Prospecto: Information for the User

Bilastina Stada 20 mg Tablets EFG

Read this prospectus carefully before starting to take this medication because it contains important information for you.

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only to you, and you should not give it to other people even if they 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 prospectus. See section 4.

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

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

3.How to take Bilastina Stada

4.Possible adverse effects

5.Storage of Bilastina Stada

6.Contents of the package and additional information

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

Bilastine 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).

Do not take Bilastina Stada

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 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 medications that may affect heart rhythm, if you have or have had a certain abnormal heart rhythm pattern (known as QTc prolongation on an electrocardiogram) that may occur in some types of severe heart disease and are also taking other medications (see “Other medications and Bilastina Stada”).

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 Stada

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, even if it is an over-the-counter medication.

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 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 (to treat HIV/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 food or taken fruit juices, 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

There are no data, or these are limited, on the use of bilastina in pregnant women, during lactation, and on its effects on fertility.

If you are pregnant or breastfeeding, believe you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

It has been demonstrated that bilastina 20 mg 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.

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 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 will tell you for how long you should take bilastina.

Use in children

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

Do not administer this medication to children under 6 years of age with a body weight of less than 20 kg since there are not enough data available.

If you take more Bilastina Stada 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 forget to take Bilastina Stada

Do not take a double dose to compensate for the 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 interrupt treatment with Bilastina Stada

Generally, there will be no consequences when treatment with bilastina is interrupted.

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

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

Stop taking the medicine and seek urgent medical advice immediately if you experience symptoms of an allergic reaction: signs may include difficulty breathing, dizziness, fainting 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 urgent medical advice immediately.

The side effects that may occur in adults and adolescents are:

Frequent: may affect up to 1 in 10 people

• headache
• drowsiness

Rare: may affect up to 1 in 100 people

• electrocardiogram alterations
• blood tests showing changes in liver function
• dizziness
• stomach 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)
• vertigo (a feeling of dizziness or instability)
• weakness
• thirst
• shortness of breath
• dry mouth
• indigestion
• itching
• herpes labialis
• 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)
• vomiting

Side effects that may occur in children:

Frequent: may affect up to 1 in 10 people

• rhinitis (nasal irritation)
• allergic conjunctivitis (inflammation of the eyes caused by an allergic reaction)
• headache
• stomach pain (abdominal pain up to the upper abdomen)

Rare: 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 leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:www.notificaRAM.esBy reporting side effects, you can contribute to providing more information about the safety of this medicine.

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

Do not use this medication after the expiration date that appears after CAD on the packaging and blister. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and unused medications at the Sigre Point of the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Bilastina Stada:

• The active ingredient 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 package:

Bilastina Stada are white and round tablets.

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

Only some package sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Responsible for manufacturing

Noucor Health, S.A.,

Av. Camí Reial 51-57

08184 Palau-Solità i Plegamans

Barcelona

Spain

This medication is authorized in the member states of the European Economic Area with 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

Last review date of this leaflet:March 2025

More detailed information about this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/