LIVOCAB

LIVOCAB direct nasal spray

Important notes (mandatory information)

Livocab direct nasal spray. Active ingredient: Levocabastine (present as levocabastine hydrochloride). Areas of application: for the treatment of complaints in the case of allergic rhinitis, e.g. hay fever.

For risks and side effects, read the package leaflet and consult your doctor or pharmacist.


PACKAGE LEAFLET: INFORMATION FOR THE USER

Livocab direct nasal spray, 0.05% nasal spray, suspension for use in children from 1 year of age, adolescents and adults
Active ingredient: Levocabastine (present as levocabastine hydrochloride)

Read the entire package leaflet carefully before you start using this medicine, because it contains important information. Always use this medicine exactly as described in this package leaflet or exactly as your doctor or pharmacist has told you.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you notice any side effects, consult your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. See section 4.
• If you do not feel better or if you feel worse after 3 days, consult your doctor.

What this package leaflet contains

1. WHAT IS LIVOCAB DIRECT NASAL SPRAY AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU BE AWARE OF BEFORE USING LIVOCAB DIRECT NASAL SPRAY?
3. HOW IS LIVOCAB DIRECT NASAL SPRAY USED?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD LIVOCAB DIRECT NASAL SPRAY BE STORED?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS LIVOCAB DIRECT NASAL SPRAY AND WHAT IS IT USED FOR?

Indication group: Antiallergic/ Antihistamine. Livocab direct nasal spray is a medicine for the treatment of allergic rhinitis. Livocab direct nasal spray is used for the treatment of complaints in the case of allergic rhinitis, e.g. hay fever. Livocab direct nasal spray is intended for use in children from 1 year of age, adolescents and adults.

2. WHAT SHOULD YOU BE AWARE OF BEFORE USING LIVOCAB DIRECT NASAL SPRAY?

Livocab direct nasal spray must not be used if you are allergic to levocabastine or any of the other ingredients of this medicine listed in section 6.

Warnings and precautions

Please talk to your doctor or pharmacist before using Livocab direct nasal spray. In the case of impaired kidney function, you may only use Livocab direct nasal spray on doctor's orders and under the supervision of a doctor.

Children

The safety and efficacy of Livocab direct nasal spray in children under 1 year of age have not been proven.

Use of Livocab direct nasal spray together with other medicines

Inform your doctor or pharmacist if you are taking/using, have recently taken/used or intend to take/use any other medicines. Decongestants with oxymetazoline can temporarily reduce the absorption of levocabastine.

Pregnancy and

breastfeeding

If you are pregnant or breastfeeding, or if you suspect you may be pregnant or intend to become pregnant, ask your doctor or pharmacist for advice before using this medicine.

Pregnancy

Studies on animals have shown no evidence of harmful effects on the development of the embryo or foetus. There is only limited data available on the use of Livocab direct nasal spray in pregnant women. The risk to humans is unknown. If you are pregnant or think you may be pregnant, you should only use Livocab direct nasal spray after consulting your doctor.

Breastfeeding

If you are breastfeeding, you should only use Livocab direct nasal spray after consulting your doctor.

Driving and operating machinery

Livocab direct nasal spray generally has no effect on concentration and alertness. After using Livocab direct nasal spray, there have been isolated reports of complaints such as listlessness, fatigue, exhaustion, dizziness or a feeling of weakness. These can also be caused by the allergic complaints themselves. In such cases, the ability to drive a car and operate machinery may be impaired and caution is advised. Please note in particular that alcohol can further impair your ability to drive.

Livocab direct nasal spray contains propylene glycol and benzalkonium chloride

Propylene glycol can cause irritation of the nasal mucosa. The preservative contained in Livocab direct nasal spray (benzalkonium chloride) can, especially with prolonged use, cause swelling of the nasal mucosa. If such a reaction is suspected (persistently blocked nose), a medicine for use in the nose without a preservative should be used if possible. If such medicines for use in the nose without a preservative are not available, a different dosage form should be considered.

3. HOW IS LIVOCAB DIRECT NASAL SPRAY USED?

Always use this medicine exactly as described in this package leaflet or exactly as agreed with your doctor or pharmacist. Check with your doctor or pharmacist if you are not quite sure.

