Avancort Duo 137 micrograms/50 micrograms/dose nasal spray suspension
Spain
Table of Contents
Patient Information Leaflet
Introduction
Package leaflet: Information for the patient
Avancort duo 137 micrograms/50 micrograms/dose 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 others, even if they have the same symptoms as you, because it could 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.
Leaflet contents
- What Avancort duo is and what it is used for
- What you need to know before using Avancort duo
- How to use Avancort duo
- Possible side effects
- How to store Avancort duo
- Contents of the pack and other information
1. What Avancort duo is and what it is used for
Avancort duo 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 are produced by the body 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 Avancort duo
Do not use Avancort duo
- 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 medicines. 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 visual 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 advised 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 the recommended doses of 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 medicine during periods of stress or elective surgery.
To avoid adrenal suppression, your doctor will advise you to take the lowest dose that effectively controls your 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. Your doctor will regularly monitor the growth of children and ensure they are taking 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.
Other medicines and Avancort duo
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 medicines: 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 a 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.
Avancort duo contains benzalkonium chloride
This medicine contains 0.014 mg of benzalkonium chloride per spray.
Benzalkonium chloride may cause irritation or inflammation inside the nose, especially when used for long-term treatment.
3. How to use Avancort duo
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 in order for the full therapeutic benefit to be 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 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 case 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 your thumb at the base of the bottle.
- Press and release the pump 6 times until a fine mist appears (see Figure 2).
- The pump is now primed and ready for use.
Figure 2
- If the nasal spray has not been used for more than 7 days, the pump must be re-primed by pressing and releasing it again.
Spraying method
-
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.
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Hold the bottle upright and carefully insert the spray nozzle into one nostril. 5. Close the other nostril with your finger, press the pump quickly once, and at the same time, inhale gently (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 administration. This prevents the medicine from running down your throat, which may 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 to 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 Avancort duo than you should
If you apply more of this medicine into your nose, it is unlikely that you will experience any problems.
If in doubt, or if you have used a higher than recommended dose for a prolonged period, consult your doctor.
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.
If you forget to use Avancort duo
Use the nasal spray as soon as you remember, then take your next dose at the usual time. Do not use a double dose to make up for a missed dose.
If you stop using Avancort duo
Do not stop treatment without consulting your doctor, as this may compromise 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 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 backwards when using the nasal spray. This taste should disappear if you drink a soft drink a few minutes after using this medicine.
- Unpleasant smell.
Uncommon side effects (may affect up to 1 in 100 people):
- Mild irritation inside the nose, which may cause slight 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 mucosal 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 cause difficulty in swallowing/breathing, and sudden appearance of a skin rash. 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 nasal corticosteroid 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 effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.
5. Storage of Avancort duo
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 following “EXP”. The expiry date refers to the last day of the month indicated.
This medicine 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 must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE Point in your pharmacy. 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 Avancort duo
The active substances are: azelastine hydrochloride and fluticasone propionate. Each gram of suspension contains 1,000 micrograms of azelastine hydrochloride and 365 micrograms of fluticasone propionate.
Each spray (0.14 g) delivers 137 micrograms of azelastine hydrochloride (=125 micrograms of azelastine) and 50 micrograms of fluticasone propionate.
The other components (excipients) are: disodium edetate, glycerol (E-422), microcrystalline cellulose and sodium carboxymethylcellulose, polysorbate 80, benzalkonium chloride, phenylethyl alcohol and purified water.
Nature of the product and pack contents
Avancort duo is a homogeneous white suspension.
Avancort duo is supplied in a Type I amber glass bottle equipped with a spray pump, a polypropylene nasal applicator (actuator) and a dust protection cap, containing 23 g (at least 120 sprays) of suspension.
Pack size:
One bottle containing 23 g of suspension in a 25 ml bottle (at least 120 sprays).
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Laboratorios Cinfa, S.A
Carretera Olaz-Chipi, 10. Polígono Industrial Areta
31620 Huarte (Navarra) – Spain
Manufacturer
ELPEN Pharmaceutical Co Inc
Marathonos Avenue, 95, Pikermi
19009, Greece
or
Laboratorios Cinfa, S.A
Carretera Olaz-Chipi, 10. Polígono Industrial Areta
31620 Huarte (Navarra) – Spain
Date of the most recent review of this leaflet: April 2025
Detailed information about this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)
You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the leaflet and packaging. You can also access this information at the following internet address:
https://cima.aemps.es/cima/dochtml/p/90298/P_90298.html
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