Kesol

Patient Information Leaflet: Important Information for the User

KESOL 50 micrograms Nasal Spray, suspension, 100 micrograms Nasal Spray, suspension

Budesonide
Generic Medicine
Please read this leaflet carefully before using this medicine, as 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 others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What KESOL is and what it is used for
2. What you need to know before using KESOL
3. How to use KESOL
4. Possible side effects
5. How to store KESOL
6. Package contents and other information

1. What KESOL is and what it is used for

KESOL contains the active substance budesonide, which belongs to a group of medicines called corticosteroids that are used to reduce inflammation of the nasal mucosa.
This medicine is indicated in adults and children aged 6 years and older for the treatment:

• of inflammation of the nasal mucosa, including that caused by allergies (seasonal allergic rhinitis, perennial allergic and non-allergic rhinitis);
• of a nasal cavity disease that makes breathing difficult (nasal polyposis);
• for the prevention of recurrence of nasal polyposis after surgery on the nasal cavities (polypectomy).

2. What you need to know before using KESOL

Do not use KESOL

• if you are allergic to budesonide or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before using KESOL.
In particular, inform your doctor if:

• you have nasal infections caused by fungi or viruses;
• you have systemic infections caused by fungi, bacteria, or viruses;
• you have an eye infection caused by the herpes virus (Herpes Simplex);
• you suffer from a contagious disease called tuberculosis. In this case, your doctor will evaluate the benefits of treatment against possible side effects;
• you are taking oral (systemic) corticosteroids. In this case, switching to KESOL should be done under careful supervision to avoid problems affecting the nervous and hormonal systems (hypothalamic-pituitary-adrenal axis imbalance).

During treatment with this medicine, especially at high doses and for prolonged periods, the following effects may occur:

• symptoms typical of Cushing's syndrome, such as excessive hair growth (hirsutism), hair loss, irregular menstrual cycles in women, loss of muscle tone, irritability, fatigue, and difficulty concentrating, or Cushingoide features such as sudden weight gain, especially around the abdomen (truncal obesity), facial rounding and redness, and development of a mild hump;
• reduced activity of the adrenal gland (adrenal suppression);
• reduced mineral content in bones (reduced bone mineral density);
• eye problems (such as increased intraocular pressure, cataract, or glaucoma); behavioral and psychological disturbances such as psychomotor agitation, anxiety, depression, aggression (particularly in children), or sleep disturbances. After treatment with this medicine, allergic reactions (immediate hypersensitivity reactions or contact dermatitis) may rarely occur. Contact your doctor if you experience blurred vision or other visual disturbances.

The use of this medicine is not recommended if you have recently had lesions (ulcers) in the nasal septum or have undergone nasal surgery or trauma, as using the medicine might delay healing of scars (on the skin).
Stop treatment with KESOL if you notice local irritation after using the medicine.

Children
This medicine must not be used in children under 6 years of age.
Your doctor will evaluate the benefits of using KESOL or similar medicines (intranasal corticosteroids) in children over 6 years of age and the possible risks of growth suppression. During treatment with this medicine, your doctor will regularly monitor growth in height, as growth retardation has been reported in children.

Other medicines and KESOL
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.
Concomitant use of cimetidine (a medicine used to treat stomach problems such as gastric ulcers and reflux) with KESOL may alter its absorption.
Some medicines may increase the effects of KESOL, and your doctor may decide to monitor you closely if you are taking these medicines (including some HIV treatments: ritonavir, cobicistat).

Laboratory tests and KESOL
Inform your doctor if you or your child need blood tests to assess the function of certain glands (ACTH stimulation test), as the test may yield false results during corticosteroid use.

Pregnancy, breastfeeding, and fertility
If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before using this medicine.
Pregnancy
The use of KESOL during pregnancy is not recommended, particularly during the first three months of pregnancy.
Breastfeeding
It is preferable not to use KESOL during breastfeeding.

Driving and using machines
This medicine does not impair the ability to drive vehicles or operate machinery.

3. How to use KESOL

Use this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The dose and duration of treatment will be determined by your doctor according to your health condition.

Treatment of nasal mucosa inflammation (rhinitis) in adults and children over 6 years of age:
The recommended dose is 2 sprays of 50 micrograms into each nostril (100 micrograms/nostril), twice daily (morning and evening), or 2 sprays of 100 micrograms into each nostril (200 micrograms/nostril) once daily in the morning.

