Assolid

Package leaflet: Information for the user

Assolid 1 mg/ml nebuliser solution

Flunisolide
Generic medicine
Please read all of this leaflet carefully before you start taking 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 you, because 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:

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

1. What ASSOLID is and what it is used for

ASSOLID contains the active substance flunisolide, which belongs to a group of medicines called glucocorticoids.
ASSOLID is indicated for the treatment of allergic respiratory diseases such as bronchial asthma, chronic asthmatic bronchitis, and chronic and seasonal rhinitis.

2. What you need to know before taking ASSOLID

Do not take ASSOLID

• if you are allergic to flunisolide or to any of the other ingredients of this medicine (listed in section 6)
• if you have active or quiescent (latent) pulmonary tuberculosis
• if you have an infection (caused by bacteria, viruses, or fungi)
• if you are in the last 6 months of pregnancy or are breastfeeding, unless after careful evaluation by your doctor (see section “Pregnancy and breastfeeding”). The medicine is not recommended during the first three months of pregnancy.

Warnings and precautions
Talk to your doctor or pharmacist before taking ASSOLID.
The use of this medicine, especially if prolonged, may cause allergic reactions and, rarely, systemic side effects typical of corticosteroids. In such cases, you must stop treatment and start appropriate therapy.
Rarely, the use of this medicine may cause a range of psychological and behavioral effects including psychomotor hyperactivity (increased movement, restlessness), sleep disturbances, anxiety, depression, aggression, and behavioral disorders (mainly in children).
This medicine may mask symptoms of infections and may lead to new infections.
Exercise particular caution:

• if you are switching from systemic corticosteroid therapy to treatment with flunisolide, especially if you are under stress or have recently experienced a severe asthma attack, as this medicine may cause adrenal dysfunction (impaired ability of the adrenal glands to produce sufficient amounts of a hormone called cortisol). In such cases, abrupt discontinuation of systemic therapy must be avoided. The switch from systemic corticosteroid therapy to local therapy should be performed under close medical supervision. Your doctor will advise you on the dose and method of administration for transitioning between therapies. Furthermore, you should be monitored for adrenal function, and morning cortisol levels (the hormone produced by the adrenal glands) should be measured under resting conditions.
• The effect of ASSOLID, like all inhaled corticosteroids, is not immediate. Therefore, bear in mind that ASSOLID is not effective during acute asthma attacks and that regular use over several days is required.
• if you have a lung infection (active or quiescent tuberculosis), untreated fungal, bacterial, or viral infections, or an eye infection caused by the herpes simplex virus. Flunisolide, like all corticosteroids, should be used with caution or avoided in such cases.
• if you have had or currently have nasal trauma, septal lesions, or recurrent nosebleeds (epistaxis), as this medicine may delay wound healing (cicatrization processes).
• if during treatment you develop an alteration in the bacterial flora (dysbiosis) of the respiratory tract. Consult your doctor, as concomitant therapy may be necessary.

Be cautious, as prolonged use of high doses of this medicine may lead to adrenal suppression, mucosal atrophy, and other systemic effects (see section 4 “Possible side effects”).
Be vigilant in case of trauma, surgery, infections, or rapid dose reduction, as these conditions may trigger an adrenal crisis.
It is important to use the lowest effective dose of inhaled corticosteroids necessary to control asthma and to be monitored regularly by your doctor.
If you are taking high doses, you should remain under medical supervision, and your dose should be gradually reduced.
Contact your doctor if you experience blurred vision or other visual disturbances.
Children and adolescents
This medicine is not recommended for children under four years of age.
Other medicines and ASSOLID
Inform your doctor 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 ASSOLID, 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.
The use of ASSOLID is not recommended during the first three months of pregnancy. During later stages of pregnancy and while breastfeeding, ASSOLID should only be used if clearly necessary and under direct medical supervision.
Driving and use of machines
The effects of this medicine on the ability to drive vehicles or operate machinery are unknown.
This medicine contains 21 mg/kg of propylene glycol per daily dose.

3. How to take ASSOLID

Take this medicine exactly as your doctor or pharmacist has told you.
If you have any doubts, consult your doctor or pharmacist.
Adults
The recommended dose is 1 mg (19 drops) twice daily.
Use in children
The recommended dose is 500 micrograms (9–10 drops) twice daily.
ASSOLID is not recommended for children under four years of age.
Method of administration:
Use ASSOLID with electric nebulizers and do not dilute it. The use of nebulizers may result in
residual medicine remaining in the ampoule, adhering to the walls or settling at the bottom, and thus
not being fully delivered. Please take this into account when preparing the medicine.
If you take more ASSOLID than you should
Do not exceed the recommended doses, as excessive administration of this medicine within a short period of time may cause hormonal disturbances (suppression of hypothalamic-pituitary-adrenal function).

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
In particular:

• cough, lowering and alteration of voice (hoarseness), mild and temporary burning of the nasal mucosa;
• fungal infections of the mouth or throat, which resolve rapidly with appropriate local therapy. These infections can be prevented or reduced if the mouth is thoroughly rinsed after administration of this medicine;
• nasal irritation, nosebleeds (epistaxis), nasal congestion, runny nose (rhinorrhoea), sore throat, irritation of the mouth and throat. If these effects are severe, stop treatment;
• nasal congestion, development of benign nasal growths (nasal polyps).

In the case of prolonged treatment with high doses, the following effects may occur: bone problems (osteoporosis), stomach and intestinal disorders (peptic ulcer), symptoms due to adrenal insufficiency (such as low blood pressure, weight loss, loss of appetite, abdominal pain, fatigue, headache, nausea, vomiting, hypoglycaemia with reduced level of consciousness and/or seizures), Cushing's syndrome, Cushingoid appearance (rounded "moon" face, obesity, red striae on the abdominal skin, swelling), growth retardation in children and adolescents, reduced bone mineral density (osteoporosis), cataract (clouding of the lens, a structure located in the front part of the eye), glaucoma (increased pressure inside the eye).
Additionally, side effects that may occur with unknown frequency are:

• psychomotor hyperactivity, sleep disorders, anxiety, depression, aggression, behavioural disturbances (mainly in children). Another side effect that may occur with unknown frequency is 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
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store ASSOLID

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label after "Exp". The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from light.
The opened package must be used within thirty days. Any remaining product should be discarded.
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 ASSOLID contains

• The active substance is flunisolide. 100 ml of solution contain 100 mg of flunisolide. One drop contains 52 micrograms of flunisolide.
• The other components are: Propylene glycol, Sodium chloride, Purified water

Description of the appearance of ASSOLID and contents of the pack
Solution for nebulization. 30 ml vial of solution at a concentration of 1 mg/ml.
Marketing Authorization Holder
Konpharma s.r.l., via Pietro Della Valle 1, 00193 Rome, Italy
Manufacturer
GENETIC S.p.A.
Contrada Canfora – 84084 Fisciano (SA)
Italy
Lachifarma S.r.l. – Laboratorio Chimico Farmaceutico Salentino
S.S. 16 Adriatica - Zona Industriale
73010 Zollino (LE)