SCHEDULING STATUS S3PROPRIETARY NAME (AND DOSAGE FORM)

TRIAMIST (Nasal Spray)COMPOSITION Each metered spray delivered by the nasal actuator contains 55 μg of triamcinolone acetonide.Preservative: Benzalkonium chloride 0,015 % w/w.The inactive ingredients are anhydrous glucose, carboxymethyl cellulose, disodium edetate, hydrochloric acid, microcrystalline cellulose, polysorbate 80, sodium hydroxide and water for injection.PHARMACOLOGICAL CLASSIFICATIONA 21.5.1 Corticosteroids and analogues.PHARMACOLOGICAL ACTIONPharmacodynamics properties:Triamcinolone acetonide is a derivative of triamcinolone, a synthetic glucocorticoid. Glucocorticoids have anti-inflammatory action, amongst others.The precise mechanism of glucocorticoid action in allergic conditions is unknown.Pharmacokinetics propertiesPharmacokinetic characterisation of the triamcinolone acetonide nasal spray formulation was determined in both normal subjects and in patients with allergic rhinitis. Single dose intranasal administration of 220 µg of triamcinolone acetonide nasal spray in normal subjects and patients demonstrated dose-related absorption of triamcinolone acetonide. The mean peak plasma concentration was approximately 0,5 ng/mℓ (range 0,1 to 1,0 ng/mℓ) and occurred at 1,5 hours post-dose. The mean plasma concentration was less than 0,06 ng/mℓ at 12 hours, and below the assay detection limit at 24 hours. The average terminal half-life was 3,1 hours.Based upon intravenous dosing of triamcinolone acetonide phosphate ester, the half-life of triamcinolone acetonide was reported to be 88 minutes. The volume of distribution (Vd) reported was 99,5 ℓ (SD ± 27,5) and clearance was 45,2 ℓ /hour (SD ± 9,1) for triamcinolone acetonide. The plasma half-life of corticosteroids does not correlate well with the biological half-life.INDICATIONSTRIAMIST nasal spray is indicated for the preventative treatment of seasonal and perennial allergic rhinitis symptoms in adults and children 6 years of age and older.CONTRAINDICATIONSTRIAMIST is contra-indicated in patients with known hypersensitivity to triamcinolone acetonide or any of the other ingredients in the formulation. In children below the age of 6 years.WARNINGS AND SPECIAL PRECAUTIONSSafety and effectiveness have not been established in children below the age of 6 years. Oral corticosteroids have been shown to cause growth suppression in children and teenagers, particularly with higher doses over extended periods. If a child or teenager on any corticosteroid appears to have growth suppression, the possibility that they are particularly sensitive to this effect of steroids should be considered.The use of TRIAMIST in combination with oral corticosteroids could increase the likelihood of hypothalamic-pituitary-adrenal axis suppression compared to a therapeutic dose of either one alone. Therefore TRIAMIST should be used with caution in patients already receiving corticosteroids.The replacement of a systemic corticosteroid with a topical corticoid, such as TRIAMIST nasal spray, can be accompanied by signs of adrenal insufficiency and, in addition, some patients may experience symptoms of withdrawal, e.g. joint and/or muscular pain, lassitude and depression. Patients previously treated for prolonged periods with systemic corticosteroids and transferred to topical corticoids such as TRIAMIST nasal spray should be carefully monitored for acute adrenal insufficiency in response to stress. In those patients who have asthma or other clinical conditions requiring long-term systemic corticosteroid treatment, too rapid a decrease in systemic corticosteroids may cause a severe exacerbation of their symptoms.Patients who are on immunosuppressant doses of corticosteroids should take particular care to avoid exposure to chickenpox and measles. In susceptible patients specific immunoglobulin or antiviral therapy may be indicated.Infections of the nose and pharynx with Candida albicans may occur. When such an infection develops it may require treatment with appropriate local or systemic therapy and discontinuance of treatment with TRIAMIST nasal spray.TRIAMIST nasal spray should be used with caution, if used at all, in patients with active or quiescent tuberculous infections of the respiratory tract or in patients with untreated fungal, bacterial, or systemic viral infections or ocular herpes simplex.Because of the inhibitory effect of corticosteroids on wound healing in patients who have experienced recent nasal septal ulcers, nasal surgery or trauma, TRIAMIST nasal spray should be used with caution until healing has occurred.Nasal septal perforations have been reported in rare instances. When used at excessive doses, systemic corticosteroid effects such as hypercorticism and adrenal suppression may appear. If such changes occur, TRIAMIST nasal spray should be discontinued slowly, consistent with accepted procedures for discontinuing oral steroid therapy.Effects on ability to drive and use machinery:TRIAMIST has no or negligible influence on the ability to drive and use machines.INTERACTIONSCorticosteroids have an inhibitory effect on wound healing and should be used with caution in conjunction with TRIAMIST (see “WARNINGS AND SPECIAL PRECAUTIONS”).PREGNANCY AND LACTATIONPregnancyCorticosteroids have been shown to be teratogenic in animals following topical application. Therefore TRIAMIST should not be used during pregnancy.Hypoadrenalism may occur in infants born to mothers receiving corticosteroids during pregnancy. Such infants should be carefully observed.LactationSafety of TRIAMIST during lactation has not been established,

