Prospect: information for the patient

Bilastina Teva 10 mg buccal dispersible tabletsEFG

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

• Keep this prospect, 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 or your child. Do not give it to other people, even if they have the same symptoms as you, as it may harm them.

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

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

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

3.How to take Bilastina Teva

4.Possible adverse effects

5Storage of Bilastina Teva

6.Contents of the package and additional information

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

Bilastine is used to relieve symptoms of allergic rhinoconjunctivitis (stuffy or runny nose, sneezing, itchy 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).

Bilastina Teva 10 mg orally disintegrating tablets is indicated for children aged 6 years and above with a minimum body weight of 20 kg, as well as for adults and adolescents.

Do not take Bilastina Teva:

• if you or your child 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 Teva if you or your child has moderate or severe renal or hepatic insufficiency, low levels of potassium, magnesium, or calcium in the blood, if you have or have had heart rhythm problems or if your heart rate is very low, if you are taking medications that can affect heart rhythm, if you have or have had a certain abnormal heart rhythm pattern (known as QTc prolongation in the electrocardiogram) that may occur in some forms of heart disease, or if you or your child is taking other medications (see “Other medications and Bilastina Teva”).

Children

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.

Other medications and Bilastina Teva

Inform your doctor or pharmacist if you or your child is taking, has taken recently, or may need to take any other medication.

Some medications should not be taken together and other medications may require a dose adjustment when taken together.

Always inform your doctor or pharmacist if you or your child is taking or receiving any of the following medications in addition to Bilastina Teva:

• Ketoconazole tablets (used to treat Cushing's syndrome, when the body produces an excess of cortisol)
• Erythromycin (an antibiotic)
• Diltiazem (to treat chest pain or pressure - angina)
• Ciclosporin (to reduce the activity of your immune system, and thus prevent transplant rejection or reduce the activity of the disease in autoimmune and allergic disorders, such as psoriasis, atopic dermatitis, or rheumatoid arthritis)
• Ritonavir (to treat HIV/AIDS)
• Rifampicin (an antibiotic)

Taking Bilastina Teva 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 or administer the tablet to your child and wait for one hour before your child eats or takes fruit juices, or
• if you or your child has eaten food or fruit juice, wait for two hours before taking the buccal dispersible tablet.

Bilastina, at the recommended dose in adults (20 mg), does not increase the drowsiness caused by alcohol.

Pregnancy, breastfeeding, and fertility

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

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

Consult your doctor or pharmacist before taking 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 or your child before driving, operating machinery, or riding a bicycle.

Bilastina Teva contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per buccal dispersible tablet; this is, essentially “sodium-free”.

Bilastina Teva contains sulfur dioxide

This medication contains sulfur dioxide. Rarely, it may cause severe hypersensitivity reactions and bronchospasm.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist.This medicationindicated by your doctor or pharmacist.Consult your doctor or pharmacist again in case of doubt.

Use in adults and adolescents 12 years and older

The recommended dose in adults, including elderly people and adolescents 12 years and older, is 20 mg (two 10 mg tablets) once a day.

Use in children

The recommended dose in children 6 to 11 years of age with a minimum body weight of 20 kg is one 10 mg tablet once a day. 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.

Since the duration of treatment depends on the underlying disease of you or your child, your doctor will determine for how long you should take Bilastina Teva.

If you take more Bilastina Teva than you should

If you or your child 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 Teva

Do nottake a double dose to compensate for the missed doses.

If you forget to administer the daily dose to your child on time, administer it the same day as soon as you notice. Then, administer the next dose the following day at the usual time as indicated by your doctor.

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

If you interrupt treatment with Bilastina Teva

Generally, there will be no effectsafter abandoningthe treatment with Bilastina Teva.

If you have any other questions about the use of thismedication, ask your doctor,orpharmacist.

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

If you or your child experiencesallergic reactions whose symptoms 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, stop administering this medicine and seek immediate medical attention.

Other side effects that may appearin children:

Frequent: may affect up to 1 in 10 people

• rhinitis (nasal irritation)
• allergic conjunctivitis (eye irritation)
• headache
• stomach pain (upper abdominal pain)

Less frequent: 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

Side effects that may appearin adults and adolescents:

Frequent: may affect up to 1 in 10 people

• headache
• drowsiness

Less frequent: 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 sensation of dizziness or spinning)
• weakness
• thirst
• shortness of breath
• dry mouth
• indigestion
• itching
• fever (herpes labial)
• 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

Reporting side effects

If your child experiences 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 Pharmacovigilance of Medicines for Human Use: 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 on thecontainerand on the blister pack after 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.Deposit the containers and medications you no longer need at the Sigre Point of the pharmacy.In case of doubtask your pharmacisthow to dispose ofthecontainers and themedications you no longerneed.By doing so, you will help protect the environment.

Composition of Bilastina Teva

• The active ingredient is bilastina.

Each tablet contains 10 mg of bilastina.

• The other componentsare:

Manitol (E 421), microcrystalline cellulose, sodium croscarmellose (see section 2 “Bilastina Teva contains sodium”), aluminium magnesium metasilicate, sucralose, grape aroma (see section 2 “Bilastina Teva contains sulfur dioxide”), magnesium stearate, anhydrous colloidal silica.

Appearance of the product and content of the container

Bilastina Teva 10 mg buccal tablets EFG are round, biconvex tablets, approximately 7.5 mm in size, white to off-white in color, smooth to speckled, engraved with "10" on one face and smooth on the other face.

The tablets are packaged in blisters of 10, 20, 30 or 50 tablets.

Only some package sizes may be commercially marketed.

Marketing authorization holder

Teva B.V.

Swensweg 5, 2031GA Haarlem

Netherlands

Responsible for manufacture:

Saneca Pharmaceuticals a.s.

Nitrianska 100 920 27 Hlohovec

Slovak Republic

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Teva Pharma, S.L.U.

C/ Anabel Segura, 11 Edificio Albatros B 1st floor

28108 Alcobendas – Madrid (Spain)

Last revision date of thisleaflet:March 2025

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