During treatment of inflammation of the nasal mucosa due to allergies (seasonal allergic rhinitis), it may be helpful to know that:

• treatment with KESOL should begin before exposure to substances causing the allergy (allergens).
• your doctor may prescribe an antiallergic medicine (antihistamine) to control eye symptoms related to the allergy.
• if you have difficulty breathing through the nose (nasal passage blockage), your doctor may prescribe a nasal decongestant to clear the nasal passages during the first two or three days of treatment with KESOL.

Treatment or prevention of nasal polyposis: The recommended dose is 1 spray of 100 micrograms into each nostril, twice daily.

Instructions for use
Before each use:

• Shake the bottle well;
• Remove the protective cap from the nasal applicator with a gentle twisting motion;
• Prime the metering valve by holding the bottle upright and away from your face, then press firmly with your fingers until a fine mist is produced (Figure 1).

Figure 1
After this step, the valve remains primed unless you disassemble the bottle or use it very infrequently.

• Gently blow your nose to clear the nostrils.
• Tilt your head slightly forward, close one nostril with a finger, and gently insert the nasal applicator into the other nostril.
• Press firmly on the bottom of the bottle to release one spray (Figure 2).
• Remove the bottle from your nose and keep your head tilted back briefly to allow the medicine to spread inside the nasal cavity.
• Repeat the procedure in the other nostril.
• Replace the protective cap.

Figure 2
If the applicator becomes blocked, remove it and wash it in lukewarm water for several minutes. Do not use any sharp object to try to clear the blockage.

If you use more KESOL than you should
Using excessive amounts of KESOL does not usually cause serious health problems.
In case of accidental ingestion/overdose, contact your doctor or go immediately to the nearest hospital.

If you forget to use KESOL
Do not use a double dose to make up for the missed 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 will experience them.
The side effects that may occur are listed below:
Common (may affect up to 1 in 10 people)

• nosebleeds

Uncommon (may affect up to 1 in 100 people)

• allergic reactions, including delayed reactions (immediate and delayed hypersensitivity) affecting the skin (itching, urticaria, rash, dermatitis, angioedema);
• sudden, involuntary muscle contraction (muscle spasm).

Rare (may affect up to 1 in 1,000 people)

• symptoms of systemic corticosteroid effects, including reduced activity of the adrenal gland (adrenal suppression) and growth retardation;
• injury (ulceration) to the nasal mucosa, nasal septum perforation;
• allergic reactions, even severe ones (anaphylactic reactions);
• voice changes (dysphonia);
• bruising;
• blurred vision.

Frequency not known (cannot be estimated from the available data)

• eye problems (cataract, glaucoma).

In rare cases, signs or symptoms of systemic side effects due to glucocorticosteroids may occur with intranasal glucocorticoids, likely depending on dose, duration of exposure, concomitant or previous exposure to corticosteroids, and individual sensitivity.
Additional side effects in children and adolescents
The use of KESOL at high doses and/or for prolonged periods may lead to widespread (systemic) side effects such as growth retardation in children and adolescents.
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 KESOL

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after "Exp". The expiry date refers to the last day of that month.
Keep the container tightly closed. Store in the original packaging.
Do not store above 25°C.
Each vial should be used within 3 months of first opening.
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 KESOL 50 micrograms Nasal Spray, suspension contains

• The active substance is budesonide. 10 ml of suspension contain 10 mg of budesonide.
• The other ingredients are anhydrous glucose, microcrystalline cellulose, sodium carboxymethylcellulose (Avicel RC-591), potassium sorbate, polysorbate 80, disodium edetate, hydrochloric acid, purified water.

What KESOL 100 micrograms Nasal Spray, suspension contains

• The active substance is budesonide. 10 ml of suspension contain 20 mg of budesonide.
• The other ingredients are anhydrous glucose, microcrystalline cellulose, sodium carboxymethylcellulose (Avicel RC-591), potassium sorbate, polysorbate 80, disodium edetate, hydrochloric acid, purified water.

Description of the appearance of KESOL and contents of the pack
Amber glass bottle equipped with a metering valve.
Marketing Authorization Holder
Genetic S.p.A.
Via G. Della Monica, 26
84083 Castel San Giorgio (SA)
Manufacturer
Genetic S.p.A. Contrada Canfora 84084 Fisciano (SA)