Introduction

Package Insert: Information for the Patient

Bilastine Cinfa 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 for you only, and you should not give it to others who may 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.

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

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

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

Do not take Bilastina cinfa

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 cinfa.

If you have moderate or severe kidney failure, 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 prolongation in the electrocardiogram) that may occur in some types of heart disease and are also taking other medications (see “Other medications and Bilastina cinfa”).

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 cinfa

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 cinfa with food, drinks, and alcohol

These tabletsmust not be taken withfood or 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 an hour before eating or taking fruit juices, or
if you have eaten food or 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 the effects on fertility.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

It has been shown 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.

3. How to take Bilastina cinfa

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

Regarding the duration of treatment, your doctor will determine the type of disease you have and will tell you for how long you should take bilastina.

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 cinfa 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 cinfa

Do not take a double dose to make up for a 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.

4. Possible Adverse Effects

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

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)

Alterations in the electrocardiogram
Blood tests showing changes in liver function
Dizziness
Abdominal 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 swelling 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 are:

Common (may affect up to 1 in 10 people)

Runny nose
Allergic conjunctivitis (eye irritation)
Headache
Abdominal pain (upper abdominal pain)

Uncommon (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 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.

5. Conservation of Bilastina cinfa

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 conditions for conservation.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and themedications that you no longer need at the Sigrecollection point of the pharmacy. In case of doubt, ask yourpharmacist how to dispose of the packaging and the medications that you no longer need. By doing so, you will help protect the environment.

6. Content of the packaging and additional information

Composition of Bilastina cinfa

The active ingredient is bilastina. Each tablet contains 20 mg of bilastina (as monohydrate).
The other excipients are: microcrystalline cellulose, crospovidone type A, magnesium stearate, and anhydrous colloidal silica.

Appearance of the product and content of the packaging

The tablets are white, round, and are packaged in Aluminio/Aluminio blisters of 20 or 30 tablets.They may only be marketed in some sizes of packaging.

Holder of the marketing authorization and Responsible for the manufacture

Holder of the marketing authorization

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra) - Spain

Responsible for the manufacture

Noucor Health, S.A.

Av. Cami Reial, 51-57;

08184 – Palau-solità i Plegamans,

Barcelona-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/

You can access detailed and updated information on this medication by scanning with your mobile phone (smartphone) the QR code included in the leaflet and packaging. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/86093/P_86093.html

QR code to:https://cima.aemps.es/cima/dochtml/p/86093/P_86093.html