LIVOCAB

LIVOCAB direct eye drops

Important notes (mandatory information)

Livocab direkt eye drops. Active ingredient: Levocabastine (present as levocabastine hydrochloride). Areas of application: for the treatment of symptoms of an allergic conjunctivitis, e.g. hay fever or so-called spring catarrh.

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Livocab direkt eye drops, 0.05% eye drops, suspension for use in children from 1 year, 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 2 days, consult your doctor.

What this package leaflet contains

1. WHAT ARE LIVOCAB DIREKT EYE DROPS AND WHAT ARE THEY USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE USING LIVOCAB DIREKT EYE DROPS?
3. HOW TO USE LIVOCAB DIREKT EYE DROPS?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE LIVOCAB DIREKT EYE DROPS?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT ARE LIVOCAB DIREKT EYE DROPS AND WHAT ARE THEY USED FOR?

Pharmacotherapeutic group: Antiallergic/antihistamine. Livocab direkt eye drops are a medicine for the treatment of allergic conjunctivitis. Livocab direkt eye drops are used for the treatment of symptoms of an allergic conjunctivitis, e.g. hay fever or so-called spring catarrh. Livocab direkt eye drops are intended for use in children from 1 year, adolescents and adults.

2. WHAT SHOULD YOU CONSIDER BEFORE USING LIVOCAB DIREKT EYE DROPS?

Livocab direkt eye drops 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 direkt eye drops. Avoid contact with soft contact lenses. Benzalkonium chloride (an other ingredient of Livocab direkt eye drops) can cause soft contact lenses to discolour. You must remove contact lenses before using Livocab direkt eye drops and may not reinsert them until 15 minutes after using Livocab direkt eye drops.

Children

The safety and efficacy of Livocab direkt eye drops in children under 1 year have not been established.

Use of Livocab direkt eye drops together with other medicines

Tell your doctor or pharmacist if you are taking/using, have recently taken/used or intend to take/use any other medicines. No interactions with other medicines are known to date.

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

Breastfeeding

If you are breastfeeding, you should only use Livocab direkt eye drops after consulting your doctor.

Driving and using machines

When using Livocab direkt eye drops, vision may be impaired for a few minutes immediately after use. Before participating in road traffic, working without a secure hold or operating machinery, wait until the visual impairment caused by blurred vision has passed.

Livocab direkt eye drops contain propylene glycol and benzalkonium chloride

Propylene glycol and benzalkonium chloride can cause conjunctival irritation.

3. HOW TO USE LIVOCAB DIREKT EYE DROPS?

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 sure.

Dosage for children from 1 year, adolescents and adults

The recommended dosage is 1 drop of Livocab direkt eye drops per eye 2 times a day. The dosage can be increased to 1 drop per eye up to 4 times a day for more severe symptoms.

Type of use

1. Remove the tamper-evident ring completely from the bottle before using Livocab direkt eye drops for the first time.
2. Livocab direkt eye drops are a suspension. Therefore, shake the bottle well before each use!
3. Tilt your head back.
4. Pull the lower eyelid down and carefully drop one drop into the conjunctival sac by squeezing the bottle (see illustration). Do not bring the bottle into contact with the eye or the area around the eye, so that the remaining contents of the bottle are not contaminated.
5. After instillation, slowly close the eye. The drop is automatically distributed over the entire eye by blinking.

Duration of use

The time between two applications is determined by the effect of Livocab direkt eye drops. Use Livocab direkt eye drops at the first signs of allergic irritation of the conjunctiva. This will give you the best treatment results. The duration of use depends on the type and course of the symptoms. You do not need to consider a 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 direkt eye drops is too strong or too weak.

Use in children

The safety and efficacy of Livocab direkt eye drops in children under 1 year have not been established.

If you have used more Livocab direkt eye drops than you should

If you accidentally swallow the contents of the bottle of Livocab direkt eye drops, you may feel sleepy. In this case, please contact a doctor and drink plenty of water.

If you forget to use Livocab direkt eye drops

Do not use a double dose to make up for a forgotten application. Continue treatment with Livocab direkt eye drops 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

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

• Eye pain and blurred vision.
• Headache.
• Discomfort at the site of administration, which is perceived as a burning/stinging sensation or irritation of the eyes.

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

• Swelling of the eyelids.

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

• Conjunctivitis, swelling of the eyes, eyelid inflammation, swelling of the small blood vessels of the conjunctiva (red eye).
• Discomfort at the site of administration, which is perceived as redness, pain, swelling, itching, watery eyes or blurred vision.
• A specific form of allergic reaction (angioedema) with swelling of the lips, tongue and eyelids, hives and shortness of breath; hypersensitivity.
• Skin inflammation, hives.

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

• Allergic reaction up to circulatory failure (anaphylaxis).
• Palpitations.

Other possible side effects

In very rare cases, patients with severe corneal damage developed corneal opacities due to calcium deposits during treatment with phosphate-containing eye drops.

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 provide more information on the safety of this medicine.

5. HOW TO STORE LIVOCAB DIREKT EYE DROPS?

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 carton after "Use by". The expiry date refers to the last day of the month indicated. Do not store above 25°C. Livocab direkt eye drops can be stored for one month after opening the bottle, but only until 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. This will help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Livocab direkt eye drops contain

The active substance is: Levocabastine (present as levocabastine hydrochloride). 1 ml suspension contains 0.5 mg levocabastine corresponding to 0.54 mg levocabastine hydrochloride. 1 drop contains approximately 0.015 mg levocabastine. The other ingredients are: Water for injections, propylene glycol, disodium hydrogen phosphate, sodium dihydrogen phosphate 1 H2O, hypromellose, polysorbate 80, benzalkonium chloride solution, sodium edetate (Ph. Eur.).

What Livocab direkt eye drops look like and contents of the pack

Livocab direkt eye drops are available in plastic bottles containing 4 ml of white sterile suspension.

Pharmaceutical entrepreneur

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

Manufacturer

Famar S.A.
Agiou Dimitriou 63
Alimos Attiki
17456
Greece

This package leaflet was last revised in October 2015.

Source: Information from the package leaflet
Status: 04/2018
Active ingredient: Levocabastine (present as levocabastine hydrochloride). Areas of application: for the treatment of symptoms of an allergic conjunctivitis, e.g. hay fever or so-called spring catarrh.