Libara

Package leaflet: Information for the user

Libara
(137 micrograms + 50 micrograms)/dose nasal
nasal aerosol, suspension
Azelastini hydrochloridum + Fluticasoni propionas
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm others, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

1. What Libara is and what it is used for
2. Important information before using Libara
3. How to use Libara
4. Possible side effects
5. How to store Libara
6. Contents of the pack and other information

1. What Libara is and what it is used for

Libara contains two active substances: azelastine hydrochloride and fluticasone propionate.

• Azelastine hydrochloride belongs to a group of medicines called antihistamines. Antihistamines work by preventing the action of substances such as histamine, which the body produces as part of an allergic reaction, thereby reducing the symptoms of allergic rhinitis.
• Fluticasone propionate belongs to a group of medicines called corticosteroids, which reduce inflammation.

Libara is used to relieve symptoms of moderate to severe seasonal and perennial allergic rhinitis when treatment with other intranasal medicinal products containing either an antihistamine or a corticosteroid alone is considered insufficient.
Seasonal and perennial allergic rhinitis is a type of allergic reaction to substances such as: plant pollens (hay fever), house dust mites, mould spores, dust, or pet dander.
Libara relieves allergy symptoms such as nasal discharge, postnasal drip, sneezing, nasal itching, and nasal congestion.

2. Important information before using Libara

When not to use Libara

• if the patient is allergic to azelastine hydrochloride or fluticasone propionate or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting treatment with Libara, discuss the following with your doctor or pharmacist:

• If the patient has recently undergone nasal surgery.
• If the patient has an infection in the nose. Nasal passage infections should be treated with antibacterial or antifungal medications. Patients who have been treated with medications for nasal infection may still treat allergies using Libara.
• If the patient has tuberculosis or untreated infection.
• If the patient experiences changes in vision or has previously been diagnosed with increased intraocular pressure, glaucoma and/or cataracts. Such patients will be closely monitored during treatment with Libara.
• If the patient has adrenal gland function disorders. Caution should be exercised when switching from systemic steroid therapy to treatment with Libara.
• If the patient has severe liver disease. In this case, the risk of systemic adverse reactions increases.

In these cases, the decision on whether Libara can be used will be made by the treating physician.
It is important that the patient uses the medicine at the dose indicated below in section 3 or as directed by the treating physician. Intranasal use of corticosteroids in doses higher than recommended may lead to adrenal suppression, a condition in which weight loss, fatigue, muscle weakness, low blood sugar, increased salt craving, joint pain, depression, and darker skin pigmentation may occur. In such cases, the doctor may recommend taking another medicine during periods of stress or before planned surgical procedures.
To avoid adrenal suppression, the doctor may recommend using the medicine at the lowest dose that still effectively controls symptoms of nasal mucosal inflammation.
If the patient experiences blurred vision or other visual disturbances, they should contact their doctor.
If in doubt whether any of the above conditions apply, consult a doctor or pharmacist before starting treatment with Libara.

Children and adolescents
Use of this medicine is not recommended in children under 12 years of age.
Long-term intranasal use of corticosteroids (such as Libara) in children and adolescents may suppress growth rate. The doctor will regularly monitor the child's growth and ensure that the lowest effective dose is being used.

Libara with other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take, including over-the-counter medicines.
Some medicines may increase the effect of Libara, and the doctor may recommend careful monitoring if the patient is taking such medicines (including certain HIV medicines: ritonavir, cobicistat, and antifungal medicines: ketoconazole). Do not use Libara if the patient is taking sedatives or medicines acting on the central nervous system.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.

Driving and operating machinery
Libara has a minor influence on the ability to drive and operate machinery.
Very rarely, fatigue and dizziness may occur, which may be caused by the illness itself or by using Libara. In such cases, driving and operating machinery should be avoided. Be aware that alcohol consumption may worsen these effects.

Libara contains benzalkonium chloride
This medicine contains 14 micrograms of benzalkonium chloride per spray. Benzalkonium chloride may cause nasal irritation or swelling, especially if used for a prolonged period.

3. How to use Libara

This medicine should always be used as directed by the physician. If in doubt, consult
your doctor or pharmacist.
For optimal therapeutic benefit, Libara must be used regularly.
Avoid contact with the eyes.

Use in adults and adolescents (aged 12 years and older)
One dose in each nostril, morning and evening, is recommended.

Use in children under 12 years of age
This medicine is not recommended for use in children under 12 years of age.

Use in patients with renal or hepatic impairment
There is no data available on the use of this medicine in patients with renal or hepatic impairment.

Method of administration
Nasal administration.
Please read the following instructions carefully and use the medicine exactly as directed.

INSTRUCTIONS FOR USE
Priming the spray

1. Gently shake the bottle for 5 seconds, moving it up and down, then remove the protective cap.
2. If the nasal spray is being used for the first time, prime the pump by releasing a dose into the air.
3. To prime the pump, hold the bottle with two fingers on either side of the pump and your thumb at the bottom.
4. Press and release the pump 6 times until a fine mist is produced (see figure a).

5. The pump is now primed and ready for use.
6. If the nasal spray has not been used for more than 7 days, re-prime the pump by pressing and releasing it once.

Using the spray

1. Gently shake the bottle for 5 seconds, moving it up and down, then remove the protective cap.
2. Blow your nose to clear the nasal passages.
3. Keep your head tilted forward slightly, towards your toes. Do not tilt your head backward.
4. Hold the bottle upright and gently insert the spray nozzle into one nostril.
5. Block the other nostril with a finger, press the pump quickly once, and at the same time inhale gently through the nose (see figure b).