SCHEDULING STATUS S3PROPRIETARY NAME AND DOSAGE FORM

TRIAMIST (Nasal spray)Read this entire leaflet carefully before you start using TRIAMIST.• Keep this leaflet. You may need to read it again• If you have further questions, please ask your doctor or your pharmacist.TRIAMIST has been prescribed for you personally and you should not share your medicine with other people. It may harm them, even if their symptoms are the same as yours.1. WHAT TRIAMIST CONTAINS:The active substance is 55 μg of triamcinolone acetonide per spray.The other ingredients are anhydrous glucose, carboxymethyl cellulose, disodium edetate, hydrochloric acid, microcrystalline cellulose, polysorbate 80, sodium hydroxide and water for injection.The preservative is benzalkonium chloride 0,015 % w/w.2. WHAT TRIAMIST IS USED FORTRIAMIST nasal spray belongs to a class of medicines called corticosteroids. It is used for the preventative treatment of allergic conditions of the nose, known as seasonal and perennial allergic rhinitis, which produce symptoms such as sneezing, itching, nasal stuffiness and runny nose. 3. BEFORE YOU USE TRIAMISTDo not use TRIAMIST:

• If you are hypersensitive (allergic) to the active substance, triamcinolone acetonide, or to any of the other ingredients in the formulation.

• If you are under the age of 6 years.Tell your doctor of the above before using TRIAMIST.Take special care with TRIAMIST:The presence of other medical conditions may impact on the use of TRIAMIST as it may require dose adjustment or special monitoring. Please inform your doctor or pharmacist if any of the following applies to you:

• You are pregnant or breastfeeding (please see "Pregnancy and breastfeeding").

• You are taking corticosteroids in tablet form or per injection. Please see "Using other medicines with TRIAMIST").

• Your immune system is suppressed.• You have an infection of the nose or throat whether it is a

viral, fungal or bacterial infection.• You are currently receiving treatment for tuberculosis or

have a history of tuberculosis.• You were recently diagnosed with an ulcer of your nasal

septum, or have recently undergone nasal surgery or recently suffered trauma to your nose.

Safety and efficacy of TRIAMIST have not been established in children younger than 6 years. Oral corticosteroids (i.e. tablets or syrup) have been shown to cause growth suppression in children and teenagers, particularly if they received high doses over extended periods. If your child is on corticosteroids and you are concerned that he/she may be growing too slowly, please discuss this with the treating doctor.TRIAMIST may cause thrush (yeast infection with Candida albicans) of the nose or throat. This will present with white plaques in the mouth, throat or nose. Please inform your doctor if such symptoms develop as you may require treatment with antifungal medicines and/or discontinuation of therapy with TRIAMIST.In some instances TRIAMIST has caused perforation of the nasal septum. This may present with nose bleeds, pain or with a nasal discharge. Please report any such symptoms to your doctor immediately.If you use excessive doses of TRIAMIST for a prolonged period of time, you may develop systemic side-effects, such as weight gain, redistribution of body fat, thinning of the skin, and suppression of adrenal gland function, amongst others. Please use TRIAMIST exactly as instructed by your doctor.Using TRIAMIST with food and drink:TRIAMIST is not affected by food and drink.Pregnancy and breastfeeding:The use of TRIAMIST during pregnancy may harm your baby as studies in animals have shown that topical application of corticosteroids, such as in TRIAMIST, may be harmful. The safe use of TRIAMIST while you are breastfeeding your baby has not been established and you should not breastfeed your infant.If you are pregnant or breastfeeding your baby please consult your doctor, pharmacist or other healthcare professional for advice before using this medicine.Driving and using machinery:There are no effects on ability to drive or use machines.Using other medicines with TRIAMIST:Always tell your healthcare professional if you are taking any other medicine. (This includes complementary or traditional medicines.)It is particularly important to inform your doctor if you have recently used or are currently using other corticosteroids, such as corticosteroid tablets or injections. If TRIAMIST is combined with other corticosteroids, you will require careful monitoring for possible side-effects. You may develop withdrawal symptoms, such as joint or muscle pain, depression, and tiredness if your dose of other corticosteroids is decreased too rapidly. This may also cause worsening of asthma symptoms. Your doctor will also monitor you for other complications, such as reduced function of your adrenal glands. If you are using very high doses of corticosteroids (to suppress the function of your immune system), you should avoid exposing yourself to people with chickenpox or measles.4. HOW TO USE TRIAMISTDo not share medicines prescribed for you with any other person.Always use TRIAMIST exactly as indicated or as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure. Your doctor will tell you how long your treatment with TRIAMIST will last. Do not stop treatment early because you feel better. If you have the impression that the effect of TRIAMIST is too strong or too weak, tell you doctor or pharmacist. This medicine will not relieve your symptoms immediately. It may provide relief from the first day of treatment, but usually you will need to use it for a few days to obtain full benefit.

