Spray-Tish is a Nasal Mist for the local treatment of blocked and stuffy noses. It contains as the active ingredient tramazoline hydrochloride in a strength of 1.18mg/mL. Benzalkonium chloride mg/mL is used as a preservative. Spray-Tish also contains sorbitol solution 70% (non-crystallising), citric acid monohydrate, sodium phosphate-dibasic dihydrate, sodium chloride and purified water.
Tramazoline hydrochloride, an alpha-sympathomimetic, has a vasoconstricting effect and rapidly reduces swelling of the nasal mucosa. This leads to a rapid and long-lasting decongestion of the nasal passages. After intranasal administration of Spray-Tish, local vasoconstriction usually occurs within 5 minutes and lasts for up to 8 hours.
For the symptomatic relief of nasal congestion associated with common cold, hayfever and rhinitis.
Spray-Tish should not be used in:
Patients with dry diseases of the nasal mucous membrane which form crusts and scabs (rhinitis sicca).
Patients after cranial surgery via the nasal cavity.
Patients with narrow-angle glaucoma
Patients with hypersensitivity to tramazoline hydrochloride, benzalkonium chloride or any other excipient in Spray-Tish.
Children under six years of age, as specific studies to establish safety are not available.
Spray-Tish should be used with caution and on medical advice in patients with arterial hypertension, heart diseases, hyperthyroidism, prostate hypertrophy, phaeochromocytoma and porphyria due to the potential risk of systemic absorption. Patients with glaucoma should consult their doctor before commencing treatment. Caution should be used in patients receiving MAO inhibitors, tricylic antidepressants, vasopressor drugs and antihypertensives (see Interactions with other Drugs). The use of Spray-Tish for prolonged periods of time is not recommended. If the symptoms have not disappeared following the use of Spray-Tish for 7 days, a physician should be consulted as to whether the treatment should be continued or not. Patients with chronic nasal stuffiness should consult their physician rather than continue the use of Spray-Tish. Prolonged use of mucous membrane-decreasing cold remedies may lead to chronic inflammation (and thus to a blocked nose) and finally to wasting (atrophy) of the nasal mucous membrane. Rebound congestion (marked mucosal swelling) can occur on cessation of continuous treatment over long periods, after the therapeutic effect has abated. Care should be taken that Spray-Tish does not enter the eyes as it may cause irritation. Spray-Tish contains the preservative benzalkonium chloride which may cause irritation of the nasal mucosa.
Safety of tramazoline hydrochloride in pregnancy has not been established. Therefore, Spray- Tish should not be used in the first trimester of pregnancy. In the second and third trimesters of pregnancy, Spray-Tish should only be used in pregnant women under medical advice if the potential benefits to the mother outweigh the possible hazards to the fetus.
Safety during lactation has not been established. No specific studies are available to determine the excretion of the active ingredient, tramazoline hydrochloride, in human breast milk following nasal administration. Therefore, Spray-Tish should only be used under medical advice if the benefits of using Spray-Tish in nursing mothers outweigh the possible effects on the child.
If monoamine oxidase inhibitors (MAO inhibitors), tricyclic antidepressants or vasopressor drugs are given simultaneously, effects on the cardiovascular system can lead to an increase in blood pressure. Combined use with tricyclic antidepressants can also lead to arrhythmias. Interactions with antihypertensives, especially those whose action involves the sympathetic nervous system, can be complex and may result in various cardiovascular effects.
No studies on the effects on the ability to drive and use machines have been performed. However, patients should be advised that they may experience undesirable effects such as hallucinations, somnolence, sedation, dizziness and fatigue during treatment with Spray-Tish. Therefore, caution is recommended when driving a car or operating machinery. If patients experience the above mentioned side effects they should avoid potentially hazardous tasks such as driving or operating machinery.
The following side effects may occur with the use of Spray-Tish:
Nervous system disorders:
Headache, somnolence, sedation, dizziness, dysgeusia
Psychiatric disorders:
Hallucinations, insomnia, restlessness
Cardiac disorders:
Palpitations, tachycardia, arrhythmias
Respiratory, thoracic and mediastinal disorders:
Rhinorrhea, epistaxis, nasal oedema, nasal discomfort, nasal dryness and sneezing.
Gastro-intestinal disorders:
Nausea
Immune system disorders:
Hypersensitivity
Skin and subcutaneous tissue disorders
Rash, pruritus, skin oedema *
General disorders and administration site conditions
Mucosal oedema *, fatigue
Investigations
Blood pressure increased
*as symptom of hypersensitivity
Adults and children six years of age and over:
The recommended dose is 1 to 2 sprays into each nostril up to 4 times a day as required. Administration should not be continued longer than 5 to 7 days without medical advice.
Directions for Use
Patients should be advised not to pierce the nozzle or attempt to enlarge the hole, as the existing hole is designed to deliver the correct dose of Spray-Tish. To use:
Remove protective cap.
Before using the spray pump for the first time, rapidly depress the spray pump until an even spray mist is released. Your Spray-Tish is now primed and ready for use. With subsequent use, the spray pump is immediately functional. However, if used infrequently, it may require repriming.
Blow nose thoroughly before using Spray-Tish.
Insert the spray adaptor into the nostril and depress the spray pump while breathing in gently through the nose. Administer 1 to 2 sprays and then repeat in the other nostril.
Replace the protective cap after use
It is recommended that the spray adaptor be cleaned after use.
In case of overdose, immediately contact the Poisons Information Centre (call 13 11 26) for advice.
An increase in blood pressure and tachycardia may, especially in children, be followed by a drop in blood pressure, subnormal temperatures, shock and reflex bradycardia. As with other alpha-sympathomimetics, the clinical picture of an intoxication with Spray-Tish may be confusing, because phases of stimulation and depression of the CNS and cardiovascular system may alternate. Especially in children, intoxications result in CNS effects with seizures and coma, bradycardia, respiratory depression. Symptoms of stimulation of the CNS are anxiety, agitation, hallucinations and seizures. Symptoms of depression of the CNS are decrease of body temperature, lethargy, somnolence and coma. In addition, the following symptoms may occur: mydriasis, miosis, sweating, fever, pallor, cyanosis of the lips, cardiovascular dysfunction including cardiac arrest, respiratory dysfunction including respiratory failure and respiratory arrest, psychological alterations.
In case of nasal overdosing, rinse out or clean the nose carefully at once. Symptomatic treatment may be required.
15 mL metered nasal mist containing tramazoline hydrochloride 1.18mg/mL. Each metered dose contains 82 micrograms of tramazoline hydrochloride. Each bottle contains 180 metered doses.
Schedule 2
Boehringer Ingelheim Pty Limited ABN 52 000 452 308 78 Waterloo Road NORTH RYDE NSW 2113 Text approved by the Therapeutic Goods Administration (TGA) on 21 August 1998 Date of most recent amendment: 5 March 2010