BILAMAX FLAS 10 mg ORALLY DISINTEGRATING TABLETS

Introduction

Patient Information Leaflet

Bilamax Flas 10 mg orodispersible tablets EFG

bilastine

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

• Keep this 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 or your child only, and you should not give it to others, even if they have the same symptoms, as it may harm them.
• If you or your child experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet

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

5 Storage of Bilamax Flas

1. Package contents and additional information

1. What Bilamax Flas is and what it is used for

Bilamax Flas contains bilastine as the active substance, which is an antihistamine.

This medication is used to relieve the symptoms of allergic rhinoconjunctivitis (sneezing, nasal itching, nasal discharge, nasal congestion, and red and watery eyes) and other forms of allergic rhinitis. It may also be used to treat skin eruptions with itching (hives or urticaria).

Bilamax Flas 10 mg tablets are indicated in children from 6 years of age with a minimum body weight of 20 kg, and are also indicated in adults and adolescents.

2. What you need to know before taking Bilamax Flas

Do not take Bilamax Flas

• if you or your child are allergic to bilastine 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 Bilamax Flas if you or your child have moderate or severe renal or hepatic impairment, low blood potassium, magnesium, or calcium levels, 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, or if you have or have had a certain abnormal heart rhythm pattern (known as QTc interval prolongation on the electrocardiogram) that may occur in certain heart diseases, and if you or your child are taking other medications (see "Other medications and Bilamax Flas").

Children

Do not administer this medication to children under 6 years of age with a body weight below 20 kg, as there is insufficient data available.

Other medications and Bilamax Flas

Tell your doctor or pharmacist if you or your child are taking, have recently taken, or may need to take any other medication.

Some medications should not be taken together, and others 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 Bilamax Flas:

• Ketoconazole (used to treat Cushing's syndrome, when the body produces excess cortisol)
• Erythromycin (an antibiotic)
• Diltiazem (to treat chest pain or pressure - angina pectoris)
• Cyclosporine (to reduce the activity of the 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 Bilamax Flas with food, drinks, and alcohol

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

• take or administer the tablet to your child 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 tablet.

Bilastine, 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 bilastine in pregnant or breastfeeding women, 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 before using this medication.

Consult your doctor or pharmacist before taking any medication.

Driving and using machines

It has been shown that bilastine 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.

Bilamax Flas contains sodium

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

3. How to take Bilamax Flas

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

Use in adults and adolescents from 12 years

The recommended dose in adults, including elderly patients and adolescents 12 years of age and older, is 20 mg once daily (2 tablets of 10 mg).

Use in children

The recommended dose in children from 6 to 11 years of age with a minimum body weight of 20 kg is 1 tablet of 10 mg once daily. Do not administer this medication to children under 6 years of age with a body weight below 20 kg, as there is insufficient data available.

• The orodispersible tablet is for oral use.
• Place the tablet in your mouth or your child's mouth. It will disperse rapidly in saliva and can then be swallowed easily.
• Alternatively, you can disperse the tablet in a spoonful of water before taking it or administering it to your child. Make sure there are no sediment remains in the spoon.
• You should use only water for dispersion; do not use grapefruit juice or any other fruit juice.
• You should take the tablet one hour before or two hours after eating or taking fruit juice. See section 2, "Taking Bilamax Flas with food, drinks, and alcohol".

Since the duration of treatment depends on the underlying disease or your child's condition, your doctor will determine how long you or your child should take Bilamax Flas.

If you take more Bilamax Flas 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 package or this 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 Bilamax Flas

Do not takea double dose to make up for forgotten doses.

If you forget to take or 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 stop treatment with Bilamax Flas

In general, no effects will appear after stopping treatment with Bilamax Flas.

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 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 using this medication and go to your doctor immediately.

Other side effects that may occur in children:

Common: 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

Side effects that may occur in adults and adolescents:

Common: 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
• tiredness
• increased appetite
• irregular heartbeat
• weight gain
• nausea (vomiting)
• anxiety
• dry or irritated nose
• abdominal pain
• diarrhea
• gastritis (inflammation of the stomach lining)
• vertigo (a feeling of dizziness or spinning)
• feeling of weakness
• thirst
• dyspnea (difficulty breathing)
• dry mouth
• indigestion
• itching
• fever blisters (cold sores)
• 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 you or your child experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Bilamax Flas

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

Do not use this medication after the expiration date stated on the package and blister after 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 any unused medication in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package contents and additional information

Composition of Bilamax Flas

• The active substance is bilastine. Each tablet contains 10 mg of bilastine.
• The other components are mannitol (E 421), microcrystalline cellulose, sodium croscarmellose (see section 2 "Bilamax Flas contains sodium"), aluminum and magnesium silicate, sucralose, strawberry flavor, magnesium stearate, and anhydrous colloidal silica.

Appearance of the product and package contents

Bilamax Flas 10 mg orodispersible tablets are white to off-white, smooth to speckled, biconvex, round tablets, approximately 7.5 mm in diameter, marked with "10" on one side and smooth on the other, with a strawberry flavor.

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

Not all pack sizes may be marketed.

Marketing authorization holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Manufacturer

Saneca Pharmaceuticals a.s.

Nitrianska 100

920 27 Hlohovec

Slovak Republic

or

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Date of the last revision of this leaflet: January 2025

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

You can access detailed information about this medication by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/88681/P_88681.html.

QR code to: https://cima.aemps.es/cima/dochtml/p/88681/P_88681.html.