Product Information for the Patient

Bilamax Flas 20 mg Buccodispersable Tablets EFG

Bilastine

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

• Keep this product information, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only to you, and you should not give it to others who have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this product information. See section 4.

5Storage of Bilamax Flas

6.Contents of the Package and Additional Information

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

This medication 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 skin eruptions with itching (hives or urticaria).

Bilamax Flas 20 mg tabletsare indicated for adults and adolescents.

Do not take Bilamax Flas

-if you 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 have moderate or severe renal insufficiency, low blood levels of potassium, magnesium, or calcium, 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 prolongation on an electrocardiogram) that may occur in certain types of heart disease and are also taking other medications (see “Other medications and Bilamax Flas”).

Children

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

Other medications and Bilamax Flas

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

Particularly, please consult with 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 chest pain or pressure - angina pectoris)
• Cyclosporine (to reduce the activity of your immune system, and thus prevent transplant rejection or reduce the activity of autoimmune and allergic diseases, 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 taking fruit juices, or
• if you have eaten or taken fruit juices, wait for two hours before taking the tablet.

Bilastine, 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 bilastine in pregnant women and during breastfeeding, and on the effects on fertility.

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

Consult your doctor or pharmacist before taking any medication.

Driving and operating machinery

It has been shown that bilastine 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 before driving or operating machinery.

Bilamax Flas contains sodium

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

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

The recommended dose in adults, including elderly patients and adolescents 12 years of age or older, is 20 mg once a day.

Use in children

For children 6 to 11 years of age with a minimum body weight of 20 kg, there are other more suitable pharmaceutical forms – bilastina 10 mg buccal dispersible 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 less than 20 kg since there are not enough data available.

• The buccal dispersible tablet is for oral administration.
• Place the tablet in the mouth. It will disperse quickly in the saliva and can then be swallowed easily.
• Alternatively, you can disperse the tablet in a spoon with water before taking it. Make sure there are no remaining sediment particles in the spoon.
• You should use exclusively water for dispersion, do notuse grapefruit juice or any other fruit juice.
• You should take the tablet one hour before or two hours after having taken any food or 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 will indicate for how long you should take Bilamax Flas.

If you take more Bilamax Flas than you should

If you, or anyone else, exceed the dose of this medication, inform your doctor or pharmacist 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 forgot to take Bilamax Flas

Do not take a double dose to compensate for the missed doses.

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

If you interrupt the treatment with Bilamax Flas

Generally, there will be no effects after abandoning the treatment with Bilamax Flas.

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

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

If you experience allergic 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 using this medicine and seek immediate medical attention.

Side effects that may appear in 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)
• dizziness (a sensation of spinning or dizziness)
• weakness
• thirst
• shortness of breath
• dry mouth
• indigestion
• itching
• fever (cold sores)
• 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

Other side effects that may appear in 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)

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

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging and on the blister pack after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medicines at the pharmacy's Take-Back Point. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Composition of Bilamax Flas

• The active ingredient is bilastine. Each tablet contains 20 mg of bilastine.
• The other components are mannitol (E 421), microcrystalline cellulose, sodium croscarmellose (see section 2 “Bilamax Flas contains sodium”), aluminium magnesium silicate, sucralose, strawberry flavor, magnesium stearate, anhydrous colloidal silica.

Appearance of the product and content of the container

Bilamax Flas 20 mg buccal tablets arewhite to off-white, smooth to speckled, biconvex, oval, approximately 10.3 x 5.5 mm, marked with “20” on one side and smooth on the other, and have a strawberry odor.

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

Only some container sizes may be commercially marketed.

Marketing authorization holder

Laboratorios Cinfa, S.A

Carretera Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra) – Spain

Responsible for manufacturing

Saneca Pharmaceuticals a.s.

Nitrianska 100

920 27 Hlohovec

Slovak Republic

or

Laboratorios Cinfa, S.A

Carretera Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra) – Spain

Last review date of this leaflet: January 2025

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/)

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