Aktanos

Patient Information Leaflet

AKTANOS 400 micrograms nasal drops suspension

Fluticasone propionate
Generic Medicine
Please read all of this leaflet carefully before you start using this medicine because 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 give it to other people, even if they have the same symptoms as yours, because it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What AKTANOS is and what it is used for

AKTANOS contains an active substance called fluticasone propionate. It belongs to a group of
medicines known as steroids (also called "corticosteroids").
AKTANOS is used for the treatment of:

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

Steroids:

• reduce inflammation;
• reduce swelling and irritation in the nose;
• help relieve itching, sneezing, and blocked or runny nose.

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

2. What you need to know before using AKTANOS

Do not use AKTANOS:
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 AKTANOS
Talk to your doctor or pharmacist before using this medicine:

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

If you are unsure whether any of the above situations apply to you, speak to your doctor or pharmacist before using
this medicine.
AKTANOS may reduce the normal production of steroid hormones in the body, particularly if used for long periods at doses higher than recommended. In such cases, consideration should be given to administering additional steroid doses during periods of acute stress, following severe injury, or before undergoing surgery.
It is therefore important that you use the lowest effective dose of AKTANOS needed to control your symptoms.
Contact your doctor if you experience blurred vision or other visual disturbances.
Other medicines and AKTANOS
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other
medicines, including those not requiring a prescription.
Some medicines may increase the effect of AKTANOS. Inform your doctor if you are taking these
medicines (including certain HIV medicines: ritonavir, cobicistat), as careful monitoring may be required.
Pregnancy and breastfeeding
Do not use AKTANOS if you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding, unless specifically instructed to do so by your doctor.
Driving and using machines
It is unlikely that AKTANOS will affect your ability to drive vehicles or operate machinery.

3. How to use AKTANOS

Use this medicine exactly as directed by your doctor or pharmacist. Do not exceed the recommended dose. If you have any doubts, consult your doctor or pharmacist.
Do not use this medicine in children under 16 years of age.
Use NOMEPRODOTTO only in the nose.
Avoid contact with the eyes.
Use AKTANOS every day. It may take several weeks before this medicine starts working, so continue using it even if you do 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 daily.
If your symptoms begin to improve, speak with your doctor, who may decide to reduce the dose.
If your symptoms do not improve after 4–6 weeks, your doctor may recommend an alternative therapy.

Instructions for use

1. Open the aluminium foil pouch by tearing one side. Do not open the package until you are ready to use the medicine.
2. Remove the strip of single-dose containers made of polyethylene from the aluminium pouch and detach one container.
3. Store the remaining containers in the aluminium pouch and return the pouch to the carton.
4. Shake and agitate the single-dose container several times. The contents must be thoroughly mixed before use.
5. Then tap 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 twisting motion.

How to administer the drops
Before administering the drops, choose one of the positions shown in the figures below. Although these positions may not be easy, they 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 are unable to do so, kneel down and then bend forward.

4. Place the opened single-dose container into one nostril and gently squeeze it.
5. Continue squeezing until the sides of the container touch each other. This means that approximately half of the dose has been administered (about 6 drops).
6. Repeat steps 4 and 5 to administer the remainder of the product into the other nostril.
7. Keep your head bent forward for at least 1 minute after administering the drops.

If these positions are difficult for you, you may lie down on a bed with your head tilted over the edge. After doing so, administer the drops and then rest your head sideways on the bed for at least 1 minute.

Take care to avoid getting the drops in the eyes or onto broken skin. If this occurs, immediately rinse the eyes or skin with water.

If you use more AKTANOS than you should
Inform your doctor if you have used more medicine than prescribed.

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

If you stop using AKTANOS
Do not stop treatment even if you feel better, unless your doctor tells you to. If you stop, your symptoms may return.

If you have any questions about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, AKTANOS may cause side effects, although not everyone gets them.

The following side effects may occur with AKTANOS.

Allergic reactions
A small number of people may experience allergic reactions to AKTANOS, which, if untreated, can progress to a more serious condition, even life-threatening.
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 symptoms are mild, but you should be aware they may become more severe. Therefore, if you notice any of these symptoms, seek immediate medical attention.
Allergic reactions to AKTANOS are very rare (may affect fewer 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 fewer than 1 in 10,000 people)

• clouded lens of the eye (cataract), increased pressure in the eye which may cause vision problems (glaucoma). These eye problems occur in patients using AKTANOS 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

Additionally, systemic effects may occur with intranasal corticosteroids, particularly when prescribed at high doses for prolonged periods. Your doctor will aim to prevent this by prescribing the lowest effective steroid dose to control your symptoms.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via 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 AKTANOS

Keep AKTANOS out of the sight and reach of children.
No special storage conditions required.
Store AKTANOS in the aluminium pouch and in the box in an upright position.
The medicine should be used within 28 days of first opening the sachet containing the single-dose containers.
Do not use this medicine after the expiry date stated on the single-dose container and on the box after "Exp.". The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What AKTANOS contains

• The active substance is fluticasone propionate.
• The other components are: Polysorbate 20, Sorbitan monolaurate, Disodium dihydrogen phosphate dihydrate, Disodium phosphate anhydrous, Sodium chloride, Water for injections.

Description of the appearance of AKTANOS and contents of the pack
AKTANOS is a nasal drop suspension.
Each container contains 400 micrograms of fluticasone propionate, at 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 Authorization 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)