Bilaxten

Package Leaflet: Information for the Patient

Bilaxten, 10 mg, Oral Disintegrating Tablets

For Children Aged 2 to 11 Years with a Body Weight of at Least 15 kg

Bilastine

Read the Package Leaflet Carefully Before Giving the Medicine to the Child, as it Contains Important Information for the Patient.

• Keep this Package Leaflet, You May Need to Read it Again.
• If You Have Any Further Questions, Ask Your Doctor or Pharmacist.
• This Medicine has been Prescribed for a Specific Child. Do Not Pass it on to Others. The Medicine May Harm Them, Even if Their Symptoms are the Same.
• If the Child Experiences Any Side Effects, Including Those Not Listed in this Package Leaflet, Tell the Doctor or Pharmacist. See Section 4.

Table of Contents of the Package Leaflet:

• 1. What is Bilaxten and What is it Used for
• 2. Important Information Before Taking Bilaxten
• 3. How to Take Bilaxten
• 4. Possible Side Effects
• 5. How to Store Bilaxten
• 6. Contents of the Pack and Other Information

1. What is Bilaxten and What is it Used for

Bilaxten Contains the Active Substance Bilastine, Which Acts as an Antihistamine.
Bilaxten is Used to Relieve the 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).
Bilaxten, 10 mg, Oral Disintegrating Tablets are Indicated for Use in Children Aged 2 to 11 Years with a Body Weight of at Least 15 kg.

2. Important Information Before Taking Bilaxten

When Not to Take Bilaxten

• If the Child is Allergic to Bilastine or Any of the Other Ingredients of this Medicine (Listed in Section 6).

Warnings and Precautions

Before Starting Treatment with Bilaxten, Discuss with the Doctor or Pharmacist if the Child has Moderate or Severe Kidney or Liver Impairment, Low Potassium, Magnesium, or Calcium Levels in the Blood, if the Child has or has Had Heart Rhythm Disorders or a Very Slow Heart Rate, if the Child is Taking Medicines that May Affect the Heart Rhythm, if the Child has or has Had an Abnormal Heart Rhythm (Known as Prolonged QTc Interval on the Electrocardiogram), Which May Occur in Certain Types of Heart Disease, or if the Child is Taking Other Medicines (See "Bilaxten and Other Medicines").

Children

Do Not Give this Medicine to Children Under 2 Years of Age or with a Body Weight Below 15 kg, as There is Limited Data on the Use of the Medicine.

Bilaxten and Other Medicines

Tell the Doctor or Pharmacist About All Medicines the Child is Taking, Including Those Obtained Without a Prescription, as Well as Any Medicines the Child May Take in the Future.
Some Medicines Should Not be Taken at the Same Time, and for Others, the Dose May Need to be Changed When Taken Together.
Always Inform the Doctor or Pharmacist if the Child is Taking Any of the Following Medicines in Addition to Bilaxten:

• Ketoconazole (an Antifungal Medicine)
• Erythromycin (an Antibiotic)
• Diltiazem (a Medicine Used for Angina - Chest Pain or Discomfort)
• Cyclosporin (a Medicine that Reduces the Activity of the Immune System, Used to Prevent Transplant Rejection or Reduce the Severity of the Disease in Cases of Autoimmune or Allergic Diseases, Such as Psoriasis, Atopic Dermatitis, or Rheumatoid Arthritis)
• Ritonavir (for HIV Treatment)
• Rifampicin (an Antibiotic)

Bilaxten with Food, Drink, and Alcohol Do Not Take the Medicine with Food, Grapefruit Juice, or Other Fruit Juices

as it Reduces the Effect of Bilaxten. To Avoid Reducing the Effect of the Medicine, You Should:

• Give the Child an Oral Disintegrating Tablet and Wait for 1 Hour Before Giving the Child a Meal or Fruit Juice or
• If the Child has Eaten or Drunk Fruit Juice, Wait for 2 Hours Before Giving the Child an Oral Disintegrating Tablet.

