SYNTARIS 0.25 MG/ML Nasal spray, solution

Зміст інструкції

1. Syntaris 0.25 mg/ml nasal spray, solution
   1. What is Syntaris and what is it used for
   2. What you need to know before using Syntaris
   3. How to use Syntaris
   4. Possible side effects
   5. How to store Syntaris
   6. Contents of the pack and other information

Syntaris 0.25 mg/ml nasal spray, solution

flunisolide

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

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed only for you. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Syntaris and what is it used for

Syntaris contains the active ingredient flunisolide.
Flunisolide belongs to a group of medicines called “corticosteroids” and possesses a marked activity
anti-inflammatory and anti-allergic.
Syntaris is used to prevent and treat the symptoms of allergic rhinitis (chronic allergic rhinitis) and
seasonal (including hay fever).

2. What you need to know before using Syntaris

Do not use Syntaris

• if you are allergic to flunisolide or any of the other ingredients of this medicine (listed in section 6)
• if you have nasal infections caused by fungi, bacteria or viruses that you are not treating.

Warnings and precautions
Talk to your doctor or pharmacist before using Syntaris.
In particular, tell your doctor if you have problems with the adrenal glands. The doctor will take particular care
in transitioning you from a corticosteroid therapy that is distributed throughout the body (systemic therapy) to a therapy with Syntaris nasal spray.
doctor. Using higher or lower doses can worsen your symptoms.
Avoid using this medicine for prolonged periods and at high doses because side effects may occur
such as Cushing's syndrome (a condition caused by excessive production of a hormone,
cortisol), Cushingoid appearance (characterized by localized obesity predominantly in the abdomen, face
and back), adrenal suppression, growth retardation in children and adolescents (they will be
regularly monitored to assess height), bone fragility, eye problems (cataracts and glaucoma),
hyperactivity, sleep disturbances, anxiety, depression, aggression, behavioral disorders (especially
in children).
The use, especially if prolonged, of products for local action (for topical use) such as Syntaris, may give rise to
allergies (sensitization phenomena). In such cases, discontinue treatment and follow appropriate therapy.
Medicines like Syntaris (corticosteroids) can mask some signs of infection and new infections
may appear during their use.
Contact your doctor if you experience blurred vision or other visual disturbances.

Children
The use of Syntaris is not recommended in children under 5 years of age, because its safety and
efficacy have not been established.

Other medicines and Syntaris
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines, including medicines obtained without a prescription.
Some medicines can increase the effects of Syntaris 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 and breastfeeding
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding with breast milk
ask your doctor or pharmacist for advice before using this medicine.
Syntaris is not recommended in the first three months of pregnancy.
If you are in the second or third trimester of pregnancy, your doctor will assess the benefits of using Syntaris in
compared to the potential risks to the fetus.
Caution should also be used during breastfeeding, ask your doctor for advice.

Driving and operating machinery
Syntaris does not affect the ability to drive vehicles and operate machinery.

Syntaris contains

• benzalkonium chloride (BAC)as a preservative. This medicine contains 0.035 mg of benzalkonium chloride per spray equivalent to 0.35 mg per ml of solution. It can cause irritation and swelling inside the nose, especially if used for long periods. If you suspect such a reaction (persistent nasal congestion), you should use, if possible, a nasal medicine without BAC. If such nasal medicines without BAC are not available, another pharmaceutical form should be considered;
• butylhydroxytoluenewhich may cause localized skin reactions (e.g. contact dermatitis) or irritation to the eyes and mucous membranes;
• propylene glycol.This medicine contains 5 mg of propylene glycol per spray equivalent to 50 mg per ml of solution.

3. How to use Syntaris

Use this medicine following exactly the instructions of your doctor or pharmacist. If you have doubts
consult your doctor or pharmacist.
Syntaris nasal spray is intended exclusively for intranasal administration.
The recommended initial dose is:

• Adults:2 sprays per nostril 2 times a day.

If symptoms are severe, or if there is a worsening, your doctor may recommend 2
sprays per nostril 3 times a day.
The maximum daily dose should not exceed 6 sprays in each nostril.

• Children (5 years of age and over):1 spray per nostril 3 times a day. The maximum daily dose should not exceed 3 sprays in each nostril.

Once the desired clinical effect is achieved, the maintenance dose should correspond to the minimum amount
necessary to control the symptoms.
In some cases, the results can be maintained with 1 spray (approximately 25 micrograms) per nostril per day.
There is no evidence that exceeding the recommended maximum dose is more effective, therefore avoid a
dose higher than the recommended one.

Instructions for use

NOTE
The effect of Syntaris is not immediate.
It may take 1-2 days before the beneficial action of the medicine manifests.
To obtain the maximum benefit, use Syntaris regularly, as prescribed by your doctor.

If you use more Syntaris than you should
Administering large quantities of Syntaris in a short period of time may determine
the alteration of the functionality of some glands of the organism (suppression of the hypothalamic-
pituitary-adrenal function). In this case, the dose of Syntaris nasal spray must be reduced immediately to the
recommended dose.
In case of accidental intake of an excessive dose of Syntaris, immediately inform your doctor or
go to the nearest hospital.

If you forget to use Syntaris
Do not use a double dose to compensate for missing the dose.

If you stop using Syntaris
To obtain the maximum benefit, use Syntaris regularly. Do not interrupt the treatment without consulting
your doctor.
If you have any doubts about 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.
The most common side effects are:

• mild temporary burning
• stinging.

Other effects observed in decreasing order of frequency are:

• nasal irritation
• nosebleed (epistaxis)
• nasal congestion
• runny nose (rhinorrhea)
• sore throat
• hoarseness
• throat irritation.

In exceptional cases, these side effects may require discontinuation of therapy.
Blurred vision may occur, with an unknown frequency.
Systemic side effects may occur with corticosteroids administered nasally, particularly if prescribed at high doses for prolonged periods, and may
include growth retardation in children and adolescents.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your
doctor or pharmacist. You can also report side effects directly through the national reporting system at http://www.agenziafarmaco.gov.it/content/come-segnalare-una-
sospetta-reazione-avversa.
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Syntaris

Store in the original package to protect the medicine from light.
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 pack after “Exp”. The expiry date
refers to the last day of that month.
Do not dispose of any medicine in waste water 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 Syntaris contains

• The active ingredient is flunisolide hemihydrate. 1 ml of solution contains 0.255 mg of flunisolide hemihydrate (equivalent to 0.25 mg of anhydrous flunisolide).
• The other ingredients are polyethylene glycol 400, propylene glycol, citric acid, disodium citrate dihydrate, butylated hydroxytoluene, sodium edetate, benzalkonium chloride, polysorbate 20, sorbitol (70% aqueous solution), purified water.

Description of the appearance of Syntaris and contents of the pack
Syntaris is presented as a nasal spray, solution.
The pack contains a 24 ml bottle with a dosing pump.
1 bottle of 24 ml provides 200 doses (sprays).

Marketing Authorisation Holder
Konpharma s.r.l,
Via Pietro Della Valle 1,
00193 Rome Italy

Manufacturer
Recordati Industria Chimica e Farmaceutica S.p.A.
Via Matteo Civitali, 1
20148 Milan, Italy