therefore women should not breastfeed their infants.DOSAGE AND DIRECTIONS FOR USEDo not exceed the prescribed dosage. Shake the bottle well before each use.Each actuation delivers 55 micrograms triamcinolone acetonide from the nose piece to the patient after an initial priming of 5 sprays until a fine mist is achieved. It will remain adequately primed for 2 weeks. If the product is unused for more than 2 weeks, then it can be adequately reprimed with one spray. The nozzle should be pointing away from the patient while the patient is priming the device.Adults and children 12 years of age and older:It is recommended that dosing be started at 220 µg as two sprays in each nostril once daily for adults and children 12 years and older.Paediatric patients aged 6 to 12 years:The recommended dose is 110 µg as 1 spray in each nostril daily. In patients with more severe symptoms, a dose of 220 µg (2 sprays in each nostril once daily) may be used. But once symptoms are controlled, patients should be maintained on the lowest effective dose. Continuous use beyond 3 months in children under 12 years is not recommended.Initial assessment for response should be made during the first three to four days and periodically until the patient's symptoms are stabilised. Some relief can be obtained in approximately two thirds of patients in that time. If adequate relief of symptoms has not been obtained after 3 weeks of treatment, TRIAMIST nasal spray should be discontinued, and consideration to alternative forms of treatment should be given.It is always desirable to titrate an individual patient to the minimum effective dose to reduce the possibility of side-effects. When the maximum benefit has been achieved and symptoms have been controlled, reducing the dose to 110 µg (one spray in each nostril once per day) has been shown to be effective in maintaining control of the allergic rhinitis symptoms in patients who were initially controlled on 220 µg/day.SIDE EFFECTS The most commonly reported adverse reactions included those involving the mucous membranes of the nose and throat.Nervous system disorders:Frequent: Headache.Eye disorders:Less frequent: Ocular hypertension.Respiratory, thoracic and mediastinal disorders:Frequent : Rhinitis and pharyngitis, burning,

dryness or other irritation inside the nose

Less frequent: Crusting inside nose or epistaxis, sore throat, ulceration of nasal mucosa, nasal candidiasis, pharyngeal candidiasis, nasal septal perforation, burning or stinging continuing after use of spray, as well as sneezing and sinus congestion, stuffy nose and throat discomfort.

Frequency unknown: Dry mucous membraneKNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENTIn the event of the entire contents of the bottle being administered all at once, either via oral or nasal application. The patient may experience some gastrointestinal upset.Overdosage should be treated symptomatically and supportively.IDENTIFICATIONWhite to off-white coloured homogenous redispersible suspension, free from visible foreign matter.PRESENTATION20 mℓ cylindrical white opaque HDPE bottle providing 120 actuations with a net fill weight of 16,5 g. Each bottle is fitted with a silver crimp nasal pump with HDPE tip, white opaque nasal actuator and a translucent dust cap for nozzle.The bottle is packed in a carton.STORAGE INSTRUCTIONSStore at or below 25 ºC.Protect from light.Discard within two months after first opening the bottle.KEEP OUT OF REACH OF CHILDREN.REGISTRATION NUMBER: 45/21.5.1/0676NAME AND BUSINESS ADDRESS OF THE HOLDER OF THE CERTIFICATE OF REGISTRATIONCIPLA MEDPRO (PTY) LTDBuilding 9, Parc du CapMispel Street, Bellville, 7530DATE OF PUBLICATION OF THE PACKAGE INSERT:2 October 2015

Each spray from the nasal actuator delivers 55 µg of the active ingredient (triamcinolone acetonide) to the nose, after initial priming of TRIAMIST nasal spray (usually 5 sprays until a uniform spray is observed). If the nasal spray has not been used for 14 days or longer, it can be adequately reprimed with one spray. You should point the nozzle away from you when you are priming the spray. Do not exceed the prescribed dosage. The usual dose in adults and children 12 years and older is two sprays in each nostril once a day. For children 6 to 12 years the usual dose is one spray per nostril once a day. In some instances your doctor may decide to decrease or increase your dose, depending on your response to treatment and/or the severity of your condition.Most patients will experience relief of symptoms within the first three to four days of treatment. However, it may take up to three weeks to experience the full benefit of treatment. If you have not responded to treatment with TRIAMIST after 3 weeks, your doctor may decide to stop treatment with TRIAMIST. Otherwise you should continue with treatment for as long as your doctor has instructed you. Continuous use of TRIAMIST beyond 3 months in children younger than 12 years is not recommendedShake bottle well before each use.If you use more TRIAMIST than you should:In the event that the entire contents of the bottle are administered all at once, via either the mouth or nose, clinically significant systemic adverse events may occur.In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre.If you forget to use TRIAMIST:Always use TRIAMIST exactly as your doctor has instructed you. To obtain maximal benefit from treatment, it is important to use TRIAMIST every day and not to skip doses. However, if you missed a dose and it is almost time for your next dose, skip the missed dose and return to your regular dosing schedule. Do not take a double dose to make up for the forgotten individual dose.Effects when treatment with TRIAMIST is stopped:TRIAMIST nasal spray should be discontinued slowly, consistent with accepted procedures for discontinuing oral steroid therapy.5. POSSIBLE SIDE EFFECTSTRIAMIST can have side effects.Not all side effects reported for TRIAMIST are included in this leaflet. Should your general health worsen while using TRIAMIST, or if you experience any untoward effects, please consult your doctor, pharmacist or other health care professional for advice.The following side-effects have been reported frequently:

• Headache.• Stuffed or runny nose, sore throat, and burning, dryness, or

other irritation inside the nose. The latter is usually mild and transient.

