NASACORT <55 MCG Назальный спрей, суспензия

Содержание инструкции

1. Nasacort 55 micrograms/dose, nasal spray, suspension
   1. What is Nasacort and what is it used for
   2. What you need to know before you take Nasacort
   3. How to take Nasacort
   4. Preparation of the vial
   5. If using the nasal spray for the first time
   6. How to use the spray
   7. After Use
   8. Possible side effects
   9. How to store Nasacort
   10. Contents of the pack and other information

Nasacort 55 micrograms/dose, nasal spray, suspension

Triamcinolone acetonide

Read this leaflet carefully before you start taking this medicine as it contains important information for you.

• Take this medicine exactly as described in this leaflet, or as your pharmacist has told you.
• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms get worse after a short period of treatment.

Contents of this leaflet:

• 1. What Nasacort is and what it is used for
• 2. What you need to know before you take Nasacort
• 3. How to take Nasacort
• 4. Possible side effects
• 5. How to store Nasacort
• 6. Contents of the pack and other information

1. What is Nasacort and what is it used for

Nasacort contains a medicine called triamcinolone acetonide. This medicine belongs to a
group of medicines called corticosteroids, which means that it is a cortisone. It is administered
as a nasal spray to treat the nasal symptoms of allergic rhinitis in adults and children aged 2 years and
over.
The nasal symptoms that characterize an allergy affecting the nose include sneezing, itching, blocked,
stuffy or runny nose. These can be caused by:
animal hair or dust mites. This type of allergy can occur at any
time of the year and is called “perennial allergic rhinitis”.
Pollen. This type of allergy, such as hay fever, can be caused by various types of
pollen in different seasons of the year. This allergy is called “seasonal allergic rhinitis”.
This medicine exerts its action only if it is taken regularly and not to immediately relieve
symptoms. Some people may experience benefit from the first day of
treatment, but for others it may take 3 or 4 days to feel better.

2. What you need to know before you take Nasacort

Do nottake Nasacort:
if you are allergic to triamcinolone acetonide or to any of the other ingredients of this
medicine (listed in section 6).
The signs of allergic reactions to Nasacort may include: skin rash (urticaria), itching,
difficulty swallowing or breathing problems, swelling of the lips, face, throat or
tongue.

Warnings and precautions
Talk to your doctor or pharmacist before taking this medicine:
if you have a nasal or throat infection that you have neglected. If you should have a fungal
infection while being treated with Nasacort, stop using the spray until the infection has been
treated;
if you have recently undergone nasal surgery, or if you have had a wound or ulcer affecting
the nose;
if you have switched therapy from injections or tablets containing steroids to Nasacort
spray;
if you have had glaucoma or cataracts.
If you have doubts about whether any of the above conditions apply to you, talk to your doctor or pharmacist
before taking this medicine.
Contact your doctor if you experience blurred vision or other visual disturbances.

Children (under 2 years)
The use of this medicine in children under 2 years of age is not recommended.

Surgery or stress management
Your doctor may advise you, for medical reasons, to take a higher dose than usual of
this medicine. If the dose is increased, inform your doctor if you need to undergo
surgery or if you should not feel well. Doses higher than usual can in fact lower the immune defenses or the ability to cope with stressful situations. If this
should happen, your doctor may decide to prescribe you treatment with other medicines to
help you.

Other medicines and Nasacort
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including
over-the-counter medicines. The use of Nasacort may in fact affect the way
other medicines work. The same applies to the use of other medicines in relation to
Nasacort.
Some medicines may increase the effects of Nasacort and your doctor may want to keep you under
close observation if you are taking these medicines (including some medicines for the treatment
of HIV: ritonavir, cobicistat).

Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, if you suspect or are planning a
pregnancy, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines
Nasacort does not or negligibly alters the ability to drive vehicles or use
machinery.

Nasacort contains benzalkonium chloride
This medicine contains 15 micrograms of benzalkonium chloride in each spray.
Benzalkonium chloride can cause irritation and swelling inside the nose, especially if used for
long periods.

