Prospect: Information for the User

Bilastina STADAPHARM 20 mg Tablets EFG

Read this prospect carefully before starting to take this medicine because it contains important information for you.

Follow exactly the administration instructions of the medicine contained in this prospect or those indicated by your doctor or pharmacist.

• Keep this prospect, as you may need to read it again.
• If you need more information, consult your doctor or pharmacist.
• If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.
• You should consult a doctor if you worsen or do not improve after 7 days.

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

2.What you need to know before starting to take Bilastina Stadapharm

3.How to take Bilastina Stadapharm

4.Possible adverse effects

5.Storage of Bilastina Stadapharm

6.Contents of the package and additional information

This medication contains bilastine as the active ingredient, which is an antihistamine.

Bilastine is used for the relief of symptoms of allergic rhinoconjunctivitis (stuffy or runny nose, sneezing, 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 Bilastina Stadapharm:

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 this medication 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 are also taking other medications (see “Other medications and Bilastina Stadapharm”).

In case you experience symptoms such as difficulty breathing, abdominal pain, nausea, vomiting, diarrhea, dizziness, or syncope, you must 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 Stadapharm

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

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 HIV/AIDS)
• Rifampicin (an antibiotic)

Taking Bilastina Stadapharm with food, drinks, and alcohol

These tabletsmust not be taken withfood or withorange juice or other fruit juices, as this would decrease 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

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, believe 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 medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

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 Stadapharm with food, drinks, and alcohol”).
• Swallow the tablet with a glass of water.

You should consult a doctor if you worsen or do 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 Stadapharm 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 forgot to take Bilastina Stadapharm

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 can cause side effects, although not everyone will experience them.

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

Common: can affect up to 1 in 10 people

• headache
• drowsiness

Uncommon: can 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)
• vertigo (a feeling of dizziness or instability)
• 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

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 swelling and redness of the skin. If you experience any of these severe side effects, stop taking this medicine and seek immediate medical attention.
• vomiting

Side effects that can occur in children:

Common: can affect up to 1 in 10 people

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

Uncommon: can 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 leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.esBy 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 after CAD on the packaging and blister. 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 through drains or in the trash. Dispose of the packaging and unused medications at the Sigre Point of the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Bilastina Stadapharm:

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

Appearance of the product and content of the packaging:

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

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

Only some packaging sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern

Spain

Responsible for manufacturing

Noucor Health, S.A.

Avinguda Camí Reial 51-57

08184 Palau-solità i Plegamans (Barcelona)

Spain

Last review date of this leaflet: February 2025

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