BILASTINA URQUIMA 10 mg ORALLY DISINTEGRATING TABLETS

2. What you need to know before taking Bilastina Urquima

Do not take Bilastina Urquima:

If your child is 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 use this medication if your child has moderate or severe renal or hepatic impairment, low blood potassium, magnesium, or calcium levels, if they have or have had heart rhythm problems or if their heart rate is very low, if they are taking medications that may affect heart rhythm, if they have or have had a certain abnormal heart rhythm pattern (known as QTc interval prolongation on the electrocardiogram) that may occur in some types of heart diseases, if your child is taking other medications (see "Using Bilastina Urquima with other medications").

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 Bilastina Urquima

Inform your doctor or pharmacist if your child is using, has recently used, or may need to use any other medication, including those purchased without a prescription. Some medications should not be taken together, and others may require a dose adjustment when taken together.

In particular, please discuss with your doctor if your child is taking any of the following medications in addition to bilastina:

• Ketoconazole (an antifungal medication)
• Erythromycin (an antibiotic)
• Diltiazem (for the treatment of angina pectoris - pain or pressure in the chest area)
• Cyclosporine (to reduce the activity of the immune system, to prevent transplant rejection or reduce disease activity in autoimmune and allergic disorders, such as psoriasis, atopic dermatitis, or rheumatoid arthritis)
• Ritonavir (for the treatment of AIDS)
• Rifampicin (an antibiotic)

Taking Bilastina Urquima with Food, Drinks, and Alcohol

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

• Administer the oral disintegrating tablet to your child and wait one hour before your child eats or drinks fruit juices, or
• If your child has eaten or drunk fruit juices, wait two hours before taking the tablet.

Bilastina, at the recommended dose in adults (20 mg), does not increase somnolence produced by alcohol.

Pregnancy, Breastfeeding, and Fertility

This medication is for use in children from 6 to 11 years old with a minimum body weight of 20 kg. However, the following information on the safe use of this medication should be taken into account. There are no data or limited data available on the use of bilastina in pregnant women, during breastfeeding, or 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 using any medication.

Driving and Using Machines

It has been demonstrated 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 your child before they ride a bicycle or other vehicles or operate machines.

3. How to Take Bilastina Urquima

Follow the exact instructions for administering this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Use in Children

The recommended dose in children from 6 to 11 years old with a minimum body weight of 20 kg is 10 mg of bilastina (1 oral disintegrating tablet) once a day for the symptomatic relief of allergic rhinoconjunctivitis and urticaria.

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.

For adults, including elderly patients and adolescents 12 years of age or older, the recommended dose is 20 mg of bilastina once a day. For this patient population, a more suitable pharmaceutical form is available - tablets; consult your doctor or pharmacist.

• The oral disintegrating tablet is for oral use.
• Place the oral disintegrating tablet in your child's mouth. It will disintegrate rapidly in the saliva and can then be swallowed easily.
• Alternatively, you can disperse the oral disintegrating tablet in a spoon with water before administering it to your child. Make sure no sediment remains in the spoon.
• You should use water exclusively for dispersion; do not use grapefruit juice or any other fruit juice.
• You should administer the oral disintegrating tablet to your child one hour before or two hours after they have eaten or drunk fruit juice.

Regarding the duration of treatment, it depends on your child's underlying disease and will be determined by your doctor.

If You Take More Bilastina Urquima Than You Should

If your child, 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 Urquima

If you forget to 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.

In no case should you administer a double dose to make up for the forgotten dose.

If You Stop Taking Bilastina Urquima

Generally, no effects will appear after stopping treatment with bilastina.

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 your child experiences 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 administering this medication and go to your doctor immediately.

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

Side Effects That May Appear in Adults and Adolescents:

Common: may affect up to 1 in 10 people

• headache
• sleepiness

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
• 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 your child experiences any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this package leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency's (AEMPS) online system: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Bilastina Urquima

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. 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 via wastewater or household waste. Return the packaging and any unused medication to a pharmacy for proper disposal. If you have any questions, consult your pharmacist. By doing so, you will help protect the environment.

6. Package Contents and Additional Information

Bilastina Urquima Composition:

• The active ingredient is bilastina. Each oral disintegrating tablet contains 10 mg of bilastina.
• The other ingredients are mannitol, ethylcellulose, crospovidone (type A), grape flavor, sucralose, and magnesium stearate.

Appearance of the Product and Package Contents:

Bilastina Urquima 10 mg oral disintegrating tablets are white, round, and biconvex, with a diameter of 8 mm. Small spots may appear during their shelf life.

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

Only certain package sizes may be marketed.

Marketing Authorization Holder

Urquima, S.A.

Avda. Camí Reial 51-57

08184 Palau-solità i Plegamans

Barcelona - Spain

Manufacturer

Noucor Health, S.A.

Avda. Camí Reial 51-57

08184 Palau-solità i Plegamans

Barcelona - Spain

Date of Last Revision of This Package Leaflet: February 2025

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