NAMBROL

PACKAGE LEAFLET: INFORMATION FOR THE USER

NAMBROL ADULTS 2 mg/2 ml nebulizer solution, ADULTS 1 mg/1 ml nebulizer solution, CHILDREN 1 mg/2 ml nebulizer solution, CHILDREN 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 their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4. Contents of this leaflet:
  1. What NAMBROL is and what it is used for
  2. What you need to know before taking NAMBROL
  3. How to take NAMBROL
  4. Possible side effects
  5. How to store NAMBROL
  6. Contents of the pack and other information

1. What NAMBROL is and what it is used for

NAMBROL contains the active substance Flunisolide, a corticosteroid with anti-inflammatory activity.
NAMBROL is indicated for the treatment of allergic conditions affecting the respiratory tract, such as:

• inflammation of the bronchi with breathing difficulty (bronchial asthma and asthmatic chronic bronchitis);
• chronic and seasonal rhinitis.

2. What you need to know before taking NAMBROL

Do not take NAMBROL:

• if you are allergic to the active substance flunisolide or to any of the other ingredients of NAMBROL (listed in section 6);
• if you have a lung infection (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 NAMBROL if:
Contact your doctor if you experience blurred vision or other visual disturbances.
Children and adolescents
NAMBROL is not recommended for children under four years of age.
Other medicines and NAMBROL
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 NAMBROL, 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 a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
NAMBROL is not recommended during the first three months of pregnancy.
During the remainder of pregnancy, the medicine should be administered only if clearly needed and under the direct supervision of a doctor.
Breastfeeding
If you are breastfeeding, use this medicine only if strictly necessary and under the direct supervision of a doctor.
Driving and using machines
For those engaged in sports activities
Using this medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.

3. How to take NAMBROL

Take this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Adults
Take half the contents of a single-dose container of NAMBROL ADULTS 2 mg/2 ml twice daily
Or
Take the full contents of a single-dose container of NAMBROL ADULTS 1 mg/1 ml twice daily
Children
Use half the contents of a single-dose container of NAMBROL CHILDREN 1 mg/2 ml twice daily
Or
Use the full contents of a single-dose container of NAMBROL CHILDREN 0.5 mg/1 ml twice daily
Administration to children under four years of age is not recommended.
Instructions for use
Do not dilute NAMBROL.
It is known that administering drugs in solution form using electric nebulizers results in a residual amount
of solution remaining, which adheres to the walls of the vial or settles at the bottom and is not delivered.
Due to this, during preparation, it is necessary to take into account the need to compensate for the undelivered portion.
If you take more NAMBROL than you should
In case of accidental ingestion/overdose of NAMBROL, contact your doctor immediately or go to the nearest hospital.
If large amounts of this medicine are administered within a short period of time, hormonal disturbances may occur
due to blockade of the connection between the brain and adrenal glands
(suppression of hypothalamic-pituitary-adrenal function).
If you forget to take NAMBROL
Do not take a double dose to make up for the missed dose.
If you stop treatment with NAMBROL
Do not stop treatment with this medicine abruptly. Before stopping treatment, consult your doctor.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

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

With high doses used over long periods, adrenal suppression (inability of the adrenal glands to produce sufficient cortisol), growth retardation in children and adolescents, decreased bone mineral density, eye problems (cataract and glaucoma), psychomotor hyperactivity, sleep disorders, anxiety, depression, aggression, and behavioural disorders (mainly in children) may occur.

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 the website: 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 NAMBROL

Keep this medicine out of the sight and reach of children.
Do not use NAMBROL after the expiry date which is stated on the packaging after "Exp.". The expiry date refers to the last day of that month.
Store the product in the original packaging to protect it from light.
Use the product within 12 hours after first opening the single-dose container. Any unused portion should be discarded.
Do not dispose of any medicine 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

NAMBROL ADULTS 2 ml nebulizing 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.

NAMBROL ADULTS 1 ml nebulizing 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.

NAMBROL CHILDREN 2 ml nebulizing 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.

NAMBROL CHILDREN 1 ml nebulizing 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 NAMBROL and contents of the pack
Nebulizing solution.
Pack sizes:
Box of 15 single-dose containers of 2 ml solution (2 mg/2 ml)
Box of 30 single-dose containers of 1 ml solution (1 mg/1 ml)
Box of 15 single-dose containers of 2 ml solution (1 mg/2 ml)
Box of 30 single-dose containers of 1 ml solution (0.5 mg/1 ml)

Marketing Authorization Holder
LANOVA FARMACEUTICI S.R.L.
Via Conca D’oro, 212
00141 – ROMA (RM)

Manufacturer
Genetic SpA - Contrada Canfora - 84084 Fisciano (SA)

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