SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
1
SUMMARY OF PRODUCT CHARACTERISTICS
2
1. NAME OF THE MEDICINAL PRODUCT
TRIAMCINOLONE ACETONIDE Sanofi Belgium 55 micrograms/dose, nasal spray, suspension
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Bottles of TRIAMCINOLONE ACETONIDE contain either 6.5 g or 16.5 g of suspension (with 3.575 mg or 9.075 mg triamcinolone acetonide respectively). One delivered dose contains 55 micrograms of triamcinolone acetonide.
Excipient with known effect: 15 micrograms of benzalkonium chloride/delivered dose.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Nasal spray, suspension. It is an unscented, off-white, thixotropic suspension of microcrystalline triamcinolone acetonide in an aqueous medium.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
TRIAMCINOLONE ACETONIDE is indicated for the treatment of symptoms of allergic rhinitis in adults aged 18 years and older.
4.2 Posology and method of administration
Posology Patients aged 18 years and over: The recommended starting dose is 220 micrograms as 2 sprays in each nostril once daily. Once symptoms are controlled patients can be maintained on 110 micrograms (1 spray in each nostril once daily).
Without medical supervision, TRIAMCINOLONE ACETONIDE is not recommended for use longer than three months. If symptoms of allergic rhinitis are not or insufficiently relieved within 14 days, a physician must be consulted.
TRIAMCINOLONE ACETONIDE does not have an immediate effect on allergic signs and symptoms. This medicine only works if used on a regular basis. An improvement in some patient symptoms may be seen within the first day of treatment with TRIAMCINOLONE ACETONIDE and relief may be expected in 3 to 4 days. When TRIAMCINOLONE ACETONIDE is prematurely discontinued symptoms may not recur for several days (see also section 5.1).
Special population Paediatric population TRIAMCINOLONE ACETONIDE is not recommended in children and adolescents under 18 years of age.
Method of administration TRIAMCINOLONE ACETONIDE is for nasal use only. It is important to shake the bottle gently before each use.
3
It is important for the patient to follow the proper administration technique by tilting the head slightly forward and pointing the nozzle away from the nasal septum to avoid local side effects.
Each actuation delivers 55 micrograms of triamcinolone acetonide from the nose piece to the patient (estimated from in vitro testing) after an initial priming of 5 sprays until a fine mist is achieved. TRIAMCINOLONE ACETONIDE 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 pointed away from you while you are doing this.
After using the spray: Wipe the nozzle carefully with a clean tissue or handkerchief, and replace the cap.
If the spray does not work and it may be blocked, clean it as follows. NEVER try to unblock it or enlarge the tiny 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
1. Remove the cap and the spray nozzle only* (pull off).
2. Soak the cap and spray nozzle 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 to air-dry.
4. Re-fit the spray nozzle.
5. Prime the unit as necessary until a fine mist is produced and use as normal.
* Part as indicated on diagram below,
Also, the bottle should be discarded after 30 actuations or within one month of starting treatment (6.5 g pack), or after 120 actuations or within 2 months of starting treatment (16.5 g pack). Do not transfer any remaining suspension to another bottle.
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
4.4 Special warnings and precautions for use
If there is any reason to suppose that adrenal function is impaired, care must be taken while transferring patients from systemic steroid treatment to TRIAMCINOLONE ACETONIDE.
4
In clinical studies with TRIAMCINOLONE ACETONIDE administered intranasally, the development of localised infections of the nose and pharynx with Candida albicans has rarely occurred. When such an infection develops it may require treatment with appropriate local therapy and temporary discontinuation of treatment with TRIAMCINOLONE ACETONIDE.
Because of the inhibitory effect of corticosteroids on wound healing in patients who have experienced recent nasal septal ulcers, nasal surgery or trauma, TRIAMCINOLONE ACETONIDE should be used with caution until healing has occurred.
Systemic effects of nasal corticosteroids may occur, particularly at high doses prescribed for prolonged periods. These effects are much less likely to occur than with oral corticosteroids and may vary in individual patients and between different corticosteroid preparations. Potential systemic effects may include Cushing’s syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, cataract, glaucoma and more rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in children).
