Bilastine Stada 20 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Bilastina Stada 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 could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

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

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

Bilastina Stada contains bilastine as the active substance, which is an antihistamine.

Bilastine is used to relieve symptoms of allergic rhinoconjunctivitis (sneezing, nasal itching, runny nose, 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 Stada

Do not take Bilastina Stada

If you are allergic to bilastine or to any of the other components 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 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 medicines that may affect heart rhythm, or 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 serious heart disease and you are also taking other medicines (see “Other medicines and Bilastina Stada”).

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 Stada

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, even if they are medicines 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 (used to treat chest pain or tightness – 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 (used to treat AIDS)
• Rifampicin (an antibiotic)

Taking Bilastina Stada with food, drinks, and alcohol

These tablets should not be taken with food or with 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 juice, 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 drowsiness caused by alcohol.

Pregnancy, breastfeeding, and fertility

There are no data or the data are limited regarding 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 responses to the medicine may vary. Therefore, assess how this medicine affects you before driving or operating machinery.

3. How to take Bilastina Stada

Follow exactly the instructions for use of 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 and 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 food or fruit juice (see section 2, “Taking Bilastina Stada 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 illness you have and advise you on how long you should take bilastine.

Use in children

For children aged 6 to 11 years, other doses of this medicine may be more appropriate.

Do not administer bilastine 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 Stada than you should

If you, or anyone else, exceed the prescribed dose of this medicine, inform your doctor immediately or go to the nearest hospital emergency department. Please remember to bring this medicine container or the package 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 Stada

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

If you forget to take your dose, take it as soon as possible, and then continue with your usual dosing schedule.

If you stop taking Bilastina Stada

Generally, there will be no consequences when treatment with bilastine is stopped.

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 will experience them.

Stop taking the medicine and seek immediate medical advice if you experience symptoms of an allergic reaction: signs of which may include difficulty breathing, dizziness, collapse or loss of consciousness, swelling of the face, lips, tongue or throat, and/or skin redness and swelling. If you notice any of these serious side effects, stop taking the medicine and seek urgent medical advice immediately.

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

• electrocardiogram abnormalities
• 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 inflammation caused by an allergic reaction)
• headache
• stomach ache (abdominal pain up to the upper abdomen)

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 may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Bilastina Stada

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated after EXP on the packaging and on the blister. The expiry date is 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 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 container and additional information

Composition of Bilastina Stada:

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

Appearance of the product and contents of the pack:

Bilastina Stada are white, round tablets.

Each pack contains 10, 20, 30, 40, 50 or 100 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

Noucor Health, S.A.,

Av. Camí Reial 51-57

08184 Palau-Solità i Plegamans

Barcelona

Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Germany: Bilastin STADA 20 mg Tabletten
Belgium: Bilastine Eurogenerics 20 mg tabletten
Bulgaria: Bilergia 20 mg tablets
Estonia: Bilastine STADA
Greece: Bilastine/Stada
Spain: Bilastina STADA 20 mg comprimidos EFG
France: BILASTINE EG 20 mg, comprimé
Croatia: Selbixo 20 mg tablete
Hungary: Bilastine Stada 20 mg tabletta
Italy: BILASTINA EG
Lithuania: Bilastine STADA 20 mg tabletes
Luxembourg: Bilastine Eurogenerics 20 mg comprimés
Latvia: Bilastine STADA 20 mg tabletes
Poland: VERPYLLO
Portugal: Bilastina Ciclum
Slovakia: Bilastin STADA 20 mg tablety

Date of the most recent review of this package leaflet: October 2025

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