BILASTINA TEVA 10 mg ORALLY DISINTEGRATING TABLETS

Introduction

Package Leaflet: Information for the Patient

Bilastina Teva 10 mg Oral Disintegrating TabletsEFG

Read the entire package leaflet carefully before starting to take this medication,as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.

• This medication has been prescribed to you or your child only. Do not give it to others, even if they have the same symptoms as you, as it may harm them.
  • If you or your child experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Bilastina Teva and what is it used for
2. What you need to know before taking Bilastina Teva
3. How to take Bilastina Teva
4. Possible side effects

5 Conservation of Bilastina Teva

1. Contents of the packaging and additional information

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

Bilastina Teva 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 skin eruptions with itching (hives or urticaria).

Bilastina Teva 10 mg oral disintegrating tablets are indicated for children from 6 years of age with a minimum body weight of 20 kg and are also indicated for adults and adolescents.

2. What you need to know before taking Bilastina Teva

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 have moderate or severe renal or hepatic impairment, 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 may affect heart rhythm, if you have or have had a certain abnormal pattern in heartbeats (known as QTc interval prolongation in the electrocardiogram) that may occur in some forms of heart disease, or if you or your child are 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 below 20 kg, as there are insufficient data available.

Other medications and Bilastina Teva

Tell your doctor or pharmacist if you or your child are taking, have recently taken, or may 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 are 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 excess cortisol)
• Erythromycin (an antibiotic)
• Diltiazem (to treat pain or pressure in the chest area - angina pectoris)
• Cyclosporine (to reduce the activity of your immune system, and thus prevent transplant rejection or reduce disease activity in autoimmune and allergic disorders, such as psoriasis, atopic dermatitis, or rheumatoid arthritis)
• Ritonavir (to treat AIDS)
• Rifampicin (an antibiotic)

Taking Bilastina Teva with food, beverages, and alcohol

These tablets should notbe taken with food or withgrapefruit juice or other fruit juices, as this would decrease the effect of bilastina. To avoid this, you can:

• Take or administer to your child the tablet and wait one hour before your child eats or takes fruit juices, or
• If you or your child have taken food or fruit juice, wait two hours before taking the oral disintegrating tablet.

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

Pregnancy, breastfeeding, and fertility

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

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

Consult your doctor or pharmacist before taking any medication.

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 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 oral disintegrating tablet; i.e., it is essentially "sodium-free".

3. How to take Bilastina Teva

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

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 from 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 below 20 kg, as there are insufficient data available.

• The tablet is for oral use.
• Please place the tablet in your mouth or in your child's mouth. It will disintegrate rapidly in saliva and can then be swallowed easily.
• Alternatively, you can disintegrate the tablet in a spoonful of water before administering it to your child. Make sure there are no sediment remains in the spoon.
• You should use water exclusively for disintegration; do not use grapefruit juice or any other fruit juice.
• You should administer the tablet one hour before or two hours after your child has eaten or taken fruit juice. See section 2, "Taking Bilastina Teva with food, beverages, and alcohol".

Since the duration of treatment depends on the underlying disease, your doctor will determine how long you or your child 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 emergency department of the nearest hospital. Please remember to bring this medication packaging or this package 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 medication and the amount ingested.

If you forget to take Bilastina Teva

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

If you forget to administer the daily dose to your child on time, administer it the same day as soon as you remember. 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 stop treatment with Bilastina Teva

In general, no effects will appear after stopping treatment with Bilastina Teva.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone gets them.

If you or your child experience allergic reactions whose symptoms may 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, stop administering this medication and go to your doctor immediately.

Other side effects that may appearin children:

Frequent: may affect up to 1 in 10 people

• rinitis (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 (vomiting)
• lip swelling
• eczema
• urticaria (hives)
• fatigue

Side effects that may appearin adults and adolescents:

Frequent: may affect up to 1 in 10 people

• headache
• somnolence

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 (vomiting)
• anxiety
• dry nose or nose discomfort
• abdominal pain
• diarrhea
• gastritis (inflammation of the stomach wall)
• vertigo (a feeling of dizziness or spinning)
• feeling of weakness
• thirst
• dyspnea (difficulty breathing)
• dry mouth
• indigestion
• itching
• fever blisters (herpes labialis)
• 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 (feeling heartbeats)
• tachycardia (rapid heartbeats)
• vomiting

Reporting side effects

If your child experiences any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of Bilastina Teva

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date shown on the packaging and on the blister 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 wastewater or household waste. Deposit the packaging and medications you no longer need at the Sigre Collection Point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Contents of the packaging and additional information

Composition of Bilastina Teva

• The active substance is bilastina.

Each tablet contains 10 mg of bilastina.

• The other components are:

Mannitol (E 421), microcrystalline cellulose, sodium croscarmellose (see section 2 "Bilastina Teva contains sodium"), aluminum and magnesium metasilicate, sucralose, strawberry flavor, magnesium stearate, and anhydrous colloidal silica.

Appearance of the product and contents of the packaging

Bilastina Teva 10 mg oral disintegrating 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 side and smooth on the other side.

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

Only some pack sizes may be marketed.

Marketing authorization holder

Teva B.V.

Swensweg 5, 2031GA Haarlem

Netherlands

Manufacturer:

Saneca Pharmaceuticals a.s.

Nitrianska 100 920 27 Hlohovec

Slovak Republic

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

Teva Pharma, S.L.U.

C/ Anabel Segura, 11 Edificio Albatros B 1ª planta

28108 Alcobendas – Madrid (Spain)

Date of the last revision of thispackage leaflet:September 2022

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