Saflineb

PATIENT LEAFLET: INFORMATION FOR THE USER

SAFLINEB 2 mg/2 ml nebulizer solution, 1 mg/1 ml nebulizer solution, 1 mg/2 ml nebulizer solution, 0.5 mg/1 ml nebulizer solution

Flunisolide
Please read this leaflet carefully before 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 could be harmful.
• If you experience any side effect, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4. Contents of this leaflet :
  1. What SAFLINEB is and what it is used for
  2. What you need to know before using SAFLINEB
  3. How to use SAFLINEB
  4. Possible side effects
  5. How to store SAFLINEB
  6. Contents of the pack and other information

1. What SAFLINEB is and what it is used for

SAFLINEB contains the active substance Flunisolide, which belongs to a group of medicines called glucocorticoid drugs.
SAFLINEB is indicated for the treatment of allergic conditions affecting the respiratory tract:
bronchial asthma, chronic asthmatic bronchitis; chronic and seasonal rhinitis.
:

2. What you need to know before taking SAFLINEB

Do not take SAFLINEB:

• if you are allergic to flunisolide or to any of the other ingredients of this medicine (listed in section 6);
• if you have a lung infectious disease (active or quiescent pulmonary tuberculosis);
• if you have infections caused by bacteria, viruses, or fungi;
• if you are pregnant or breastfeeding (see section “Pregnancy and breastfeeding”).

Warnings and precautions
Talk to your doctor or pharmacist before taking SAFLINEB if you have:

• a lung infection (active or quiescent tuberculosis);
• a respiratory tract infection;
• an untreated infection caused by fungi, bacteria, or viruses;
• an eye infection caused by a virus called herpes simplex;
• a nasal lesion (nasal trauma), ulceration of the nasal septum, or frequent nosebleeds (recurrent epistaxis).

With prolonged and high-dose inhaled use, systemic effects on the body may occur, such as Cushing's syndrome, cushingoid appearance, adrenal suppression, psychomotor hyperactivity, depression, aggression (especially in children). Loss of appetite (anorexia), abdominal pain, weight loss, fatigue, headache, nausea, vomiting, and reduced blood sugar levels (hypoglycemia) may occur, potentially leading to decreased level of consciousness and/or seizures. Contact your doctor if you experience blurred vision or other visual disturbances.

Children and adolescents
SAFLINEB is not recommended for children under four years of age.

Other medicines and SAFLINEB
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.
Some medicines may increase the effects of SAFLINEB, and your doctor may wish to monitor you closely if you are taking these medicines (including certain HIV treatments: ritonavir, cobicistat).

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
This medicine is not recommended during the first three months of pregnancy. During later stages of pregnancy, use this medicine only if clearly needed and under direct medical supervision.

Breastfeeding
If you are breastfeeding, use this medicine only if strictly necessary and under direct medical supervision.

Driving and using machines
The effects of SAFLINEB on the ability to drive vehicles and operate machinery are unknown.

For athletes
Using this medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.

3. How to take SAFLINEB

Take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.

Adults
The recommended dose is:
half the contents of a single-dose container of SAFLINEB 2 mg/2 ml twice daily
or
the contents of a single-dose container of SAFLINEB 1 mg/1 ml twice daily

Children
The recommended dose is:
half the contents of a single-dose container of SAFLINEB 1 mg/2 ml twice daily
or
the contents of a single-dose container of SAFLINEB 0.5 mg/1 ml twice daily

SAFLINEB is not recommended for children under four years of age.

Method of administration
Do not dilute SAFLINEB.
When using a nebulizer, part of the solution placed in the vial is not delivered.
Taking this into account, during preparation it is necessary to consider supplementing the amount to compensate for the portion that will not be delivered.

If you take more SAFLINEB than you should
If you accidentally ingest or take an excessive dose of SAFLINEB, contact your doctor immediately or go to the nearest hospital.
Administration of large amounts of this medicine within a short period of time may cause hormonal disturbances due to blockade of the connection between the brain and the adrenal glands (suppression of hypothalamic-pituitary-adrenal function).

If you forget to take SAFLINEB
Do not take a double dose to make up for the forgotten dose.

If you stop taking SAFLINEB
Do not stop treatment with this medicine abruptly. Before stopping treatment, consult your doctor, who will advise you on how to gradually reduce the dosage.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, SAFLINEB may cause side effects, although not everybody gets them.
Contact your doctor if you experience any of the following side effects:

• cough, lowering and alteration of voice (hoarseness), mild and transient burning sensation of the nasal mucosa;
• fungal infections of the mouth or throat. These infections can be prevented or reduced by thoroughly rinsing the mouth after administration of this medicine by aerosol;
• nasal irritation, nosebleeds (epistaxis), nasal congestion, runny nose (rhinorrhea), sore throat, irritation of the mouth and throat. If these effects are severe, stop treatment.
• nasal congestion, development of benign nodules in the nose (nasal polyps), bone problems (osteoporosis), stomach and intestinal disorders (peptic ulcer), symptoms due to adrenal insufficiency such as reduced blood pressure (hypotension) and weight loss;
• blurred vision (frequency not known).

At high doses used for prolonged periods, adrenal suppression (inability of the adrenal glands to produce sufficient cortisol), growth retardation in children and adolescents, eye problems (cataract and glaucoma), psychomotor hyperactivity, sleep disorders, anxiety, depression, aggression, behavioural disturbances (mainly in children) may occur.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, speak to your doctor or pharmacist. You may also report side effects directly via the national reporting system at 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 SAFLINEB

Keep this medicine out of the sight and reach of children.
Do not use SAFLINEB after the expiry date stated on the packaging after "Exp.". The expiry date refers to the last day of that month.
Store the product in its original packaging to protect it from light.
Use the product within 12 hours after the first opening of the single-dose container. Any remaining product should be discarded.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

SAFLINEB 2 ml nebulizer solution
One single-dose container of 2 ml contains:

• The active substance is: Flunisolide 2 mg;
• The other components are: Propylene glycol, sodium chloride, water for injections.

SAFLINEB 1 ml nebulizer solution
One single-dose container of 1 ml contains:

• The active substance is: Flunisolide 1 mg;
• The other components are: Propylene glycol, sodium chloride, water for injections.

SAFLINEB 2 ml nebulizer solution
One single-dose container of 2 ml contains:

• The active substance is: Flunisolide 1 mg;
• The other components are: Propylene glycol, sodium chloride, water for injections.

SAFLINEB 1 ml nebulizer solution
One single-dose container of 1 ml contains:

• The active substance is: Flunisolide 0.5 mg;
• The other components are: Propylene glycol, sodium chloride, water for injections.

Description of the appearance of SAFLINEB and package contents
Nebulizer solution.
Pack: 15 single-dose containers of 2 ml solution (2 mg/2 ml)
Pack: 30 single-dose containers of 1 ml solution (1 mg/1 ml)
Pack: 15 single-dose containers of 2 ml solution (1 mg/2 ml)
Pack: 30 single-dose containers of 1 ml solution (0.5 mg/1 ml)

Marketing Authorization Holder
Genetic S.p.A., Via G. Della Monica, 26 - 84083 Castel San Giorgio (SA), Italy

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

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