LIVOCAB Nasal Spray 15 ml
Livocab direct nasal spray. Active ingredient: Levocabastine (present as levocabastine hydrochloride). Indications: For the treatment of symptoms of allergic rhinitis, e.g., hay fever.
For risks and side effects, read the package leaflet and ask 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 experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
- If you do not feel better or even feel worse after 3 days, consult your doctor.
What this leaflet contains:
- WHAT IS LIVOCAB DIRECT NASAL SPRAY AND WHAT IS IT USED FOR?
- WHAT SHOULD YOU CONSIDER BEFORE USING LIVOCAB DIRECT NASAL SPRAY?
- HOW SHOULD LIVOCAB DIRECT NASAL SPRAY BE USED?
- WHAT SIDE EFFECTS ARE POSSIBLE?
- HOW SHOULD LIVOCAB DIRECT NASAL SPRAY BE STORED?
- PACKAGE CONTENTS AND FURTHER 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 to treat the symptoms 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 YOU SHOULD KNOW BEFORE USING LIVOCAB DIRECT NASAL SPRAY:
Do not use Livocab direct nasal spray 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. If you have kidney problems, you should only use Livocab direct nasal spray on the advice of 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 established.
Using Livocab direct nasal spray with other medicines:
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Decongestants containing oxymetazoline may temporarily reduce the absorption of levocabastine.
Pregnancy and breastfeeding:
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy:
Animal studies have not shown any harmful effects on the developing embryo or fetus. There is limited data 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 does not affect concentration or attention. However, in isolated cases, symptoms such as fatigue, drowsiness, exhaustion, dizziness, or weakness have been reported after using Livocab direct nasal spray. These symptoms may also be caused by the allergic reaction itself. In such cases, the ability to drive and operate machinery may be impaired, and caution is advised. Please note that alcohol can further impair your ability to drive.
Livocab direct nasal spray contains propylene glycol and benzalkonium chloride:
Propylene glycol can cause nasal irritation. The preservative in Livocab direct nasal spray (benzalkonium chloride) can cause swelling of the nasal mucosa, especially with prolonged use. If such a reaction is suspected (persistent nasal congestion), a preservative-free nasal spray should be used, if possible. If such preservative-free nasal sprays are not available, an alternative dosage form should be considered.
3. HOW TO USE LIVOCAB DIRECT NASAL SPRAY?
Always use this medicine exactly as described in this leaflet or exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Dosage for children from 1 year of age, adolescents and adults:
The recommended dose is 2 sprays of Livocab Direct Nasal Spray into each nostril twice a day. The dosage can be increased to up to 4 sprays into each nostril twice a day for more severe symptoms.
Dosage for patients with impaired kidney function:
If you have impaired kidney function, you should halve the dose, as the active ingredient levocabastine is mainly excreted via the kidneys.
Method of administration:
- Clean your nose thoroughly before use.
- Livocab nasal spray is a suspension. Please shake the bottle before each use!
- Remove the protective cap from the bottle.
- Before using Livocab Direct Nasal Spray for the first time, hold the spray bottle with the opening pointing upwards and pump several times until a fine mist is produced. For subsequent uses, the spray bottle is usually ready to use immediately.
- Tilt your head slightly forward and spray twice into each nostril.
- Breathe in through your nose during application.
- Replace the protective cap after use.
Duration of use:
The time between 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 ensure the best treatment results. The duration of use depends on the type and course of the symptoms. You do not need to observe any time limit. If the recommended dose is insufficient, you should consult your doctor.
Please talk to your doctor or pharmacist if you feel 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 established.
If you have used more Livocab direct nasal spray than you should:
If you accidentally swallow the contents of the Livocab direct nasal spray bottle, 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 a double dose to make up for a missed dose. Continue treatment with Livocab Direct Nasal Spray as described in the dosage instructions.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
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 treated):
- Nausea, fatigue, pain
- Sore throat – larynx area, nosebleeds, cough
- Dizziness, drowsiness
- sinusitis
Occasionally (may affect up to 1 in 100 people treated):
- Swelling of the eyelids
- Discomfort, irritation, pain and dryness at the application site
- Hypersensitivity
- Shortness of breath, nasal congestion, blocked nose, spasm of the bronchial muscles (bronchospasm)
- heart palpitations
Rare (may affect up to 1 in 1,000 people treated):
- Heart palpitations
- Burning sensation, discomfort at the injection site
- Swelling of the nose
Not known (frequency cannot be estimated based on the available data):
- Allergic reaction leading to circulatory failure (anaphylaxis)
Symptoms such as fatigue, dizziness, drowsiness, or malaise may also be caused by the underlying illness.
Reporting of side effects:
If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. Pharmacovigilance, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, Germany, website: www.bfarm.de. By reporting side effects, you can help provide more information on the safety of this medicine.
5. HOW TO STORE LIVOCAB DIRECT NASAL SPRAY?
Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the bottle and carton after "EXP". The expiry date refers to the last day of that month. Do not store above 30°C. Once opened, Livocab direct nasal spray can be used for three months, but no later than the expiry date shown. Medicines should be disposed of according to local regulations. Ask your pharmacist how to dispose of medicines you no longer need. This will help 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 levocabastine equivalent to 0.54 mg levocabastine hydrochloride. One spray (approx. 0.1 ml of suspension) contains approximately 0.05 mg levocabastine. The other ingredients are: Purified water, propylene glycol, disodium hydrogen phosphate, sodium dihydrogen phosphate monohydrate, 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-dose spray in 5 ml and 10 ml plastic bottles of white suspension. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer:
Johnson & Johnson GmbH,
Johnson & Johnson Platz 2,
41470 Neuss, Germany.