Bilastina alterpharma 20 mg comprimidos

Package Insert: Information for the Patient

Bilastina Alterpharma 20 mg Tablets

Bilastina

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, 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 any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Bilastina Alterpharma contains bilastine as the active ingredient, which is an antihistamine.

Bilastine is used to relieve the symptoms of allergic rhinoconjunctivitis (stuffy or runny nose, sneezing, itchy nose, nasal congestion, and red, itchy eyes) and urticaria (hives) that are mild, in adults and adolescents 12 years of age and older.

Consult a doctor if symptoms worsen or do not improve after 7 days.

Do not take BilastinaAlterpharma

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take bilastina if you have moderate or severe renal insufficiency, low blood levels of potassium, 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 pattern of your heartbeat (known as QTc interval prolongation in the electrocardiogram) that may occur in some types of heart disease and you are also taking other medications (see “Other medications and bilastina”).

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

Children

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

Do not exceed the recommended dose. If symptoms persist, consult your doctor.

Other medications and Bilastina Alterpharma

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medication, including those purchased without a prescription.

Particularly, please consult with your doctor if you are taking any of the following medications:

• Ketoconazole (an antifungal medication)
• Erythromycin (an antibiotic)
• Diltiazem (to treat angina pectoris)
• Ciclosporin (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 Bilastina Alterpharma with food, drinks, and alcohol

These tabletsmust not be taken withfood or withfreshly squeezed orange juice or other fruit juices, as this would reduce the effect of bilastina. To avoid this, you can:

• take the tablet and wait for one hour before eating or taking fruit juices, or
• if you have eaten food or taken fruit juice, wait for 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 intend to become pregnant, consult your doctor or pharmacist before using this medication.

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

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

It has been demonstrated that bilastina does not affect performance during driving in adults. However, the response of each patient to the medication may be different. Therefore, check how this medication affects you before driving or operating machinery.

This medication contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per tablet; this is, essentially “sodium-free”.

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. In case of 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 to be taken orally.
• The tablet should be taken one hour before or two hours after taking any food or 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 it worsens or does not improve after 7 days.

Use in children

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

Do not administer this medication to children under 6 years of age with a body weight less than 20 kg since there are not enough data available.

If you take more Bilastina Alterpharma than you should

If you, or anyone else, exceed the dose of this medication, inform your doctor immediately or go to the nearest hospital emergency service. Please remember to bring this medication packaging or this leaflet with you.

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

If you forgot to take Bilastina Alterpharma

Do nottake a double dose to compensate for a missed 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.

Like all medicines, this medicine may cause side effects, although not everyone will experience 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:

Frequent: may affect up to 1 in 10 people

• headache
• drowsiness

Rare: may affect up to 1 in 100 people

• electrocardiogram alterations
• blood tests showing changes in liver function
• dizziness
• stomach pain
• fatigue
• increased appetite
• irregular heartbeat
• weight gain
• nausea (urge to vomit)
• anxiety
• dry or irritated nose
• abdominal pain
• diarrhea
• gastritis (inflammation of the stomach lining)
• dizziness (a feeling of dizziness or instability)
• weakness
• thirst
• shortness of breath
• dry mouth
• indigestion
• itching
• herpes labialis
• fever
• tinnitus (ringing in the ears)
• difficulty sleeping
• blood tests showing changes in kidney function
• increased blood fats

Unknown frequency: cannot be estimated from available data

• palpitations (feeling the heartbeat)
• tachycardia (rapid heartbeat)
• vomiting

Side effects that may appear in children:

Frequent: may affect up to 1 in 10 people

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

Rare: may affect up to 1 in 100 people

• eye irritation
• dizziness
• loss of consciousness
• diarrhea
• nausea (urge to vomit)
• swelling of the lips
• eczema
• urticaria (hives)
• fatigue

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly to the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the Sigre point of your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Composition of Bilastina Alterpharma

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

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

Appearance of the product and content of the packaging

Round, biconvex tablets, white to off-white in color.

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

Holder of the marketing authorization and responsible for manufacturing

Laboratorios Alter, S.A.

C/ Mateo Inurria, 30

28036 Madrid

Spain

Last review date of this leaflet:February 2025

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