BILASTINA STADAPHARM 20 mg TABLETS

Introduction

Package Leaflet: Information for the User

Bilastine STADAPHARM 20 mg tablets EFG

Read this package leaflet carefully before you start taking this medicine because it contains important information for you.

Follow exactly the administration instructions of the medicine contained in this package leaflet or as indicated by your doctor or pharmacist.

• Keep this package leaflet, you may need to read it again.
• If you need advice or more information, consult your doctor or pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if it is a side effect not listed in this package leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve after 7 days.

Contents of the package leaflet

1. What is Bilastine Stadapharm and what is it used for
2. What you need to know before taking Bilastine Stadapharm
3. How to take Bilastine Stadapharm
4. Possible side effects
5. Storage of Bilastine Stadapharm
6. Package contents and additional information

1. What is Bilastine Stadapharm and what is it used for

This medicine contains bilastine as the active substance, which is an antihistamine.

Bilastine is used for the relief of symptoms of allergic rhinoconjunctivitis (sneezing, nasal itching, nasal discharge, nasal congestion, and red and itchy eyes) and urticaria (hives) that occur with mild symptoms, in adults and adolescents from 12 years of age.

You should consult a doctor if it worsens or does not improve after 7 days.

2. What you need to know before taking Bilastine Stadapharm

Do not take Bilastine Stadapharm:

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

Warnings and precautions

Consult your doctor or pharmacist before taking this medicine if you have moderate or severe kidney failure, low blood potassium levels, magnesium, calcium, 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 heart rhythm, if you have or have had a certain abnormal heart rhythm pattern (known as QTc interval prolongation in the electrocardiogram) that may occur in some types of heart diseases and are also taking other medications (see "Other medications and Bilastine Stadapharm").

In case you experience symptoms such as difficulty breathing, abdominal pain, nausea, vomiting, diarrhea, dizziness, or fainting, you should seek urgent assistance due to the risk of anaphylaxis.

Children

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

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

Other medications and Bilastine Stadapharm

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication.

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

• Ketoconazole (a medicine for fungi)
• Erythromycin (an antibiotic)
• Diltiazem (to treat chest pain)
• 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 (to treat AIDS)
• Rifampicin (an antibiotic)

Taking Bilastine Stadapharm with food, drinks, and alcohol

These tablets should notbe 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 taking fruit juices, or
• if you have taken food or fruit juice, wait two hours before taking the tablet.

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

Pregnancy, breastfeeding, and fertility

There are no data or limited data on the use of bilastine in pregnant women, during the lactation period, or on the 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 medicine.

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.

3. How to take Bilastine Stadapharm

Follow exactly the administration instructions of the medicine contained in this package leaflet or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

The recommended dose in adults, including elderly patients and adolescents from 12 years of age, 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 taking any food or fruit juice (see section 2, "Taking Bilastine Stadapharm with food, drinks, and alcohol").
• Swallow the tablet with a glass of water.

You should consult a doctor if it worsens or does not improve after 7 days.

Use in children

For children from 6 to 11 years of age with a minimum body weight of 20 kg, there are other pharmaceutical forms more suitable - bilastine 10 mg orodispersible tablets or bilastine 2.5 mg/mL oral solution -, consult your doctor or pharmacist.

Do not administer this medicine to children under 6 years of age with a body weight below 20 kg, as there are not enough data available.

If you take more Bilastine Stadapharm than you should

If you or anyone else takes more of this medicine than they should, inform your doctor immediately or go to the emergency department of the nearest hospital. Please remember to take this medicine 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 medicine and the amount ingested.

If you forget to take Bilastine Stadapharm

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 usual dosing schedule.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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 (feeling sick)
• 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 fats

Frequency not known: cannot be estimated from the available data

• palpitations (feeling the heartbeat)
• tachycardia (fast 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 medicine and seek immediate medical attention.
• 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 (feeling sick)
• lip swelling
• eczema
• urticaria (hives)
• fatigue

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if it is a possible side effect not listed in this package leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: www.notificaRAM.es By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Bilastine Stadapharm

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

Do not use this medicine after the expiry date stated on the package and blister after EXP. The expiry date is the last day of the month stated.

This medicine does not require special storage conditions.

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

6. Package contents and additional information

Composition of Bilastine Stadapharm:

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

Appearance of the product and package contents:

Bilastine Stadapharm tablets are white, round, 7 mm in diameter.

The tablets are packaged in blisters of 10 and 20 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern

Spain

Manufacturer

Noucor Health, S.A.

Avinguda Camí Reial 51-57

08184 Palau-solità i Plegamans (Barcelona)

Spain

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

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