Bilastina Amertil

Package Leaflet: Information for the Patient

Bilastyna Amertil, 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 after 3 days there is no improvement or the patient feels worse, they should contact their doctor.

Table of Contents of the Leaflet:

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

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

Bilastyna Amertil contains the active substance bilastine, which has antihistamine properties.
Bilastyna Amertil is used to relieve symptoms of hay fever (sneezing, itching, runny nose, nasal discharge, stuffy nose, and red, itchy eyes) and other forms of allergic rhinitis. The medicine may also be used to treat itchy skin rashes (hives or urticaria).
Bilastyna Amertil is indicated for use in adults and adolescents 12 years of age and older.

2. Important information before taking Bilastyna Amertil

When not to take Bilastyna Amertil

• 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 Amertil, 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 may occur in certain types of heart disease, and the patient is taking other medicines (see "Bilastyna Amertil 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.

Bilastyna Amertil 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 about taking any of the following medicines:

• ketokonazole (an antifungal medicine)
• erythromycin (an antibiotic)
• diltiazem (a medicine used for coronary heart disease)
• cyclosporin (a medicine that reduces the activity of the immune system, used in patients who have had organ transplants or have autoimmune or allergic diseases, such as psoriasis, atopic dermatitis, or rheumatoid arthritis)
• ritonavir (used to treat AIDS)
• rifampicin (an antibiotic)

Bilastyna Amertil with food, drink, and alcohol Do not take the medicine with food or grapefruit juice or other fruit juices

becauseit reduces the effect of Bilastyna Amertil. To avoid reducing the effect of the medicine, the patient should:

• swallow the tablet and wait one hour before eating or drinking fruit juice (see section 2, "Bilastyna Amertil with food, drink, and alcohol").
• after eating or drinking fruit juice, wait 2 hours before taking the tablet.

Bilastyna Amertil 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, or 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. Before taking any medicine, the patient should consult their 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.

The medicine contains sodium

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

3. How to take Bilastyna Amertil

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 in doubt, the patient 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 one hour before or two hours after any meal or fruit juice (see section 2, "Bilastyna Amertil 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 Amertil for more than 10 days without consulting a doctor.

If after 3 days there is no improvement or the patient feels worse, they should consult their doctor.
The duration of treatment depends on the type of disease, its duration, and course.

Use in children

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

Overdose of Bilastyna Amertil

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

Missed dose of Bilastyna Amertil

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 return to their regular dosing schedule.
If the patient has any further questions on the use of this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Bilastyna Amertil 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) swelling and redness of the skin, they should stop taking the medicine and consult their doctor immediately (frequency not known).
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
• anxiety
• 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
• blood test abnormalities indicating kidney problems
• increased lipid levels in the blood

Frequency not known: frequency 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

• nasal congestion (nasal irritation)
• allergic conjunctivitis (eye irritation)
• 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
• 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 Monitoring of Adverse Reactions to 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, it is possible to gather more information on the safety of the medicine.

5. How to store Bilastyna Amertil

The medicine should be stored out of 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.
This medicine does not require any special storage conditions.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Bilastyna Amertil 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 Bilastyna Amertil looks like and contents of the pack

Bilastyna Amertil tablets are white or almost white, oblong, biconvex, with the imprint B20 and a score line on one side.
The tablets are packaged in Aluminum/Polyamide/Aluminum/PVC or Aluminum/PVC/PE/PVDC blisters, together with the patient leaflet in a cardboard box.
Package sizes: 10 or 20 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

Biofarm Sp. z o.o.
ul. Wałbrzyska 13
60-198 Poznań
phone: +48 61 66 51 500
fax: +48 61 66 51 505
e-mail: biofarm@biofarm.pl

Manufacturer

Laboratorios NORMON, S.A.
Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid
Spain

Date of last revision of the leaflet: