Package leaflet: Information for the user

DORICOFLU 1mg/ml solution for nebuliser

Flunisolid
Equivalent 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 their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

What DORICOFLU is and what it is used for
What you need to know before using DORICOFLU
How to use DORICOFLU
Possible side effects
How to store DORICOFLU
Contents of the pack and other information

1. What DORICOFLU is and what it is used for

DORICOFLU contains the active substance flunisolide, which belongs to a group of medicines called corticosteroids that reduce inflammation and relieve allergy symptoms.
DORICOFLU is indicated for the treatment of allergic diseases affecting the respiratory tract, such as:

bronchial asthma and chronic asthmatic bronchitis, characterized by inflammation of the bronchi causing severe breathing difficulty;
seasonal and chronic rhinitis, characterized by inflammation and irritation of the nasal mucosa.

2. What you need to know before using DORICOFLU

Do not use DORICOFLU

if you are allergic to flunisolide or to any of the other ingredients of this medicine (listed in section 6);
if you have tuberculosis (active or quiescent), or a severe lung infection;
if you have developed infections caused by bacteria, viruses, or fungi;
if you are pregnant or breastfeeding, except for cases listed in the section “Pregnancy and breastfeeding”, which still require careful medical monitoring.

Warnings and precautions
Talk to your doctor or pharmacist before using DORICOFLU.
If you are already being treated with corticosteroid medicines taken by mouth or by injection, which act systemically (systemic treatment), your doctor will prescribe DORICOFLU cautiously and monitor you closely if there is suspicion of reduced adrenal function (adrenal dysfunction). Initially, you must continue using this medicine alongside systemic corticosteroid therapy; subsequently, your doctor will gradually adjust the doses of both medicines through periodic check-ups.
If, during this transition period, you experience stressful situations or a severe asthma attack, inform your doctor, as resuming systemic corticosteroid therapy may become necessary. During treatment, your doctor must perform regular tests to monitor adrenal function (adrenocortical function), including specific blood tests measuring levels of a hormone (cortisol), carried out early in the morning under resting conditions.
Inform your doctor if you have nasal congestion or excessive nasal discharge, as it may be helpful to take medicines that reduce mucus buildup (topical vasoconstrictors).
Contact your doctor if you experience blurred vision or other visual disturbances.
Furthermore, if any of the following conditions apply to you, inform your doctor, who will decide whether to use DORICOFLU cautiously or prescribe an alternative therapy (See also the section “Do not use DORICOFLU”):

you have a severe respiratory tract infection called tuberculosis;
you have developed infections caused by fungi, bacteria, or viruses and are not taking any medication to treat them;
you have an eye infection caused by a virus known as herpes simplex;
you have previously had nasal trauma or injury (nasal septum ulceration) or frequently experience nosebleeds (epistaxis), as this medicine may delay wound healing (inhibitory effect on healing processes).

Do not use DORICOFLU to treat acute asthma attacks, as the effect of this medicine is not immediate. Use this medicine regularly for several days as prescribed by your doctor.
During treatment with DORICOFLU, especially over long periods and at high doses, the following adverse effects may occur (See section “Possible side effects”):

disorders due to excess corticosteroids in the blood (Cushing's syndrome);
fat accumulation in the face and abdomen (Cushingoid appearance);
reduced activity of certain glands called the adrenal glands (adrenal suppression, suppression of adrenal function);
growth retardation in children and adolescents;
bone fragility (reduced bone mineral density);
eye problems (cataract, glaucoma);
restlessness accompanied by excessive and involuntary body movements (psychomotor hyperactivity);
sleep disturbances;
anxiety;
depression or aggression, especially in children;
allergic reactions (sensitization phenomena). In such cases, inform your doctor, who will determine the most appropriate treatment for you;
mucosal changes (mucosal atrophy);
rarely, disruption of the normal microbial flora in the upper airways (dysmicrobism). For this reason, your doctor will carry out specific checks, especially if you are using this medicine for prolonged periods, and will prescribe appropriate therapy based on the results.

To minimize the risk of adverse effects, your doctor will prescribe the lowest dose capable of controlling your symptoms. Do not exceed the recommended doses.
DORICOFLU, like other corticosteroids, may mask symptoms of infections, and new infections may develop during treatment with this medicine.
For individuals engaged in sports, using this medicine without genuine therapeutic need constitutes doping and may lead to a positive anti-doping test.
Children
The use of this medicine is not recommended in children under 4 years of age.
Other medicines and DORICOFLU
Inform your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription.
Some medicines may increase the effects of Doricoflu, 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, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Do not use DORICOFLU during the first 3 months of pregnancy.
If you are more than 3 months pregnant or are breastfeeding, use this medicine only if strictly necessary and under strict medical supervision (See section “Do not use DORICOFLU”).
Driving and operating machinery
No effects of this medicine on the ability to drive vehicles or operate machinery are known.

3. How to use DORICOFLU

Use this medicine exactly as directed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
DORICOFLU must be used with electric nebulizers and must not be diluted. Since some
medicinal solution may adhere to the walls of the ampoule or to the bottom of the nebulizer, it may be
necessary to add extra volume during preparation.
Adults
The recommended dose is 1 mg (25 drops), twice daily.
Use in children
In children over 4 years of age, the recommended dose is 500 micrograms (12–13
drops), twice daily.
If you use more DORICOFLU than you should
If you take an excessive dose of this medicine within a short period of time, disturbances in normal adrenal gland function may occur (suppression of hypothalamic-pituitary-adrenal function). In such a case, the dose of the medicine should be reduced.
In case of accidental ingestion/overdose of DORICOFLU, contact your doctor immediately or go to the nearest hospital.
If you forget to use DORICOFLU
Do not use a double dose to make up for a forgotten dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur:
Frequency not known (frequency cannot be estimated from the available data):

restless behaviour, accompanied by excessive and involuntary body movements (psychomotor hyperactivity);
sleep disorders;
anxiety (anxiety);
depression, aggression and other behavioural disorders, especially in children;
cough and voice changes (hoarseness) in particularly sensitive individuals;
burning sensation of the nasal mucosa;
fungal infections of the mouth and throat. These effects can be reduced by rinsing the mouth after each administration;
irritation of the nose, mouth and throat, nosebleeds (epistaxis), nasal congestion, runny nose (rhinorrhoea), sore throat. In more severe cases, these symptoms may require discontinuation of treatment;
mucus accumulation in the nose (nasal congestion) and development of nodules inside the nasal cavities (nasal polyps), in individuals undergoing systemic corticosteroid therapy (corticosteroid-dependent patients);
bone fragility (osteoporosis), stomach and intestinal damage (peptic ulcer), problems with adrenal gland function (secondary adrenal insufficiency, acute hypoadrenalism), with symptoms such as reduced blood pressure (hypotension) and weight loss, in individuals using this medicine for prolonged periods. In such cases, your doctor should monitor you closely to prevent these effects from occurring;
blurred vision.

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
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 DORICOFLU

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Expiry".
The expiry date refers to the last day of that month.
Store the medicine at a temperature not exceeding 25°C, protected from light.
Use within 30 days of first opening the bottle. Discard any unused medicine remaining.
Do not dispose of any medicine 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

What DORICOFLU 1 mg/ml nebuliser solution contains

The active substance is flunisolide. 100 ml of solution contain 100 mg of flunisolide.
The other components are: propylene glycol, sodium chloride, purified water.
This medicinal product contains 7.4 mg of propylene glycol in 25 drops, equivalent to 7.4 mg/1 ml of solution.
This medicinal product contains less than 1 mmol of sodium in 25 drops, i.e. it is essentially "sodium-free".

Description of the appearance of DORICOFLU and package contents
30 ml bottle with dropper.
Marketing Authorization Holder
Sanitas Farmaceutici S.r.l. – Via Guala, 4 – Tortona (AL) - Italy
Manufacturers
FARMILA-THEA Farmaceutici S.p.A. – Via E. Fermi, 50 – Settimo Milanese (MI) - Italy
LACHIFARMA Laboratorio Chimico Farmaceutico Srl – S.S.16 Zona Industriale – Zollino (LE) - Italy