NAKAFRI 400 MICROGRAMS Nasal drops, suspension

Зміст інструкції

1. NAKAFRI 400 micrograms nasal drops suspension
   1. What is NAKAFRI and what is it used for
   2. What you need to know before using NAKAFRI
   3. How to use NAKAFRI
   4. Possible side effects
   5. How to store NAKAFRI
   6. Contents of the pack and other information

NAKAFRI 400 micrograms nasal drops suspension

Fluticasone propionate

Equivalent Medicinal Product
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 for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could 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 NAKAFRI is and what it is used for
• 2. What you need to know before you use NAKAFRI
• 3. How to use NAKAFRI
• 4. Possible side effects
• 5. How to store NAKAFRI
• 6. Contents of the pack and other information

1. What is NAKAFRI and what is it used for

NAKAFRI contains an active substance called fluticasone propionate. It belongs to a group of
medicines called steroids (also called “corticosteroids”).
NAKAFRI is used for the treatment of:

• Small formations inside the nose (polyps)
• Symptoms associated with nasal obstruction.

Steroids:

• reduce inflammation;
• reduce swelling and irritation of the nose;
• help to relieve itching, sneezing and a stuffy or runny nose.

NAKAFRI is contained in single-dose containers made of low-density polyethylene.

2. What you need to know before using NAKAFRI

Do not use NAKAFRI:
if you are allergic to fluticasone propionate or to any of the other ingredients of this medicine (listed in
section 6).

Take special care with NAKAFRI
Talk to your doctor or pharmacist before using this medicine:

• If you have an infection in your nose.
• If you are taking an antiviral medicine known as a protease inhibitor (e.g. ritonavir).
• If you are taking a medicine used to treat fungal infections (e.g. ketoconazole).
• If you have taken steroids for a prolonged period of time, either by injection or orally.

If you are not sure whether any of the above applies to you, talk to your doctor or pharmacist before using
this medicine.
NAKAFRI may reduce the normal production of steroid hormones in the body, particularly if doses higher than
those recommended are used for a long period. In this situation, consideration should be given to steroid
replacement therapy in periods of acute stress, following serious injury, or before surgery.
It is therefore important that you use the lowest dose of NAKAFRI to control your symptoms.
Contact your doctor if you experience blurred vision or other visual disturbances.

Other medicines and NAKAFRI
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines, including those available without a prescription.
Some medicines can increase the effect of NAKAFRI, tell your doctor if you are taking these
medicines (including some medicines for HIV: ritonavir, cobicistat) as careful monitoring may be necessary.

Pregnancy and breastfeeding
Do not use NAKAFRI if you are pregnant, suspect you may be pregnant, are planning a pregnancy or if you
are breastfeeding, unless your doctor has expressly told you to do so.

Driving and using machines
It is unlikely that NAKAFRI will affect your ability to drive or operate machinery.

3. How to use NAKAFRI

Use this medicine following exactly the instructions of your doctor or pharmacist. Do not exceed the
recommended dose. If you have any doubts, consult your doctor or pharmacist.
Do not use the medicine in children under 16 years of age.
Use NAKAFRI only in the nose.
Avoid contact with the eyes.
Use NAKAFRI every day. It may take several weeks before this medicine
takes effect, so continue to use it, even if you may not feel better immediately.

Dosage
Adults and adolescents (over 16 years of age)
The usual starting dose is:
1 single-dose container (400 micrograms) divided equally between each nostril, 1 or 2 times a day.
If your symptoms start to improve, talk to your doctor who may decide to reduce the dose.
If your symptoms do not improve after 4-6 weeks, your doctor may advise you on alternative therapy.

Instructions for use

• 1. Open the aluminum pouch by tearing one side. Do not open the package until you need to use the medicine.
• 2. Remove the strip of single-dose containers made of polyethylene from the aluminum pouch and detach one container.
• 3. Replace the remaining containers in the aluminum pouch and put the aluminum pouch back in the box.
• 4. Shake and agitate the single-dose container several times. The contents of the container must be well mixedbefore use.
• 5. Then shake downwards to ensure that the liquid is not in the neck of the container.
• 6. Open the container by removing the cap with a slight rotation.

