Bilastine Stadapharm 20 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Bilastina STADAPHARM 20 mg tablets EFG

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

Follow exactly the instructions for taking this medicine as described in this leaflet or as directed by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your doctor or pharmacist.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
• You should consult a doctor if your condition worsens or does not improve after 7 days.

Contents of the leaflet

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

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

This medicine contains bilastine as the active substance, which is an antihistamine.

Bilastine is used to relieve symptoms of allergic rhinoconjunctivitis (sneezing, nasal itching, nasal discharge, nasal congestion, and red, watery eyes) and urticaria (hives) that present with mild symptoms, in adults and adolescents aged 12 years and older.

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

2. What you need to know before taking Bilastina Stadapharm

Do not take Bilastina Stadapharm:

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 taking this medicine 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, or if you have or have had a specific abnormal heart rhythm pattern (known as QTc interval prolongation on the electrocardiogram), which may occur in certain types of heart disease and you are also taking other medicines (see “Other medicines and Bilastina Stadapharm”).

If you experience symptoms such as difficulty breathing, abdominal pain, nausea, vomiting, diarrhea, dizziness, or fainting, seek urgent medical attention due to the risk of anaphylaxis.

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 Stadapharm

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

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 angina)
• Cyclosporine (used 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 Stadapharm with food, drinks, and alcohol

These tablets must 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 the drowsiness caused by alcohol.

Pregnancy, breastfeeding, and fertility

There are no data, or 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 shown that bilastine 20 mg does not impair driving performance in adults. However, individual patient response to the medicine may vary. Therefore, assess how this medicine affects you before driving or operating machinery.

3. How to take Bilastina Stadapharm

Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

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

• The tablet is for oral administration.
• The tablet should be taken one hour before or two hours after eating food or drinking fruit juice (see section 2, “Taking Bilastina Stadapharm with food, drinks and alcohol”).
• Swallow the tablet with a glass of water.

Consult a doctor if symptoms worsen or do not improve after 7 days.

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 – 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 Stadapharm 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 package or the leaflet with you.

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

If you forget to take Bilastina Stadapharm

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 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 will experience them.

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
• diarrhea
• gastritis (inflammation of the stomach lining)
• vertigo (a sensation of dizziness or instability)
• feeling of weakness
• thirst
• dyspnea (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)
• allergic reactions, symptoms 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 experience any of these serious adverse effects, stop taking this medicine immediately and contact your doctor without delay.
• 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
• diarrhea
• nausea (feeling sick)
• swelling of the lips
• eczema
• urticaria (hives)
• fatigue

Reporting of adverse effects

If you experience any type of adverse effect, talk to 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: www.notificaRAM.es By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Bilastina Stadapharm

Keep this medicine out of the 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 packaging and any unused medicines at the Sigre Point located at your pharmacy. If you are unsure, ask your pharmacist how to dispose of packaging and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Bilastina Stadapharm:

• 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 anhydrous colloidal silica.

Appearance of the product and contents of the pack:

Bilastina Stadapharm tablets are white, round, 7 mm in diameter.

The tablets are packed in blisters of 10 and 20 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

Spain

Manufacturer

Noucor Health, S.A.

Avinguda Camí Reial 51-57

08184 Palau-solità i Plegamans (Barcelona)

Spain

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 for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/