Treatment with higher than recommended doses may result in clinically significant adrenal suppression. If there is evidence of using higher than recommended doses, then additional systemic corticosteroid cover should be considered during periods of stress or elective surgery.
Glaucoma and/or cataracts have been reported in patients receiving nasal corticosteroids. Therefore, close monitoring is warranted in patients with a change in vision or with a history of increased intraocular pressure, glaucoma and/or cataracts.
Visual disturbance Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.
TRIAMCINOLONE ACETONIDE contains benzalkonium chloride, long term use may cause oedema of the nasal mucosa.
Paediatric population TRIAMCINOLONE ACETONIDE is not recommended in children and adolescents under 18 years of age.
4.5 Interaction with other medicinal products and other forms of interaction
Co-treatment with CYP3A inhibitors, including cobicistat-containing products, is expected to increase the risk of systemic side-effects. The combination should be avoided unless the benefit outweighs the increased risk of systemic corticosteroid side-effects, in which case patients should be monitored for systemic corticosteroid side-effects.
4.6 Fertility, pregnancy and lactation
Clinical experience in pregnant women is limited. In animal studies, corticosteroids have been shown to induce teratogenic effects. Triamcinolone acetonide may pass into human breast milk. Triamcinolone acetonide should not be administered during pregnancy or lactation unless the therapeutic benefit to the mother is considered to outweigh the potential risk to the foetus/baby.
4.7 Effects on ability to drive and use machines
5
TRIAMCINOLONE ACETONIDE has no or negligible influence on the ability to drive and use machines.
4.8 Undesirable effects
The adverse reactions reported in clinical trials with TRIAMCINOLONE ACETONIDE most commonly involved the mucous membranes of the nose and throat.
The following terminologies have been used in order to classify the occurrence of adverse reactions: Very common (≥ 1/10); Common (≥ 1/100 to <1/10); Uncommon (≥ 1/1,000 to < 1/100); Rare (≥ 1/10,000 to < 1/1,000); Very rare (1/10,000); and not known (cannot be estimated from the available data).
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
The most frequent adverse reactions were:
Infections and infestations Common: flu syndrome, pharyngitis, rhinitis
Immune system disorders Not known: hypersensitivity (including rash, urticaria, pruritus and facial oedema)
Psychiatric disorders Not known: insomnia
Nervous system disorders Common: headache Not known: dizziness, alterations of taste and smell
Eye disorders Not known: chorioretinopathy, cataract, glaucoma, increased ocular pressure, blurred vision (see also section 4.4)
Respiratory, thoracic and mediastinal disorders Common: bronchitis, epistaxis, cough Rare: nasal septum perforations Not known: nasal irritation, dry mucous membrane, nasal congestion, sneezing, dyspnoea
Gastrointestinal disorders Common: dyspepsia, tooth disorder Not known: nausea
General disorders and administration site conditions Not known: fatigue
Investigations Not known: decreased blood cortisol
Systemic effects of nasal corticosteroids may occur, particularly when prescribed at high doses for prolonged periods.
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare
6 professionals are asked to report any suspected adverse reactions via [the national reporting system listed in Appendix V*.] [* To be adapted nationally]
4.9 Overdose
Like any other nasally administered corticosteroid, acute overdosing with TRIAMCINOLONE ACETONIDE is unlikely in view of the total amount of active ingredient present. In the event that the entire contents of the bottle were administered all at once, via either oral or nasal application, clinically significant systemic adverse events would most likely not result. The patient may experience some gastrointestinal upset if taken orally.
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE, Corticosteroids, ATC code: R 01 AD11.
Mechanism of action TRIAMCINOLONE ACETONIDE is a more potent derivative of triamcinolone and is approximately 8 times more potent than prednisone. Although the precise mechanism of corticosteroid antiallergic action is unknown, corticosteroids are very effective in the treatment of allergic diseases in man.
