the nose)
• allergic conjunctivitis (irritation of the eyes)
• headache
• stomach pain (abdominal pain, pain in the upper abdomen).

Uncommon: occurring less frequently than 1 in 100 treated patients

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

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor or pharmacist, or nurse. 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:
Al. 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, more information can be collected on the safety of the medicine.

5. How to store Bilastyna Hitaxa

The medicine should be stored 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 month.
There are no special precautions for storage.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Bilastyna Hitaxa contains

• The active substance is bilastine. Each tablet contains 20 mg of bilastine.
• The other ingredients are: microcrystalline cellulose, crospovidone (type A), magnesium stearate, anhydrous colloidal silica.

What Bilastyna Hitaxa looks like and contents of the pack

Bilastyna Hitaxa tablets are white, round, and 7 mm in diameter.
The tablets are packaged in PA/Aluminum/PVC/Aluminum blisters.
Pack sizes: 10 or 20 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

Adamed Pharma S.A.
Pieńków, ul. Mariana Adamkiewicza 6A
05-152 Czosnów
phone: +48 22 732 77 00

Manufacturer

Adamed Pharma S.A.
ul. Marszałka Józefa Piłsudskiego 5
95-200 Pabianice
NOUCOR HEALTH, S.A.
Avda. Camí Reial 51-57
08184 Palau-Solità i Plegamans (Barcelona)
Spain
Date of last revision of the leaflet:04.2025