BILASTINA TARBIS 20 mg TABLETS

2. What you need to know before taking Bilastine Tarbis

Do not take Bilastine Tarbis

If you are allergic to bilastine or any of the other ingredients of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take bilastine if you have moderate or severe kidney impairment, low blood potassium, magnesium, or calcium levels, if you have or have had heart rhythm problems or if your heart rate is very low, if you are taking medications that may affect your heart rhythm, if you have or have had a certain abnormal heart rhythm pattern (known as QTc interval prolongation on the electrocardiogram) that may occur in some types of heart disease and are also taking other medications (see "Other medications and Bilastine Tarbis").

Children

Do not administer this medication to children under 12 years of age

Do notexceed the recommended dose. If symptoms persist, consult your doctor.

Other medications and Bilastine Tarbis

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medication, including those obtained without a prescription.

In particular, please inform your doctor if you are taking any of the following medications:

• Ketoconazole (an antifungal medication)
• Erythromycin (an antibiotic)
• Diltiazem (for the treatment of angina pectoris)
• Cyclosporine (to reduce the activity of your immune system, to prevent transplant rejection or reduce the activity of autoimmune diseases and allergic disorders, such as psoriasis, atopic dermatitis, or rheumatoid arthritis)
• Ritonavir (for the treatment of HIV)
• Rifampicin (an antibiotic)

Taking Bilastine Tarbis with food, beverages, and alcohol

These tablets should not be taken with foodor with grapefruit juice or other fruit juices, as this would decrease the effect of bilastine. To avoid this, you can:

• take the tablet and wait one hour before eating or drinking fruit juices, or
• if you have eaten or drunk fruit juices, wait two hours before taking the tablet.

Bilastine, at the recommended dose (20 mg), does not increase the somnolence produced by alcohol.

Pregnancy, breastfeeding, and fertility

There are no data or limited data on the use of bilastine in pregnant women, during breastfeeding, or on its effects on fertility.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Consult your doctor or pharmacist before using any medication.

Driving and using machines

It has been shown that bilastine 20 mg does not affect performance during driving in adults. However, each patient's response to the medication may be different. Therefore, check how this medication affects you before driving or using machines.

Bilastine Tarbis contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially "sodium-free".

3. How to take Bilastine Tarbis

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose in adults, including elderly patients and adolescents 12 years of age or 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 eating or drinking fruit juice (see section 2, "Taking Bilastine Tarbis with food, beverages, and alcohol").
• Swallow the tablet with a glass of water.
• The score line is only for breaking the tablet if you find it difficult to swallow it whole.

Regarding the duration of treatment, your doctor will determine the type of disease you have and indicate how long you should take Bilastine Tarbis.

Use in children

For children 6 to 11 years of age with a minimum body weight of 20 kg, other pharmaceutical forms are more suitable, such as orodispersible tablets or oral solution; consult your doctor or pharmacist.

Do not administer bilastine to children under 6 years of age with a body weight below 20 kg, as there are insufficient data.

If you take more Bilastine Tarbis than you should

If you or anyone else takes more of this medication than they should, inform your doctor immediately or go to the emergency department of the nearest hospital. Please remember to bring this medication package or this package leaflet with you.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20 (indicating the medication and the amount ingested).

If you forget to take Bilastine Tarbis

Do nottake a double dose to make up for a forgotten dose.

If you forget to take your dose, take it as soon as possible, and then return to your regular dosing schedule.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

If you experience allergic reactions whose symptoms may include difficulty breathing, dizziness, collapse, or loss of consciousness, swelling of the face, lips, tongue, or throat, and/or swelling and redness of the skin, stop taking this medication and seek medical attention immediately.

Other side effects that may occur in adults and adolescents are:

Common: may affect up to 1 in 10 people

• headache
• drowsiness

Uncommon: may affect up to 1 in 100 people

• electrocardiogram changes
• blood tests showing changes in liver function
• dizziness
• stomach pain
• fatigue
• increased appetite
• irregular heartbeat
• weight gain
• nausea (vomiting)
• anxiety
• dry or irritated nose
• abdominal pain
• diarrhea
• gastritis (inflammation of the stomach lining)
• vertigo (a feeling of dizziness or instability)
• feeling of weakness
• thirst
• shortness of breath
• dry mouth
• indigestion
• itching
• cold sores
• fever
• tinnitus (ringing in the ears)
• difficulty sleeping
• blood tests showing changes in kidney function
• increased blood fat levels

Frequency not known: cannot be estimated from available data

• palpitations (feeling the heartbeat)
• tachycardia (rapid heartbeat)
• allergic reactions whose symptoms may include difficulty breathing, dizziness, collapse, or loss of consciousness, swelling of the face, lips, tongue, or throat, and/or swelling and redness of the skin. If you experience any of these serious side effects, stop taking this medication and seek medical attention immediately.
• vomiting

Side effects that may occur in children:

Common: may affect up to 1 in 10 people

• rhinitis (nasal irritation)
• allergic conjunctivitis (eye irritation)
• headache
• stomach pain (abdominal pain/upper abdominal pain)

Uncommon: may affect up to 1 in 100 people

• eye irritation
• dizziness
• loss of consciousness
• diarrhea
• nausea (vomiting)
• lip swelling
• eczema
• urticaria (hives)
• fatigue

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency's online reporting system: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Bilastine Tarbis

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date stated on the carton and blister pack after EXP. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of via wastewater or household waste. Return the medication packaging and any unused medication to the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and medication you no longer need. This will help protect the environment.

6. Contents of the pack and further information

Composition of Bilastine Tarbis

The active ingredient is bilastine.

Each tablet contains 20 mg of bilastine.

Other ingredients are:

Colloidal anhydrous silica, microcrystalline cellulose, sodium starch glycolate (type A), magnesium stearate.

Appearance of the product and pack contents

White to off-white tablets, 10.0 mm x 5.0 mm, oval, biconvex, with the inscription "B" and "H" engraved on either side of the score line on one face and "2" on the other.

The score line is only for breaking the tablet if you find it difficult to swallow it whole, not for dividing into equal doses.

Bilastine Tarbis is available in blister packs containing 20 tablets.

Marketing authorization holder

Tarbis Farma S.L.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Manufacturer

Amarox Pharma B.V.

Rouboslaan 32

2252 TR Voorschoten

Netherlands

This medication is authorized in the Member States of the European Economic Area under the following names:

Germany: Bilastin Amarox 20 mg Tablets

Spain: Bilastina Tarbis 20 mg Tablets EFG

Italy: Bilastina Amarox 20 mg Tablets

Date of the last revision of this package leaflet: March 2025

Detailed information on this medication is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es/