Bilastine at the Recommended Dose for Adults (20 mg) Does Not Increase Drowsiness Caused by Alcohol Consumption.

Pregnancy, Breast-Feeding, and Fertility

This Medicine is Intended for Use in Children Aged 2 to 11 Years with a Body Weight of at Least 15 kg. However, the Following Information Should be Considered Regarding the Safe Use of this Medicine. There is Limited Data on the Use of Bilastine in Pregnant Women, During Breast-Feeding, and on Fertility.
If the Patient is Pregnant or Breast-Feeding, or Plans to Have a Child, She Should Consult a 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 Vehicles in Adults. However, the Response to Treatment May Vary from Patient to Patient.
Therefore, Check How the Medicine Affects the Child Before Allowing the Child to Ride a Bicycle, Drive Other Vehicles, or Operate Machinery.

Bilaxten Contains Ethanol and Sodium

This Medicine Contains 0.0015 mg of Alcohol (Ethanol) per Oral Disintegrating Tablet, Which is Equivalent to 1 mg/100 g (0.001% w/w). The Amount of Alcohol in the Oral Disintegrating Tablet is Equivalent to Less than 0.00004 ml of Beer or 0.00002 ml of Wine.
The Small Amount of Alcohol in this Medicine Will Not Produce Noticeable Effects.
This Medicine Contains Less than 1 mmol (23 mg) of Sodium per Oral Disintegrating Tablet, Which Means the Medicine is Considered "Sodium-Free".

3. How to Take Bilaxten

This Medicine Should Always be Taken Exactly as Prescribed by the Doctor or Pharmacist. If You are Not Sure, Consult the Doctor or Pharmacist.

Use in Children

The Recommended Dose for Children Aged 2 to 11 Years with a Body Weight of at Least 15 kg is 10 mg of Bilastine (1 Oral Disintegrating Tablet) Once a Day to Relieve the Symptoms of Allergic Rhinitis and Urticaria.
Do Not Give this Medicine to Children Under 2 Years of Age or with a Body Weight Below 15 kg, as There is Limited Data on the Use of the Medicine.
For Adults, Including the Elderly and Adolescents Aged 12 Years and Older, the Recommended Dose of Bilastine is 20 mg Once a Day. For this Population of Patients, a More Suitable Form of the Medicine is Available - a Tablet; Consult a Doctor or Pharmacist.

• The Oral Disintegrating Tablet is Intended for Oral Administration.
• Place the Oral Disintegrating Tablet in the Child's Mouth. It Will Dissolve Quickly in Saliva and Can be Swallowed Easily.
• The Oral Disintegrating Tablet Can Also be Dissolved in a Spoonful of Water Before Administration to the Child. This is Highly Recommended for Children Under 6 Years of Age, as They are at a Higher Risk of Choking on the Tablet. Make Sure There are No Residues Left on the Spoon.
• To Dissolvethe Tablet, Only WaterShould be Used, Not Grapefruit Juice or Other Fruit Juices.
• Give the Oral Disintegrating Tablet to the Child 1 Hour Before or 2 Hours After Any Meal or Fruit Juice.

The Duration of Treatment Depends on the Type of Disease in the Child. The Doctor Will Decide How Long the Child Should Take Bilaxten.

Overdose of Bilaxten

If the Child Takes More Bilaxten Than Prescribed, or if Someone Else Takes the Medicine, Consult a Doctor or Go to the Emergency Department of the Nearest Hospital Immediately. Take the Package Leaflet and the Medicine with You.

Missed Dose of Bilaxten

If a Dose is Missed, Give it to the Child as Soon as Possible on the Same Day. Then, Give the Next Dose the Next Day at the Usual Time, as Prescribed by the Doctor. Never Give a Double Dose to Make Up for a Missed Dose.

Stopping Treatment with Bilaxten

No Consequences are Expected if Treatment with Bilaxten is Stopped.
If You Have Any Further Questions on the Use of this Medicine, Ask Your Doctor or Pharmacist.