Systemic effects
When corticosteroids, including triamcinolone acetonide, are used for long periods of
time or at high doses for long periods of time, undesirable effects may occur due to
absorption of the drug into the body (e.g. normal production of
steroid hormones may be affected). These undesirable effects are much less likely with the use of corticosteroid nasal sprays than with corticosteroids taken orally (e.g. tablets). Talk to
your doctor if you experience any side effects.

3. How to take Nasacort

NASACORT is for intranasal use only.
Always take this medicine exactly as described in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist. The medicine is
effective only if taken regularly. It may take 3 to 4 days before you notice an
improvement in symptoms.

How much Nasacort to take
Adults and children (over 12 years)

• the initial dose is 2 sprays in each nostril once a day.
• Once allergy symptoms are under control, the dosage may be reduced to one spray per nostril once a day. Children (6 to 12 years)
• the recommended dose is 1 spray in each nostril once a day.
• If symptoms persist, the dosage may be increased to two sprays in each nostril once a day.
• The dosage may be reduced again to 1 spray in each nostril once a day. Children (2 to 5 years)
• The recommended dose is 1 spray in each nostril once a day.

Do not use Nasacort for more than 3 months in children under 12 years of age.
An adult should help the child use the medicine.

How to use the spray
Before using the nasal spray, gently blow your nose to clear your nostrils.

1. Preparation of the vial

• Remove the cap by pulling upwards.
• Shake the vial gently before use.

2. If using the nasal spray for the first time

• Hold the vial vertically.
• Point the applicator away while performing this operation.
• Prime the pump by pressing down on the nozzle. This operation is called priming.
• Press and release 5 times.
• Perform this operation until a fine mist is obtained.
• The vial is then ready for use.

3. How to use the spray

• Close one nostril with your finger.
• Hold the bottle upright and insert the applicator properly into the other nostril.
• Gently inhale through your nose, keeping your mouth closed.
• While performing the operation described above, press the applicator downwards to release a spray.

• 4.Exhale through your mouth.
• 5.Repeatthe operations described in points 3 and 4 if you need to spray again in the same nostril and in the other nostril.

6. After Use

Clean the applicator thoroughly with a clean paper or cloth wipe after use.
Replace the cap on the applicator.

If the nasal spray remains unused for more than 2 weeks:

• It is necessary to re-prime the bottle to allow the nozzle to fill.
• The applicator must be pointed away while spraying.
• Before use, spray once into the air to prime.
• Always shake the bottle gently before use.

Cleaning the spray
If the applicator does not work, the nozzle may be blocked. Do not attempt to unblock it EVER,
or to widen the applicator hole with a needle or other sharp object, as this will prevent the
spray from working.

The nasal spray must be cleaned at least once a week, or even more often if it becomes blocked.

Instructions for cleaning the spray
Remove the cap.
Remove only the applicator gently.

Soak both the cap and the applicator in lukewarm water for a few minutes.
Rinse with cold tap water.

Shake to remove excess water.
Let air dry.
Re-insert the spray applicator onto the bottle.
Prime the spray unit as needed until
a fine mist is produced.
Use as usual.

If you take more Nasacort than you should
It is important that you take the dose as recommended by the pharmacist or doctor. Only use
the amount recommended by the doctor, using more or less can worsen symptoms.
An overdose is unlikely to cause problems, however, if you have
taken the entire contents of the bottle at once, by mouth, you may experience stomach
or intestinal discomfort. Contact your doctor if you take more Nasacort than you should.

If you forget to take Nasacort
If you forget to take Nasacort, take it as soon as you remember. Do not take a double
dose to make up for a missed dose.

If you stop taking Nasacort
If you stop treatment with this medicine, symptoms may return within a few days.
If you experience any adverse effects (withdrawal symptoms) following
sudden discontinuation of this medicine after prolonged use, talk to your doctor. For more
information see section 4 “Possible side effects”.
If you have any questions about using 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 treatment and see a doctor or go to hospital immediately if:
you experience allergic reactions to Nasacort. Signs (frequency not known) may include:
skin rash (urticaria), itching, difficulty swallowing or problems breathing, swelling of the
lips, face, throat or tongue.

