BILASTINA NORMON 20 mg TABLETS

2. What you need to know before you take Bilastine Normon

Do not take Bilastine Normon:

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Bilastine Normon if you have moderate or severe kidney problems, 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 in the electrocardiogram) that may occur in some types of heart disease and you are also taking other medicines (see "Using Bilastine Normon with other medicines").

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

Children

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

Do notexceed the recommended dose. If symptoms persist, talk to your doctor.

Other medicines and Bilastine Normon

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines, including those obtained without a prescription.

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

• Ketoconazole (a medicine for fungi)
• Erythromycin (an antibiotic)
• Diltiazem (for angina pectoris)
• Cyclosporine (to reduce the activity of your immune system, to prevent transplant rejection or reduce the activity of autoimmune diseases and allergic disorders, such as psoriasis, atopic dermatitis, or rheumatoid arthritis)
• Ritonavir (for AIDS)
• Rifampicin (an antibiotic)

Taking Bilastine Normon with food, drinks, and alcohol

These tablets must notbe taken with foodor 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 juices, wait two hours before taking the tablet.

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

Pregnancy, breastfeeding, and fertility

There are no data or limited data on the use of bilastine in pregnant women, during breastfeeding, or on fertility.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Consult your doctor or pharmacist before using 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 using machines.

3. How to take Bilastine Normon

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

The recommended dose in adults, including elderly patients and adolescents 12 years of age and older, is one tablet (20 mg) per day.

• The tablet is for oral use.
• The tablet should be taken one hour before or two hours after any food or fruit juice (see section 2, "Taking Bilastine Normon with food, drinks, and alcohol").

• Swallow the tablet with a glass of water.
• The score line is only for breaking the tablet if you find it difficult to swallow whole.
• Regarding the duration of treatment, your doctor will determine the type of disease you have and tell you how long you should take Bilastine Normon 20 mg tablets.

Use in children

For children 6 to 11 years of age with a minimum body weight of 20 kg, there are other pharmaceutical forms more suitable - bilastine 10 mg orodispersible 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 not enough data available.

If you take more Bilastine Normon than you should

If you or anyone else takes more of this medicine than they should, tell your doctor immediately or go to the casualty department of the nearest hospital. Remember to take this medicine 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 medicine and the amount ingested).

If you forget to take Bilastine Normon

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

If you forget to take your dose, take it as soon as possible, and then go back to your normal dosing schedule.

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.

The side effects that may occur in adults and adolescents are:

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 (feeling sick)
• anxiety
• dry or irritated nose
• abdominal pain
• diarrhea
• gastritis (inflammation of the stomach lining)
• vertigo (feeling of dizziness or instability)
• feeling of weakness
• thirst
• shortness of breath
• dry mouth
• indigestion
• itching
• cold sore
• 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 the available data

• palpitations (feeling your heartbeat)
• tachycardia (fast heartbeat)
• 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. If you experience any of these serious side effects, stop taking this medicine and seek immediate medical attention.
• vomiting

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 (feeling sick)
• lip swelling
• eczema
• urticaria (hives)
• fatigue

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. You can also report side effects directly to the Spanish Medicines and Healthcare Products Agency (AEMPS) at www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Bilastine Normon

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

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of the month.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Bilastine Normon 20 mg tablets EFG:

The active substance is bilastine. Each tablet contains 20 mg of bilastine.

The other ingredients are microcrystalline cellulose, sodium carboxymethylcellulose type A (derived from potato), anhydrous colloidal silica, magnesium stearate.

Appearance of the product and pack contents:

Bilastine Normon 20 mg tablets EFG are white or almost white, elongated, biconvex, scored, and engraved.

The tablets are available in packs of 20 and 30 tablets.

Marketing authorization holder and manufacturer

Laboratorios Normon, S.A.

Ronda de Valdecarrizo, 6

28760 – Tres Cantos

Madrid (Spain)

Date of the last revision of this package leaflet:February 2025

Other sources of information

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/).