Tibumoca

Leaflet accompanying the packaging: patient information

Tibumoca, (137 micrograms + 50 micrograms)/dose nasal spray, suspension

Azelastine hydrochloride + Fluticasone propionate

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Tibumoca and what is it 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 as part of an allergic reaction, and thereby reduce the symptoms of allergic rhinitis.
• Fluticasone propionate belongs to a group of medicines called corticosteroids, which reduce inflammation.

Tibumoca is used to relieve the symptoms of moderate to severe seasonal and perennial allergic rhinitis, if the use of other nasal products containing only an antihistamine or corticosteroid is considered insufficient.

Seasonal and perennial allergic rhinitis is a type of allergic reaction to substances such as plant pollen (hay fever), house dust mites, mold spores, dust, or pet dander.

Tibumoca relieves allergy symptoms, such as nasal discharge, posterior nasal drip, sneezing, and itching or a feeling of nasal congestion.

2. Important information before using Tibumoca

When not to use Tibumoca

• If the patient is allergic to azelastine hydrochloride or fluticasone propionate, or 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 had nose or mouth surgery or injury.
• If the patient has a nasal infection. Nasal infections should be treated with antibacterial or antifungal medicines. Patients who have been treated with medicines for a nasal infection may continue to treat their allergy with Tibumoca.
• If the patient has tuberculosis or an untreated infection.
• If the patient notices a change in vision or has been diagnosed with increased intraocular pressure, glaucoma, and/or cataract. Patients with these conditions will be closely monitored during treatment with Tibumoca.
• If the patient has adrenal gland disorders. Caution is advised when switching from systemic steroid therapy to Tibumoca treatment.
• If the patient has severe liver disease. This increases the risk of systemic side effects.

In these cases, the doctor will decide whether Tibumoca can be used.

It is essential to take the dose prescribed by the doctor. Only the dosage recommended by the doctor should be used.

Children

Tibumoca is not recommended for children under 12 years of age.

Tibumoca and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take, including those available without a prescription.

Some medicines may enhance the effect of Tibumoca nasal spray, and your doctor may recommend close monitoring if you are taking such medicines (including certain HIV medicines: ritonavir, cobicistat, and antifungal medicines: ketoconazole). Do not use Tibumoca if you are taking sedatives or medicines that act on the central nervous system.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this medicine.

Driving and using machines

Tibumoca has a minor effect on the ability to drive and use machines.

Rarely, fatigue, weakness, and dizziness may occur, which may be caused by the disease itself or the use of Tibumoca. In such cases, do not drive or operate machines. Be aware that drinking alcohol may enhance such effects.

Tibumoca contains benzalkonium chloride

This medicine contains 14 micrograms of benzalkonium chloride per spray.

Benzalkonium chloride may cause irritation or swelling inside the nose, especially if used for a long time.

If you experience discomfort while using the spray, tell your doctor or pharmacist.

3. How to use Tibumoca

Always use this medicine exactly as your doctor or pharmacist has told you.

To get the most benefit from the treatment, Tibumoca must be used regularly.

Avoid contact with the eyes.

Adults and adolescents (12 years and older)

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

Use in children under 12 years

• Tibumoca is not recommended for children under 12 years of age.

Use in patients with renal and hepatic impairment

• There are no data on the use of Tibumoca in patients with renal and hepatic impairment.

Method of administration

Nasal spray.

Read the instructions carefully and use the medicine only as directed.

INSTRUCTIONS FOR USE

Preparing the spray

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

Figure 1

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

Using the spray

• 1. Gently shake the bottle for 5 seconds, moving it up and down, then remove the protective cap (see Figure 1).
• 2. Blow your nose to clear your nostrils.
• 3. Tilt your head forward towards your toes. Do not tilt your head back.
• 4. Hold the bottle upright and gently place the tip of the spray into one nostril.
• 5. Close the other nostril with your finger, press the pump quickly once, and breathe in gently at the same time (see Figure 3).
• 6. Breathe out through your mouth. Figure 3

• 7. Repeat the same steps for the other nostril.
• 8. After using the spray, breathe in gently and do not tilt your head back. This will prevent the medicine from going down your throat and tasting unpleasant (see Figure 4).

