Ovison

Package leaflet: Information for the user

OVISON 1 MG/G CUTANEOUS SOLUTION

mometasone furoate
Equivalent medicine (only for the 30 ml bottle)
Please read all of this leaflet carefully before you start 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 may be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

1. What OVISON is and what it is used for

OVISON contains the active substance mometasone furoate and is a corticosteroid for topical use.
Topical corticosteroids are classified into four categories based on potency and efficacy: low potency, moderate potency, high potency, and very high potency. Mometasone furoate belongs to the category of "high potency" corticosteroids.
Adults and children above 6 years of age:
OVISON has an anti-inflammatory effect and reduces itching. OVISON is used to relieve symptoms associated with inflammatory skin diseases that can be treated with a corticosteroid, for example psoriasis (excluding widespread plaque psoriasis) and other types of dermatitis. This medicine does not cure the skin disease you suffer from, but it helps to relieve its symptoms.

2. What you need to know before using OVISON

Do not use OVISON

• if you are allergic to mometasone furoate, to other corticosteroids, or to any of the other ingredients of this medicine (listed in section 6).
• for other skin diseases that may worsen, particularly rosacea (a skin condition affecting the face), acne, perioral dermatitis (skin rash around the lips), skin atrophy, genital or perianal itching, diaper rash, bacterial infections such as impetigo, tuberculosis (a lung disease), syphilis (a sexually transmitted disease), viral infections such as mouth ulcers, shingles, chickenpox, athlete’s foot (skin scaling and redness of the feet, associated with itching), or Candida infection in the genital area, possibly accompanied by discharge or itching, or for other skin conditions.
• if you have recently experienced adverse reactions following vaccination (e.g. after receiving an influenza vaccine).
• on wounds or ulcerated skin.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using OVISON.

• Inform your doctor if you are pregnant, suspect you may be pregnant, or are breastfeeding.
• Inform your doctor immediately if you develop irritation or hypersensitivity during treatment with OVISON.
• As with all potent topical corticosteroids, treatment should not be stopped abruptly. If prolonged treatment is discontinued suddenly, a relapse may occur in the form of a skin infection with intense redness, stinging pain, and burning. This condition can be prevented by gradually reducing treatment, for example by applying the solution less frequently before stopping therapy completely.
• Treatment of psoriasis with this medicine may cause a worsening of skin problems (e.g. a pustular form of the disease may develop, characterized by the appearance of numerous small ulcers on the skin). Your doctor should monitor the progression of your condition periodically, as this type of treatment requires careful supervision.
• OVISON must not be applied to damaged skin.
• Do not apply this solution to the eyelids. Be careful and avoid contact of the solution with the eyes.
• Contact your doctor if you experience blurred vision or other visual disturbances.

Other medicines and OVISON
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Treatment with OVISON during pregnancy or breastfeeding should only begin after receiving specific instructions from your doctor.
If your doctor prescribes the use of this solution during pregnancy or breastfeeding, you should avoid applying it in large amounts and should use it only for a short period. OVISON must not be applied to the breasts or to nearby skin areas during breastfeeding.
OVISON contains propylene glycol
OVISON contains propylene glycol, which may cause skin irritation.

3. How to use OVISON

OVISON is intended for cutaneous (external) use only. OVISON may only be used on the skin.
Always use this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult
your doctor or pharmacist.
Your doctor should monitor the treatment periodically.
Do not apply the solution to the face unless specifically instructed by your doctor.
Avoid contact of the solution with the eyes.
To reduce the risk of adverse events, do not cover the treated area with gauze or bandages unless specifically
instructed by your doctor.
Administration:
Carefully apply a thin layer of the solution once daily to the affected skin areas. Use the smallest amount
necessary. The bottle is equipped with a dropper to facilitate application of the solution. Never use a larger
amount or apply this medicine more frequently than recommended by your doctor or pharmacist.
Adults, including elderly patients:
Do not apply the solution over extensive areas (more than 20% of body surface area) or for prolonged periods.
Use in children (from 6 years of age onwards):

• Do not apply the solution to children over 6 years of age without medical prescription.
• Do not apply the solution to more than 10% of the child’s body surface area.

Children under 6 years of age
The use of OVISON in children under 6 years of age is not recommended.
If you use more OVISON than you should
Accidental ingestion of the solution is unlikely to cause adverse effects.
If you have not followed your doctor's instructions and have used the solution too frequently and/or for a prolonged
period, consult your doctor or pharmacist for advice.
If you forget to use OVISON
If you forget to apply the solution at the scheduled time, do so as soon as you remember, then continue as before.
Do not use a double amount and do not apply the solution twice in one day to make up for a missed application.
If you stop using OVISON
If you have been using the solution for a long time, do not stop treatment abruptly, as this may be dangerous.
Treatment should be gradually tapered off according to your doctor's instructions.
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.

Side effects reported during the use of topical corticosteroids in children and adults include:

Very rare (may affect up to 1 in 10,000 people):

• Inflammation of hair follicles
• Itching
• Increased visibility of superficial blood vessels or appearance of capillaries
• Burning sensation

Not known (frequency cannot be estimated from the available data):

• Pain or other reactions at the application site
• Secondary infections (infections that occur during or after treatment of another infection or illness)
• Facial ulcers
• Paresthesia (abnormal sensations or numbness of the skin)
• Blurred vision
• Changes in skin colour
• Maceration of the skin (skin becomes lighter in colour and soft or soggy)
• Heat rash (miliaria) (skin redness due to heat, itchy eruptions)
• Inflammations (including development of acne-like skin reactions)
• Thinning of the skin
• Appearance of irregular streaks or patches on the skin
• Excessive hair growth
• Increased skin sensitivity
• Dry skin

More frequent use, treatment of larger skin areas, prolonged use, and treatment under occlusive dressing may increase the risk of side effects.

Corticosteroids may affect the body's normal hormone production. This is more likely to occur with high doses administered over a prolonged period of time.

Additional side effects in children

In particular, in children treated with corticosteroid solutions, creams, and ointments, the product may be absorbed through the skin, potentially causing a condition known as Cushing's syndrome. This syndrome is characterized by several symptoms, including weakness and a rounding of the facial features. Prolonged use may suppress growth in children. To minimize this risk, the doctor will prescribe the lowest possible dose of corticosteroids needed to control symptoms effectively.

Reporting of side effects

If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system at 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 OVISON

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the vial and carton following Exp. The expiry date refers to the last day of that month.
Do not store above 30°C.
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

What OVISON contains

• The active substance is mometasone furoate. Each gram of OVISON topical solution contains 1 mg of mometasone furoate.
• The other ingredients are propylene glycol, isopropyl alcohol, hydroxypropyl cellulose, sodium dihydrogen phosphate dihydrate, concentrated phosphoric acid (for pH adjustment) and purified water.

See section 2 "OVISON contains propylene glycol".
Description of the appearance of OVISON and package contents
OVISON 1 mg/g topical solution is a low-viscosity solution, colourless to pale yellow, contained in white polyethylene bottles with a dropper and a white polyethylene screw cap.
Pack sizes: 30 ml, 100 ml and 2x100 ml.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
ABIOGEN PHARMA S.p.A.
Via Meucci, 36
Ospedaletto - PISA
Italy
Manufacturer
Laboratorio Reig Jofré S.A.
Gran Capitán 10
Sant Joan Despí
08970 Barcelona
Spain
This medicinal product is authorised in the European Economic Area Member States under the following
names: