Tibumoca

Patient Information Leaflet

Tibumoca, (137 micrograms + 50 micrograms)/dose nasal aerosol, suspension
Azelastine hydrochloride + Fluticasone propionate
Please read this leaflet carefully before using the medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, 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.

Leaflet Contents

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

1. What Tibumoca is and what it is used for

Tibumoca 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 during an allergic reaction, thereby reducing symptoms of allergic rhinitis.
• Fluticasone propionate belongs to a group of medicines called corticosteroids, which reduce inflammation.

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

2. Important information before using Tibumoca

When not to use Tibumoca

• 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 Tibumoca, discuss with your doctor or pharmacist:

• If the patient has recently undergone nasal or oral surgery or has experienced nasal trauma.
• If the patient has an infection in the nose. Nasal infections should be treated with antibacterial or antifungal medications. Patients who have received treatment for nasal infection may continue to treat their allergies using Tibumoca.
• If the patient has tuberculosis or an 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 Tibumoca.
• If the patient has adrenal gland function disorders. Caution should be exercised when switching from systemic steroid therapy to treatment with Tibumoca.
• If the patient has severe liver disease. In such cases, the risk of systemic adverse effects increases.

In these situations, the decision on whether Tibumoca can be used will be made by the treating physician.
It is important that the patient uses the medicine at the dose specified below in section 3 or as directed by the treating physician. Using intranasal corticosteroids at doses higher than recommended may suppress adrenal function, a condition in which symptoms such as weight loss, fatigue, muscle weakness, low blood sugar, increased salt craving, joint pain, depression, and darkening of the skin may occur. In such cases, the doctor may recommend taking an alternative medicine during periods of stress or before a scheduled surgical procedure.
To avoid adrenal suppression, the doctor may recommend using the lowest effective dose of Tibumoca that still controls nasal mucosal inflammation symptoms adequately.
In children and adolescents, long-term use of intranasal corticosteroids (such as Tibumoca) may result in slowed growth rate. The doctor will regularly monitor the child's growth and ensure that the child is receiving the lowest effective dose.
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 Tibumoca.

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

Tibumoca and 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 effects of Tibumoca nasal aerosol, and the doctor may recommend careful monitoring if the patient is taking such medicines (including certain HIV medications: ritonavir, cobicistat, and antifungal agents: ketoconazole). Do not use Tibumoca if the patient is taking sedatives or medicines affecting 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 child, she should consult her doctor or pharmacist before using this medicine.

Driving and operating machinery
Tibumoca has a minor influence on the ability to drive and operate machinery. Very rarely, fatigue, weakness, and dizziness may occur, which could be caused by the disease itself or by using Tibumoca. In such cases, patients should not drive or operate machinery. Be aware that alcohol consumption may worsen these effects.

Tibumoca contains benzalkonium chloride
This medicine contains 14 micrograms of benzalkonium chloride per spray. Benzalkonium chloride may cause nasal irritation or swelling, especially with prolonged use.
If the patient experiences discomfort while using the aerosol, inform the doctor or pharmacist.

3. How to use Tibumoca

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

Adults and adolescents (aged 12 years and older)

• The recommended dose is one spray into each nostril in the morning and evening.

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
Preparing the aerosol

1. Gently shake the bottle up and down for 5 seconds, then remove the protective cap (see Figure 1).

Figure 1

2. If the nasal aerosol is being used for the first time, prime the pump by releasing a dose into the air.
3. Prime the pump by placing two fingers on either side of the pump and the thumb on the bottom of the bottle.
4. Press and release the pump 6 times until a fine mist is produced (see Figure 2).
5. The pump is now primed and ready for use.

Figure 2

6. If the nasal aerosol has not been used for more than 7 days, re-prime the pump. Gently shake the bottle up and down for 5 seconds, remove the protective cap (see Figure 1), press the pump once, then release.