Figure 4

• 9. After each use, wipe the spray tip with a clean tissue or cloth and replace the protective cap.
• 10. If the spray does not spray, do not poke the spray tip. Wash the spray tip with water.

It is essential to use the prescribed dose. Only the dosage recommended by the doctor should be used.

Duration of treatment

Tibumoca can be used for a long time. The duration of treatment should correspond to the period during which allergy symptoms occur.

Using a higher dose of Tibumoca than recommended

If too much nasal spray is used, there is a small chance of complications. Consult your doctor if you are concerned or if you have been using a higher dose than recommended for a long time. If someone, especially a child, accidentally swallows Tibumoca, seek medical attention immediately or go to the nearest hospital emergency department.

Missing a dose of Tibumoca

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

Stopping treatment with Tibumoca

Do not stop using Tibumoca without consulting your doctor, as this may lead to a lack of treatment effectiveness.

If you have any further doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

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

• Nosebleeds

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

• Headache
• Bitter taste in the mouth, especially if you tilt your head back during nasal spray use. This taste should disappear if you drink a non-alcoholic beverage a few minutes after using the spray
• Unpleasant odor

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

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

Rare side effects (may affect up to 1 in 1000 people):

• Dry mouth

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

• Dizziness or drowsiness
• Cataract, glaucoma, or increased eye pressure, which may cause vision loss and/or eye redness and pain. These side effects have been reported after long-term use of nasal sprays containing fluticasone propionate
• Skin and nasal mucosa damage
• General feeling of being unwell, tiredness, exhaustion, or weakness
• Rash, itching, or redness of the skin, itchy blisters on the skin
• Bronchospasm (narrowing of the airways)

Seek medical attention immediately if you experience any of the following symptoms:

• Swelling of the face, lips, tongue, or throat, which may cause difficulty swallowing or breathing, and sudden appearance of skin rash. These may be symptoms of a severe allergic reaction.This occurs very rarely.

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

• Blurred vision
• Ulceration of the nasal mucosa

When used in high doses for a long time, systemic side effects (affecting the whole body) may occur. The likelihood of this is much lower when using nasal corticosteroids than when taking oral corticosteroids. These effects may vary between patients and after using different corticosteroid medicines (see section 2).

Corticosteroids used nasally may affect the normal production of hormones in the body, especially when used for a long time in high doses. In children and adolescents, these side effects may cause growth retardation.

Rare cases of decreased bone density (osteoporosis) have been observed when corticosteroids were used nasally for a long time.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor or pharmacist.

Side effects can be reported directly to the Department of Drug Safety Monitoring, 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

Side effects can also be reported to the marketing authorization holder.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Tibumoca

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the label and carton after "EXP" or "EXP". The expiry date refers to the last day of the month.

Do not store in the refrigerator or freeze.

Shelf life after first opening the bottle: Do not use Tibumoca after 6 months from the first opening of the nasal spray bottle.

Medicines should 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 packaging and other information

What Tibumoca contains

The active substances are azelastine hydrochloride and fluticasone propionate.

Each mL of suspension contains 1000 micrograms of azelastine hydrochloride and 365 micrograms of fluticasone propionate.

After each spray (0.14 g), 137 micrograms of azelastine hydrochloride (equivalent to 125 micrograms of azelastine) and 50 micrograms of fluticasone propionate are released.

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

What Tibumoca looks like and contents of the pack

Tibumoca is a white nasal spray suspension in a brown glass bottle with a pump spray, nasal applicator, and cap.

Each bottle with a capacity of 25 mL contains 23 g of nasal spray suspension (at least 120 doses).

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

Marketing authorization 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 medicine is authorized in the Member States of the European Economic Area under the following names:

Germany: Tibumoca, 137 micrograms/50 micrograms per spray nasal spray, suspension

Poland: Tibumoca

Date of last revision of the leaflet: