Package Insert: Patient Information

Bilastina Tevagen 20 mg Tablets EFG

Read this entire package insert carefully before taking this medicine, as it contains important information for you.

• Follow exactly the administration instructions contained in this package insert or those given by your doctor or pharmacist.
• Keep this package insert, as you may need to refer to it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.
• You should consult a doctor if your condition worsens or does not improve after 7 days.

Bilastina Tevagen is used for the relief of allergic rhinoconjunctivitis (stuffy or runny nose, sneezing, nasal congestion, and red, itchy eyes) and urticaria (hives) with mild symptoms 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 Tevagen

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 Tevagen if you have moderate or severe renal insufficiency, low levels of potassium, magnesium, or calcium in the blood, if you have or have had heart rhythm problems or if your heart rate is very low, if you are taking medications that can affect heart rhythm, if you have or have had a certain abnormal heart rhythm pattern (known as QTc prolongation on an electrocardiogram) that can occur in some forms of heart diseaseand are also taking other medications (see “Other medications and Bilastina Tevagen”).

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 Tevagen

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:

Taking Bilastina Tevagen with food, drinks, and alcohol

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

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 and 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 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.

Bilastina Tevagen contains sodium

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

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.

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

Use in children

Other forms of this medication - bilastina 10 mg chewable tablets or bilastina 2.5 mg/ml oral solution - may be more suitable for children 6 to 11 years of age with a minimum body weight of 20 kg. 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 is insufficient data.

If you take more Bilastina Tevagen than you should

If you, or anyone else, exceed the dose of this medication, inform your doctorimmediatelyor 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 Tevagen

Do nottake a double dose to compensate for a missed dose.

If you forget to take your dose on time, 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 symptoms of an allergic reaction that 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 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)
• vomiting

Side effects that may appear in children are:

Frequent: may affect up to 1 in 10 people

• rhinitis (nasal irritation)
• allergic conjunctivitis (eye irritation)
• headache
• stomach pain (abdominal pain/upper 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 through 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 usethis medicationafter the expiration date that appears onthe packagingafter CAD/EXP.The expiration date refers to the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or trash. Dispose of packaging and medications you no longer need at the SIGRE collection pointat 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 Tevagen

• The active ingredient is bilastina. Each tablet contains 20 mg of bilastina.
• The other components are: mannitol (E421), microcrystalline cellulose, carboxymethylcellulose sodium glycinate from potato (type A), magnesium aluminosilicate, magnesium stearate, anhydrous colloidal silica.

Appearance of the product and content of the container

Bilastina Tevagen tablets are round, white to off-white, biconvex, approximately 7 mm in diameter.

The tablets are packaged in blisters of 10, 20, 30, 50 or 100 tablets or single-dose blisters of 10 x 1, 20 x 1, 30 x 1 tablets.

Only some sizes of packaging may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Teva Pharma, S.L.U.

C/ Anabel Segura, 11, Edificio Albatros B, 1st floor,

Alcobendas 28108, Madrid (Spain

Responsible for manufacturing

Saneca Pharmaceuticals a.s.

Nitrianska 100

920 27 Hlohovec

Slovak Republic

Last review date of this prospectus:March 2025

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

You can access detailed and updated information about this medication by scanning the QR code included in the carton with your smartphone. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/85922/P_85922.html