The following side-effects have been reported less frequently:• Crusting inside the nose or nose bleeds, especially if the

spray is improperly aimed towards the nasal septum and not to the sides.

• Ulceration of the cells lining the nose.• Thrush (Candida albicans infection) of the nose presenting

with white patches inside the nose or throat.• Perforation of the nasal septum, which may present with

nose bleeding, pain or a nasal discharge.• Burning or stinging continuing after the use of the spray.• Sneezing.• Sinus congestion and stuffy nose.• Throat discomfort.• Raised pressure inside the eye.

The incidence of the following side-effect is not known:• Dryness of the mucous membrane (lining) inside the nose

or mouth.6. STORING AND DISPOSING OF TRIAMISTStore at or below 25 ºC. In order to protect from light, do not store in open cupboards exposed to light.Discard within two months after first opening the bottle.STORE ALL MEDICINES OUT OF REACH OF CHILDREN.Return all unused medicine to your pharmacist.Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).7. PRESENTATION OF TRIAMIST20 mℓ cylindrical white opaque HDPE bottle providing 120 actuations with a net fill weight of 16,5 g. Each bottle is fitted with a silver crimp nasal pump with HDPE tip, white opaque nasal actuator and a translucent dust cap for nozzle.The bottle is packed in a carton.8. IDENTIFICATION OF TRIAMISTWhite to off-white coloured homogenous redispersible suspension, free from visible foreign matter.9. REGISTRATION NUMBER45/21.5.1/067610. NAME AND ADDRESS OF REGISTRATION HOLDERCIPLA MEDPRO (PTY) LTDBuilding 9, Parc du CapMispel Street, Bellville, 753011. DATE OF PUBLICATION2 October 2015

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SKEDULERINGSTATUS S3EIENDOMSNAAM (EN DOSEERVORM)

TRIAMIST (Neussproei)SAMESTELLINGElke afgemete spuit wat die nasale aktueerder lewer, bevat 55 μg triamsinoloonasetonied.Preserveermiddel: Bensalkoniumchloried 0,015 % m/m.Die onaktiewe bestanddele is anhidriese glukose, karboksi-metielsellulose, dinatriumedetaat, soutsuur, mikrokristallyne sellulose, polisorbaat 80, natriumhidroksied en water vir inspuiting.FARMAKOLOGIESE KLASSIFIKASIEA 21.5.1 Kortikosteroïede en analoë.FARMAKOLOGIESE WERKINGFarmakodinamiese eienskappe:Triamsinoloonasetonied is ‘n derivaat van triamsinoloon, ‘n sintetiese glukokortikoïed. Glukokortikoïede het onder meer anti-inflammatoriese werking.Die presiese werkingswyse van glukokortikoïed in allergiese toestande is onbekend.Farmakokinetiese eienskappe:Farmakokinetiese karakterisering van die triamsinoloon- asetonied neussproei formulasie is in beide normale persone en in pasiënte met allergiese rinitis bepaal. ‘n Enkeldosis van 220 µg triamsinoloonasetonied neussproei intranasaal toegedien in normale persone en pasiënte het dosisverwante absorpsie van triamsinoloonasetonied aangetoon. Die gemiddelde piek plasmakonsentrasie was ongeveer 0,5 ng/mℓ (reikwydte 0,1 tot 1,0 ng/mℓ) en het teen 1,5 uur ná dosering voorgekom. Die gemiddelde plasmakonsentrasie was minder as 0,06 ng/mℓ teen 12 uur, en laer as die essai se waarnemingslimiet na 24 uur. Die gemiddelde terminale halfleeftyd was 3,1 uur.Gebaseer op intraveneuse dosering van triamsinoloon- asetonied-fosfaatester, is aangemeld dat die halfleeftyd van triamsinoloonasetonied 88 minute is. Die aangemelde volume van verspreiding (Vd) was 99,5 ℓ (SD ± 27,5) en opruiming was 45,2 ℓ/uur (SD ± 9,1) vir triamsinoloonasetonied. Die plasmahalf-leeftyd van kortikosteroïede korreleer nie goed met die biologiese halfleeftyd nie.INDIKASIESTRIAMIST neussproei word aangedui vir die voorkomende behandeling van die simptome van seisoenale en nie-seisoenale (meerjarige) allergiese rinitis in volwassenes en kinders 6 jaar en ouer.KONTRA-INDIKASIESTRIAMIST word teenaangedui in pasiënte wat hipersensitief is vir triamsinoloonasetonied of enige van die ander bestanddele in die formulasie.In kinders jonger as 6 jaar.WAARSKUWINGS EN SPESIALE VOORSORGMAATREËLSVeiligheid en effektiwiteit is nie in kinders jonger as 6 jaar bepaal nie. Dit is aangetoon dat orale kortikosteroïede groei onderdruk in kinders en tieners, veral met hoër dosisse oor verlengde tydperke. Indien dit voorkom of ‘n kind of tiener wat op behande-ling met enige kortikosteroïed is se groei onderdruk word, moet die moontlikheid oorweeg word dat hulle veral sensitief is vir hierdie uitwerking van steroïede.