Pharmacodynamic effects TRIAMCINOLONE ACETONIDE does not have an immediate effect on allergic signs and symptoms. An improvement in some patient symptoms may be seen within the first day of treatment with TRIAMCINOLONE ACETONIDE and relief may be expected in 3 to 4 days. When TRIAMCINOLONE ACETONIDE is prematurely discontinued symptoms may not recur for several days.
In clinical studies performed in adults and children at doses up to 440 μg/day intranasally, no suppression of the Hypothalamic-Pituitary-Adrenal (HPA) axis has been observed.
5.2 Pharmacokinetic properties
Single dose intranasal administration of 220 micrograms of TRIAMCINOLONE ACETONIDE in normal adult subjects and in adult patients with allergic rhinitis demonstrated low absorption of triamcinolone acetonide. The mean peak plasma concentration was approximately 0.5 ng/ml (range 0.1 to 1 ng/ml) and occurred at 1.5 hours post dose. The mean plasma drug 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. Dose proportionality was demonstrated in normal subjects and in patients following a single intranasal dose of 110 micrograms or 220 micrograms TRIAMCINOLONE ACETONIDE. Following multiple doses in paediatric patients, plasma drug concentrations, AUC, Cmax and Tmax were similar to those values observed in adult patients.
5.3 Preclinical safety data
In pre-clinical studies, only effects typical of glucocorticoids were observed.
Like other corticosteroids, triamcinolone acetonide (administered by inhalation or other routes) has been shown to be teratogenic in rats and rabbits, resulting in cleft palate and/or internal hydrocephaly and axial skeletal defects. Teratogenic effects, including CNS and cranial malformations, have also been observed in non-human primates.
No evidence of mutagenicity was detected in in vitro gene mutation tests.
7
Carcinogenicity assays in rodents show no increase in the incidence of individual tumour types.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients microcrystalline cellulose and carmellose sodium (dispersible cellulose) polysorbate 80 purified water anhydrous glucose benzalkonium chloride (50% w/v solution) disodium edetate hydrochloric acid or sodium hydroxide (for pH-adjustment).
6.2 Incompatibilities
Not applicable
6.3 Shelf life
Unopened: 2 years. After first opening: 1 month for the 6.5 g (30 actuation) pack and 2 months for the 16.5 g (120 actuations) pack.
6.4 Special precautions for storage
Do not store above 25°C For storage conditions after first opening of the medicinal product, see section 6.3.
6.5 Nature and contents of container
TRIAMCINOLONE ACETONIDE is contained in a 20 ml high density polyethylene (HDPE) bottle fitted with a metered-dose spray pump unit. One bottle of TRIAMCINOLONE ACETONIDE contains either 6.5 g or 16.5 g of suspension, providing 30 or 120 actuations respectively.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
No special requirements
7. MARKETING AUTHORISATION HOLDER
[To be completed nationally]
8. MARKETING AUTHORISATION NUMBER(S)
[To be completed nationally]
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
8
[To be completed nationally]
10. DATE OF REVISION OF THE TEXT
[To be completed nationally]
9
LABELLING
10
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer Carton
1. NAME OF THE MEDICINAL PRODUCT
TRIAMCINOLONE ACETONIDE Sanofi Belgium 55 micrograms/dose, nasal spray, suspension Triamcinolone acetonide
2. STATEMENT OF ACTIVE SUBSTANCE(S)
One delivered dose contains 55 micrograms of Triamcinolone acetonide.
3. LIST OF EXCIPIENTS
Microcrystalline cellulose and carmellose sodium (dispersible cellulose), polysorbate 80, purified water, glucose anhydrous, benzalkonium chloride (see leaflet for further information), edetate disodium and hydrochloric acid or sodium hydroxide (for pH-adjustment).
4. PHARMACEUTICAL FORM AND CONTENTS
Nasal spray suspension <1 bottle (30 sprays)> <1 bottle (120 sprays)> [delete as appropriate nationally]
5. METHOD AND ROUTE(S) OF ADMINISTRATION
Shake well before use. Read the package leaflet before use. Nasal use
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN
Keep out of the sight and reach of children.
