Properties
What is it?
Rinoduo 137 micrograms/50 micrograms /spray solution, nasal spray azelastine hydrochloride/fluticasone propionate Read the entire leaflet carefully before you start using this medicine because it contains important information for you. - Keep this leaflet. You may need to read it again. - If you have any doubts, ask your doctor or pharmacist. - This medicine has been prescribed for you personally and should not be passed on to others, even if they have the same symptoms as you, as it may harm them. - If you notice any side effects, even if they are not mentioned in this leaflet, tell your doctor or pharmacist. See section 4. Contents of the leaflet 1. What Rinoduo is and what it is used for. 2. What you need to know before using Rinoduo. 3. How to use Rinoduo. 4. Possible side effects. 5. How to store Rinoduo. 6. 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 antihistamines. Antihistamines work by preventing the effects of substances such as histamine, which the body produces as part of an allergic reaction; in this way, it reduces the symptoms of allergic rhinitis. · Fluticasone propionate belongs to a group of corticosteroids, which reduce inflammation. This medicine is used to relieve the symptoms of moderate to severe seasonal allergic rhinitis and perennial allergic rhinitis, when treatment with intranasal antihistamines or corticosteroids alone is not sufficient. Seasonal or perennial allergic rhinitis is an allergic reaction to substances such as pollen (hay fever), house dust mites, mold, dust or pets. The medicine relieves allergy symptoms, such as: runny nose, rhinorrhea, sneezing, 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 any of the other ingredients of this medicine (listed in section 6). Warnings and precautions Before using the medicine, talk to your doctor or pharmacist if: · you have recently had surgery on your nose. · you have a nasal infection. Nasal infections should be treated with antibacterial or antifungal medicines. If you have been prescribed medicine to treat a nasal infection, you can continue to take this medicine to treat your allergy. · you have tuberculosis or an untreated infection. · you have vision problems or a history of increased intraocular pressure, glaucoma and/or cataracts. If you suffer from any of these conditions, this medicine should be used under medical supervision. · you have impaired adrenal function. Caution is required when switching from systemic steroid therapy to this medicine. · you have severe liver disease. The likelihood of systemic side effects will increase. In this case, your doctor will decide if you can use this medicine. It is important to take the dose indicated in section 3 or the dose prescribed by your doctor. Taking higher than recommended doses of nasal corticosteroids may lead to adrenal suppression, which can result in weight loss, fatigue, muscle weakness, low blood glucose levels, salt craving, joint pain, depression, and skin darkening. If any of these side effects occur, your doctor may advise you to take another medication during periods of stress or selective surgery. To prevent adrenal suppression, your doctor will advise you to take the lowest dose necessary to effectively control your rhinitis symptoms. Long-term use of nasal corticosteroids (such as this medicine) may cause growth retardation in children and adolescents. The child's growth should be monitored regularly by the doctor, who will ensure that they are taking the lowest possible dose. Consult your doctor if you experience blurred vision or other visual disturbances. If you are unsure whether any of the above conditions apply to you, consult your doctor or pharmacist before taking the medicine. Children This medicine is not recommended for use in children under 12 years of age. Rinoduo with other medicines Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. Some medicines may increase the effect of this medicine, so your doctor will monitor you carefully if you are taking these medicines (including certain medicines for HIV infection: ritonavir, cobicistat and medicines for fungal infections: ketoconazole). Pregnancy and breastfeeding. If you are pregnant or breastfeeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine. Driving and using machines. This medicine has a minimal effect on the ability to drive and use machines. Very rarely, dizziness or fatigue may occur, which may be caused by the disease itself or by taking this medicine. In such cases, do not drive or use machines. Note that alcohol consumption may enhance these side effects. Rinoduo contains benzalkonium chloride. This medicine may cause inflammation of the nasal mucosa, especially with prolonged use, as it contains benzalkonium chloride. If you suspect such a reaction (persistent nasal congestion), a nasal medicine that does not contain this excipient should be used if possible. 3. How to use Rinoduo. Follow your doctor's or pharmacist's instructions for taking the medicine exactly. If you have any doubts, consult your doctor or pharmacist again. For full effect, it is necessary to take the medicine regularly. Avoid contact with eyes. Adults and adolescents (over 12 years of age) · The recommended dose is one spray in each nostril, 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 kidney and liver failure. There is no data for patients with kidney and liver failure. Method of administration Nasal. Read the following instructions carefully and use the medicine only as directed. Instructions for use. Preparing the spray 1. Gently shake the bottle up and down for 5 seconds, then remove the protective cap (see Figure 1). 2. When using the nasal spray for the first time, the pump must be activated by spraying into the air. 3. Activate the pump by pressing down on both sides of the pump with two fingers and the base of the bottle with your thumb. 