Die gebruik van TRIAMIST in kombinasie met orale kortikosteroïede kan die waarskynlikheid van hipotalamiese-pituïtêre-adrenale as onderdrukking laat toeneem in vergelyking met ‘n terapeutiese dosis van enigeen daarvan alleen. TRIAMIST moet dus met omsigtigheid gebruik word in pasiënte wat alreeds kortikosteroïede ontvang.Die vervanging van ‘n sistemiese kortikosteroïed met ‘n topikale kortikoïed, soos TRIAMIST neussproei, kan gepaardgaan met tekens van adrenale ontoereikendheid en daarby kan sommige pasiënte onttrekkingsimptome ervaar, bv. gewrigs- en/of spierpyn, lusteloosheid en depressie. Pasiënte wat voorheen vir verlengde tydperke met sistemiese kortikosteroïede behandel is en oorgeskakel is na topikale kortikoïede soos TRIAMIST neussproei, moet noukeurig gemoniteer word vir akute adrenale ontoereikendheid in reaksie op stres. In daardie pasiënte wat asma of ander kliniese toestande het wat langtermynbehandeling met sistemiese kortikosteroïede vereis, kan ‘n te vinnige verlaging van sistemiese kortikosteroïede ‘n ernstige verergering in hulle simptome veroorsaak.Pasiënte wat immuunonderdrukkende dosisse kortikosteroïede ontvang, moet besondere sorg neem om blootstelling aan waterpokkies en masels te vermy. In vatbare pasiënte mag spesifieke immunoglobulien- of antivirale terapie nodig wees.Infeksies van die neus en farinks met Candida albicans mag voorkom. Wanneer sodanige infeksie ontwikkel mag behandeling met gepaste plaaslike of sistemiese terapie en staking van behandeling met TRIAMIST neussproei nodig wees.TRIAMIST neussproei moet versigtig gebruik word, indien dit enigsins gebruik word, in pasiënte met aktiewe of dormante tuberkuleuse infeksies van die respiratoriese weg of in pasiënte met onbehandelde fungus-, bakteriële of sistemiese virusinfek-sies of okulêre herpes simplex.Weens die onderdrukkende effek wat kortikosteroïede op wondgenesing het, moet TRIAMIST neussproei met omsigtig-heid gebruik word in pasiënte wat onlangs neusseptumulkusse, nasale chirurgie of trouma gehad het, totdat genesing plaasgevind het.Perforasies van die neusseptum is selde aangemeld. Wanneer dit in oormatige dosisse gebruik word, mag sistemiese kortikosteroïed-effekte soos hiperkortisisme en bynieronderdruk-king verskyn. Indien sulke veranderings voorkom, moet TRIAMIST neussproei geleidelik gestaak word, in ooreenstem-ming met aanvaarde prosedures vir staking van orale sterioïed- terapie.Effek op die vermoë om te bestuur en masjinerie te hanteer:TRIAMIST het geen of onbeduidende invloed op die vermoë om te bestuur en masjiene te hanteer.INTERAKSIESKortikosteroïede het ‘n onderdrukkende effek op wondgenesing en moet versigtig saam met TRIAMIST gebruik word (sien “WAARSKUWINGS EN SPESIALE VOORSORG-MAATREËLS”).SWANGERSKAP EN BORSVOEDINGSwangerskapDit is aangetoon dat kortikosteroïede teratogenies in diere is na

SKEDULERINGSTATUS S3EIENDOMSNAAM EN DOSEERVORM

TRIAMIST (Neussproei)Lees hierdie hele inligtingsblad noukeurig voordat u begin om TRIAMIST te neem.

• Hou hierdie inligtingsblad. Dit mag nodig wees dat u dit weer lees.

• Indien u verdere vrae het, vra asseblief u dokter of u apteker.

TRIAMIST is vir u persoonlik voorgeskryf en u moet nie u medisyne met ander mense deel nie. Dit mag skadelik wees vir hulle, selfs al het hulle dieselfde simptome as u.1. WAT TRIAMIST BEVAT:Die aktiewe bestanddeel is 55 μg triamsinoloonasetonied per spuit.Die ander bestanddele is anhidriese glukose, karboksimetiel-sellulose, dinatriumedetaat, soutsuur, mikrokristallyne sellulose, polisorbaat 80, natriumhidroksied en water vir inspuiting.Die preserveermiddel is bensalkoniumchloried 0,015 % m/m.2. WAARVOOR TRIAMIST GEBRUIK WORD TRIAMIST neussproei behoort aan ‘n klas medisyne genaamd kortikosteroïede. Dit word gebruik vir die voorkomende behande-ling van allergiese toestande van die neus, bekend as seisoenale en nie-seisoenale (meerjarige) rinitis, wat simptome veroorsaak soos nies, gejeuk, toe neus en loopneus. 3. VOORDAT U TRIAMIST GEBRUIK Moenie TRIAMIST gebruik nie:

• Indien u hipersensitief (allergies) is vir die aktiewe bestand-deel, triamsinoloonasetonied, of vir enige van die ander bestanddele in die formulasie.

• Indien u jonger as 6 jaar is.Bespreek bogenoemde met u dokter voordat u TRIAMIST gebruik.Neem spesiale sorg met TRIAMIST:Die teenwoordigheid van ander mediese toestande mag ‘n invloed hê op die gebruik van TRIAMIST aangesien dit dosisaan-passing of spesiale monitering mag nodig maak. Lig asseblief u dokter of apteker in indien enige van die volgende op u van toepassing is:

• U is swanger of borsvoed u baba (sien asseblief "Swanger-skap en borsvoeding").

