Label: information for the patient

Rinoduo 137 micrograms/50 micrograms /pulsation suspension for nasal spray

azelastine hydrochloride/ fluticasone propionate

Read this label carefully before starting to use this medication, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only to you, and you should not give it to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

1. What is Rinoduo and for what it is used

2. What you need to know before starting to use Rinoduo

3. How to use Rinoduo

4. Possible adverse effects

5. Storage of Rinoduo

6. Contents of the package and additional information

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

• Azelastine hydrochloride belongs to a group of medicines called antihistamines. Antihistamines act by preventing the effects of substances such as histamine, produced by the body 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.

This medicine is used to relieve the symptoms of moderate to severe seasonal allergic rhinitis and perennial allergic rhinitis, if treatment with an antihistamine or intranasal corticosteroid alone is considered insufficient.

Seasonal or perennial allergic rhinitis are allergic reactions to substances such as pollen (hay fever), house dust mites, moulds, dust or domestic animals.

This medicine relieves allergy symptoms, for example: runny nose, postnasal drip, sneezing, itching or nasal congestion.

Do not use Rinoduo

• If you are allergic to hydrochloride of azelastine or propionate of fluticasona or to any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to use this medication if:

• You have had a recent nasal operation.
• You have a nasal infection. Nasal infections should be treated with antibiotics or antifungals. If you have been given medication for a nasal infection, you may continue to use this medication to treat your allergy.
• You have tuberculosis or an untreated infection.
• You have vision changes or a history of high intraocular pressure, glaucoma, and/or cataracts. If you have any of these conditions, you will be closely monitored during the use of this medication.
• You have adrenal function impairment. Caution should be exercised when switching from systemic steroid treatment to this medication.
• You have severe liver disease. The risk of systemic adverse effects will be increased.

Your doctor will decide if you can use this medication in these cases.

It is essential to take the indicated dose in section 3 or the dose indicated by your doctor. Treatment with doses higher than the recommended corticosteroid nasal doses may lead to adrenal suppression, which can cause weight loss, fatigue, muscle weakness, low blood glucose levels, salt craving, joint pain, depression, and skin darkening. If you experience any of these adverse effects, your doctor may recommend another medication during periods of stress or selective surgery.

To avoid adrenal suppression, your doctor will advise you to take the lowest dose that maintains effective control of your allergic rhinitis symptoms.

The use of nasal corticosteroids (such as this medication) may cause slower growth in children and adolescents when used for a long period. Your doctor will regularly monitor the growth of children and ensure they take the minimum effective dose.

Contact your doctor if you experience blurry vision or other visual disturbances.

If you are unsure if you are in any of the above situations, consult your doctor or pharmacist before using this medication.

Children

This medication is not recommended for use in children under 12 years old.

Use of Rinoduo with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including those purchased without a prescription.

Some medications may increase the effects of this medication, so your doctor will perform thorough checks if you are taking these medications (including some for HIV: ritonavir, cobicistat, and medications for fungal infections: ketoconazol).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machinery

This medication has a minimal influence on the ability to drive and operate machinery.

Very rarely, you may experience fatigue or drowsiness due to the disease itself or during the use of this medication. In these cases, do not drive or operate machinery. Note that alcohol consumption may exacerbate these effects.

Rinoduo contains benzalkonium chloride

This medication may cause nasal mucosa inflammation, especially with long-term treatments, because it contains benzalkonium chloride.

If such a reaction is suspected (persistent nasal congestion), a nasal medication that does not contain this excipient should be used whenever possible.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

It is essential that the use of this medication be regular for the therapeutic benefit to be complete.

Avoid contact with the eyes.

Adults and adolescents (over 12 years)

• The recommended dose is one puff in each nasal fossa, in the morning and at night.

Use in children under 12 years

• No use of this medication is recommended in children under 12 years.

Use in case of renal and hepatic insufficiency

No data is available in patients with renal and hepatic insufficiency.

Administration form

Nasal route.

Read the following instructions carefully and use the product only as indicated.

USAGE INSTRUCTIONS

Preparation of the spray

1. Shake the bottle gently for 5 seconds, tilting it from top to bottom, and then remove the protective cap (see Figure 1).

Figure 1

2. The first time the nasal spray is used, the pump must be activated by spraying into the air.

3. Activate the pump by placing two fingers on either side of the spray pump and placing the thumb on the base of the bottle.

4. Press and release the pump 6 times until a fine spray appears (see Figure 2).

Figure 2

5. Now, the pump is activated and ready to use. 6. If the nasal spray has not been used for more than 7 days, the pump will need to be reactivated by pressing and releasing it.

Method of spraying

1. Shake the bottle gently for 5 seconds, tilting it from top to bottom, and then remove the protective cap (see Figure 1).

2. Clear the nasal fossae by blowing your nose.

3. Keep your head tilted forward. Do not tilt your head back.

4. Hold the bottle upright and carefully insert the spray tip into one nasal fossa.

5. Close the other nasal fossa with your finger, press the pump once quickly, and at the same time, take a gentle breath (see Figure 3).

6. Breathe through your mouth.

Figure 3

7. Repeat the procedure in the other nasal fossa.

8. Breathe gently and do not tilt your head back after the puff, as this may cause the medication to reach your throat, resulting in an unpleasant taste (see Figure 4).

Figure 4

9. After each use, clean the spray tip with a clean tissue or cloth and replace the protective cap.

10. Do not pierce the nozzle if the spray does not come out. Clean the valve with water.

It is essential to use the prescribed dose. Use only the amount recommended by your doctor.

Treatment duration

This medication is suitable for long-term use. The treatment duration corresponds to the period during which you experience allergic symptoms.

If you use more Rinoduo than you should

If you apply more of this medication to your nose, it is unlikely that you will experience any problems. In case of doubt, or if you have used a higher dose than recommended for a long period, consult your doctor. If someone, especially a child, accidentally ingests this medication, consult your doctor immediately or go to the nearest medical center, or call the Toxicological Information Service. Telephone (91) 562 04 20, indicating the medication and the amount ingested.

If you forget to use Rinoduo

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

If you interrupt treatment with Rinoduo

Do not stop treatment without consulting your doctor, as this may put your treatment at risk.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

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

• Nasal bleeding.

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 use of the nasal spray. This taste should disappear if you drink a soft drink a few minutes after using this medicine.
• Unpleasant odor.

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

• Mild irritation of the inside of the nose, which may cause mild itching, tickling, or sneezing.
• Nasal dryness, cough, dry throat, or throat irritation.

Rare side effects (may affect up to 1 in 1,000 people):

• Dry mouth.

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

• Drowsiness or drowsiness.
• Cataracts, glaucoma, or increased eye pressure, with possible vision loss and/or eye redness and pain. These side effects have been observed with prolonged treatment with nasal sprays of fluticasone propionate.
• Skin and mucous membrane lesions in the nose.
• Sensation of discomfort, fatigue, exhaustion, or weakness.
• Rash, redness, or itching of the skin, urticaria.
• Bronchospasm (constriction of the airways of the lungs).

Seek immediate medical attention if you develop any of the following symptoms:

• Swelling of the face, lips, tongue, or throat, which may make swallowing/respiration difficult and sudden appearance of rash on the skin. These may be signs of a severe allergic reaction.Be aware that this is very rare.

Side effects of unknown frequency (frequency cannot be estimated from available data)

• Blurred vision
• Nose ulcers

When this medicine is administered at high doses for a prolonged period of time, systemic side effects (side effects affecting the entire body) may occur. The likelihood of these side effects occurring is much lower if a nasal corticosteroid spray is used instead of oral corticosteroids. These side effects may vary between individual patients and between different corticosteroid preparations (see section 2).

Nasal corticosteroids may affect normal hormone production in your body, especially if high doses are used for a long time. In children and adolescents, this side effect may cause them to grow more slowly.

In rare cases, a reduction in bone density (osteoporosis) occurs when corticosteroids are administered nasally for a long period of time.

Reporting of side effects

Ifyou experience any type of side effect, consult your doctororpharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through theSpanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of thismedicine.

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

Do not use this medication after the expiration date that appears on the bottle and packaging after “CAD”. The expiration date is the last day of the month indicated.

This product does not require special storage conditions.Do not refrigerate orfreeze.

Expiration date after opening: Discard any unused portion of the medication 6 months after first opening the nasal spray pump.

Medications should not be disposed of through drains or in the trash. Deposit empty containers and unused medications at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of empty containers and unused medications. By doing so, you will help protect the environment.

Composition of Rinoduo

• The active principles are hydrochloride of azelastine and propionate of fluticasone.Each pulse (0.137 g) releases 137 micrograms of hydrochloride of azelastine (= 125 micrograms of azelastine) and 50 micrograms of propionate of fluticasone.

• The other components are benzalkonium chloride, phenylethyl alcohol, glycerol, disodium edetate, polisorbate 80, microcrystalline cellulose, and sodium carmellose and purified water.

Appearance of the product and contents of the packaging

Rinoduo is a homogeneous white suspension.

Rinoduo is presented in an amber glass bottle, equipped with a spray pump, an applicator, and a protective cap.

The 25 ml bottle contains 23 g of the nasal spray suspension (at least 120 pulses).

Holder of the marketing authorization and responsible for manufacturing

Laboratorio Aldo-Unión, S.L.

Baronesa de Maldá, 73

08950 Esplugues de Llobregat

Barcelona – Spain

Last review date of this leaflet: March 2022

The detailed information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).