N-CORT 0.055% Nasal Spray For nasal use. PATIENT INFORMATION LEAFLET Active substance(s): Triamcinolone acetonide (w/w%) 0.055 Excipient(s): Benzalkonium chloride 50%, sodium hydroxide, hydrochloric acid, EDTA disodium, polysorbate 80, Avicel RC 591, dextrose monohydrate and deionized water Read this PATIENT INFORMATION 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 further questions, please ask your doctor or pharmacist. This medicine has been prescribed for you only. Do not pass it on to others. If you go to a doctor or hospital during the use of this medicine, inform your doctor about this. Follow the instructions in this leaflet exactly. Do not use higher or lower doses than the dose which was recommended for you. What is in this leaflet 1. What N-CORT is and what it is used for 2. Before you use N-CORT 3. How to use N-CORT 4. Possible side effects 5. How to store N-CORT 1. What N-CORT is and what it is used for N-CORT contains triamcinolone acetonide as active substance. It is presented in a packaging containing 13.5 g suspension for 120 sprays with a measuring cup and a nasal applicator. Each dose contains 55 micrograms of triamcinolone acetonide. N-CORT is an antiallergic corticosteroid. It is used for the treatment of seasonal and perennial allergic rhinitis in adults and children at 2 years of age and older. 2. Before you use N-CORT Do not use N-CORT in the following conditions: If you or your children above 2 years of age are allergic to triamcinolone acetonide or to any of the other ingredients of this medicine. TAKE SPECIAL CARE WITH N-CORT in the following conditions If you or your children; are switching from current or previous long term systemic steroid therapy to N-CORT due to possible deterioration of the function of your suprarenal gland (adrenal). (Your doctor may want to follow up you closely in order to prevent acute renal insufficiency.) have fungal infection in your nose or larynx (In such cases your doctor will stop N-CORT treatment temporally and will give you required local therapy.) have experienced recent nasal ulcers, nasal surgery, or nasal trauma and not completely healed yet (Corticosteroids may delay wound healing.) If your child is under 2 years of age (There is not sufficient evidence on its efficacy and safety in children at this age.) 1
If the drug will be used in children or adolescents at high doses and for a long period (Corticosteroids, especially at high doses and long periods, have been reported to cause growth suppression in children and adolescents. Your doctor will closely monitor the results regarding the suppression of growth and will regularly measure the height of your children and determine the possible effects of the treatment on the growth rate.) have a change in vision or have had eye problems such as increased intraocular pressure, glaucoma, or cataracts. (Corticosteroids have been reported to cause such eye problems. Your doctor will perform regular eye examinations and follow you closely.) Please consult your doctor, even if these statements were applicable to you at any time in the past. Using N-Cort with food and drink: N-CORT is used as a nasal spray. It does not have any interactions with food and drinks due to its method of administration. Pregnancy Ask your doctor or pharmacist for advice before taking the medicine. If you are pregnant, you should not use N-CORT. Therefore, pregnancy status should be evaluated before initiation of the treatment. Your doctor may recommend you to use the medicine if he/she thinks that benefit to the mother justifies the potential risk to the fetus. If you notice that you are pregnant during treatment, please consult your doctor or pharmacist immediately. Breast-feeding Ask your doctor or pharmacist for advice before taking the medicine. If you have to take N-CORT during breast feeding, you should discontinue breast feeding in order to preserve the baby from small amounts of drug which excretes into human milk. Effects on ability to drive and use machines N-CORT has no known effect on the ability to drive or use machines. Important information about some of the ingredients of N-CORT N-CORT contains benzalkonium chloride as an excipient. This substance is an irritant, which may cause skin reactions. Using with other medicines There is no evidence showing interaction of N-CORT with any medicinal product. Please tell your doctor or pharmacist if you are taking or have recently taken any other prescription or nonprescription medicine. 3. How to use N-CORT Instructions for appropriate method and dose/frequency of administration: Your doctor will tell you how and in what dosage you should use your medicine. Adults and patients above 12 years of age; 2
The recommended starting dose is 220 mcg as two sprays in each nostril once daily. When symptoms have been controlled, the dose is reduced to 110 mcg as one spray in each nostril once a day. An improvement of symptoms may be seen at the first day after initiation of treatment in some patients. However, for maximum benefit several days of treatment may be necessary. Children between 6 and 12 years of age: The recommended dose is 110 mcg as 1 spray in each nostril once daily. In patients with more severe symptoms the dose of 220 mcg once daily may be used. Once symptoms have been controlled, treatment may be maintained at minimum effective dose. Children between 2 and 5 years of age: The recommended dose is 110 mcg as 1 spray in each nostril once daily. Maximum daily dose in this age group is 110 micrograms. Children younger than 2 years of age: There is not sufficient evidence on the efficacy and safety of the drug in children at this age group. Therefore it should not be used in children at this age group. Route and method of administration: N-CORT is used by intranasal route only and should be used regularly for optimal efficacy. Administration of N-CORT: N-CORT is used as a nasal spray only. 1. Push the white cover upwards and remove. Shake the bottle slowly before use. 2. Before using the Nasal Spray for the first time, hold it upright, push the top of it downwards and fill the pump and do this pumping 5 times until a fine spray appears. Spray is ready for use. 3