• U neem kortikosteroïede in tabletvorm op per inspuiting (sien asseblief "Die gebruik van ander medisyne saam met TRIAMIST").

• U immuunstelsel is onderdruk.• U het ‘n infeksie van die neus of keel, hetsy ‘n virale, swam-

of bakteriële infeksie.• U ontvang huidiglik behandeling vir tuberkulose of het ‘n

geskiedenis van tuberkulose.• U is onlangs gediagnoseer met ‘n ulkus van u neusseptum,

of het onlangs nasale chirurgie ondergaan of u het onlangs besering van u neus gehad.

Veiligheid en effektiwiteit van TRIAMIST is nie in kinders jonger as 6 jaar bepaal nie. Dit is aangetoon dat mondelikse kortikosteroïede (bv. tablette of stroop) onderdrukking van groei in kinders en tieners veroorsaak, veral indien hulle hoë dosisse oor lang tye ontvang het. Indien u kind kortikosteroïede ontvang en u is bekommerd dat hy/sy te stadig groei, bespreek dit asseblief met die behandelende dokter.TRIAMIST mag sproei (infeksie met die gis Candida albicans) van die neus en keel veroorsaak. Dit sal presenteer met wit plakette in die mond, keel of neus. Lig asseblief u dokter in indien sulke simptome ontstaan, aangesien behandeling met antiswam-middels en/of staking van TRIAMIST terapie mag nodig wees.In sommige gevalle het TRIAMIST perforasie van die neussep-tum veroorsaak. Dit mag presenteer met neusbloedings, pyn of met ‘n nasale afskeiding. Rapporteer asseblief dadelik enige sodanige simptome aan u dokter.Indien u oormatige dosisse TRIAMIST vir ‘n verlengde tydperk gebruik, mag u sistemiese newe-effekte ontwikkel, soos onder meer gewigstoename, herverspreiding van vet, velverdunning, en onderdrukking van bynierfunksie. Gebruik TRIAMIST asseblief presies soos wat u dokter voorgeskryf het.Die gebruik van TRIAMIST met kos en drinkgoed:TRIAMIST word nie deur kos en drinkgoed geaffekteer nie.Swangerskap en borsvoeding:Die gebruik van TRIAMIST tydens swangerskap mag skadelik wees vir u baba, aangesien dierestudies aangetoon het dat topikale aanwending van kortikosteroïede, soos in TRIAMIST, skadelik mag wees. Die veiligheid van die gebruik van TRIAMIST terwyl u u baba borsvoed is nie vasgestel nie en u moet nie u baba borsvoed nie.Indien u swanger is of u baba borsvoed, raadpleeg asseblief u dokter, apteker of ander gesondheidsorgwerker voordat hierdie medisyne gebruik word.Bestuur en die gebruik van masjinerie:Dit het geen uitwerking op die vermoë om te bestuur of masjinerie te gebruik nie.Die gebruik van ander medisyne saam met TRIAMIST:Sê altyd vir u gesondheidsorgwerker indien u enige ander medisyne gebruik. (Dit sluit komplementêre of tradisionele medisynes in.)Dit is veral belangrik om u dokter in te lig indien u ander kortikosteroïede, soos kortikosteroïedtablette of -inspuitings, onlangs gebruik het of tans gebruik. Indien TRIAMIST met ander kortikosteroïede gekombineer word, sal dit nodig wees dat u noukeurig dopgehou word vir moontlike newe-effekte. U mag onttrekkingsimptome ontwikkel, soos gewrigs- of spierpyn, depressie en moegheid, indien u dosis van ander kortikosteroïede te vinnig verminder word. Dit mag ook vererge-ring van asmasimptome veroorsaak. U dokter sal u ook moniteer vir ander komplikasies, soos verlaagde bynierfunksie. Indien u baie hoë dosisse kortikosteroïede gebruik (om die funksie van u immuunstelsel te onderdruk), moet u blootstelling aan mense met waterpokkies of masels vermy.4. HOE OM TRIAMIST TE GEBRUIKMoenie medisyne wat vir u voorgeskryf is, met enigiemand anders deel nie.Gebruik TRIAMIST altyd presies soos aangedui of soos wat u dokter voorgeskryf het. Kontroleer met u dokter of apteker indien u onseker is. U dokter sal vir u sê hoe lank behandeling met TRIAMIST sal duur. Moenie behandeling vroeër staak omdat u beter voel nie. Indien u die indruk kry dat die uitwerking van

