Leaflet: information for theuser

Bilina0.5 mg/ml nasal spray suspension

Leverbasta

Read this leaflet carefully before starting to use this medicine, 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 medicine has been prescribed only for you and should not be given to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.See section 4.

1. What isBilinaand for what it is used

2. What you need to know before starting touseBilina

3. How to useBilina

4. Possible side effects

5. Storage ofBilina

6. Contents of the package and additional information

Bilina contains levocabastine which is anantihistamineused for the symptomatic treatment of allergic rhinitisin adults and in children and adolescents from 4 years old to less than 18 years old.

Levocabastine is a highly selective antagonist of the H1histamine receptors.After application in the nose, almost immediately and for hours, relief of symptoms of allergic rhinitis (sneezing, nasal itching and rhinorrhea) occurs.

Do not use Bilina

• If you are allergic to levocabastine or to any of the other ingredients of this medicine (listed in section 6.1).

Warnings and precautions

If you have kidney problems since levocabastine is mainly excreted through the renal route. Bilina should be used with caution in patients with renal alterations.

Consult your doctor or pharmacist before starting to use Bilina.

Children and adolescents

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

Older people

Since levocabastine is mainly eliminated through the renal route and because it is common for there to be a decrease in renal function in older people, precautions should be taken when Bilina is administered to this group of patients.

Use of Bilina with other medicines

Inform your doctor or pharmacist if you are using, have used recently or might have to use any other medicine.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you might be pregnant or intend 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 medicine.

Driving and operating machinery

Bilina does not produce drowsiness, nor does it interfere with psychomotor activity. However, if you feel drowsy, avoid driving or operating machinery.

Bilina contains benzalkonium chloride and propylene glycol

This medicine contains 0.15 mg of benzalkonium chloride in each ml of nasal suspension.

The benzalkonium chloride may cause irritation or inflammation inside the nose, especially when used for long periods of treatment.

This medicine contains 50 mg of propylene glycol in each ml of nasal suspension.

Dosage

Follow exactly the administration instructions for this medication as indicated by your doctor.This includes consulting your doctor or pharmacist again if you are unsure.

Adults and children and adolescents aged 4 to less than 18 years

The recommended dose is 2 applications per nasal fossa, twice a day.The dose may be increased to 2 applications, 3 to 4 times a day.The treatment should be continued until the symptoms are eliminated.

Use in children under 4 years

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

Seniors

No data are available on the use of levocabastine in seniors.

Instructions for use

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

Clean the nasal passages before administering the medication and inhaling it through the 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 once or twice until a fine spray is released
3. Blow your nose
4. Incline your head as shown in the image and insert the dosing device of the bottle into one of the nostrils while pressing firmly on the other nostril
5. Press the atomizer twice on the nostril at the same time as you breathe 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 ingest the contents of a container, you may feel drowsy.Drink plenty of non-alcoholic liquids to help speed up the 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 Toxicological Information Service at 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to use Bilina

Do not use a double dose to make up for the missed dose.

If you have any other questions about the use of this product, ask your doctor or pharmacist.

Like all medicines, Bilina may 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 site of administration
• Stuffy nose
• Nasal discomfort

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

• Abnormal and rapid heartbeats (tachycardia)
• Difficulty breathing
• Hypersensitivity, anaphylaxis (Allergic reactions)
• General feeling of 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 System of 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 out of sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30°C.

Do not dispose of medications through drains or trash. Deposit empty containers and unused medications at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of empty containers and unused medications. By doing so, you will help protect the environment.

Composition of Bilina

• The active principle is levocabastine.Each milliliter of Bilina contains 0.5 milligrams of levocabastine.

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

Appearance of the product and contents of the packaging

Bilina is a sterile white suspension presented in plastic containers.

Each container contains 10 milliliters of suspension.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Esteve Pharmaceuticals, S.A.

Passeig de la Zona Franca, 109

08038 Barcelona

Spain

Responsible for manufacturing

Janssen Pharmaceutica, N.V.

Turnhoutseweg, 30

B-2340 Beerse (Belgium)

Last review date of this leaflet: December 2021

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