BILASTINA ALTERPHARMA 20 mg TABLETS

Introduction

Patient Information Leaflet

Bilastina Alterpharma 20 mg tablets

bilastina

Read this leaflet carefully before starting to take this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What is Bilastina Alterpharma and what is it used for

Bilastina Alterpharma contains bilastina as the active substance, which is an antihistamine.

Bilastina is used to relieve the 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 your symptoms worsen or do not improve after 7 days.

2. What you need to know before taking Bilastina Alterpharma

Do not take Bilastina Alterpharma

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

Warnings and precautions

Consult your doctor or pharmacist before taking bilastina 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 bilastina").

If you experience symptoms such as difficulty breathing, abdominal pain, nausea, vomiting, diarrhea, dizziness, fainting, you should seek urgent medical attention due to the risk of anaphylaxis.

Children

Do not give this medicine to children under 12 years of age.

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

Other medications and Bilastina Alterpharma

Tell your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication, including those purchased 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 AIDS)
• Rifampicin (an antibiotic).

Taking Bilastina Alterpharma with food, drinks, and alcohol

These tablets should notbe taken with foodor with grapefruit juice or other fruit juices, as this would reduce the effect of bilastina. To avoid this, you can:

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

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

Pregnancy, breastfeeding, and 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.

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

Consult your doctor or pharmacist before using any medication.

Driving and using machines

It has been shown that bilastina 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.

This medicine contains sodium

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

3. How to take Bilastina Alterpharma

Follow the instructions for administration of the medicine contained in this leaflet or 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 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 eating or drinking fruit juice (see section 2, "Taking Bilastina Alterpharma with food, drinks, and alcohol").
• Swallow the tablet with a glass of water.

You should consult a doctor if your symptoms worsen or do 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 - bilastina 10 mg orodispersible tablets or bilastina 2.5 mg/ml oral solution -, consult your doctor or pharmacist.

Do not give 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 Bilastina Alterpharma 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 bring this medicine package or this 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 Bilastina Alterpharma

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.

If you experience allergic reactions whose symptoms may include 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 this medicine and seek immediate medical attention.

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 (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 your heartbeat)
• rapid heartbeat
• 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 side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Bilastina Alterpharma

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

Do not use this medicine after the expiry date stated on the package after CAD. The expiry date is the last day of the month indicated.

This medicine does not require special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package contents and additional information

Composition of Bilastina Alterpharma

The active substance is bilastina. Each tablet contains 20 mg of bilastina.

The other ingredients are microcrystalline cellulose, sodium carboxymethyl starch type A (derived from potato), colloidal anhydrous silica, magnesium stearate.

Appearance of the product and package contents

Round, biconvex tablets, white or almost white in color.

The tablets are packaged in blisters in packs of 7, 14, and 20 tablets.

Marketing authorization holder and manufacturer

Laboratorios Alter, S.A.

C/ Mateo Inurria, 30

28036 Madrid

Spain

Date of the last revision of this leaflet:February 2025

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