TRIAMIST te sterk of te swak is, sê vir u dokter of apteker. Hierdie medisyne sal nie u simptome onmiddellik verlig nie. Dit mag verligting bring van die eerste dag van behandeling af, maar gewoonlik is dit nodig dat dit ‘n paar dae gebruik word om die volle voordeel te verkry.Elke spuit van die nasale aktueerder lewer 55 µg van die aktiewe bestanddeel (triamsinoloonasetonied) in die neus, na aanvank-like voorbereiding van TRIAMIST neusspuit (gewoonlik 5 spuite totdat ‘n eenvormige sproei waargeneem word). Indien die neusspuit vir 14 dae of langer nie gebruik is nie, kan dit weer voldoende voorberei word met een sproei. U moet die neusstuk weg van u af laat wys wanneer u die spuitstuk voorberei. Moenie die voorgeskrewe dosis oorskry nie. Die gewone dosis vir volwassenes en kinders 12 jaar en ouer is twee spuite in elke neusgat een keer per dag. Vir kinders 6 tot 12 jaar is die gewone dosis een spuit per neusgat een keer per dag. In sommige gevalle mag u dokter besluit om u dosis te verlaag of te verhoog, afhangende van u respons op die behandeling en/of die ernstigheidsgraad van u toestand.Die meeste pasiënte sal verligting van die simptome binne die eerste drie tot vier dae van behandeling voel. Dit mag egter tot drie weke neem om die volle voordeel van die behandeling te ervaar. Indien u na 3 weke nog nie gereageer het op TRIAMIST behande-ling nie, mag u dokter besluit om behandeling met TRIAMIST te staak. Andersins moet u aanhou met behandeling vir so lank as wat u dokter voorgeskryf het. Gebruik van TRIAMIST langer as 3 maande aaneenlopend in kinders jonger as 12 jaar word nie aanbeveel nie.Skud die bottel deeglik voor elke gebruik.Indien u meer TRIAMIST gebruik het as wat u behoort:In geval die hele inhoud van die bottel op een slag toegedien word, hetsy via die mond of die neus, kan klinies beduidende sistemiese ongunstige effekte voorkom.In geval van oordosering, konsulteer u dokter of apteker. Indien nie een van hulle beskikbaar is nie, kontak die naaste hospitaal of gifbeheersentrum.Indien u vergeet om TRIAMIST te gebruik:Gebruik altyd TRIAMIST presies soos wat u dokter vir u voorgeskryf het. Om maksimale voordeel uit die behandeling te kry, is dit belangrik om TRIAMIST elke dag te gebruik en nie dosisse oor te slaan nie. Indien u egter ‘n dosis oorgeslaan het en dis amper tyd vir u volgende dosis, ignoreer die oorgeslane dosis en keer terug na u gewone doseringskedule. Moenie ‘n dubbele dosis neem om te vergoed vir die vergete individule dosis nie.Effekte wanneer behandeling met TRIAMIST gestaak word:TRIAMIST neussproei moet geleidelik gestaak word, in ooreenstemming met aanvaarde prosedures vir die staking van mondelikse steroïedterapie.5. MOONTLIKE NEWE-EFFEKTETRIAMIST kan newe-effekte hê.Nie alle newe-effekte wat vir TRIAMIST aangemeld is, word in hierdie inligtingsblad ingesluit nie. Indien u algemene gesondheid agteruitgaan terwyl u TRIAMIST gebruik, of indien u enige ongunstige effekte ervaar, raadpleeg asseblief u dokter, apteker of ander gesondheidswerker.Die volgende newe-effekte is dikwels aangemeld:

• Hoofpyn.• Toe neus of loopneus, seer keel en ‘n brandgevoel,

droogheid of ander irritasie binne die neus. Laasgenoemde is gewoonlik lig en verbygaande.

Die volgende newe-effekte is minder dikwels aangemeld:• Korsvorming binne-in die neus of neusbloedings, veral

indien die sproei verkeerdelik na die neusseptum gerig word en nie na die kante toe nie.

• Ulserasie van die selle van die neusvoering.• Sproei (Candida albicans infeksie) van die neus, wat

presenteer met wit plakette binne-in die neus of keel.• Perforasie van die neusseptum, wat mag presenteer met

neusbloeding, pyn of ‘n nasale afskeiding.• Brand- of steekgevoel wat aanhou nadat die sproei gebruik

is.• Nies.• Sinuskongestie en toe neus.• Keelongemak.• Verhoogde druk binne in die oog.

Die insidensie van die volgende newe-effek is onbekend:• Droogheid van die slymvliesmembraan (voering) binne die

neus of mond.6. BERGING EN WEGDOENING VAN TRIAMISTBerg teen of benede 25 °C.Moenie in oop kaste bêre waar dit blootgestel is aan lig nie.Gooi weg binne twee maande nadat die bottel die eerste keer oopgemaak is.BÊRE ALLE MEDISYNE BUITE BEREIK VAN KINDERS.Neem alle ongebruikte medisyne terug na u apteker.Moenie ongebruikte medisyne in dreine of rioolsisteme (bv. toilette) weggooi nie.7. AANBIEDING VAN TRIAMIST20 mℓ silindriese wit ondeursigtige HDPE-bottel wat 120 afgemete dosisse verskaf met ‘n netto vulgewig van 16,5 g. Elke bottel het ‘n neusspuit met ‘n wit HDPE punt wat met ‘n silwer sluitstuk aan die bottel vasgeheg is, ‘n wit ondeursigtige aktueerder en ‘n deurskynende doppie vir die spuitpunt.Die bottel word in ‘n karton verpak.8. IDENTIFIKASIE VAN TRIAMISTWit tot naaswit homogene heroplosbare suspensie, sonder enige sigbare deeltjies.9. REGISTRASIENOMMER45/21.5.1/067610. NAAM EN ADRES VAN DIE REGISTRASIEHOUERCIPLA MEDPRO (PTY) LTDGebou 9, Parc du CapMispelstraat, Bellville, 753011. DATUM VAN PUBLIKASIE2 Oktober 2015

