BILASTINA STADA 20 mg TABLETS

Introduction

Package Leaflet: Information for the User

Bilastina Stada 20 mg Tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

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

Bilastina is used to relieve the symptoms of allergic rhinoconjunctivitis (sneezing, nasal itching, nasal discharge, nasal congestion, and red and itchy eyes) and other forms of allergic rhinitis. It may also be used to treat itchy skin eruptions (hives or urticaria).

2. What you need to know before you take Bilastina Stada

Do not take Bilastina Stada

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

Warnings and precautions

Consult your doctor or pharmacist before taking bilastina if you have moderate or severe kidney problems, low blood potassium, magnesium, or calcium levels, 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 your heart rhythm, if you have or have had a certain abnormal heart rhythm pattern (known as QTc interval prolongation in the electrocardiogram) that may occur in some types of severe heart disease and are also taking other medicines (see "Other medicines and Bilastina Stada").

Children

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

Do notexceed the recommended dose. If symptoms persist, consult your doctor.

Other medicines and Bilastina Stada

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.

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

• Ketoconazole (a medicine for fungi)
• Erythromycin (an antibiotic)
• Diltiazem (to treat chest pain or tightness - 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 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 decrease the effect of bilastina. To avoid this, you can:

• take the tablet and wait one hour before eating or taking fruit juices, or
• if you have eaten or taken fruit juice, wait 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 limited data on the use of bilastina in pregnant women, during breastfeeding, and on fertility.

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

It has been shown that bilastina 20 mg does not affect performance during driving in adults. However, each patient's response to the medicine may be different. Therefore, check how this medicine affects you before driving or using machines.

3. How to take Bilastina Stada

Follow exactly the administration instructions of this medicine given 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 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 any 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 disease you have and indicate how long you should take bilastina.

Use in children

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

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

If you take more Bilastina Stada than you should

If you or anyone else takes more of this medicine than they should, tell your doctor immediatelyor go to the nearest hospital emergency department. Please remember to take this medicine pack or this leaflet with you.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Bilastina Stada

Do nottake a double dose to make up for the forgotten dose.

If you forget to take your dose, take it as soon as possible, and then return to your regular dosing schedule.

If you stop taking Bilastina Stada

There are usually no consequences when treatment with bilastina is stopped.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking the medicine and seek immediate medical advice if you experience symptoms of an allergic reaction: which can 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 notice any of these serious side effects, stop taking the medicine and seek immediate medical advice.

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

• electrocardiogram changes
• blood tests showing changes in liver function
• dizziness
• stomach pain
• fatigue
• increased appetite
• irregular heartbeat
• weight gain
• nausea (feeling sick)
• anxiety
• dry or irritated nose
• abdominal pain
• diarrhea
• gastritis (inflammation of the stomach lining)
• vertigo (a feeling of dizziness or instability)
• feeling weak
• thirst
• shortness of breath
• dry mouth
• indigestion
• itching
• cold sore
• 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 the available data

• palpitations (feeling your heartbeat)
• tachycardia (fast heartbeat)
• vomiting

Side 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 pain (abdominal pain up to the upper abdomen)

Uncommon: may affect up to 1 in 100 people

• eye irritation
• dizziness
• loss of consciousness
• diarrhea
• nausea (feeling sick)
• lip swelling
• eczema
• urticaria (hives)
• fatigue

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Agency's website: www.notificaRAM.es By reporting side 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 on the carton and blister after EXP. The expiry date is the last day of the month stated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Bilastina Stada:

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

Appearance and packaging:

Bilastina Stada are white and round tablets.

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

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

info@stada.es

Manufacturer

Noucor Health, S.A.,

Av. Camí Reial 51-57

08184 Palau-Solità i Plegamans

Barcelona

Spain

This medicine is authorised in the Member States of the European Economic Area under the following names:

Germany: Bilastin STADA Arzneimittel 20 mg Tabletten

Belgium: Bilastine EG 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 EG 20 mg comprimés

Latvia: Bilastine STADA 20 mg tabletes

Poland: VERPYLLO

Portugal: Bilastina Ciclum

Slovakia: Bilastin STADA 20 mg tablety

Date of last revision of this leaflet:March 2025

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