Common side effects (may affect up to 1 in 10 people)
Runny nose, headache, sore throat and/or cough.
Nosebleed.
Inflammation/irritation of the airways (bronchitis).
Heartburn or indigestion.
Flu-like symptoms (fever, muscle aches, weakness and/or fatigue).
Dental problems.

Other side effects (Not known: the frequency cannot be estimated based on the available
data)
Irritation and dryness inside the nose.
Naso-sinus congestion.
Sneezing.
Changes in taste or smell.
Feeling unwell (nausea).
Sleep disturbances, feeling dizzy or tired.
Shortness of breath (dyspnea).
Reduced levels of cortisol in the blood (laboratory value).
Clouding of the lens of the eye (cataract), increased pressure inside the eyeball
(glaucoma).
Blurred vision.
Sudden stopping of corticosteroids after prolonged use can cause withdrawal symptoms such as joint pain, muscle pain, tremor, weight loss, anxiety, nasal drip and nosebleeds. However, these symptoms are extremely rare with the use of
corticosteroid nasal sprays and less likely with corticosteroid nasal sprays than with corticosteroids taken orally (e.g. tablets).
In some people, Nasacort can cause damage to the median wall located inside the nose
(called the “nasal septum”). If you are in any way concerned about this, talk to your doctor
or pharmacist.

Additional side effects in children
If your child takes this medicine, this may affect their growth. This means that the
doctor will regularly check your child's height and the doctor may then decide
to reduce the dose. In addition, the doctor may consider referring your child to
a pediatric specialist.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Nasacort

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 packaging and the bottle
after “Exp.”. The expiry date refers to the last day of that month.
Do not store at a temperature above 25°C.
Once opened, the bottle should not be stored for more than 1 month for the 30 spray pack or
for more than 2 months for the 120 spray pack.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Nasacort contains
The active ingredient is triamcinolone acetonide. Each delivered dose contains 55 micrograms of
triamcinolone acetonide.
The excipients are:
microcrystalline cellulose and sodium carboxymethylcellulose (dispersible cellulose)
polysorbate 80
purified water
anhydrous glucose
benzalkonium chloride (50% p/v solution)
disodium edetate
hydrochloric acid or sodium hydroxide (for pH adjustment).

Description of Nasacort and contents of the pack

Nasacort is a nasal spray in the form of a suspension. It is presented
as a white plastic bottle equipped with a pump to
spray Nasacort into the nostril using the applicator. The bottle has
a protective cap to keep the applicator clean and prevent
accidental leakage of the product.
This bottle delivers at least 120 sprays (16.5 g of suspension that
contains 9.075 mg of triamcinolone acetonide), another bottle delivers
at least 30 sprays (6.5 g of suspension that contains 3.575 mg of
triamcinolone acetonide).
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation Holder:
Opella Healthcare Italy S.r.l.
Viale L. Bodio, 37/B, Milan, Italy
Manufacturer:
Recipharm HC Limited
London Road, Holmes Chapel
Cheshire, CW4 8BE
United Kingdom
or:
Sanofi Winthrop Industrie
30-36, avenue Gustave Eiffel 37100 Tours
France
or:
Sanofi-Aventis Deutschland GmbH
Industriepark Hӧchst Brüningstraße 50
65926 Frankfurt am Main
Germany

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
Belgium: Nasacort
Bulgaria: Nasacort
Czech Republic: Triamcinolone sanofi 55 micrograms/dose
Finland: Nasacort
Germany: Nasacort 55 Micrograms/Dose
Greece: Nasacort
Ireland: Nasacort nasal spray
Italy: Nasacort
Luxembourg: Nasacort
Malta: Nasacort
Netherlands: Nasacort
Portugal: Nasacort
Romania: Nasacort 55 micrograms/dose nasal spray, suspension
Slovakia: Nasacort 55 micrograms/dose
Slovenia: Nasacort
Spain: Nasacort
Sweden: Nasacort
United Kingdom: Nasacort nasal spray