topikale aanwending. TRIAMIST moet gevolglik nie tydens swangerskap gebruik word nie.Hipo-adrenalisme mag voorkom in babas van moeders wat kortikosteroïede tydens swangerskap ontvang het. Hierdie babas moet noukeurig dopgehou word.BorsvoedingDie veiligheid van TRIAMIST tydens borsvoeding is nie bepaal nie, gevolglik moet vrouens nie hulle babas borsvoed nie.DOSIS EN GEBRUIKSAANWYSINGSMoenie die voorgeskrewe dosis oorskry nie. Skud die bottel elke keer deeglik voor gebruik.Elke aktuasie lewer 55 mikrogram triamsinoloonasetonied uit die neusstuk aan die pasiënt, nadat dit aanvanklik voorberei is deur die pomp 5 keer te druk totdat ‘n fyn missproei gelewer word. Dit sal vir 2 weke voldoende voorberei wees. Indien die produk vir meer as 2 weke nie gebruik word nie, kan dit weer voldoende voorberei word met een sproei. Die neusstuk moet weg van die pasiënt af wys terwyl die pasiënt besig is om die toestel voor te berei.Volwassenes en kinders 12 jaar en ouer:Dit word aanbeveel dat die dosering begin word teen 220 µg as twee sproeie in elke neusgat een keer daagliks vir volwassenes en kinders 12 jaar en ouer.Pediatriese pasiënte van 6 tot 12 jaar oud:Die aanbevole dosis is 110 µg as 1 spuit in elke neusgat daagliks. In pasiënte met ernstiger simptome kan ‘n dosis van 220 µg (2 spuite in elke neusgat een keer daagliks) gebruik word. Sodra simptome egter onder beheer is, moet pasiënte op die laagste effektiewe dosis in stand gehou word. Gebruik langer as 3 maande aaneenlopend in kinders jonger as 12 jaar word nie aanbeveel nie.

Aanvanklike assessering vir respons moet gedurende die eerste drie tot vier dae gemaak word en periodiek daarna totdat die pasiënt se simptome gestabiliseer is. ‘n Mate van verligting kan in ongeveer twee derdes van pasiënte in daardie tyd verkry word. Indien voldoende verligting van simptome nie na 3 weke se behandeling verkry is nie, moet TRIAMIST neussproei gestaak word en alternatiewe vorms van behandeling moet oorweeg word.Dit is altyd gewens om ‘n individuele pasiënt te titreer tot die minimum effektiewe dosis om die moontlikheid van newe-effekte te verminder. Wanneer die maksimum voordeel bereik is en simptome onder beheer is, is aangetoon dat vermindering van die dosis na 110 µg (een spuit in elke neusgat een keer per dag) effektief is om simptome van allergiese rinitis onder beheer te hou in pasiënte wat aanvanklik op 220 µg/dag beheer is.NEWE-EFFEKTEDie ongunstige reaksies wat die algemeenste aangemeld is, sluit dié in wat die slymvliesmembrane van die neus en keel behels. Senuweesisteemversteurings:Dikwels: Hoofpyn.Oogversteurings:Minder dikwels: Okulêre hipertensie.Respiratoriese, torakale en mediastinale versteurings:Dikwels: Rinitis en faringitis, brandgevoel,

droogheid of ander irritasie binne-in die neus.

Minder dikwels: Korsvorming binne die neus of neusbloeding, seer keel, ulserasie van neusslymvliese, nasale kandidiase, faringeale kandidiase, nasale septum perforasie, brand- of steekgevoel wat aanhou nadat sproei gebruik is, sowel as nies en sinuskongestie, toe neus en keelongemak.

Frekwensie onbekend: Droë slymvliese.BEKENDE SIMPTOME VAN OORDOSERING EN BESONDER-HEDE VIR DIE BEHANDELING DAARVANIn geval die hele inhoud van die bottel meteens toegedien word, hetsy via orale of nasale toediening. Die pasiënt mag gastro-intestinale ongemak ervaar.Oordosering moet simptomaties en ondersteunend behandel word.IDENTIFIKASIEWit tot naaswit homogene heroplosbare suspensie, sonder enige sigbare deeltjies.AANBIEDING20 mℓ silindriese wit ondeursigtige HDPE-bottel wat 120 afgemete dosisse verskaf met ‘n netto vulgewig van 16,5 g. Elke bottel het ‘n neusspuit met ‘n wit HDPE punt wat met ‘n silwer sluitstuk aan die bottel vasgeheg is, ‘n wit ondeursigtige aktueerder en ‘n deurskynende doppie vir die spuitpunt.Die bottel word in ‘n karton verpak.BERGINGSINSTRUKSIESBerg teen of benede 25 °C.Beskerm teen lig.Gooi weg binne twee maande nadat die bottel die eerste keer oopgemaak is.HOU BUITE BEREIK VAN KINDERS.REGISTRASIENOMMER45/21.5.1/0676NAAM EN BESIGHEIDSADRES VAN DIE HOUER VAN DIE REGISTRASIESERTIFIKAATCIPLA MEDPRO (PTY) LTDGebou 9, Parc du CapMispelstraat, Bellville, 7530DATUM VAN PUBLIKASIE VAN DIE VOUBILJET:2 Oktober 2015

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