OVISON 1 mg /G Topical Solution

Зміст інструкції

1. OVISON 1 MG/G CUTANEOUS SOLUTION
   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

OVISON 1 MG/G CUTANEOUS SOLUTION

mometasone furoate
Equivalent medicinal product (only for 30 ml bottle)

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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you use 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 ingredient mometasone furoate and is a corticosteroid for topical use. Topical corticosteroids are divided into four categories, based on dosage and efficacy: mildly potent, moderately potent, potent and very potent. Mometasone furoate belongs to the category of “potent” corticosteroids.

Adults and children over 6 years of age:
OVISON has an anti-inflammatory effect and reduces itching. OVISON is used to reduce symptoms related to inflammatory skin conditions 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 condition you have, but it relieves the 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, in particular for rosacea (a skin disease of the face), acne, rashes (dermatitis) around the lips, skin atrophy, itching in the genital area and around the anus, 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 (scaling and redness of the skin of the feet, associated with itching) or Candidainfection in the genital area, with possible presence of secretions or itching, or for other skin diseases.
• if you have recently experienced adverse events after a vaccination (e.g. after the administration of an influenza vaccine).
• on wounds or on ulcerated skin.

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

• Inform your doctor if you are pregnant, even if suspected, or if you are breastfeeding.
• Immediately inform your doctor if you develop irritation or hypersensitivity during the use of OVISON.
• As with all potent topical corticosteroids, treatment should not be discontinued abruptly. If a prolonged treatment is interrupted, a relapse may occur in the form of a skin infection with severe redness, stinging pain and intense burning. This condition can be prevented by reducing the treatment gradually, e.g. by applying the solution less frequently before stopping therapy.
• Treatment of psoriasis with this medicine may worsen skin problems (e.g. a pustular form of this disease may develop, characterized by the appearance of many small ulcers on the skin). The doctor will have to monitor the course of your disease periodically, as this type of treatment requires careful monitoring.
• OVISON should 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
Tell 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, suspect you are pregnant, are planning a pregnancy, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Treatment with OVISON during pregnancy or breastfeeding may only be started after receiving
instructions from your doctor.
If your doctor prescribes the use of this solution during pregnancy or breastfeeding, you should avoid
applying it in large quantities and should only use it for a short period. OVISON should not be
applied to the breast or the 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. OVISON can only be used on the skin.
Use this medicine following the instructions of your doctor or pharmacist exactly. If you have any doubts
consult your doctor or pharmacist.
Your doctor will need to monitor the treatment periodically.
Do not apply the solution to the face unless your doctor has prescribed it.
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 you have received
these instructions from your doctor.

Administration:
Carefully apply a thin layer of solution once a day to the affected skin areas. The amount
of solution to be used must be minimal. The bottle is equipped with a dropper that facilitates the application
of the solution. Never use a larger amount and do not apply this medicine more often than
recommended by your doctor or pharmacist.

Adults, including the elderly:
Do not apply the solution to extensive areas (more than 20% of the skin surface) or for a prolonged
period of time.

Use in children (from 6 years of age onwards):

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

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
If you accidentally ingest the solution, this should not cause any adverse effects.
If you have not followed your doctor's instructions and have used the solution too often and/or for a prolonged
period of time, ask your doctor or pharmacist for advice.

If you forget to use OVISON
If you forget to apply the solution when you should, do so as soon as you remember and then continue as
before. Do not use a double dose and do not apply the solution twice in one day to compensate for the
omission of treatment.

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. The treatment must be reduced gradually, following your doctor's instructions.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The side effects reported during the use of corticosteroids for topical use in children and adults
include:

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

• Inflammation of hair follicles
• Itching
• Increased superficial blood vessels or appearance of capillaries
• Burning sensation Not known (frequency cannot be estimated from available data)
• Pain or other reactions at the site of application
• Secondary infections (infections that occur during or after treatment of another infection or disease)
• Facial ulcers
• Paresthesia (abnormal sensations or numbness of the skin)
• Blurred vision
• Changes in skin color
• Skin maceration (skin becomes lighter in color and soft in texture)
• Miliaria (heat rash), (skin redness caused by heat, itchy rash)
• Inflammations (including the appearance of skin reactions similar to acne)
• Thinning of the skin
• Appearance of streaks or irregular spots on the skin
• Excessive hair growth
• Increased skin sensitivity
• Dry skin

More frequent use, treatment of larger skin areas, prolonged use, and treatment with an
occlusive dressing may increase the risk of side effects.
Corticosteroids can affect the normal production of hormones by the body. This is
more likely to occur in the case of high doses administered for a prolonged period of
time.

Additional side effects in children
In particular, in children treated with solutions, creams and ointments based on corticosteroids, the product may
be absorbed by the skin and this can cause a disease known as Cushing's syndrome. This
syndrome is characterized by many symptoms, including weakness and rounding of the facial features.
Prolonged use can inhibit growth in children. The doctor will prevent this risk by prescribing the lowest possible dose of corticosteroids, in order to obtain controlled symptom treatment.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your
doctor, pharmacist or nurse. You can also report side effects directly through 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 which is stated on the bottle and the carton after Exp. The
expiry date refers to the last day of that month.
Do not store at a temperature above 30°C.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What OVISON contains

• The active ingredient is mometasone furoate. Each gram of OVISON cutaneous solution contains 1 mg of mometasone furoate.
• The other ingredients are propylene glycol, isopropyl alcohol, hydroxypropylcellulose, disodium hydrogen 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 contents of the pack
OVISON 1 mg/g cutaneous solution is a low viscosity solution, from colorless 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 Member States of the European Economic Area under the following
names: