Rinoduo 137 micrograms/50 micrograms/puff nasal spray suspension
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Rinoduo 137 micrograms/50 micrograms per spray nasal spray suspension
azelastine hydrochloride / fluticasone propionate
Read this entire leaflet carefully before you start using this medicine, because it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Contents of the leaflet
- What Rinoduo is and what it is used for
- What you need to know before using Rinoduo
- How to use Rinoduo
- Possible side effects
- How to store Rinoduo
- Contents of the pack and other information
1. What Rinoduo is and what it is used for
Rinoduo contains two active substances: azelastine hydrochloride and fluticasone propionate.
- Azelastine hydrochloride belongs to a group of medicines called antihistamines. Antihistamines work by preventing the effects of substances such as histamine, which the body produces as part of an allergic reaction; thus, they reduce the symptoms of allergic rhinitis.
- Fluticasone propionate belongs to a group of medicines called corticosteroids, which reduce inflammation.
This medicine is used to relieve symptoms of moderate to severe seasonal allergic rhinitis and perennial allergic rhinitis, when treatment with either an antihistamine or an 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 such as rhinorrhea, post-nasal drip, sneezing, nasal itching, or nasal congestion.
2. What you need to know before using Rinoduo
Do not use Rinoduo
- if you are allergic to azelastine hydrochloride or fluticasone propionate or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Consult your doctor or pharmacist before starting to use this medicine if:
- You have recently undergone nasal surgery.
- You have a nasal infection. Nasal infections should be treated with antibacterial or antifungal agents. If you have been prescribed medication for a nasal infection, you may continue using this medicine to treat your allergy.
- You have tuberculosis or an untreated infection.
- You have vision changes or a history of elevated intraocular pressure, glaucoma, and/or cataracts. If you have any of these conditions, you will be closely monitored during treatment with this medicine.
- You have impaired adrenal function. Caution is required when switching from systemic steroid therapy to this medicine.
- You have severe liver disease. The risk of experiencing systemic adverse effects may be increased.
In these cases, your doctor will decide whether you can use this medicine.
It is important that you take the dose indicated in section 3 or as prescribed by your doctor. Treatment with doses higher than recommended for nasal corticosteroids may lead to adrenal suppression, which can cause weight loss, fatigue, muscle weakness, low blood sugar levels, salt craving, joint pain, depression, and skin darkening. If you experience any of these adverse effects, your doctor may recommend an alternative treatment during periods of stress or elective surgery.
To avoid adrenal suppression, your doctor will advise you to take the lowest dose that maintains effective control of rhinitis symptoms.
The use of nasal corticosteroids (such as this medicine) may cause slower growth in children and adolescents when used over a long period of time. The doctor will regularly monitor the growth of children and ensure they receive the lowest effective dose possible.
Contact your doctor if you experience blurred vision or other visual disturbances.
If you are unsure whether any of the above situations apply to you, consult your doctor or pharmacist before using this medicine.
Children
The use of this medicine is not recommended in children under 12 years of age.
Using Rinoduo with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.
Some medicines may increase the effects of this medicine, so your doctor will carry out careful monitoring if you are taking these medicines (including certain HIV treatments: ritonavir, cobicistat, and antifungal medications: ketoconazole).
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Driving and using machines
This medicine has minimal influence on the ability to drive and operate machinery.
Very rarely, you may experience fatigue or dizziness due to the underlying disease or during use of this medicine. In such cases, do not drive or operate machinery. Bear in mind that alcohol consumption may worsen these effects.
Rinoduo contains benzalkonium chloride
This medicine may cause inflammation of the nasal mucosa, especially with long-term treatment, because it contains benzalkonium chloride.
If such a reaction is suspected (persistent nasal congestion), a nasal medicine not containing this excipient should be used whenever possible.
3. How to use Rinoduo
Follow exactly the administration instructions for this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.
It is essential that this medicine is used regularly so that the full therapeutic benefit is achieved.
Avoid contact with the eyes.
Adults and adolescents (over 12 years of age)
- The recommended dose is one spray into each nostril, in the morning and at night.
Use in children under 12 years of age
- This medicine is not recommended for use in children under 12 years of age.
Use in cases of renal and hepatic impairment
No data are available in patients with renal or hepatic impairment.
Method of administration
Nasal use.
Read the following instructions carefully and use the product only as directed.
INSTRUCTIONS FOR USE
Priming the spray
- Gently shake the bottle for 5 seconds by tilting it up and down, then remove the protective cap (see Figure 1).
Figure 1
- The first time the nasal spray is used, the pump must be primed by spraying into the air.
- Prime the pump by placing two fingers on either side of the spray pump and placing your thumb at the base of the bottle.
- Press and release the pump 6 times until a fine mist appears (see Figure 2).
