BILASTINE KERN PHARMA 20 MG TABLETS EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

Bilastina Kern Pharma 20 mg tablets EFG

Read the entire leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, since it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if the effects are not listed in this leaflet. See section 4.

Leaflet contents:

1. What Bilastina Kern Pharma is and what it is used for
2. What you need to know before taking Bilastina Kern Pharma
3. How to take Bilastina Kern Pharma
4. Possible side effects
5. How to store Bilastina Kern Pharma
6. Contents of the pack and other information

1. What Bilastina Kern Pharma is and what it is used for

This medicine contains bilastine as the active substance, which is an antihistamine. Bilastine is used to relieve the symptoms of allergic rhinoconjunctivitis (sneezing, nasal itching, nasal discharge, nasal congestion, and red, watery eyes) and other forms of allergic rhinitis. It may also be used to treat itchy skin rashes (hives or urticaria).

2. What you need to know before taking Bilastina Kern Pharma

Do not take Bilastina Kern Pharma:

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

Warnings and precautions

Consult your doctor or pharmacist before starting to use bilastine if you have moderate or severe renal impairment, low blood levels of potassium, magnesium, or calcium, if you have or have had heart rhythm problems, if your heart rate is very low, if you are taking medicines that may affect heart rhythm, or if you have or have had a specific abnormal heart rhythm pattern (known as QTc interval prolongation on the electrocardiogram), which may occur in certain types of heart disease and especially if you are also taking other medications (see “Other medicines and Bilastina Kern Pharma”).

Children

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

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

Other medicines and Bilastina Kern Pharma

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

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

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

Taking Bilastina Kern Pharma with food, drinks, and alcohol

These tablets must not be taken with food or with grapefruit juice or other fruit juices, as this would reduce the effect of bilastine. To avoid this, you may:

• take the tablet and wait one hour before eating or drinking fruit juices, or
• if you have eaten food or drunk fruit juice, 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 the data are limited on the use of bilastine in pregnant women, during breastfeeding, or on effects on fertility.

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

Consult your doctor or pharmacist before using any medicine.

Driving and use of machines

It has been demonstrated that bilastine 20 mg does not impair driving performance in adults. However, individual patient responses to the medicine may vary. Therefore, assess how this medicine affects you before driving or operating machinery.

Bilastina Kern Pharma contains sodium:

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

3. How to take Bilastina Kern Pharma

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose in adults, including elderly patients and adolescents aged 12 years and older, is 1 tablet (20 mg) per day.

• The tablet is for oral use.
• The tablet should be taken one hour before or two hours after eating food or drinking 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 your specific condition and advise you on how long you should take Bilastina Kern Pharma.

Use in children

For children aged 6 to 11 years with a minimum body weight of 20 kg, other more suitable pharmaceutical forms are available – bilastine 10 mg orodispersible tablets or bilastine 2.5 mg/ml oral solution. Please consult your doctor or pharmacist.

Do not administer this medicine to children under 6 years of age with a body weight below 20 kg, as sufficient data are not available.

If you take more Bilastina Kern Pharma than you should

If you, or anyone else, exceed the recommended dose of this medicine, inform your doctor or pharmacist immediately or go to the nearest hospital emergency department. Please remember to bring this medicine container or the package leaflet with you.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 91 562 04 20 (indicating the medicine and the amount ingested).

If you forget to take Bilastina Kern Pharma

Do not take a double dose to make up 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 further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them. If you experience symptoms of an allergic reaction, signs of which 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 taking this medicine and seek immediate medical attention.

Adverse 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

• changes in electrocardiogram
• blood tests showing changes in liver function
• dizziness
• stomach pain
• fatigue
• increased appetite
• irregular heartbeat
• weight gain
• nausea (feeling sick)
• anxiety
• dry nose or nasal discomfort
• abdominal pain
• diarrhoea
• gastritis (inflammation of the stomach lining)
• vertigo (a sensation of dizziness or unsteadiness)
• feeling of weakness
• thirst
• dyspnoea (difficulty breathing)
• dry mouth
• indigestion
• itching
• 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 (awareness of heartbeats)
• tachycardia (rapid heartbeat)
• vomiting

Adverse 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
• diarrhoea
• nausea (feeling sick)
• swelling of the lips
• eczema
• urticaria (hives)
• fatigue

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Bilastina Kern Pharma

Keep this medicine out of sight and reach of children.

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

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the Punto Sigre collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Bilastina Kern Pharma

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

Appearance of the product and contents of the pack

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

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

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Manufacturer

Saneca Pharmaceuticals a.s.

Nitrianska 100

920 27 Hlohovec

Slovakia

This medicinal product is authorized in the European Economic Area member states under the following names:

Spain: Bilastina Kern Pharma 20 mg tablets EFG

Portugal: Bilastina Pharmakern 20 mg tablets

Sweden: Bilastin Kern Pharma 20 mg tablets

Date of the most recent revision of this leaflet: February 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/