7. OTHER SPECIAL WARNING(S), IF NECESSARY
8. EXPIRY DATE
EXP : mm-yyyy
11
9. SPECIAL STORAGE CONDITIONS
Do not store above 25°C.
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
Not applicable
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
[To be completed nationally]
{Name and Address} <{tel}> <{fax}> <{e-mail}>
12. MARKETING AUTHORISATION NUMBER(S)
[To be completed nationally]
13. BATCH NUMBER
Lot:
14. GENERAL CLASSIFICATION FOR SUPPLY
[To be completed nationally]
15. INSTRUCTIONS ON USE
[To be completed nationally]
16. INFORMATION IN BRAILLE
[To be completed nationally]
17. UNIQUE IDENTIFIER – 2D BARCODE
<2D barcode carrying the unique identifier included.>
12
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA
PC: {number} SN: {number} NN: {number}
13
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION
TRIAMCINOLONE ACETONIDE Sanofi Belgium 55 micrograms/dose, nasal spray, suspension Triamcinolone acetonide Nasal use
2. METHOD OF ADMINISTRATION
Shake well before use. Read the package leaflet before use.
3. EXPIRY DATE
EXP: mm-yyyy
4. BATCH NUMBER
Lot:
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
<1 bottle (30 sprays)> <1 bottle (120 sprays)> [delete as appropriate nationally]
6. OTHER
Keep out of the sight and reach of children Do not store above 25°C
14
PACKAGE LEAFLET
15
Package leaflet: Information for the user
Triamcinolone acetonide Sanofi Belgium 55 micrograms/dose, nasal spray suspension Triamcinolone acetonide
Read all of this leaflet carefully before you start using this medicine because it contains important information for you The name of your medicine is ‘Triamcinolone acetonide Sanofi Belgium 55 micrograms/dose, nasal spray suspension’, throughout the rest of this document it will be referred to as ‘Triamcinolone acetonide. This medicine is available without prescription. However, you still need to use Triamcinolone acetonide carefully to get the best results from it. Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Keep this leaflet. You may need to read it again. Ask your doctor or pharmacist if you need more information or advice. If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. You must talk to a doctor if you do not feel better or if you feel worse after 14 days.
What is in this leaflet What Triamcinolone acetonide is and what it is used for What you need to know before you use Triamcinolone acetonide How to use Triamcinolone acetonide Possible side effects How to store Triamcinolone acetonide Contents of the pack and other information
1. What triamcinolone acetonide is and what it is used for
Triamcinolone acetonide contains a medicine called triamcinolone acetonide. This belongs to a group of medicines called corticosteroids which means it is a type of steroid. It is given as a spray in the nose to treat the nasal symptoms of allergic rhinitis.
Nasal symptoms of allergy include sneezing, itching, and having a blocked, stuffy or runny nose. These can be caused by things such as: • Animal fur or house dust mites. This type of allergy can happen at any time of the year. • Pollen. This type of allergy, such as hay fever, can be caused by different pollens in different seasons of the year.
This medicine only works if used on a regular basis and may not help your symptoms straight away. It helps some people within the first day of treatment, however, for other people it may take 3 to 4 days to feel a relief.
2. What you need to know before you use triamcinolone acetonide
Do not use Triamcinolone acetonide: if you are allergic to triamcinolone acetonide or any of the other ingredients of this medicine (listed in section 6) Signs of an allergic reaction to Triamcinolone acetonide include: a rash (hives), itching, swallowing or breathing problems, swelling of your lips, face, throat or tongue.
16
Warnings and precautions Talk to your doctor or pharmacist before using Triamcinolone acetonide if:
You have any infection of the nose or throat that is not treated. If you get a fungal infection while using Triamcinolone acetonide, stop using the spray until the infection has been treated. You have recently had a nose operation, or had an injury or ulcer in the nose. You are being transferred from steroid injections or tablets to Triamcinolone acetonide spray. You have had glaucoma or cataracts. If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before using this medicine.