How to insert the drops
Before inserting the drops, you must choose one of the positions shown in the figures below.
Although they are not simple, these positions will ensure that the drops are administered
correctly.

• 1. Gently blow your nose to clear it.
• 2. From an upright position, bend forward.

• 3. If you cannot manage this, kneel and then bend forward.

• 4. Place the opened single-dose container in one nostril and press gently.
• 5. Continue to press it until the sides of the container touch each other. This means that about half of the dose has been administered (about 6 drops).
• 6. Repeat steps 4 and 5 to administer the rest of the product into the other nostril.
• 7. Remain with your head bent down for at least 1 minute after inserting the drops.

If these positions are difficult for you, you can lie on a bed with your head tilted over the edge. After
doing so, insert the drops and then rest your head on one side of the bed for at least one minute.

Be careful not to get the drops into your eyes or on broken skin.If this should happen,
immediately rinse your eyes or skin with water.

If you use more NAKAFRI than you should
Tell your doctor if you have used more medicine than you were prescribed.

If you forget to take a dose of NAKAFRI
If you forget a dose, do not worry, wait until it is time for the next dose and take it only
then. Do not use a double dose to make up for the missed dose.

If you stop taking NAKAFRI
Do not stop treatment even if you feel better, unless your doctor tells you to. If you were
to stop it, the symptoms may return.
If you have any doubts about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, NAKAFRI can cause side effects, although not everybody gets them.
The following side effects may occur with NAKAFRI
Contact your doctor if you experience:

Allergic reactions
A small number of people experience allergic reactions to NAKAFRI, which if untreated can
develop into a more serious problem, even life-threatening.
The signs include:

• shortness of breath, coughing or difficulty breathing;
• sudden feeling of weakness or dizziness (may lead to fainting or loss of consciousness);
• swelling of the face, mouth or tongue;
• skin rash or redness.

In most cases, these signs are mild but you should be aware that they can
become more serious, therefore, if you notice any of these symptoms seek immediate medical
attention.
Allergic reactions to NAKAFRI are very rare (may affect less than 1 in 10,000 people).

Other side effects include:

Very common(may affect more than 1 in 10 people)

• nosebleeds.

Common(may affect up to 1 in 10 people)

• dry or irritated throat or nose.

Very rare(may affect less than 1 in 10,000 people)

• clouding of the lens of the eye (cataract), increased pressure in the eye that can cause vision problems (glaucoma). These eye problems occur in patients who use NAKAFRI for long periods.
• small holes (perforations) in the nasal septum separating the nostrils.

Not known(frequency cannot be estimated from available data)

• blurred vision
• sores in the nose

In addition, systemic effects may occur with intranasal corticosteroids, particularly if prescribed at
high doses for prolonged periods. Your doctor will ensure this does not happen by giving you therapy with the
lowest dose of steroids to control these effects.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist.
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 NAKAFRI

Keep NAKAFRI out of sight and reach of children.
No special storage conditions.
Store NAKAFRI in the aluminum sachet and in the package in an upright position.
The medicine must be used within 28 days of first opening the sachet containing the single-dose containers
Do not use this medicine after the expiry date which is stated on the single-dose container and on the package
after "Exp.". The expiry date refers to the last day of that month.
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 NAKAFRI contains

• The active ingredient is fluticasone propionate
• The other ingredients are: Polysorbate 20 Sorbitan monolaurate Dihydrate disodium phosphate Anhydrous disodium phosphate Sodium chloride Water for injections

Description of the appearance of NAKAFRI and contents of the pack
NAKAFRI is presented as nasal drops suspension.
Each container contains 400 micrograms of fluticasone propionate, with a concentration of 1 mg/ml.
Each box contains 6 strips of 5 single-dose containers (30 single-dose containers per box) or 18 strips of
5 single-dose containers (90 single-dose containers per box)

Marketing Authorisation Holder
Genetic S.p.A. Via Della Monica n. 26, 84083 Castel San Giorgio (SA)

Manufacturer
Genetic S.p.A. Contrada Canfora, 84084 Fisciano (SA)