4. Press and release the pump 6 times until a fine spray appears (see Figure 2). 5. The pump is now activated and ready for use. 6. If you have not used the nasal spray for more than 7 days, you will need to reactivate the pump by pressing and releasing the liquid. Spraying method 1. Gently shake the bottle up and down for 5 seconds, then remove the protective cap. (See Figure 1). 2. Clear your nostrils. 3. Tilt your head downwards. Do not tilt your head back. 4. Hold the bottle upright and carefully insert the applicator into one nostril. 5. Close the other nostril with your finger, spray once quickly and, at the same time, inhale gently. (See Figure 3). 6. Breathe through your mouth. 7 Repeat the operation in the other nostril. 8. Inhale gently and do not tilt your head back after spraying. This will prevent the medicine from entering your throat, which causes an unpleasant taste (see Figure 4). 9. After each use, clean the spray device with a clean tissue or cloth and replace the protective cap. 10. Do not press the filter if the spray does not come out. 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 The medicine is used for a long period. The duration of treatment depends on how long you have allergy symptoms. If you have used more Rinoduo than you should. If you have sprayed more of this medicine into your nose than you should, it is unlikely that you will have any problems. If you have any doubts, or if you have been using more than the recommended dose for a long time, consult your doctor. If anyone, especially a child, accidentally swallows the medicine, contact your doctor or the nearest medical center immediately, or call the toxicology information service at (91) 562 04 20, stating the medicine and the amount taken. If you forget to take Rinoduo. Take the nasal spray as soon as you remember, then take the next dose at the usual time. Do not take a double dose to make up for a missed dose. If you stop taking Rinoduo. Do not stop treatment without consulting your doctor, as this may jeopardize the results of your treatment. If you have any further questions about taking this medicine, ask your doctor or pharmacist. 4. Possible side effects. Like all medicines, this medicine can cause side effects, although not everyone 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 when using the nasal spray. This taste will disappear if you drink a carbonated drink a few minutes after taking the medicine. · Unpleasant smell. Uncommon side effects (may affect up to 1 in 100 people): · Mild irritation of the inside of the nose, which may cause mild stinging, itching or sneezing. · Dryness of the nose, cough, dry throat or throat irritation. Rare side effects (may affect up to 1 in 1,000 people): · Dry throat. Very rare side effects (may affect up to 1 in 10,000 people): · Feeling faint or sleepy. · Cataracts, glaucoma or increased eye pressure, with possible loss of vision and/or redness and pain in the eyes. These side effects have been observed with long-term treatment with fluticasone propionate nasal spray. · Lesions of the skin and nasal mucosa. · Feeling unwell, tired or weak. · Skin rash, redness or itching, hives. · Bronchospasm (narrowing of the airways in the lungs). Seek immediate medical attention if you experience any of the following symptoms: swelling of the face, lips, tongue or throat, which may cause difficulty swallowing/breathing, and sudden appearance of a rash on the skin. These may be signs of a severe allergic reaction. Note that this is very rare. Side effects of unknown frequency (frequency cannot be estimated from the available data). · Blurred vision. · Ulcers in the nose. Taking high doses of this medicine may lead to systemic side effects (side effects affecting the whole body). The probability of these side effects developing is lower if a corticosteroid nasal spray is used instead of oral corticosteroids. These side effects may vary depending on individual patients and different corticosteroid medicines. (See section 2). Nasal corticosteroids can 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 can cause growth retardation. In rare cases, a decrease in bone density (osteoporosis) may occur when corticosteroids are used for a long time. Reporting of side effects. If you get any side effects, talk to your doctor or pharmacist, including any side effects not listed in this leaflet. By reporting side effects, you can help provide more information about the safety of this medicine. 5. How to store Rinoduo. Keep the medicine out of the reach of children. Do not use the medicine after the expiry date indicated on the carton, the expiry date refers to the last day of that month. Expiry after opening: Discard any unused nasal spray 6 months after first opening. Medicines should not be disposed of down the drain or in household waste. Take containers and medicines that you no longer need to the Punto SIGRE point in the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines that you no longer need. In this way, you will help protect the environment. 6. Contents of the pack and other information. Composition of Rinoduo - The active substances are azelastine hydrochloride and fluticasone propionate. Each spray (0.137 g) contains 137 micrograms of azelastine hydrochloride (=125 micrograms azelastine) and 50 micrograms of fluticasone propionate. - Other excipients are: benzalkonium chloride, phenylethyl alcohol, glycerol, disodium edetate, polysorbate 80, microcrystalline cellulose and sodium carboxymethylcellulose, and purified water. Appearance and contents of the pack. Rinoduo is a white, homogeneous solution. Rinoduo is presented in an amber glass bottle, equipped with a spray pump, applicator and protective cap. The 25 ml bottle contains 23 g of nasal spray (minimum 120 sprays).