Bilastine Tecnigen 20 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Bilastina TecniGen 20 mg tablets EFG

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.

If you have any questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Bilastina TecniGen is and what it is used for
2. What you need to know before taking Bilastina TecniGen
3. How to take Bilastina TecniGen
4. Possible adverse effects
5. How to store Bilastina TecniGen
6. Contents of the pack and other information

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

This medicine contains bilastine as the active substance, which is an antihistamine. Bilastina TecniGen is used to relieve the symptoms of allergic rhinoconjunctivitis (sneezing, itching of the nose, nasal discharge, nasal congestion, and red, watery eyes) and other forms of allergic rhinitis. It may also be used to treat itchy skin rashes (hives or urticaria).

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

Do not take Bilastina TecniGen

If you are allergic to bilastine or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take bilastine if you have moderate or severe renal impairment, 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 medicines that may affect heart rhythm, if you have or have had a specific abnormal heart rhythm pattern (known as QTc interval prolongation on the electrocardiogram) that may occur in certain types of heart disease and are also taking other medicines (see “Other medicines and Bilastina TecniGen”).

Children

Do not administer this medicine to children under 12 years of age

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

Other medicines and Bilastina TecniGen

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

In particular, please discuss with your doctor if you are taking any of the following medicines:

• Ketoconazole (a medicine for fungal infections)
• Erythromycin (an antibiotic)
• Diltiazem (to treat angina pectoris)
• Cyclosporine (to reduce the activity of your immune system, to prevent transplant rejection, or to 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 TecniGen with food, drinks, and alcohol

These tablets should not be taken with food or grapefruit juice or other fruit juices, as this would reduce the effect of bilastine. To avoid this, you may:

• take the tablet and wait one hour before eating or drinking fruit juices, or
• if you have eaten food or drunk fruit juice, wait two hours before taking the tablet.

Bilastine, at the recommended dose (20 mg), does not increase the drowsiness caused by alcohol.

Pregnancy, breastfeeding, and fertility

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

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

It has been demonstrated that bilastine 20 mg does not affect driving performance in adults. However, individual patient response to the medicine may vary. Therefore, check how this medicine affects you before driving or using machines.

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

3. How to take Bilastina TecniGen

Follow exactly the administration instructions for this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose in adults, including elderly patients and adolescents aged 12 years or older, is 1 tablet (20 mg) per day.

• The tablet is for oral use.
• The tablet should be taken one hour before or two hours after eating any food or fruit juice (see section 2, “Taking bilastine with food, drinks, and alcohol”).
• Swallow the tablet with a glass of water.
• The tablet's notch is intended solely for splitting the tablet if you have difficulty swallowing it whole.

Regarding the duration of treatment, your doctor will determine the type of illness you have and advise you on how long you should take bilastine.

Use in children

For children aged 6 to 11 years with a minimum body weight of 20 kg, other more suitable pharmaceutical forms are available—bilastine 10 mg orodispersible tablets or bilastine 2.5 mg/mL oral solution. Please consult your doctor or pharmacist.

Do not administer this medicine to children under 6 years of age with a body weight below 20 kg, as sufficient data are not available.

If you take more Bilastina TecniGen than you should

If you or anyone else exceeds the prescribed dose of this medicine, inform your doctor immediately or go to the nearest hospital emergency department. Please remember to bring this medicine's packaging or this leaflet with you.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Bilastina TecniGen

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, then return to your regular dosing schedule.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

If you experience 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, stop taking this medicine and contact your doctor immediately.

Other adverse 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

• changes in electrocardiogram
• blood tests showing changes in liver function
• dizziness
• stomach pain
• fatigue
• increased appetite
• irregular heartbeat
• weight gain
• nausea (feeling sick)
• anxiety
• dry nose or nasal discomfort
• abdominal pain
• diarrhoea
• gastritis (inflammation of the stomach lining)
• vertigo (a sensation of dizziness or instability)
• feeling of weakness
• thirst
• dyspnoea (difficulty breathing)
• dry mouth
• indigestion
• itching
• cold sores
• fever
• tinnitus (ringing in the ears)
• difficulty sleeping
• blood tests showing changes in kidney function
• increased blood fats

Frequency not known: cannot be estimated from available data:

• Palpitations (awareness of heartbeats)
• Tachycardia (rapid heartbeat)
• Vomiting

Adverse effects that may occur in children:

Common: may affect up to 1 in 10 people

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

Uncommon: may affect up to 1 in 100 people

• eye irritation
• dizziness
• loss of consciousness
• diarrhoea
• nausea (feeling sick)
• swelling of the lips
• eczema
• urticaria (hives)
• fatigue

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Bilastina TecniGen

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated after "EXP" on the packaging and on the blister. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Bilastina TenciGen

• The active substance is bilastine. Each tablet contains 20 mg of bilastine.
• The other components are microcrystalline cellulose, sodium carboxymethyl starch type A (from potato), colloidal anhydrous silica and magnesium stearate.

Appearance of the product and contents of the pack:

White to off-white tablets, oval-shaped, approximately 10.2 mm x 5.2 mm, smooth on one side and scored on the other, marked with the number "2" on one side of the score line and the number "0" on the other side.

The medicine is packaged in a blister (Alu/Alu).

Pack size: 20 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Tecnimede España Industria Farmacéutica, S.A.

Avda. de Bruselas, 13, 3º D. Edificio América. Polígono Arroyo de la Vega,

28108 Alcobendas (Madrid)

Spain

Manufacturer

Atlantic Pharma – Produções Farmacêuticas, S.A.

Rua da Tapada Grande, n.º 2

Abrunheira, 2710-089 Sintra

Portugal

Or

Tecnimede – Sociedade Técnico-Medicinal S.A.

Quinta da Cerca, Caixaria

2565-187 Dois Portos

Portugal

Date of the most recent revision of this leaflet: February 2025

Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): http://www.aemps.gob.es/