4. Possible Side Effects

Like All Medicines, Bilaxten Can Cause Side Effects, Although Not Everybody Gets Them.
If the Child Experiences 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, Stop Taking the Medicine and Consult a Doctor Immediately.

Other Side Effects that May Occur in Children Include:

Common: Occurs in Less than 1 in 10 Patients

• Allergic Conjunctivitis (Eye Irritation)
• Headache

Uncommon: Occurs in Less than 1 in 100 Patients

• Eye Irritation
• Dizziness
• Loss of Consciousness
• Diarrhea
• Nausea
• Lip Swelling
• Rash
• Urticaria
• Fatigue
• Rhinitis (Nasal Irritation)
• Abdominal Pain (Stomach Pain, Pain in the Upper Abdomen)

Side Effects that May Occur in Adults and Adolescents Include:

Common: Occurs in Less than 1 in 10 Patients

• Headache
• Drowsiness

Uncommon: Occurs in Less than 1 in 100 Patients

• Abnormal ECG
• Changes in Blood Tests Indicating Liver Impairment
• Dizziness
• Abdominal Pain
• Fatigue
• Increased Appetite
• Heart Rhythm Disorders
• Weight Gain
• Nausea
• Anxiety
• Dryness or Discomfort in the Nose
• Abdominal Pain
• Diarrhea
• Gastritis (Inflammation of the Stomach Lining)
• Dizziness (Dizziness or a Feeling of Spinning)
• Weakness
• Increased Thirst
• Shortness of Breath (Difficulty Breathing)
• Dry Mouth
• Indigestion
• Itching
• Oral Thrush
• Fever
• Tinnitus (Ringing in the Ears)
• Sleep Disorders
• Changes in Blood Tests Indicating Kidney Impairment
• Increased Lipid Levels in the Blood

Frequency Not Known: Cannot be Estimated from the Available Data

• Palpitations (Feeling of Heartbeats)
• Tachycardia (Fast Heart Rate)
• Vomiting.

Reporting Side Effects

If the Child Experiences Any Side Effects, Including Those Not Listed in this Package Leaflet, Tell the Doctor or Pharmacist. Side Effects can be Reported Directly to the Department of Drug Safety, 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. 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 Bilaxten

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 Pack 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 Bilaxten Contains

• The Active Substance is Bilastine. Each Oral Disintegrating Tablet Contains 10 mg of Bilastine.

Other Ingredients are: Mannitol (E 421), Croscarmellose Sodium, Sodium Stearyl Fumarate, Sucralose (E 955), Red Grapefruit Flavor (Main Components: Gum Arabic, Ethyl Maltol, Triacetin, Methyl Anthranilate, Ethanol, D-Limonene, Linalool).

What Bilaxten Looks Like and Contents of the Pack

Bilaxten, Oral Disintegrating Tablets are Round, Slightly Biconvex, White Tablets with a Diameter of 8 mm.
The Oral Disintegrating Tablets are Packaged in Blisters. Pack Sizes: 10, 20, 30, or 50 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

• A. Menarini Manufacturing Logistics and Services S.r.l. Via Campo di Pile, 67100 L’Aquila Italy

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 10 mg Schmelztabletten
France: Inorial 10 mg Comprimé Orodispersible
Greece: Bilargen 10 mg Δισκία Διασπειρόμενα Στο Στόμα
Italy: Robilas 10 mg Compressa Orodispersibile
Poland: Bilaxten
Portugal: Bilaxten 10 mg Comprimido Orodispersível
Spain: Bilaxten Flas 10 mg Comprimidos Bucodispersables
To Obtain More Detailed Information on this Medicine, Contact the Local Representative of the Marketing Authorization Holder:
Berlin-Chemie/Menarini Polska Sp. z o.o.
Tel: +48 22 566 21 00
Fax: +48 22 566 21 01
Date of Last Revision of the Package Leaflet:03/2025