3. Close one of your nostrils by pressing with your finger. Hold the bottle upright and insert the spray tip into your nostril avoiding any discomfort. While your mouth is closed and breathing smoothly, push the top of the bottle and pump the spray. 4. Breathe in your mouth. 5. Repeat steps 3, 4 with the second nostril. 6. If you are 12 years of age or older, repeat steps 3, 4, 5 in order to pump 2 sprays for each nostril. For best results, the product should be used regularly. 7. After using the spray: Wipe the spray nozzle carefully with a soft cloth and close the bottle with dust cover. If you did not use the nasal spray for more than 2 weeks, you have to spray it once in the air before you start using it again. While you are doing this, hold the bottle so that the spray nozzle is pointing away from you. Shake well before each use. If the spray does not work, the nozzle may be blocked; clean it according to the following instructions. Do not try to unblock it. Do not enlarge the spray hole with a pin or other sharp object because this will destroy the spray mechanism. The nasal spray should be cleaned at least once a week or more often if it gets blocked. TO CLEAN THE SPRAY: l. Remove the dust cover and the spray nozzle that is shown in the picture only. Spray nozzle 2. Soak the spray nozzle and dust cover in warm water for a few minutes, and then rinse under cold running tap water. 3. Shake or tap off the excess water and allow air-drying. 4. Re-fit the spray nozzle. 4
5. Spray the unit until a fine mist is produced and use as usual. Starting from the first application, the bottle should be discarded after 120 sprays or in 2 months (13.5 g/packaging). Any remaining suspension should not be transferred to another bottle. Follow these instructions unless recommended otherwise by your doctor. Your doctor will tell you how long you will use N-CORT. Do not stop treatment earlier than you should, otherwise your symptoms may be seen again. Different age groups: Use in children: Children between 6 and 12 years of age: The recommended dose is 110 mcg as 1 spray in each nostril once daily. In patients with more severe symptoms the dose of 220 mcg once daily may be used. Once symptoms have been controlled, treatment may be maintained at minimum effective dose. Children between 2 and 5 years of age: The recommended dose is 110 mcg as 1 spray in each nostril once daily. Maximum daily dose in this age group is 110 micrograms. Children younger than 2 years of age: There is not sufficient evidence on the efficacy and safety of the drug in children at this age group. Therefore it should not be used in children at this age group. Use in elderly: The efficacy and safety of N-CORT in elderly patients have not been established. Special populations Kidney/liver failure: The safety and efficacy of N-CORT in the patients with kidney and liver failure have not been studied. If you have the impression that the effect of N-CORT is too strong or too weak, talk to your doctor or pharmacist. If you have used more N-CORT than you should: Acute overdose is not expected due to the active substance content of your drug. If you may have taken more N-CORT than you should, talk to a doctor or pharmacist. If you forget to use N-CORT: If you miss a dose and it is not very close to the time of the next dose, take the missed dose soon as you remember it. Do not use a double dose to make up for a forgotten dose. If you stop using N-CORT If you stop N-CORT without consulting to your doctor, your allergy symptoms may reoccur. 5
4. Possible side effects Like all medicines, side effects can occur in people sensitive to the contents of N-CORT. If any of the following occur stop using N-CORT and IMMEDIATELY inform your doctor or go to the nearest emergency department: Hypersensitivity reaction (difficulty in breathing, swelling of the throat) Generalized swelling of the skin on eyelids, around the mouth and hands and feet with itching These are all very serious side effects. If you have any of them, this means you have serious allergy to N-CORT. You may need emergency medical care or hospitalization. These very serious side effects occur very rarely. If you notice any of the following immediately inform your doctor or go to the nearest emergency department: Cataract Glaucoma Increased intraocular pressure Nose bleeding Cough Inflammation of the airways (bronchospasm) Tooth disorder These serious side effects occur very rarely. If you notice any of the following, inform your doctor: Drying of the mucous membrane of the nose and throat, nasal congestion and sneezing Inflammation of the intranasal mucous (rhinitis) Inflammation of pharynx (Pharyngitis) Flu syndrome Headache Dizziness Malaise Difficulty in breathing Insomnia Indigestion, abdominal pain Alterations in taste and smell, nausea Pharyngolaryngeal pain Diarrhea Exfoliation of the skin These are mild side effects of N-CORT. These side effects disappear when the dose is reduced or treatment is discontinued. If you notice any side effects not mentioned in this leaflet inform your doctor or pharmacist. 6
Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via clicking Reporting of Drug Side Effects icon on the website www.titck.gov.tr or Turkish Pharmacovigilance Center (TUFAM) by calling the phone number 0 800 314 00 08 for side effects reporting line. By reporting side effects, you can help provide more information on the safety of this medicine. 5. How to store N-CORT Keep in the original package and out of the reach and sight of children. Store in room temperature under 25 C in dry place. Discard 2 months after opening N-CORT. Use in accordance with expiry date. Do not use N-CORT after the expiry date which is stated on the package. Marketing Authorization Holder: Berko İlaç ve Kimya San. A.Ş. Yenişehir Mah. Özgür Sok. No: 16-18 Ataşehir/İstanbul 0 216 456 65 70 (Pbx) 0 216 456 65 79 (Fax) info@berko.com.tr Manufacturer: Berko İlaç ve Kimya San. A.Ş. Adil Mah. Yörükler Sok. No: 2 Sultanbeyli/İstanbul 0 216 592 33 00 (Pbx) 0 216 592 00 62 (Fax) This patient information leaflet was approved on 31/12/2015. 7