Package Insert: Information for the Patient

Bilastina Normon 20 mg Tablets EFG

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.

Contents of the package and additional information

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

Bilastina Normon is used to relieve symptoms of allergic rhinoconjunctivitis (stuffy or runny nose, sneezing, nasal congestion, and red, itchy eyes) and other forms of allergic rhinitis. It may also be used to treat skin eruptions with itching (hives or urticaria).

Do not take Bilastina Normon:

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 use Bilastina Normon if you have moderate or severe renal insufficiency, low blood levels of potassium, magnesium, or 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 "Use of Bilastina Normon with other medications").

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

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 Normon

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

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

Taking Bilastina Normon with food, drinks, and alcohol

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

• take the tablet and wait an hour before eating or taking fruit juices, or
• if you have eaten food or taken fruit juices, 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

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

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

It has been demonstrated that bilastina 20 mg 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.

Follow exactly the administration instructions for this medication as 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 Normon with food, drinks, and alcohol”).

• Swallow the tablet with a glass of water.
• The groove is only for breaking the tablet if it is difficult to swallow whole.
• Regarding the duration of treatment, your doctor will determine the type of disease you have and will indicate for how long you should take Bilastina Normon 20 mg tablets.

Use in children

For children aged 6 to 11 years 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 Normon 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 package 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 forget to take Bilastina Normon

Do nottake a double dose to compensate for the missed 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 medication, ask your doctor or pharmacist.

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

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

Frequent: may affect up to 1 in 10 people

• Headache
• Drowsiness

Less frequent: 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 labial
• 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)
• Allergic reactions whose symptoms may include difficulty breathing, dizziness, collapse, or loss of consciousness, swelling of the face, lips, tongue, or throat, and/or skin hives and redness. If you experience any of these severe side effects, stop taking this medicine and seek immediate medical attention.
• Vomiting

Side effects that may occur in children:

Frequent: may affect up to 1 in 10 people

• Runny nose
• Allergic conjunctivitis (eye irritation)
• Headache
• Stomach pain (abdominal pain/upper abdominal pain)

Less frequent: 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 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 through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information about 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 after CAD on the packaging and blister. The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

Medications should not be disposed of through drains or trash. Dispose of packaging and medications you no longer need at the Sigre point of the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Bilastina Normon 20 mg tabletsEFG:

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:

Bilastina Normon 20 mg tablets EFG are white or almost white, elongated, biconvex, scored, and printed.

The tablets are presented in packs of 20 and 30 tablets.

Holder of the marketing authorization and responsible for manufacturing

Normon Laboratories, S.A.

Ronda de Valdecarrizo, 6

28760 – Tres Cantos

Madrid (Spain)

Date of the last review of this leaflet:February 2025

Other sources of information

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