Using the aerosol

1. Gently shake the bottle up and down for 5 seconds, then remove the protective cap (see Figure 1).
2. Blow your nose to clear the nasal passages.
3. Keep your head tilted forward, 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 (see Figure 3).
6. Breathe out through your mouth. Figure 3

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 will prevent the medicine from running into the throat and causing an unpleasant taste (see Figure 4).

Figure 4

9. After each use, wipe the spray nozzle with a clean tissue or cloth and replace the protective cap.
10. If the aerosol does not spray, do not pierce the spray nozzle. Clean the nozzle with water.

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

Duration of treatment
Tibumoca 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 Tibumoca
If too much nasal spray is used, the risk of complications is low. However, consult a doctor if you have any concerns or if a higher than recommended dose has been used for a prolonged period. If anyone, especially a child, accidentally swallows Tibumoca, contact a doctor or the nearest hospital emergency department immediately.

Missed dose of Tibumoca
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 Tibumoca treatment
Do not stop using Tibumoca without consulting your doctor, due to the risk of reduced treatment effectiveness.

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

4. Possible adverse effects

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

Very common adverse effects (may occur in more than 1 in 10 people):

• Nosebleeds

Common adverse effects (may occur in 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 odour

Uncommon adverse effects (may occur in less than 1 in 100 people):

• Mild irritation inside the nose. This may cause mild stinging, itching or sneezing
• Dryness in the nose, cough, dry throat or throat irritation

Rare adverse effects (may occur in less than 1 in 1,000 people):

• Dryness in the mouth

Very rare adverse effects (may occur in 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 effects have been reported after long-term use of nasal aerosol containing fluticasone propionate
• Damage to the skin and nasal mucosa
• 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 onset of skin rash. These may be symptoms of a severe allergic reaction. Note: these symptoms are very rare.

Frequency not known (frequency cannot be estimated from available data):

• Blurred vision
• Ulceration of the nasal mucosa

When the medicine is used in high doses for a prolonged period, systemic adverse effects (affecting the whole body) may occur. The likelihood of such effects is considerably lower when corticosteroids are administered as a nasal aerosol than when administered orally. These effects may vary between individual patients and with different corticosteroid medicines (see section 2). Nasally administered corticosteroids may affect normal hormone production processes in the body, especially when used long-term at high doses. In children and adolescents, these adverse effects may cause a reduction in growth rate.

Rare cases of decreased bone density (osteoporosis) have been observed with long-term nasal administration of corticosteroids.

Reporting of adverse effects

If any adverse effects occur, including any not listed in this leaflet, tell your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring 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 effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Tibumoca

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

6. Contents of the pack and other information

What Tibumoca contains
The active substances in this medicine are: azelastine hydrochloride and fluticasone propionate.
Each mL of 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 (equivalent to 125 micrograms of azelastine) and 50 micrograms of fluticasone propionate.

The other ingredients are: disodium edetate, glycerol (E 422), microcrystalline cellulose, sodium carboxymethylcellulose, polysorbate 80, benzalkonium chloride, phenylethyl alcohol, and water for injections.

What Tibumoca looks like and contents of the pack
Tibumoca is a white nasal aerosol suspension in a 25 mL amber glass bottle with a spray pump, a nasal applicator, and a protective cap.
Each 25 mL bottle contains 23 g of nasal aerosol suspension (providing at least 120 doses).

Each pack contains 1 bottle with 23 g of nasal aerosol suspension. Multipacks contain 3 bottles, each with 23 g of nasal aerosol suspension.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Day Zero ehf.
Reykjavikurvegi 62
220 Hafnarfjoerdur
Iceland
Tel: +354 6950467

Manufacturer
Teva Czech Industries s.r.o.
Ostravská 305/29
747 70 Opava - Komárov
Czech Republic

This medicinal product is authorised in the European Economic Area (EEA) Member States under the following names:
Germany: Tibumoca, 137 Mikrogramm/50 Mikrogramm pro Sprühstoß Nasenspray, Suspension
Poland: Tibumoca