Prospect: Information for the Patient

Bilastina Kern Pharma 20 mg Tablets EFG

Read this prospect carefully before starting to take this medicine because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only to you and should not be given to other people, even if they 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 prospect. See section 4.

This medication contains bilastine as the active ingredient, which is an antihistamine. Bilastine is used to relieve symptoms of allergic rhinoconjunctivitis (stuffy or runny nose, sneezing, nasal congestion, and red, itchy eyes) and other forms of allergic rhinitis. It may also be used to treat skin eruptions with itching (hives or urticaria).

Do not take Bilastina Kern Pharma:

If you are 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 bilastina if you have moderate or severe renal insufficiency, low blood levels of potassium, magnesium, 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 pattern of your heartbeat (known as QTc interval prolongation in the electrocardiogram) that may occur in some types of heart disease and are also taking other medications (see “Other medications and Bilastina Kern Pharma”).

Children

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

Do not exceed the recommended dose. If symptoms persist, consult your doctor.

Other medications and Bilastina Kern Pharma

Inform your doctor or pharmacist if you are using, have used recently or may need to use any other medication, including those purchased without a prescription.

Particularly, please consult with your doctor if you are taking any of the following medications:

• Ketoconazole (an antifungal medication)
• Erythromycin (an antibiotic)
• Diltiazem (to treat angina pectoris)
• Ciclosporin (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 (to treat AIDS)
• Rifampicin (an antibiotic)

Taking Bilastina Kern Pharma with food, drinks, and alcohol

These tabletsmust not be taken withfood or withorange juice or other fruit juices, as this would decrease the effect of bilastina. To avoid this, you can:

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

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

Pregnancy, breastfeeding, and fertility

There are no data, or these are limited, on the use of bilastina in pregnant women, during lactation, or on its effects on fertility.

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

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

It has been demonstrated that bilastina 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.

Bilastina Kern Pharma contains sodium:

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

Follow exactly the administration instructions for this medication as 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 1 tablet (20 mg) per day.

• The tablet is to be taken orally.
• The tablet should be taken one hour before or two hours after taking any food or fruit juice (see section 2, “Taking Bilastina Kern Pharma with food, drinks, and alcohol).
• Swallow the tablet with a glass of water.

Regarding the duration of treatment, your doctor will determine the type of disease you have and will tell you for how long you should take Bilastina Kern Pharma.

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 chewable 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, as there are not enough data available.

If you take more Bilastina Kern Pharma 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 Bilastina Kern Pharma

Do nottake a double dose to compensate for a missed dose.

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

If you have any other questions 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 symptoms of an allergic reaction that 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 taking this medicine and seek immediate medical attention.

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

Frequent: may affect up to 1 in 10 people

• headache
• drowsiness

Less frequent: may affect up to 1 in 100 people

• alterations in the electrocardiogram
• blood tests showing changes in liver function
• dizziness
• stomach pain
• fatigue
• increased appetite
• irregular heartbeat
• weight gain
• nausea (feeling like vomiting)
• anxiety
• dry or irritated nose
• abdominal pain
• diarrhea
• gastritis (inflammation of the stomach lining)
• dizziness (a feeling of spinning or instability)
• weakness
• thirst
• shortness of breath
• dry mouth
• indigestion
• itching
• herpes labialis
• 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

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 (feeling like vomiting)
• swelling of the lips
• eczema
• urticaria (hives)
• fatigue

Reporting of 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 leaflet. 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 after CAD on the packaging 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 through drains or in the trash.Deposit the packaging and medications you no longer need at the Sigre Point of your pharmacy.Ask your pharmacist if you are unsure how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Bilastina Kern Pharma

• The active ingredient is bilastina. Each tablet contains 20 mg of bilastina.
• The other components are: mannitol (E-421), microcrystalline cellulose, sodium carboxymethylcellulose type A (from potato), aluminium magnesium silicate, magnesium stearate, and anhydrous colloidal silica.

Appearance of the product and content of the packaging

Bilastina Kern Pharma tablets are round, biconvex, white to off-white tablets, approximately 7 mm in diameter.

The tablets are presented in blisters of 10, 20, 30, 50, or 100 tablets.

Only some sizes of packaging may be commercially available.

Holder of the marketing authorization

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Responsible for manufacturing

Saneca Pharmaceuticals a.s.

Nitrianska 100

920 27 Hlohovec

Slovakia

This medicine is authorized in the member states of the European Economic Area with the following names:

Spain: Bilastina Kern Pharma 20 mg tablets EFG

Portugal: Bilastina Pharmakern 20 mg tablets

Sweden: Bilastin Kern Pharma 20 mg tablets

Last review date of this leaflet: February 2025

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/