6. Breathe out through the mouth.
7. Repeat the same procedure for the other nostril.
8. After administering the medicine, take gentle breaths and do not tilt your head backward. This helps prevent the medicine from draining into the throat and causing an unpleasant taste.
9. After each use, wipe the spray nozzle with a clean tissue or cloth and replace the protective cap.
10. If the spray nozzle becomes blocked, do not pierce it or use a sharp object to unblock it. Clean the nozzle with water.

It is important to use the dose prescribed by your doctor. Always follow the dosage instructions given by your physician.

Duration of treatment
Libara may be used long-term. The duration of treatment should correspond to the period during which allergy symptoms occur.

Use of more than the recommended dose of Libara
If too much nasal medicine is used, the risk of complications is low. However, consult your doctor if you experience any concerns or if a higher-than-recommended dose has been used for a prolonged period. If anyone, especially a child, accidentally swallows Libara, contact a doctor or the nearest hospital emergency department immediately.

Missed dose of Libara
Use the nasal spray as soon as you remember, then continue with the next dose at the usual time. Do not use a double dose to make up for a missed dose.

Stopping Libara
Do not stop using Libara without consulting your doctor, due to the risk of ineffective treatment.

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

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.

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

• Nosebleeds

Common adverse reactions (may affect less than 1 in 10 people):

• Headache
• Bitter taste in the mouth, especially if the patient tilts the head backwards during nasal aerosol administration. This taste should disappear if the patient drinks a non-alcoholic beverage several minutes after using the medicine
• Unpleasant smell

Uncommon adverse reactions (may affect less than 1 in 100 people):

• Slight irritation inside the nose. This may cause mild prickling, itching, or sneezing
• Dryness in the nose, cough, dry throat, or sore throat

Rare adverse reactions (may affect less than 1 in 1,000 people):

• Dry mouth

Very rare adverse reactions (may affect less than 1 in 10,000 people):

• Dizziness or drowsiness
• Cataract, glaucoma, or increased intraocular pressure, which may lead to loss of vision and (or) redness and eye pain. These adverse reactions have been reported after long-term use of nasal aerosol containing fluticasone propionate.
• Skin and nasal mucosa damage
• Malaise, feeling of fatigue, exhaustion, or weakness
• Rash, itching, or redness of the skin, itchy blisters on the skin
• Bronchospasm (narrowing of the lower airways)

Seek immediate medical help if any of the following symptoms occur:

• Swelling of the face, lips, tongue, or throat, which may cause difficulty in swallowing and (or) breathing, and sudden appearance of a skin rash. These may be symptoms of a severe allergic reaction. Note: these symptoms are very rare.

Adverse reactions with unknown frequency (frequency cannot be estimated from available data):

• Blurred vision
• Nasal mucosa ulceration

When the medicine is used in high doses for a prolonged period, systemic adverse reactions (affecting the whole body) may occur. The likelihood of such reactions is significantly lower with corticosteroids administered as a nasal aerosol than with oral corticosteroid therapy. These effects may vary among individual patients and with different corticosteroid medicines (see section 2). Nasal corticosteroids may affect normal hormone production processes in the body, especially when used long-term at high doses. In children and adolescents, these adverse reactions may lead to growth suppression. In rare cases, decreased bone density (osteoporosis) has been observed with long-term intranasal administration of corticosteroids.

Reporting of adverse reactions

If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Libara

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the label of the bottle and outer carton
following: Expiry (EXP). The expiry date refers to the last day of the stated month.
Do not store in the refrigerator or freeze.
Period of use after first opening: Any unused medicine should be discarded 6 months after
first opening of the nasal aerosol.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the
environment.

6. Contents of the pack and other information

What Libara contains

• The active substances in this medicine are: azelastine hydrochloride and fluticasone propionate. Each gram of the suspension contains 1000 micrograms of azelastine hydrochloride and 365 micrograms of fluticasone propionate.

Each spray actuation (0.14 g) delivers 137 micrograms of azelastine hydrochloride (= 125 micrograms of azelastine) and 50 micrograms of fluticasone propionate.

• Other ingredients are: disodium edetate, glycerol, microcrystalline cellulose, sodium croscarmellose, polysorbate 80, benzalkonium chloride, phenylethyl alcohol, and purified water.

What Libara looks like and contents of the pack
Libara is a white or almost white, homogeneous suspension.
Libara is available in a 25 mL amber glass bottle with a spray pump, applicator, and protective cap, packed in a cardboard carton.
The 25 mL bottle contains 23 g of nasal suspension aerosol (providing at least 120 doses).
Libara is available as:
Pack containing 1 bottle with 23 g of nasal suspension aerosol.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Berlin-Chemie AG
Glienicker Weg 125
12489 Berlin, Germany

Manufacturers
FARMEA
10, rue Bouché Thomas
ZAC d’Orgemont
49007 Angers
France
FARMACLAIR
440 Avenue Du Général De Gaulle
14200 Hérouville-Saint-Clair
France

For further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Berlin-Chemie/Menarini Polska Sp. z o.o.
Tel.: + 48 22 566 21 00
Fax: + 48 22 566 21 01

This medicine is authorised in the European Economic Area countries under the following names:
Poland: Libara
Sweden: Libara
Czech Republic: Libara