Figure 2
- The pump is now primed and ready for use. If the nasal spray has not been used for more than 7 days, the pump must be re-primed by pressing and releasing it several times.
Spraying technique
- Gently shake the bottle for 5 seconds by tilting it up and down, then remove the protective cap (see Figure 1).
- Blow your nose to clear the nasal passages.
- Tilt your head forward slightly. Do not tilt your head backward.
- Hold the bottle upright and carefully insert the spray nozzle into one nostril.
- Close the other nostril with your finger, press the pump once quickly, and at the same time, gently inhale (see Figure 3).
- Breathe through your mouth.
Figure 3
- Repeat the procedure in the other nostril.
- Breathe gently and do not tilt your head backward after spraying. This prevents the medicine from reaching your throat, which could cause an unpleasant taste (see Figure 4).
Figure 4
- After each use, clean the spray nozzle with a clean tissue or cloth, and replace the protective cap.
- Do not pierce the nozzle if no spray is obtained. Clean the valve with water.
It is important that you use the dose prescribed by your doctor. Use only the amount recommended by your doctor.
Duration of treatment
This medicine is suitable for long-term use. The duration of treatment corresponds to the period during which you experience allergic symptoms.
If you use more Rinoduo than you should
If you apply more of this medicine to your nose, it is unlikely that you will experience any problems. If in doubt, or if you have used more than the recommended dose for a prolonged period, consult your doctor. If someone, especially a child, accidentally drinks this medicine, contact your doctor immediately, go to the nearest medical center, or call the Toxicology Information Service at telephone number (91) 562 04 20, stating the name of the medicine and the amount ingested.
If you forget to use Rinoduo
Use the nasal spray as soon as you remember, then take the next dose at your usual time. Do not use a double dose to make up for a missed dose.
If you stop using Rinoduo
Do not stop treatment without consulting your doctor, as this may jeopardize the success of your treatment.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone will get 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 backwards during use of the nasal spray. This taste should disappear if you drink a soft drink a few minutes after using this medicine.
- Unpleasant odour.
Uncommon side effects (may affect up to 1 in 100 people):
- Slight irritation inside the nose, which may cause mild stinging, itching or sneezing.
- Dry nose, cough, dry throat or sore throat.
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):
- Dizziness or drowsiness.
- Cataracts, glaucoma or increased eye pressure, possibly leading to vision loss and/or redness and eye pain. These side effects have been observed with prolonged treatment with fluticasone propionate nasal sprays.
- Skin and mucous membrane lesions of the nose.
- Feeling unwell, tiredness, exhaustion or weakness.
- Rash, redness or itching of the skin, urticaria.
- Bronchospasm (narrowing of the airways in 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 or breathing difficult, and sudden appearance of a rash on the skin. These could be signs of a severe allergic reaction. Note that this is very rare.
Side effects with unknown frequency (frequency cannot be estimated from the available data):
- Blurred vision
- Nasal ulcers
When this medicine is administered at high doses over a prolonged period of time, systemic side effects (side effects affecting the whole body) may occur. The likelihood of such effects is much lower when using a corticosteroid nasal spray compared to oral corticosteroids. These effects may vary between individual patients and between different corticosteroid preparations (see section 2).
Nasal corticosteroids may affect the normal production of hormones in your body, especially if high doses are used for a long time. In children and adolescents, this side effect may result in slower growth.
In rare cases, reduced bone density (osteoporosis) may occur when corticosteroids are administered via the nasal route over a long period of time.
Reporting of side effects
If you experience any side effect, talk to your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.
5. Storage of Rinoduo
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the bottle and packaging after "EXP". The expiry date refers to the last day of the month indicated.
This product does not require any special storage conditions. Do not refrigerate or freeze.
Expiry after first opening: Discard any unused portion of the medicine 6 months after first opening the nasal spray.
Medicines should not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Rinoduo
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The active substances are azelastine hydrochloride and fluticasone propionate. Each spray (0.137 g) delivers 137 micrograms of azelastine hydrochloride (=125 micrograms of azelastine) and 50 micrograms of fluticasone propionate.
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The other components are benzalkonium chloride, phenylethyl alcohol, glycerol, disodium edetate, polysorbate 80, microcrystalline cellulose and sodium carmellose, and purified water.
Appearance of the product and contents of the container
Rinoduo is a homogeneous white suspension.
Rinoduo is supplied in an amber glass bottle equipped with a spray pump, an applicator, and a protective cap.
The 25 ml bottle contains:
- 20 g of nasal spray suspension with at least 100 sprays.
- 23 g of nasal spray suspension with at least 120 sprays.
- 25 g of nasal spray suspension with at least 150 sprays.
Only some pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Laboratorio Aldo-Unión, S.L.
Baronesa de Maldá, 73
08950 Esplugues de Llobregat
Barcelona – Spain
Date of the most recent review of this leaflet: March 2022
Detailed information about this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).