Dosage for children from 1 year of age, adolescents and adults

The recommended dosage is 2 sprays of Livocab direct nasal spray per nostril, 2 times a day. The dosage can be increased to up to 4 sprays per nostril, 2 times a day in the case of more severe complaints.

Dosage for patients with impaired kidney function

If you suffer from impaired kidney function, you should halve the dose, as the active ingredient levocabastine is mainly excreted via the kidneys.

Method of administration

1. Blow your nose thoroughly before use.
2. Livocab nasal spray is a suspension. Therefore, please shake the bottle before each use!
3. Remove the protective cap from the bottle.
4. Before using Livocab direct nasal spray for the first time, hold the spray bottle with the opening facing upwards and pump several times until a fine mist is produced. The spray bottle is usually ready for use immediately for subsequent applications.
5. Tilt your head slightly forwards and spray twice into each nostril.
6. Inhale through your nose during application.
7. Replace the protective cap after use.

Duration of use

The time between two applications is determined by the effect of Livocab direct nasal spray. Use Livocab direct nasal spray at the first signs of allergic rhinitis. This will achieve the best treatment results. The duration of use depends on the type and course of the complaints. You do not need to take into account any time limit. If the recommended dosage is not sufficient, you should consult your doctor. Please talk to your doctor or pharmacist if you have the impression that the effect of Livocab direct nasal spray is too strong or too weak.

Use in children

The safety and efficacy of Livocab direct nasal spray in children under 1 year of age have not been proven.

If you have used more Livocab direct nasal spray than you should

If you accidentally swallow the contents of the bottle of Livocab direct nasal spray, you may feel drowsy. In this case, please contact a doctor and drink plenty of water.

If you forget to use Livocab direct nasal spray

Do not use double the dose to make up for a forgotten application. Continue treatment with Livocab direct nasal spray as described in the dosage.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Possible side effects

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

• Headache

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

• Nausea, tiredness, pain
• Pain in the throat-larynx area, nosebleeds, cough
• Dizziness, drowsiness
• Sinusitis

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

• Swelling of the eyelids
• Unwell; irritation, pain and dryness at the site of administration
• Hypersensitivity
• Shortness of breath, nasal discomfort, blocked nose, spasm of the bronchial muscles (bronchospasm)
• Palpitations

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

• Rapid heartbeat
• Burning, discomfort at the site of administration
• Swelling of the nose

Not known (frequency cannot be estimated from the available data):

• Allergic reaction up to and including circulatory failure (anaphylaxis)

Complaints such as tiredness, dizziness, drowsiness or unwell can also be caused by the disease process.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. of Pharmacovigilance, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help to provide more information on the safety of this medicine.

5. HOW SHOULD LIVOCAB DIRECT NASAL SPRAY BE STORED?

Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the bottle and the outer carton after "Use by". The expiry date refers to the last day of the month indicated. Do not store above 30°C. Livocab direct nasal spray can be stored for three months after opening the bottle, but no longer than the end of the stated expiry date. Medicines should be disposed of in accordance with local requirements. Ask your pharmacist how to dispose of the medicine when you no longer use it. You will help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Livocab direct nasal spray contains

The active ingredient is: Levocabastine (present as levocabastine hydrochloride). 1 ml of suspension contains 0.5 mg of levocabastine corresponding to 0.54 mg of levocabastine hydrochloride. 1 spray (approx. 0.1 ml of suspension) contains approximately 0.05 mg of levocabastine. The other ingredients are: Purified water, propylene glycol, disodium hydrogen phosphate, sodium dihydrogen phosphate 1 H2O, hypromellose, polysorbate 80, benzalkonium chloride solution, sodium edetate (Ph. Eur.).

What Livocab direct nasal spray looks like and contents of the pack

Livocab direct nasal spray is available as a metered spray in plastic bottles with 5 ml and 10 ml of white suspension. Not all pack sizes may be marketed.

Pharmaceutical entrepreneur

Johnson & Johnson GmbH
Johnson & Johnson Platz 2
41470 Neuss
Tel.: 00800 260 260 00 (free of charge)

Manufacturer

Janssen Pharmaceutica N.V.
Turnhoutseweg 30
2340 Beerse
Belgium

This package leaflet was last revised in October 2015.

Source: Information from the package leaflet
Status: 05/2018
Active ingredient: Levocabastine (present as levocabastine hydrochloride). Areas of application: for the treatment of complaints in the case of allergic rhinitis, e.g. hay fever.