BILASTINA TEVA 20 mg ORALLY DISINTEGRATING TABLETS

Introduction

Package Leaflet: Information for the Patient

Bilastina Teva 20 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, consult your doctor or pharmacist.

• This medication has been prescribed to you only. Do not give it to others, even if they have the same symptoms as you, as it may harm them.
  • If you experience side effects, consult your doctor or pharmacist, even if they are 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 pack 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 20 mg oral disintegrating tablets are 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 have moderate or severe renal 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 heart rhythm pattern (known as QTc interval prolongation in the electrocardiogram) that may occur in some forms of heart disease or if you are taking other medications (see "Other medications and Bilastina Teva").

Children

Do not administer this medication to children under 12 years of age.

Other medications and Bilastina Teva

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

In particular, always inform your doctor if you are taking any of the following medications:

• Ketoconazole tablets (used to treat Cushing's syndrome, when the body produces an excess of cortisol)
• Erythromycin (an antibiotic)
• Diltiazem (to treat pain or pressure in the chest area - angina pectoris)
• Ciclosporin (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 oral disintegrating 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 oral disintegrating tablet and wait one hour before eating or taking fruit juices, or
• if you 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 the drowsiness produced by alcohol.

Pregnancy, breastfeeding, and fertility

There are no data or limited data on the use of bilastina in pregnant and breastfeeding women, and on its 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 before driving or operating machinery.

Bilastina Teva contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per oral disintegrating tablet; this is, essentially "sodium-free".

3. How to take Bilastina Teva

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

The recommended dose in adults, including elderly patients and adolescents 12 years and older, is 20 mg once daily.

Use in children

For children 6 to 11 years of age with a minimum body weight of 20 kg, there are other pharmaceutical forms of this medication more suitable – bilastina 10 mg oral disintegrating tablets or bilastina 2.5 mg/ml oral solution.

Consult your doctor or pharmacist.

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 administration.
• Place the tablet in your 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 taking it. Make sure no sediment remains in the spoon.
• You should use only water for disintegration, do not use grapefruit juice or any other fruit juice.
• You should administer the tablet one hour before or two hours after taking any food or fruit juice. See section 2, "Bilastina Teva with food, beverages, and alcohol".

As the duration of treatment will be determined by your doctor, who will determine the type of disease you have and how long you should take Bilastina Teva.

If you take more Bilastina Teva than you should

If you or anyone else exceeds 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 package 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 not take a double dose to make up for forgotten doses.

If you forget to take the daily dose on time, take it as soon as possible, and then return to the usual dosing schedule.

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 will experience them.

If you 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 taking this medication and go to your doctor immediately.

Side effects that may appearin adults and adolescents:

Frequent: may affect up to 1 in 10 people

• headache
• drowsiness

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 or irritated nose
• 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

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 (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

Reporting side effects

If your child experiences any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency's online system: www.notificaRAM.es. By reporting side effects, you can help provide 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 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 wastewater or household waste. Deposit the packaging and medications you no longer need at the pharmacy's SIGRE collection point. 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 pack and additional information

Composition of Bilastina Teva

• The active substance is bilastina.

Each tablet contains 20 mg of bilastina.

• The other components are:

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

Appearance of the product and contents of the pack

Bilastina Teva 10 mg oral disintegrating tablets EFG are oval tablets approximately 10.3 x 5.5 mm in size, white to off-white in color, smooth to speckled, biconvex, engraved with "20" on one side and smooth on the other side.

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

Not all 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 from 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 Healthcare Products (AEMPS) (http://www.aemps.gob.es/)