BILINA 0.5 mg/ml NASAL SPRAY SUSPENSION

Introduction

Leaflet: information for theuser

Bilina0.5 mg/ml nasal spray suspension

Levocabastina

Read the entire leaflet carefully before starting to use this medication, as it contains important information for you.

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

Contents of the leaflet

1. What is Bilina and what is it used for
2. What you need to know before taking Bilina
3. How to use Bilina
4. Possible side effects
5. Storage of Bilina
6. Package contents and additional information

1. What is Bilina and what is it used for

Bilina contains levocabastina, which is an antihistamine used for the symptomatic treatment of allergic rhinitis in adults and in children and adolescents from 4 to less than 18 years of age.

Levocabastina is a highly selective H1 histamine receptor antagonist. After nasal application, it provides rapid and long-lasting relief from allergic rhinitis symptoms (sneezing, nasal itching, and rhinorrhea).

2. What you need to know before taking Bilina

Do not use Bilina

• If you are allergic to levocabastina or any of the other components of this medication (listed in section 6.1).

Warnings and precautions

If you have kidney problems, as levocabastina is primarily excreted through the kidneys. Bilina should be used with caution in patients with renal impairment.

Consult your doctor or pharmacist before starting to use Bilina.

Children and adolescents

• The safety and efficacy of this medication have not been established in children under 4 years of age.
• Bilina should only be used to treat children and adolescents from 4 to less than 18 years of age.

Elderly

Since levocabastina is primarily eliminated through the kidneys and renal function often decreases in the elderly, precautions should be taken when administering Bilina to this group of patients.

Using Bilina with other medications

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medication.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, do not use Bilina, as safety studies have not been conducted in pregnant women and Bilina passes into breast milk. Consult your doctor or pharmacist before using this medication.

Driving and using machines

Bilina does not cause sedation or interfere with psychomotor activity. However, if you feel drowsy, avoid driving or operating machines.

Bilina contains benzalkonium chloride and propylene glycol

This medication contains 0.15 mg of benzalkonium chloride per ml of nasal spray suspension.

Benzalkonium chloride may cause irritation or inflammation inside the nose, especially when used for extended periods.

This medication contains 50 mg of propylene glycol per ml of nasal spray suspension.

3. How to use Bilina

Dose

Follow your doctor's instructions for administering this medication exactly. If in doubt, consult your doctor or pharmacist again.

Adults and children and adolescents from 4 to less than 18 years of age

The recommended dose is 2 applications per nostril, twice a day. The dose may be increased to 2 applications, 3 to 4 times a day. Treatment should continue until symptoms are relieved.

Use in children under 4 years of age

The safety and efficacy of this medication have not been established in children under 4 years of age. No data are available.

Elderly

No data are available on the use of levocabastina in the elderly.

Instructions for use

Bilina is a microsuspension. The container should be shaken before each application.

You should clean your nasal passages before administering the medication and inhale it through your nose.

Follow these steps:

1. Shake the bottle before removing the cap
2. Before using Bilina for the first time, remove the cap and press the bottle one or two times until a fine spray is released
3. Blow your nose
4. Tilt your head as shown in the image and insert the dosifier into one of the nostrils while pressing the other nostril firmly
5. Press the sprayer twice in the nostril while breathing in through that nostril
6. Repeat steps 4 and 5 for the other nostril.

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If you use more Bilina than you should

If you accidentally drink the contents of a container, you may feel drowsy. In this case, it is recommended to drink plenty of non-alcoholic liquids to accelerate renal excretion of the medication and contact your doctor immediately

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 use Bilina

Do not use a double dose to make up for forgotten doses.

If you have any further questions about using this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, Bilina can cause side effects, although not everyone will experience them.

The frequency of the possible side effects listed below is defined using the following convention:

Very common (may affect more than 1 in 10 people)

Common (may affect up to 1 in 10 people)

Uncommon (may affect up to 1 in 100 people)

Rare (may affect up to 1 in 1,000 people)

Very rare (may affect up to 1 in 10,000 people)

Frequency not known (cannot be estimated from available data)

Headache is the most common side effect with Bilina.

Common side effects (may affect up to 1 in 10 people):

• Nausea
• Fatigue
• Sinusitis
• Drowsiness
• Dizziness
• Sore throat (pharyngolaryngeal pain)
• Nosebleed (epistaxis)
• Cough
• Constant pain

Uncommon side effects (may affect up to 1 in 100 people):

• Irritation, discomfort, pain, burning, or dryness at the application site
• Stuffy nose
• Nasal discomfort

Very rare side effects (may affect up to 1 in 10,000 people):

• Fast and abnormal heartbeats (tachycardia)
• Difficulty breathing
• Hypersensitivity, anaphylaxis (allergic reactions)
• Feeling of general discomfort
• Swelling of the eyelids
• Obstruction of the airways (bronchospasm)
• Palpitations

If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.

Reporting side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency's (AEMPS) online system: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Bilina

Keep out of sight and reach of children.

Do not use this medication after the expiration date stated on the container after CAD. The expiration date is the last day of the month indicated.

Do not store above 30°C.

Medications should not be disposed of through wastewater or household waste. Deposit the containers and medications you no longer need at the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Bilina

• The active ingredient is levocabastina. Each milliliter of Bilina contains 0.5 milligrams of levocabastina.

• The other components (excipients) are benzalkonium chloride, propylene glycol, anhydrous disodium phosphate, monosodium phosphate monohydrate, hypromellose, polysorbate 80, disodium edetate, and purified water.

Appearance of the product and package contents

Bilina is a sterile white suspension presented in plastic containers.

Each container contains 10 milliliters of suspension.

Marketing authorization holder and manufacturer

Marketing authorization holder

Esteve Pharmaceuticals, S.A.

Passeig de la Zona Franca, 109

08038 Barcelona

Spain

Manufacturer

Janssen Pharmaceutica, N.V.

Turnhoutseweg, 30

B-2340 Beerse (Belgium)

Date of last revision of this leaflet: December 2021

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