Contact your doctor if you experience blurred vision or other visual disturbances.
Children and adolescents (under 18 years) This medicine is not recommended for use in children and adolescents under 18 years of age.
Operations or times of stress Your doctor may advise you to take a higher than normal dose of this medicine for medical reasons. If your dose is increased, tell your doctor if you are going to have an operation or are feeling unwell. This is because higher than normal doses of this medicine can lower your body’s ability to heal or cope with stress. If this happens, your doctor may decide you need further treatment with another medicine to help.
Other medicines and Triamcinolone acetonide Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is because Triamcinolone acetonide can affect the way some other medicines work. Also some medicines can affect the way Triamcinolone acetonide works. Some medicines may increase the effects of Triamcinolone acetonide and your doctor may wish to monitor you carefully if you are taking these medicines (including some medicines for HIV: ritonavir, cobicistat).
Pregnancy and breast-feeding and fertility If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines Triamcinolone acetonide has no or negligible influence on the ability to drive and use machines.
Triamcinolone acetonide contains benzalkonium chloride This medicine contains 15 micrograms benzalkonium chloride in each spray. Benzalkonium chloride may cause irritation or swelling inside the nose, especially if used for a long time.
3. How to use Triamcinolone acetonide
Triamcinolone acetonide is for nasal use only.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
Check with your doctor or pharmacist if you are not sure. The medicine only works if it is used regularly. It can take 3 to 4 days before you notice your symptoms getting better.
How much Triamcinolone acetonide to use Adults (18 years and over)
17
The usual starting dose is 2 sprays in each nostril each day Once the symptoms of allergy are under control, the dose may be lowered to 1 spray in each nostril each day If the symptoms do not go away (sufficiently) after 14 days, check with your doctor or pharmacist You should not use the spray for longer than three months without consulting your doctor
Children and adolescents (under 18 years) This medicine is not recommended for use in children and adolescents under 18 years of age.
How to use the spray Before using your nasal spray, blow your nose gently to clear your nostrils.
1. Preparing the bottle Remove the cap by pulling upwards. Shake the bottle gently before use.
2. If you are using the spray for the first time Hold the bottle upright. Point the spray away from you while doing this. Fill the pump with spray by pressing the nozzle downwards. This is called priming.
Press and release it 5 times Do this until a fine spray is produced The spray is now ready to use. 3. Using the spray Close one nostril with your finger Slightly tilt the head forward Hold the bottle upright and put the nozzle into the other nostril as far as is comfortable and point the nozzle away from the nasal septum (the partition in the nose which separates the nostrils) (see picture)
Breathe in gently through your nose with your mouth closed While you are doing this, press the nozzle to deliver one spray It is important to use the proper administration technique in order to avoid local side effects. 4. Then breathe out through your mouth 5. Repeat steps 3 and 4 if you have to spray again in the same nostril and for the other nostril
18
6. After using the spray To keep the spray nozzle clean, wipe it carefully with a clean tissue or handkerchief after each use Replace the cap over the nozzle
If the nasal spray has not been used for more than 2 weeks: It needs to be primed again, to fill the nozzle with the spray The nozzle should be pointed away from you while you are doing this To prime, spray into the air once before use Always shake the bottle gently before use
Cleaning the spray If the spray does not work, the nozzle may be blocked. Never try to unblock it or enlarge the tiny spray hole with a pin or other sharp objects. This is because it can stop the spray from working.
The nasal spray should be cleaned at least once a week. It can be cleaned more often if it gets blocked.
Instructions for cleaning the spray: Remove the cap Gently pull off the spray nozzle only
Soak the cap and spray nozzle in warm water for a few minutes Rinse under the cold running tap water
19
Shake or tap to remove any water that is left Allow to dry in the air Re-fit the spray nozzle Prime the nasal spray until a fine mist is formed Use as normal
If you use more Triamcinolone acetonide than you should
It is important that you take your dose as stated on the pharmacist’s label or as advised by your doctor or pharmacist. You should use only as much as your pharmacist or doctor recommends; using more or less may make your symptoms worse.
