Prospecto:Information for the Patient

Bilastina Sandoz 20 mg Tablets EFG

Read this prospect carefully before starting to take this medicine,because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• 1. If you have any doubts, consult yourdoctororpharmacist.

-This medicine has been prescribedonlyto you, and you should not give it to other people even if they havethe same symptomsas you, as it may harm them.

• If you experience any adverse effects,consult your doctor or pharmacist,evenif they are not listed in this prospect. See section 4.

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

2.What you need to knowbeforestarting totake Bilastina Sandoz

3.How to take Bilastina Sandoz

4.Possible adverse effects

5Storage of Bilastina Sandoz

6.Contents of the package and additional information

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

Bilastine is used to relieve symptoms of allergic rhinoconjunctivitis(runny nose, nasal itching, nasal discharge, nasal congestion, and red, watery 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 Sandoz

• if you are allergic to bilastina or any of the other ingredients of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Bilastina Sandoz.

Consult your doctor or pharmacist before starting to take bilastina if you have moderate or severe renal insufficiency and are also taking other medications (see “Other medications and Bilastina Sandoz”).

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 Sandoz

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including those purchased without a prescription.

In particular, please consult your doctor if you are taking any of the following medications:

• Ketoconazole (an antifungal medication).
• Erythromycin (an antibiotic).
• Diltiazem (to treat chest pain or pressure - 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 Sandoz 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, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Consult your doctor before taking this medication.

Driving and operating machinery

It has been shown 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 Sandoz 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

There are other pharmaceutical forms more suitable for children aged 6 to 11 years.

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

If you take more Bilastina Sandoz than you should

If you, or anyone else, have taken too much bilastina, 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 Sandoz

Do not take a double dose to compensate for the missed doses.

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 Sandoz

Generally, there are 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.

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

Frequent: can affect up to 1 in 10 people

• headache,
• drowsiness.

Rare: can 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),
• sense of weakness,
• thirst,
• shortness of breath,
• dry mouth,
• indigestion,
• itching,
• cold sores,
• 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),
• allergic reactions with symptoms that may include difficulty breathing, dizziness, fainting, or loss of consciousness, swelling of the face, lips, tongue, or throat, and/or hives and redness of the skin. If you notice any of these severe side effects, stop taking the medicine and seek immediate medical attention,
• vomiting.

Side effects that may occur in children are:

Frequent: can affect up to 1 in 10 people

• rhinitis (nasal irritation),
• allergic conjunctivitis (allergic irritation of the eye conjunctiva),
• headache,
• stomach pain (abdominal pain to the upper abdomen).

Rare: can 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 prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears onthe packaging and in the blisterafter CAD/EXP. 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 packaging and medications you no longer need at the SIGRE collection pointat 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 Sandoz

• 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, anhydrous colloidal silica.

Appearance of the product and content of the container

Bilastina Sandoz are round white tablets.

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

Only some container sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible for manufacturing

Noucor Health, S.A

Avda. Cami Reial, 51-57

08184 Palau Solita I Plegamans

Barcelona

Spain

or

Lek Pharmaceuticals d.d

Verovskova 57

1526 Ljubljana

Slovenia

This medicine is authorized in the member states of the European Economic Area with the following names:

Germany: Bilastin HEXAL 20 mg tablets

Estonia: Bilastine Sandoz

Spain: Bilastina Sandoz 20 mg EFG tablets

Italy: Bilastina Sandoz

Latvia: Bilastine Sandoz 20 mg tablets

Lithuania: Bilastine Sandoz 20 mg tablets

Poland: BILARGIN

Last review date of this leaflet: May 2021

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/