BILAMAX FLAS 20 mg ORALLY DISINTEGRATING TABLETS

Introduction

Patient Information Leaflet

Bilamax Flas 20 mg Oral Disintegrating Tablets EFG

bilastine

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed to you only, and you should 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 leaflet. See section 4.

Contents of the Leaflet

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

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

This medicine 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 can also be used to treat itchy skin eruptions (hives or urticaria).

Bilamax Flas 20 mg tablets are indicated for adults and adolescents.

2. What you need to know before taking Bilamax Flas

Do not take Bilamax Flas

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

Warnings and precautions

Consult your doctor or pharmacist before taking Bilamax Flas if you have moderate or severe kidney 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 medicines that may affect your heart rhythm, if you have or have had a certain abnormal heart rhythm pattern (known as QTc interval prolongation on the electrocardiogram) that can occur in some types of heart diseases and are also taking other medicines (see "Other medicines and Bilamax Flas").

Children

Do not give this medicine to children under 12 years of age.

Other medicines and Bilamax Flas

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

In particular, please inform your doctor if you are taking any of the following medicines:

• Ketoconazole tablets (used to treat Cushing's syndrome, when the body produces too much cortisol)
• Erythromycin (an antibiotic)
• Diltiazem (to treat chest pain or pressure - 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 Bilamax Flas 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 bilastine. To avoid this, you can:

• take the tablet and wait one hour before eating or drinking fruit juices, or
• if you have eaten or drunk fruit juice, wait two hours before taking the tablet.

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

Pregnancy, breastfeeding, and fertility

There are no data or limited data 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 taking this medicine.

Consult your doctor or pharmacist before taking any medicine.

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 medicine may be different. Therefore, check how this medicine affects you before driving or operating machines.

Bilamax Flas contains sodium

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

3. How to take Bilamax Flas

Follow the instructions for administration of this medicine 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 of age 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, other pharmaceutical forms are more suitable - bilastine 10 mg oral disintegrating tablets or bilastine 2.5 mg/ml oral solution.

Consult your doctor or pharmacist.

Do not give this medicine to children under 6 years of age with a body weight below 20 kg, as there are insufficient data.

• The oral disintegrating tablet is for oral use.
• Place the tablet in the mouth. It will disintegrate rapidly in the saliva and can then be swallowed easily.
• Alternatively, you can disperse the tablet in a spoonful of water before taking it. Make sure 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 drinking fruit juice. See section 2, "Taking Bilamax Flas with food, drinks, and alcohol".

Regarding the duration of treatment, your doctor will determine the type of disease you have and indicate how long you should take Bilamax Flas.

If you take more Bilamax Flas than you should

If you or anyone else takes more of this medicine than they should, inform your doctor or pharmacist immediately or go to the nearest hospital emergency department. Please remember to bring this medicine 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 medicine and the amount taken.

If you forget to take Bilamax Flas

Do not take a double dose to make up for forgotten doses.

If you forget to take your dose, take it as soon as possible and then return to your regular dosing schedule.

If you stop taking 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 medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets 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 using this medicine and go to your doctor immediately.

Side effects that may appear in adults and adolescents:

Common: 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 lining)
• vertigo (a feeling of dizziness or spinning)
• feeling of weakness
• thirst
• shortness of breath
• 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 (fast heartbeats)
• vomiting

Other side effects that may appear 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

Reporting side effects

If you 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 Medicines and Healthcare Products Agency's online system: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Bilamax Flas

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

Do not use this medicine after the expiry date stated on the packaging and blister after EXP. The expiry date is the last day of the month indicated.

This medicine does not require special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Return the packaging and any unused medicine to a pharmacy for proper disposal. If in doubt, consult your pharmacist about how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package contents and additional information

Composition of Bilamax Flas

• The active substance is bilastine. Each tablet contains 20 mg of bilastine.
• The other ingredients 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 20 mg oral disintegrating tablets are white to off-white, smooth to speckled, biconvex, oval tablets, approximately 10.3 x 5.5 mm in size, marked with "20" 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 medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) (http://www.aemps.gob.es/).

You can access detailed information about this medicine 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/88682/P_88682.html.

QR code to: https://cima.aemps.es/cima/dochtml/p/88682/P_88682.html.