An overdose is unlikely to cause problems, however, if you have taken the entire contents of the bottle by mouth, you may have stomach or gut discomfort.
Talk to a doctor or pharmacist if you use more Triamcinolone acetonide than you should.
If you forget to use Triamcinolone acetonide If you have forgotten to use Triamcinolone acetonide, use it as soon as you remember. Do not use a double dose to make up for a forgotten dose.
If you stop using Triamcinolone acetonide If you stop using this medicine, your symptoms may return within a few days.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop using Triamcinolone acetonide and see a doctor or go to a hospital straight away if: You have an allergic reaction to Triamcinolone acetonide. The signs (frequency not known) may include: a rash (hives), itching, swallowing or breathing problems, swelling of your lips, face, throat or tongue.
Common side effects (may affect up to 1 in 10 people) Runny nose, headache, sore throat and/or cough Nosebleeds Inflammation/irritation of the airways (bronchitis) Heartburn or indigestion Flu-like symptoms (fever, muscle pain, weakness and/or fatigue) Problems with teeth
Other side effects (Not known: frequency cannot be estimated from the available data) Irritation and dryness on the inside of your nose
20
Sinuses become congested or blocked Sneezing Changes in the way things taste or smell Feeling sick (nausea) Sleeping problems, feeling dizzy or tired Shortness of breath (dyspnoea) A decrease in the levels of cortisol in the blood (laboratory value) Cloudiness of the lens in the eye (cataract), elevated pressure inside the eye ball (glaucoma) Blurred vision. chorioretinopathy (eye disorder characterized by fluid accumulation under the retina that can impair the vision)
In some people, Triamcinolone acetonide can cause damage to the middle part of the inside of the nose (called ‘nasal septum’). Discuss any worries you may have about this with your doctor or pharmacist.
Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly [via the national reporting system listed in Appendix V*]. By reporting side effects you can help provide more information on the safety of this medicine. [* To be adapted nationally]
5. How to store triamcinolone acetonide
Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton and the bottle after “EXP”. The expiry date refers to the last day of that month. Do not store above 25°C. Following the first opening Triamcinolone acetonide should be used within 1 month for the 30 spray pack or 2 months for the 120 spray pack. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Triamcinolone acetonide contains The active substance is triamcinolone acetonide. One delivered dose contains 55 micrograms of triamcinolone acetonide. The other ingredients are: - microcrystalline cellulose and carmellose sodium (dispersible cellulose) - polysorbate 80 - purified water - anhydrous glucose - benzalkonium chloride (50% w/v solution) - disodium edetate - hydrochloric acid or sodium hydroxide (for pH-adjustment)
What Triamcinolone acetonide looks like and contents of the pack
21
Triamcinolone acetonide is a nasal spray suspension. It comes in a white plastic bottle which has a pump to spray Triamcinolone acetonide into your nostril through the spray nozzle. The bottle has a protective purple cap to keep the nozzle clean and to stop it from spraying accidentally.
This one spray bottle holds at least 120 sprays (16.5 g of suspension which contains 9.075 mg triamcinolone acetonide) or at least 30 sprays (6.5 g of suspension which contains 3.575 mg triamcinolone acetonide). Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder: [To be completed nationally] Name/address Tel: Fax: email:
Manufacturer: Recipharm HC Limited, 72 London Road, Holmes Chapel, Crewe, Cheshire, CW4 8BE, United Kingdom
Sanofi-Aventis Deutschland GmbH, Industriepark Hoechst-Brüningstraße 50, 65929 Frankfurt am Main, Germany
Sanofi Winthrop Industrie, 30-36, avenue Gustave Eiffel 37100 Tours, France
This medicinal product is authorised in the Member States of the EEA under the following names:
Belgium: TRIAMCINOLONE ACETONIDE Sanofi Belgium 55 micrograms/dose, nasal spray, suspension Luxembourg: TRIAMCINOLONE ACETONIDE Sanofi Belgium 55 micrograms/dose, nasal spray, suspension
This leaflet was last revised in MM/YYYY
22