PATIENT INFORMATION LEAFLET

Transcription

1 N-CORT 0.055% nasal spray, suspension It is used by spraying into the nose. Active substance: (w/w%) Triamcinolone acetonide PATIENT INFORMATION LEAFLET Excipients: Benzalkonium chloride 50%, sodium hydroxide, hydrochloric acid, EDTA disodium, polysorbate 80, Avicel RC 591 (microcrystalline cellulose and sodium carboxymethylcellulose), dextrose monohydrate, deionised 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. When you go to a doctor or hospital while using this medicine, tell your doctor that you are receiving this medicine. Follow strictly what has written on this leaflet. Do not use higher or lower dose other than the recommended to 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 is it used for N-CORT contains triamcinolone acetonide as active substance. It is presented in a packaging containing 13.5 g suspension for 120 actuations with a metered dose valve 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 if: You or your children above 2 years of age are allergic to triamcinolone acetonide or to any of the other ingredients. 1

2 Take special care with N-Cort if: You receive systemic steroid treatment or if you received long term systemic steroid treatment previously, an impairment in the function of adrenal gland may be possible when you begin to use N-CORT. (Your doctor may want to follow up you closely in order to prevent the sudden onset of kidney failure.) 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.) Your child is under 2 years of age (There is not sufficient evidence on its efficacy and safety in children at this age.) 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.) If these warnings are valid for you even for any period in the past, please consult your doctor. Taking 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 Consult your doctor or pharmacist before taking this medicine. If you are pregnant, you should not use N-CORT Nasal Spray. 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 realize that you are pregnant during your treatment, consult your doctor or pharmacist immediately. Breast-feeding Consult your doctor or pharmacist before taking this medicine. If you have to take N-CORT Nasal Spray during breast feeding, you should discontinue breast feeding in order to preserve the baby from small amounts of drug which excretes into human milk. Driving and using machines N-CORT has no known effect on the ability to drive or use machines. 2

3 Important information about some of the excipients of N-CORT N-CORT contains benzalkonium chloride as an excipient. This substance is an irritant, which may cause skin reactions. Taking with other medicines There is no evidence showing interaction of N-CORT with any medicinal product. If you are currently using or recently used a prescribed or non-prescribed medicine, please inform your doctor or pharmacist about it. 3. How to use N-CORT? Instructions for appropriate usage and dose/application frequency: Your doctor will tell you how and at which doses you need to take your drug. Adults and patients above 12 years of age: The recommended starting dose is 220 mcg per day 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 per day 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 per day 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 by spraying into the nose only. 3

4 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. 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. Exhale through the 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 clean tissue and close the bottle with dust cover. If you did not use the nasal spray for more than 2 weeks, you should reprime with 1 actuation. While you are doing this, hold the bottle so that the spray nozzle is pointing away from you. Shake well before 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 4

5 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 cover and the spray nozzle that is shown in the picture only. 2. Soak the spray nozzle and cover in warm water for a few minutes, and then rinse under cold running tap water. Spray Valve 3. Shake or tap off the excess water and allow to air-dry. 4. Re-fit the spray nozzle. 5. Prime the nasal spray 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/bottle). 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. Various age groups: Children: Children between 6 and 12 years of age: The recommended dose is 110 mcg per day 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 per day 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. Elderly: Efficacy and safety of N-CORT in elderly patients have not been established. SpecialPopulations Kidney/liver failure: Safety and efficacy of N-CORT in the patients with renal and hepatic failure have not been studied. If you feel that the effect of N-CORT is too weak or too strong, talk to your doctor or pharmacist. 5

6 If you take N-CORT more than you should: Acute overdose is not expected due to the active substance content of your drug. If you have taken N-CORT more than you should, consult your doctor or pharmacist. If you forget to use N-CORT: If you miss a dose and the time of the next dose is not close, take the dose as soon as you remember. Do not take a double dose to make up for the missed dose. If you stop using N-CORT If you stop N-CORT without consulting to your doctor, your allergy symptoms may reoccur. 4. Possible side effects As it is for all medicines, side effects can be seen in people who are sensitive to the ingredients of N-CORT. If you experience any of the following, stop using N-CORT and immediately consult your doctor or apply to the emergency service of the nearest hospital: 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 All of these are very serious side effects. If you have any one of these side effects, then it indicates that you have serious allergy to N-CORT. You may require medical intervention or you should be hospitalized. All these very severe side effects are observed very rarely. Immediately contact your doctor or apply to the emergency service of the nearest hospital, if you experience any of the following symptoms: Cataract Glaucoma Increased intraocular pressure Nose bleeding Cough Inflammation of the airways (bronchospasm) Tooth disorder All these are serious side effects. Immediate medical attention may be required. Serious side effects are seen very rarely. Consult your doctor if you realize any of the following: Dryness of the mucous membrane of the nose and throat, congestion of the nose, and sneezing 6

7 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 Excoriation of the skin These are the mild side effects of N-CORT. These reactions are resolved upon dose reduction or withdrawal. If you experience any side effect not mentioned in this leaflet, please inform your doctor or pharmacist. 5. How to store N-CORT Keep N-CORT out of the sight and reach of children and in its package. Store at room temperature below 25 in a dry place and in its original packaging. Discard opened N-CORT after 2 months. Use in accordance with its expiry date. Use N-CORT before the expiry date indicated on the package. Marketing authorization holder: Berko İlaç ve Kimya Sanayi A.Ş. Yenişehir Mah. Özgür Sok. No: Ataşehir/İstanbul-Turkey (Pbx) (Fax) info@berko.com.tr Manufacturer: Berko İlaç ve Kimya Sanayi A.Ş. Adil Mah. Yörükler Sok. No: 2 Sultanbeyli/ İstanbul-Turkey (Pbx) (Fax) This patient information leaflet was last approved at 31/12/